This report is based on research conducted by the Vanderbilt University Evidence-based 

Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality 

(AHRQ), Rockville, MD (Contract No. HHSA 290-2007-10065-I). The findings and 

conclusions in this document are those of the authors, who are responsible for its content, 

and do not necessarily represent the views of AHRQ. No statement in this report should 

be construed as an official position of AHRQ or of the U.S. Department of Health and 

Human Services. 

The information in this report is intended to help clinicians, employers, policymakers, 

and others make informed decisions about the provision of health care services. This 

report is intended as a reference and not as a substitute for clinical judgment. 

This report may be used, in whole or in part, as the basis for the development of clinical 

practice guidelines and other quality enhancement tools, or as a basis for reimbursement 

and coverage policies. AHRQ or U.S. Department of Health and Human Services 

endorsement of such derivative products may not be stated or implied. 
Evidence Report/Technology Assessment 

Number 187 

Treatment of Overactive Bladder in Women 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-2007-10065-I 

Prepared by: 

Vanderbilt Evidence-based Practice Center 

Institute for Medicine and Public Health 

Vanderbilt University Medical Center 

2525 West End Avenue 

Nashville, Tennessee 37203-1738 

Investigators

Katherine E. Hartmann, M.D., Ph.D. 

Melissa L. McPheeters, Ph.D., M.P.H. 

Daniel H. Biller, M.D. 

Renée M. Ward, M.D. 

J. Nikki McKoy, B.A. 

Rebecca N. Jerome, M.L.I.S., M.P.H. 

Sandra R. Micucci, M.Sc. 

Laura Meints, M.D., M.B.A. 

Jill A. Fisher, Ph.D. 

Theresa A. Scott, M.S. 

James C. Slaughter, Dr.P.H. 

Jeffrey D. Blume, Ph.D. 

AHRQ Publication No. 09-E017 

August 2009 

i 
This document is in the public domain and may be used and reprinted without permission 

except those copyrighted materials noted for which further reproduction is prohibited 

without the specific permission of copyright holders. 

Suggested Citation: 

Hartmann KE, McPheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci 

SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD. Treatment of Overactive 

Bladder in Women. Evidence Report/Technology Assessment No. 187 (Prepared by the 

Vanderbilt Evidence-based Practice Center under Contract No. 290-2007-10065-I). 

AHRQ Publication No. 09-E017. Rockville, MD: Agency for Healthcare Research and 

Quality. August 2009.

No investigators have any affiliations or financial involvement (e.g., employment, 

consultancies, honoraria, stock options, expert testimony, grants or patents received or 

pending, or royalties) that conflict with material presented in this report. 
iii 

Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. This report was requested by the American Urological 

Association in preparation for clinical guideline development. These reports and assessments 

provide organizations with comprehensive, science-based information on common, costly 

medical conditions and new health care technologies. The EPCs systematically review the 

relevant scientific literature on topics assigned to them by AHRQ and conduct additional 

analyses when appropriate prior to developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by e-mail to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. 

Director 

Agency for Healthcare Research and Quality 

Beth A. Collins Sharp, Ph.D. 

Acting Director, EPC Program 

Agency for Healthcare Research and Quality 

Jean Slutsky, P.A., M.S.P.H. 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Shilpa H. Amin, M.D, M.Bsc, FAAFP 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 
Acknowledgments 

We are indebted to a tireless group of colleagues who made this report possible. Each step of 

systematic reviews draws on the skills and attention of an entire team. 

Dr. Shilpa Amin has been an insightful task order officer who brought special considerations and 

decisions into focus. She was patient with our many questions, created a strong link with our 

project partner, and provided practical advice as we tackled challenges. 

Ms. Rachel Bazan was our energetic student worker. She spent hours helping to track and file 

documents, always positive, and always ready to ensure that the project investigators had what 

they needed to do their work. 

Dr. Liana Castel served as a quality grader and brought to the project her expertise in study 

design and analytic methods. We thank her for her thoughtful attention to the process of quality 

grading and willingness to help. Her comments on approaches to study reporting, particularly as 

they related to the implications of loss to followup and drop out, were especially valued. 

Ms. Allison Glasser provided research assistance on this report, including combing papers for 

specific data points requested by the investigators and formatting summary and evidence tables. 

We appreciate her eagerness to learn and employ systematic review methods and her 

commitment to ensuring that tables were formatted exactly to specification. Ms. Glasser 

demonstrated great flexibility under pressure filling many needs. 

Dr. Mark Hartmann brought his extraordinary attention to detail – and his commitment to 

perfection – to completion of the evidence tables. He spent many, many hours checking and 

rechecking tables both for formatting and for content. His ability to point out inconsistencies and 

enhance uniformity was key to ensuring smooth development of the evidence tables. 

Ms. Sarah McLellan was a source of energy for all as she enthusiastically went about formatting 

evidence tables and completing and organizing appendices. We are grateful to lean on such detail 

oriented and focused research staff with a gift for encouraging others. 

Ms. Toye Spencer oversaw the completion and formatting of the summary tables, and other 

critical elements of the report as a whole. She transferred data from investigator-developed 

spreadsheets into more tables than we imagined – and made sure that formatting was consistent, 

keeping track of the innumerable sets of changes that came her way. 

Ms. Rachel Walden is a key member of the library science staff – her support of Ms. Jerome, 

including her creative insights and detailed approach to literature searching was invaluable. Her 

thoughtful attention to detail in reviewing abstracts and articles for inclusion in the review was a 

generous gift to the project and to the EPC as a whole. 

iv 
Structured Abstract 

Objectives: The Vanderbilt Evidence-based Practice Center systematically reviewed evidence 

on treatment of overactive bladder (OAB), urge urinary incontinence, and related symptoms. We 

focused on prevalence and incidence, treatment outcomes, comparisons of treatments, modifiers 

of outcomes, and costs. 

Data: We searched PubMed, MEDLINE®, EMBASE, and CINAHL. 

Review Methods: We included studies published in English from January 1966 to October 

2008. We excluded studies with fewer than 50 participants, fewer than 75 percent women, or 

lack of relevance to OAB. Of 232 included publications, 20 were good quality, 145 were fair, 

and 67 poor. We calculated weighted averages of outcome effects and conducted a mixed-effects 

meta-analysis to investigate outcomes of pharmacologic treatments across studies. 

Results: OAB affects more than 10 to 15 percent of adult women, with 5 to 10 percent 

experiencing urge urinary incontinence (UUI) monthly or more often. Six available medications 

are effective in short term studies: estimates from meta-analysis models suggest extended release 

forms (taken once a day) reduce UUI by 1.78 (95 percent confidence interval (CI): 1.61, 1.94) 

episodes per day, and voids by 2.24 (95 percent CI: 2.03, 2.46) per day. Immediate release forms 

(taken twice or more a day) reduce UUI by 1.46 (95 percent CI: 1.28, 1.64), and voids by 2.17 

(95 percent CI: 1.81, 2.54). As context, placebo reduces UUI episodes by 1.08 (95 percent CI: 

0.86, 1.30), and voids by 1.48 (95 percent CI: 1.19, 1.71) per day. No one drug was definitively 

superior to others, including comparison of newer more selective agents to older antimuscarinics. 

Current evidence is insufficient to guide choice of other therapies including sacral 

neuromodulation, instillation of oxybutynin, and injections of botulinum toxin. Acupuncture was 

the sole complementary and alternative medicine treatment, among reflexology and hypnosis, 

with early evidence of benefit. The strength of the evidence is insufficient to fully inform choice 

of these treatments. Select behavioral interventions were associated with symptom improvements 

comparable to medications. Limited evidence suggests no clear benefit from adding behavioral 

interventions at the time of initiation of pharmacologic treatment. 

Conclusions: OAB and associated symptoms are common. Treatment effects are modest. 

Quality of life and treatment satisfaction measures suggest such improvements can be important 

to women. The amount of high quality literature available is meager for helping guide women’s 

choices. Gaps include weak or absent data about long-term followup, poorly characterized and 

potentially concerning harms, information about best choices to minimize side effects, and study 

of how combinations of approaches may best be used. This is problematic since the condition is 

chronic and a single treatment modality is unlikely to fully resolve symptoms for most women. 

v 
Contents 

 

Executive Summary.................................................................................................................. 1 

Evidence Report ..................................................................................................................... 13

Chapter 1. Introduction ............................................................................................................ 15 

Importance of Overactive Bladder Treatment................................................................... 15 

Defining OAB............................................................................................................... 15 

OAB and Awareness of the General Public.................................................................. 16 

Treatment Options............................................................................................................. 17 

This Evidence Report ........................................................................................................ 17 

Scope of the Report....................................................................................................... 17 

Key Questions............................................................................................................... 17 

Analytic Framework ..................................................................................................... 18 

Organization of this Evidence Report........................................................................... 19 

Technical Expert Panel (TEP) ...................................................................................... 19 

Uses of this Report ............................................................................................................ 20 

Chapter 2. Methods...................................................................................................................21 

Literature Review Methods ............................................................................................... 21 

Inclusion and Exclusion Criteria................................................................................... 21 

 Literature Search and Retrieval Process ....................................................................... 22 

Literature Synthesis........................................................................................................... 25 

Development of Evidence Tables and Data Abstraction Process................................. 25 

Synthesis of the Evidence ............................................................................................. 25 

Quality Rating of Individual Studies ............................................................................ 27 

Strength of Available Evidence......................................................................................... 30 

External Peer Review ........................................................................................................ 31 

Chapter 3. Results .....................................................................................................................33 

KQ1. Prevalence and Incidence of Overactive Bladder.................................................... 33 

 Prevalence of Overactive Bladder ................................................................................ 33 

 Prevalence of Urge Urinary Incontinence..................................................................... 37 

 Other Measures ............................................................................................................. 38 

 Incidence of Overactive Bladder and Urge Urinary Incontinence................................ 38 

KQ2. Outcomes of Treatment of Overactive Bladder....................................................... 39 

Pharmacologic Treatments............................................................................................ 39 

Harms of Pharmacologic Treatments............................................................................ 61 

Procedural and Surgical Treatments ............................................................................. 64 

Behavioral Treatments.................................................................................................. 72 

Complementary and Alternative Medicine Treatments................................................ 78 

vi 
KQ3. Comparisons of Treatments..................................................................................... 79 

 Comparisons between pharmacologic treatments......................................................... 79 

 Comparisons between procedural and pharmaceutical treatments ............................... 82 

 Comparisons between behavioral and pharmacologic treatments................................ 82 

 Comparisons of combined behavioral and pharmacologic treatment to pharmacologic 

treatment alone ............................................................................................................ 85 

 Comparisons of combined behavioral and pharmacologic treatment to behavioral 

treatment alone.............................................................................................................. 87

KQ4: Modifiers of Treatment Outcomes .......................................................................... 88 

 Identified modifiers....................................................................................................... 88 

KQ5: Costs of Overactive Bladder Treatment .................................................................. 92 

Chapter 4. Discussion ............................................................................................................... 97 

Strength of Evidence ......................................................................................................... 97

Principal Findings and Considerations.............................................................................. 97 

KQ1: Incidence and Prevalence of Overactive Bladder ............................................... 97 

KQ2: Outcomes of Treatments for Overactive Bladder ............................................... 99 

KQ3: Comparisons of Treatments ..............................................................................102 

KQ4: Modifiers of Treatment Outcomes....................................................................103 

KQ5: Costs of Overactive Bladder Treatment............................................................104 

Future Research...............................................................................................................105 

State of the Literature..................................................................................................105 

Future Research Directions.........................................................................................107 

Conclusions .....................................................................................................................108 

References and Included Studies ............................................................................................109 

List of Acronyms/Abbreviations.............................................................................................118 

Tables 

Table 1. Executive Summary. Estimates of mean reductions in incontinent episodes 

 and voids per day ...................................................................................................... 5 

Table 1. Inclusion and Exclusion Criteria ................................................................................21 

Table 2. PubMed search strategies (last updated October 1, 2008)..........................................22 

Table 3. EMBASE search (OVID) (last updated October 1, 2008)..........................................23 

Table 4. CINAHL search (EBSCO) (last updated October 1, 2008)........................................24 

Table 5. Scoring algorithm for quality rating of individual studies.......................................... 30 

Table 6. Study characteristics of the prevalence and incidence literature ................................ 34 

Table 7. Prevalence of OAB ..................................................................................................... 36 

Table 8. RCT arms for oxybutynin chloride effect on urge incontinence ................................ 41 

Table 9. RCT arms for oxybutynin chloride effect on voids per day ....................................... 42 

Table 10. RCT arms for tolterodine tartrate effect on urge incontinence................................. 44 

Table 11. RCT arms for tolterodine tartrate effect on voids per day........................................ 46 

Table 12. RCT arms for fesoterodine fumarate effect on urge incontinence and voids ........... 50 

Table 13. RCT arms for solifenacin succinate effect on urge incontinence and voids............. 51 

vii 
viii 

Table 14. RCT arms for darifenacin effect on urge incontinence............................................. 54 

Table 15. RCT arms for darifenacin effect on voids per day.................................................... 54 

Table 16. RCT arms for trospium chloride effect on urge incontinence .................................. 56 

Table 17. RCT arms for trospium chloride effect on voids per day ......................................... 56 

Table 18. Effect on quality of life and satisfaction for pharmacologic treatment ................... 58 

Table 19. Side effects and harms of pharmacologic treatment................................................. 63 

Table 20. Outcomes of clinical trials of procedures ................................................................. 66 

Table 21. Effect on quality of life and satisfaction of procedural treatments........................... 69 

Table 22. Outcomes of behavioral treatment trials................................................................... 74 

Table 23. Effects on quality of life and satisfaction of behavioral treatments ......................... 77 

Table 24. Direct comparisons of pharmaceutical treatments on urge incontinence ................. 81 

Table 25. Direct comparisons of pharmaceutical treatments on voids per day ........................ 81 

Table 26. Direct comparisons between pharmacologic and behavioral interventions.............. 82 

Table 27. Comparisons of pharmaceuticals with and without behavioral interventions .......... 85 

Table 28. Effect on quality of life and satisfaction of combination treatment ......................... 87 

Table 29. Study definitions used for cost determination ......................................................... 93 

Table 30. Total cost differences in annual medical care among persons filling 

 prescriptions for OAB drug treatment ...................................................................... 94 

Table 31. Estimates of mean reductions in incontinent episodes and voids per day 100 

Table 32. Funding sources and conflict of interest by decade of publication 107 

Figures

Figure 1. Analytic framework for the treatment of OAB in women ........................................ 17 

Figure 2. Disposition of articles for the treatment of OAB ...................................................... 24 

Appendixes 

Appendix A: Exact Search Strings 

Appendix B: Sample Data Abstraction Forms 

Appendix C: Evidence Tables 

Appendix D: List of Excluded Studies 

Appendix E: Peer Reviewers 

Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/bladder/bladder.pdf. 
Executive Summary 

Introduction 

Importance of Overactive Bladder Treatment 

At minimum, 11 to 16 million women in the United States cope on a daily basis with 

symptoms that include sudden strong urges to urinate, difficulty delaying voids, frequent trips to 

the bathroom, and in many cases involuntary loss of urine when urgency strikes.1-4 They may 

wear pads for accidents, plan ahead for access to bathrooms, and modify their social and work 

lives to accommodate their symptoms. Some are very distressed by the symptoms whether mild 

or severe, and others find mechanisms to adapt, reporting little trouble with symptoms or 

interference with normal routines. Others report their symptoms negatively influence quality of 

life factors as varied as self-esteem, self-assessment of attractiveness, and sexual function. Many 

women believe that some amount of urinary incontinence is inevitable with aging. The majority 

of women with these symptoms do not talk with their health care providers concerning their 

bladder dysfunction, and providers may not systematically inquire. As a result, a small minority 

receive treatment. 

Popular wisdom encourages self-management of symptoms of OAB through reduction of 

fluid intake, cutting back on caffeine, modifying voiding habits, and taking note of what 

individual factors influence severity of symptoms. 

For this review, we operationally defined OAB as “idiopathic urinary urgency and frequency 

with or without associated urge urinary incontinence in adult females, not related to neurogenic 

conditions or as a result of (stress incontinence) surgery.” The report is focused on treatments 

that are prescribed or provided by a healthcare practitioner and have been formally investigated 

including: 

• Pharmacologic treatments, including prescription medications, both pills and patches 

• Surgeries and procedures, such as sacral neuromodulation and botulinum injections 

• Behavioral interventions, such as behavior modification programs and bladder training 

• Complementary and alternative medicine, such as acupuncture and reflexology 

OAB management is usually individualized to address the component symptom(s) that the 

patient finds most bothersome. Where possible, we have tried to address treatments with respect 

to the primary component symptoms of OAB: urge urinary incontinence, urgency, and 

frequency, so that the women, their health care providers, payors, policy-makers, and others have 

a detailed picture of the expected outcomes of available treatments. 

Key Questions 

In preparing this report, we have answered the following key questions: 

KQ1. What is the prevalence and incidence of overactive bladder as estimated in 

representative populations? 

KQ2. Among women with overactive bladder, what are the short and long-term 

outcomes of the following treatment approaches, or combinations of treatment 

approaches? 

1 
a. Pharmacologic treatments 

b. Procedural and surgical treatments 

c. Behavioral and physical therapy treatments 

d. Complementary and alternative medicine treatments 

KQ3. Where direct comparisons have been made between or among treatment 

modalities of interest, which modalities achieve superior outcomes with respect to 

benefits, short and long-term risks, and quality of life? 

KQ4. Are the short and long term outcomes of these treatment approaches modified by 

clinical presentation, physical exam findings, urodynamic findings, menopausal status, 

age or other factors? 

KQ5. What are the costs associated with these treatment approaches? 

Methods 

Literature search. We employed multi-term search strategies to retrieve research about 

treatment of overactive bladder in women, including exploration of three databases: PubMed, 

MEDLINE®, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature 

(CINAHL). We also hand-searched the reference lists of relevant articles to identify additional 

studies. Controlled vocabulary terms served as the foundation of our searches in each database, 

complemented by additional keyword phrases to represent the myriad ways in which overactive 

bladder is referred to in the clinical literature. We also employed indexing terms within each of 

the databases to exclude undesired publication types (e.g., reviews, case reports, CME handouts) 

and items published in languages other than English. We excluded studies that (1) were 

published in languages other than English; (2) did not report information pertinent to the key 

questions; (3) had fewer than 50 participants [at enrollment]; (4) were not original studies; and 

(5) provided data only for stress or mixed urinary incontinence.

Study selection. Two reviewers separately evaluated abstracts for inclusion or exclusion. If 

one reviewer concluded the abstract should be included for full review of the article, it was 

retained. For the full article review, two reviewers read each article and decided whether it met 

our inclusion criteria. Discordance was resolved by third-party adjudication. 

Quality assessment. The research team used a quality assessment approach that ensured 

capture of key points most relevant to this literature. Quality was assessed by two reviewers 

independently, who resolved differences through discussion, review of the publications and 

coming to consensus with the team. 

Data extraction. All team members shared the task of entering information into the evidence 

tables. After initial data extraction, another member of the team reviewed the article and checked 

all table entries for accuracy, completeness, and consistency. The two abstractors reconciled 

disagreements concerning the information reported in the evidence tables. 

Evidence synthesis. The information included in tables reflects those outcomes most 

consistently reported in the literature: urge incontinence episodes and number of voids per day. 

(Studies with weekly or other metrics that could be converted to daily metric are included.) 

When common measures were available across studies using roughly comparable assessments 

(i.e., index questions, time intervals, etc.), we compiled tables to summarize outcomes of 

treatments. Measures of quality of life, interference with daily activities, degree of distress from 

symptoms, and satisfaction with the outcomes of treatment were also common and helpful 

metrics in this literature. 

2 
For behavioral, surgical, and complementary and alternative treatments, we produced 

evidence tables, summary tables of common outcomes where possible, and provided analysis in 

text form. For pharmacologic treatment, we produced similar summary tables and conducted a 

limited meta-analysis. 

Conduct of meta-analysis. Descriptive statistics were computed and examined for 

homogeneity among studies. Studies that reported weekly rates for UUI (urinary urge 

incontinence) episodes and voids were standardized to daily rates. When only ranges of 

continuous variables were reported (instead of standard deviations), we estimated the standard 

deviations by dividing the range by four.5

 Study results were combined and summarized using 

two meta-analysis techniques, weighted averages and fixed effects regression models.6

 Minimum 

variance weighted averages of the mean daily decrease in UUI and voids per arm were computed 

using weights that were inversely proportional to their standard errors. To borrow strength across 

arms, we used fixed effect regression models with robust standard errors (to account for the 

clustering by study), and weighted the study arms inversely proportional to their standard errors 

of the mean. Each arm was treated as a fixed effect, and study was not included in the model 

except in the sense that the clustering was addressed by the robust standard errors. Fixed effects 

models were also adjusted for mean age and proportion of women in each arm. 

Literature search yield. As a result of the search, 2,559 non-duplicate articles were 

identified. Two hundred thirty-two articles were included in the review, representing one 

hundred seventy-nine distinct studies, with 75 articles pertaining to KQ1, 150 to KQ2, 34 to 

KQ3, 32 to KQ4, and 5 to KQ5. Reasons and process for exclusions are described in the full 

report. 

Conflict of interest. We used a two-step process to describe the contribution of industrysponsored research to the evidence base. The first step was to calculate the proportion of 

publications that explicitly state the source of the funding for research, and the second step was 

to calculate the proportion supported by industry among those that report funding source. These 

counts are important because several studies have shown that industry-sponsored research tends 

to produce results that are favorable to the drug manufacturer even when the research is 

conducted in academic medical centers.7-9

Results 

KQ1. Prevalence and incidence of overactive bladder 

Content of the literature. We identified 75 publications,2-4, 10-81 from 60 distinct study 

populations. Fifteen studies were conducted in United States populations; 24 in European 

populations; 13 Asian; and 8 in other countries. Thirty-eight of these studies (63 percent) 

appeared in print after the 2002 International Continence Society (ICS) revised definitions and 

37 percent of these reported specifically about incidence or prevalence of OAB. One study prior 

to the standardized definitions used fully comparable definitions and the term “overactive 

bladder”. The strength of the evidence for understanding prevalence of OAB is moderate and for 

understanding incidence is weak. 

Prevalence estimates. A total of 15 studies provided information specifically about OAB 

prevalence in adult women. These studies included a total of 64,528 women in 16 distinct 

populations. Estimates of prevalence ranged from 7.7 to 31.3 percent. Across all studies the 

3 
average prevalence of OAB was 16.1 percent. Excluding the highest and lowest estimates, an 

estimated 15.1 percent of women meet criteria for OAB, with 8.2 percent of those surveyed, 

having OAB with a component of urge incontinence. Combined estimates from the two 

populations from the United States are similar 15.1 percent with OAB and 11.0 percent with a 

component of urge incontinence. 

A larger number of studies (n=48) examined urge urinary incontinence as the primary 

prevalence estimate of interest. Twenty-eight appeared after the ICS 2002 standardization of 

definitions. Across populations, prevalence of urge incontinence ranged from 1.5 to 22.0 percent. 

Average urge incontinence prevalence was 9.7 percent in the United States, 10.6 percent in 

Europe, and 9.6 percent in Asia. 

Incidence and resolution. Ten studies provided incidence data and two reported on 

resolution of symptoms. Estimates for annual incidence of OAB ranged from 2.6 to 143 cases 

per thousand, with higher estimates in the oldest population groups. A proportion of cases, 23 

percent to 35 percent, resolve over a year’s time; however the majority of women have 

symptoms for years. No studies evaluated lifetime natural history. 

KQ2: Outcomes of Treatment for Overactive Bladder 

Pharmacologic treatment. 

Content of the literature. We identified 13 randomized controlled trials (RCTs) of 

oxybutynin for treatment of OAB. A total of 22 study arms compared oxybutynin at varied 

doses, formulations, and intervals. These studies included five placebo arms. Most participants 

were recruited from specialty populations with seven studies performed in the United States,82-88

three in Europe,89-91 and one each in Japan,92 Taiwan,93 and South Korea.94 These studies 

included a total of 2,575 women in treatment arms, and 383 women in the placebo arms. 

For tolterodine there were 19 RCTs, including 29 drug arms and 13 placebo arms. Most were 

multinational studies conducted at centers in Europe, the United States, Australia, and Asia. A 

total of 6,564 women were in the treatment arms, with 3,109 women in the placebo arms. 

Two RCTs compared fesoterodine at 4 and 8 mg to placebo for reducing symptoms of OAB 

and met criteria for inclusion in the systematic review.95, 96 These studies included a total of 

1,017 women in the treatment arms, and a total of 518 women in the placebo arms. 

Three RCTs investigated solifenacin compared to placebo for reducing symptoms of OAB.97-

99 These studies included a total of 1,541 women in the solifenacin treatment arms, and a total of 

638 women in the placebo arms. 

Four RCTs provided data on the effectiveness of darifenacin.82, 100-102 These four studies 

included at total of 690 women in the darifenacin treatment arms and a total of 304 women in the 

placebo arms. 

Five RCTs evaluated trospium for reduction of symptoms of OAB. Four trials compared 

trospium to placebo, and one compared trospium to oxybutynin. Four were conducted in the 

United States,103-106 and the fifth at multiple centers in Europe and Asia.90 These studies included 

a total of 1,309 women in the trospium treatment arms, and a total of 1,130 women in the 

placebo arms.103-106

Three studies assessed the role of oral estrogen therapy in different doses and formulations in 

the alleviation of OAB symptoms.107-109 All studies were performed in Europe and Scandinavia 

with a total of 514 women. Two were RCTs and one was a prospective cohort. After review and 

analysis of all 110 studies, of which four were good quality, 75 fair and 31 poor, including 68 

4 
RCTs, the strength of the evidence for managing OAB with pharmacologic treatment is weak to 

moderate for short term outcomes and weak for long term outcomes and harms. 

Outcomes of treatment. All pharmacologic treatments were effective at improving one or 

more OAB symptoms when compared to placebo. Reductions ranged from 0.9 to 4.6 in 

incontinence episodes per day across all drug treatments and from 0.7 to 4.2 in voids per day. 

Study by study, extended release formulations achieved modestly better effects than immediate 

release, statistical significance varied. No one drug was definitively superior to others by 

preponderance of evidence, including more recently approved drugs. As estimated by metaanalysis, extended release forms (taken once a day) reduce UUI by 1.78 (95 percent CI: 1.61, 

1.94) episodes per day, and voids by 2.24 (95 percent CI: 2.03, 2.46) per day. Immediate release 

forms (taken twice or more a day) reduce UUI episodes by 1.46 (95 percent CI: 1.28, 1.64) per 

day, and voids by 2.17 (95 percent CI: 1.81, 2.54) per day. Of note, placebo reduces UUI 

episodes by 1.08 (95 percent CI: 0.86, 1.30), and voids by 1.48 (95 percent CI: 1.19, 1.71) per 

day. Even in the context of small to moderate affect on symptoms, pharmacologic treatments 

were generally associated with increased quality of life and reductions in measures of impact or 

distress, compared to baseline and to placebo. 

Table 1 below provides estimates of treatment effects for pharmacologic treatments 

represented by more than one trial arm. Some drugs and doses of drugs are not reported because 

the publications with trial arms for that treatment did not provide sufficient information to 

estimate variance in meta-analysis models. 

Table 1. Estimates of mean reductions in incontinent episodes and voids per day 

Decrease in Incontinent Episodes 

per Day Decrease in Voids per Day Drug 

Estimate 95% CI Estimate 95% CI 

Single drug estimates 

Placebo 1.08 0.86 1.30 1.48 1.19 1.71 

Oxybutynin IR 1.49 1.18 1.80 2.18 1.75 2.61 

Oxybutynin ER * * * * * * 

Tolterodine IR 1.45 1.24 1.66 2.19 1.76 2.61 

Tolterodine ER 1.75 1.65 1.85 2.48 1.94 3.02 

Fesoterodine 2.03 1.74 2.31 1.84 1.64 2.03 

Darifenacin * * * * * * 

Solifenacin 1.46 1.32 1.59 2.19 1.94 3.02 

Trospium IR * * * * * * 

Trospium ER 2.45 2.19 2.70 2.68 2.38 2.98 

Combined comparison of extended versus immediate release formulations 

Placebo 1.08 0.86 1.30 1.48 1.19 1.71 

Extended Release 1.78 1.61 1.94 2.24 2.03 2.46 

Immediate Release 1.46 1.28 1.64 2.17 1.81 2.54 

*Estimates could not be calculated for these formulations because publications did not include adequate data on 

variance for weighting of the raw data. 

Since baseline episodes of UUI per day ranged from 1.6 to 5.3, and voids per day from 7.2 to 

13.7, these reductions (Table 1) reflect modest margins of benefit from baseline above placebo. 

Data was not consistently provided across studies to estimate the proportion of women who 

became symptom free. 

5 
Procedural and surgical treatment. 

Content of the literature. We identified 18 studies about surgical treatments and procedures 

for OAB. Eleven were of sacral neuromodulation, one of peripheral neuromodulation, and one of 

electromagnetic therapy. Three studied bladder instillation or injection of drugs; one was on 

bladder distention; and one about bladder transection. This literature included 13 case series 

studies: nine prospective110-118 and three retrospective.119-121 One study had both retrospective 

and prospective components.122 Given consideration of 18 studies, of which 11 were fair quality 

and seven poor, including five RCTs, the strength of the evidence for managing OAB with 

procedural and surgical treatment is weak for all aspects of understanding outcomes of care. 

One study was a prospective cohort that compared outcomes among participants receiving 

sacral neuromodulation to participants who had lead placement without activation of electrical 

stimulation.123 Four studies were RCTs: one looked at sacral neuromodulation versus medical 

therapy,124 one evaluated transcutaneous electromagnetic stimulation versus sham,125 and two 

evaluated instillation of a drug into the bladder versus placebo – one using oxybutynin126 and one 

using resiniferatoxin.127

Outcomes of treatment. Among the trials of procedures and surgery, one study demonstrated 

a statistically significant benefit of sacral neuromodulation over usual care for the reduction of 

episodes of incontinence per day (average reduction of 7.1 compared to 2.1 increase among 

subjects who had failed medical management).124 One trial demonstrated benefit of instillation of 

oxybutynin compared to sterile water in the reduction of voids per day (average reduction of 6.8 

compared to 2.4)126 and another reported benefits from botulinum toxin treatment which is 

compatible with the findings of a recent Cochrane Collaboration literature review and metaanalysis.128

Behavioral interventions. 

Content of the literature. We identified nine studies that included only behavioral 

approaches; no two studies compared the same set of approaches. They included assessment of 

bladder training, multicomponent behavioral training, with or without biofeedback, pelvic 

muscle exercises or training, vaginal electrical stimulation, and caffeine reduction. The literature 

base included three retrospective case series.129-131 All three were conducted in community-based 

clinical settings. 

One prospective cohort study compared three approaches to providing bladder training: selfadministered, coaching, and cognitive strategies.132 Five studies were RCTs. One compared 

bladder training to a “control” condition.133 One compared bladder training to pelvic muscle 

exercises.134 One included three arms: pelvic floor muscle training, pelvic floor muscle training 

assisted with biofeedback, and vaginal electrical stimulation.93 Another compared three different 

approaches to multicomponent behavioral training: biofeedback, verbal feedback and selfadministered.135 A last study compared bladder training to bladder training with caffeine 

reduction.136 After review and analysis of 29 studies, of which 14 were fair quality and 15 poor, 

including 17 RCTs, the strength of the evidence for managing OAB with behavioral approaches 

treatment is moderate to weak for short term outcomes and weak for long term outcomes and 

harms. 

Outcomes of treatment. No two studies could be combined to produce summary data. 

Overall, behavioral approaches can be effective in reducing episodes of incontinence and daily 

voids. Multicomponent approaches are most effective, and they perform relatively equivalently 

to pharmacologic treatment. Generally speaking, improvements were modest, with decreases in 

6 
incontinence episodes of up to 1.9 per day, and reductions in voids per day of up to about four. 

The addition of caffeine reduction reduced frequency, but made no difference in reduction of 

incontinence episodes. There is no evidence that behavioral approaches enhance the 

effectiveness of pharmacologic therapy for reducing episodes of incontinence or voiding, 

although they may improve patient satisfaction and quality of life measures. 

Complementary and alternative therapies. 

Content of the literature. We identified three studies that used complementary and alternative 

medicine therapies to treat OAB: a fair quality trial of acupuncture,137a fair quality trial of foot 

reflexology,138 and a poor quality prospective case series of hypnotherapy.139 There is weak to no 

evidence for complementary and alternative approaches to managing OAB. 

Outcomes of treatment. The small trial of acupuncture has intriguing results related to 

decreased frequency of voiding and reduced symptoms of urgency which are associated with 

changes in cystometrics related to improved bladder capacity that are logical intermediates of the 

improvement in symptoms. Women felt they were improved as measured by scales that capture 

bother and quality of life. Evidence is insufficient to support definitive choice of acupuncture but 

offers preliminary information that promises modest improvements similar to those reported in 

many pharmacologic trials. 

Reflexology is represented by a small trial with unmasking of participants that could have 

biased the results. No evidence supports choice of this modality. Likewise, hypnotherapy is not 

supported by the scant information provided by one case series with little detail, patient reported 

outcomes, or statistical assessment. Given the scope of placebo effects demonstrated in other 

well-conducted studies of OAB treatment, it is difficult to know whether to attribute any effect to 

hypnotherapy. 

Conflict of interest. Changing trends in editorial standards have resulted in more complete 

reporting of funding source and author conflict of interest over the period in which the OAB 

literature was developing. Sources of funding were not reported for the majority of publications 

that appeared in the 1980s; and no publications in that decade reported on author conflict of 

interest. In the 1990s through the end of 2008, nine (56 percent) studies of procedural treatments 

(including sacral neuromodulation and bladder instillation or injection) reported source of 

funding, and six of the nine studies (67 percent) were industry sponsored. The other three were 

institutionally funded. Among studies of medications, 89 (77 percent) reported source of funding 

and among those, 82 (92 percent) were industry sponsored. Among studies that had a behavioral 

component, 13 (68 percent) reported on funding source and four had industry support. Author 

conflict of interest was poorly reported until the current decade, with fewer than half of all 

publications providing information. Within papers that did report conflict of interest, more than 

half of the authors (272 of 407) indicated that they had a financial relationship with one or more 

companies relevant to the research.

KQ3: Comparisons of Treatments 

Comparisons between pharmacologic treatments. 

Content of the literature. Twelve RCTs included direct comparisons of pharmacologic 

approaches. Specific comparisons have been made in the literature for the following pairs of 

drugs to identify differences in reduction in urge urinary incontinence or voids per day: 

• Oxybutynin ER to Tolterodine ER84

• Oxybutynin ER to Tolterodine IR83

7 
• Oxybutynin IR to Tolterodine IR89, 91, 94

• Oxybutynin IR to Darifenacin82

• Oxybutynin IR to Trospium IR90

• Oxybutynin TDS to Tolterodine ER88

• Tolterodine ER to Tolterodine IR140, 141

• Tolterodine ER to Solifenacin99

• Tolterodine ER to Fesoterodine96

• Tolterodine IR to Solifenacin97

Outcomes of treatment. In the majority of comparisons, neither drug was reported more 

effective at reducing either incontinence episodes or voids per day with a few exceptions. Both 

oxybutynin and tolterodine in their extended release forms demonstrated superiority in reducing 

urge incontinence episodes over tolterodine immediate release.83, 140, 142 Oxybutynin extended 

release was more effective at reducing voids per day than tolterodine in immediate83 or extended 

release formulations.84

Comparisons between procedural and pharmaceutical treatments. 

Content of the literature. One RCT compared sacral neuromodulation to medical therapy. In 

this study, 98 participants were randomized to immediate sacral nerve stimulation or delayed 

sacral nerve stimulation. The delay group continued unspecified medical management for a six 

month period before having the procedure.

Outcomes of treatment. This study, which randomized after successful test stimulation, found 

a reduction in daily urge incontinence episodes from 9.7 to 2.6 in the sacral neuromodulation 

group, compared to an increase of 9.3 to 11.3 in the medical management group at 6 months 

(p<0.01) for patients with refractory OAB.124 At 18 months, 76 percent of participants receiving 

sacral neuromodulation reported that they were completely dry or had experienced a reduction in 

symptoms of 50 percent or greater. Note that the comparison is not ideal, as subjects continuing 

to receive medical therapy had already failed medical management. 

Comparisons between behavioral and pharmacologic treatments. 

Content of the literature. Seven studies (nine papers) included behavioral and pharmacologic 

arms in direct comparisons.93, 143-150 This literature included one prospective cohort study,147 and 

six RCTs.93, 143-146, 148-150 

The behavioral approaches examined included bladder training,151 146-150 multicomponent 

behavioral approaches,143-145 and electrical stimulation.93

One study reported significantly greater reductions in incontinence episodes with 

multicomponent behavioral modification compared to oxybutynin,143 but no studies found a 

difference in reductions in voids per day. In the same study that found greater reductions in 

incontinence with behavioral treatment, participants reported higher satisfaction with behavioral 

compared to pharmacologic interventions. 

Comparison of combined behavioral and pharmacologic treatment to pharmacologic 

alone. 

Content of the literature. Six studies examined the effect of adding a behavioral intervention 

to drug compared to drug alone.150-155 In all but one study, the drug was tolterodine. The 

literature included five RCTs150-152, 154, 155 and one randomized open-label trial.153

Outcomes of treatment. No added benefit for reducing incontinence episodes or voids per day 

was found by adding behavioral treatments to pharmacologic approaches for reduction in 

8 
incontinence. Two studies associated the addition of behavioral modification with reductions in 

voids per day, but two reported no difference. 

KQ4: Modifiers of Treatments 

Age. Eight publications examined the relationship of age to response to pharmacologic 

treatment.83, 102, 156-161 Tolterodine was the focus of four of these studies;156-158, 160 and one 

compared oxybutynin to tolterodine.83 The largest study of tolterodine using clinically adjusted 

doses, was from an open-label clinical cohort of 2,250 patients from 462 urology practices in 

Germany. Participants on average were taking 2 mg per day and age did not predict response.157

No studies reported lack of efficacy for reducing UUI, voids per day, or symptom distress among 

older participants. While effect was in some cases reduced, it was not the case that age predicted 

worse treatment response. Older individuals do benefit from treatment. 

Prior treatment. Eight publications investigated whether prior treatment with 

antimuscarinics predicted treatment response.85, 86, 102, 162-165 In two placebo-controlled trials of 

oxybutynin transdermal system85 and tolterodine IR,162 participants who had previously been on 

medication for OAB had comparable outcomes to those who were treatment naïve. The 

tolterodine study specifically commented on prior treatment failures, noting improvements 

among those who had failed prior treatments that were above placebo but not statistically 

significant; few participants were in this category making conclusions difficult to reach.162

Baseline severity. Two studies contrasted those with UUI at baseline to those without. In an 

open-label study of 3,824 participants with nine months of treatment, urgency, frequency, 

nocturia, and OAB scales were similarly improved regardless of UUI baseline status.166 In the 

other, open-label, study of solifenacin, with the exception of nocturia, the point estimates for 

improvement in individual OAB indicators were better in the group with UUI at baseline though 

not in each instance statistically significantly better than among those without UUI.167 

Severity of UUI, grouped as severe for those with 21 or more episodes per week, did not 

prevent tolterodine from having an effect above placebo, and both severe and non-severe groups 

had a high percentage reduction in incontinence episodes per day: a decrease of 67.6 percent 

among those with severe UUI and 71.4 percent among those with mild to moderate UUI.168 In 

another study, those with severe baseline symptoms were less likely than others be symptom free 

at 12 weeks.157 Cure rates were reported to be comparable when comparing participants with 

UUI to those with MUI.169 

Urodynamic findings. Five publications related baseline urodynamic findings to outcomes 

of treatment.89, 170-173 Three did not identify urodynamic findings that predicted poor response or 

non-response to treatment. Both women with and without detrusor instability had comparable 

benefits from treatment.171 Classification of participants as having detrusor overactivity or 

sensory urgency based on urodynamics was not statistically significant as an effect modifier or 

predictor of treatment outcomes.170 The third study to group participants by urodynamic findings 

had group sizes (n = 6, 25, 36, 40) too small to make definitive assessments but suggested in the 

two larger groups that those with low volume and high pressure profiles had comparable results 

to those with low volume and low pressure profiles. Among women with proven detrusor 

instability, those with detrusor activity in response to provocations like washing hands or running 

water, were less likely to improve,172 and women who reported coital incontinence were more 

likely to be non-responders to treatment.173

9 
Urodynamic findings. Five publications related baseline urodynamic findings to outcomes 

of treatment.17, 98-101 Three did not identify urodynamic findings that predicted poor response or 

non-response to treatment. Both women with and without detrusor instability had comparable 

benefits from treatment.99 Classification of participants as having detrusor overactivity or 

sensory urgency based on urodynamics was not statistically significant as an effect modifier or 

predictor of treatment outcomes.98 The third study to group participants by urodynamic findings 

had group sizes (n = 6, 25, 36, 40) too small to make definitive assessments but suggested in the 

two larger groups that those with low volume and high pressure profiles had comparable results 

to those with low volume and low pressure profiles. Among women with proven detrusor 

instability, those with detrusor activity in response to provocations like washing hands or running 

water, were less likely to improve,100 and women who reported coital incontinence were more 

likely to be non-responders to treatment.101

BMI. A single trial of tolterodine ER, tolterodine IR, and placebo (n=1,235) reported that 

women who were above the mean for BMI (> 27kg/m2

) were more likely to have UUI at 

baseline but achieved comparable results after 12 weeks of treatment. 

Gender. Authors frequently reported that men, especially older men, fared less well in 

resolution of symptoms of OAB.85, 106, 156, 157, 174 This evidence review was focused on outcomes 

of treatment among women. However, in order to retain landmark studies we included a number 

of studies that enrolled men as long as the proportion of women in the study was 75 percent or 

more. This means that treatment effects may be attenuated when men are included. 

KQ5: Costs of Treatments 

Content of the literature. We identified five studies on financial costs related to OAB that 

met criteria for inclusion.175-179 All studies included assessment of direct medical costs, and two 

included costs due to lost productivity. One study additionally assessed financial implications for 

pain and suffering. 

Costs of treatment. Total direct health care costs for women with OAB in 2000 were 

estimated at $6.9 billion, of which $1.1 billion were for pharmacologic treatment and $550 

million for surgical treatment. The rest was estimated for “consequences” costs, which would 

include things like falls, longer hospital length of stay and skin conditions. Medication costs for 

OAB with the two most commonly used drugs (oxybutynin and tolterodine) ranged from $56 to 

$360 over a twelve month period for newly diagnosed patients. However, total health care costs 

were highest for patients who take oxybutynin, relative to tolterodine in any formulation, with 

costs lowest for patients on tolterodine ER. Explanations for this were not apparent. 

Discussion 

The study of OAB as a syndrome is entering its second decade. As is typical of advancing 

areas of research, publications based on case series are giving way to observational cohorts. 

Trials, beyond those required for FDA approval of indication for OAB, are appearing in the 

literature and health services researchers are investigating population-level factors such as cost of 

care and risk of rare but serious side effects of treatments. 

The 2002 ICS standardization of terminology180 was associated with a productive trend 

toward greater attention to and clarity of operational definitions in research. Documentation of 

inclusion and exclusion criteria, baseline characteristics, and change in symptom profiles have 

10 
become more detailed and nuanced in the last five to seven years. Improved clarity about 

research definitions for conducting the study and analyzing data was the case even when authors 

departed from ICS definitions. Simultaneously important research gains have been made in 

crafting, refining, and validating questionnaire and interview instruments for classifying 

symptoms, assessing severity of symptoms, describing impact of OAB on quality of life, and 

measuring satisfaction with outcomes. Despite this momentum the overall content of the current 

literature is fair to poor with a preponderance of study designs that do not provide strong 

evidence. 

We find a concerning lack of high-quality evidence to inform clinical decision-making for 

millions of women in the United States. Medications can provide symptom relief which is often 

not complete, but valued by women who struggle with OAB. Well-conducted trials of greater 

duration and sophistication, separate from drug development and marketing efforts, are crucial. 

Because benefits of current treatments are modest, opportunities exist to study how to gain 

synergy from combinations of types of treatments. We must note that lack of evidence of 

benefits is not equivalent to evidence of no benefit. A number of treatments that are potentially 

promising warrant continued investigation. Cross-cutting concerns about the quality of research 

must be addressed to achieve literature that can be meaningfully synthesized. Current literature 

does not permit definitive conclusions about relative benefit, harm, or costs to achieve similar 

results. Given how common and concerning OAB is, a priority on promoting high-quality 

research in the United States is imperative. Women and their care providers deserve better 

information to guide their choices. 

11 
12 
13 

Evidence Report 
14 
Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/bladder/bladder.pdf

15 

Chapter 1. Introduction

Importance of Overactive Bladder Treatment 

At minimum, 11 to 16 million women in the United States cope on a daily basis with 

symptoms that include sudden strong urges to urinate, difficulty delaying voids, frequent trips to 

the bathroom, and in many cases involuntary loss of urine when urgency strikes.1 They may wear 

pads for accidents, plan ahead for access to bathrooms, and modify their social and work lives to 

accommodate their symptoms. Some women are very distressed by the symptoms whether mild 

or severe, and some find mechanisms to adapt, reporting little trouble with symptoms or 

interference with normal routines. Others report their symptoms negatively influence factors as 

varied as self-esteem, self-assessment of attractiveness, and sexual function. Many women 

believe that some amount of incontinence is inevitable with aging and the majority of women 

with these symptoms do not talk with their health care providers about their concerns with 

bladder function. As a result, a small minority receive treatment. 

Defining OAB 

Overactive bladder syndrome, referred to as OAB in this report, is formally defined as: 

• urgency, which is the complaint of sudden need to void; 

• with or without urge incontinence, involuntary loss of urine with urgency symptoms; 

• usually with frequency, which is the individual’s perception that she voids too often 

during the day, and is often defined as more than eight voids during waking hours; 

• usually with nocturia, which is awakening from sleep to empty the bladder. 

This operational definition was formally standardized as part of a consensus process of 

experts, in 2002 by the International Continence Society (ICS) as part of an effort to promote 

healthcare professionals’ and researchers’ use of common terminology in the care and study of 

women with OAB. Components of the syndrome have had varied, and at times conflicting, 

nomenclature that include detrusor (bladder muscle) instability; detrusor dysfunction; detrusor 

dysynergia; detrusor overactivity, and irritable bladder. In each case, these terms shared a causal 

model that hypothesizes that mistimed or poorly regulated bladder contractions create the 

sensation of sudden need to void with or without leakage. However clinical study of bladder 

muscle function using urodynamic testing to measure characteristics like bladder capacity, 

pattern and timing of bladder contractions, and bladder volume at which women first 

experienced the urge to void, did not reveal uniform test results among women who had identical 

complaints. Lacking a reliable biologic marker to define and describe the severity of the 

condition with objective tests of the bladder itself, clinicians, researchers, pharmaceutical 

companies, and others came to conceptualize the symptoms of OAB, which often appeared in 

combination, as a syndrome. 

Syndromes are medical conditions defined by the symptoms, which are the sensations 

(urgency), changes (frequency), or events (incontinence episodes) experienced by the individual. 

A syndrome is not defined by a known biologic cause. The pathophysiology of OAB is 

incompletely characterized and the syndrome is a diagnosis of exclusion reached when other 

causes of the symptoms, like urinary tract infection, urethral inflammation, or neurologic causes 

of incontinence are ruled out as the cause. OAB symptoms may be life long, relapsing and 
remitting; or may completely resolve; which manifestations of the syndrome a woman has may 

also vary over time. However followup studies that track women who have OAB find that on 

average it is a chronic condition that women experience for a year or more at a time, and may 

have into the indefinite future. 

Little is known about causes and most physiology and clinical research aimed at 

understanding etiology is now focused at the descriptive and hypothesis development and testing 

phase of investigation. The most promising theories postulate abnormalities in control of bladder 

function resulting from aberrations in neurologic signals from the bladder (sensation) and in 

central and peripheral nervous system regulation. 

OAB and Awareness of the General Public

Prior to the mid-1990s research and clinical care focused on describing and managing frank 

incontinence. The term “overactive bladder” was introduced into the lexicon in the mid-1990s by 

Pharmacia (acquired by Pfizer in 2002) to describe the frequent urge to urinate as part of its 

advanced marketing campaign of Detrol (tolterodine). The company framed this as an 

opportunity to “destigmatize” a range of symptoms encompassing urgency, frequent voiding, and 

urge incontinence, so that patients would not be afraid to speak with their doctors about the 

problem.181 The construct – and subsequent marketing success – of OAB medications revolved 

around encouraging women to reflect on how their symptoms influenced their quality of life and 

the degree to which the symptoms caused inconvenience, emotional distress, withdrawal from 

activities, or sexual problems. 

As a result, a broader spectrum of women, extending beyond those with incontinence, 

became candidates for treatment. This included those who were inconvenienced by or worried 

about frequent urination or who engaged in what has been referred to as “defensive voiding”, 

emptying the bladder in an attempt to extend the interval between symptoms or to reduce the 

amount of urine that leaks with incontinence, and “toilet mapping,” being aware of where 

bathrooms are and canvassing new locations to be sure the options are known. The group of 

those encouraged to consider treatment also came to include women who perceive they urinate 

more than “normal” and women whose jobs or lifestyles do not accommodate frequent, strong 

urges to urinate. Early advertisements featured school crossing guards and jurors who could not 

readily take a break. Momentum toward a very broad definition in marketing was a factor in the 

updated consensus definition of OAB by the ICS in 2002, so that the biomedical community 

would have an opportunity to formally standardize the definition with specificity. 

Marketing of drug and the drug indication to physicians occurred through the usual channels, 

such as paid educational trips, speaking engagements, outsourcing drug studies, etc.182, 183 Nearly 

simultaneously, as a result of less restrictive rules about direct to consumer marketing, women 

were reached directly through the power of television and print media in new ways.184 Use of 

“buzz drivers,” or people paid to promote the drug during news broadcasts or celebrity 

interviews came into play as new marketing techniques.185 By 2006, the first drug to specifically 

target the broader definition of OAB hit the blockbuster mark of $1 billion in sales for the 

year.186 Two drugs, tolterodine tartrate and oxybutynin, were the only drugs approved in the 

United States specifically for OAB until 2004 when trospium, darifenacin, and solifenacin were 

introduced.187 Fesoterodine, a metabolite of tolterodine was approved in October 2008. 

Oxybutynin is now available in a transdermal formulation. Thus over roughly a decade – a very 

short time window in clinical medicine – both the condition of OAB and pharmaceutical 

treatments for OAB became part of the consciousness of the public and the general medical 

community alike. 

16 
Treatment Options

Popular wisdom encourages self-management of symptoms of OAB through reduction of 

fluid intake, cutting back on caffeine, modifying voiding habits, and taking note of what factors 

like phase of the menstrual cycle, food choices, or contraceptives may influence severity of 

symptoms in order to adapt or reduce the impact of OAB. Over-the-counter remedies like 

cranberry capsules and herbal preparations are reported to promote bladder health, reduce 

bladder irritation, or reduce the urgency associated with bladder infections while also taking 

antibiotics, have crossed-over into use by women who have the symptoms without an infection. 

While perhaps quite common, these strategies are not well-reflected in the scientific literature. 

This report is focused on those treatments that have been formally investigated including: 

• Pharmacologic treatments, including prescription medications, both pills and patches 

• Surgeries and procedures, such as sacral neuromodulation and botulinum injections 

• Behavioral interventions, such as behavior modification programs and bladder training 

• Complementary and alternative medicine, such as acupuncture and reflexology 

Note that when initiated, treatment should be prompted by distress over symptoms and their 

influence on quality of life. The symptoms are not de facto harmful, though consequences such 

as sleep interruption or risks of falls and fractures from rushing to the toilet may be harmful.188, 

189 As a result OAB management is usually individualized to address the component symptom(s) 

that the individual finds most bothersome. Where possible we have tried to address treatments 

with respect to the primary component symptoms of OAB: urgency, frequency (daytime and 

nighttime), and urge urinary incontinence, so that the women, their health care providers, payors, 

policy-makers and others have a detailed picture of the expected outcomes of available 

treatments. 

This Evidence Report 

Scope of the Report 

Evidence reviews of therapeutics seek to identify and systematically summarize objective 

information about the evidence related to: 

• Effectiveness of specific, well-defined treatments 

• Relative benefit of one treatment over another 

• Common side effects and serious risks of a treatment 

• Whether individual characteristics help predict who will benefit or be harmed 

• Degree to which individuals find the treatment acceptable or satisfactory 

• Costs of care or risk-benefit assessments 

Key Questions 

For this review, we operationally defined OAB as “idiopathic urinary urgency and frequency 

with or without associated incontinence in adult females, not related to neurogenic conditions or 

as a result of (incontinence) surgery.” This review is restricted to OAB, rather than exclusively 

mixed incontinence, stress incontinence, painful bladder syndrome, and other lower urinary tract 

symptoms (LUTS). 

We have synthesized evidence in the published literature to address these key questions: 

KQ1. What is the prevalence and incidence of overactive bladder as estimated in 

representative populations? 

17 
KQ2. Among women with overactive bladder, what are the short and long-term outcomes of 

the following treatments, or combinations of treatment approaches: 

a. Pharmacologic treatments 

b. Surgical and procedural treatments 

c. Behavioral and physical therapy treatments 

d. Complementary and alternative medicine treatments 

KQ3. Where direct comparisons have been made between or among treatment modalities of 

interest, which modalities achieve superior outcomes with respect to benefits, short and longterm risks, and quality of life? 

KQ4. Are the short and long term outcomes of these treatment approaches modified by 

clinical presentation, physical exam findings, urodynamic findings, menopausal status, age, 

or other factors? 

KQ5. What are the costs associated with these treatment approaches? 

Analytic Framework for the Treatment of OAB Women 

The analytic framework in Figure 1 summarizes the conceptual model used to guide this 

systematic review by focusing the key questions on critical health care-related pathways and 

decision points. We recognize a number of other factors like provider prescribing preferences 

and types of testing performed for a patient presenting with symptoms are part of this pathway. 

However little literature was available to inform other nodes in the process of care. 

Figure 1. Analytic framework for the treatment of OAB in women

 Population of US women 

Health care system: provider preference and experience, availability of services, insurance coverage, product marketing

KQ4 Individual characteristics: clinical presentation, physical exam findings, urodynamics, menopausal status, other factors

Women 

presenting 

with 

symptoms 

of OAB

History

Clinical exam Testing

Further evaluation:

• STI screening

• Urinalysis

• Urine culture

• Urodynamic 

testing

None

Diagnosis Treatment

choice

Treatment approach:

• Pharmacologic

• Behavioral/ Physical 

therapy

• Surgical

• CAM

Short & Long-term outcomes

• Symptom status

• Adverse events associated 

with treatment

• Need for additional 

treatment

• Influence on other aspects 

of health

• Quality of life

• Other outcomes

KQ2

KQ3

KQ5

KQ1. Population prevalence 

18 
Organization of this Evidence Report 

Chapter 2 describes our methods including our search strategy, inclusion and exclusion 

criteria, approach to review of abstracts, to review of full publications, and for extraction of data 

into evidence tables, compiling evidence, and when possible conducting meta-analysis. We also 

describe the approach to grading of the quality of the literature and to describing the strength of 

the literature. 

Chapter 3 presents the results of the evidence report by key question, synthesizing the 

findings across treatment type. We report the number and type of studies identified and we 

differentiate between total numbers of publications and unique studies to bring into focus the 

number of duplicate publications in this literature in which multiple publications are derived 

from the same study population. We emphasize the effect of treatment on the core symptom 

complex of OAB. Chapter 4 discusses the results in Chapter 3 and enlarges on methodologic 

considerations relevant to each key question. We also outline the current state of the literature 

and challenges for future research on OAB. 

We have prioritized reporting on clinically relevant commonalities for United States care 

settings, being aware of the fact that primary care generalists and specialists alike are called upon 

to evaluate and treat OAB patients. We placed greatest value on the studies, and the content 

within studies, that is most likely to be applicable to help guide patient care, such as treatment 

selection, as well as inform anticipatory guidance about likely magnitude of treatment effects and 

risk of both nuisance side effects and serious harms. 

Technical Expert Panel (TEP) 

We identified technical experts on the topic of OAB in the fields of urology, urogynecology, 

gynecology, primary care, nursing, and patient advocacy to provide assistance during the project. 

The TEP (see Appendix E) was expected to contribute to AHRQ's broader goals of (1) creating 

and maintaining science partnerships as well as public-private partnerships and (2) meeting the 

needs of an array of potential customers and users of its products. Thus, the TEP was both an 

additional resource and a sounding board during the project. The TEP included twelve members 

serving as technical or clinical experts, including an AUA representative. To ensure robust, 

scientifically relevant work, we called on the TEP to provide reactions to work in progress and 

advice on substantive issues or possibly overlooked areas of research. TEP members participated 

in conference calls and discussions through e-mail to: 

• Refine the analytic framework and key questions at the beginning of the project; 

• Discuss the preliminary assessment of the literature, including inclusion/exclusion 

criteria; 

• Provide input on the information and categories included in evidence tables; 

• Develop a hierarchy of participant characteristics and outcomes to systematically assess; 

• Advise about the clinical availability, use, and most common doses for therapeutics. 

Because of their extensive knowledge of the literature, including numerous articles authored 

by TEP members themselves, and their active involvement in professional societies and as 

practitioners in the field, we also asked TEP members to participate in the external peer review 

of the draft report. 

19 
20 

Uses of This Report 

This evidence report addresses the key questions outlined above using methods described in 

Chapter 2 to conduct a systematic review of published literature including a meta-analysis of 

effects of pharmacologic treatment. We anticipate that the report will be of value to all urologic 

and women's health care providers, including AUA (our partner), the American College of 

Obstetrician Gynecologists, the American Urogynecologic Society, the American Academy of 

Family Physicians, American Academy of Nurse Practitioners, and other clinical groups who 

care for women from menarche through the remainder of their lives, such as the American 

Geriatrics Society. In addition, this review will be of use to the National Institutes of Health, 

Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, and the 

Health Resources and Services Administration – all of which have offices or bureaus devoted to 

women's health issues. This report can bring practitioners up to date about the current state of 

evidence, and it provides an assessment of the quality of studies that aim to determine the 

outcomes of therapeutic options for the management of OAB. It will be of interest to individual 

women and the general public because of the high prevalence of OAB and the recurring need for 

women and their health care providers to make the best possible decisions among numerous 

options. We also anticipate it will be of use to private sector organizations concerned with 

women's health, such as Our Bodies Ourselves, the National Women's Health Network, the 

National Association for Continence, the Society of Urodynamic and Female Urology (SUFU), 

and the Simon Foundation for Continence. 

Researchers can obtain a concise analysis of the current state of knowledge in this field. They 

will be poised to pursue further investigations that are needed to understand the prevalence and 

natural history of OAB, to clarify risk factors, develop prevention strategies, develop new 

treatment options, and optimize the effectiveness and safety of clinical care for those with OAB. 
Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/bladder/bladder.pdf

21 

Chapter 2. Methods 

In this chapter, we document the procedures that the Vanderbilt Evidence-based Practice 

Center used to develop this comprehensive evidence report on the treatment of OAB in women. 

We first describe our strategy for identifying articles relevant to our five key questions, our 

inclusion/exclusion criteria, and the process we used to abstract relevant information from the 

eligible articles and generate our evidence tables. We also discuss our criteria for grading the 

quality of individual articles and for rating the strength of the evidence as a whole. Finally, we 

describe the peer review process. 

Literature Review Methods 

Inclusion and Exclusion Criteria 

Our inclusion/exclusion criteria were developed in consultation with the TEP, to capture the 

literature most tightly related to the key questions. Criteria are summarized below. 

Table 1. Inclusion and Exclusion Criteria 

Category Criteria 

Study population Adult, community-dwelling females 

Publication languages English only 

Admissible evidence 

(study design and other criteria) 

Admissible designs

Randomized controlled trials, cohorts with comparison, case-control, and 

case series 

Other criteria 

Original research studies that provide sufficient detail regarding methods 

and results to enable use and aggregation of the data and results 

Patient populations must include women with overactive bladder 

Studies must have relevant population ≥ 50 participants 

Studies must address one or more of the following for overactive bladder: 

Treatment modality 

Symptom management approach 

Short- and long-term outcomes and quality of life 

Prevalence and/or incidence 

Relevant outcomes must be able to be abstracted from data in the papers 

We excluded studies that (1) were not published in English; (2) did not report information 

pertinent to the key questions; (3) had fewer than 50 female participants [at enrollment]; (4) had 

less than 75 percent female participants or failed to report results by gender; and (5) were not 

original studies. 

For this review, the relevant population for all key questions was women with overactive 

bladder, defined as “idiopathic urinary urgency and frequency with or without associated urge 

urinary incontinence, not related to neurogenic conditions or as a result of (incontinence) 

surgery.” The same inclusion/exclusion criteria were applied to identify papers for treatmentrelated key questions. We applied additional restrictions for inclusion and exclusion of incidence 

and prevalence publications for KQ1. To inform this question about the epidemiology of OAB 

and/or its component symptoms, we required that the study methods specify a population base a 
 priori from which a sample of individuals was drawn as a representative selection to estimate 

the true proportion of prevalent and incident cases of OAB in the larger population. Additional 

information is provided in the results for KQ1. For KQ5, we required that publications provide 

data on direct costs in United States dollars for treatments reviewed in this report. 

Treatment studies that included at least 75 percent women were included. This level was 

selected with expert input to avoid restricting to studies with only female participants as a large 

proportion of this literature includes both men and women, and to establish a threshold below 

which the difference in underlying processes (e.g., BPH in men) might substantially influence 

treatment effects. Studies with lower proportions of women were included if they presented 

results separately for women; or indicated that an interaction with gender was tested and found 

not to exist; or gender was controlled in the analysis. Publications about incontinence that did not 

distinguish between, or present results by urge, stress, and/or mixed incontinence were excluded. 

Literature Search and Retrieval Process 

Databases. We employed multi-term search strategies to retrieve research about treatment of 

overactive bladder in women, including exploration of three databases: PubMed, MEDLINE®, 

EMBASE, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We 

also hand-searched the reference lists of relevant articles to identify additional studies for review. 

Search terms. Controlled vocabulary terms served as the foundation of our search in each 

database, complemented by additional keyword phrases to represent the myriad ways in which 

overactive bladder is referred to in the clinical literature. We also employed indexing terms 

within each of the databases to exclude undesired publication types (e.g., reviews, case reports, 

CME handouts) and items published in languages other than English. 

Tables 2 to 4 outline our search terms and the yield from each database. Our searches were 

executed between April and October, 2008, and were not limited by date. From PubMed, we 

identified 2,400 items for further review; EMBASE yielded 318 items, including 310 already 

identified in PubMed and 8 unique items; CINAHL yielded 264 citations, including 240 

duplicates with PubMed and 24 new articles for review. 

Table 2. PubMed search strategies (last updated October 1, 2008) 

Search terms Search 

results 

#1 ("Urinary Bladder, Overactive"[Mh] OR "overactive bladder" OR "urge 

incontinence" OR urinary incontinence, urge[mh] OR "detrusor instability" OR 

"overactive detrusor" OR "urinary urgency" OR "urinary frequency" OR "irritable 

bladder" OR “detrusor overactivity”) AND "female"[MeSH Terms] AND 

"humans"[MeSH Terms] AND English[lang] 

2,886 

#2 #1 AND editorial[pt] 10 

#3 #1 AND letter[pt] 30 

#4 #1 AND case reports[pt] 164 

#5 #1 AND review[pt] 299 

#6 #1 AND practice guideline[pt] 2 

#7 #1 NOT (#2 OR #3 OR #4 OR #5 OR #6) 2,400*† 

* Approximately 250 of these citations represent pediatric literature (due to variability in indexing for this topic, we 

were unable to exclude pediatric literature at the search strategy level). 

† Numbers do not total due to exclusions in more than one category; 5 items were indexed as both letters and case 

reports and 14 items were indexed as both reviews and case reports 

22 
Table 3. EMBASE search (OVID) (last updated October 1, 2008) 

Search Terms Search 

Results

#1 *overactive bladder/ or *urinary urgency/ or *urge incontinence/ or 

*urinary frequency/ or *detrusor dyssynergia/ or *bladder irritation/ 

1624 

#2 limit 1 to (human and female and english language and (adult <18 to 64 

years> or aged <65+ years>)) 

363 

#3 #2 and review.pt. 12 

#4 #2 and conference paper.pt. 4 

#5 #2 and editorial.pt. 1 

#6 #2 and letter.pt. 0 

#7 #2 and note.pt. 3 

#8 #2 and short survey.pt. 4 

#9 #2 and case report/ 18 

#10 #2 and practice guideline/ 4 

#11 #2 and "systematic review"/ 1 

#12 #2 and meta analysis/ 1 

#13 #2 not (3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12) 318*†

* Overlap with PubMed: 310 citations; 8 new citations retrieved for inclusion. 

† Numbers do not total due to exclusions in more than one category: 1 item was indexed as both a case report and 

review; 1 item was indexed as both a case report and a note; and 1 item was indexed as both a review and a 

systematic review. 

Table 4. CINAHL search (EBSCO) (last updated October 1, 2008) 

Search Terms Search 

Results

#1 (MH “Urge Incontinence”) or (MH “Overactive Bladder”) or “overactive 

bladder” or “urge incontinence” or “urge urinary incontinence” or 

“detrusor instability” or “overactive detrusor” or “urinary urgency” or 

“urinary frequency” or “detrusor overactivity” and (MH “Adult+”) and 

(ZL “ENGLISH”) and (PT “Journal Article”) 

305 

#2 #1 and case reports 18 

#3 #1 and review 6 

#4 #1 and CE material 5 

#5 #1 and abstract/commentary 7 

#6 #1 and consumer literature 5 

#7 1 not (2 or 3 or 4 or 5 or 6) 264* 

* Overlap with PubMed: 240 citations; 24 new citations retrieved for inclusion.

Yield of literature searches. Figure 2 presents the yield and results from our searches. 

Beginning with a yield of 2,559 articles, we retained 232 articles covering 221 studies that we 

determined were relevant to answer our key questions and met our inclusion/exclusion criteria. 

23 
Figure 2. Disposition of articles for the treatment of overactive bladder (OAB) 

Non-duplicate articles 

identified in searches 

n = 2,559 

• Search 1: n = 2,287 

• Search 2: n = 145 

• Hand-searching: n = 28 

• Search 3: n = 99 

Full text articles 

reviewed 

n = 586 

Articles excluded 

n = 1,972 

Full text articles excluded 

n = 355 

• Not about OAB 

n = 11 

• Stress/mixed incontinence 

n = 17* 

• POP 

n = 1 

• Neurogenic conditions 

n = 5 

• Basic science/anatomy 

n = 4* 

• Imaging/diagnostic 

n = 20* 

• Other 

n = 72 

• Not original research 

n = 45 

• < 75% female study population 

n = 40* 

• Not ambulatory population 

n = 1 

• Ineligible study type 

n = 39 

• Sample size < 50 

n = 77* 

• Did not address study questions 

n = 9 

• Treatment not available in US 

n = 20 

• Unable to obtain full text 

n = 4 

Unique full text 

articles included in 

review 

n = 232 

 75 KQ1 

150 KQ2 

 34 KQ3 

 32 KQ4 

 5 KQ5 

KQ = key question 

*The number of articles addressing each key question and those excluded exceed the total number of articles in each 

category because some of articles fit into multiple exclusion categories or addressed more than one key question. 

The excluded papers focused exclusively on populations of individuals with movement disorders, spinal cord injuries, 

or multiple sclerosis, for example. As a result, they did not meet the criteria for an “idiopathic” syndrome which was a 

requirement of the report. 

24 
Article selection process. Once we identified articles through the electronic database 

searches, review articles, and bibliographies, we examined abstracts of articles to determine 

whether studies met our criteria. Two reviewers separately evaluated the abstracts for inclusion 

or exclusion, using an Abstract Review Form (Appendix B). If one reviewer concluded that the 

article could be eligible for the review based on the abstract, we retained it. The group included 

three physicians (KH, DB, RW), and two senior health services researchers (MM, SM). 

Of the entire group of 2,559 articles, 586 required full text review. For the full article review, 

two reviewers read each article and decided whether it met our inclusion criteria, using a Full 

Text Inclusion/Exclusion form. Reasons for article exclusion are listed in Appendix D. 

Literature Synthesis 

Development of Evidence Tables and Data Abstraction Process 

The staff members and clinical experts who conducted this review jointly developed the 

evidence tables. We designed the tables to provide sufficient information to enable readers to 

understand the studies and to determine their quality; we gave particular emphasis to essential 

information related to our KQs. We based the format of our evidence tables on successful 

designs used for prior systematic reviews. 

The team was trained to abstract by abstracting several articles into evidence tables and then 

reconvening as a group to discuss the utility of the table design. We repeated this process 

through several iterations until we decided that the tables included the appropriate categories for 

gathering the information contained in the articles. A priori, with the technical expert panel, a 

hierarchy of baseline characteristics and outcome measures was developed: UUI episodes, 

urgency, incontinence, voids, nocturia, QoL, urodynamic measures, and adverse events. All team 

members shared the task of initially entering information into the evidence tables. Another 

member of the team also reviewed the articles and edited all initial table entries for accuracy, 

completeness, and consistency. The two abstractors reconciled disagreements concerning the 

information reported in the evidence tables. The full research team met regularly during the 

article abstraction period and discussed global issues related to the data abstraction process. In 

addition to outcomes related to treatment effectiveness, we abstracted all data available on 

harms. Harms encompasses the full range of specific negative effects, including the narrower 

definition of adverse events. 

The final evidence tables are presented in their entirety in Appendix C. Studies are presented 

in the evidence tables alphabetically by the last name of the first author. When possible, studies 

resulting from the same study population were grouped into a single evidence table. A list of 

abbreviations and acronyms used in the tables appears at the beginning of that appendix. 

Synthesis of the Evidence 

A series of spreadsheets was created to support systematic tabulation and assessment of study 

characteristics including key study population characteristics, number of participants by group, 

treatment received, length of followup, age of participants by group, outcomes measured and 

outcomes. This allowed us to identify common threads in reporting across publications. 

Within the pharmaceutical treatment studies all unique trial arms were entered into a 

spreadsheet with exact values to two-decimal points as available for baseline measures, followup 

measures, difference from baseline, and for the related statistical indicators of precision (such as 

25 
standard deviations, standard errors, or confidence bounds). This was done to facilitate 

calculation of weighted averages and to support meta-analysis. 

Conduct of meta-analysis. Descriptive statistics were computed and examined for 

homogeneity among studies. Studies that reported weekly rates for UUIs and voids were 

standardized to daily rates. When only ranges of continuous variables were reported (instead of 

standard deviations), we estimated the standard deviations by dividing the range by four.5

 Study 

results were combined and summarized using two meta-analysis techniques, weighted averages 

and fixed effects regression models.6

 In particular, minimum variance weighted averages of the 

mean daily decrease in UUI and voids per arm were computed using weights that were inversely 

proportional to their standard errors. To borrow strength across arms, we used fixed effect 

regression models with robust standard errors (to account for the clustering by study) and 

weighted the study arms inversely proportional to their standard errors of the mean. Each arm 

was treated as a fixed effect and study was not included in the model except in the sense that the 

clustering was addressed by the robust standard errors. Fixed effects models were also adjusted 

for mean age and proportion of women in each arm. We used STATA 10.0 and R statistical 

packages for computations. 

Summary tables within this report. Each of the pharmacologic agents in this report is 

available in a least one dose form for clinical use. As part of the process of Food and Drug 

Administration (FDA) approval each has been determined superior to placebo for at least one 

facet of the syndrome, e.g., urge urinary incontinence, frequency of urination, symptoms of 

urgency, or nocturia. The experience of having overactive bladder is a constellation of these selfreported events, symptoms, and the impact that they have on an individual’s life. Thus measures 

of quality of life, interference with daily activities, degree of distress from symptoms, and 

satisfaction with the outcomes of treatment are also common and helpful metrics in this 

literature. Where common measures are available across studies using roughly comparable 

assessments (i.e., similar index questions, time intervals, etc), we have compiled tables to 

summarize outcomes of treatments. 

Given the content of the literature, this means that the majority of the information included in 

tables is for the outcomes of number of urge incontinence episodes per day and number of voids 

per day. (Studies with weekly or other metrics that could be converted to daily metric are 

included.) Because momentum in drug development within related classes of drugs has been 

toward daily dosing, the pharmacologic treatments are arranged from highest dose at lowest 

frequency of administration (daily) to lower doses and greater administration frequency (twice or 

more daily). Placebo arms from the same trials in which the drugs were evaluated are included 

within the table, or for areas in which the literature is large, in companion placebo outcome 

tables. The number of weeks of treatment and timing of followup outcome assessment were the 

same in these trials. The weeks of treatment column is therefore comparable to weeks at 

evaluation of outcomes. 

Summary tables include data from distinct clinical trial arms in which the drug and dose or 

other type of treatment were evaluated for the related outcome. As a result, a single study may 

contribute more than one treatment arm as well as a placebo arm to the summary tables. For 

pharmacologic treatment we included only study arms in which no dose adjustment was allowed. 

Because many studies are dose finding with multiple drug arms or are direct comparisons of 

pharmacologic agents, there are more drug arms than placebo arms for virtually all drugs and 

treatment types. 

26 
Quality Rating of the Individual Studies 

Rating the quality of individual articles. We developed our approach to assessing the 

quality of individual articles based on our prior experience with conducting systematic reviews. 

Internal validity. The criteria for assessing internal validity were as follows: 

Randomized allocation to treatment. This assessment combines randomization and method of 

randomization into a single criterion with a three-point scale. 

Rationale: By randomly assigning groups to the intervention of interest, other factors that 

may confound the results are equally distributed between groups (assuming a large enough 

sample size). This equal distribution minimizes the chances of over- or underestimation of 

treatment effect based on unequal distribution of confounding factors. 

If randomized, we also evaluated the study for randomization methods, using the rationale 

described in Matchar and colleagues, 2001.190

Rationale: “Pseudo-randomization” methods may be susceptible to bias, as demonstrated by 

evidence of unequal distribution of subject characteristics191 and larger effect sizes compared 

with studies using more rigorous methods.192 In addition, methods of allocation concealment are 

also important in preventing bias (e.g., use of prepared sealed envelopes). 

We combined these elements into a single operational definition, as described below: 

Operational definition: Criterion met if randomization methods were not susceptible to bias, 

such as computer-generated numbers in sealed sequentially numbered envelopes (+). Criterion 

not met by studies that either used methods more prone to bias, such as alternate medical record 

numbers, or did not describe randomization methods or methods of allocation concealment (-). 

Criterion not applicable if treatment was not randomly allocated (NA). 

Masking. 

Rationale: Masking, also known as blinding, refers to the concealment of treatment allocation 

from the care provider, the assessor, and the patient.193 In certain trials, particularly surgical 

trials, masking the patient or the surgeon from the treatment allocation can be challenging or 

impossible. Similarly, masking the assessor assigned to record immediate post-procedural 

outcomes such as wound healing can also be difficult. Nevertheless, when possible, masking 

prevents expectations from influencing findings. 

Operational definition: Criterion was met if assessors and participants were masked to 

treatment or group (+). Criterion was not met if either care provider, assessor, or patient were not 

masked (-). Criterion not applicable if treatment was not randomly allocated. 

Adequate description of patients and control selection criteria. 

Rationale: Patient characteristics that might affect outcomes (such as severity of symptoms, 

duration of symptoms, failure of prior treatment, or medical comorbidities) are likely to differ 

between two interventions. If these differences are not characterized, then erroneous conclusions 

may be drawn. 

Operational definition: Criterion met if (a) inclusion and exclusion criteria for participation in 

the study were well described. 

We expected that the study population should be adequately described to make clear the 

potential for confounding in the analysis. We expected the study authors to adequately describe 

the study population such that it could theoretically be reproducible by another investigator. We 

expected comparable methods to be used to identify and screen participants across exposure or 

treatment groups. 

27 
Description of loss to followup. 

Rationale: Failing to account for patients lost to followup may lead to erroneous conclusions, 

especially if the loss to followup is related to either the underlying disease or the intervention 

(e.g., patients seeking care elsewhere because of continuing symptoms or unacceptable side 

effects of treatment). 

Operational definition: Criterion met for adequate followup (+) if (a) loss to followup was 

explicitly reported and (b) no more than 20 percent of any study arm was lost to followup. Those 

studies with less than 10 percent lost to followup were given an extra (+). Studies with greater 

than 20 percent lost to followup were considered inadequate for this measure (-). 

Description of dropout rates. 

Rationale: Dropout rates may reflect differences in clinically important variables, such as 

side effects or treatment response. Failure to account for dropouts may result in erroneous 

conclusions similar to those seen with failure to account for loss to followup. 

Operational definition: Criterion met if (a) patients dropping out of the study prior to 

completion were reported and (b) no more than 10 percent in any study arm left the study for 

reasons related to the study intervention or withdrawal of consent. 

Power calculation provided. 

Rationale: Many studies, especially case series, lack sufficient power to detect clinically 

important differences in outcomes or patient characteristics. 

Operational Definition: Criterion met if a power calculation (pre or post) was provided. 

Recognition and description of statistical issues. 

Rationale: Use of inappropriate tests may lead to misleading conclusions. For example, 

variables such as number of voids per day or costs are often not normally distributed; use of 

means instead of medians when data may be affected by outlying observations can be 

misleading. 

Operational definition: Criterion met if (a) appropriate statistical tests were used (e.g., 

nonparametric methods for variables with nonnormal distributions, or survival analysis 

techniques to account for loss to followup and dropouts) and (b) potential study limitations 

regarding design and analysis were discussed. Criterion not met if (a) inappropriate statistical 

tests were used or (b) study limitations were not discussed. An intention-to-treat (ITT) analysis 

was required of clinical trials. 

External validity. The criteria for assessing external validity were as follows: 

Baseline characteristics: We created a composite score for adequacy of the description of 

baseline characteristics. At minimum, we expected age and baseline OAB status to be presented. 

If either of these were omitted, criteria were not met. If the authors provided additional 

information above and beyond age and OAB status at baseline on any of the following, they 

were awarded an additional +: race/ethnicity, BMI, parity, menopausal status, prior 

treatment/surgery, duration of symptoms. 

Required elements: 

Description of age of study population. 

Rationale: The outcomes of many interventions are affected by patient age. Age is especially 

important in studies related to reproductive health in women and associated with rates of 

overactive bladder. 

Operational definition: Criterion met if summary statistics of subject age were given by 

comparison group. Criterion not met if summary statistics were not given. 

28 
Baseline OAB status. 

Rationale: The baseline level of severity of OAB could affect the likelihood of successful 

treatment. Furthermore, definitions of OAB are not consistent across studies and may include 

different combinations of urgency, frequency, and incontinence that could affect interpretation of 

the outcomes. Therefore, we sought to determine whether studies defined OAB status by ICS or 

other criteria, by UUI alone or by combinations of UUI, urgency and frequency. 

Operational definition: Criterion met if symptoms of OAB were presented by study group. 

Length of followup. 

Rationale: Outcome measures may vary depending on when they are obtained. Description of 

when outcomes were measured facilitates comparison between studies. We considered three 

months to be a minimally acceptable period of followup for observing effectiveness of treatment 

for OAB. 

Operational definition: Criterion met if the study followed participants for at least three 

months, with an extra point provided for greater than or equal to six months. 

Adequate description of methods used for outcome measurement. 

Rationale: Comparison between studies requires common methods of measurement, which in 

turn requires adequate description of the methods used to assess comparability. 

Operational definition: Criterion met if (a) methods used to measure outcomes were 

adequately described or referenced (e.g., 2002 ICS; QoL scales), (b) definitions were given (e.g., 

description of outcomes classified as “adverse events”), or (c) outcomes were unambiguous (e.g., 

reduction in number of voids per day). Criterion not met if (a), (b), or (c) was not present. 

Adequate description of validity and reliability of outcome measurement. 

Rationale: Measurements of outcomes are only useful if changes in the outcome being 

measured are reflected in changes in the measurement (validity) and if these changes are 

reasonably consistent between the same observer measuring at different times or between 

different observers (reliability). For example, changes in a scale to assess menstrual blood flow 

should correlate with some other physiological measure of menstrual blood loss, and this 

correlation should be consistent when different women apply the same scale. 

Operational definition: Criterion met if (a) a description of the methods used to assess 

validity and reliability of at least one outcome measure was provided, (b) a reference to another 

article documenting validity and reliability was provided, or (c) only unambiguous outcomes 

were included as primary outcomes. Criterion not met if (a), (b), or (c) was not present. 

Adequate description of the intervention provided to subjects. 

Rationale: The ability to replicate study results is dependent on adequate description of 

methods. Additionally, readers should be aware of aspects of clinical care that might influence 

outcomes. 

Operational definition: Criterion met if (a) a detailed description of the therapy (dose, dosing 

schedule, protocols for behavioral interventions, and route of administration for medications 

and/or techniques for invasive therapies) was provided; (b) a reference to another publication 

describing the procedure was provided; or (c) statistical adjustment was made for likely sources 

of variation in clinical care (e.g., site where care was given, type of specialist providing care, 

individual provider, dose and timing). 

Criterion not met if (a), (b), or (c) was not provided. 

29 
Table 5. Scoring algorithm for quality rating of individual studies 

Definition and Scoring Algorithm Rating 

Score Algorithm for Internal Validity Quality Rating 

• No negative scores, lowest loss-to-followup score, and lowest dropout rate Good internal validity 

• One negative score or intermediate loss-to-followup Fair internal validity 

• High loss-to-followup score, or high dropout rate OR

• Two negative scores OR

• One negative score and intermediate loss-to-followup score 

Poor internal validity 

Score Algorithm for External Validity Quality Rating 

• No negative scores Good external validity 

• One or two negative scores Fair external validity 

• Three or more negative scores Poor external validity 

Score Algorithm for Overall Quality Rating 

• Good internal validity and good external validity Good overall 

• Fair internal validity and fair external validity OR

• Good internal validity and fair external validity OR

• Good internal validity and poor external validity OR

• Fair internal validity and good external validity OR

• Poor internal validity and good external validity 

Fair overall 

• Poor internal validity and poor external validity OR

• Fair internal validity and poor external validity OR

• Poor internal validity and fair external validity 

Poor overall 

Strength of Available Evidence 

Our scheme follows the criteria applied in earlier systematic reviews of systems for rating the 

strength of a body of evidence.194, 195 That system includes three domains: quality of the research, 

quantity of studies (including number of studies and adequacy of the sample size), and 

consistency of findings. Two senior investigators assigned grades by consensus. 

We graded the body of literature for each key question and present those ratings as part of the 

discussion in Chapter 4. The possible grades were: 

I. Strong: The evidence is from studies of strong design; results are both clinically important 

and consistent with minor exceptions at most; results are free from serious doubts about 

generalizability, bias, or flaws in research design. Studies with negative results have sufficiently 

large samples to have adequate statistical power. 

II. Moderate: The evidence is from studies of strong design, but some uncertainty remains 

because of inconsistencies or concern about generalizability, bias, research design flaws, or 

adequate sample size. Alternatively, the evidence is consistent but derives from studies of 

weaker design. 

III. Weak: The evidence is from a limited number of studies of weaker design. Studies with 

strong design either have not been done or are inconclusive. 

IV. No evidence: No published literature. 

30 
External Peer Review 

As is customary for all systematic evidence reviews done for AHRQ, this report was 

reviewed by a wide array of individual outside experts in the field, including our TEP, and from 

relevant professional societies and public organizations. AHRQ also requested review from its 

own staff. The Scientific Resource Center sent 11 invitations for peer review. Reviewers 

included clinicians (e.g., urologists, urogynecologists, gynecologists, geriatricians, family 

medicine physicians, and nurse practitioners), representatives of federal agencies, advocacy 

groups, and potential users of the report. 

The Scientific Resource Center charged peer reviewers with commenting on the content, 

structure, and format of the evidence report, providing additional relevant citations, and pointing 

out issues related to how we had conceptualized and defined the topic and KQs. We also asked 

reviewers to complete a peer review checklist. The Scientific Resource Center received eight 

responses in addition to comments from AHRQ staff. The individuals listed in Appendix E gave 

us permission to acknowledge their review of the draft. We compiled all comments and 

addressed each one individually, revising the text as appropriate. 

31 
32 
Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/bladder/bladder.pdf

Chapter 3. Results 

KQ1. Prevalence and Incidence of Overactive Bladder 

To understand the epidemiology of OAB and associated symptoms (frequency, urgency, and 

urge incontinence), we sought publications that provided estimates of prevalence, which is the 

proportion of the population with the condition, or those that examined the proportion with onset 

of new symptoms over time, which is termed incidence. The strongest estimates come from a 

well-specified population-base that allows sampling to generate a representative group. 

We applied operational criteria to select those studies best suited to estimate prevalence and 

incidence. The key criterion for inclusion was that the study authors specified a population base 

a priori from which a sample of individuals was drawn as a representative selection of 

individuals to estimate the true proportion in the larger population. The population was required 

to be clearly defined and capable of being enumerated such as the population of a region, the 

participants in a health plan or individuals on voter registration roles. This “roster” defines the 

sampling frame from which stratified samples are drawn. Often the research team has an explicit 

statistical goal of randomly selecting participants with aggregate characteristics (range of age, 

race/ethnicity, income level, etc.) that approximate the entire population of a city, region, or 

country. Common approaches include random digit dialing within a specific geographical region, 

or mailings of questionnaires to a sample of individuals who are in a pool of registered voters, 

registered residents, or on the patient panels of a national health systems or large healthcare 

organizations. Outside the United States, household canvassing and administered interviews 

were also common. 

The characteristic of being able to define a sampling frame from which participants were 

subsequently drawn was a required characteristic for inclusion in the prevalence and incidence 

summary. Other approaches to the study of large groups, such as enrolling individuals who are 

presenting for clinical care, or who have just had a health event like childbirth or surgery, can be 

informative, however, such studies do not by virtue of their design, generate participant pools 

who are representative of a larger population. They represent those with access to care, who have 

sought care for a problem visit, chronic condition, or preventive care, or who have a medical 

condition or experience in common. Such designs may also reflect characteristics of the site of 

care at which the cohort was recruited, such as a high proportion of indigent patients or specialty 

referral patients. For this reason, cohort studies and clinical samples, without a population-based 

sampling frame were excluded in order to emphasize the broadest picture of the epidemiology 

and natural history of OAB is as possible. 

Prevalence of Overactive Bladder 

Using this approach, we identified 75 publications,2-4, 10-81 from 60 distinct study populations. 

Detailed summaries for all studies are included in Appendix C and a summary is provided in 

Table 6. 

33 
34 

Table 6. Study characteristics of the prevalence and incidence literature 

Population Studied 

Study Characteristic US 

(n=15) 

European 

(n=24) 

Asian 

(n=13) 

Other 

(n=8) 

Total 

(n=60) 

Publications after 2002 ICS Definitions 

Distinct populations 

 Prevalence Only 

 Incidence Only 

 Both

(n=13) 

10 

2 

1 

(n=11) 

7 

-- 

4 

(n=7) 

7 

-- 

-- 

(n=7) 

6 

-- 

1

(n=38) 

30 

2 

6

Assessment Method 

Mailed 

Telephone 

Administered 

Other 

3 

2 

6 

2 

7 

2 

1 

1 

2 

1 

4 

-- 

-- 

3 

3 

1 

12 

8 

14 

4 

Conditions Assessed* 

Urge Incontinence 

Overactive Bladder 

Urgency 

Frequency

11 

2 

4 

3 

7 

4 

3 

3 

5 

5 

4 

5 

5 

3 

3 

3 

28 

14 

14 

14 

Funding Source 

National (NIH, MRC, etc.) 

Foundation/Other 

Industry 

Not Reported

8 

-- 

4 

1 

4 

2 

3 

2 

1 

-- 

1 

5 

-- 

1 

2 

4 

13 

3 

10 

12 

Publications before 2002 ICS Definitions

Distinct populations 

 Prevalence Only 

 Incidence Only 

 Both

(n=2) 

-- 

-- 

2 

(n=13) 

13 

-- 

-- 

(n=6) 

6 

-- 

-- 

(n=1) 

1 

-- 

-- 

(n=22) 

20 

-- 

2 

Assessment Method 

Mailed 

Telephone 

Administered 

Other 

-- 

1 

1 

-- 

8 

2 

2 

1 

2 

2 

2 

-- 

1 

-- 

-- 

-- 

11 

5 

5 

1 

Conditions Assessed* 

Urge Incontinence 

Overactive Bladder 

Urgency 

Frequency

2 

-- 

-- 

-- 

11 

1 

3 

3 

6 

-- 

2 

2 

1 

-- 

-- 

-- 

20 

1 

5 

5 

Funding Source 

National (NIH, MRC, etc.) 

Foundation/Other 

Industry 

Not Reported

2 

-- 

-- 

-- 

3 

1 

4 

5 

-- 

1 

1 

4 

-- 

1 

-- 

-- 

5 

3 

5 

9 

* Inclusive: Total is greater than number of studies because some publications report multiple conditions.
35 

Fifteen studies were conducted in United States populations; 24 in European populations; 13, 

Asian; and 8 other countries. Thirty-eight of these studies appeared in print after the 2002 

International Continence Society revised definitions and 37 percent of these reported specifically 

about incidence or prevalence of OAB. One study prior to the consensus definitions used fully 

comparable definitions and the term “overactive bladder”. 

A total of 15 studies provided information about OAB prevalence (Table 7). These studies 

included a total of 64,528 women in 16 distinct populations. The majority of respondents 

completed questionnaires returned by mail. The highest estimates of OAB prevalence was 31.3 

percent in a telephone questionnaire study conducted in Korea in which the average age of 

participants was 59 years; the lowest was 7.7 percent in a mailed questionnaire conducted in the 

United Kingdom among women of nearly identical average age. Across all studies the weighted 

average prevalence of OAB was 13.7 percent. Excluding the highest and lowest estimates, an 

estimated 14.8 percent of women meet criteria for OAB, with 8.0 percent of those surveyed 

having OAB with a component of urge incontinence. Combined estimates from the two United 

States populations are similar: 14.7 percent with OAB and 11.3 percent with a component of 

urge incontinence. 

No clear pattern of higher or lower estimates for prevalence of OAB was associated with 

survey response rates. The direction of bias is therefore difficult to estimate: researchers have 

noted both that those with symptoms may be more likely to be interested in the topic and to 

respond and that the social stigma or embarrassment associated with bladder control symptoms 

may prompt under-response. In each case in which the authors addressed non-response, they 

report the demographic characteristics of those who did not respond were similar to those who 

did with the exception of several authors who noted modest under-representation of the very 

oldest residents. 

Age and prevalence of OAB. The relationship between OAB and age was fairly uniform 

across studies with a trend to increase with age.2, 3, 12-14, 38, 42 As discussed below, this 

increase appears to be more notable for OAB than UUI. Because OAB criteria can be met with 

urgency combined with incontinence, frequency, or nocturia, the “amplification” of age effects 

for OAB risk may in part be related to well-documented increases in stress urinary incontinence 

and therefore also mixed stress and urge incontinence with age. Prevalence of OAB for women 

in their 20s was in the range of 4.6 to 5.9 percent 2, 3, 11, 13 while uniformly double digits, 11.7 

to 19 percent 2, 3, 11, 13 for women older than 60. Several researchers noted a threshold effect 

such that prevalence was not statistically different until an inflection in the 60s or 70s.12, 14, 38, 

42 Few data were provided, however discussion materials often noted that all component 

symptoms: urgency, frequency, nocturia, and urge and mixed incontinence, increased with age 

therefore contributing to the rise in OAB. 
36 

Table 7. Prevalence of OAB 

Author, Year 

Country 

Respondents 

Response* Measurement 

Age of 

Respondents†

Mean, Range

OAB Prevalence 

(%) 

Lawrence et al.2, 3, 13

2008 US 

4,103 

34.0% 

Mailed 

EPIQ 

56.5 ± 15.8 

(25, 84) 

Any: 13.3 

Wet: 12.7 

Wagner et al.4, 42

2002 US 

2,735 

83.9% Telephone 54.2 (18, ≥ 75) 

Any: 16.9 

Wet: 9.3 

Herschorn et al.12

2007 Canada 

518 

NR Telephone 44.5 ± 17.2 (18, 90) 

Any: 14.7 

Wet: 7.1 

Irwin et al.18

2006 Europe & 

Canada 

9,000^ 

33.0% Telephone (18, ≥ 70) Any: 12.8 Wet: 6.3 

Corcos et al.38

2004 Canada 

1,683 

53.7% Telephone 50.9 (35, ≥ 75) 

Any: 21.3 

Wet: 6.5 

McGrother et al.26

2006 UK 

12,570 

65.3% Mailed 59.5 ± 13.0 (40, 98) Any: 7.7 

Dallosso et al.39

2004 UK 

12,568 

30.2% Mailed Median: 61 Any: 15.9 

Van Der Vaart et al.48

2002 Netherlands 

933 

67.0% 

Mailed 

UDI 

34.2 ± 3.2 

(20, 45) Any: 11.9 

Choo et al.14

2007 Korea 

1,005 

NR Telephone 59.4 ± 11.6 (40, 89) 

Any: 31.3 

Wet: 15.0 

Yu et al.30

2006 Taiwan 

925 

33.5% Administered 49.9 (30, 79) Any: 18.3 

Homma et al.31

2005 Japan 

2,380 

45.0% Mailed 61 (41, 100) 

Any: 11.0 

Wet: 7.0 

Song et al. 29, 33, 34

2005 China 

4,684 

77.2% 

Mailed 

BFLUTS 40.4 ± 11.1 Any: 8.0 Wet: 5.6 

Chen et al. 41, 47

2003 Taiwan 

1,247 

78.7% 

Administered 

Bristol 

43.2 ± 15.1 

(20, ≥ 65) 

Any: 18.6 

Wet: 9.1 

Teloken et al.23

2006 Brazil 

449 

NR Written (15, 55) Any: 23.2 

Milsom et al.51

2001 Europe 

9,728 

NR Telephone (40, ≥ 75) Any: 17.4 

Total: 64,528

Weighted 

average: 

49.5% 

Weighted averages: 

Any: 13.7

Any (without 

extremes): 14.8

Wet: 8.0 

* Proportion of eligible sample who responded to survey and had responses included in analysis. 

^Exact number of women not reported. 

† Data provided is that included by the authors. Hierarchy was to provide mean if no indication of skew; median if 

author provided only median or data to show that median better captured a skewed distribution, and then range. 

Range was only provided when other options were not available. Complete information for each study is included in 

evidence tables; OAB-wet indicates OAB with incontinence. 
37 

Prevalence of Urge Urinary Incontinence 

A larger number of studies (n=48) examined urge urinary incontinence as the primary 

prevalence estimate of interest. Twenty-six distinct study populations, with 36 publications, 

appeared after the ICS 2002 consensus definitions.2, 3, 10-14, 17-19, 21, 25, 27, 29, 31-38, 70, 72, 75, 80 These 

are presented here in greater detail because the definitions used are more similar to those that 

define “OAB-wet” and therefore are more likely to have comparability in the measures. Across 

all these populations, prevalence of urge incontinence ranged from a low of 1.5 percent in a large 

European study of all adult women from ages 18 to 70, 18 up to a high estimate of 22.0 percent in 

a United States mall-based consumer survey36 and 26.4 percent among a household sample of 

Jordanian women age 50 to 65.35 Each of the latter had somewhat ambiguous survey items. 

Average urge incontinence prevalence by region was: 

United States: 9.7 percent among 37,596 respondents from nine populations2-4, 10, 11, 13, 

17, 19, 25, 27, 32, 36, 40, 42, 72 

Europe: 10.6 percent among 68,051 respondents from seven studies including nine 

countries18, 37, 43, 45, 48, 75, 81 

Asia: 9.6 percent among 14,537 respondents from five populations in three countries14, 21, 

29, 31, 33, 34, 41, 47, 80 

Other: 12.5 percent among 6,219 respondents in five populations from five countries12, 35, 

38, 49, 70 

Though more than half of studies did not report the frequency of urge incontinence episodes 

required to meet the case definition (e.g., weekly, monthly), or used nonspecific terms such as 

“mostly” and “sometimes” in definition, these estimates are concordant with the range of 

estimates for the prevalence of OAB with urge incontinence features, suggesting that the 

measurement instruments captured similar features. These estimates are consistent with the 

AHRQ report on the Prevention of Fecal and Urinary Incontinence in Adults, which reported 

prevalence of UUI in community dwelling adults as increasing "from 5 percent in younger 

women to 10 percent in women 45-64 (32 studies), and to 12 percent in women older than 65 

years (28 studies)”.196

In the nine studies in which the interval of occurrence required to meet the definition of urge 

incontinence was specified, there was not a clear pattern of relationship between length of the 

interval and proportion of women classified as having urge incontinence.10, 17, 27, 31, 34, 37, 38, 72, 80

Overall the average prevalence of UUI across these nine studies was 8.9 percent. The two studies 

that required weekly symptoms reported a prevalence of 7.0 and 6.5 percent (in populations 

which had an average age of 61, and an age range from 35 to 75 without a mean reported, 

respectively).21, 31, 38 The average across six studies that reflect a wide age range and required at 

least monthly episodes was 9.4 percent, and the sole study reporting any urge incontinence 

within the year was 7.9 percent with an average respondent age of 51.72 This lack of a pattern 

associated with the operational definition of frequency of urge incontinence episodes may result 

from variation in the methods of measurement or characteristics of the respondents that obscures 

any trend, or, more likely given large population-based samples, similarity in estimates may 

reflect that most women who are affected have fairly frequent symptoms and are detected and 

properly classified regardless of interval definition required. 
38 

Other Measures 

Urgency symptoms. Individually, the symptoms of urgency and frequency are common. The 

range of prevalence for urgency symptoms (in post ICS studies) was from 8.0 percent in a young 

population of pre-menopausal Indian women,50 to the highest estimate of 45.4 percent among an 

even younger population of European women (mean age 34).48 Despite this wide range, which 

may reflect varied operational definitions used by researchers, nine of ten estimates for the 

prevalence of urgency are 10 percent or above.12, 14, 18, 34, 38, 47, 48, 50, 73 

Frequency. Thirteen studies with fourteen groups reported on frequency. Most defined 

frequency as more than eight voids per day (or more). The range of estimates for women with 

daily frequency was 5.2 percent among Thai women ages 20 to 59,20 to 34 percent among 

Danish women ages 20 to 45,48 and 49 percent among Japanese women with an average age of 

61.31 The average proportion of women with frequent voiding across study groups was 16.0 

percent, with five estimates between 5 and 15 percent,12, 18, 20, 45, 50 and four estimates 

between 15 and 25 percent.14, 34, 38, 47 

Age as a predictor of UUI. The relationship between urge urinary incontinence and 

increasing age was less consistent across studies than that for OAB and age, with some authors 

reporting nearly identical prevalence across all age brackets and no statistical trend15, 53 and 

others noting increases parallel to OAB,11, 12, 14, 42 more modest increases64 or threshold ages 

as in OAB which are inflection points at which prevalence was meaningfully increased, typically 

among the oldest age strata: >60,11 >65,42 >70,55 and >75.38 In aggregate, the trend was less 

pronounced or not apparent for a strong and continuous influence of age on prevalence of UUI. 

Thresholds in older age seem more likely with risk being similar across wide ranges of younger 

ages. We must also note that such effects may not be results of age per se but of comorbidities 

and medication use that change with age. 

Other predictors. Other factors noted across studies were the influence of race and ethnicity 

in United States populations. Three studies (one of high quality and two of fair quality), several 

with more than one related publication, documented statistical association showing black women 

were more likely than white to have urge urinary incontinence (while noting higher risk of mixed 

and stress among white women compared to black).11, 17, 25, 197 Another high quality United 

States study found no difference with adjusted estimates of prevalence of 3.5 percent among 

black women and 3.6 percent among white women.10 

Incidence of Overactive Bladder and Urge Urinary Incontinence 

Ten studies provide incidence data. Three investigated the occurrence of new OAB 

symptoms over varied periods of time.22, 26, 39 Seven investigated the onset of urge urinary 

incontinence.15, 17, 49, 64, 74, 77, 81 Two provide information about resolution of symptoms among 

those with symptoms at baseline.64, 77

Estimates for annual incidence of OAB ranged from 2.6 to 143 cases per thousand. The 

lowest estimates came from a population-based estimate using the national health services 

database of the United Kingdom and including all adults; the highest is from the top age bracket 

(≥ 80 year) in another UK study.39 In that study, by decade beginning at 40, the annual incidence 

was 78, 65, 100, 117 and 143 per 1,000; the remaining report had participants with a mean of 59 

years and an estimate of 54 new cases per 1,000 women per year.39

The largest study to address urge urinary incontinence was conducted in the United States 

within the Nurses Health Study. They report followup from 64,650 respondents with two-year 

data. In each five year age bracket from 35 to 55 years of age, the annual incidence among those 

without symptoms at baseline was 4 per 1,000 with the exception of the 46 to 50 category at 5 
39 

per 1,000.15 A separate analysis within the Nurses Health Study, using supplemental data 

collection to gather additional details, reported two-year incidence of urge incontinence of 14 per 

1,000, which annualized to approximately 7 new cases per 1,000 women per year.69, 74 A six 

state urban sample that recruited 16,065 women and followed a subset of 3,032 for five years, 

reported 5-year incidence of urge incontinence of 15.9 percent or 3 cases per thousand per 

year.17 Work in Finland in a much smaller population sample of adults who were in their 50s 

and 60s at baseline and followed into 60s and 70s report the equivalent of 1.1 case per 1,000 per 

year, and if mortality is taken into account, 1.7 cases per year. A single study in Southern 

Australia, reports estimates that are meaningfully higher than these. Defining urge incontinence 

as that which occurs at least occasionally, and without providing a specific definition of how 

urge was queried, they report annual incidence of 226 cases per thousand. Of note the entire 

study population was 70 or older and no information about adjustment for competing morbidity 

is provided.49 

A study of 2,025 women older than 65 who lived in rural Iowa provides additional 

information. This interview-based study was conducted prior to ICS consensus definitions, the 

research team used the index item “How often do you have difficulty holding your urine until 

you can get to a toilet?”, classifying those who answered “never” and “hardly ever” as free of 

urge incontinence. Estimated 3-year incidence of urge incontinence, over two rounds of followup 

was 20.4 and 24 percent, which annualizes to 6.8 to 8.0 per 1,000 among older women.64

The authors also report on remission: among those with UUI, 31.7 to 34.9 percent had 

resolution of their symptoms over the 3-year followup windows.64 Other research in a single 

United States county, among women 60 and older, found annual incidence of 17 per 1000, with 

22.7 percent of women with urge incontinence symptoms reporting resolution within a year.77 

KQ2: Outcomes of Treatment of OAB 

This section presents results of our literature search and findings about outcomes of 

pharmacologic treatments for OAB. We review the basic mechanism of action of the family of 

medications classified as antimuscarinic agents. Six specific agents are available to United States 

practitioners: oxybutynin, tolterodine, fesoterodine, solifenacin, darifenacin, and trospium. 

Because a number of the studies are dose ranging and safety studies, we have included doses and 

preparations that may not be available. We also summarize studies of estrogen treatment for 

OAB. Each pharmacologic agent is presented individually with a thorough description of the 

content of the literature followed by the findings from trials and information from cohorts and 

case series, when those studies provided additional information beyond that provided by trials. 

Side effect and harms of treatment are reviewed together at the end of this section. 

Pharmacologic Treatments 

Pharmacologic treatments for OAB include antimuscarinic agents which have differing 

affinities for multiple subtypes of muscarinic receptors found both in the bladder as well as 

throughout the body. These agents generally bind to muscarinic receptors on the bladder muscle 

blocking the input required for contraction of the muscle. In short, such drugs prevent or 

decrease the intensity of involuntary bladder contractions. 

Because muscarinic receptors are present throughout the body, nonselective agents affect 

other processes explaining the occurrence of side effects such as dry mouth (reduced action on 

salivation), constipation (slowing gut contractions), dry eyes (affecting tear ducts), and altered 

cognition (affecting central nervous system). In an attempt to decrease the effect on other organs 
40 

and improve tolerability, the development of agents purported to be more specific in targeting 

subtypes of muscarinic receptors found in the bladder has been undertaken. 

Medication is often initiated with the lowest dose of an agent and adjusted to the desired 

clinical effect while minimizing adverse effects. The two most frequently prescribed 

pharmacologic treatments for OAB in the United States are oxybutynin and tolterodine. 

Oxybutynin is available in an oral immediate-release (IR) and an extended-release (ER) form, a 

transdermal patch, and a topical gel, approved by the FDA in January 2009. Tolterodine is also 

available in both immediate and extended-release pills. Fesoterodine was approved by the FDA 

in October 2008. Fesoterodine is a first order metabolite of tolterodine with similar selectivity. 

Newer agents available in the United States include solifenacin, darifenacin, and trospium, which 

is available in both immediate and extended-release formulations. 

We reviewed 110 studies,82-96, 98-109, 140-172, 174, 198-255 of which four were good quality, 75 fair 

and 31 poor. This section of the report presents summary data for each pharmacologic treatment, 

including varied doses, intervals, and delivery mechanism. Direct comparisons across or among 

types of treatment (including pharmacologic, behavioral and procedural, and others) are 

presented in KQ3. Additional information is also provided in that section about comparisons 

across extended release versus immediate release. Detailed information on all studies relating to 

pharmacologic treatment of OAB can be found in evidence tables in Appendix C. 

The summary tables included here compile unique arms of randomized trials that did not 

allow dose adjustment within the arm. Each drug and dose combination, as well as the related 

placebo arms, is presented here if data for the outcome in the summary table was provided in the 

publication. When necessary, weekly or monthly measures were converted to daily in order to 

allow ready assessment of the baseline similarity, outcomes, and effect size across studies. Each 

of these pharmacologic agents has been shown to be statistically superior to placebo for some 

facet of OAB symptoms. Complete details of measurement approach and statistical comparisons 

are available in Appendix C; comparisons among doses of the same drug are discussed in this 

section, and direct comparisons between or among drugs are presented with KQ3. 

Treatment with oxybutynin. 

Content of the literature. We identified 13 randomized controlled studies of oxybutynin for 

treatment of OAB. A total of 22 study arms compared oxybutynin at various doses and intervals, 

and included five placebo arms (Tables 8 and 9). Most participants were recruited from nonprimary care populations with seven studies performed in the United States,82-88 three in 

Europe,89-91 and one each in Japan,92 Taiwan,93 and South Korea.94 These studies included a total 

of 2,575 women in treatment arms, and 383 women in the placebo arms. Participants had an 

average age of 59.3 and 60.9, in the treatment and placebo groups, respectively. 

Outcomes of treatment. Baseline numbers of incontinence episodes per day in the oxybutynin 

treatment groups ranged from 1.0 to 7.2, and in the placebo arms from 0.0 to 3.0. Because many 

trials were drug to drug comparisons, this difference in range does not reflect marked differences 

between placebo and comparison groups within studies, rather the higher severity of symptoms 

in the drug to drug comparison studies which were more likely to include more individuals with 

multiple urge incontinence episodes per day. Study participants using oral oxybutynin achieved a 

reduction in mean episodes of urge urinary incontinence of between 0.0 and 4.6 over the course 

of placebo-controlled studies that ranged in followup from 2 to 52 weeks. Of the formulations 

studied, 10 mg per day appeared to achieve the greatest reduction with a range of 2.9 to 7.2 

(Tables 8 and 9). However, all estimates in this section of the report should be assessed with 

reference to the placebo arms, in which participants also reported reductions in incontinence 
41 

episodes. In oxybutynin trials, in the placebo arms, reduction in UUI episodes ranged from 0 to 

1.4. 

Oxybutynin was also associated with a decrease in voids per day in both oral and transdermal 

formulations. Baseline voids per day in drug and placebo arms were similar (7.2 to 11.7 overall). 

Voids per day were lowered by 1.8 to 2.3 in the transdermal arms, 0.7 to 4.2 in oral oxybutynin 

IR, 3.4 to 4.1 in oral oxybutynin ER and 0.8 to 1.7 in the placebo arms. 

Meta-analysis was possible for immediate release but not extended release. Immediate 

release reduced UUI by 1.49 episodes per day (95 percent CI: 1.18, 1.80); and voids by 2.18 

episodes per day (95 percent CI: 1.75, 2.61). 

Table 8. RCT arms for oxybutynin chloride effect on urge incontinence 

Author 

Year 

N 

(% Women) Mean age 

Episodes per 

day baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes per 

day 

Weeks 

treated 

Oxybutynin 10 mg once a day 

Sand et al.83

2004 

147 

(100.0) 

58.4 3.6 0.9 2.7 12 

Diokno et al.84

2003 

339 

(100.0) 

60.0 5.3 1.5 3.8 12 

Oxybutynin 5 mg twice a day 

Halaska et al.90

2003 

66 

(87.0) 

52.2 2.1 1.1 1.0 52 

Lee et al.94

2002 

90 

(79.0) 

52.0 2.4 1.0 1.4 8 

Oxybutynin 5 mg three times a day 

Zinner et al.82

2005 

13 

(93.4) 

59.9 2.9 1.4 1.6 2 

Abrams et al.91

1998 

117 

(74.5) 

58.0 2.6 0.9 1.7 12 

Oxybutynin 2.5 mg two or three times a day 

Wang et al.93

2006 

23 

(NR) 

NR 1.0 1.0 0.0 12 

Davila et al.87

2001 

36 

(97.0) 

63.0 7.2 2.6 4.6 6 

Transdermal Oxybutynin 3.9 mg (or cm2) 

Homma and 

Koyama92

2006 

164 

(81) 

62.7 2.9 0.9 1.0 8 

Transdermal Oxybutynin 3.9 mg (or cm2) 

Dmochowski et 

al.88 2003 

121 

(90.1) 

63.1 4.7 1.9 2.8 12 
42 

Table 8. RCT arms for oxybutynin chloride effect on urge incontinence (continued) 

Author 

Year 

N 

(% Women) Mean age 

Episodes per 

day baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes per 

day 

Weeks 

treated 

Oral Placebo 

Wang et al.93

2006 

23 

(NR) 

NR 0.0 0.0 0.0 12 

Abrams et al.91

1998 

56 

(75.4) 

58.0 3.3 2.4 0.9 12 

Transdermal Placebo 

Homma et al.92

2006 

161

(72.7) 

62.9 3.0 1.6 1.4 8 

Table 9. RCT arms for oxybutynin chloride effect on voids per day 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Oxybutynin 10 mg once a day 

Sand et al.83

2004 

147 

(100.0) 

58.4 13.1 9.7 3.4 12 

Diokno et al.84

2003 

339 

(100.0) 

60.0 13.6 9.5 4.1 12 

Oxybutynin 5 mg twice a day 

Halaska et al.90

2003 

66 

(87.0) 

52.2 12.5 8.3 4.2 52 

Lee et al.94

2002 

90 

(79.0) 

52.2 12.4 10.6 1.8 8 

Oxybutynin 5 mg three times a day 

Abrams et al.91

1998 

117 

(74.5) 

58.0 10.7 8.4 2.3 12 

Giannitsas et al.89

2004 

6 

(100.0) 

53.0 7.2 6.1 1.1 6 

Giannitsas et al.89

2004 

25 

(100.0) 

57.0 8.0 7.3 0.7 6 

Giannitsas et al.89

2004

36 

(100.0) 

57.0 8.3 7.5 0.8 6 

Giannitsas et al.89

2004 

40 

(100.0) 

54.0 9.3 8.3 1.0 6 

Zinner et al.82

2005 

13 

(93.4) 

59.9 10.4 9.2 1.2 2 

Transdermal Oxybutynin 3.9 mg patch 

Dmochowski et 

al.88

2003 

121 

(90.1) 

63.1 12.4 10.4 2.0 12 

Transdermal Oxybutynin 3.9 mg patch 

Dmochowski et 

al.85

2002 

123 

(94.4) 

59.4 12.3 10.0 2.3 12 
43 

Table 9. RCT arms for oxybutynin chloride effect on voids per day (continued) 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Oral Placebo 

Abrams et al.91

1998 

56 

(75.4) 

58.0 11.7 10.1 1.6 12 

Zinner et al.82

2005 

15 

(93.4) 

59.9 10.4 9.6 0.8 2 

Transdermal Placebo 

Dmochowski et 

al.85 2002 

130 

(89.4) 

62.7 NR NR 1.7 12 

Quality of life outcomes in these studies were measured with several validated tools, 

including the Kings Health Questionnaire, Incontinence Inventory Questionnaire (IIQ), and 

Urinary Distress Inventory (UDI) (Table 18). In all studies, statistically significant improvements 

were observed relative to baseline, and in drug groups compared to placebo.85, 86, 88, 92, 93 The 

MATRIX study assessed HRQoL in patients treated with transdermal oxybutynin.245, 246 This 

patient population included 2,508 women with an average age of 62.5 years, and followed 

patients for a minimum of six months. Sand and colleagues used the KHQ and the PPBC to 

assess general quality of life improvement, and reported improvement in nine of ten domains 

versus baseline (p<0.001).245 A second paper by Sand and colleagues employed the BeckDepression Inventory (BDI-II) and the KHQ, and demonstrated improvement in embarrassment 

scores, effect on sex life, and relationships with partners, all p <0.001. The BDI-II also showed 

improvement in interest in sex from baseline to study end (p<0.001).246

Treatment with tolterodine. 

Content of the literature. We included 20 RCTs83, 84, 86, 88, 89, 91, 94, 96, 97, 99, 140, 141, 154, 162, 168, 209, 

223, 233, 240, 241 and 11 prospective cohort studies157, 160, 166, 169, 172, 212, 224, 227, 232, 239, 243 of tolterodine. 

Among the RCTs were 30 tolterodine arms and 14 placebo arms (Tables 10 and 11). Most were 

multinational studies conducted at centers in Europe, the United States, Australia, and Asia. A 

total of 6,746 women were in the treatment arms, with 3,298 women in the placebo arms. The 

average ages were 58.1 and 59.9, respectively. 

Outcomes. At baseline, women reported between 1.6 and 5.0 episodes of urge urinary 

incontinence per day. Treatment with 4 mg of drug once a day reduced episodes of urge in 

continence an average of 0.9 to 3.7 episodes each day, compared to a reduction of 1.3 to 2.4 for 2 

mg taken twice a day. These doses and intervals are common in clinical practice; other doses and 

intervals also are included in Tables 10 and 11. Overall, reductions in urge urinary incontinence 

episodes on active therapy ranged from 0.9 to 3.7, compared to reductions in the placebo arms of 

0.6 to 2.1. 

With respect to frequency of voiding, tolterodine was associated with 0.9 to 3.6 fewer voids 

per day in study populations that had baseline voiding frequencies of 7.2 to 13.7. The range of 

response for placebo was 0.4 to 2.2 fewer voids per day, in study populations that had baseline 

voiding frequencies of 10.3 to 12.3 per day. Reductions differed by treatment dosage and timing, 

with a reduction of 1.7 to 3.6 with 4 mg once daily, 0.9 to 1.1 for 4 mg twice daily, and 1.4 to 3.3 

for 2 mg twice daily. 

Estimates were developed in the meta-analysis for decreases in UUI episodes and voids per 

day in tolterodine immediate release and tolterodine extended release formulations. Tolterodine 

immediate release reduced UUI by 1.45 episodes per day (95 percent CI: 1.24, 1.66) and voids 
44 

per day by 2.19 (95 percent CI: 1.76, 2.61). Tolterodine extended release reduced UUI by 1.75 

episodes per day (95 percent CI: 1.65, 1.85) and voids per day by 2.48 (95 percent CI: 1.94, 

3.02). The aggregate effect of placebo across all available study arms was a decrease in UUI 

episodes per day of 1.08 (95 percent CI: 0.86, 1.30) and voids by 1.48 (95 percent CI: 1.19, 1.71) 

per day. 

Two RCTs included urodynamic parameters to assess intermediate effects of tolterodine 

treatment.221, 238 In a dose-finding study, tolterodine 2 mg twice a day demonstrated statistically 

significant increase in the volume at first contraction (p=0.03), and an in increase in maximal 

cystometric capacity following four weeks of treatment compared to baseline urodynamic 

parameters.221 In contrast, mean volume at first contraction was significantly increased after two 

weeks of treatment compared to baseline (p=0.046), but no improved outcome effect was seen 

for maximum cystometric capacity, bladder compliance, or number of detrusor contractions.238

Table 10. RCT arms for tolterodine tartrate effect on urge incontinence 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Tolterodine 4 mg once a day 

Rogers et al.241

2008 

182 

(100) 

49.0 2.5 NR 1.8 12 

Chapple et al.99

2007 

297 

(87.1) 

56.9 NR NR 0.9 4 

Chapple et al.96

2007 

253 

(78.0) 57.7 3.8 2.1 1.7 12 

Robinson et 

al.240 2007 

53 

(100) NR 2.3 0.7 1.7 8 

Landis et al.168

2004 

321 

(81.6) 

60.9 1.6 0.5 1.1 12 

Landis et al.168

2004 

284 

(83.6) 

60.0 4.7 1.6 3.3 12 

Millard et al.154

2004 

205 

(75.4) 

53.6 3.2 1.1 2.2 12 

Millard et al.154

2004 

191 

(75.4) 

53.6 3.2 1.0 2.3 24 

Diokno et al.84

2003 

357 

(100) 

60.0 5.3 1.6 3.7 12 

Tolterodine 4 mg once a day 

Dmochowski et 

al.88 2003 

123 

(95.1) 

62.9 5.0 1.9 3.1 12 

Swift et al.140

2003 

417 

(100) 

59.0 3.2 1.5 1.7 12 

Van 

Kerrebroeck et 

al.141 2001 

507 

(82.0) 

60.0 3.2 1.5 1.2 12 
45 

Table 10. RCT arms for tolterodine tartrate effect on urge incontinence (continued) 

Tolterodine 2 mg twice a day 

Sand et al.83

2004 

161 

(100) 

58.8 3.6 1.2 2.4 12 

Chapple et al.97

2003 

279 

(72.9) 

58.1 2.3 0.9 1.4 12 

Swift et al.140

2003 

408 

(100) 

59.0 3.3 1.8 1.4 12 

Lee et al.94

2002 

97 

(74.0) 

52.0 2.6 0.4 2.2 8 

Jacquetin162

2001 

103 

(81.6) 

58.0 3.2 1.9 1.3 4 

Van 

Kerrebroeck et 

al.141 2001 

514 

(79) 

60.0 3.3 1.8 1.5 12 

Millard et al.233

1999 

116 

(77.0) 

60.2 3.6 1.9 1.7 12 

Abrams et al.91

1998 

118 

(77.1) 

55.0 2.9 1.6 1.3 12 

Tolterodine 2 mg three times a day 

Chancellor et 

al.209 2000 

514 

(80.0) 

60.0 3.3 1.8 1.5 12 

Tolterodine 1 mg twice a day 

Jacquetin et 

al.162 2001 

97 

(76.3) 

53.0 3.7 2.6 1.1 4 

Millard et al.233

1999 

114 

(78.0) 

60.1 3.9 2.2 1.7 12 

Placebo 

Chapple et al.96

2007 

252 

(81.0) 

56.0 3.7 2.6 1.1 12 

Landis et al.168

2004 

171 

(78.5) 

60.6 1.6 1.0 0.6 12 

Landis et al.168

2004 

210 

(84.8) 

61.8 4.5 3.2 1.3 12 
46 

Table 10. RCT arms for tolterodine tartrate effect on urge incontinence (continued) 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Placebo 

Rogers et al.241

2008 

189 

(100) 

47.0 2.2 NR 1.4 12 

Robinson et 

al.240

2007 

59 

(100) 

NR 2.9 2.2 0.7 8 

Chapple et al.97

2003 

267 

(76.3) 

57.7 2.0 1.4 0.6 12 

Dmochowski et 

al.88

2003 

117 

(93.2) 

64.5 5.0 2.9 2.1 12 

Swift et al.140

2003 

410 

(100) 

60.0 3.4 2.4 1.0 12 

Van 

Kerrebroeck et 

al.141 2001 

507 

(81.0) 

61.0 3.3 2.3 1.0 12 

Table 11. RCT arms for tolterodine tartrate effect on voids per day 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Tolterodine 4 mg once a day 

Rogers et al.241

2008 

182 

(100) 

49.0 13.0 NR 3.3 12 

Chapple et al.96

2007 

253 

(78.0) 57.7 11.5 9.8 1.7 12 

Chapple et al.99

2007 

267 

(87.1) 

56.9 NR NR 1.5 4 

Robinson et al.240

2007 

53 

(100) 

NR 13.2 10.6 2.6 8 

Landis et al.168

2004 

321 

(81.6) 

60.9 9.6 NR 1.2 12 

Landis et al.168

2004 

171 

(78.5) 

60.6 10.3 NR 0.9 12 

Millard et al.154

2004 

191 

(75.4) 

53.6 12.8 9.2 3.6 24 

Millard et al.154

2004 

205 

(75.4) 

53.6 12.8 9.4 3.4 12 

Diokno et al.84

2003 

357 

(100) 

60.0 13.7 10.2 3.6 12 

Dmochowski et al.88

2003 

123 

(95.1) 

62.9 12.1 9.9 2.2 12 
47 

Table 11. RCT arms for tolterodine tartrate effect on voids per day (continued) 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Tolterodine 4 mg once a day 

Swift et al.140

2003 

417 

(100) 

59.0 10.8 9.0 1.8 12 

Van Kerrebroeck et 

al.141 2001 

507 

(82.2) 

60.0 10.9 7.4 3.5 12 

Tolterodine 4 mg twice a day 

Giannitsas et al.89

2004 

6 

(100) 

53.0 7.2 6.3 0.9 6 

Giannitsas et al.89

2004 

25 

(100) 

57.0 8.0 7.0 1.0 6 

Giannitsas et al.89

2004 

36 

(100) 

57.0 8.3 7.2 1.1 6 

Giannitsas et al.89

2004 

40 

(100) 

54.0 8.5 7.6 0.9 6 

Tolterodine 2 mg twice a day 

Sand et al.83

2004 

161 

(100) 

58.8 13.1 10.2 2.9 12 

Chapple et al.97

2003 

279 

(72.9) 

58.1 12.1 9.9 2.2 12 

Swift et al.140

2003 

408 

(100) 

59.0 11.1 9.3 1.8 12 

Lee et al.94

2002 

97 

(74.0) 

52.0 12.2 9.6 2.6 8 

Tolterodine 2 mg twice a day (continued) 

Jacquetin et al.162

2001 

103 

(81.6) 

58.0 10.8 9.4 1.4 4 

Van Kerrebroeck et 

al.141 2001 

514 

(79) 

60.0 11.1 7.8 3.3 12 

Millard et al.233

1999 

116 

(77.0) 

60.2 11.2 8.9 2.3 12 

Abrams et al.91

1998 

118 

(77.1) 

55.0 11.5 8.8 2.7 12 

Tolterodine 2 mg three times a day 

Chancellor et al.209

2000 

514 

(80.0) 

60.0 11.1 9.4 1.7 12 

Tolterodine 1 mg twice a day 

Jacquetin et al.162

2001 

97 

(76.3) 

53.0 10.7 9.3 1.4 4 

Millard et al.233

1999 

114 

(78.0) 

60.1 11.5 9.2 2.3 12 
48 

Table 11. RCT arms for tolterodine tartrate effect on voids per day (continued) 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Placebo 

Rogers et al.241 2008 189 

(100) 

47.0 12.5 NR 2.3 12 

Chapple et al.96

2007 

252 

(81.0) 

56.0 11.5 11.1 1.0 12 

Robinson et al.240

2007 

59 

(100) 

NR 11.9 10.1 1.8 8 

Landis et al.168

2004 

210 

(84.8) 

61.8 11.1 NR 0.4 12 

Landis et al.168

2004 

284 

(83.6) 

60.0 10.7 NR 1.9 12 

Chapple et al.97

2003 

267 

(76.3) 

57.7 12.2 11.0 1.2 12 

Dmochowski et al.88

2003 

117 

(93.2) 

64.5 12.3 10.9 1.4 12 

Swift et al.140

2003 

410 

(100) 

60.0 11.2 9.9 1.3 12 

Van Kerrebroeck et 

al.141 2001 

507 

(81.0) 

61.0 11.3 9.1 2.2 12 

Findings from cohort studies and case series were compatible with these results. Twelve such 

studies demonstrated improvement in urinary urgency, frequency, and urge incontinence with 

tolterodine treatment.142, 157, 160, 166, 169, 172, 212, 224, 227, 232, 239, 243, 247

Twelve studies including RCTs, prospective cohorts and extension studies evaluated the 

effect of tolterodine on patient reported outcomes, including quality of life in at least one arm.86, 

88, 91, 99, 142, 158, 160, 174, 223, 240, 241, 247 Participants in tolterodine arms consistently reported greater 

changes in quality of life, including on various domains of the Kings Health Questionnaire, IIQ, 

and UDI-6 when compared to placebo that were similar to those experienced by participants of 

oxybutynin arms in the studies. 

One study evaluated the impact of treatment with tolterodine ER 4 mg once daily on 

emotional and sexual health. Sexual Quality of Life Questionnaire- Female (SQoL-F), Pelvic 

Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), and the Hospital Anxiety 

and Depression scale (HAD) were used to assess patient reported outcomes. Treatment with 

tolterodine resulted in improved scores versus placebo in SQoL-F; PISQ- total score, and HAD 

anxiety (p=0.004, p=0.009, p=0.03 respectively).241

One study stratified outcomes by treatment in patients with prolapse and found no significant 

difference in changes in quality of life between those with anterior vaginal wall prolapse and 

those without.243 Another study stratified patients by those with urge incontinence and those with 

OAB syndrome without incontinence, and found similar bother and severity scores in each group 

in an open label study of tolterodine ER.159

Most outcomes were equivalent in studies comparing tolterodine IR versus ER; however, in 

two RCTs, extended release tolterodine resulted in a greater reduction in incontinence episodes 

per day, p=0.036 and p=0.05, respectively.140, 141 Other outcome parameters including voids per 
49 

day and pads per day showed a similar reduction compared to placebo with no statistical 

difference seen between the two formulations. 

Treatment with fesoterodine. 

Content of the literature. Two randomized controlled trials compared fesoterodine at 4 and 8 

mg to placebo for reducing symptoms of OAB in this literature that met criteria for inclusion in 

the systematic review (Table 12).95, 96 These studies included a total of 1,017 women with a 

mean age of 57.7 in the treatment arms, and a total of 518 women with a mean age of 57.5 in the 

placebo arms. Both studies reported outcome data at 12 weeks of treatment. One study included 

a tolterodine 4 mg arm, discussed in KQ3.96 There is one paper included which is a post hoc 

analysis of this study population96 assessing treatment effect on health-related quality of life.142

Outcomes. At baseline, women in the treatment arms reported between 2.2 and 3.2 episodes 

of urge urinary incontinence per day. Treatment with drug resulted in reductions of 1.95 and 3.2 

episodes per day. In the placebo arms at baseline, participants had an average of 3.7 episodes of 

urge incontinence per day. UUI in the placebo group was reduced by 1.14 to 1.48 episodes per 

day after 12 weeks of treatment.95, 96

At baseline, women in the treatment arms reported between 11.6 and 12.9 voids per day. 

Treatment with drug resulted in reductions of 1.4 to 1.9 voids per day. Women in the placebo 

arms reported between 12.0 to 12.2 voids per day at baseline, and reported a reduction of voids 

per day ranging from 0.7 to 0.95.95, 96

In the meta-analysis, fesoterodine decreased UUI per day by 2.03 (95 percent CI: 1.74, 2.31) 

episodes and voids per day by 1.84 (95 percent CI: 1.64, 2.03) episodes. placebo reduces UUI 

episodes by 1.08 (95 percent CI: 0.86, 1.30), and voids by 1.48 (95 percent CI: 1.19, 1.71) per 

day. The aggregate effect of placebo across all available study arms was a decrease in UUI 

episodes per day of 1.08 (95 percent CI: 0.86, 1.30) and voids by 1.48 (95 percent CI: 1.19, 1.71) 

per day. 

The post hoc analysis of fesoterodine arms showed significant improvement in HRQoL as 

assessed by KHQ and ICIQ-SF in both fesoterodine 8 mg arm and the tolterodine ER 4 mg arm 

versus placebo, but there was no significant difference between arms. The fesoterodine arm 

showed significant improvement in eight of nine domains (non significant in General Health 

domain). A subset of patients who reported incontinence at baseline showed similar 

improvements versus baseline; however, no significant difference was seen between arms as well 

as between subsets of those reporting incontinence at baseline versus those without.142
50 

Table 12. RCT arms for fesoterodine fumarate effect on urge incontinence and voids 

Author 

Year 

N 

(% Women) Mean age 

Episodes per 

day baseline 

Episodes per 

day on 

treatment 

Decrease in 

episodes per 

day 

Weeks 

treated 

Episodes of urge incontinence 

Fesoterodine 8 mg once a day 

Chapple et 

al.96 2007 

252 

(81.0) 55.6 3.7 1.5 2.2 12 

Nitti et al.95

2007 

267 

(78.0) 

59.0 3.9 0.7 3.2 12 

Fesoterodine 4 mg once a day 

Chapple et 

al.96 2007 

231 

(82.0) 

57.1 3.8 1.9 2.0 12 

Nitti et al.95

2007 

267 

(76.0) 

59.0 3.9 1.3 2.6 12 

Voids per day 

Fesoterodine 8 mg once a day 

Chapple et 

al.96 2007 

252 

(81.0) 

55.6 11.9 10.0 1.9 12 

Nitti et al.95

2007 

267 

(78.0) 

59.0 12.0 10.1 1.9 12 

Fesoterodine 4 mg once a day 

Chapple, et 

al.96 2007 

231 

(82.0) 57.1 11.6 9.8 1.8 12 

Nitti et al.95

2007 

267 

(76.0) 

59.0 12.9 11.5 1.4 12 

Treatment with solifenacin. 

Content of the literature. Three RCTs investigated solifenacin compared to placebo for 

reducing symptoms of OAB (Table 13).97-99 These studies included at total of 1,541 women, with 

a mean age of 58.2 years in the solifenacin treatment arms, and a total of 638 women with a 

mean age of 59.3 in the placebo arms. Two were conducted at multiple centers across Europe, 

and the other in Japan at academic health centers. One of these trials compared solifenacin to 

tolterodine, without a placebo arm, and is described in KQ3.99, 211 A newly published RCT 

performed at multiple centers in the United States comparing solifenacin at various doses to 

placebo over twelve weeks focused on outcomes of urgency and “warning time” showing 

significant decrease in urgency episodes per day (p<0.001), and an increase of 31.5 seconds in 

median warning time (p=0.008).222 Voids per day and UUI episodes per day were significantly 

reduced compared to placebo (both p<0.001).222

Outcomes. The first study compared solifenacin 5 mg and 10 mg daily to placebo and 

propiverine 10 mg.98 Women in the two solifenacin arms (713 women with a mean age of 60.2) 

had an average decrease in the number of UUI episodes per of 1.45 and 1.52 at 12 weeks 

compared to a reduction in the placebo arm of 0.89 (p<0.001 for comparisons of both dosages to 

placebo).98 Participants had a significant decrease in the number of voids per day of 1.9 to 2.9 

(p<0.001 for both doses) 
51 

The second study also studied 5 mg and 10 mg doses, compared to placebo. Women in the 

two solifenacin arms, 5 mg and 10 mg, (531 women with a mean age of 57.1) experienced 

reductions in number of UUI episodes per day of 1.4 and 0.9, respectively at 12 weeks. The 

placebo arm (267 women with a mean age of 57.7) demonstrated a reduction in urge urinary 

incontinence episodes per day of 0.6.97

Solifenacin was associated with a decrease of 1.46 episodes of UUI per day (95 percent CI: 

1.32, 1.59) and of 2.19 voids per day (95 percent CI: 1.94, 3.02) in the meta-analysis. 

Quality of life was assessed in four studies of solifenacin.98, 99, 218, 225 Quality of life measures 

improved significantly in the solifenacin arms218 including when compared to placebo.98, 225

Significant improvement in quality of life was maintained upon sub- analysis for African 

Americans and Hispanics.205, 229 Perception of bladder condition was better in one solifenacin 

arm that was compared to tolterodine99 (p=0.006). 

Two prospective case series with multiple publications evaluated solifenacin in the treatment 

of OAB.205, 218, 220, 229 One study included 1,280 women with a mean age of 56.4 years.220

Participants had a 66 percent reduction in incontinence episodes per day (from 2.66 to 0.93), a 23 

percent reduction in voids per day (12.16 to 9.18), a 63 percent reduction in urgency episodes per 

day (5.76 to 2.28), and a 32 percent reduction in nocturia episodes (1.95 to 1.25) as assessed by 

urinary diary at one-year followup. 

A dose ranging study evaluating treatment with solifenacin 5 and 10 mg daily after washout 

from tolterodine 4 mg ER, darifenacin or trospium found significant improvement in UUI 

episodes per day and voids per day over a 12 week treatment period after 14 day washout period 

(p<0.001). Patient reported outcomes assessed by the PPBC and OAB-q questionnaires indicated 

significant subjective improvement (p<0.001 in all domains).208

Another prospective randomized trial compared Solifenacin 5 and 10 mg daily to placebo. 

This study used the PPIUS (Patient Perception of Intensity of Urgency Scale) to assess treatment 

effect on urgency, and demonstrated that Solifenacin at the two doses demonstrated significant 

improvement in severe urgency episodes over placebo (p<0.001). In addition, patient reported 

outcomes of urgency bother, patient PBC score, and treatment satisfaction were significantly 

reduced compared to placebo (p<0.001).206

Table 13. RCT arms for solifenacin succinate effect on urge incontinence and voids 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease 

in episodes 

per day 

Weeks 

treated 

Episodes of urge incontinence 

Solifenacin 10 mg once a day 

Yamaguchi et al.98

2007 

349 

(85.7) 

59.9 1.9 0.4 1.5 12 
52 

Table 13. RCT arms for solifenacin succinate effect on urge incontinence and voids (continued) 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease 

in episodes 

per day 

Weeks 

treated 

Episodes of urge incontinence 

Solifenacin 10 mg once a day 

Chapple et al.97

2003 

263 

(80.0) 

56.9 1.9 1.0 0.9 12 

Solifenacin 5 mg once a day 

Yamaguchi et al.98

2007 

364 

(83.0) 

60.4 2.0 0.4 1.5 12 

Chapple et al.99

2007 

297 

(87.5) 

56.6 NR NR NR 4 

Chapple et al.97

2003 

268 

(71.2) 

57.2 2.1 0.8 1.4 12 

Placebo 

Yamaguchi et al.98

2007 

371 

(84.3) 

60.8 1.7 0.8 0.9 12 

Chapple et al.97

2003 

267 

(76.3) 

57.7 2.0 1.4 0.6 12 

Voids per day 

Solifenacin 10 mg once a day 

Chapple et al.97

2003 

263 

(80.0) 

56.9 12.1 10.2 1.9 12 

Solifenacin 5 mg once a day 

Chapple et al.99

2007 

297 

(87.5) 

56.6 NR NR 1.7 4 

Chapple et al.97

2003 

268 

(71.2) 

57.2 12.3 9.7 2.6 12 

Placebo 

Chapple et al.97

2003 

267 

(76.3) 

57.7 12.2 11.0 1.2 12 

Treatment with darifenacin. 

Content of the literature. Five RCTs provided data on the effectiveness of darifenacin.82, 100-

102, 210 Three compared 15 and 30 mg daily relative to placebo (Tables 14 and 15).82, 100, 101 These 

three studies included a total of 690 women, with a mean age of 57.6 years in the darifenacin 

treatment arms and a total of 304 women with a mean age of 57.6 in the placebo arms. Two of 

the three were conducted in the United States in a non-primary care population.82, 101 The other 

was performed at multiple centers in Europe including community-based ambulatory 

populations, and also included a 7.5 mg arm.100 The fourth study compared only darifenacin 7.5 

mg to placebo and included 269 women with mean age of 57.5 in the treatment arm, and 129 

women with an average of 58.5 in the placebo arm. This was a dose change study without report 

of outcomes by dosage.102 A fifth RCT also compared darifenacin 7.5 mg to placebo in a 

multinational, multicenter trial. This was a dose changing study without reporting of outcome by 

dosage. The treatment arm included 206 women with an average age of 72 years and a placebo 
53 

arm including 100 women with an average age of 73 years.210 One of these studies82 also 

compared darifenacin to oxybutynin; the darifenacin arm is presented in Tables 14 and 15, but 

the comparison is described in the chapter on KQ3. 

Outcomes. Baseline urge urinary incontinence episodes per day in the darifenacin arms 

ranged from 2.0 to 2.9. Urge urinary incontinence episodes per day on treatment ranged from 0.8 

to 1.6, for a decrease in episodes of UUI per day ranging from 1.2 to 1.8. This is compared to an 

average reduction in the placebo groups of 0.8 to 1.0, with similar baseline measures of 2.3 to 

3.0. 

At baseline, participants reported an average of 10.3 to 11.0 voids per day. The treatment 

groups reported reductions ranging from 1.1 to 2.2 per day, compared to 0.8 to 1.8 in the placebo 

group. Study followup ranged from 2 to 12 weeks. Daily episodes of the symptom of urinary 

urgency also were reported to be reduced after treatment with darifenacin (range of reduction: 

1.4 to 3.0 compared to 0.6 to 1.2 in placebo). The one study that reported reduction in urgency 

on a weekly basis, however, found no significant difference between treatment and placebo.101

Because of a lack of uniform information provided in the studies on variance measures, we 

could not use meta-analysis techniques to estimate effects of darifenacin on UUI or voids per 

day. 

In the first dose-adjustment trial, urge urinary incontinence episodes were not reported, but 

voiding frequency was significantly reduced in the treatment arm versus placebo, p=0.001.102 In 

the second dose changing trial changes in urge urinary incontinence episodes per week were not 

statistically different between the two arms (p=0.328), but reductions in voids per day were 

statistically greater in the treatment arm versus placebo (p=0.006). This study also assessed 

urgency episodes per day, but found no statistically significant difference in effect (p=0.174).210

Three studies assessed quality of life (QoL) with validated questionnaires using Visual 

Analog Scale (VAS), OAB-q, King’s Health Questionnaire (KHQ), and ICIQ. The arms using 15 

and 30 mg showed statistically significant improvement versus placebo, p=0.045 and p=0.011, 

respectively.100 Zinner evaluated 15 mg versus placebo and showed significant improvement in 

quality of life questionnaires, OAB-q (p<0.001), ICIQ (p<0.001) and KHQ (p<0.05).101 Chapple 

demonstrated improvement in all domains of the OAB-q versus placebo (p<0.001).210 A single 

prospective cohort study evaluated the efficacy and tolerability of darifenacin.219 This 

prospective, non-comparative, open-label extension study was conducted in multiple countries in 

Europe, Australia, and North America.102 The authors stratified results by age. All outcome 

parameters were similar between groups showing similar reductions in voids per day, urgency 

episodes per day, and severity of urgency in those over and under 65 years old.219 A second 

paper describing the open labeled extension study of those patients219 demonstrated significant 

improvement from baseline in eight of nine domains (p<0.001) in health related quality of life 

outcomes as measured by the KHQ at 24 months. Significant reductions were confirmed in the 

subgroup of subjects 65 years old and greater. The only domain that did not show improvement 

was the General Health Perceptions.217
54 

Table 14. RCT arms for darifenacin effect on urge incontinence 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Darifenacin 30 mg once a day 

Hill et al.100

2006 

96 

(86.0) 

54.0 2.7 1.1 1.6 12 

Zinner et al.82

2005 

15 

(93.4) 

59.9 2.9 1.3 1.7 2 

Darifenacin 15 mg once a day 

Hill et al.100

2006 

93 

(86.0) 

55.1 2.5 1.0 1.5 12 

Zinner et al.101

2006 

185 

(86.4) 

59.1 2.7 0.9 1.8 12 

Zinner et al.101

2006 

185 

(86.4) 

59.1 2.7 1.4 1.3 2 

Zinner et al.82

2005 

17 

(93.4) 

59.9 2.9 1.6 1.4 2 

Darifenacin 7.5 mg once a day 

Hill et al.100

2006 

99 

(87.0) 

56.1 2.0 0.8 1.2 12 

Placebo 

Hill et al.100

2006 

101 

(83.0) 

53.7 2.3 1.5 0.8 12 

Zinner et al.101

2006 

188 

(88.0) 

59.1 3.0 2.0 1.0 2 

Zinner et al.82

2005 

15 

(93.4) 

59.9 2.9 2.1 0.8 2 

Table 15. RCT arms for darifenacin effect on voids per day 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Darifenacin 7.5 mg once a day 

Hill et al.100

2006 

99 

(87.0) 

56.1 10.3 8.6 1.7 12 

Darifenacin 15 mg once a day 

Hill et al.100

2006 

93 

(86.0) 

55.1 11.0 9.1 1.9 12 

Zinner et 

al.101

2006 

185 

(86.4) 

59.1 11.0 8.8 2.2 12 

Zinner et al.82

2005 

17 

(93.4) 

59.9 10.4 9.3 1.1 2 
55 

Table 15. RCT arms for darifenacin effect on voids per day (continued) 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Darifenacin 30 mg once a day 

Hill et al.100

2006 

96 

(86.0) 

54.0 10.4 8.2 2.2 12 

Zinner et al.82

2005 

15 

(93.4) 

59.9 10.4 8.9 1.6 2 

Placebo 

Zinner et al.101

2006 

188 

(88.0) 

59.1 11.2 9.4 1.8 12 

Hill et al.100

2006 

101 

(83.0) 

53.7 10.1 9.0 1.1 12 

Zinner et al.82

2005 

15 

(93.4) 

59.9 10.4 9.6 0.8 2 

Treatment with trospium chloride. 

Content of the literature. Five RCTs evaluated trospium for reduction of symptoms of OAB. 

Four trials compared trospium to placebo, and one compared trospium to oxybutynin (5 mg 

twice daily) (Table 16). Four were conducted in the United States,103, 104 , 105, 106 and the fifth at 

multiple centers in Europe and Asia (Tables 16 and 17).90 These studies included a total of 1,309 

women, with a mean age of 59.8 years in the trospium treatment arms, and a total of 1,130 

women with a mean age of 60.1 in the placebo arms.103-106 One trial included a comparison to 

oxybutynin (5 mg twice a day).90 The trospium arm is included in Tables 16 and 17; and the drug 

to drug comparison in noted in KQ3. 

Outcomes. Reductions in numbers of urge urinary incontinence episodes per day at 12 weeks 

ranged from 1.8 to 2.5 relative to reductions in the placebo arms of 1.3 to 1.9. Reduction in voids 

per day on treatment ranged from 2.4 to 3.5 at 12 weeks, compared to placebo at 1.3 to 2.1 

Meta-analysis could be used to estimate effects of trospium extended release only. This 

formulation reduced UUI episodes per day by 2.45 (95 percent CI: 2.19, 2.70) and voids per day 

by 2.68 (95 percent CI: 2.38, 2.98) episodes. The aggregate effect of placebo across all available 

study arms was a decrease in UUI episodes per day of 1.08 (95 percent CI: 0.86, 1.30) and voids 

by 1.48 (95 percent CI: 1.19, 1.71) per day. 

Three studies evaluated urgency severity using the Indevus Urgency Severity Scale (IUSS). 

All three studies found statistically significant improvements in severity of urgency at trial end in 

the trospium arms versus placebo: p=0.0004, p≤0.001, and p<0.0001 respectively.103-105
56 

Table 16. RCT arms for trospium chloride effect on urge incontinence 

Author 

Year 

N 

(% Women) Mean age 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Trospium 60 mg once a day 

Dmochowski et 

al.105 2008 

267 

(82.1) 

61.2 4.0 1.6 2.4 12 

Trospium 60 mg once a day 

Staskin et al.103

2007 

263 

(85.2) 

59.6 4.1 1.6 2.5 12 

Staskin et al.103

2007 

263 

(85.2) 

59.6 4.1 1.8 2.4 4 

Trospium 20 mg twice a day 

Rudy et al.104, 

242 2006 

323 

(81.8) 

61.1 2.9 1.0 1.9 12 

Halaska et al.90

2003 

200 

(85.0) 

54.2 1.5 0.5 1.0 52 

Zinner et al.106

2004 

256 

(77.9) 

63.0 3.0 1.2 1.8 12 

Placebo 

Dmochowski et 

al.105 2008 

276 

(87.7) 

58.4 4.0 2.4 1.6 12 

Staskin et al.103

2007 

273 

(84.5) 

59.3 4.1 2.2 1.9 12 

Rudy et al.104, 

242 2006 

325 

(81.2) 

61.0 2.9 1.6 1.3 12 

Zinner et al.106

2004 

256 

(71.6) 

61.5 4.3 2.4 1.9 12 

Staskin et al.103

2007 

273 

(84.5) 

59.3 4.1 2.4 1.8 4 

Table 17. RCT arms for trospium chloride effect on voids per day 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Trospium 60 mg once a day 

Dmochowski et 

al.105 2008 

267 

(82.1) 

61.2 12.8 10.3 2.5 12 

Staskin et al.103

2007 

263 

(85.2) 

59.6 11.9 8.8 3.1 12 

Staskin et al.103

2007 

263 

(85.2) 

59.6 11.9 9.2 2.7 4 
57 

Table 17. RCT arms for trospium chloride effect on voids per day (continued) 

Author 

Year 

N 

(% Women) Mean age 

Voids per 

day 

baseline 

Voids per 

day on 

treatment 

Decrease in 

voids per 

day 

Weeks 

treated 

Trospium 20 mg twice a day 

Rudy et al.104, 242

2006 

323 

(81.8) 

61.1 12.9 10.3 2.7 12 

Trospium 20 mg twice a day 

Zinner et al.106

2004 

256 

(77.9) 

63.0 12.7 10.3 2.4 12 

Halaska et al.90

2003 

200 

(85.0) 

54.2 11.4 7.9 3.5 52 

Placebo 

Dmochowski et 

al.105 2008 

276 

(87.7) 

58.4 12.9 11.1 1.8 12 

Staskin et al.103

2007 

273 

(84.5) 

59.3 11.8 9.7 2.1 12 

Staskin et al.103

2007 

273 

(84.5) 

59.3 11.8 10.1 1.7 4 

Rudy et al.104, 242

2006 

325 

(81.2) 

61.0 13.2 11.4 1.8 12 

Zinner et al.106

2004 

256 

(71.6) 

61.5 12.9 11.6 1.3 12 

Quality of life was addressed in three studies using the OAB-SCS validated questionnaire103, 

104 and the IIQ in one.106 Only one of the studies using the OAB-SCS reported statistically 

significant improvement in quality of life compared to placebo, p<0.05.103

Treatment with estrogen. 

Content of the literature. Three studies assessed the role of hormonal therapy in different 

doses and formulations in the alleviation of OAB symptoms.107-109 All studies were performed in 

Europe and Scandinavia. They included a total of 508 women with a mean age of 62.4 years. 

Three were RCTs and one was a case series. 

Outcomes. One RCT compared oral estriol 3 mg per day to placebo at academic centers in 

England. They found that estriol was not significantly superior to placebo at improving 

symptoms or objective measures for all patients at one or three months.107

The second RCT compared an estradiol releasing vaginal ring to an estriol vaginal pessary in 

a community population in Denmark, and found both equal in improvement of UUI episodes, 

urgency, and nocturia. In each arm, 58 percent of participants had decreased UUI at 24 weeks; 

51 and 56 percent had decreased urgency, respectively.108 This is difficult to interpret in the 

absence of a placebo comparison. 

A recently published RCT compared tolterodine 2 mg twice daily with and without CEE 

(conjugated equine estrogens) vaginal cream 0.625 mg twice weekly. Voids per day decreased 

significantly in the CEE arm (p=0.001), but did not show significant difference in UUI events 

per day. Subjective assessment with UDI-6 and IIQ-7 showed significant improvement in the 

tolterodine with CEE arm (p=0.001).247 

One case series found oral HRT significantly improved frequency at six-month followup 

where dosage was not associated with outcome. Hormone replacement therapy in the form of 
58 

estriol significantly decreased frequency in the OAB arm at six weeks.109 Outcomes were 

assessed with a five-point unvalidated rating system and no helpful comparison group. 

Table 18. Effect on quality of life and satisfaction for pharmacologic treatment 

Author 

Year 

Comparison 

Groups, N Outcomes 

Oxybutynin 

Dmochowski et 

al.85

2002 

G1: Oxybutynin TDS 1.3 mg 

G2: Oxybutynin TDS 2.6 mg 

G3: Oxybutynin TDS 3.9 mg 

G4: Placebo 

• Participants in the treatment arm had significantly 

improved scores on the IIQ relative to placebo 

(p=0.033) 

• UDI scores showed greater improvement for 

treated patients compared to those on placebo 

(p=0.027) 

Dmochowski et 

al.88

2003 

G1: Oxybutynin TDS 3.9 mg 

G2: Tolterodine ER 4 mg 

G3: Placebo

• Compared to those receiving placebo, participants 

in both the oxybutynin and tolterodine groups had 

significantly greater improvement in the travel 

domain of the IIQ (p<0.05 for both) and on the 

irritative symptoms domain of the UDI (p<0.02 for 

both)

Homma et al.92

2006 

G1: Oxybutynin TDS 26 cm2

G2: Oxybutynin TDS 39 cm2

G3: Oxybutynin TDS 52 cm2

G4: Placebo 

• Participants in the treatment arm had statistically 

significant improvements across all domains of the 

KHQ compared to placebo (p<0.05 for all 

comparisons) 

Sand et al.245, 246

2006, 2007 

G1: Oxybutynin TDS 

G2: Educational intervention 

• Participants in the oxybutynin arm showed 

improvement in nine of ten domains on the KHQ 

and the PPBC vs. baseline (p<0.001), 

• Participants in the oxybutynin arm also showed 

improvement in embarrassment scores, effect on 

sex life, and relationships with partners (p<0.001) 

on BDI-II and KHQ 

• Oxybutynin also improved in interest in sex from 

baseline on BDI-II (p<0.001) 

Sussman et al.86

2002 

G1: Tolterodine ER 2 mg 

G2: Tolterodine ER 4 mg 

G3: Oxybutynin ER 5 mg 

G4: Oxybutynin ER 10 mg 

• Patients on tolterodine ER reported greater 

improvements after 8 weeks of treatment in 

bladder condition compared to tolterodine IR, 

oxybutynin ER or oxybutynin IR, on a validated 6-

point Likert scale (all comparisons p<0.01). 

Wang et al.93

2006 

G1: Electrical Stimulation 

G2: Oxybutynin 2.5 mg 

G3: Placebo 

• Statistically significant differences were seen on 

the overall score and the incontinence impact 

domain of the KHQ between the ES group and 

oxybutynin (p<0.001 and p=0.038, respectively) 

and between the ES group and placebo (p=0.006 

and p=0.012) 

• The difference between oxybutynin and placebo 

was also significant for the overall score only 

(p<0.001) 
59 

Table 18. Effect on quality of life and satisfaction for pharmacologic treatment (continued) 

Author 

Year 

Comparison 

Groups, N Outcomes 

Tolterodine 

Abrams et al.91

1998 

G1: Tolterodine 2 mg 

G2: Oxybutynin 5 mg 

G3: Placebo 

• After 12 weeks, 50% of patients on tolterodine, 

49% on oxybutynin and 47% on placebo reported 

a perceived improvement in symptoms 

Chapple et al.142

2008 

G1: Tolterodine ER 4 mg

G2: Fesoterodine 8 mg

G3: Placebo

• Significant improvement in HRQoL as assessed 

by KHQ and ICIQ-SF in both fesoterodine 8 mg 

arm and the tolterodine ER 4 mg arm vs. placebo, 

but no significant difference between arms 

• Fesoterodine arm showed significant improvement 

in eight of nine domains (non significant in 

General Health domain) 

• Subset of patients who reported incontinence at 

baseline showed similar improvements versus 

baseline; however, no significant difference was 

seen between arms as well as between subsets of 

those reporting incontinence at baseline versus 

those without 

Elinoff et al.160

2006 

G1: Tolterodine ER 4 mg • After 12 weeks of treatment, improvement in 

bladder condition was noted on the PPBC by 

78.8% of the intent to treat population, 86.2% of 

those bothered by urgency, 78.5% with nocturnal 

frequency and 74.6% of those with urge urinary 

incontinence 

• All patients reported significant decreases in OAB 

symptoms. Median percentage change for those 

with urge urinary incontinence was -86.1 (95% CI: 

-91.7, -80.0) 

Freeman et al.174

2003 

G1: Tolterodine ER 4 mg 

G2: Placebo

• Significantly more participants in the tolterodine 

group reported “much benefit” and bladder 

symptom improvement than in the placebo group 

(43% vs. 24%; p<0.001 and 62% vs. 48%; 

p<0.001, respectively) 

• Participants in the tolterodine ER group had 

greater improvement in self reported urgency 

compared with placebo (46.6% vs. 26.6%; 

p=0.001) 

Kelleher et al.223

2001 

G1: Tolterodine ER 4 mg 

G2: Placebo 

• Participants on tolterodine had significant 

improvements in several domains of the KHQ 

relative to placebo: incontinence impact, role 

limitations, physical limitations, sleep and energy, 

severity (coping), symptom severity, all at p<0.05 

• No significant differences were observed for social 

limitations, personal relationships, etc. 

• A significantly higher proportion of patients on 

receiving placebo compared to tolterodine 

reported improvement in their bladder condition 

(58% vs. 43%; p=0.001) 
60 

Table 18. Effect on quality of life and satisfaction for pharmacologic treatment (continued) 

Author 

Year 

Comparison 

Groups, N Outcomes 

Tolterodine 

Robinson et al.240

2007 

G1: Tamsulosin OCAS 0.25 mg

G2: Tamsulosin OCAS 0.5 mg 

G3: Tamsulosin OCAS 1.0 mg 

G4: Tamsulosin OCAS 1.5 mg 

G5: Tolterodine ER 

G6: Placebo 

• No significant improvements were seen on the 

KHQ in either the tolterodine or tamsulosin 

groups 

Rogers et al.241

2008 

G1: Tolterodine ER 4 mg 

G2: Placebo

• Treatment group had improvements in sexual 

and emotional health versus placebo. SQoL-F; 

PISQ-total score, and HAD anxiety; p=0.004, 

p=0.009, p=0.03 respectively 

Tseng et al.247

2009 

G1: Tolterodine 2 mg 

G2: Tolterodine 2 mg + vaginal 

CEE

• Both groups had improvements over baseline 

on the UDI-6 and IIQ-7 

Zinner et al.158

2002 

G1: Tolterodine ER 4 mg 

G3: Placebo 

G3: Tolterodine ER 4 mg 

G4: Placebo

• After 12 weeks, 69.8% of older (≥65) 

participants considered the treatment beneficial, 

compared to 46.9% on placebo (p<0.001) 

• In the younger group, 78.3% of treated patients 

considered the treatment beneficial, compared 

to 58.3% placebo (p<0.001) 

Solifenacin 

Chapple et al.99, 211

2007 

G1: Solifenacin 5 mg 

G2: Tolterodine ER 4 mg 

• Significant change was seen on PPBC in 

solifenacin group compared to tolterodine group 

at 4 weeks (-1.51 vs. -1.33; p=0.006) 

Garely et al.218

2006 

G1: Solifenacin 5 mg or 10 mg 

(flexible dosing) 

• Significant change was seen on the PPBC scale 

from baseline to study end (4.4 vs. 2.9; p<0.001)

• Participants reported improvement on all 

subscales of the OAB-q (mean changes, 14.7 to 

29.6; all p<0.001) 

• Using the VAS, participants reported significant 

reductions in degree of bother associated with 

urgency, urge urinary incontinence, frequency 

and/or nocturia (all p<0.001) 

Kelleher et al.225

2005 

G1: Solifenacin 5 mg 

G2: Solifenacin 10 mg 

G3: Placebo 

• Patients in the solifenacin arms had significantly 

greater improvement in nine of ten domains of 

the KHQ (except personal relationships) after 12 

weeks (p<0.05) 

Yamaguchi et al.98

2007 

G1: Solifenacin 5 mg 

G2: Solifenacin 10 mg 

G3: Propiverine 20 mg 

G4: Placebo 

• Solifenacin and propiverine were both 

associated with significant improvements in QoL 

as measured by the KHQ when compared to 

placebo (p<0.05 on all subscales) 

• Greater improvements were reported on the 

severity domain in the solifenacin 10 mg group 

compared to placebo (p<0.05) 
61 

Table 18. Effect on quality of life and satisfaction for pharmacologic treatment (continued) 

Author 

Year 

Comparison 

Groups, N Outcomes 

Trospium 

Rudy et al.104

2006 

G1: Trospium 20 mg 

G2: Placebo 

• Participants in the trospium arm had significantly 

greater reduction in the OAB-SCS score 

compared to placebo (-8.4 vs. -4.6; p<0.0001) 

Staskin et al.103

2007 

G1: Trospium 60 mg 

G2: Placebo 

• Using the OAB-SCS, the study demonstrated 

significant improvement of quality of life in the 

treatment group relative to placebo at 12 weeks 

(-11.2 vs. -7.8; p<0.001) 

Zinner et al.106

2004 

G1: Trospium 20 mg 

G2: Placebo 

• Participants in the trospium arm had a reduction 

of their IIQ score of 59 compared to 36 in the 

placebo group (p≤0.05) 

Darifenacin 

Hill et al.100

2006 

G1: Darifenacin 7.5 mg 

G2: Darifenacin 15 mg 

G3: Darifenacin 30 mg 

G4: Placebo 

• VAS was used to assess changes in severity of 

urgency before and after treatment 

• Although changes were significant in pre-post 

measures in G2 and G3, no statistical 

comparisons are reported between groups 

Chapple et al.210

2007 

G1: Darifenacin 7.5/15 mg

G2: Placebo

• Participants in darifenacin arm showed 

statistically significant improvement in all 

domains of the OAB-q versus placebo (p<0.001)

Dwyer et al.217 G1: Darifenacin 7.5/15 mg • Improvement in patient reported outcomes from 

baseline as measured by KHQ (eight of nine 

domains, p<0.001) at 24 months 

Steers et al.102

2005 

G1: Darifenacin 7.5 mg 

G2: Placebo 

• Participants in the darifenacin arm reported 

significantly greater reduction in the severity of 

urgency episodes (p<0.05), by validated 100 

mm VAS 

Zinner et al.101

2006 

G1: Darifenacin 15 mg 

G2: Placebo 

• Participants in the darifenacin arm had a 

significantly greater change in OAB-q score after 

12 weeks of treatment (26.4 vs. 19.1; p<0.001) 

• Changes were also significantly greater in the 

treatment group for incontinence impact (-24.7 

vs. -17.8; p=0.022) and severity measures 

(-24.3 vs. -15.6; p<0.001) by ICIQ KHQ 

Harms of Pharmacologic Treatments 

Proportions of individuals reporting harms in RCTs of pharmacologic treatments ranged 

from 9.7 to 63.6 percent of study participants; however, harms were generally mild in nature, and 

withdrawals due to adverse events did not exceed 17 percent in any study (Table 19). The risk of 

occurrence of harms reported in treatment arms often overlapped those observed with placebo. 

Dry mouth was the most commonly reported harm, ranging from 5.9 percent to 88 percent in 

studies of oxybutynin IR, compared to 1.6 to 21 percent in placebo arms. Studies of transdermal 

oxybutynin had the lowest reported estimates of dry mouth (2.6 to 9.6 percent). Impaired 

urination, not defined by the authors, was reported in studies of oxybutynin and tolterodine. It 
62 

was highest in two studies of oxybutynin IR (14 to 29 percent), compared to 3.2 to 4.0 percent in 

two studies of oxybutynin ER, no events to 9.0 percent in six studies of tolterodine IR and 1.0 

percent in one study of tolterodine ER. Urinary tract infections were reported by up to 11 percent 

of participants in eight placebo arms. Immediate release formulations of oxybutynin and 

tolterodine both had reports of up to about 18 percent of participants experiencing a UTI, 

compared to up to 12 percent in studies of oxybutynin ER and 4.1 percent in studies of 

tolterodine ER. Between 0 and 32 percent of participants in treatment arms reported constipation; 

again, the highest rate was reported in an oxybutynin IR arm. Darifenacin had the second highest 

proportion of participants reporting constipation (18.5 to 27.8 percent). Up to seven percent of 

participants in placebo arms also reported constipation. 

Cardiac events, including new abnormalities on EKG, were very rare and reported in only a 

few studies. The highest reported rate of cardiac events was five percent in tolterodine ER. 

Generally, however, less than one percent of participants experienced any cardiac event, mostly 

tachycardia and arrhythmias in treatment arms, with events also occurring in placebo arms (0 to 

0.9 percent). 
63 

Table 19. Side effects and harms of pharmacologic treatment 

Range 

(Number of 

studies 

reporting) 

Placebo Oxybutynin IR Oxybutynin ER Oxybutynin TDS Tolterodine IR Tolterodine ER Trospium Darifenacin Solifenacin Fesoterodine 

Cardiac 

events* 

0-0.9 

(3) 

0.2-1.2 

(3) NR 0.8 (1) 

0 

(1) 

0-5 

(2) 

0.1 

(1) 

0.5 

(1) 

0.3 

(1) 

3.3-3.9 

(1) 

Constipation 0-7 

(19) 

0-32 

(10) 

6.4-8.6 

(5) 

3.3-5.4 

(2) 

2.6-10.4

(12) 

2.5-10.2

(11) 

7-10.9 

(5) 

18.5-

27.8 

(5) 

6.4-18.9

(9) 

3.3-14 

(2) 

Diarrhea 2-5.4 

(4) 

2-5 

(2) 

7.9-14 

(3) NR 3-3.4 (2) 

2-6.8 

(4) 

1-3.1 

(3) NR NR NR 

Dizziness 0-3.8 

(5) 

1.6-38 

(6) 

3.8-11 

(5) 

4 

(1) 

1.7-4.3 

(4) 

1.4-2.5 

(5) NR 0 (1) 

1.2 

(1) 

1-1.5 

(1) 

Dry mouth 1.6-21 

(23) 

5.9-88 

(15) 

14-68 

(9) 

2.6-9.6 

(3) 

10-50 

(15) 

7.3-39 

(13) 

8.7-33 

(5) 

20.4-

59.1 

(5) 

17.9-

34.1 

(9) 

21.7-99

(2) 

Dyspepsia 0.9-5 

(4) 

3-27 

(5) 

5.3-11 

(3) NR 3-9 (7) 

2.7-3 

(3) 

5 

(1) 

5.2-8.7 

(2) NR NR 

Fatigue <1-1.6 

(3) 

15 

(1) 

1.6-18 

(2) NR 1-3.6 (2) 

2-3.4 

(2) NR NR NR <1 (1) 

Headache 0-5 

(12) 

1.2-22 

(7) 

5.6-12 

(6) NR 3-10.4 (10) 

3-7 

(9) 

1-5.5 

(4) 

3.8-8.1 

(4) 

3.4-3.6 

(4) 

2.4-12 

(2) 

Impaired 

urination 

0 

(2) 

14-29 

(2) 

3.2-4 

(2) NR 0-9 (6) 

1 

(1) NR NR NR NR 

Insomnia 2-2.2 

(2) 

2 

(1) 

0.5-1.8 

(3) NR 0.5-1.8 (4) 

0.8-1.7 

(3) 

4 

(1) NR 0.8 (1) NR 

Nausea 2-11 

(4) 

2-17 

(7) 

3.2-5 

(3) 

4.6 

(1) 

1.6-7 

(6) 

1-2.7 

(4) 

2 

(1) NR 1.8 (1) 

<1-1.4 

(1) 

Respiratory 

events 

0-14 

(5) 

3-13 

(2) 

6 

(1) NR 10-16 (2) 

4 

(1) 

6.4 

(1) 

0.3-5.6 

(2) 

3.1-4.6 

(3) NR 

Somnolence 0-2 

(4) 

3-40 

(3) 

1-4.3 

(4) 

1.6 

(1) 

1.6-2.7 

(4) 

2.3-3 

(3) NR NR NR NR 

Urinary tract 

infections 

0-11 

(8) 

<1-18 

(3) 

5.1-12 

(2) 

2.4 

(1) 

3-19 

(4) 

2.7-4.1 

(6) 

4.9-12 

(2) 

1.1-4.8 

(3) 

3.4-3.6 

(2) 

10-15 

(1) 

Vision 

changes 

0-7.7 

(12) 

1.2-22 

(8) 

2.2-3.3 

(4) 

2.3 

(1) 

0.6-7.5 

(6) 

<1-6 

(6) 

3 

(1) 

0-3.5 

(2) 

0.7-6.9 

(9) 

2.2-4.2 

(1) 

Any adverse 

event 

17.5-

48.9 

(6) 

57 

(1) 

51 

(1) NR 53 (1) 

9.7-74 

(6) 

26.8-

59.6 

(2) 

47.9-

63.6 

(2) 

59.4 

(2) 

50-69 

(2) 

Withdrawals 

due to 

adverse 

events 

0-6 

(11) 

16-17 

(2) 

6.2-13 

(4) 

10.7 

(1) 

1.9-15 

(6) 

2.8-6.3 

(5) 

7.3-8.8 

(1) 

3.2 

(1) 

3.7-9.7 

(4) 

6-9 

(1) 

* Includes new abnormal EKG, tachycardia, other arrhythmias, palpitations, and other cardiac events as grouped 

together in the literature. 
64 

Procedural and Surgical Treatments of OAB 

We reviewed 18 studies, of which 11were fair quality and 7 poor. This section presents the 

results of our literature search and findings about outcomes of procedural and surgical treatments 

for OAB. These treatments include sacral neuromodulation, peripheral neuromodulation, 

electromagnetic nerve stimulation, injection or instillation of drugs into the bladder, bladder 

distention and bladder transection. No studies regarding augmentation cystoplasty or detrusor 

myomectomy met our search criteria. Detailed information on all studies relating to surgical 

management of OAB can be found in evidence tables in Appendix C. 

Sacral neuromodulation. Stimulation of the sacral nerve roots is a technique in which an 

electrical stimulus directly stimulates the S3 sacral nerve root.256 The technique has evolved over 

time, but typically it is performed as a staged procedure. The first stage involves a “test” 

stimulation using a percutaneous needle to stimulate the S3 nerve root. If there is a favorable 

response during the trial period, then long-term stimulation can be provided by implanting an 

implantable pulse generator surgically. The implantable pulse generator is usually placed in the 

fatty tissues overlying the buttocks, although abdominal placement was used with some of the 

earlier studies. Recent evolutions in this technique now permit a permanent lead to be used for 

the test stimulation. If the test is unsuccessful, the lead can be removed, but if it is successful, 

this lead is attached to the permanent implantable pulse generator. This has the advantage of 

ensuring that stimulation is provided in the exact location as during the test period. (Previously, a 

new lead was placed at the time of the implantable pulse generator placement.) The mechanism 

by which neuromodulation acts to improve symptoms is not completely understood. The 

technique is used for urinary urgency, frequency, and urge incontinence refractory to other 

treatment modalities.256 It is also used for urinary retention. Given these seemingly contradictory 

applications, it is thought that the electrical stimulation affects the afferent nerves (which 

perceive bladder sensation), thus allowing them to appropriately transmit bladder sensations. 

Peripheral neuromodulation. Other techniques for neuromodulation involve stimulating the 

S3 nerve fibers more peripherally, at the posterior tibial nerve or cutaneous stimulation of the 

pudendal nerve via an anal or vaginal probe.257 For the posterior tibial nerve stimulation, a 

needle is placed percutaneously near the ankle and is attached to an external electrical device. 

Instead of implanting an implantable pulse generator, the patient returns for periodic sessions, 

often weekly for a series of treatments. Small case series suggest that posterior tibial nerve 

stimulation may improve OAB symptoms.258-260 There were no studies involving this technique 

which met our search criteria. One study evaluating neuromodulation of the pudendal nerve with 

anal and/or vaginal probes met our search criteria. Similarly, this is performed on an outpatient 

basis with weekly treatment sessions. 

For the purposes of this report, sacral neuromodulation will refer to techniques that directly 

stimulate the S3 nerve root. Peripheral neuromodulation will refer to nerve stimulation 

peripherally, such as the use of an anal or vaginal probe to stimulate the pudendal nerve. These 

approaches are reviewed in the same section of this text. 

Electromagnetic sacral nerve stimulation. Electromagnetic stimulation is yet another 

modality to modulate the neurologic control of the bladder. Most treatments involve large, 

powerful magnets which require a dedicated facility as the magnets are not portable.261 The study 

included in this review evaluated the use of a smaller, portable electromagnetic system. 

Bladder instillation/injection of a drug. Another approach to treating urinary frequency, 

urgency, and urge incontinence is to instill or inject a drug into the bladder. Numerous drugs 
65 

have been administered using this approach. Two categories of intravesical drugs are included in 

this review, antimuscarinic agents and neurotoxins. By instilling or injecting the drug directly 

into the bladder, systemic adverse effects are theoretically avoided. 

Two neurotoxins discussed in this review are resiniferatoxin and botulinum toxin. Botulinum 

toxin is a neuromuscular blocking agent which prevents nerve conduction. Typically botulinum 

toxin-A is used and can be injected directly into the wall of the bladder under cystoscopic 

guidance as a treatment for refractory OAB.262-264 It is not FDA approved for this indication at 

the time of the writing of this document. Concerns with this approach are the risk of urinary tract 

infections and urinary retention and that the ideal dosing has not yet been determined. 

Additionally, the effects of botulinum toxin are temporary and multiple courses of treatment 

would be anticipated. An RCT comparing botulinum toxin A to placebo for women with 

refractory urge incontinence found that incontinence episodes decreased from over 20 episodes 

per three day diary to less than 5 episodes per three day diary among those receiving botulinum 

toxin A, while those taking placebo had no difference in the number of incontinence episodes. 

Using a Patient Global Impression of Improvement score, approximately 60% of the women who 

received botulinum toxin A had a clinical response, and this response lasted six times longer than 

that achieved with placebo. The study was stopped early due to increased postvoid residuals in 

43% of women receiving botulinum toxin A and a high rate of urinary tract infections among 

those with elevated postvoid residuals.265 Resiniferatoxin is a neurotoxin in the same category as 

capsaicin; these do not have FDA approval for the treatment of OAB. These agents block 

transmission along the C-fibers, nerve fibers involved in transmitting noxious stimuli.127 It has 

been hypothesized that inhibition of these fibers may be a treatment for overactive bladder. 

A review of RCTs evaluating the use of intravesical botulinum toxin for OAB was published 

by the Cochrane Collaboration in 2007.128 Eight studies met their search criteria: five were 

published abstracts and three were full papers. Only one of the eight studies exclusively dealt 

with idiopathic OAB, the definition we used for our literature search. The remaining seven 

studies in the Cochrane review included subjects with neurogenic OAB. 

The findings from the Cochrane review were that botulinum toxin injections were more 

effective than placebo, with fewer incontinence (unspecified type) episodes per day at 2 to 24 

weeks and fewer incontinence episodes compared to baseline. Improvements following treatment 

were also seen in incontinence specific and overall quality of life. Urodynamic changes were 

also seen, including decreased pressure during a detrusor contraction and increased bladder 

capacity following treatment with botulinum toxin. The postvoid residual, the amount of urine 

left in the bladder after voiding, was also elevated. The numerical data were not provided by the 

author. Adverse events included cases of urinary retention requiring intermittent self 

catheterization following treatment. Of the patients requiring catheterization, 25 percent had a 

lower urinary tract infection. 

In the Cochrane Collaboration, the limited number of studies, their small size and 

heterogeneous population highlight the need for more research regarding treatment with 

botulinum toxin.128 One study compared botulinum toxin to bladder instillations with 

resiniferatoxin and found lower rates of incontinence, increased bladder capacity and lower 

detrusor pressure during uninhibited bladder contractions at 6 to 18 months with the botulinum 

toxin treatment. The optimal dose or long term effects of elevated postvoid residuals has not 

been determined. 

Bladder distention and bladder transection. Two treatments that are no longer in common 

practice, prolonged bladder distention and bladder transection, are also included in this review. 

The bladder distention study describes distending the bladder to maximum capacity at a pressure 

equal to systolic blood pressure for four hours.118 Bladder transection involves cutting the 
66 

bladder wall and detrusor muscle. Both have significant morbidity and have been abandoned by 

most practitioners. 

Outcomes of procedural and surgical treatments. 

Content of the literature. We identified 18 studies reporting on surgical treatments and 

procedures for OAB (clinical trials reported in Table 20).110-127

Eleven were of sacral neuromodulation, one of peripheral neuromodulation and one of 

electromagnetic sacral nerve stimulation. Three studied bladder instillation or injection of drugs, 

one was of bladder distention and one was of bladder transection. 

Six of the 11 studies on sacral neuromodulation come from a family of papers financially 

supported by one company.110, 111, 114, 115, 123, 124 The patient population for this family of studies 

included an RCT to evaluate sacral neuromodulation versus medical therapy for six months.124

The other studies involved similar inclusion and exclusion criteria, but varied in regards to the 

number of centers involved in recruitment (between 12 and 17 centers) and timing for 

enrollment. Given this, it is not possible to determine the degree of subject duplication. 

Table 20. Outcomes of clinical trials of procedures 

Author 

Year 

Design Groups N 

Per day 

baseline 

Per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks at 

evaluation 

Episodes of urge incontinence per day 

Rios et al. G1: Resiniferatoxin 34 3.1 2.7 0.4* 4 127

2007 

G2: Placebo 24 5.8 4.2 1.6* 4 

Schmidt et G1: SNM 34 9.7 2.6 7.1^ 24 

al.124 

1999 G2: Usual care 42 9.3 11.3 +2.0^ 24 

Voids per day 

G1: Trans-sacral 

magnetic stimulation 33 10.0 9.0 1.0* 12 

O’Reilly et 

al.125

2008 

G2: Sham 

treatment 30 9.0 9.0 0.0* 12 

Rios et al. G1: Resiniferatoxin 34 9.7 9.0 0.7* 4 127

2007 G2: Placebo 24 9.9 9.2 0.7* 4 

G1: Oxybutynin 

instillation 26 12.6 5.8 6.8^ 4 Enzelsberger 

et al.126 

1995 G2: Sterile water 

instillation 26 12.8 10.4 2.4^ 4 

* Not significant differences between groups; ^ = p <0.01 

This literature included 13 case series studies, which we operationally defined as descriptive 

analyses of a sequence of participants having the same type of procedure without a comparison 

to another type of surgery or treatment. Three of these studies are retrospective case series of a 

particular surgical treatment: two report on sacral neuromodulation119, 120 and one on bladder 

transection.121 Nine studies are prospective case series: six report on sacral neuromodulation,110-

115 one on peripheral nerve stimulation with anal and/or vaginal probes,116 one on botulinum-A 

toxin injections117 and one on prolonged bladder distention.118 One case series had both a 

retrospective arm as well as a prospective arm; this study looked at sacral neuromodulation.122
67 

One study is a prospective cohort that compared outcomes among subjects receiving sacral 

neuromodulation and subjects receiving a control surgery for sacral neuromodulation, but 

without active electrical stimulation.123 

Four studies were RCTs: one looked at sacral neuromodulation versus medical therapy,124

one evaluated transcutaneous electromagnetic stimulation versus sham,125 and two evaluated 

instillation of a drug into the bladder versus placebo – one using oxybutynin126 and one using 

resiniferatoxin.127

The majority of the studies were conducted in Europe, six of which included involvement 

from Canada and the United States (there is subject duplication among these six studies). One 

study was conducted in the United States only. Two studies were performed in Australia and one 

in Brazil. Two of the studies involved national registries, one from Switzerland and one from 

Italy. Five studies specified that they occurred in an academic setting, three in a specialty setting 

and the remainder did not specify the clinical setting for the study. 

The quality of the studies varied widely. Of the four randomized controlled trials, three had 

an appropriate control group, the fourth compared sacral neuromodulation to continued medical 

treatment among subjects who had already failed medical management for refractory OAB.124 

This does not adequately control for the placebo effect, which is quite prominent among these 

treatments. It is challenging to create an appropriate control group when evaluating sacral 

neuromodulation. This is illustrated by a cohort study in which surgical controls received sacral 

neuromodulation, but no electrical stimulation was applied. Given that subjects feel the electrical 

stimulation, they would be aware that this has been de-activated following the test stimulation.123

Of the 11 studies on sacral neuromodulation, seven did not restrict the study population to OAB. 

Although sacral neuromodulation may be used to treat urinary retention, grouping these studies 

in such a fashion severely limited our ability to analyze the results. We restricted our discussion 

to the OAB findings in these papers. Case series studies are limited by the lack of a control 

group. 

Outcomes assessed. Half of the studies reported on urge urinary incontinence outcomes 

(usually incontinence episodes per day as measured by a bladder diary, but also pad counts, pad 

weight, severity of incontinence or other measures). Nearly two-thirds of the studies reported 

some measure of urinary frequency, such as voids per day. Nearly all of the studies reported on a 

subjective measure of symptoms (such as percent cured, perceived severity, QoL). A third of the 

studies reported on urodynamic outcomes, such as the bladder volume at which there was a 

normal desire to void, and bladder capacity. 

The majority (78 percent) of the studies, reported data on adverse effects or harms. Six 

studies reported on problems with constipation or gastrointestinal symptoms,111, 114, 116, 119, 120, 126

eight reported the presence of pain, six reported on infection and nearly half of the sacral 

neuromodulation studies reported the presence of lead migration. Other adverse effects were 

reported in 72 percent of studies. 

Outcomes of sacral neuromodulation and peripheral neuromodulation. 

The one RCT comparing sacral neuromodulation to medical therapy found a reduction in 

daily incontinence episodes from 9.7 to 2.6 in the intervention group, compared to an increase of 

9.3 to 11.3 in the medical management group at six months (p<0.01).124 Of note, all subjects 

receiving medical therapy had already failed medical management; no benefit from continued 

medical therapy would be expected. The remaining six case series that reported on change in 

UUI had decreases in mean incontinence episodes per day of 51 percent to 80 percent111, 114, 115, 

119, 122 and from a median of five down to zero incontinence episodes a day.112 Length of 

followup in these studies ranged for six months to five years. 
68 

Pad use per day also decreased with sacral neuromodulation. Most studies started with a 

baseline of five or more pads used daily. One RCT reported an 82 percent decrease in pad use 

from 6.2 to 1.1 pads daily, six months following initiation of sacral neuromodulation.124 Three 

case series evaluating sacral neuromodulation also found significant decreases in pad use ranging 

from 49 to 84 percent fewer mean pads111, 114, 115 and a 75 percent decrease in median pad use.112

Length of followup on these studies ranged from six months to five years. 

Some of the studies tried to characterize the severity of incontinence episodes. One RCT and 

two case series found a 64 percent to 92 percent decrease in the number of moderate to heavy 

urge urinary incontinence episodes at six months to five years of followup.111, 115, 124 The RCT 

reported the highest rate of decreased heavy incontinence episodes with a mean baseline in the 

neuromodulation group of 3.4 per day, reduced to 0.3 per day six months after treatment. In 

comparison, those with refractory OAB receiving usual therapy experienced an increase in mean 

heavy episodes per day from 2.6 to 3.9.124 

Improvement in episodes of urinary urgency without incontinence is difficult to measure as it 

is a more elusive symptom. Nonetheless, on a 3 point scale, (1=mild, 2=moderate, 3=severe), 69 

percent of participants in one study reported improvement,114 with a second study showing no 

change in experience of urgency.115 

Reduction in urinary frequency of between 31 and 45 percent is seen consistently across 

studies of sacral neuromodulation, regardless of study design. The majority of studies of sacral 

neuromodulation reported urinary frequency as the mean number of voids in 24 hours as 

recorded by a bladder diary. Six studies reported mean voids per day, one of which was a 

prospective cohort study comparing subjects with sacral neuromodulation and controls who had 

sacral neuromodulation placed, but did not receive active electrical stimulation.123 At six months, 

those receiving sacral neuromodulation had a 45 percent decrease in the number of voids per 

day; no change was seen in the controls. Similar results were seen in the other studies, which 

found 31 to 40 percent fewer voids per day with sacral neuromodulation, regardless of whether 

they were prospective or retrospective case series studies.114, 115, 119 One study reported its results 

as a 40 percent decrease in the median number of voids per day.112 Another study reported the 

results from an Italian national registry; they did not have baseline information regarding the 

number of voids in the registry prior to treatment, but 42 percent of subjects had fewer than 8 

voids daily after treatment.122 The 31 to 45 percent decrease in mean (and median) voids per day 

seen across the studies was present at six months and up to two years following initiation of the 

sacral neuromodulation.112, 114, 115, 119, 123 The longest followup data was available from a 

prospective case series which found a 33 percent decrease in mean voids per day at one year 

which was reduced to a 23 percent decrease in mean voids per day at five years.115

Some studies also looked at the mean voided volume as a measure of treating urinary 

frequency. One cohort study and two case series found that sacral neuromodulation increased the 

mean voided volume between 1.7 to 1.9 fold, an increase of 78 mL to 108 mL per void.114, 115, 123

Peripheral neuromodulation and electromagnetic stimulation were clinically ineffective in 

changing voiding frequency. One prospective case series found a 12 percent decrease in the 

mean voids per 24 hours was seen six weeks following 12 sessions of peripheral 

neuromodulation with an anal and/or vaginal probe.116 No decrease in mean voids per day was 

seen with electromagnetic stimulation of the sacral nerves.125

Neither sacral neuromodulation nor peripheral neuromodulation with an anal and/or vaginal 

probe had a clinically relevant impact on nocturia rates, which were very low in these studies at 

baseline. Both treatment approaches reduced already low rates by approximately 30 percent.116, 

119
69 

Several of the studies comment on clinical “cures” or “improvements”, but lack definitions 

for these criteria. Moreover, several of the case series on sacral neuromodulation include diverse 

patient populations which may include urinary retention or pelvic pain in addition to patients 

with symptoms of overactive bladder. The clinical endpoints for improvement in urinary 

retention are very different from those for urinary urgency and frequency. 

Studies evaluating improvements following sacral neuromodulation describe cure rates of 26 

to 65 percent (cure was defined as “completely dry” at six to twelve months).111, 122, 124 One study 

looked at improvements following the initial test stimulation and found 39 percent had greater 

than a 90 percent improvement in urinary frequency and/or urgency.113 As would be expected, 

higher rates are seen for classifications of “success” or “improvement” as compared to “cure.” 

Compared to these rates, peripheral neuromodulation only had an 8.1 percent cure rate, with 

31 percent reporting no change.116

Several studies evaluated QoL, either with the KHQ, a VAS or other validated QoL 

questionnaire (Table 21). Two studies evaluated the impact of sacral neuromodulation on QoL 

and found the treatment beneficial.122, 123 There was no improvement in QoL with 

electromagnetic stimulation. 

Table 21. Effect on quality of life and satisfaction of procedural treatments 

Author, Year 

Study Type 

Comparison 

Groups, N Outcomes 

Hassouna et al.123

2000 

Cohort 

G1: Neuromodulation (25) 

G2: Control (25) 

• At six months, the neuromodulation group 

reported greater improvement in quality of life 

compared to controls (p<0.0001) 

• SF-36 scores266 were significantly higher 

(p<0.01) for sacral neuromodulation participants 

relative to controls on physical function, role 

physical, bodily pain, vitality, social function and 

mental health domains 

O’Reilly et al.125

2008 

RCT 

G1: Electromagnetic 

sacral nerve stimulation 

(33) 

G2: Sham (30) 

• No significant differences were observed by 

group for the KHQ domain(s) or the Australian 

Quality of Life Questionnaire domain(s) after 

Bonferroni correction for multiple testing 

Rios et al.127 2007 

RCT 

G1: Single dose 100 ml 50 

nM resiniferatoxin (34) 

G2: Placebo (24) 

• No differences were reported from baseline to 

post-treatment QoL scores by the KHQ for 

general health perception, social limitations or 

personal relationships. 

• Incontinence impact decreased a similar amount 

in both groups following intervention (p<0.05 

pre-post). Emotions, sleep/energy and symptom 

severity scores decreased more for G1 following 

the intervention (no between group testing) 

• Role limitations decreased for G2 (p<0.05) but 

not G1 following the intervention 

Schmid et al.117

2006 

Prospective case 

series 

Botulinum Toxin (100) • 90% of patients experienced improvement in at 

least one category of the KHQ at three months, 

with a waning of benefit by nine months. 

Spinelli et al.122

2001 

Case series 

G1: Sacral 

neuromodulation 

retrospective cases (93) 

G2: SNM prospective 

cases (103) 

• In a validated QoL questionnaire267 completed 

by 54% of prospective participants, all reported 

significant increases in life quality at all time 

points. 
70 

The evaluation of overactive bladder with urodynamics provides objective data, but the 

clinical relevance of this information is not always clear. Urodynamic parameters may indicate 

changes in bladder function, but unless symptoms were also evaluated, they do not necessarily 

carry over into improvements in clinical outcomes. 

During bladder filling, known as cystometry, the first sensation of bladder filling can be 

measured. This is known to be one of the more variable urodynamic measurements.268 The 

bladder volume at first sensation increased by 80 mL after sacral neuromodulation in one case 

series 110 and by 36 mL after peripheral neuromodulation with an anal/vaginal probe.116 Both of 

these studies also looked for changes in bladder capacity and found this increased 1.4 fold for 

sacral neuromodulation and found no difference for peripheral neuromodulation.110, 116

By their very nature, surgical and procedural treatments are likely to have a higher incidence 

of adverse events than conservative and medical treatments for OAB. In the early studies of 

sacral neuromodulation, there was an average of 1.1 to 1.7 adverse events per participant.115, 124

Advances in technology, such as the use of tined leads, have decrease this rate and the more 

recent studies report 0.1 to 0.5 events per participant.112, 119 None of the studies exclusively used 

the newer technology. Of the adverse events, pain, lead migration or problems with the lead, 

infection and explantation of the device were the most common adverse events. From the test 

stimulation phase, pain at the needle site was 0.5 percent in a study employing newer 

technology112 and 7 percent in a study with older technology.113 When the implantation phase is 

included, pain rates and uncomfortable stimulation responses were seen in 3.9 to 43 percent of 

subjects, with studies employing new techniques at the lower end of this spectrum.112, 114, 115, 120, 

122, 124 The one RCT found a pain rate of 19.1 percent, but this was compared to medical 

management, not a sham procedure.124 Pain at the implantable pulse generator implantation site 

was typically reported separately and occurred 15.4 to 27 percent of the time.114, 115, 120, 124

Problems with the lead or lead migration occurred between 3.3 and 11 percent of the time.114, 115, 

120, 122, 124 This may be less common with the new tined leads, as one study had lead migration 

only with the older non-tined leads112 and another found a lower loss of efficacy, 12.3 percent, 

with the tined leads compared to the non-tined leads, 31.7 percent.119 Infection occurred in 1.9 to 

6.1 percent of participants, sometimes requiring hospitalization for intravenous antibiotics or 

removal of the device.114, 119, 120, 122, 124 Two papers noted a 0.5 to 1.7 percent risk of neuropraxia 

or nerve injury.114, 120 There was a high rate of needing surgical revision, with most studies 

showing 33 to 48.3 percent of subjects required a return to the operating room.114, 120, 124 Lower 

rates were documented in a study using newer technology, 7 percent,112 and in a national 

registry, 9.7 percent.122 One study looked at return to the operating room rates at five years and 

found that that there was a 67 percent risk of return (numbers based on the population 

enrolled).115 However, at five years, many of the subjects were returning for new implantable 

pulse generator batteries, an expected development over time, thus this is not truly an adverse 

event. Unfortunately, the number of surgeries which were to replace implantable pulse generator 

batteries was not reported. Of the surgical adverse events, a significant proportion included 

explantations of the device. This occurred in 3.9 percent of subjects in the national registry;122

higher rates were seen in the remaining studies, 9.8 to 14 percent.111, 115, 120

Adverse events following peripheral neuromodulation with an anal and/or vaginal probe led 

to a 19 percent dropout rate, with 29 percent of the dropouts attributed to pain. The other most 

common complaint was bowel irritation.116 Currently, techniques of peripheral neuromodulation 

with an anal/vaginal probe are not routinely used. 

Outcomes of bladder instillation/injection of drugs. An RCT of resiniferatoxin bladder 

instillations versus placebo found no improvement in the number of urge urinary incontinence 

episodes per day with either arm.127 However, bladder instillations with oxybutynin did decrease 
71 

mean voids per day. In an RCT evaluating bladder instillations with oxybutynin versus a placebo 

with sterile water, those receiving oxybutynin had a 47 percent decrease compared to a 16 

percent decrease in mean voids per day with the placebo at two weeks following completion of 

treatment.126 This decrease is similar to that seen with sacral neuromodulation. In a prospective 

case series evaluating the use of botulinum-A toxin injected into the detrusor muscle of the 

bladder wall, 74 percent of the subjects had 8 or fewer voids per day four weeks following 

treatment. All subjects had greater than 8 voids per day at the start of the study.117 In an RCT of 

bladder instillations with resiniferatoxin versus placebo, there was no difference in the mean 

voids per day four weeks following treatment.127 Bladder instillations with oxybutynin decreased 

nocturia 65 percent from 5 to 1.8 episodes per night.126 Following injection of botulinum-A toxin 

into the bladder, 66 percent had no urgency at 12 weeks and 80 percent reported no urge 

incontinence.117 No difference was seen compared to baseline or placebo in an RCT evaluating 

resiniferatoxin bladder instillations.127 

Two studies looked at what volume the normal desire to void occurred, finding this increased 

1.6 fold (55 mL increase) for instillation of oxybutynin into the bladder126 and 1.7 fold (83 mL) 

for botulinum-A toxin bladder injections.117 Theoretically these increases would result in less 

urinary frequency, and possibly less urgency. Similar changes were also seen in terms of bladder 

capacity after treatment, with bladder instillations of oxybutynin increasing capacity 1.5 fold 

(105 mL)126 and 1.6 fold (135 mL) with botulinum-A toxin injections.117

A potential adverse effect of intravesical oxybutynin or botulinum-A toxin is impairment of 

the bladder’s ability to empty.265 The goal of treatment with these agents is to provide a dose 

large enough to decrease the symptoms of OAB, without impairing the ability to void when 

physiologically necessary. An objective measurement that can serve as a proxy for this parameter 

is a postvoid residual, the volume of urine that remains in the bladder after voiding; however the 

clinical importance of an increased postvoid residual in the absence of symptomatic urinary 

retention is not clear. The mean postvoid residual following treatment with intravesical 

oxybutynin increased twofold to a mean of 40 mL (range 10 to 50 mL) and for botulinum-A 

toxin, increased fourfold to a mean of 75 ± 10 mL.117, 126 Both treatments seem to have similar 

effects on bladder capacity, but the risk of urinary retention may be higher with use of 

botulinum-A toxin.117, 126 Currently, oxybutynin and resiniferatoxin instillations are not routinely 

used for the treatment of OAB. 

For instilled/injected bladder drugs, there were small benefits seen in the emotions, 

sleep/energy and symptoms severity subscales of the KHQ for subjects receiving the treatment 

compared to placebo. Incontinence impact scores improved a similar amount for both 

resiniferatoxin and placebo (p<0.05). Emotions, sleep/energy and symptom severity scores 

decreased more for resiniferatoxin following the intervention (p<0.05).127 Ninety percent of 

subjects receiving botulinum A toxin had an improvement in QoL scores at 3 months; this effect 

was waning at 9 months.117
72 

Outcomes of bladder distention and transection. Bladder distention and transection are 

treatment methods no longer in routine use. Following bladder distention, 18 percent were 

symptom free at 18 months with 52 percent unchanged.118 The study on bladder transection 

reports 65 percent were cured at two to five years and 16 percent were unchanged, but provides 

no information about the criteria for these categories.121 Prolonged bladder distention had a 4 

percent rate of bladder rupture.118 Bladder transection was associated with a 14 percent rate of 

vesicoureteral reflux on urodynamics, the clinical significance of which was not determined, and 

1 percent rate of a persistent urine leak requiring reoperation. The authors also noted “minor 

chest and urinary tract infections” but the rates of these adverse events were not reported.121

Behavioral Treatments 

This section presents the results of our literature search and findings about outcomes of 

behavioral techniques to reduce overactive bladder in women. Behavioral treatment options for 

OAB have been used for managing urinary incontinence for more than 50 years, although largescale and well-designed studies on them are fairly uncommon. We reviewed 27 studies, of which 

14 were fair quality and 13 poor. 

Behavioral techniques include the use of bladder training, pelvic floor muscle exercises 

(PME), biofeedback, dietary changes, and multicomponent approaches that combine bladder 

training with PME and/or biofeedback. Detailed information on all studies related to behavioral 

techniques for OAB can be found in evidence tables in Appendix C. 

Bladder training. Bladder training was introduced in the 1960s (Jeffcoate and Francis), and 

modified by Frewen in the 1970s. It involves education, a strict schedule of daytime voiding with 

progressive increases in time between voids, urgency suppression techniques, and positive 

reinforcement. Frewen recommended that women be treated initially on an inpatient basis, and 

the training was often combined with antimuscarinic medication or sedatives to manage extreme 

urgency. Inpatient bladder training is no longer standard practice, and the technique has been 

modified to be administered on an outpatient basis, with the use of patient education and bladder 

diaries. Although the underlying mechanism for bladder training in OAB is not well understood, 

it is thought to reverse dysfunctional habits, increase bladder capacity and provide techniques for 

handling feelings of urgency. 

Pelvic muscle exercises. Training the pelvic floor muscles were originally suggested for 

patients with stress incontinence, the idea being that patients could learn to contract the 

periurethral muscles to occlude the urethra during activities that caused leakage. However, it 

may also be useful in inhibiting detrusor contractions. PME can be implemented alone or with 

additional techniques such as biofeedback to help patients identify and contract the appropriate 

muscles. 

Multicomponent approaches. Although both bladder training and PME can and are 

administered alone, they may also be combined with or without biofeedback for a 

multicomponent approach to reducing incontinence. 

Tools for behavioral training. Behavioral training can be administered with written 

materials, verbal feedback, coaching in person or on the phone, in groups, or using other 

strategies, such as cognitive approaches or biofeedback for increasing the potential for success. 

Behavioral approaches can also be combined with medications such as antimuscarinics. Various 

combinations of approaches are examined in the literature and are described in this review. 

For the purposes of this report, we will use the term “bladder training” to refer to bladder 

training alone (i.e., without PME without biofeedback). “Behavioral training” will refer to a 

multicomponent approach that includes bladder training. We indicate when biofeedback is used 

in conjunction with other behavioral techniques. 
73 

Behavioral treatments. 

Content of the literature. We identified 29 papers from 27 studies that included arms with 

outcomes of behavioral interventions. We have divided the studies into three primary categories: 

those that compare only behavioral approaches, those that compare behavioral approaches to 

pharmaceutical ones directly and those that measure the effect of adding a behavioral approach 

to a pharmaceutical one (combination approaches). The first category is presented here and the 

second two are covered in KQ3. 

Nine studies met criteria and included only behavioral arms. Among these, two studies 

focused on comparing delivery mechanisms or approaches and provide insight into techniques 

for teaching and encouraging participants in behavioral management.132, 135

Four additional studies (represented in six papers) with multiple arms, including 

pharmacologic ones, provided data that allowed the comparison of behavioral management to 

placebo93, 143-145 or to another behavioral intervention.148, 201 These are counted in the direct 

comparisons section, and therefore are not represented in the counts below, but relevant 

outcomes are described here as well as the direct comparisons section, and they appear in tables 

in both sections. All three of these are RCTs. 

The literature base of studies that had only behavioral arms included three retrospective case 

series, which we have operationally defined as a sequence of participants having the same 

intervention without a comparison to another type of intervention. One examined bladder 

training alone,129 one examined pelvic muscle exercises130 and the third reported on a series of 

participants who were provided either bladder training or biofeedback, but presented results only 

for the two groups combined.131 All three were conducted in community-based clinical settings. 

One was a prospective cohort study comparing three bladder training approaches: selfadministered, coaching and cognitive strategies.132

Five studies were randomized controlled trials. One compared bladder training to a “control” 

condition.133 One compared bladder training to pelvic muscle exercises.134 One included the 

following three arms: pelvic floor muscle training, pelvic floor muscle training assisted with 

biofeedback, and electrical stimulation.93 One compared three different approaches to 

multicomponent behavioral training: biofeedback, verbal feedback and self-administered using 

an instruction booklet.135 One compared bladder training to bladder training with an additional 

caffeine reduction component.136

Three of the studies were conducted in the United States, four in Europe, one in Australia and 

one in Taiwan. Four were conducted at academic medical centers; five were in community 

settings, of which two included an inpatient component. 

Outcomes measured. For each type of intervention, we combed the publications for the 

outcomes and complications summarized in the analytic framework presented in Chapter 1. 

Five studies reported a change in numbers of episodes of incontinence,93, 134-136, 143 although 

the time period varied, and three of these calculated a percent reduction in incontinence 

episodes.135, 136, 143 Three of the studies measured incontinence episodes over the course of a 

week,134, 135, 143 two did so over 24 hours.93, 136 One study reported that a significant decrease in 

frequency of voiding was observed, but did not provide data that could be included in this 

table.132

Five studies presented the outcome of cure or improvement in incontinence (using various 

definitions)129-131, 133, 269 with three defining cure as complete resolution of incontinence.129, 131, 133

One study presented data on episodes of urgency separate from incontinence.136

Changes in frequency were reported in three studies.131, 136, 145 Two specified voids per day as 

an outcome.136, 145 In addition, Jarvis and colleagues133 reported on the numbers of women 

indicating that they had nocturnal and diurnal frequency before and after treatment. One study 
74 

recorded frequency over a three-day period132 and reported a statistically significant effect, but 

did not report numbers of episodes, and one reported time between voids.131 One reported that 

cure included achieving a minimum of three to four hours between voids129 and was therefore 

related to frequency but not summarized as effect on frequency. 

Other patient-reported outcomes in this literature included reports of resolution or 

improvement and changes in severity, quality of life, and satisfaction. 

Five of the studies provided some patient-reported outcome, with four reporting on perceived 

improvement.130, 131, 134, 135 Three provided some report on severity;130, 135, 143 four measured 

bother;132, 134, 135, 143 two measured impact or interference with daily activity;134, 135 one assessed 

changes in quality of life overall;134 and three reported on patient satisfaction.134, 135, 143

Outcomes of behavioral treatment. 

UUI episodes. Lack of consistency in study design, interventions or comparison groups 

makes it impossible to provide consistent summary results across studies. Although each 

intervention was associated with reductions in incontinence episodes, no behavioral approach 

performed better than any other in any study in this category on incontinence outcomes over any 

time period greater than 12 weeks. Trials are summarized in Table 22. 

Table 22. Outcomes of behavioral treatment trials 

Author 

Year Groups N 

Per day 

baseline 

Per day 

on 

treatment 

Decrease in 

episodes 

Weeks at 

evaluation 

Episodes of incontinence per day 

G1: Oxybutynin 22 2.0 1.0 1.0 12 

G2: Functional 

electrostimulation 

21 1.9 1.1 0.8 12 

Arruda et 

al.201 2008 

G3: Pelvic floor 

training 

21 2.3 1.1 1.2 12 

G1: Electrical 

stimulation 

25 1.0 0.5 0.5 12 

G2: Oxybutynin 

2.5 mg 3x/day 

26 0.0 0.0 0.0 12 

Wang et al.93

2006 

G3: Placebo 23 1.0 1.0 0.0 12 

G1: Bladder training 

+ caffeine reduction

Bryant et 48 2.8 1.2 1.6* 4 

al.136

2002 G2: Bladder 

training 

47 3.1 1.4 1.7* 4 

G1: Multicomponent 

via biofeedback 

73 2.2 0.9 1.3* 10 

G2: Multicomponent 

via verbal 

74 2.5 0.9 1.6* 10 

Burgio et 

al.135

2002 

G3: Selfadministered 75 2.2 1.0 1.2* 10 

G1: Multicomponent 65 2.3 0.4 1.9^ 10 

G2: Oxybutynin 

(range of doses)

67 2.3 0.8 1.5^ 10 

Burgio et 

al.143 1998 

G3: Placebo 65 2.2 1.2 1.0^ 10 
75 

Table 22. Outcomes of behavioral treatment trials (continued) 

Author 

Year Groups N 

Per day 

baseline 

Per day 

on 

treatment 

Decrease in 

episodes 

Weeks at 

evaluation 

Episodes of incontinence per day (continued) 

G1: Bladder 

Training

68 2.0 0.9 1.1† 12 

G2: Pelvic muscle 

exercise

64 3.0 1.7 1.3† 12 

Wyman et 

al.134 1998 

G3: Combination 

therapy

61 2.3 0.8 1.5† 12 

Voids per day 

G1: Oxybutynin 22 7.7 6.4 1.3 12* 

G2: Functional 

electrostimulation 

21 8.6 7.9 0.7 12* 

Arruda et 

al.201 2008 

G3: Pelvic floor 

training 

21 6.8 7.1 0.3^ 12* 

G1: Electrical 

Stimulation 

25 12.8 7.8 5.0^ 12 

G2: Oxybutynin 2.5 

mg 3x/day 

26 11.5 7.4 4.1^ 12 

Wang et al.93

2006 

G3: Placebo 23 11.5 10.0 1.5^ 12 

G1: Bladder training 

+ caffeine reduction 

Bryant et 48 11.1 6.8 4.3^ 4 

al.136 2002 

G2: Bladder 

Training 

47 11.2 7.9 3.3^ 4 

G1: Multicomponent 

behavioral ± 

biofeedback 

65 10.0 8.2 1.8 10 

G2: Oxybutynin 

(range of doses)

67 10.9 8.8 2.1 10 

Goode et 

al.145 2002

G3: Placebo + 

bladder diary

65 10.0 9.7 0.3 10 

* Not significant differences between groups. ^p<0.05 † Significant comparisons BT vs. CT and PME vs. CT

One study evaluated the ability of biofeedback to improve outcomes associated with 

multicomponent behavioral therapy,135 relative to providing the training with verbal feedback. 

The intervention included multicomponent behavioral training with either biofeedback or verbal 

feedback, compared to a self-help booklet. Multicomponent behavioral training combined 

bladder training techniques (e.g., relaxation approaches in the presence of urge, extending time 

between voids) with pelvic muscle exercises. The interventions took place over an eight-week 

period with four visits, followed by a two-week bladder diary. Reductions (mean: 58.6 to 69.4 

percent) in episodes of incontinence were seen in all groups, with median percentage reductions 

ranging from 70.4 (IQR: -29.4, 100) to 82.8 (IQR: 0, 100). The wide IQR makes this finding 

somewhat difficult to interpret, and overall there were no by-group differences (p=0.23), 

Nonetheless, patients’ perceptions of treatment benefit differed (see section below on patientreported outcomes) with patients in the self-administered training significantly less satisfied 

(p=0.001). 
76 

Burgio et al 135 also compared their multicomponent behavioral approach to oxybutynin and 

placebo (study described in KQ3) and observed reductions in incontinence episodes of 81 

percent among those in the behavioral group relative to 39 percent in the placebo arm. 

Wyman and colleagues attempted to separate the role of pelvic muscle strengthening from 

bladder drill, and assess the potential for a combined impact. Combining the approaches 

provided the greatest reduction in incontinence episodes immediately after the 12 week 

intervention (p=0.050), but the difference did not persist at three months (p=0.587).134

Only one study in this body of literature included vaginal electrical stimulation.269 In this 

study of pelvic floor muscle training with or without biofeedback compared to electrical 

stimulation, about half of women reported subjective improvement or cure in OAB when treated 

with electrical stimulation or biofeedback assisted pelvic floor muscle exercises, compared to 38 

percent of women instructed in pelvic floor muscle exercises and told to perform them at 

home.269

Frequency outcomes. Number of voids per day was a common, objective measure of 

treatment effectiveness for behavioral interventions – particularly as a key element of the 

training is generally encouraging patients to extend time between voiding progressively, with a 

goal of reaching three to four hours between voids. Bryant found greater reduction in frequency 

when a caffeine reduction component was added to bladder training (reduction of 4.3 versus 3.3; 

p=0.037).136 Women who simultaneously reduced caffeine intake had a 35 percent decrease in 

number of voids per day compared to 25 percent for those using bladder training alone. In the 

study described above of multicomponent behavioral intervention compared to placebo (and 

oxybutynin), frequency of micturition was reduced significantly in the behavioral arm, but not 

the placebo arm with a reduction of 1.8 micturitions per day. 

Urodynamic outcomes. Three studies examined urodynamic measures pre- and posttreatment.131, 133, 135 In all of the studies, increased bladder capacity was seen along with changes 

in incontinence and frequency measures. 

Pelvic muscle strength. Wang and colleagues269 found that biofeedback associated pelvic 

floor muscle exercises resulted in greater change in muscle strength than electrical stimulation, 

but the clinical significance of the change was not examined.

Patient reported outcomes. The nature of OAB is such that while specific morbidities and 

mortality are not primary outcomes, the interference that OAB creates in patients’ lives, along 

with embarrassment and stigma, is often the concern that results in treatment seeking. Therefore, 

characteristics that make up and affect quality of life are of concern for studies of women with 

OAB, and are the focus of the results presented below. Four studies presented data on patientreported outcomes other than urgency and frequency or cure/improvement.130, 132, 134, 135 

Wyman134 examined the potential impact of combining pelvic muscle exercises with bladder 

training in an RCT of 204 women, of whom 59 had detrusor instability (results for the 145 

women with SUI are not reported here as they are not relevant to this report). Although both 

impact (measured by the IIQ-R) and quality of life (measured by the UDI) were most improved 

in the combination group, relative to pelvic muscle exercises alone immediately after treatment, 

those effects were not sustained three months later. The combination group also had greater 

perceived improvement immediately after treatment, but again, no differences by group were 

sustained. 

In the Burgio study135 comparing biofeedback to verbal feedback and a pamphlet to teach 

multicomponent behavioral training, both biofeedback and verbal feedback performed equally 

well on all measures of patient perceptions of improvement, with verbal feedback better than the 

self-help booklet on five measures (accidents are smaller, p<0.006; comfortable with treatment, 

p=0.01; description of progress, p<0.001; satisfaction with progress, p<0.001; and restriction of 
77 

activities, p=0.002). The biofeedback group performed better on three measures (description of 

progress, p<0.001; satisfaction with progress, p=0.03 and restriction of activities, p=0.002). The 

biofeedback and verbal feedback groups saw no significant differences. All three groups had 

significantly improved quality of life scores (per Hopkins Symptom Checklist and Incontinence 

Impact Questionnaire), with no by-group differences. Similarly, Wang and colleagues269 found 

that biofeedback produced greater change in the overall Kings Health Questionnaire score among 

the group with biofeedback assisted pelvic floor muscle training relative to those who received 

PFMT without biofeedback or those who received electrical stimulation. Quality of life and 

satisfaction outcomes are summarized in Table 23. 

Table 23. Effects on quality of life and satisfaction of behavioral treatments 

Author 

Year 

Comparison 

Groups Outcomes

Burgio et al.135

2002 

RCT 

G1: Behavioral training 

with biofeedback 

G2: Behavioral training 

with verbal feedback 

G3: Self-administered 

behavioral training 

• 86% of those who received behavioral training with verbal 

feedback were completed satisfied relative to 75% of those 

receiving biofeedback and 56% in the self-administered group 

• Significantly more participants in the verbal feedback (89%) and 

biofeedback (79%) groups reported smaller accidents than in the 

self-administered group (68%) (p=0.02) 

• Almost all participants in the verbal (100%) and biofeedback 

(98%) groups were “comfortable enough” to continue treatment 

indefinitely, relative to self-administered (89%) (p=0.009) 

Dorey et al.130

2006 

Case Series 

G1: Pelvic muscle 

exercises 

• 64 of 75 reported pelvic muscle exercises were useful 

• Severity of UUI at discharge was reported to be severe in four 

(6%) and moderate in 12 (18%) participants, relative to 32 (37%) 

and 40 (46%) at baseline, respectively 

Dowd et al.132

2003 

Cohort 

G1: Bladder health 

information 

G2: Bladder health 

information + cognitive 

strategies (CS) 

G3: Bladder health 

information + CS + 

coaching 

• Persons in G1 and G3 saw modest gains in UFICQ scores over 

time; G2 did not. Significant group-by-type of UI interaction: G1 

and G3 with urge had more improvement than participants with 

stress or other UI (F=3.61; p=0.037) 

Wang et al.269

2004 

RCT 

G1: Pelvic floor muscle 

training (PFMT)

G2: Biofeedback assisted 

PFMT 

G3: Electrical Stimulation 

(ES)

• Significantly greater changes on the KHQ were observed for both 

biofeedback assisted PFMT and ES compared to PFMT alone 

(p=0.003), but not between biofeedback assisted PFMT and ES

• Significantly greater changes were observed for ES compared to 

both other interventions on two specific domains of the KHQ: 

emotions and severity

Wyman et al.134

1998 

RCT 

G1: Bladder training (BT) 

G2: Pelvic muscle 

exercise (PME) 

G3: Combination therapy 

(CT) 

• Immediately after treatment, the combination group showed 

significantly more improvement in quality of life measures on the 

UDI (p=0.054) but the improvement was not sustained at three 

months (p=0.126) 

• Changes in life impact as measured by the IIQ-R was greatest in 

the combination group immediately after treatment (p=0.03), but 

not at three months (p=0.85) 

• Satisfaction levels were highest among the combination group 

immediately after treatment (82% very satisfied, relative to 73% in 

the PME group and 64% in the BT group); however, differences 

were not statistically significant (p=0.096) 
78 

Complementary and Alternative Therapies 

Complementary and alternative therapies span a broad range of which only a small subset of 

modalities were used in studies of OAB. Acupuncture is an ancient Chinese medical system 

based on the balance of subtle energy flows (chi) in which imbalance of energy flows can result 

in disease. Acupuncture therapy aims to manipulate these energies through the insertion of fine 

needles at key, highly specific points related to chi flow to specific organs for varying periods of 

time. Foot reflexology is a variation of acupressure that postulates all body organs have 

corresponding external “reflex points on the foot” and the manipulation of these points can 

enhance the flow of energy to the reference organ. Specific areas of the sole of the foot are 

treated for specific medical conditions or symptoms. Hypnotherapy involves direct suggestion of 

symptom removal through therapeutic relaxation. Treatment of OAB is aimed at reduction of the 

component symptoms of urgency, frequency, and UUI. 

We identified three publications that used complementary and alternative medicine therapies 

to treat OAB: a fair quality trial of acupuncture,137 a fair quality trial of foot reflexology,138 and a 

poor quality prospective case series of hypnotherapy.139 See complete evidence tables in 

Appendix C. 

Acupuncture. The acupuncture trial was conducted in Oregon at an academic teaching 

center and was notable for incorporating sham acupuncture treatment as the comparison 

group.137 Among 85 women randomized, 74 (87 percent) completed all four weekly treatment 

sessions and had complete outcome data at two to four weeks after treatment. Outcomes included 

comparison of baseline and post-treatment three-day voiding diaries as well as cystometrics, 

measurements of post-void residuals, the Urinary Distress Inventory, and the Incontinence 

Impact Questionnaire. 

Episodes of urge urinary incontinence were statistically equivalent across groups at 

completion of four weeks of treatment. Number of voids per day were reduced 14 percent in the 

acupuncture group compared to 4 percent in the sham treatment group (p=0.03). This equated to 

a reduction of 1.4 voids per day among those receiving acupuncture. The experience of 

symptoms of urgency was reduced 30 versus 3 percent, with those treated having 1.6 fewer 

distinct episodes of awareness of urgency per day (p<0.02). 

Some measures, including functional bladder capacity and cystometric maximum capacity, 

were modestly improved in the treatment group (p<0.05); others, including volume at urge to 

void and detrusor contractions during cystometry, were comparable across groups with no 

apparent trends. Scores improved meaningfully on both validated instruments that evaluate 

distress and impact on quality of life, with statistical significance.137 No subjects withdrew for 

adverse events and treatment was well tolerated. 

Reflexology. The study of foot reflexology was conducted in an academic center in Hong 

Kong. They incorporated sham reflexology in the form of a nonspecific foot massage without 

deep pressure. Among 120 women randomized, 97 (81 percent) completed all treatments and the 

assessment at three weeks. The reflexology group had three of 60 drop out; the sham group had 

six of 60 drop out. Losses were related to various competing demands, including four individuals 

who reported fear of SARS which was a threat during the study period in Hong Kong, with five 

losses to followup for other personal or medical reasons. There were no withdrawals because of 

discomfort or complications of treatment. Outcomes included comparisons of baseline and 

followup 24-hour voiding diaries and the King’s Health Questionnaire. 
79 

At completion, number of urge incontinence episodes, urgency episodes, and nocturnal voids 

were equivalent across groups. Daytime voids were reduced by 1.9 voids in the reflexology 

treatment group compared to 0.55 in the sham massage group (p=0.03). Quality of life measures 

did not differ. The authors note that their participants may have been unmasked by their 

familiarity with what to expect from reflexology treatments: as 88.9 percent of those in the 

reflexology group and 67.4 percent of those in the sham massage group believed that they had 

received “true” reflexology. This difference in unblinding could bias the findings. 

Hypnotherapy. The hypnotherapy study was conducted in a UK academic setting and 

followed 63 women who were prospectively enrolled, had urodynamics, received 12 weeks of 

weekly hypnotherapy, and had followup urodynamic evaluation. Descriptive information is 

provided with little statistical analysis.139

Ten of 63 participants discontinued hypnotherapy before completing all sessions. Of those 

completing all sessions, 29 were reported to be entirely free of OAB symptoms with 14 

“considerably improved”. Of 44 women who had repeated urodynamics, 22 initially classified as 

having unstable bladder “converted to stability”, other improvements in cystometrics were also 

reported. This case series lacks masking of assessors and does not provide key patient reported 

outcomes. 

In summary, a well-conducted small trial of acupuncture has intriguing results related to 

decreased frequency of voiding and reduced symptoms of urgency which are associated with 

changes in cystometrics related to improved bladder capacity that are logical intermediates of the 

improvement in symptoms. Women in the study felt they were improved as measured by scales 

that capture bother and quality of life. This evidence is insufficient to support definitive choice of 

acupuncture but offers preliminary information that promises modest improvements that are 

similar to those reported in many pharmacologic trials. 

Reflexology is represented by a small trial with unmasking of participants that could have 

biased the results. There is not evidence to support choice of this modality. Likewise, 

hypnotherapy is not supported by the scant information provided by one case series with little 

detail, patient reported outcomes, or statistical assessment. Given the scope of placebo effects 

demonstrated in other well-conducted studies of OAB treatment, it is difficult to know whether 

to attribute any effect to hypnotherapy. 

KQ 3: Comparisons of Treatments 

Direct comparisons of treatments are made between entire approaches to management of 

OAB (e.g., pharmacologic to behavioral) or within approaches (e.g., drug to drug). In this section 

we present the results of any direct comparisons of either type, beginning with comparisons 

within the pharmacologic approach, followed by procedures compared to medical therapy or one 

another, and finally any comparison involving behavioral approaches. This third group 

comprises three distinct subgroups: behavioral compared directly to pharmacologic; combination 

pharmacologic plus behavioral compared to pharmacologic alone, and combination behavioral 

plus pharmacologic compared to behavioral alone. 

Comparisons between pharmacologic treatments 

All trial arms for RCTs of pharmacologic treatment for OAB are presented in evidence tables 

in Appendix C. Specific comparisons have been made in the literature for the following pairs of 

drugs that describe differences in reduction in urge urinary incontinence or voids per day: 

• Oxybutynin ER to Tolterodine ER84

• Oxybutynin ER to Tolterodine IR83
80 

• Oxybutynin IR to Tolterodine IR89, 91, 94

• Oxybutynin IR to Darifenacin82

• Oxybutynin IR to Trospium IR90

• Oxybutynin TDS to Tolterodine ER88

• Tolterodine ER to Tolterodine IR140, 141

• Tolterodine ER to Solifenacin99

• Tolterodine ER to Fesoterodine96, 142

• Tolterodine IR to Solifenacin97

These studies are generally powered simplistically only to assess non-inferiority; studies 

would need to be much larger for full assessment of comparability at robust power for small 

differences between pharmacologic agents. Nonetheless, in the majority of comparisons, neither 

drug was reported more effective at reducing either urge urinary incontinence episodes or voids 

per day with a few exceptions (Tables 24 and 25). 

Both oxybutynin and tolterodine in their extended release forms demonstrated superiority in 

reducing incontinence episodes over tolterodine immediate release.83, 140 In the OBJECT trial, 

oxybutynin 10 mg ER was compared to tolterodine 2 mg IR twice a day.83 At the end of 12 

weeks, women taking oxybutynin reduced their episodes per week of urge urinary incontinence 

from 25.2 to 6.2, compared to a change from 25.1 to 8.5 in the tolterodine arm. The difference of 

2.4 episodes per week between groups was statistically significant. However, upon stratifying by 

age group, the difference was maintained only among those age 64 and younger. Two studies 

compared the effectiveness of tolterodine 4 mg once per day to tolterodine 2 mg, taken twice per 

day, and found that the extended release formulation resulted in significantly greater reductions 

in incontinence episodes.140, 141

Sand and colleagues found that voids per week diminished from 91.7 to 68.0 in the 

oxybutynin 10 mg extended release arm, compared to 91.6 to 71.2 in the tolterodine 2 mg 

immediate release twice a day arm (p=0.024).83 However, as with the difference observed for 

incontinence episodes, upon stratifying by age, the difference was maintained only among those 

64 years and younger. Diokno and colleagues (2003)84 observed greater reductions in voids per 

week (p=0.05) in women taking oxybutynin 10 mg ER compared to those taking tolterodine 4 

mg ER in the OPERA trial. Both studies provided treatment for 12 weeks, and data were 

obtained via bladder diaries. Harms were rare in both studies, although Diokno and colleagues 

report significantly higher rates of dry mouth with oxybutynin (p=0.02). 

No other comparisons yielded statistically significant differences in terms of our primary 

outcomes. 
81 

Table 24. Direct comparisons of pharmaceutical treatments on urge incontinence Oxybutynin, ER Oxybutynin, IR Tolterodine, ER Tolterodine, IR Solifenacin Darifenacin Trospium, ER 

Trospium, IR Fesoterodine Oxybutynin TDS 

Oxybutynin, ER 

Oxybutynin, IR 

Tolterodine, ER = 

Tolterodine, IR O>T^ = ER>IR*

Solifenacin = = 

Darifenacin = 

Trospium, ER 

Trospium, IR = 

Fesoterodine, IR = 

Oxybutynin, TDS = 

Equivalence assigned if shown to be statistically insignificant or outcomes similar and no significance testing. 

^Oxybutynin ER superior for this outcome to Tolterodine IR83

*Tolterodine ER superior for this outcome to Tolterodine IR140

Table 25. Direct comparisons of pharmaceutical treatments on voids per day Oxybutynin, ER Oxybutynin, IR Tolterodine, ER Tolterodine, IR Solifenacin Darifenacin 

Trospium, ER Trospium, IR Fesoterodine Oxybutynin TDS 

Oxybutynin, ER 

Oxybutynin, IR 

Tolterodine, ER O>T* 

Tolterodine, IR O>T^ = = 

Solifenacin = = 

Darifenacin = 

Trospium, ER 

Trospium, IR = 

Fesoterodine = 

Oxybutynin TDS = 

Equivalence assigned if shown to be statistically insignificant or outcomes similar and no significance testing. 

*Oxybutynin ER superior for this outcome to Tolterodine ER84

^Oxybutynin ER superior for this outcome to Tolterodine IR83
82 

Comparisons between procedural and pharmacologic treatments 

The only procedure to be compared to another treatment modality was sacral 

neuromodulation, which was compared to medical therapy in one RCT. In this study, 98 

participants refractory to medical therapy were randomized to immediate sacral nerve 

stimulation or delayed sacral nerve stimulation. The delay group continued unspecified medical 

management for a six month period before having the procedure. The study found a reduction in 

daily urge urinary incontinence episodes from 9.7 to 2.6 in the sacral neuromodulation group, 

compared to an increase from 9.3 to 11.3 in the medical management group at six months 

(p<0.01).124 At 18 months, 76 percent of patients reported that they were completely dry or had 

experienced a reduction in symptoms of 50 percent or greater. It is important to note that those 

receiving medical therapy knew they were awaiting treatment with a modality that they were 

invested in believing was superior to their current level of symptom management. The 

differences in risk between sacral neuromodulation and medical management are important. Six 

patients had permanent explantation: three for pain, two for infection, and three for change in 

bowel function. 

Comparisons between behavioral and pharmacologic treatments 

Nine studies, with 11 publications, included behavioral and pharmaceutical arms in direct 

comparison to one another.93, 143-150, 201, 254

The literature base included one prospective cohort study,147 and eight RCTs.93, 133, 143-146, 148, 

150

Three of the studies were conducted in Europe, two were in the United States, two were in 

Asia (Taiwan and Korea), one in Brazil, and one in New Zealand. Seven were conducted at 

academic medical centers; two were in community settings. 

The behavioral approaches examined included bladder training,146-150, 254 multicomponent 

behavioral approaches,143-145 pelvic floor training,201, and electrical stimulation (Table 26).93

Table 26. Direct comparisons between pharmacologic and behavioral interventions 

Author 

Year 

Design Groups N 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Urge incontinence per day 

G1: Oxybutynin 5 

mg b.i.d. 

22 2.0 1.0 1.0 12* 

G2: Electrical 

stimulation 

21 1.9 1.1 0.8 12* 

Arruda et al. 

201

2008 

G3: Pelvic floor 

training 

21 2.3 1.1 1.2 12* 

G1: Oxybutynin 21 2.2 0.8 1.4 12* 

G2: Bladder 

retraining 

16 1.0 0.1 0.9 12* 

Lauti et al.254

2008 

G3: Combination 19 1.8 0.6 1.2 12* 
83 

Table 26. Direct comparisons between pharmacologic and behavioral interventions (continued) 

Author 

Year 

Design Groups N 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Urge incontinence per day 

G1: Multicomponent 

behavioral ± 

biofeedback

65 2.3 0.4 1.9^ 10 

G2: Oxybutynin 

(range of doses)

67 2.3 0.8 1.5^ 10 

Burgio et 

al.143 1998 

G3: Placebo 65 2.2 1.2 1.0^ 10 

G1: Electrical 

stimulation 

25 1.0 0.5 0.5* 12 

G2: Oxybutynin (2.5 

mg 3x/day) 26 0.0 0.0 0.0* 12 

Wang et al.93

2006 

G3: Placebo 23 1.0 1.0 0.0* 12 

Voids per day 

G1: Oxybutynin 

(5 mg b.i.d.) 

22 7.7 6.4 1.3 12* 

G2: Electrical 

stimulation 

21 8.6 7.9 0.7 12* 

Arruda et 

al.201

2008 

G3: Pelvic floor 

training 

21 6.8 7.1 0.3^ 12 

G1: Oxybutynin 21 7.8 6.7 1.1 12* 

G2: Bladder 

retraining 

16 8.0 6.3 1.3 12* 

Lauti et al.254

2008 

G3: Combination 19 8.4 6.7 1.7 12* 

G1: Bladder training 46 10.9 8.1 2.8*^ 12 

G2: Tolterodine 

(2 mg qd) 

47 11.6 8.1 3.5* 12 

Song et al.150 

2006 

RCT 

G3: Tolterodine + 

bladder training 

46 11.9 7.9 4.0^ 12 

G1: Electrical 

stimulation 

25 12.8 7.8 5.0^ 12 

G2: Oxybutynin 

(2.5 mg 3x/day) 

26 11.5 7.4 4.1^ 12 

Wang et al.93 

2006 

G3: Placebo 23 11.5 10.0 1.5^ 12 

G1: Multicomponent 

behavioral ± 

biofeedback 

65 10.0 8.2 1.8† 10 

G2: Oxybutynin 

(range of doses)

67 10.9 8.8 2.1† 10 

Goode et 

al.145

2002 

RCT

G3: Placebo 65 10.0 9.7 0.3† 10 

* Not significant differences between groups; ^p‹0.05; †significance not reported. 
84 

Episodes of Incontinence. Two RCTs considered urge urinary incontinence episodes as a 

primary outcome.93, 143 One compared multicomponent behavioral interventions to 

pharmacologic interventions143 and reported on changes in incontinence episodes. This study was 

a three-arm study in which multicomponent behavioral treatment was compared to 

pharmacologic treatment and to placebo. The behavioral arm had a significantly higher percent 

reduction in episodes of incontinence at the ten-week followup (p<0.001) (80.7 percent 

compared to 68.5 percent for pharmacologic and 39.4 percent for placebo). In a pilot study 

comparing oxybutynin to bladder retraining, no difference was observed in effectiveness by 

group.254The authors calculated that to observe a difference between these arms in a full-scale 

study would require 165 women in each arm, rather than the approximately 20 in the pilot. This 

study also had a combination therapy arm. Two studies examined the effects of electrical 

stimulation with different comparison groups.93, 201 One93 found no difference in reduction of 

incontinence comparing electrical stimulation to oxybutynin or to placebo either within or by 

groups. The other201 showed no difference in effectiveness between three groups: electrical 

stimulation, oxybutynin (5 mg b.i.d.) or pelvic floor exercises. 

Cure. Three studies reported on numbers of patients who achieved “cure” or resolution of 

UUI, without further definition.146, 147, 149 The results were inconsistent, the studies were of 

poor quality, and all were conducted prior to the ICS definition of OAB. The behavioral 

intervention in Jarvis, 1981149, was inpatient bladder drill, which is not a current treatment 

approach.149 Diokno (1995) is a report on a series of patients who chose their own treatment 

modality.147 Only Colombo (1995) in this series was an RCT.146 Bladder training was 

provided over a six-week period on an outpatient basis; although cure rates at the end of 

treatment were essentially the same, after six months, those who had received bladder training 

maintained a higher cure rate (96 percent of those initially cured in the bladder training group 

versus 57 percent in the oxybutynin group). However, the numbers reported in this study were 

quite small (only 53 in all groups at six months followup). 

Frequency. Of the six studies that provided data on voids per day, all found that both 

pharmacologic and behavioral approaches could reduce frequency, but that there was no 

difference between the two approaches.93, 145, 148, 150, 201, 254 Goode and colleagues 

conducted a secondary analysis of the original Burgio and colleagues 1998 study. They used 

structural equation modeling to determine that changes in voiding frequency were not mediating 

factors associated with decreases in incontinence.145 

Similarly, both bladder training approaches (either multicomponent or bladder drill) and 

pharmacologic treatment were associated with urodynamic changes, including increased 

maximum cystometric capacity overall and at first and strong desire to void. These changes were 

statistically significant, and large enough to be clinically relevant as well. However, Goode and 

colleagues145 examined the potential role of urodynamic changes to mediate the perceived effects 

of behavioral and pharmacologic treatment on incontinence and found, once again, that they did 

not seem to be associated with observed reductions in incontinence.145 

Patient reported outcomes. Burgio and colleagues used the Hopkins Symptom checklist to 

consider psychological changes potentially associated with improvement in continence.144 

Behavioral management and individually titrated oxybutynin were both associated with 

improvement in psychological status overall (including the placebo condition) and on a range of 

subscales, but psychological changes measured on the Hopkins Symptom checklist did not 

correlate with changes in rates of incontinence episodes. Satisfaction was highest among patients 

who received behavioral management (77.6 versus 54.7 percent with oxybutynin); interestingly, 

satisfaction on placebo was not substantially different than that on drug (43.1 percent). A very 

high proportion of the women receiving multicomponent behavioral training felt that they were 
85 

“comfortable enough” to continue with the approach (96.5 percent) relative to those on drug 

(54.7 percent) or placebo (43.1 percent). 

Comparisons of combined behavioral and pharmacologic treatment to 

pharmacologic treatment alone 

Seven studies examined the effect of adding a behavioral intervention to drug compared to 

drug alone, one of which was a feasibility study.150-155, 254 In all but two studies, the drug was 

tolterodine. The literature included six RCTs 143, 150, 151, 154, 155 and two randomized open-label 

trial (Table 27).153, 254

Two of the studies were conducted in the United States, one was in Canada, one was in 

multiple Scandinavian countries, one in Korea, one in New Zealand, and one did not specify, but 

indicated that it took place internationally in multiple sites. The two United States studies, the 

Korean one, and the one in New Zealand were conducted at academic medical centers. 

Burgio and colleagues (2008) provided multicomponent behavioral treatment as an adjunct to 

pharmacologic treatment compared to pharmacologic treatment alone152 to examine the potential 

for behavioral management to aid patients in ceasing medication use and staying off. The 

primary endpoint of interest was a combined effect of a 70 percent reduction in incontinence plus 

no medication use or other therapy for incontinence. This study examined outcomes at 10 weeks, 

immediately after treatment, and at 8 months after a period of no treatment to examine persistent 

effects. During the post-treatment period, participants could request a return to medication. The 

participants in the behavioral group reported a greater reduction in episodes of incontinence than 

those in the oxybutynin group at 10 weeks; however the difference did not persist to 8 months 

(ability to discontinue drugs was 41 percent in both groups at 8 months). The two groups also 

experienced similar percentage reductions in episodes of urge incontinence (20.4 percent in the 

behavioral group versus 18.5 percent in tolterodine alone). The behavioral group did report 

statistically significantly greater satisfaction or quality of life. 

Table 27. Comparisons of pharmaceuticals with and without behavioral interventions 

Author 

Year Groups N 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Episodes of urge incontinence per day 

G1: Tolterodine ER 

4 mg+ behavioral 

Burgio et 153 3.3 0.4 2.9† 10 

al.152

2008 G2: Tolterodine 154 3.3 0.7 2.6† 10 

G1: Darifenacin 

(ranges 7-15 mg 

qd) + behavioral 

Chancellor et 190 2.8 1.5 1.3* 12 

al.153

2008 

G2: Darifenacin 205 3.0 1.0 1.0* 12 
86 

Table 27. Comparisons of pharmaceuticals with and without behavioral interventions (continued) 

Author 

Year Groups N 

Episodes 

per day 

baseline 

Episodes 

per day on 

treatment 

Decrease in 

episodes 

per day 

Weeks 

treated 

Episodes of urge incontinence per day 

G1: Oxybutynin 21 7.8 6.7 1.1 12* 

G2: Bladder 

retraining 

16 8.0 6.3 1.3 12* 

Lauti et al.254

2008 

G3: Combination 19 8.4 6.7 1.7 12* 

G1: Tolterodine 

2 mg b.i.d. with 

PFME 

Millard et 227 3.4 1.3 2.1* 12 

al.154 2004 

G2: Tolterodine 253 3.2 1.1 2.1* 12 

G1: Tolterodine 

2 mg b.i.d. + BT 

Mattiasson et 244 2.0 0.3 1.7* 24 

al.151

2003 G2: Tolterodine 257 2.3 0.3 2.0* 24 

Voids per day 

G1: Tolterodine 

ER 4 mg + 

behavioral 

Burgio et 153 NR NR 0.5† 10 

al.152 2008 

G2: Tolterodine 154 NR NR 0.04† 10 

G1: Tolterodine 

2 mg b.i.d. + BT 

46 11.9 7.9 4.0^* 12 

G2: BT 46 10.9 8.1 2.8^ 12 

Song et al.150

2006 

G3: Tolterodine 47 11.6 8.1 3.5* 12 

G1: Tolterodine 

+ behavioral 

information 

Herschorn et 39 NR NR 1.8† 16 

al.155

2004 

G2: Tolterodine 45 NR NR 2.2† 16 

G1: Tolterodine 

2 mg b.i.d. + 

PFME 

Millard et 227 11.9 9.2 2.7† 12 

al.154 2004 

G2: Tolterodine 253 12.8 9.4 3.4† 12 

G1: Tolterodine 

2 mg b.i.d.+ BT 

Mattiasson et 244 10.3 6.9 3.4† 24 

al. 151

2003 G2: Tolterodine 257 10.6 8.0 2.6† 24 

* Not significant differences between groups. ^p<0.05; † significance not reported; increase in episodes per day. 

Three additional studies compared the effectiveness of combinations of drug and behavioral 

approaches to drug alone in changing episodes of incontinence as well as episodes of urgency 

per day.151, 153, 154 Differences between the groups were small and non-significant, although there 

were significant decreases within all groups. Episodes of urgency decreased in all groups as well, 

with decreases ranging from approximately 1.9 to 2.7 episodes per day, but again there were no 

differences between the study groups. 

Two studies found that adding behavioral training to tolterodine was associated with further 

reductions in frequency compared to tolterodine alone;151, 152 two found no significant effect of 
87 

adding behavioral training.150, 155 However, the type of the training provided differed 

dramatically – for example, the intervention provided by Herschorn155 was purely informational, 

while Burgio152 provided a multicomponent system that included biofeedback and pelvic floor 

muscle exercises. Per one study,154 addition of pelvic floor exercises alone in addition to 

tolterodine immediate release (2 mg b.i.d.) did not confer added reductions in frequency. 

In those studies that measured quality of life and participant satisfaction, improvements were 

significantly greater among those patients receiving combination therapy compared to those 

receiving pharmacologic therapy alone (Table 28). 

Table 28. Effect on quality of life and satisfaction of combination treatment 

Author 

Year 

Comparison 

Groups, N Quality of Life and Patient Satisfaction Outcomes 

Burgio et al.

152

2008 

G1: Tolterodine ER 4 mg 

plus behavioral training 

G2: Tolterodine ER 4 mg 

• 53% of participants in the combination group were 

completely satisfied at 10 weeks, compared to 40% in 

the drug only group (difference of 13, range 1–25) 

• At 8 months, 33% of the combination group were 

completely satisfied compared to 30% in the drug only 

group 

• OAB-q bother scores decreased by 36.7 at 10 weeks 

and 30.4 at 8 months in the combination group relative 

to 30.9 and 20.4 in the drug only group The difference 

was statistically significant (p<0.0001) 

• Health related quality of life improved in both groups 

with only small differences between groups 

Chancellor et al.153

2008 G1: Darifenacin (7.5-15 

mg qd) 

G2: Darifenacin + 

behavioral modification

• Improvement in total OAB-q scores and OAB-SAT-q at 

12 wks, no difference between groups (numbers not 

provided) 

Song et al.150 2006 G1: BT 

G2: Tolterodine 2 mg 

b.i.d. 

G3:Tolterodine 2 mg b.i.d. 

+ BT 

• More participants in combination treatment group 

(71%) had improved satisfaction scores at completion 

compared to the drug group (63%) or the bladder 

training group (54%) (difference not significant) 

• Urgency scores were reduced by 60% in the 

combination group, relative to 62% in the drug group 

and 45% in the bladder training group. The difference 

between drug and combination was not statistically 

significant, but differences between bladder training 

and combination and between bladder training and 

drug were at p<0.05 

Comparisons of combined behavioral and pharmacologic treatment to 

behavioral treatment alone

Three studies measured the effect of adding a pharmaceutical approach to a behavioral one. 

All three of these studies used bladder training as the behavioral technique. 

Ghei and colleagues253 describe a series of cases in which patients chose management 

approaches that could include either bladder training alone, or bladder training in addition to an 

antimuscarinic agent. Only 52 of 708 patients chose the bladder training alone, and although they 

experienced greater reduction in frequency (p<0.0001), those in the combination group had 

greater reductions in incontinence episodes (p=0.024). 

A retrospective chart review of 92 patients treated with bladder retraining drill, among whom 

36 also received antimuscarinics, was reported by Fantl et al.252 The outcome of cure, in this 
88 

clinical populations with 6 months to 6 years of followup, was defined as no further episodes of 

incontinence and voiding every 3 to 5 hours with no associated symptoms. Cure was achieved in 

83.3 percent of patients using bladder training with antimuscarinics and 78.6 percent of patients 

using bladder training alone; this difference was not significant (p>0.6). 

In a double-blind, placebo-controlled RCT, patients were randomized to receive placebo or 

oxybutynin 2.5 mg twice a day in addition to bladder training.255 The patients taking oxybutynin 

had a greater reduction in daytime frequency when compared to the patients taking placebo 

(p<0.05). There were no differences between groups in the change in incontinence episodes. 

Finally, Burgio and colleagues251 provided the opportunity to patients in their trial of 

biofeedback-assisted therapy versus oxybutynin143 whose treatment was not completely 

successful from the patient perspective to receive combined pharmacologic and behavioral 

management. Of the 35 individuals who met criteria and agreed to move onto combined 

treatment, eight crossed from behavioral alone to combination, and 27 went from pharmacologic 

alone to combined. Both groups experienced significant reductions in incontinence over the 

effect of the initial treatment. The behavioral to combined group went from 58 percent reduction 

at the end of single therapy to 89 percent reduction after combined therapy for an additional eight 

weeks. The pharmacologic to combined group also improved from 73 percent reduction to 84 

percent reduction in incontinence episodes. 

KQ 4. Modifiers of Treatment Outcomes 

This section includes information related to how individual characteristics may influence 

likelihood of responding to treatment and outcomes of treatment. We included publications that 

explicitly presented stratification by a baseline characteristic that can be determined in a clinical 

setting and that presented statistical analysis related to interpreting the influence of the 

characteristic on treatment effects as they relate to outcomes. Detailed analyses of personality 

characteristics or psychometrics that require specialized expertise or survey instruments unlikely 

to be used by those providing care for women with OAB are not reviewed here. 

Identified Modifiers 

Age. Eight publications examined the relationship of age to response to pharmacologic 

treatment.83, 102, 156-161 

Tolterodine was the focus of four of these studies;156-158, 160 and one compared oxybutynin to 

tolterodine.83 The largest study of symptom-related outcomes was an open label clinical cohort 

with 2,250 patients from 462 urology practices in Germany. The mean dose received was 3.8 ± 

1.2 mg, with a median of 2 mg. Average age of those treated was 61 ± 14 years with range not 

provided. Increasing age was associated with being more likely to have incontinence episodes 

which were not strictly required to be urge incontinence. In multivariable regression models, 

with age as a continuous variable, each year of increasing age was associated with small absolute 

reductions in global efficacy (OR for global efficacy 0.986; 95 percent CI: 0.98, 0.99 per year of 

age). Global efficacy was defined as eight or fewer voids a day, fewer than two urge episodes, 

and no incontinence episodes per day.157 

The largest RCT evaluated age effects among 1,015 participants and found that tolterodine 

drug was superior to placebo among patients aged younger than 65 compared to those 65 and 

older. They reported that treatment effects on incontinence episodes per week, voids per day, and 

subjective reports of experience of urgency and the ability to hold urine, were comparable across 

age groups at 12 weeks. A side-light of interest was that placebo effect was more pronounced for 
89 

reduction of voids per day in the younger group (p<0.045); however change from baseline in the 

treatment arm was comparable regardless of age.158

The IMPACT trial enrolled 896 individuals with urge incontinence from primary care 

settings and conducted an open-label evaluation of tolterodine extended release 4 mg once 

daily.160, 239 All parameters, including UUI, urgency, frequency, and nocturnal frequency, were 

improved at 12 weeks for both those younger than 65 and those older. However, decreases in 

frequency were less pronounced among the older group who experienced on average a 22.2 

percent reduction in daytime frequency (95 percent CI: -26.7, -15.2) and 28.6 percent decrease in 

nighttime frequency (95 percent CI: -35.7, -20.0); while younger participants had a 33 percent 

decrease in daytime frequency (95 percent CI: -36.0,-30.3) and a 50 percent decrease in 

nighttime frequency (95 percent CI: -53.8, 40.0). The most common treatment-related adverse 

events among those younger than 65 were dry mouth (11.4 percent), constipation (2.7 percent), 

and dry eyes (1.0 percent); among those who were older dry mouth (6.6 percent), constipation 

(4.4 percent) and headache (2.2 percent) were most common. Retention (<1 percent) occurred 

only among those older than 75 and none of four individuals with this complication required 

catheterization. Statistical comparisons for harms by age were not provided.160

A prescription-event monitoring study, conducted in the United Kingdom to assess 

population impact of tolterodine (range 1 to 4 mg) entering the prescription drug market, 

monitored more than 14,500 patients who filled prescriptions over a minimum of six months.156

Average age was 63 ± 16. Analysis of risks of rare adverse events (fewer than 40 events in the 

full population) found the upper quartile of age, those over 74, had greater risk of rare events 

including hallucination, heart palpitations, and tachycardia. Those under 50 had the lowest risk 

of cardiac events. No note was made of whether more common side effects varied with age. 

A small comparative study of oxybutynin (10 mg once daily) and tolterodine (2 mg twice 

daily) (n=315) found an advantage for oxybutynin extended release over tolterodine twice daily 

for decreasing urge incontinence, urgency, and frequency, among those 64 and younger. This 

effect was not apparent in older age groups in which both were comparably effective.83

Other pharmacologic treatments. A single placebo controlled RCT of trospium (20 mg twice 

a day) evaluated whether CNS adverse effects, specifically daytime drowsiness, varied with age. 

Using the Stanford Sleepiness Scale, they found fewer than 1.5 percent of those on trospium (and 

2.5 percent of those on placebo) experienced a clinically relevant three or more point increase. 

Using continuous scores, neither age grouping as <65 and older or <75 and older revealed 

meaningful differences. Average changes in scores across groups were most often improvements 

of less than half a point, generally less than a quarter point.161 Darifenacin has been studied 

among those age 65 and older in a two-year, open-label extension of 716 participants, that 

documented comparable effectiveness among older and younger participants with respect to 

sustained or improved treatment response over time as defined by a global response score, and 

individual measures that included incontinence episodes, voiding frequency, urgency, and OABrelated nocturnal waking.159 All statistical testing for these outcomes across time points through 

24 months had p<0.088 for the comparisons with baseline status.159 A trial that allowed dose 

adjustment of darifenacin over the course of the study found the mean age of those requiring 

dose adjustments “for additional efficacy” was equal to those who did not change dose.102

Though some studies reported reduced efficacy for specific endpoints among older 

participants in their study populations, none reported complete lack of benefit among older 

populations. 

Prior treatment. Seven publications investigated whether prior treatment with 

antimuscarinics predicted treatment response.85, 86, 102, 162-165 In three placebo-controlled trials of 

oxybutynin patch,85, and tolterodine IR,162 participants who had previously been on 
90 

antimuscarinics had comparable outcomes to those who were treatment naïve. The tolterodine 

study specifically commented on prior treatment failures, noting improvements in those who had 

failed prior treatments that were above placebo but not statistically significant; few participants 

were in this category.162

In two drug-to-drug comparison trials, outcomes, including UUI, total incontinence episodes, 

and “perceived improvement of bladder condition,” were likewise reported to be comparable for 

treatment naïve and previously treated participants. These studies investigated oxybutynin ER (5 

mg and 10 mg) and tolterodine ER (2 mg and 4 mg);86 and oxybutynin ER (10 mg) and 

tolterodine ER (4 mg).164 A nine-month open label study of tolterodine 2 mg twice daily found 

that 89 percent of individuals previously unable to tolerate oxybutynin, tolerated tolterodine 

well.163 One study included participants who had not been on medications as well as those 

switching from oxybutynin immediate release to extended release. In a subanalysis of those 

switching from immediate to extended release, the total proportions continent at 12 weeks is 

similar to that presented for the whole study population; no statistical test related to this 

comparison is provided. Some who had been on IR dosing regimens had worsening of symptoms 

on comparable total doses of ER.165 This study was small (n=256 spread across 16 centers 

without placebo comparisons) which hinders interpretation. In a trial that allowed dose 

adjustments, prior treatment was associated with higher rates of dose increase.102

Baseline severity. 

Presence, type, and severity of incontinence. Two studies contrasted those with UUI at 

baseline to participants without UUI. In an open-label study of tolterodine 3,824 participants 

with nine months of treatment, urge, frequency, nocturia, and OAB scales were similarly 

improved regardless of UUI baseline status.166 The VOLT study of solifenacin was an open label 

study of flexible dosing.167 Participants who had UUI at baseline and reported it was their most 

bothersome symptom, reported improvements in urgency, UUI, frequency, and nocturia, from 

“moderate to severe” to “very minor to some minor.” With the exception of nocturia, the point 

estimates for improvement in individual measures were better in the group with UUI at baseline, 

although not always statistically significantly better.167 Severity of UUI was not significantly 

associated with improvement in UUI. Subjects with severe UUI (defined as >20 episodes per 

week) had 67.6 percent decrease in UUI episodes, compared with 71.4 percent in subjects with 

less severe UUI.168

The response of those with UUI (n=552) was compared to those with urge-predominant 

mixed urinary incontinence (n=171) in a 16-week single blind trial of tolterodine that allowed 

dose adjustments from 1 mg twice daily to 2 mg twice daily. The authors reported cure rates 

were comparable: 44 percent of those with UUI achieved “dryness” and 39 percent of those with 

mixed urinary incontinence; 24.0 and 23.5 percent respectively had normalized voiding 

frequency (<8 voids per 24 hours).169 Other studies included participants with urge-dominant 

mixed urinary incontinence, or failed to specifically address inclusion or exclusion of those with 

mixed urinary incontinence, and did not report assessing trial data for differential treatment 

effects. 

Specific symptoms and outcomes. A single study of transdermal oxybutynin and tolterodine 

ER 4 mg reported on ability to improve frequency in the lowest quartile of frequency, which was 

those with <10 voids a day at baseline, and found that neither drug had a significant effect in that 

subgroup compared to placebo.88 The IMPACT trial, an open label trial of tolterodine ER in 

primary care practices, documented improvements among all groups of participants whether the 

most bothersome symptom was daytime frequency, nocturnal frequency, urge urinary 

incontinence, or urgency. Statistical testing was not provided to determine if specific groups 

were more likely to benefit; the data presented suggests similar improvements in self-reported 
91 

improvement, symptom bother, coping, health-related quality of life, and AUA symptom index 

scores across all groups.239

Other authors used severity scales or single questionnaire items to group participants and to 

conduct sub-analyses by severity. In the German open-label, observational study of tolterodine 2 

mg twice daily, patients with greater baseline symptom severity experienced greater magnitude 

of improvements. This trend was for global efficacy; individual component symptoms varied 

across groups and were not statistically significant. Overall, those with severe baseline symptoms 

were less likely than others be symptom free at 12 weeks.157 In the ACET study among those 

whose self-reported symptom scores were graded as moderate to severe, those on tolterodine ER 

achieved greater magnitude of improvements on a global improvement scale than those on 

oxybutynin ER; comparison across moderate-to-severe to less affected participants was not 

provided.86

Urodynamic findings. Four publications related baseline urodynamic findings to outcomes 

of treatment.89, 170, 171, 173 Three of these studies did not identify urodynamic findings that 

predicted poor response or non-response to treatment. The finding of detrusor overactivity 

compared to its absence was not associated with outcomes in a case series of 365 women treated 

with bladder retraining and oxybutynin 2.5 mg twice a day. Both women with and without 

detrusor instability had comparable benefits from treatment, as measured by voids per day and 

incontinence episodes.171 Likewise in an RCT of duloxetine (an SSRI) versus placebo which 

showed treatment benefits for OAB with and without UUI, the classification of participants as 

having detrusor overactivity or sensory urgency based on urodynamic findings was not 

statistically significant as an effect modifier or predictor of treatment outcomes.170 The third 

study to group participants by urodynamic finding had group sizes (n = 6, 25, 36, 40) too small 

to make definitive assessments but suggested in the two larger groups that those with low 

volume and high pressure profiles had comparable results to those with low volume and low 

pressure profiles. The last case series, reporting on 111 women with OAB based on symptoms 

and urodynamic diagnosis of detrusor overactivity, found that those women who had involuntary 

detrusor contractions with provocative maneuvers like coughing, washing hands in cold water, 

and the sound of running water, were less likely to respond to treatment, which was not 

operationally defined by the authors, with tolterodine 4 mg a day than those who did not respond 

to provocation (p=0.0008).172

A last study conducted urodynamics among 1,133 women of whom 132 met the criteria for 

detrusor overactivity “conforming” to the definitions of the ICS; the researchers then compared 

treatment outcomes among women with and without coital incontinence. Among women with 

DO treated with tolterodine ER 4 mg daily for 12 weeks, those women with coital incontinence 

at orgasm were more likely to be non-responders to treatment (“unimproved by self-report”) for 

their OAB (41.2 percent) than those without coital incontinence (17.0 percent), (p=0.23).173

Other candidate modifiers.

Race and ethnicity. The VOLT study, an open label trial of solifenacin has resulted in two 

publications addressing race and ethnicity. The authors report these analyses were motivated by 

lack of literature that explicitly addresses whether minority groups achieve comparable outcomes 

to the overall study group; the publications focused on Hispanic and black participants in VOLT. 

They provide detailed symptom and outcome profiles and report that outcomes were similar to 

the larger cohort. However direct statistical comparison is not provided by race/ethnicity.205, 229

A single three-arm trial of tolterodine ER 4 mg, tolterodine IR 2 mg twice daily, and placebo 

(n=1,235) reported that women who were above the mean for BMI (> 27kg/m2

) were more likely 

to have UUI at baseline but achieve comparable reductions in number of incontinence episodes, 

to those with lower BMI after 12 weeks of treatment.140 
92 

Anterior vaginal wall prolapse. Anterior vaginal wall prolapse was the sole pelvic organ 

prolapse measure that we identified in the literature about treatment outcomes. Anterior vaginal 

wall prolapse was defined as descent to at least 1 cm proximal to the hymen (POP-Q 

measurement ≥ stage IIa). Women with such prolapse in this clinical case series of women 

treated with 4 mg of tolterodine extended release formula once daily were more likely to show 

no improvement at 12 weeks (39.2 percent) compared to those without prolapse (14.1 percent) 

using a three-point scale of no change, improved, and cured (p=0.0002).243

Gender. Authors frequently reported that men, especially older men, fared less well in 

resolution of symptoms of OAB.85, 106, 156, 157, 174 This evidence review was focused on outcomes 

of treatment among women. However, in order to retain landmark studies we included a number 

of studies that enrolled men as long as the proportion of women in the study was 75 percent or 

more. This means that treatment effects may be attenuated when men are included. 

KQ5. Costs of Overactive Bladder Treatment 

This section presents the results of our literature search and findings about financial costs 

associated with treatment for overactive bladder. Direct medical costs, indirect medical costs, 

and lost productivity for individuals with OAB are significant issues, in part because these 

women may be at greater risk for comorbidities such as falls and fractures, urinary tract 

infections, depression, and skin conditions.188, 189 OAB symptoms can interfere substantially with 

work and other activities,250 affecting productivity. Nonetheless, the proportion of individuals 

with OAB who seek medical treatment for OAB has been estimated to be extremely low with 

possibly as few as 4 percent of individuals with symptoms seeking treatment.24 Therefore, 

estimates of costs of care for OAB are likely a reflection of care provided to only a small 

proportion of a group that may be able to benefit from effective treatment. 

Although several studies have estimated the cost of illness of urinary incontinence, few 

studies in the United States have estimated the cost of illness of OAB, and even fewer have 

focused on treatment costs, as specified for this review. In particular it is difficult to estimate 

costs related to OAB because it is a symptom-based syndrome with significant inter- and intraindividual variation in etiology and in symptoms. To answer the question of costs related to the 

treatments reviewed in this systematic review, we restricted our analysis to studies that included 

direct costs of treatment for OAB in the United States. 

Detailed information on all studies related to financial costs associated with management of 

OAB can be found in Appendix C. Studies analyzed costs for at least one of the following cost 

categories: 

• Direct costs. Depending on the bundle of treatment for OAB, costs may include PCP 

services, specialist care, skilled nursing facilities, home health care, and/or surgery. 

Direct costs include diagnostic costs, radiology costs, laboratory costs, treatment costs, 

and costs related to the consequences of OAB. 

• Indirect Costs. Indirect medical costs include lost productivity and an informal 

caregiver’s time. 

Financial Costs

Content of the literature. We identified five studies on financial costs related to OAB that 

met criteria for inclusion.175-179 All studies included assessment of direct medical costs related to 

OAB, and two included costs due to lost productivity. One study additionally assessed financial 

implications for pain and suffering. Two additional studies do not meet criteria for measuring 

direct costs of treatment, but provide context related to health care utilization.24, 250 
93 

The literature base included three analyses of administrative-claims databases: one using 

Medicare data; one using a large, private health plan affiliated with Ingenix; one using seven 

plans administered by UnitedHealth Group. These studies analyzed claims for ICD-9 codes they 

selected as indicative of OAB; some ICD-9 codes were unique to specific studies. 

One study was a national telephone survey of community-dwelling adults179 that was 

designed to measure prevalence in the community. A followup survey was sent to a selected set 

of age and sex-matched cases (with OAB) and controls to estimate treatment use, medication, 

routine care, OAB related consequences and work productivity. 

One focused on community-dwelling adults, one on persons younger than 65 years of age 

who filled prescriptions for drug treatment of OAB, one on persons of any age with prescriptiondrug benefit who filled prescriptions for drug treatment of OAB, and one on persons who had 

failed tolterodine ER and sought alternative drug therapy. Each of the studies used a different 

definition of OAB (Table 29). Because Jensen’s study177 represents the Medicare population in 

1994 to 1995 and is therefore likely substantially out of date, we do not summarize the data here. 

Data are available in the evidence table (Appendix C). 

Table 29. Study definitions used for cost determination 

Author 

Year Population Definition of Costs 

Definition of OAB 

(ICD-9 Codes) 

Hu et al.179

2003 

National 

telephone survey 

of communitydwelling adults 

Direct: 

Routine care 

Diagnostic costs 

Treatment costs 

Consequences of OAB 

Indirect: 

Lost productivity 

Informal caregiver’s time 

Self report in the NOBLE 

study 

Hall et al.176

2001 

Claims database 

of seven plans 

affiliated with 

UnitedHealth 

Group 

Physician office visits 

Pharmacy claims 

Laboratory claims 

Radiology claims 

Outpatient hospitalizations 

Inpatient hospitalizations 

ER visits 

(788.30, 788.31, 788.33, 

788.34, 788.35, 788.36, 

788.37, 788.39, 788.40, 

788.41, 788.42, 788.43) 

Nitz et al.178

2005 

Claims database 

associated with 

Ingenix 

Hospital ER 

Physician outpatient visits 

Laboratory 

Other non-pharmacy 

(595.3, 596.51, 597.81, 

788.30, 788.31, 788.33, 

788.34, 788.36, 788.39, 

788.4, 788.41, 788.43) 

Jensen et 

al.177 2003 

Medicare-claims 

database 

Hospital inpatient care 

Outpatient care 

Physician services 

Laboratory and x-ray services 

Skilled nursing facility care 

Home health care services 

(596.51, 596.59, 788.30, 

788.31, 788.33, 788.41, 

788.43) 

Varadharajan 

et al.175 2005 

PharMetrics 

Patient-Centric 

database 

Pharmacy claims 

Outpatient medical care 

Laboratory/diagnostic costs 

Inpatient costs and days in hospital 

(596.5x [excluding 596.53, 

596.54], 788.3x, 788.41, 

788.43) 
94 

Costs of treatment. Only Varadharajan and colleagues provided expenditures on 

medications for OAB, comparing sets of matched patients who used either tolterodine or 

oxybutynin in their extended release form, or who used tolterodine ER compared to oxybutynin 

in its immediate release formulation. They did not provide estimates by gender. Costs of drug 

ranged from an average low of $56 over 12 months for oxybutynin immediate release to a high 

of $360 for extended release tolterodine. The extended release formulation of oxybutynin had 

intermediate costs at $317. Tolterodine extended release was significantly more expensive over 

the course of treatment than both oxybutynin ER and oxybutynin IR (p<0.001). These 

differences in part reflect higher number of prescriptions filled in the extended release groups 

over the study period compared to the immediate release group (p<0.0001). Nonetheless, total 

healthcare costs, including those specifically related to OAB, were highest for users of 

oxybutynin immediate release compared to the extended release formulations (p<0.0001). 

Three studies examined total medical costs (not just treatment costs) for persons who filled 

prescriptions for OAB drug treatment (Table 30). These studies calculated the total healthcare 

costs for persons with OAB, per person per year by drug (PPPY). No studies did so by surgical 

or behavioral approach and only Varadharajan presented data for women only.175

Table 30. Total cost differences in annual medical care among persons filling prescriptions for OAB drug 

treatment 

Author 

Year Groups Cost Outcomes 

Type of 

prescription filled 

Average PPPY 

Total Costs 

before treatment 

($), Unadjusted, 

Mean $ cost ± SD

Average PPPY Total 

Costs after treatment 

initiation ($), 

Unadjusted, Mean $ ± 

SD 

Statistical 

significance 

Reference 

standard 

Nitz et al.178

2005 

G1: Oxybutynin IR 

G2: Oxybutynin ER 

G3: Tolterodine ER 

G1: 4956 ± 14396

G2: 4146 ± 8695 

G3: 3349 ± 6715 

G1: 7083 ± 39420 

G2: 5980 ± 13263 

G3: 5074 ± 11007 

G1/G3:

P<0.05 

G1/G2: NS 

G2/G3: NS 

NR 

Hall et al.176

2001 

G1: Tolterodine 

G2: Oxybutynin 

G3: Flavoxate or 

other OAB 

medication 

G4: No drug 

treatment for OAB 

G1: 5004 

G2: 5688 

G3: 5352 

G4: 2928 

G1: 7020 

G2: 7116 

G3: 7380 

G4: 5040 

NR NR 

Varadharajan 

et al.175 2005 

(women only) 

G1: Tolterodine 

ER* 

G2: Oxybutynin ER 

G3: Tolterodine 

ER* 

G4: Oxybutynin IR 

NR G1: 8303 ± 18802 

G2: 8862 ± 18684 

G3: 9975 ± 42860 

G4: 10521 ± 22602 

G1vG2: 

p=0.0109 

G3vG4: 

p=0.3612 

2004 US 

dollars 

PPPY = per person per year; *Separate groups matched according to G2 and G4

In their followup survey of individuals with OAB, Hu and colleagues179 collected data on a 

range of health care utilization measures, including pharmacologic and surgical treatment for 

OAB. They used several sources of cost data, including the Red Book, to assign the annual costs 

of treatment for OAB in the United States in 2000. Pharmacologic treatment costs for women in 

2000 were estimated at approximately $1.2 billion for women overall, with approximately equal 
95 

costs across age groups. OAB surgical costs among women in 2000 were estimated at 

approximately $550 million.179 Overall health care costs, including lost productivity for the 

nation were $7.4 billion for women (approximately $3.1 billion for those under 65). 

This body of literature is particularly challenged by the varying methodology for identifying 

and defining patients with OAB. In part, this variability is a reflection of the overall literature on 

OAB, which also uses varying definitions. Most problematic for definitional purposes is whether 

and when authors included incontinence in any of its forms. 

None of the cost papers qualifying for inclusion used data beyond 2002, when the ICS 

definition of OAB was put into place. 
96 
Chapter 4. Discussion 

This chapter summarizes the strength of the evidence to address our key questions and then 

presents methodologic considerations and a discussion of the findings for each of our five key 

questions. We conclude with a discussion of the status of research, limitations of the current 

literature, and our recommendations for future research priorities. 

Strength of Evidence 

We have summarized the quality of individual studies in categories of good, fair, or poor 

(with grading explained in Chapter 2) for each key question or sub-question within the 

summaries below and the information is included on the evidence table for each study in 

Appendix C. The strength of the evidence for each question or sub-question is a broad 

assessment of the totality of the literature available to provide evidence on a specific question or 

sub-question. 

To reiterate the strength grades, the levels of strength of evidence are as follows: 

I. Strong: The evidence is from studies of strong design; results are both clinically 

important and consistent with minor exceptions at most; results are free from serious 

doubts about generalizability, bias, or flaws in research design. Studies with negative 

results have sufficiently large samples to have adequate statistical power. 

II. Moderate: The evidence is from studies of strong design, but some uncertainty 

remains because of inconsistencies or concern about generalizability, bias, research 

design flaws, or adequate sample size. Alternatively, the evidence is consistent but 

derives from studies of weaker design. 

III. Weak: The evidence is from a limited number of studies of weaker design. Studies 

with strong design either have not been done or are inconclusive. 

IV. No evidence: No published literature. 

As a global assessment of this literature, no treatments reach the level of strong evidence. For 

the majority of interventions, strength hovers between moderate and weak because of crucial 

study design and reporting flaws. When there is no evidence we have noted that. 

Principal Findings and Considerations 

KQ1: Prevalence and Incidence of OAB 

Methodologic issues. Data related to prevalence and incidence of OAB and urge urinary 

incontinence is notably coherent given the immense technical challenges to comparability. 

Response rates vary widely across studies with no clear patterns relating type of questionnaire 

(phone, mailed, administered) or population to completeness of response. Most research teams 

documented exhausting conventional options for improving response rates and many presented 

thoughtful analyses of non-response. While estimates, especially of self-reported symptom 

complexes, are very sensitive to the operational definitions used, these measures were able to be 

compared when the authors provided information about details like wording of survey items and 

the required frequency of an event to meet criterion definitions. With some exceptions, such 

information provided sufficient context to provide a global and United States picture of OAB and 

urge incontinence. 

Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/bladder/bladder.pdf

97 
Publications that appeared after the ICS consensus definitions had more similar results, even 

when they used operational definitions that differed from ICS. In general, greater detail was 

provided in the publications after the ICS standardization to support comparisons across studies. 

We found no evidence that studies supported by pharmaceutical companies returned higher 

estimates for similar measures, with the exception of a single United States publication reporting 

on a cluster of consumer surveys done in malls. The estimates from those surveys were high 

enough to be considered outliers and the operational definitions used to derive the estimates were 

not provided in order to determine how their results compared to others.36 There was no readily 

apparent relationship between method of administration (e.g., mailed survey, administered, or 

other methods) and findings which is reassuring. 

Summary of prevalence and incidence findings. Overactive bladder and urge urinary 

incontinence occur in women of all ages around the world. The type of healthcare system 

appears not to clearly relate to the proportion of women affected at any point in time, suggesting 

that universal access to care such as in the United Kingdom and Canada versus more 

socioeconomically correlated access in the United States, is not the driver of whether or not 

women currently report symptoms. Several factors work in synergy to determine whether a 

woman with OAB symptoms is counted among prevalent OAB cases: degree of bother of 

symptoms, which varies widely; individual decision to seek care, which is shown to be a low 

proportion of those affected (13 percent of nurses in the Nurses Health Study); availability of 

care; and the degree to which an individual woman is distressed by the symptoms or interprets 

them as a normal part of aging. 

Conservatively estimated more than 10 to 15 percent of adult, community-dwelling women 

in the United States meet criteria for OAB and as many as 5 to 10 percent have urinary 

incontinence associated with urgency. OAB and continence status are not static; both OAB and 

urge incontinence can resolve, though the data suggest most women are affected for multiple 

years at minimum if they develop symptoms.64, 77 How often resolution is related to treatment, 

individual behavioral change, or the natural history of the condition is completely 

undocumented. Evidence to describe the relationship of UUI or OAB with age is varied. The 

preponderance of the literature suggests that OAB risk is more directly associated with 

increasing age than urge incontinence. For both conditions the relationship may be complex, 

such that rates of increase in the proportion of women who are symptomatic are relatively 

consistent until a threshold age. The most probable threshold ages at which rates plateau are well 

past the average age of menopause and reported to fall between 60 and 75 years of age. 

Because of the population-based design of these reports, often details like recent urinary tract 

infections or childbirth were not able to be taken into account, though future researchers could 

incorporate self-reported status in inclusion and exclusion for the studies as some of the strongest 

publications in this literature did. Likewise, future research on incidence and regression of 

symptoms would do well to attempt to account for intercurrent diagnosis and whether or not an 

individual has received treatment. 

The epidemiology of OAB and urge incontinence lead us to conclude, as have others, that the 

conditions are common, occur across the lifespan, and that providers of all types – primary care, 

specialists, and advanced practice nurses and health educators – will be called on to advise 

patients and provide care.196 Opportunities for detection and treatment in clinical settings should 

be frequent and attention should be addressed to the degree to which patients find the symptoms 

distressing including impact of self-image, quality of life, and sexual function. 

98 
KQ2: Outcomes of Treatments for OAB

Pharmacologic treatments. 

Methodologic consideration for pharmacologic treatment studies. The content of this 

literature is predominantly of fair to poor quality and strength of the evidence is at best moderate, 

and improved only by the consistency with which medications for OAB are shown to have 

modest advantage over placebo. The duration of followup during the masked portion of trials is 

short, rarely longer than 12 weeks. Given the longevity of treatment likely to be used by patients 

this is concerning and limits the generalizability to clinical practice. No investigators were able 

to determine whether or not there is a time period after which individuals can discontinue 

treatment and still retain some or all of the benefits of treatment reduction. Statistical and 

methodologic concerns are addressed in detail in the Future Research Section of this chapter. 

After review and analysis of 110 studies, of which four were good quality, 75 fair and 31 poor, 

with 68 RCTs, the strength of the evidence for managing OAB with pharmacologic treatment is 

weak to moderate for short term outcomes and weak for long term outcomes and harms. 

Findings from pharmacologic treatment studies. All pharmacologic treatments were effective 

at improving one or more OAB symptoms when compared to placebo. Reductions ranged from 

0.9 to 4.6 in urge urinary incontinence episodes per day across all drug treatments and from 0.7 

to 4.2 in voids per day. Study by study, extended release formulations achieved better effects 

than immediate release, although statistical significance varied. No one drug was definitively 

superior to others by preponderance of evidence, including comparison of newer selective agents 

to older antimuscarinics. As estimated by meta-analysis extended release forms (taken once a 

day) reduce UUI by 1.78 (95 percent CI: 1.61, 1.94) episodes per day, and voids by 2.24 (95 

percent CI: 2.03, 2.46) per day. Immediate release forms (taken twice or more a day) reduce UUI 

by 1.46 (95 percent CI: 1.28, 1.64), and voids by 2.17 (95 percent CI: 1.81, 2.54). Of note, 

placebo reduces UUI by 1.08 (95 percent CI: 0.86, 1.30), and voids by 1.48 (95 percent CI: 1.19, 

1.71). Even in the context of small to moderate affect on symptoms, pharmacologic treatments 

were generally associated with increased quality of life and reductions in measures of impact or 

distress, compared to baseline and to placebo. 

Findings reported in this review are consistent with three prior reviews.196, 270, 271 The most 

recent found: (1) antimuscarinics are efficacious compared to placebo, (2) mean decrease in UUI 

episodes per day ranged from 0.4 to 1.1, (3) mean decrease in the number of voids per day 

ranged from 0.5 to 1.3, (4) every treatment, with two exceptions, was associated with greater risk 

of adverse events compared to placebo, and (5) improvements were seen in quality of life.271

This review added an additional 28 studies and incorporated evidence from study designs other 

than randomized clinical trials. 

Table 31 below provides estimates of treatment effects for pharmacologic treatments 

represented by more than one trial arm. Some drugs and doses of drugs are not reported because 

the publications with trial arms for that treatment did not provide sufficient information to 

estimate variance in meta-analysis models. The models required that we have some estimate of 

the variance of the effect size such as standard deviation, standard error, or confidence bound, in 

order to achieve appropriate estimates. 

99 
Table 31. Estimates of mean reductions in incontinent episodes and voids per day 

Decrease in Incontinent Episodes 

per Day Decrease in Voids per Day Drug 

Estimate 95% CI Estimate 95% CI 

Single drug estimates 

Placebo 1.08 0.86 1.30 1.48 1.19 1.71 

Oxybutynin IR 1.49 1.18 1.80 2.18 1.75 2.61 

Oxybutynin ER * * * * * * 

Tolterodine IR 1.45 1.24 1.66 2.19 1.76 2.61 

Tolterodine ER 1.75 1.65 1.85 2.48 1.94 3.02 

Fesoterodine 2.03 1.74 2.31 1.84 1.64 2.03 

Darifenacin * * * * * * 

Solifenacin 1.46 1.32 1.59 2.19 1.94 3.02 

Trospium IR * * * * * * 

Trospium ER 2.45 2.19 2.70 2.68 2.38 2.98 

Combined comparison of extended versus immediate release formulations 

Placebo 1.08 0.86 1.30 1.48 1.19 1.71 

Extended Release 1.78 1.61 1.94 2.24 2.03 2.46 

Immediate Release 1.46 1.28 1.64 2.17 1.81 2.54 

*Estimates could not be calculated for these formulations because authors did not provide adequate data on variance 

for weighting of the raw data 

Since baseline episodes of UUI per day ranged from 1.6 to 5.3, and voids per day from 7.2 to 

13.7, these reductions (Table 31) reflect modest margins of benefit from baseline above placebo. 

Data was not consistently provided across studies to estimate the proportion of women who 

became symptom free. 

Procedural and surgical treatments. 

Methodologic consideration for procedural and surgical treatment studies. Studies in this 

treatment domain are of limited quality and predominantly case series in specialized treatment 

settings. Sacral neuromodulation has not had properly masked randomized clinical trials,193 and 

botulinum toxin injections are promising but based on a small number of studies that identified 

urinary retention as a distinct risk factor that is self-resolving but troublesome.193 Other 

procedures found no benefits or are no longer used in practice. Given consideration of 18 studies, 

of which 11 were fair quality and seven poor, with five RCTs, the strength of the evidence for 

managing OAB with procedural and surgical treatment is weak for all aspects of understanding 

outcomes of care. 

Findings from procedural and surgical treatment studies. Among the trials of procedures and 

surgery, one demonstrated a statistically significant benefit of sacral neuromodulation over usual 

care for the reduction of episodes of urge urinary incontinence per day (average reduction of 7.1 

compared to 2.1 increase with usual care) among subjects with OAB known to be refractory to 

medical therapy.124 Enthusiasm is tempered primarily by reports from multiple case series that 

harms are not rare with these treatment approaches. Data that reflects newer sacral 

neuromodulation techniques in this refractory population are lacking. 

Surgical and procedural treatments for OAB are not first line management due to the cost and 

risks of these types of procedures. Sacral neuromodulation decreases the number of urge 

incontinence episodes by at least 50 percent among patients refractory to conservative therapies. 

Moreover, the number of moderate-heavy incontinence episodes also decreases. These results 

persist even at five years. Sacral neuromodulation seems to have less of a benefit for urinary 

urgency (mixed results found in our review) and frequency (31 to 45 percent decrease), with 

benefits in frequency tapering off over time (23 percent reduction in daily voids at 5 years). 

These benefits come with a relatively high rate of adverse events. Early studies using older 

100 
technology had more than one adverse event per subject, on average;115, 124 studies employing 

newer technology report lower rate, with events in 11 to 53 percent of subjects.112, 119 Nearly 40 

percent describe pain or an unpleasant stimulation, 7 to 48 percent returned to the operating room 

(this increased to 67 percent at five years, but includes the need to change the implantable pulse 

generator battery) and between 2 to 6 percent have an infection (often requiring hospitalization, 

intravenous antibiotics or explantation). The overall explantation rate hovers around 10 percent. 

Our review included only one study on peripheral neuromodulation, using an anal and/or 

vaginal probe. Benefits in frequency were unlikely to be clinically significant (decrease from 9 to 

8 voids daily) and there was a high dropout rate due to pain and effects on the bowels. Other 

forms of peripheral neuromodulation such as posterior tibial stimulation were not reviewed. 

Electromagnetic stimulation with a portable unit was not found to be beneficial for OAB. 

Of the drugs injected or instilled into the bladder, botulinum toxin and oxybutynin had the 

greatest benefit. One trial demonstrated benefit of instillation of oxybutynin compared to sterile 

water in the reduction of voids per day (average reduction of 6.8 compared to 2.4).126 A trial we 

identified and the recent review by the Cochrane Collaboration found that small trials suggest 

benefit though researchers continue to evaluate means to decrease the risk of undesired side 

effects like urinary retention with botulinum toxin. Both botulinum toxin and instilled 

oxybutynin increase the postvoid residuals and the long term effects of higher residuals in terms 

of bladder infection and other risks is not known. Although evidence for these approaches is 

promising, the strength of the literature is inadequate to recommend any of these approaches for 

broader use in general practice. As of the date of the report, neither treatment is FDA approved 

for OAB. 

Resiniferatoxin injection was not beneficial in the study reviewed. Older treatment modalities 

such as prolonged bladder distention or bladder transection are no longer commonly used due to 

the morbidity of these procedures. The reviewed studies also lacked rigorous methods for 

evaluating treatment benefit. 

Behavioral treatments. 

Methodologic considerations in behavioral treatment studies. Most of the literature 

addressing behavioral interventions (with or without comparison to pharmacologic intervention) 

was of fair or poor quality. In general, studies of behavioral approaches rarely included a true 

and comparable placebo arm. Although it is well recognized that there are inherent challenges to 

developing placebos for behavioral techniques, a reasonably strong evidence base on means of 

doing so suggests that it is possible. Burgio and colleagues143 worked to mitigate this issue by 

maintaining similar visit schedules and through the use of bladder diaries in all groups, which 

was considered adequate masking for quality grading purposes. Particularly in older studies 

(prior to 2002), the behavioral approach often is not fully described; and inconsistency in the 

language used to identify different approaches requires the reader to examine the manuscripts 

very carefully – multiple studies may have called their approach by the same name, but in fact be 

studying quite different interventions. 

To mitigate against such confusion, we have attempted in this report to always describe the 

intervention along with the first description of results from a given study. Studies conducted 

prior to the ICS definition of OAB in 2002 tended to examine more limited approaches to 

bladder training, while later studies focused more on multicomponent approaches and delivery of 

the training in different ways. Prior treatment attempts are rarely documented in this work, which 

may make it difficult to compare treatment groups across studies. Finally, this body of literature 

includes very few studies that included similar combinations of intervention and comparator 

making it almost impossible to summarize across them. After review and analysis of 29 studies, 

of which 14 were fair quality and 15 poor, including 17 RCTs, the strength of the evidence for 

101 
managing OAB with behavioral approaches treatment is moderate to weak for short term 

outcomes and weak for long term outcomes and harms. 

Findings from behavioral treatment studies. Conclusions about the effectiveness of 

behavioral techniques for addressing the symptoms of overactive bladder are based on a total of 

29 papers (27 studies) that encompass behavioral to behavioral comparisons as well as studies of 

combining behavioral approaches with pharmacologic treatment, and the reverse, combining 

pharmacologic approaches with behavioral ones. No two studies could be combined to produce 

summary data. Overall, behavioral approaches can be effective in reducing episodes of 

incontinence and daily voids. Multicomponent approaches are most effective, and they perform 

relatively equivalent to pharmacologic treatment. Generally speaking, reductions in symptoms 

were modest, with potential decreases in incontinence episodes of up to 1.9 per day, and 

reductions of up to about four voids per day. The addition of caffeine reduction to behavioral 

modification reduced frequency, but made no difference in reduction of incontinence episodes. 

There is no evidence the behavioral approaches enhance the effectiveness of pharmacologic 

therapy to reduce episodes of incontinence; and like pharmacologic approaches, there is no 

evidence for long term effectiveness beyond the period during which the intervention is being 

provided in the health care setting. 

Complementary and alternative medicine treatments. 

Findings from complementary and alternative therapy studies. We identified three studies 

that used complementary and alternative medicine therapies to treat OAB: a fair quality trial of 

acupuncture,137 a fair quality trial of foot reflexology,138 and a poor quality prospective case 

series of hypnotherapy. There is weak to no evidence for complementary and alternative 

approaches to managing OAB. 

Outcomes of treatment. The small trial of acupuncture has intriguing results related to 

decreased frequency of voiding and reduced symptoms of urgency which are associated with 

changes in cystometrics related to improved bladder capacity that are logical intermediates of the 

improvement in symptoms. Women felt they were improved as measured by scales that capture 

bother and quality of life. Evidence is insufficient to support definitive choice of acupuncture but 

offers preliminary information that promises modest improvements similar to those reported in 

many pharmacologic trials. 

Reflexology is represented by a small trial with unmasking of participants that could have 

biased the results. No evidence supports choice of this modality. Likewise, hypnotherapy is not 

supported by the scant information provided by one case series with little detail, patient reported 

outcomes, or statistical assessment. Given the scope of placebo effects demonstrated in other 

well-conducted studies of OAB treatment, it is difficult to know whether to attribute any effect to 

hypnotherapy. 

KQ3: Comparisons of Treatments 

Methodologic issues in studies that compare treatments. Evidence for direct comparisons 

of treatments was based on 19 studies: 12 were fair and 7 poor. Of these, 14 were RCTS. 

Evidence is currently weak to absent for choosing one therapy over another.

Pharmacologic. A number of pharmaceutical agents have been studied in direct comparison. 

Nine of these comparisons explicitly examined outcomes for urge urinary incontinence episodes 

and voids per day. Fewer report on the symptom of urgency. Five of these studies are 

comparability studies in which a new drug aimed to establish equivalence to oxybutynin, the first 

drug FDA approved for OAB. One study tested the hypothesis of whether the ER formulation of 

tolterodine was superior to the IR formulation and the remaining studies were “challenges” of 

newer drugs to tolterodine, which was the second drug to receive FDA approval. In this context 

102 
lack of statistical differences between active drugs is somewhat uninformative as trials were 

often powered for the comparison of the drugs individually to placebo and in many cases 

statistical testing of the outcomes of drug-to-drug comparison are not provided. Where studies 

reported being powered to detect differences between drugs, the postulated differences were 

unlikely and/or the withdrawals from protocol prevented meaningful effectiveness analysis 

beyond ITT. In a health services context, ideal comparisons would be of extended durations, 

since OAB is a chronic condition, and would report on all primary outcomes of relevance 

including differences in medication adherence, satisfaction with treatment, and quality of life. 

Procedures. Participants in these studies were often not exclusively those with OAB. Strict 

application of inclusion criteria for this review would have eliminated virtually all studies of 

procedures for this reason. Studies of OAB included those with urinary retention and at times 

neurologic conditions as the indication. Masking, though challenging, was approximated by 

insertion of leads for sacral neuromodulation without activation; however given that a test period 

is done to establish efficacy before implantation of the permanent device, individuals may have 

been aware of their status and assessment of unmasking is not provided. Developing sham 

procedure methods may be of special importance in this area. 

Behavioral. Variations in the behavioral approaches used and methods for teaching them, as 

well as differences in the duration and intensity of treatment make comparisons challenging. As 

a category the methods were generally strong with the continued challenge of developing 

attention control comparison methods and documenting testing of the degree to which 

individuals believed they knew their treatment status. 

Findings of direct comparisons of treatments. 

Pharmacologic. Among 14 pharmacologic RCTs that made ten unique comparisons among 

pharmacologic agents, the majority did not report statistical tests that showed one drug to be 

superior to another. The exceptions were from three RCTs. Both oxybutynin and tolterodine in 

extended release form were superior to tolterodine in immediate release forms.83, 140 One trial 

reported oxybutynin ER superior to tolterodine ER for reducing voids per day.84 Given 

heterogeneity of participant populations and study designs, this limited number of studies is 

insufficient for any drug to be considered definitively superior. 

Procedures. For procedures, sacral neuromodulation was compared to wait list participants 

on medications. It is important to note that failure of prior medical management was a criteria for 

entry into the study; those waiting had worsening of many symptoms. This is in contradistinction 

to improvements noted in virtually all other comparison groups and likely reflects bias from the 

knowledge that they were awaiting what they considered more definitive treatment for severe 

OAB. No conclusions can be reached with this data and future research should address the 

differences in risk profile of sacral neuromodulation versus medications.124

Behavioral. Seven studies compared behavioral to pharmacologic treatments. One study in 

this group reported significant reductions in incontinence episodes with a multi-component 

intervention;143 no study found differences in reductions in voids per day. Participants in one 

study who were queried reported a preference for behavioral treatment over pharmacologic.143

Adding behavioral treatments to pharmacologic treatments did not improve outcomes for 

incontinence episodes or voids per day above pharmacologic treatment alone. 

KQ4: Modifiers of Treatment Outcomes 

Methodologic issues for study of modifiers. Individual characteristics of participants in 

OAB studies were highly varied on characteristics that are plausibly related to treatment 

outcomes such as: age, menopausal status, prior treatment, prior refractory symptoms during 

treatment, prior incontinence or gynecologic surgeries, severity of OAB at baseline, and presence 

103 
and type of incontinence. Higher quality studies reported on these characteristics and either 

found them comparable across trial arms or adjusted for baseline differences in their analyses. 

However, few studies indicated a priori goals of conducting sub-analyses in order to better 

understand treatment response. Among publications that did report on predictors of treatment 

response, the majority were under-powered to detect differences so the resulting claims of 

comparability are of limited value from an individual study. We found cross-cutting similarities 

for several of these characteristics such as age, severity, and prior treatment and have compiled 

those to present the limited picture that is coming into view. Overall this treatment literature is at 

an early stage of development in which the primary objective has been documenting superiority 

of the treatment to placebo. Population-based cohorts, such as the few provided by national and 

payor databases and larger clinical trials designed explicitly to more closely examine treatment 

response patterns and long-term effectiveness and tolerability will be required to have definitive 

information that can be used clinically with confidence. 

Findings about modifiers of treatment outcomes. Advancing age was associated with 

more severe symptoms at baseline and with potentially observed attenuated treatment effects. 

Nonetheless, the majority of studies that reported on the effect of age in relationship to treatment 

outcomes found significant improvements in the older groups when active treatment was 

compared to placebo. No studies reported lack of efficacy among older participants. Older 

individuals do benefit from treatment. Race and ethnicity were not associated with outcomes in 

two analyses addressing this topic. 

Presence of UUI, or urge-dominant mixed urinary incontinence, was not associated with 

treatment failure. Neither was severity of symptoms; in some cases those with the most severe 

symptoms, including more severe UUI, achieved the greatest treatment gains but were less likely 

to be symptom free. 

Urodynamic findings do not provide consistent information about likelihood of treatment 

benefit or failure. A single study noted, among women who all had documented detrusor 

overactivity at enrollment, that those who had detrusor response to provocative maneuvers such 

as running water and washing hands were more likely to fail treatment. Further investigation of 

this finding from a small study would be intriguing as would examining the overall self-reported 

relationship between cues, urgency, UUI and treatment response. Another small study reported 

that anterior vaginal wall prolapse was a strong predictor of non-response to treatment. It is 

important to note that while these factors were associated with lower likelihood of treatment 

response, the majority of those treated with these characteristics did see improvement in 

symptoms. 

Gender, while not a focus of this report, is important in interpreting findings with caution. 

Multiple research teams noted outcomes were not as favorable in men as in women. This likely 

reflects different pathophysiology behind the symptoms. Because some studies in this report 

included men (up to 25 percent of participants), results should be viewed in light of this potential 

bias. 

KQ5: Costs of OAB Treatment 

Methodologic considerations about cost studies. Studies that use administrative data are 

limited in their ability to adjust by clinical comorbidities and concomitant conditions, although 

they benefit from large enough numbers to provide a reasonable global estimate. Conversely 

studies that survey patients on their own health and health care may obtain more detailed 

information, but suffer from recall bias on the part of the respondents. None of the studies reports 

on their funding source; nor do they provide any information on investigator conflict of interest. 

104 
Findings about costs of treatment. Total direct health care costs for women with OAB in 

2000 were estimated at $6.9 billion, of which $1.1 billion was for pharmacologic treatment and 

$550 million for surgical treatment. The rest was estimated for “consequences” costs, which 

would include things like falls, longer hospital LOS and skin conditions. Medication costs for 

OAB with the two most commonly used drugs (oxybutynin and tolterodine) range from $56 to 

$360 over a twelve month period for newly diagnosed patients. However, overall health care 

costs were highest for patients who take oxybutynin, relative to tolterodine in any formulation, 

with costs lowest for patients on tolterodine ER. No study adequately determines why the 

observed differences exist, in particular whether they are actually a reflection of the differences 

in the populations who are prescribed the various medications. The one study that measures 

baseline costs found that patients whose incident OAB prescription was for tolterodine ER had 

lower costs in the six months prior to prescription than did patients whose incident prescription 

was either oxybutynin ER or oxybutynin IR. None of the studies conducted a cost effectiveness 

analysis, although cost-utility analyses have been conducted in Europe (which would be difficult 

given the low effectiveness of any of the drugs, and short followup of almost all efficacy 

studies). Nor does any study specifically assess the effect of medication on peripheral outcomes 

of OAB such as falls. 

In studies of adherence and persistence, most of which are conducted in managed care 

populations, fewer than half of patients ever refill their prescriptions for OAB medications. 

Average quit time is about a month; among those who persist, adherence is best among patients 

taking extended release versus immediate release formulations. Even in this group, adherence is 

low; the highest medication possession ratio noted in the studies we identified was about 36 

percent.272-275 

Future Research 

State of the Literature 

The study of OAB as a syndrome is entering its second decade. As is typical of advancing 

areas of research, publications based on case series are giving way to observational cohorts. 

Trials, beyond those required for FDA approval of indication for OAB, are appearing in the 

literature and health services researchers are investigating population-level factors such as cost of 

care and risk of rare but serious side effects of treatments. 

The 2002 ICS standardization of terminology180 was associated with a productive trend 

toward greater attention to and clarity of operational definitions in research. Documentation of 

inclusion and exclusion criteria, baseline characteristics, and change in symptom profiles have 

become more detailed and nuanced in the last five to seven years. Improved clarity about 

research definitions for conducting the study and analyzing data was the case even when authors 

departed from ICS definitions. Simultaneously important research gains have been made in 

crafting, refining, and validating questionnaire and interview instruments for classifying 

symptoms, assessing severity of symptoms, describing impact of OAB on quality of life, and 

measuring satisfaction with outcomes. 

Concerning deficits. As a body of literature, a number of concerning deficits were common. 

Fewer than seven percent of included studies met criteria for good quality. For example, for 

clinical trials, this meant that publications lacked one or more of the following: 

• Any description of randomization method 

• Masking of participants and assessors to treatment assignment 

• Description of participant and selection process sufficient to understand generalizability 

105 
• Details of intervention provided to subjects sufficient to replicate 

• Followup of treatment effects for 12 weeks or longer 

• Loss to followup less than 10 percent 

• Drop out less than 10 percent 

• Power calculations (preferably for two-sided tests) 

• Use of appropriate statistical comparisons and tests 

• Clear description of methods used to measure outcomes 

• Description of validity or reliability of outcome measures for primary outcomes 

Each of these criteria is fundamental to the conduct and reporting of research of sufficient quality 

to build knowledge and inform care. The treatment literature is currently hindered by critical 

flaws that must be eliminated. These include use of data from only those who completed the 

whole treatment course and not intention-to-treat analyses. Likewise authors frequently noted 

covariates that were associated with either baseline severity or outcomes and did not adjust for 

these factors in analysis or conduct stratified analyses. This was often the case because the size 

of the study would not support modeling or sub-analyses. Conclusions often over-reached 

findings in ways that in some instances were blatantly biased in favor of a newer treatment. 

The large magnitude of placebo effect in OAB studies deserves special note. The fact of 

robust placebo response implies that uncontrolled studies will be notably biased. Indeed in this 

literature observational studies, with rare exceptions, overestimated treatment benefits when 

compared to trials. High quality trials and innovations in masking treatment group (especially for 

procedural and behavioral studies) will be essential to firmly establishing treatment effects. 

Conflict of Interest. Trends in increasing transparency about sources of funding and 

potential conflicts of interest have been steadily positive over the past two decades (Table 32). 

However, a fundamental mismatch exists between the initial research needed to obtain regulatory 

approval and broader, longer term research needs to assess a wider range of questions about 

outcomes of care in typical practice settings. For a condition as common as OAB, the funding 

and conflict of interest picture that emerges suggests a research area that is urgently in need of 

additional sources of independent funding for the next wave of clinical effectiveness research. 

106 
Table 32. Funding sources and conflict of interest by decade of publication 

Source of funding for the research Reporting of conflict of 

conflict of interest 

Publications 

reporting 

research funding 

source, (%) 

Industry funded 

among those 

reporting funding 

source, (%) 

Publications 

reporting on 

author conflict of 

interest, (%) 

Authors with COI 

for publications 

reporting COI, (%)*

Study Focus 

1980s 1990s 2000s 1980s 1990s 2000s 1980s 1990s 2000s 1980s 1990s 2000s 

Surgical or 

procedural 

treatments 

(n =18) 

0/2 

(0) 

1/4 

(25) 

8/12

(75)

---

1/1

(100)

5/8

(63)

0/2

(0)

1/4 

(25)

6/12 

(50) 

--- 

5/7 

(71) 

32/64

(50)

Medications 

(n=119) 

1/3 

(33) 

11/17 

(65) 

78/99

(79)

0/1

(0)

9/11

(82)

73/78

(94)

0/3

(0)

0/17

(0)

50/99 

(50) 

--- --- 

228/329

(69)

Behavioral 

interventions 

(n = 25) 

1/6 

(17) 

3/5 

(60) 

10/14 

(71)

0/1

(0)

1/3

(33)

3/10

(30)

0/6

(0)

0/5

(0)

1/14 

(7) 

--- --- 

7/7

(100)

Complementary 

and alternative 

medical 

treatments (n=3) 

0/1 

(0) 

--- 

1/2

(50)

--- ---

0/1

(0)

0/1

(0)

---

0/2 

(0) 

--- --- ---

* Data presented is the total number of authors reporting they had a conflict of interest (numerator) over the total 

number of authors in those publications that reported on their individual conflict of interest status (denominator). All 

other data in the table is the number of publications with the characteristic over the number of publications of that 

type in the respective decades. 

Future Research Directions 

Momentum in the direction of higher quality and more informative research will follow from 

attention to: 

• Reporting greater information about key characteristics of populations studied in order to 

allow assessment of comparability of study populations and applicability of findings. 

This also facilitates understanding of candidate confounders and variations in findings 

across studies and study types. 

• Conducting studies of sufficient size to conduct hypothesis testing or assess treatment 

effects. Small studies preclude meaningful descriptive analysis of modifiers and 

appropriate adjustment of confounders. Inclusion of small numbers of men in much 

larger studies was a recurrent example of a modifier of treatment outcomes that was 

noted or ignored without sufficient study size to meaningfully interpret. 

• Continuing the expansion of standardized nomenclature and use of validated measures. 

The current literature is challenging to synthesize and interpret because outcomes 

measured are varied, not cross-cutting, and measured on different time scales (e.g., 

episodes per day, per week or per other unit of time). Use of validated measures is 

improving but measures are perhaps too numerous to help bring results into focus. 

107 
108 

Networks of researchers or those working in common areas would benefit from a 

rigorous, evidence-based consensus process to prioritize tools to use across studies to 

improve comparability of measures of outcomes like severity and quality of life. 

Content priorities. Well-conducted larger studies with study populations that reflect the 

severity of conditions seen in both primary care and specialty practice settings are critical. It is 

imperative that the time window of followup be extended. The literature suggests that treatment 

effects can be achieved in the early weeks of treatment with pharmacologic, procedural, 

behavioral, and complementary and alternative therapies. However this does not mean that the 

duration of study should be truncated. To the degree that long-term efficacy and effectiveness is 

poorly documented, the resolution or worsening of side effects is poorly characterized, and 

satisfaction and continuation of treatment is not assessed over extended periods of time, the 

literature is not relevant for informing care for this chronic condition. 

Each area that was a focus of this report would benefit from continued study of: 

• Etiology and natural history of disease, risk factors and potential preventive measures 

• Novel treatments 

• Properly powered investigations of direct comparisons of existing treatments 

• Longer term investigation of benefits and side effects of treatment 

• Continued study of combinations of treatments 

• Further investigation of complementary and alternative treatments 

• Investigation of predictors of both good and poor treatment responses across 

treatment modalities. 

• Selection of treatment options after prior treatment failure 

Conclusions 

We find a concerning lack of high-quality evidence to inform clinical decision-making for 

millions of women in the United States. Both medical and behavioral interventions can provide 

symptom relief which is often not complete, but valued by women who struggle with OAB. 

Well-conducted trials of greater duration and sophistication, separate from drug development and 

marketing efforts, are crucial. Because benefits of current treatments are modest, because drug 

side effects can be bothersome, opportunities exist to study how to gain synergy from 

combinations of types of treatments. We must note that lack of evidence of benefit is not 

equivalent to evidence of no benefit. A number of treatments that are potentially promising 

warrant continued investigation. Cross-cutting concerns about the quality of research must be 

addressed to achieve literature that can be meaningfully synthesized. Current literature does not 

permit definitive conclusions about relative benefit, harm, or costs to achieve similar results. 

Given how common and concerning OAB is, a priority on promoting high-quality research in the 

United States is imperative. Women and their care providers deserve better information to guide 

their choices. 
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204. Boone TB, Kusek JW, Nyberg LM, et al. Treatment 

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1;119(2):237-41. 

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247. Tseng LH, Wang AC, Chang YL, et al. Randomized 

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116 
117 

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91. 

251. Burgio KL, Locher JL and Goode PS. Combined 

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258. van Balken MR, Vandoninck V, Gisolf KW, et al. 

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259. Vandoninck V, Van Balken MR, Finazzi Agro E, et 

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263. Karsenty G, Reitz A, Lindemann G, et al. Persistence 

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List of Acronyms/Abbreviations 

± plus or minus 

≤ less than or equal to 

≥ greater than or equal to 

AE adverse events 

AHCPR Agency for Health Care Policy and Research 

AHRQ Agency for Healthcare Research and Quality 

AUC area under the curve 

AUM ambulatory urodynamic monitoring 

avg. average 

BAPFMT biofeedback-assisted pelvic floor muscle training 

BFQ Bladder Function Questionnaire 

b.i.d. twice a day 

BL baseline 

BM bowel movements 

BMI body mass index 

BOO bladder outlet obstruction 

BPH benign prostatic hyperplasia 

bpm beats per minute 

BRD bladder retraining drill 

BT bladder training 

CEE Conjugated equine estrogens 

CHF Congestive heart failure 

CI confidence interval(s) 

cm centimeter 

cmH2O centimeters of water 

CR controlled release 

CS cognitive strategies 

CT combination therapy 

CUBS Compromised urinary bladder syndrome 

d day 

d/t drug treatment 

DI Detrusor instability 

dL deciliter 

DM Diabetes mellitus 

DO detrusor overactivity 

Dx diagnosis 

EKG electrocardiogram 

ER extended release 

ES electrical stimulation (electrostimulation) 

etc. et cetera 

EtOH Ethanol (alcohol) 

F F-distribution 

G group 

GI gastrointestinal 

GII global impression of improvement 

GSI genuine stress incontinence 

GU genitourinary 

HAD Hospital Anxiety and Depression Scale 

H2O water 

hr(s) hour(s) 

HRQoL Health related quality of life 

HRT hormone replacement therapy 

118 
Hx history 

Hz hertz 

IBD irritable bowel disease 

IC interstitial cystitis 

ICIQ International Consultation on Incontinence Modular Questionnaire 

ICIQ-SF International Consultation on Incontinence Questionnaire-Short 

Form 

IIQ Incontinence Impact Questionnaire 

IIQ-R Incontinence Impact Questionnaire-Revised 

IMPACT Improvement in Patients: Assessing symptomatic control with 

tolterodine 

IQR interquartile range 

IR immediate release 

ITT intention to treat 

IUSS Indevus Urgency Severity Scale 

KQ key question 

kg/m2 kilograms per meter squared 

KHQ King’s Health Questionnaire 

L liter 

LCB low-compliance bladder 

LOCF last observation carried forward 

LOS length of stay 

LS least square 

Ltd limited 

LTFU Loss to followup 

LUT Lower urinary tract 

LUTS Lower urinary tract syndrome 

mg milligram 

min minute(s) 

mL milliliter 

mL/s milliliters per second 

mm millimeter 

MMSE Mini Mental Status Exam 

mo(s) month(s) 

MUI Mixed urinary incontinence 

MVV Mean volume voided 

n, N number 

ng nanogram 

NIH National Institutes of Health 

NR not reported 

NS Not significant 

OAB Overactive bladder 

OAB-q OAB questionnaire 

OAB-SCS OAB-Symptom Composite Score 

OCAS oral controlled absorption system 

P, p p value 

PFME pelvic floor muscle exercises 

PFMT pelvic floor muscle training 

PGA patient-reported goal achievement 

PISQ Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 

PME pelvic muscle exercises 

PNN50 measure of heart rate variability 

P.O. per oral (by mouth) 

PPBC Patient perception of bladder condition 

119 
120 

PPBCS Patient perception of bladder condition scale 

PPIUS Patient Perception of Intensity of Urgency Scale 

PPPY per person per year 

PRO Patient reported outcome(s) 

Pt patient 

PVR post-void residual 

qAM every morning 

qd every day 

qid four times per day 

QoL quality of life 

QTcB QT interval correct for heart rate using Bazett’s formula 

RCT randomized controlled trial 

RTX resiniferatoxin 

s second 

SCL-90-R Symptom Checklist-90-Revised 

SD standard deviation 

SE standard error 

SF Sexual function 

sec second 

SNM sacroneuromodulation 

SQoL-F Sexual Quality of Life Questionnaire-Female 

subj. subjects 

SUI Stress urinary incontinence 

Sx symptoms 

t.i.d. three times a day 

TDS transdermal delivery system 

UDI Urogenital Distress Inventory 

UDS urodynamics 

UFICQ Urinary Frequency and Incontinence Questionnaire 

UI urinary incontinence 

US United States 

UTI urinary tract infection 

UUDI Urge Urogenital Distress Inventory 

UUI Urge urinary incontinence 

VAS visual analog scale 

vs., v versus 

w/ with 

wk(s) week(s) 

x times 

yr(s) year(s) 
APPENDIX A. Exact Search Strings 

PubMed search strategies (last updated October 1, 2008) 

Search terms Search 

results 

#1 ("Urinary Bladder, Overactive"[Mh] OR "overactive bladder" OR "urge 

incontinence" OR urinary incontinence, urge[mh] OR "detrusor instability" 

OR "overactive detrusor" OR "urinary urgency" OR "urinary frequency" OR 

"irritable bladder" OR “detrusor overactivity”) AND "female"[MeSH Terms] 

AND "humans"[MeSH Terms] AND English[lang] 

2886 

#2 #1 AND editorial[pt] 10 

#3 #1 AND letter[pt] 30 

#4 #1 AND case reports[pt] 164 

#5 #1 AND review[pt] 299 

#6 #1 AND practice guideline[pt] 2 

#7 #1 NOT (#2 OR #3 OR #4 OR #5 OR #6) 2400*† 

* Approximately 250 of these citations represent pediatric literature (due to variability in indexing for this 

topic, we were unable to exclude pediatric literature at the search strategy level). 

† Numbers do not total due to exclusions in more than one category; 5 items were indexed as both letters 

and case reports and 14 items were indexed as both reviews and case reports 

EMBASE search (OVID) (last updated October 1, 2008) 

Search Terms Search 

Results

#1 *overactive bladder/ or *urinary urgency/ or *urge incontinence/ or 

*urinary frequency/ or *detrusor dyssynergia/ or *bladder irritation/ 

1624 

#2 limit 1 to (human and female and english language and (adult <18 to 64 

years> or aged <65+ years>)) 

363 

#3 #2 and review.pt. 12 

#4 #2 and conference paper.pt. 4 

#5 #2 and editorial.pt. 1 

#6 #2 and letter.pt. 0 

#7 #2 and note.pt. 3 

#8 #2 and short survey.pt. 4 

#9 #2 and case report/ 18 

#10 #2 and practice guideline/ 4 

#11 #2 and "systematic review"/ 1 

#12 #2 and meta analysis/ 1 

#13 #2 not (3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12) 318*†

* Overlap with PubMed: 310 citations; 8 new citations retrieved for inclusion. 

† Numbers do not total due to exclusions in more than one category: 1 item was indexed as both a case report and 

review; 1 item was indexed as both a case report and a note; and 1 item was indexed as both a review and a 

systematic review. 

A-1 
A-2 

CINAHL search (EBSCO) (last updated October 1, 2008) 

Search Terms Search 

Results

#1 (MH “Urge Incontinence”) or (MH “Overactive Bladder”) or “overactive 

bladder” or “urge incontinence” or “urge urinary incontinence” or 

“detrusor instability” or “overactive detrusor” or “urinary urgency” or 

“urinary frequency” or “detrusor overactivity”) and (MH “Adult+”) and 

(ZL “ENGLISH”) and (PT “Journal Article”) 

305 

#2 #1 and case reports 18 

#3 #1 and review 6 

#4 #1 and CE material 5 

#5 #1 and abstract/commentary 7 

#6 #1 and consumer literature 5 

#7 1 not (2 or 3 or 4 or 5 or 6) 264*

* Overlap with PubMed: 240 citations; 24 new citations retrieved for inclusion.
C-3 
APPENDIX B. Sample Data Abstract Forms 

Systematic Review of the Etiology and Treatment of Overactive Bladder in Women 

Abstract Review Form 

First Author, Year: ___________________ 

Reference #__________ Abstractor Initials: ___ ___ ___ 

Primary Inclusion/Exclusion Criteria 

1. Applies to SER topic 

 (If not, select at least one of the following reasons): 

a. ___Not OAB (including post-operative/iatrogenic) 

b. ___Stress or mixed incontinence 

c. ___Isolated nocturia 

d. ___Interstitial cystitis/painful bladder syndrome 

e. ___Pelvic organ prolapse 

f. ___Neurogenic conditions 

g. ___Basic science or anatomy only 

h. ___Imaging/diagnostic study only 

i. ___Other ____________________________ 

Yes No Cannot 

Determine 

2. Original research 

 (exclude editorials, commentaries, letters to editor, reviews, 

etc) 

Yes No Cannot 

Determine 

3. Study published in English Yes No 

4. Adult female study population (or includes women) Yes No Cannot 

Determine 

5. Ambulatory population 

 (exclude if exclusively institutionalized or home-bound) Yes No 

6. Eligible Study type 

a. ___RCT 

b. ___Cohorts with comparison 

c. ___Case-control 

d. ___Case series 

e. ___Incidence/prevalence in representative populations 

f. ___Cost of treatment in US populations 

 (monetary & non-monetary) 

Yes No Cannot 

Determine 

7. Eligible study size 

 Record N if < 50 relevant subjects enrolled:____________ Yes No Cannot 

Determine 

OAB is operationalized as idiopathic urinary urgency and frequency 

Retain for: 

 _____BACKGROUND/DISCUSSION 

_____REVIEW OF REFERENCES 

_____Other________________________________________ 

COMMENTS: 

B-1 
Systematic Review of the Treatment Alternatives of Overactive Bladder in Women 

Full-text Review Form 

First Author, Year: ___________________ 

Reference #__________ Abstractor Initials: ___ ___ ___ 

OAB is operationalized as idiopathic urinary urgency and frequency 

Primary Inclusion/Exclusion Criteria 

8. Applies to SER topic 

 (If not, select at least one of the following reasons): 

a. ___Not OAB (including post-operative/iatrogenic) 

b. ___Stress or mixed incontinence 

c. ___Isolated nocturia 

d. ___Interstitial cystitis/painful bladder syndrome 

e. ___Pelvic organ prolapse 

f. ___Neurogenic conditions 

g. ___Basic science or anatomy only 

h. ___Imaging/diagnostic study only 

i. ___Other ____________________________ 

Yes No

9. Original research 

 (exclude editorials, commentaries, letters to editor, reviews, etc) Yes No

10. Study published in English Yes No

11. Adult female study population (or reports data by gender) 

 If No, % female___________ Yes No

12. Ambulatory population 

 (exclude if exclusively institutionalized or home-bound) Yes No

13. Eligible Study type 

g. ___RCT /CCT 

h. ___Cohorts with comparison 

i. ___Case-control 

j. ___Case series 

k. ___Incidence/Prevalence study (survey-based) 

l. ___Cost benefit/utility/effectiveness study 

Yes No

14. Eligible study size 

 Record N if < 50 relevant subjects enrolled:____________ Yes No 

15. Does study address one of the following: 

a. ___Treatment of OAB 

b. ___Incidence/prevalence of OAB 

c. ___Monetary costs of treatment 

d. ___Non-monetary costs/harms of treatment 

Yes No 

EXCLUDE IF AN ITEM IN A GRAY BOX IS SELECTED 

B-2 
Content Inventory 

1. ______Treatment of women with symptoms of OAB 

a. _____Pharmacologic 

b. _____Surgical 

i. _____Botox 

ii. _____Central neuromodulation 

 _____Sacral 

iii. _____Peripheral neuromodulation 

 _____Tibial 

 _____Pudendal 

iv. _____Augmentation cystoplasty 

v. _____Other_______________________ 

c. _____Behavioral/Physical Therapy 

d. _____Complementary and alternative therapies 

e. _____Other______________________________ 

2. Modification of outcomes by: 

a. _____Age 

b. _____Body habitus/BMI 

c. _____Clinical presentation, physical exam findings, urodynamic findings, symptom 

cluster 

d. _____Diabetes 

e. _____Functional status 

f. _____Hormone replacement therapy 

g. _____Menopausal status 

h. _____Parity/post-partum/route-of-delivery 

i. _____Prior treatment 

j. _____Race/ethnicity 

k. _____Smoking 

l. _____Hysterectomy 

m. _____Other factors____________________ 

Length of follow-up:_________________________________ 

Retain for: 

 _____BACKGROUND/DISCUSSION 

_____REVIEW OF REFERENCES 

_____Other________________________________________ 

COMMENTS: 

B-3 
B-4 

Evidence Table 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Country and 

setting: 

Enrollment 

period: 

Funding: 

Author industry 

relationship 

disclosures: 

 

Design: 

Intervention: 

Groups: 

N at enrollment: 

N at follow-up: 

Age, yrs ± SD: 

Race/ethnicity, 

mean ± SD: 

Women, N (%): 

Parity mean ± 

SD: 

Inclusion criteria: 

Exclusion criteria:

Incontinence: 

Urgency: 

Frequency: 

Outcomes: 

Modifiers 
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Aaron et al., 2002 

Country: 

India 

Study period: 

NR 

Funding: 

Department of 

Community Health 

and Development, 

Christian Medical 

College 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Permanent 

residents of the 

Kaniambadi rural 

development block 

of Vellore district 

in Tamil Nadu 

Sampling frame: 

Residents of 7 

representative 

villages as 

enumerated by 

census; 

menopausal 

participant 

selected then 

matched to 

premenopausal 

control in same 

age strata 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

Menopausal: 100 

Pre-menopausal: 

100 

N respondents: 

NR 

N included: 

Menopausal: 100 

Pre-menopausal: 

100 

Age, mean ± SD: 

Menopausal: 46.6 

± 2.2 

Pre-menopausal: 

45.4 ± 2.3 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age 40 to 49 

Exclusion 

criteria: 

• hysterectomy 

Effective 

response: 

NR 

Urgency: 

NR 

Frequency: 

NR 

Prevalence of 

urgency, %: 

Menopausal: 18 

Pre-menopausal: 

8 

Prevalence of 

frequency, %: 

Menopausal: 17 

Pre-menopausal: 

11 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

 C-1
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued)

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Bogren et al., 

1997 

Country: 

Sweden 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross sectional 

mailed 

questionnaire 

Base population: 

Primary 

healthcare district 

in southwest 

Sweden 

Sampling frame: 

All residents 

N screened: 

Total: 458 

Women: 225 

N eligible: 

Total: 458 

Women: 225 

N respondents: 

Total: 419 

Women: 216 

N included: 

Total: 419 

Women: 216 

Age, %: 

65: 100 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• 65 years old 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

96^ 

UUI: 

NR 

Prevalence UUI, 

%: 

18.5 

Overall quality: 

Poor 

Internal validity 

score: 5, ++ 

External Validity 

Score: 1,- 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

96 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: 0? 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-2
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued)

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Bortolotti et al., 

2000 

Country: 

Italy 

Study period: 

March 1997 to 

October 1997 

Funding: 

Pharmacia & 

Upjohn Italia 

Author industry 

relationship 

disclosures: 

At least 2 of 12 

Pharmacia & 

Upjohn (2) 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Registered 

participants in 

primary care 

networks in six 

areas of Italy 

Sampling frame: 

NR 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

Women: 2,767 

N included: 

Women: 2,767 

Age, %:^ 

40-50: 22.6 

51-60: 30.4 

61-70: 19.8 

> 70: 27.2 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• women age ≥ 40

• men age ≥ 50 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

NR (“practically 

100%”) 

Incontinence: 

Loss of urine at 

least once in prior 

year 

UUI: 

NR 

SUI: 

NR 

MUI: 

NR 

Prevalence of 

UUI, %:* 

1.4 

Prevalence of 

MUI, %:* 

2.7 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: + 

^Data presented for women only. 

 C-3
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued)

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Brieger et al., 

1997 

Yip and Chung, 

2003 

Country: 

Territory of Hong 

Kong 

Study period: 

May 1996 to 

November 1996 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Chinese women in 

Hong Kong 

Sampling frame: 

Multistage random 

sample of more 

than 1.7 million 

residential 

telephone listings 

in Hong Kong 

N screened: 

3,509 

N eligible: 

NR 

N respondents: 

1,500 

N included: 

1,500 

Age, mean ± SD: 

45 ± 15 

Race/ethnicity, 

%: 

Chinese: 100 

BMI, mean ± SD: 

22.4 ± 2.8 

Parity, %: 

83 

Inclusion criteria: 

• women 

• oldest of 

eligibles in 

household 

• ethnic Chinese 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

43 

UUI: 

NR 

MUI: 

NR 

Detrusor 

dysfunction: 

One or more of 

the following: UUI, 

urgency, 

frequency, or 

nocturia, in the 

absence of SUI 

Urgency: 

NR 

Frequency: 

NR 

Prevalence of 

UUI, %: 

0.7 

Prevalence of 

MUI, %: 

4.7 

Prevalence of 

detrusor 

dysfunction, %: 

2.4 

Prevalence of 

urgency, %: 

4.3 

Prevalence of 

frequency, %:

4.2 

Overall quality: 

Poor 

Internal validity 

score: 4, + 

External Validity 

Score: 1, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

43 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

 C-4
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued)

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Brieger et al., 

1996 

Country: 

Territory of Hong 

Kong 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross sectional 

telephone 

questionnaire 

(Kings College 

Urodynamics 

Questionnaire) 

Base population: 

Chinese women in 

Hong Kong 

Sampling frame: 

Multistage random 

sample of more 

than 1.7 million 

residential 

telephone listings 

in Hong Kong 

N screened: 

3,248 

N eligible: 

NR 

N respondents: 

NR 

N included: 

819 

Age, mean ± SD: 

41.5 ± 16 

Race/ethnicity: 

NR 

Parity, %: 

66.9 

Inclusion criteria:

• women 

• age between 10 

and 90 

• oldest of 

eligibles in 

household 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

25.2 

UI: 

Involuntary loss of 

urine that is 

socially or 

hygienically 

unacceptable 

UUI: 

NR 

Frequency: 

NR 

Prevalence of 

urgency and/or 

UUI, %:

14.7 

Prevalence of 

frequency, %: 

18.8 

Overall quality: 

Poor 

Internal validity 

score: 3, - 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

25.2 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

^Data presented for women only. 

Prevalence also reported by age. 

 C-5
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Chen, Lin, Hu et 

al., 2003 

Chen, Chen, Hu et 

al., 2003 

Country: 

Taiwan 

Study period: 

1999 

Funding: 

National Science 

Council in Taiwan 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

(Bristol) 

Base population: 

Female residents 

of Dali 

Sampling frame: 

3% random 

sample based on 

national census 

records to achieve 

nationally 

representative age 

strata 

N sampled: 

1,584 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,253 

N included: 

1,247 

Age, mean ± SD: 

43.2 ± 15.1 

Race/ethnicity: 

NR 

BMI, mean ± SD: 

23.1 ± 3.3 

Parity, % 

86.5 

Inclusion criteria: 

• women 

• age ≥ 20 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

78.7 

UUI: 

Involuntary loss of 

urine preceded by 

the urge to void or 

relatively 

uncontrollable 

voiding with little 

or no warning, 

without 

requirement for 

“bother” or 

perceived social or 

hygienic problem. 

OAB: 

Frequency and 

urgency, or 

nocturia, with or 

without UUI 

Urgency:

Per ICS 2002 

Frequency:

Per ICS 2002 

Strict 

definitions:* 

Above with 

requirement for 

“bother” and/or 

perceived social or 

hygienic problem 

Prevalence of 

UUI, %: 

9.1 

Prevalence of 

UUI-strict, %: 

1.5 

Prevalence of 

MUI, %: 

17.1 

Prevalence of 

MUI by age, %: 

20-30: 10.0 

>30-40: 16.2 

>40-50: 23.1 

>50-65: 20.2 

> 65: 16.6 

P < 0.05 

Prevalence of 

MUI-strict, %: 

1.8 

Prevalence of 

MUI-strict by age, 

%: 

20-30: 0.8 

>30-40: 0.5 

>40-50: 3.5 

>50-65: 3.7 

> 65: 2.1 

P < 0.05 

Prevalence of 

OAB, % 

18.6 

Prevalence of 

OAB by age, % 

20-30: 11.7 

>30-40: 13.3 

>40-50: 20.7 

>50-65: 20.2 

> 65: 39.3 

P < 0.05 

Prevalence of 

OAB-strict, % 

2.5 

Prevalence of 

OAB-strict by 

age, % 

20-30: 0.9 

>30-40: 0.5 

>40-50: 1.5 

>50-65: 4.8 

> 65: 9.7 

P < 0.05 

Overall quality: 

Fair 

Internal validity 

score: 4+ 

External Validity 

score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

78.7 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-6
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Chen, Lin, Hu et 

al., 2003 

Chen, Chen, Hu et 

al., 2003 

(continued) 

Prevalence of 

urgency, %: 

12.6 

Prevalence of 

urgency-strict, 

%: 

1.7 

Prevalence of 

frequency, %: 

21.1 

Prevalence of 

frequency-strict, 

%: 

2.3 

* Authors provide the strict definition and term it “meeting the criteria of the ICS” in the publication. 

 C-7
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Choo et al., 2007 

Country: 

Korea 

Study period: 

2000 

Funding: 

Korean 

Continence 

Society-Johnson & 

Johnson Medical 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Representative 

cross section of 

Korean population 

stratified by age, 

sex, and region 

Sampling frame: 

Random selection 

of telephone 

numbers 

N sampled/ 

screened: 

14,559 

N eligible: 

Total: 2,005 

Women: 1,005 

Age, mean ± 

SD:^ 

59.4 ± 11.6 

Age, median:^ 

59.0 

Age, n (%):^ 

40-49: 254 (25.3) 

50-59: 252 (25.1) 

60-69: 246 (24.5) 

≥ 70: 253 (25.2) 

Race/ethnicity:

NR 

Inclusion criteria: 

• adults 

• age 40 to 89 

• communitydwelling 

Exclusion 

criteria: 

None 

Effective 

response: 

NA 

Urgency: 

“Do you have to 

rush to the toilet?”

Frequency: 

“How often do you 

pass urine on 

average?” 

UUI: 

“When you have 

an urge to urinate, 

do you loose urine 

before you could 

reach the 

bathroom?” 

OAB: 

Per ICS 

OAB-dry: 

Per ICS urge + 

freq; or urge + 

nocturia; or urge + 

freq + nocturia, 

without UUI 

OAB-wet: 

Any combination 

with UUI 

Prevalence of 

UUI by age, %: 

All: 19.2 

40-49: 13.0 

50-59: 15.1 

60-69: 24.4 

≥ 70: 24.5 

Prevalence of 

OAB-wet by age, 

%: 

All: 15.0 

40-49: 10.2 

50-59: 11.9 

60-69: 19.5 

≥ 70: 18.6 

Prevalence of 

OAB-dry by age, 

%: 

All: 16.3 

40-49: 16.9 

50-59: 15.5 

60-69: 14.2 

≥ 70: 18.6 

Prevalence of 

urgency by age, 

%:

All: 32.5 

40-49: 29.1 

50-59: 28.6 

60-69: 35.0 

≥ 70: 37.5 

Prevalence of 

frequency by 

age, %:

All: 17.7 

40-49: 16.5 

50-59: 14.7 

60-69: 17.1 

≥ 70: 22.5 

Overall quality: 

Fair 

Internal validity 

score: 3,- 

External Validity 

Score: 3,+ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: - 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-8
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Corcos and 

Schick, 2004 

Country: 

Canada 

Study period: 

Spring 2002 

Funding: 

Pfizer 

Novartis 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Canada 

Sampling frame: 

Stratified random 

sample of census 

areas in four 

census 

metropolitan areas 

by gender from 

the telephone 

registry 

N sampled: 

Total: 7,487 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

Total: 3,249 

Women: 1,683 

N included: 

Total: 3,249 

Women: 1,683 

Age, %:^ 

35-44: 35.6 

45-54: 28.1 

55-64: 17.0 

65-74: 11.9 

≥ 75: 6.8 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age ≥ 35 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

53.7 

OAB-wet (UUI): 

Urgency with 

urinary leaks 

OAB-dry 

(urgency): 

“Urgency with 

need to urinate 

that runs the risk 

of urine loss” at 

least weekly; or 

half the time or 

more it is “difficult 

to postpone 

urination” and they 

engage in 

bathroom seeking 

behavior. 

OAB: 

NR 

Frequency:

≥ 9 voids per day 

Prevalence of 

OAB-wet, %: 

6.5 

Prevalence of 

OAB, %: 

21.3 

Prevalence of 

OAB by age, %: 

35-44: 17.9 

45-54: 21.1 

55-64: 26.8 

65-74: 24.0 

≥ 75: 21.4 

Prevalence of 

urgency, %: 

23.3 

Prevalence of 

frequency, %: 

15.5 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

53.7 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-9
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Dallosso et al., 

2004 

Country: 

UK 

Study period: 

October 1998 to 

December 1998* 

Follow-up 1999 

Funding: 

Medical Research 

Council 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire with 

repeated 

measures 

mailed food 

frequency (FFQ) 

questionnaire 

Base population: 

Patients registered 

in any of 108 

general practices 

in Leicestershire 

Sampling frame: 

Random sample 

Leicestershire 

Health Authority 

registry 

N sampled: 

20,247 

N screened: 

NR 

N eligible: 

19,241 

N respondents: 

Baseline: 12,568 

FFQ: 7,046 

Follow-up FFQ: 

5,816 

N included: 

5,816 

Age, median: 

61 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age ≥ 40 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

30.2 

OAB: 

Urge leakage at 

least several times 

a month and/or 

very strong or 

overwhelming 

urgency 

Annual incidence 

of OAB, %: 

8.8 

Incidence of OAB 

by age, %: 

40-49: 7.8 

50-59: 6.5 

60-69: 10.0 

70-79: 11.7 

≥ 80: 14.3 

Baseline 

prevalence of 

OAB, %: 

15.9 

Baseline 

prevalence of 

OAB by age, %: 

40-49: 12.1 

50-59: 15.4 

60-69: 16.8 

70-79: 18.5 

≥ 80: 26.1 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

30.2 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

*Initial mailing in October with two reminders sent in four week intervals 

 C-10
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Dooley et al., 

2008* 

Minassian et al., 

2008 

Country: 

US 

Study period: 

2001 to 2004* 

2001 to 2002 

Funding: 

NR*, NR

Author industry 

relationship 

disclosures: 

NR*, NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base Population: 

NHANES a 

probability sample 

of the US noninstitutionalized 

civilian population 

Sampling frame: 

NHANES 

participants 

N sampled: 

21,161* 

11,039 

N screened: 

NA 

N eligible: 

4,541* 

2,875 

N participants: 

4,229* 

2,577 

Age, %:* 

20-39: 36.3 

40-59: 28.0 

≥ 60: 35.7 

Age, mean ± SD: 

50.8 ± 20.1 

Race/ethnicity, 

%:* 

White: 57.9 

Black: 20.5 

Hispanic: 21.5 

Race/ethnicity, 

%: 

White: 55 

Black: 18 

Hispanic: 24 

Other: 3 

BMI, kg/m2

 n:* 

≤ 25.0: 1,361 

25.0-29.9: 1,320 

30.0-39.9: 1,238 

≥ 40.0: 310 

BMI, mean ± SD: 

28.6 ± 6.8 

Inclusion criteria: 

• women 

• age 20 or older 

• completed the 

standardized 

interview and 

examination 

• answered the 

questions about 

incontinence 

Exclusion 

criteria: 

• ethnicity 

classified as 

“other”* 

Effective 

response: 

NA 

UUI: 

in past 12 months, 

“leaked or lost 

control of even a 

small amount of 

urine with an urge 

or pressure to 

urinate and you 

could not get to a 

toilet fast enough” 

SUI: 

In past 12 months, 

“leaked or lost 

control of even a 

small amount of 

urine with an 

activity like 

coughing, lifting, 

or exercise.” 

MUI: affirmative 

response to both 

SUI and UUI. 

Severity of 

incontinence: 

Mild: few times a 

year 

Moderate: few 

times a month 

Severe: daily or 

few times a week

Prevalence of 

UUI, %:* 

7.9 

Prevalence of 

UUI, %: 

8.8 

Prevalence of 

UUI by Age, %:* 

20-39: 4.6 

40-59: 8.7 

≥ 60: 11.7 

Severity of UUI, 

% 

Mild: 41 

Moderate: 31 

Severe: 57 

Prevalence of 

MUI, %:* 

17.0 

Prevalence of 

MUI, %: 

13.0 

Prevalence of 

MUI by Age, %:* 

20-39: 7.7 

40-59: 18.6 

≥ 60: 28.7 

Severity of MUI, 

% 

Mild: 13 

Moderate: 31 

Severe: 57 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-11
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Ege et al., 2008 

Country: 

Turkey 

Study period: 

May 2006 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Female residents 

of Konya 

Sampling frame: 

All postpartum 

women registered 

in seven health 

centers in the 

metropolitan area 

N sampled: 

2,200 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,749 

N included: 

1,749 

Age, mean ± SD: 

26.8 ± 5.1 

Race/ethnicity: 

NR 

BMI, mean ± SD: 

25.9 ± 3.8 

Inclusion criteria: 

• women 

• within 12 months 

postpartum 

Exclusion 

criteria: 

• pregnant again 

at time of 

interview 

Effective 

response, %: 

79.5 

UUI: 

NR 

SUI: 

NR 

MUI: 

NR 

Prevalence of 

UUI postpartum, 

%: 

2.0 

Prevalence of 

MUI postpartum, 

%: 

9.3 

Overall quality: 

Poor 

Internal validity 

score: 4, + 

External Validity 

Score: 1, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

79.5 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

 C-12
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Espino et al., 2003 

Country: 

US 

Study period: 

Fall 1993 to 

Spring 1994 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered inhome interview 

Base population: 

MexicanAmericans, age ≥

65 residing in 

southwestern 

states (AZ, CA, 

CO, NM, TX) 

Sampling frame: 

Representative 

probability sample 

from the Hispanic 

EPESE* 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,755 

N included: 

1,589 

Age, mean ± SD: 

73.3 ± 6.2 

Race/ethnicity, 

%: 

Hispanic: 100 

BMI:

NR for total N 

Inclusion criteria: 

• women 

• age ≥ 65 

• community 

dwelling 

• MexicanAmerican 

Exclusion 

criteria: 

• individuals with 

indwelling 

catheters 

Effective 

response, %: 

90.5 

UUI: 

Feeling need to 

urinate before 

loosing urine 

MUI: 

UUI and leaking 

urine during 

sneezing, 

coughing, 

vomiting, lifting, 

laughing or 

straining 

Prevalence of 

UUI, %: 

5.0 

Frequency of 

UUI, %:

Hardly ever: 17.7 

Some of the time: 

59.5 

Most of the time: 

13.9 

All of the time: 8.9 

Volume of urine 

loss UUI, %:

Small: 50.0 

Moderate: 39.5 

Large: 10.5 

Wear protection 

all the time UUI, 

%: 

10.1 

UUI Inhibits 

social activity, %:

16.7 

Prevalence of 

MUI, %: 

6.3 

Frequency of 

MUI, %:

Hardly ever: 12.0 

Some of the time: 

60.0 

Most of the time: 

18.0 

All of the time: 

10.0 

Volume of urine 

loss MUI, %:

Small: 59.2 

Moderate: 31.6 

Large: 9.2 

Wear protection 

all the time MUI, 

%:

16.0 

MUI Inhibits 

social activity, %:

21.0 

Overall quality: 

Fair 

Internal validity 

score: 3, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

90.5 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-13
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Eva et al., 2003 

Country: 

Sweden 

Study period: 

1997 

Funding: 

County of 

Östergötland 

(Folkshalsoanslag

et); Linköping 

University Hospital 

Author -industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Women in 

Östergötland born 

in 1937 or 1957 

Sampling frame: 

39% random 

sample of the 

base 

N screened: 

2,000 

N eligible: 

NR 

N respondents: 

1,336 

N included: 

1,317 

Age, n (%): 

40-yr olds: 643 

(48.8) 

60-yr olds: 674 

(51.2) 

Race/ethnicity:

NR 

Inclusion criteria: 

• women 

• born in 

designated 

years 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

65.9 

UUI: 

Urge to void 

before leaking 

Prevalence of 

UUI, %:

40-yr olds: 

Sometimes: 11.3 

Mostly: 2.1 

60-yr olds: 

Sometimes: 15.1 

Mostly: 5.2 

Prevalence of 

daytime voids, 

Number %:

40-yr olds: 

8-10: 4.2 

> 10: 2.1 

60-yr olds: 

8-10: 7.8 

> 10: 2.1 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

65.9 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-14
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Fenner et al., 

2008 

Country: 

US 

Study period: 

Summer 2002 to 

Fall 2004 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

2 of 7: 

Johnson & 

Johnson (1) 

Novartis (1) 

Novasys (1) 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Residents of 3 

Michigan counties 

Sampling frame: 

Telephone listings 

from commercial 

survey sampling 

group 

N sampled: 

12,541 

N screened: 

9,199 

N eligible: 

3,692 

N respondents: 

2,814 

Age, %: 

35-44: 40.6 

45-54: 37.7 

55-64: 21.7 

Race/ethnicity, n 

(%): 

Black: 1,922 

(68.3) 

White: 892 (31.7) 

Vaginally Parous, 

%: 

69.3 

Inclusion criteria: 

• black or white 

women 

• age 35 to 64 

• community 

dwelling 

Exclusion 

criteria: 

• pregnancy in last 

12 months 

Effective 

response, %: 

69 

Incontinence: 

Losing urine ≥ 12 

times in 12 

months 

UUI: 

based on at least 

one factor from 

urge component of 

factor analysis and 

no stress factors

SUI: 

based on at least 

one factor from 

stress component 

of factor analysis 

Prevalence of 

UUI, %: 

3.6 

Prevalence of 

UUI by 

race/ethnicity, %: 

Black: 3.5 

White: 3.6 

Prevalence of 

MUI, %: 

6.0 

Prevalence of 

MUI by 

race/ethnicity, %: 

Black: 4.1 

White: 7.1 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

69 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

Estimates of proportions of population with different types of UI use weights “constructed based on age, race and 

geographic location to adjust for the oversampling and for survey nonresponse.” Estimates of the prevalence of UUI 

and MUI are computed by multiplying the overall prevalence of UI (reported at the top of page 1457) by the 

proportions of types of UI (reported in Table 4 on page 1459). For example, overall prevalence of UUI is 

0.265x13.6%=3.6% 

 C-15
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Fitzgerald et al., 

2006^ 

Thom et al., 2006 

* 

Huang et al., 

2006† 

Country: 

US 

Study period: 

NR 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

4 of 7^ 

Allergan (2) 

Eli Lilly (1) 

Novartis (1) 

Pfizer (3) 

Q-med(1) 

Watson (1) 

Yamanouchi (4) 

Design: 

Cross-sectional 

Written 

questionnaire and 

in-person 

interview follow-up 

Base population: 

Members of 

Kaiser 

Permanente 

Northern Care 

California 

Sampling frame: 

Random sampling 

of women by age 

and race strata to 

achieve equal 

strata size for age 

and fixed ratios by 

race/ethnicity 

N screened: 

10,230* 

N screened: 

8,835* 

N eligible: 

3,240 estimated 

N respondents: 

2,109* 

N included: 

2,109 

1,348† 

Age, mean ± SD: 

56 ± 9 

Asian: 53.2 ± 7.4† 

White: 56.0 ± 9.1† 

Race/ethnicity, 

%: 

White: 48 

Black: 18 

Latina: 17 

Asian: 16 

Race/ethnicity, 

%:† 

White: 74 

Asian: 26 

Inclusion criteria: 

• women 

• age 40 to 69 

• members since 

age 18 

• ≥ 50% births 

with Kaiser 

Exclusion 

criteria: 

• race/ethnicity 

other than White 

or Asian† 

Effective 

response, %: 

65.1 

Urgency: 

Strong urge or 

pressure to urinate 

without actually 

leaking, at least 

monthly 

Frequency: 

≥ 7 voids/day; 

NR† 

UUI: 

NR, at least 

weekly; 

At least weekly 

incontinence with 

only or 

predominantly 

urge episodes in 

the last 7 days† 

UUI only:* 

NR, at least 

weekly 

MUI: 

NR, at least 

weekly 

MUI, 

predominantly 

urge:* 

NR, at least 

weekly 

MUI, equal stress 

and urge:* 

NR, at least 

weekly 

Prevalence of 

UUI, %: 

10 

Prevalence of 

UUI, %:† 

Asian: 7.3 

White: 9.5 

P=.04 

Prevalence of 

UUI only, ageadjusted, by 

race/ethnicity, % 

(95%CI):* 

White: 4.8 (3.9, 

5.7) 

Hispanic: 5.8 (4.8, 

6.8) 

Black: 7.6 (6.5, 

8.8) 

Asian-American: 

3.0 (2.3, 3.8) 

P = 0.027 

Prevalence of 

MUI, %: 

5 

Prevalence of 

MUI, predominantly urge, by 

race/ethnicity, % 

(95%CI):* 

White: 4.0 (3.1, 

4.8) 

Hispanic: 4.2 (3.3, 

5.0) 

Black: 6.0 (5.0, 

7.1) 

Asian-American: 

4.4 (3.5, 5.2) 

P = NS 

Prevalence of 

MUI, predominantly urge, by 

race/ethnicity, % 

(95%CI):* 

White: 3.3 (2.5, 

4.1) 

Hispanic: 5.3 (4.3, 

6.3) 

Black: 1.9 (1.3, 

2.5) 

Asian-American: 

3.2 (2.5, 4.0) 

P = NS 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

65.1 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-16
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Fitzgerald et al., 

2006^ 

Thom et al., 2006 

* 

Huang et al., 

2006† 

(continued) 

BMI, mean ± SD:

NR for total N 

Asian: 25.8 ± 4.8† 

White: 28.0 ± 6.7† 

Parity, %: 

Total: 80 

White: 80.8† 

Asian: 79.3† 

Prevalence of 

urgency, %: 

34 

Prevalence of 

frequency, %: 

24% 

Prevalence of 

daily frequency, 

%:†

Asian: 7.8 

White: 13.0 

Prevalence of 

weekly 

frequency, %:†

Asian: 10.6 

White: 17.8 

P<.01 

 C-17
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Hannestad et al., 

2000 

Rortveit et al., 

2003* 

Country: 

Norway 

Study period: 

1995 to 1997 

Funding: 

National Health 

Screening Service 

of Norway; 

National Institute 

of Public Health; 

Norwegian 

University of 

Science and 

Technology; 

Research Council 

of Norway 

Author industry 

relationship 

disclosures: 

NR 

Design: 

cross-sectional 

mailed 

questionnaire 

(EPINCONT) 

Base population: 

Nord-Trøndelag 

County 

Sampling frame: 

All female 

residents of 

county; 

All women with 

vital records 

linkage* 

N sampled: 

47,313 

N screened: 

NR 

N eligible:^ 

34,755 

Birth substudy:* 

15,307 

N respondents:^ 

27,936 

Birth substudy:* 

15,307 

N included: 

27,936 

Birth substudy:* 

15,307 

Age, %: 

20-24: 6.7 

25-29: 7.6 

30-34: 8.9 

35-39: 9.7 

40-44: 10.5 

45-49: 10.7 

50-54: 9.9 

55-59: 7.3 

60-64: 6.6 

65-69: 6.6 

70-74: 6.4 

75-79: 5.1 

80-84: 2.7 

85-89:1.0 

≥ 90: 0.2 

Inclusion criteria: 

• women 

• age ≥ 20 

• community 

dwelling 

Birth substudy: 

• no births, only 

cesareans, or 

only vaginal 

births of 

singletons* 

Exclusion 

criteria: 

NR; 

Birth substudy:* 

• more than four 

children (no 

women had 

more than four 

cesareans) 

• births prior to 

1967 (start of 

compulsory birth 

registration) 

• age ≥ 65 (birth 

records not 

consistently 

accurate) 

Effective 

response, %: 

80.4% 

UUI: 

Any loss of urine 

with sudden and 

strong urge to go 

to the toilet 

SUI: 

Any loss of urine 

with coughing, 

sneezing, 

laughing, lifting, 

etc. 

MUI: 

Both UUI and SUI 

Prevalence of 

UUI, %:** 

2.7 

Prevalence of 

UUI by age, %:** 

20-24: 1.3 

25-29: 1.9 

30-34: 1.8 

35-39: 1.5 

40-44: 1.9 

45-49: 2.0 

50-54: 2.1 

55-59: 2.5 

60-64: 2.6 

65-69: 4.4 

70-74: 4.8 

75-79: 6.4 

80-84: 7.4 

85-89: 8.0 

≥ 90: 4.8 

Prevalence of 

UUI, by birth 

type, %:* 

None: 1.6 

Cesarean: 2.2 

Vaginal: 1.8 

P = NS 

Prevalence of 

MUI, %:** 

8.8 

Prevalence of 

MUI by age, %:** 

20-24: 3.4 

25-29: 4.0 

30-34: 4.9 

35-39: 6.1 

40-44: 6.9 

45-49: 7.7 

50-54: 10.9 

55-59: 10.2 

60-64: 12.1 

65-69: 

70-74: 

75-79: 

80-84: 

85-89: 

≥ 90: 

Prevalence of 

MUI, by birth 

type, %:* 

None: 3.1 

Cesarean: 5.5 

Vaginal: 6.8 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

80.4 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-18
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Hannestad et al., 

2000 

Rortveit et al., 

2003* 

(continued) 

Age, birth 

substudy, %:* 

20-24: 12.1 

25-29: 13.0 

30-34: 14.0 

35-39: 15.4 

40-44: 16.9 

45-49: 16.5 

50-54: 8.7 

55-59: 2.2 

60-64: 1.2 

Race/ethnicity:

NR 

BMI birth substudy kg/m2

, %:* 

< 25.0: 54.2 

25.5-29.0: 32.9 

≥ 30: 12.9 

P vaginal 

compared to 

none:* 

P < 0.05 

P vaginal 

compared to 

cesarean:* 

P = NS 

^ Data presented for women only; for each type of incontinence severity increased with age. 

** Prevalence is calculated by multiplying the prevalence of incontinence by the reported proportion of each type of 

incontinence 

 C-19
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Herschorn et al., 

2008 

Country: 

Canada 

Study period: 

October 2002 

Funding: 

Janssen-Ortho 

Canada 

Author industry 

relationship 

disclosures: 

3 of 4 

Astellas (1) 

Gynecare (1) 

Janssen-Ortho (3) 

Pfizer (2) 

Purdue (1) Triton 

(2) 

Design: 

Cross-sectional 

telephone 

questionnaire in 

English or French 

Base population: 

Representative 

cross section of 

Canadian 

population 

stratified by age, 

sex, province, and 

census division 

Sampling frame: 

Modified 

random-digit 

dialing 

N sampled: 

NA 

N screened: 

2,500 

N eligible: 

Total: 1,000 

Women: 518 

Age, mean ±

SD:^ 

44.5 ± 17.2 

Age, %:^ 

18-40: 42.8 

41-64: 45.8 

≥ 65: 11.4 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age 18 or older 

• community 

dwelling 

Exclusion 

criteria: 

• institutionalized 

men and women

Effective 

response: 

NR 

OAB: 

Per ICS 

Urgency: 

Per ICS 

Frequency: 

Per ICS 

UUI: 

Per ICS 

Prevalence of 

UUI, %: 

Total (any): 9.3 

≤ 1x/wk: 5.0 

2-3x/wk: 1.4 

~1x/day: 1.0 

Several x/day: 0.8 

All the time: 0.6 

Prevalence of 

UUI by age, %: 

18-40: 4.6 

41-64: 10.7 

≥ 65: 22.4 

Prevalence of 

OAB, %: 

14.7 

Prevalence of 

OAB by age, %: 

18-40: 12.8 

41-64: 13.7 

≥ 65: 27.5 

Prevalence of 

urgency, %: 

Total (any): 14.1 

≤ 1x/wk: 4.4 

2-3x/wk: 2.9 

~1x/day: 3.7 

Several x/day: 2.0 

All the time: 1.2 

Prevalence of 

urgency by age, 

%: 

18-40: 13.3 

41-64: 14.2 

≥ 65: 19.0 

Prevalence of 

frequency, %: 

14.9 

Prevalence of 

frequency by 

age, %: 

18-40: 15.1 

41-64: 13.3 

≥ 65: 22.4 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: + 

N included 

respondents: - 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-20
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Herzog et al., 

1990 

Country: 

US 

Study period: 

1983 to 1986* 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Baseline with 

follow-up 

telephone 

questionnaire 

Base population: 

Residents of 

Washtenaw 

County 

Sampling frame: 

Multistage 

stratified random 

sample of 

households 

N screened: 

Total: 13,912 

N eligible: 

Total: 2,968 

Women: NR 

N respondents: 

1,956 

N included:^ 

Baseline: 1,154 

One-Yr: 1,056 

Two-Yrs: 776 

Age, %: 

NR 

Race/ethnicity:

NR 

Inclusion criteria: 

• adults 

• age ≥ 60 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

Total: 65.9 

UUI: 

Urine loss 

preceded by urge 

to void or 

uncontrollable 

voiding with little 

or no warning 

SUI: 

Urine loss at times 

of exertion such 

as sneezing, 

lifting, bending 

MUI: 

Both UUI and SUI 

Annual incidence 

of UUI, %: 

Baseline to Yr1: 

1.7 

Yr1 to Yr2: 1.5 

Annual incidence 

of MUI, %: 

Baseline to Yr1: 

9.8 

Yr1 to Yr2: 5.4 

Annual 

remission of UUI, 

%: 

Baseline to Yr1: 

22.7 

Yr1 to Yr2: 24.0 

Annual 

remission of MUI, 

%: 

Baseline to Yr1: 

4.8 

Yr1 to Yr2: 8.6 

Baseline 

prevalence of 

UUI, %: 

2.8 

Baseline 

prevalence of 

MUI, %: 

21.2 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

65.9 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

*Baseline was in 1983 and 1984 with one year and two year follow-up from those dates. 

 C-21
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Homma et al., 

2005 

Homma et al., 

2006 

Country: 

Japan 

Study period: 

November 2002 to 

March 2003 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

None 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Population of 

Japan age ≥ 40 

Sampling frame: 

Two-stage random 

sample of 

households 

N sampled: 

10,096 

N screened: 

NA 

N returned: 

4,605 

N participants: 

Total: 4,570 

Women: 2,380 

Age, mean 

(range):^ 

61 (41,100) 

Race/ethnicity:

NR 

Inclusion criteria:

• adults 

• age ≥ 40 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

Total: 45 

Women: NR 

OAB: 

≥8 voids per day 

and ≥1 episode of 

urgency/week 

UUI: 

ICS definition 

Frequency: 

≥ 8 voids per day 

Frequency: 

≥ 11 voids per day

Urgency: 

ICS definition per 

day or week 

Prevalence of 

UUI , %: 

7 

Prevalence of 

OAB, %:

11 

Prevalence of 

UUI and OAB by 

age: 

Prevalence of both 

types increase 

with age. 

P=NS

Prevalence of 

urgency ≥ 1/day, 

%: 

7 

Prevalence of 

urgency ≥ 1/wk, 

%: 

13 

Prevalence of 

frequency ≥

8/day, %:

49 

Prevalence of 

frequency ≥

11/day, %:

10 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

45 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

^Data presented for women only. 

 C-22
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Hording et al., 

1986 

Country: 

Denmark 

Study period: 

April 1981 to July 

1982 

Funding: 

The Legacy of 

Emmy Lange, née 

Kramp, Rahbek 

Foundation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Female residents 

of the Glostrup 

area of 

Copenhagen 

county born in 

1936 

Sampling frame: 

All women born in 

1936 and living in 

the Glostrup area 

N sampled: 

613 

N screened: 

NR 

N respondents: 

528 

N included: 

515 

Age: 

45 

Race/ethnicity: 

NR 

Parity, %: 

93 

Inclusion criteria: 

• Women 

• Age 45 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

85 

UUI: 

Involuntary loss of 

urine following a 

pathologically 

strong desire to 

void 

SUI: 

Urine loss 

accompanying 

coughing, 

laughing, 

sneezing, running, 

or jumping with a 

full bladder or 

during sexual 

intercourse 

MUI: 

Mixture of UUI and 

SUI 

Prevalence of 

UUI, %: 

5.4 

Prevalence of 

MUI, %: 

3.1 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: 1 

N eligible 

provided: +-N 

included 

respondents: + 

Response Rate:* 

85 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: 

Required 

frequency 

defined*: - 

 C-23
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Hsieh et al., 2006 

Country: 

Taiwan 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Female residents 

of Taiwan 

Sampling frame: 

Three stage 

random sample: 

township, block, 

individual to obtain 

nationally 

representative 

sample 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

4,546 

N respondents: 

3,537 

N included: 

3,519 

Age, %: 

20-29: 27.1 

30-39: 29.8 

40-49: 26.5 

50-59: 16.6 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age 20 to 59 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

77.4 

Frequency:

“void too often 

during the day” 

Prevalence of 

frequency, %: 

5.2 

Prevalence of 

frequency, voids 

per day, %: 

8-15: 2.4 

16-23: 1.9 

24-31: 0.05 

≥ 32: 0.7 

Prevalence of 

frequency by 

age, %: 

20-29: 4.7 

30-39: 5.8 

40-49: 5.2 

50-59: 5.9 

P = 0.33 

Overall quality: 

Poor 

Internal validity 

score: 4, + 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

77.4 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

3537 was described by authors as 77.8% response rate. Therefore ‘N” whom they considered eligible would be 

4546, so effective response rate is 3519/4546 = 77.4% 

 C-24
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Iosif and Bekassy, 

1984 

Country: 

Sweden 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Malmöhus County, 

Sweden 

Sampling frame: 

Approximately 

3,000 female 

residents born in 

1921 

N sampled: 

1,200 

N screened: 

NA 

N eligible: 

NA 

N respondents: 

902 

Age: 

NR 

Race/ethnicity:

NR 

Inclusion criteria: 

• women 

• born in 1921 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

75 

UUI: 

“do you usually 

get such a very 

strong urge that 

you cannot hold 

back until you 

reach a toilet?” 

MUI: 

Combination of 

urge and stress 

(“involuntary loss 

of urine when 

cough, laugh,” etc) 

incontinence 

Prevalence UUI, 

%: 

8.0 

Prevalence MUI, 

%: 

9.5 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 2 - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

75 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-25
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Irwin et al., 2006 

Country: 

Canada, 

Germany, Italy, 

Sweden, UK 

Study period: 

April 2005 to 

December 2005 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

10 of 11 

Astellas (5) 

Bayer (1) 

BoehringerIngelheim (1) 

Diagnostic 

Ultrasound (1) 

Ferring (1) 

Janssen-Ortho (1) 

Lilly (2) 

Novartis (3) 

Paladin (1) 

Pfizer (10) 

Plethora (1) 

Schwarz-Pharma 

(1) 

Tena (1) 

UCB (1) 

Yamanouchi (1) 

Design: 

Cross-sectional 

telephone 

questionnaire 

(EPIC) 

Base population: 

Residents of 

Canada, 

Germany, Italy, 

Sweden, UK 

Sampling frame: 

Two-step random 

sampling of 

households and 

individuals via 

residential 

telephone 

N screened: 

58,139 

N eligible: 

NR 

N respondents: 

19,165 

N included: 

Total: 19,165 

Women: NR 

Age, %:^ 

18-29: 13.6 

30-34: 7.5 

35-39: 10.2 

40-44: 11.7 

45-49: 10.5 

50-54: 9.7 

55-59: 9.2 

60-64: 7.0 

≥ 70: 12.5 

Race/ethnicity, 

%: 

White: 95.6 

Inclusion criteria: 

• adults 

• age ≥ 18 

• most recent 

birthday in 

household 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

33 

Urgency: 

Per ICS 2002 

Frequency: 

Per ICS 2002 

UUI: 

Per ICS 2002 

MUI: 

Per ICS 2002 

Prevalence of 

UUI, % (95% CI):

1.5 (1.2, 1.7) 

Prevalence of 

UUI by age, % 

(95% CI): 

≤ 39: 1.0 (0.6, 1.3) 

40-59: 1.1 (0.7, 

1.5) 

≥ 60: 2.5 (1.9, 3.0) 

Prevalence of 

MUI, % (95% CI): 

2.4 (2.1, 2.7) 

Prevalence of 

MUI by age, % 

(95% CI): 

≤ 39: 1.0 (0.6, 

1.3) 

40-59: 2.4 (1.9, 

3.0) 

≥ 60: 4.1 (3.4, 4.8) 

Prevalence of 

urgency, % (95% 

CI): 

12.8 (12.2, 13.5) 

Prevalence of 

urgency by age, 

% (95% CI): 

≤ 39: 9.7 (8.8, 

10.7) 

40-59: 11.2 (10.1, 

12.3) 

≥ 60: 18.3 (16.9, 

19.6) 

Prevalence of 

frequency, % 

(95% CI):

7.4 (6.9, 7.9) 

Prevalence of 

frequency by 

age, % (95% CI):

≤ 39: 7.9 (7.0, 8.8) 

40-59: 5.8 (5.0, 

6.6) 

≥ 60: 8.4 (7.5, 9.4) 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

33 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-26
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Ju, et al. 1991 

Country: 

Singapore 

Study period: 

July 1989 to 

November 1989 

Funding: 

National University 

of Singapore 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire, with 

follow-up interview 

if incontinent 

Base population: 

Elderly residents 

of a postal district 

in Telok Blangah 

Housing Estate 

Sampling frame: 

All elderly people 

in Ministry of 

Home Affairs 

registry for study 

district 

N sampled: 

1,511 

N eligible: 

1,143 

N respondents: 

919 

N included: 

Total: 919 

Women: 484 

Age: 

NR by gender 

Race/ethnicity: 

NR by gender 

Inclusion criteria: 

• Adults 

• Age ≥ 65 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

80.4 

Incontinence: 

Leakage of urine 

two or more times 

in the past month 

UUI: 

Urine loss 

because of 

inability to delay 

voiding following 

an urge to 

micturition 

SUI: 

Urine loss 

associated with 

increases in intraabdominal 

pressure (physical 

exertion, straining, 

coughing, or 

laughing) 

MUI: 

NR 

Prevalence of 

UUI, %: 

3.3 

Prevalence of 

UUI, %: 

0.8 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4,++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

82 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented is for women only. 

 C-27
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Kay et al., 1999 

Country: 

Denmark 

Study period: 

NR 

Funding: 

Gammelgårds 

Grant, 

Synthélabo 

Scandinavia 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

(DAN-PPS) 

Base population: 

Population of 

Herlev 

municipality 

Sampling frame: 

Gender and age 

stratified random 

sample of adults in 

age range 

N sampled: 

Total: 500 

Women: 250 

N screened: 

NA 

N eligible: 

NR 

N respondents: 

All: 368 

Women: 158 

Age, n:^ 

40-49: 33 

50-59: 40 

60-69: 28 

70-79: 36 

80-89: 21 

Age, mean:^ 

62.5 

Age, median 

(range):^ 

61 (41, 89) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age 40 to 89 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

All: 74 

Women: 63 

All measures are 

for two week 

window 

UUI: 

NR 

Urgency: 

NR 

Frequency: 

NR 

Prevalence of 

UUI, % (95% CI):

25.3 (18.9, 33.0) 

Prevalence of 

urgency, % (95% 

CI): 

67.1 (59.1, 74.2) 

Prevalence of 

frequency, % 

(95% CI):

42.2 (34.7, 50.5) 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 3,+ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

63 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: + 

 C-28
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Kim et al., 2006 

Country: 

US 

Study period: 

2000 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

5 of 5 

Pfizer (5) 

Design: 

Database linkage 

study 

Base population: 

US population 

Sampling frame: 

National 

Ambulatory 

Medical Care 

Survey, National 

Hospital 

Ambulatory 

Medical Care 

Survey, National 

Hospital 

Discharge Survey 

data for 2000 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

NR 

N included: 

NR 

Age: 

NR 

Inclusion criteria: 

• adults 

• age ≥ 18 

• first three coded 

diagnoses per 

care episode 

Exclusion 

criteria: 

NR 

Effective 

response: 

NA 

OAB visits: 

ICD-9: 788.31, 

788.41 and 788.33

Frequency: 

coded indication 

for visit. 

Urge 

incontinence: 

Coded indication 

for visit. 

Prevalence:

expressed as 

number of adults 

with visit type per 

10,000 adult 

population 

weighted for 

gender based on 

2000 census. 

National annual 

OAB visits: 

1.4 million (1.1, 

1.8) 

Prevalence of 

visits for UUI: 

16 per 10,000 

adults 

Prevalence of 

visits for MUI: 

5 per 10,000 

adults 

Prevalence of 

visits for any 

OAB symptom: 

Women: 

81/10,000 

Men: 56/10,000 

Prevalence of 

visits for 

frequency: 

48 per 10,000 

adults 

Overall quality: 

Fair 

Internal validity 

score: (+) 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: NA 

N eligible 

provided: NA 

N included 

respondents: NA 

Response Rate:* 

NA 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-29
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Koyama et al., 

1998 

Country: 

Japan 

Study period: 

NR 

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Residents of the 

selected farming 

village or 

suburban town 

Sampling frame: 

Distribution to all 

residents, 970 in 

village; 1,508 in 

suburb 

N sampled: 

Village: 970 

Suburb: 1,508 

N screened: 

NA 

N eligible: 

NA 

N respondents: 

Village: 937 

Suburb: 934 

Women: 1,120 

Age, %: 

60-69*: 31.7 

70-79: 47.9 

≥ 80: 20.4 

Race/ethnicity:

NR 

Inclusion criteria: 

• adults 

• age > 65 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

Village: 98.4 

Suburb: 65.0 

Incontinence: 

“even a small 

amount of urinary 

leakage at a time 

when there was 

no intention of 

urinating.” 

UUI: 

Not specified, 

however “urgency” 

subtype presented

Prevalence of 

UUI, %: 

Women: 5.3** 

Overall quality: 

Poor 

Internal validity 

score: 4, + 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

>65 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

*Age range as presented “60-69” however, inclusion says all participants >65 years old?! 

**Denominator for total community dwelling in Table 1 = 1120 women, Table 3 = 59 with urgency as “nature of urinary 

incontinence” 

^Data presented for women only. 

 C-30
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Kuh et al., 1999 

Country: 

UK 

Study period: 

1993 to 1994 

Funding: 

Medical Research 

Council 

Author industry 

relationship 

disclosures: 

None 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Women in the UK 

Sampling frame: 

Members of the 

Medical Research 

Council National 

Survey of Health 

and Development 

a nationally 

representative 

birth cohort begun 

in March 1946 

N sampled: 

1,486 

N screened: 

NR 

N eligible: 

1,486 

N respondents: 

1,378 

N included: 

1,333 

Age, %: 

48: 100% 

Race/ethnicity: 

NR 

BMI kg/m2

, %: 

< 20: 7.2 

20.1-25.0: 55.9 

25.1-30.0: 25.0 

> 30.0: 12.0 

Vaginally parous, 

%: 

81.7 

Inclusion criteria: 

• women 

• born in March 

1946 

• members of 

cohort 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

89.7 

UUI: 

Urgent and strong 

desire to pass 

urine which is 

difficult to control 

and ever any loss 

of urine before 

getting to toilet 

SUI: 

Loss of urine 

when you cough, 

sneeze, laugh, 

run, or exercise 

MUI: 

Both UUI and SUI 

Prevalence of 

UUI, %: 

22 

Prevalence of 

MUI, %: 

20 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

89.7 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-31
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Lara and Nacey, 

1994 

Country: 

New Zealand 

Study period: 

NR 

Funding: 

Wellington 

Medical Research 

Foundation

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Female residents 

of three areas of 

central Wellington 

Sampling frame: 

Random sample 

of the electoral roll 

N sampled: 

1,028 

N screened: 

NA 

N eligible: 

NA 

N respondents: 

556 

Age, mean 

(range): 

Maoris: 39.1 (18, 

95) 

Pacific Islanders: 

34.9 (18, 79) 

Europeans: 47 

(18, 90) 

Race/ethnicity, 

%:

Maoris: 25.7 

Pacific Islanders: 

21.9 

Europeans: 52.3 

Inclusion criteria: 

• women on 

electoral roll 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

54 

Incontinence 

definition: 

“any involuntary 

loss of urine” 

UUI: 

“sudden 

involuntary loss” 

MUI: 

Elements of UUI 

and stress (“loss 

with increased 

intraabdominal 

pressure”) 

Prevalence of 

UUI, %: 

9.2 

Prevalence of 

MUI, %: 

7.4 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

54 

Inclusion 

(Exclusion) 

Specified: - 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-32
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Link et al., 2007 

Hall et al., 2008 

Country: 

US 

Study period: 

2002 to 2005 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Residents of 16/17 

Boston residential 

planning districts* 

Sampling frame: 

Two-stage random 

sample stratified 

to achieve gender 

and race/ethnicity 

representation 

N screened: 

24,063 

households* 

9,066 individuals* 

N eligible: 

8,702* 

N respondents: 

5,506* 

N included: 

Total: 5,506 

Women: 3,205* 

Age, %:^ 

30-39: 24.7* 

40-49: 26.2* 

50-59: 24.3* 

60-79: 24.7* 

Race/ethnicity, n 

(%):^ 

Black: 1,070* 

(33.4) 

White: 1,024* 

(32.0) 

Hispanic: 1,111* 

(34.7) 

Inclusion criteria: 

• adults 

• age 30 to 79 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

57.3* 

Frequency: 

Needed to urinate 

again < 2hrs after 

urinating (fairly 

often, usually, 

almost always) 

and/or frequent 

urination during 

the day (fairly 

often, usually, 

almost always) 

and/or on average 

8 or more 

urinations per day 

Urgency: 

Difficulty 

postponing 

urination (fairly 

often, usually, 

almost always) 

and/or strong urge 

or pressure to 

urinate 

immediately with 

little or no warning 

(fairly often, 

usually, almost 

always) and/or 

strong urge to 

urinate 

immediately 

whether or not 

they urinated or 

leaked urine 

(several times, 

many times per 

day) 

† Cluster 

analysis 

groupings: 

Four symptomatic 

clusters emerged 

which cannot be 

readily mapped to 

clinically useful 

tool/descriptors. 

Prevalence of 

urgency, %: 

14.2 

Prevalence of 

frequency, %: 

36.9 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

57.3 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:+ 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

† Groupings may have etiologic or other research utility see publication for details. 

 C-33
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Liu and Andrews, 

2002 

Country: 

Australia 

Study period: 

1992 to 1994 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Repeated 

measures 

telephone 

questionnaire 

Base population: 

Residents of 

Southern Australia 

Sampling frame: 

Random sample, 

stratified by age 

from the State 

Electoral Data 

Base for South 

Australia 

N sampled: 

4,184* 

N screened: 

NR 

N eligible: 

2,272 

N respondents: 

2,087 

N included: 

2,087 

Age: 

“sample size of 

more than 190 in 

each gender and 

age group [70-74, 

75-79,80-84,≥85]” 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age ≥ 70 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

49.9 

UUI: 

NR, “at least 

occasionally” 

SUI: 

NR, “at least 

occasionally” 

Mixed: 

Both UUI and SUI, 

“at least 

occasionally” 

Annual Incidence 

of UUI, %: 

22.6 

Two-Year 

Incidence of UUI, 

%:

37.5 

Prevalence of 

UUI by year, %:** 

Yr 1: 18.2 

Yr 2: 16.1 

Yr 3: 21.2 

Prevalence of 

MUI by year, %:** 

Yr 1: 23.2 

Yr 2: 26.5 

Yr 3: 26.8 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

49.9 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:- 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

* Study also included 151 individuals identified within households sampled 

** Prevalence for UUI and MUI is calculated by multiplying the prevalence of the combined UUI and MUI (reported in 

Table 1) by the relevant proportions from Table 3, e.g. 41.4 * 0.384/(0.384+0.495)=18.2 

 C-34
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Lukacz et al., 

2006 

Lawrence et al., 

2007^ 

Lawrence et al., 

2008† 

Country: 

US 

Study period: 

April 2004 to 

January 2005 

Funding: 

NIH 

NIH; Kaiser 

Permanente Direct 

Community 

Benefit Funds^† 

Author industry 

relationship 

disclosures: †

2 of 5 

Astellas (1) 

Novartis (1) 

Pfizer (2) 

Watson (1) 

Design: 

Cross-sectional 

mailed 

questionnaire 

(EPIQ*) 

Base population: 

Kaiser 

Permanente 

Southern 

California 

members 

Sampling frame: 

Age-stratified 

random sample of 

950,000 female 

members in age 

range in April 

2004 

N sampled: 

12,200 

N eligible: 

12,200 

N respondents: 

4,458 

N included: 

4,103 

3,962^ 

Age, mean ± SD: 

56.5 ± 15.8 

56.6 ± 15.8^ 

Race/ethnicity, 

%:

White: 61.0 

Hispanic: 19.4 

Black: 9.7 

Asian/Pacific: 7.9 

Other: 2.1 

Race/ethnicity, 

%:^

White: 61.7 

Hispanic: 19.2 

Black: 9.6 

Asian/Pacific: 8.2 

Other/unknown: 

1.3 

BMI, mean ± SD: 

27.4 ± 6.3 

27.8 ± 6.2^ 

Parity, %: 

80.8 

Inclusion criteria: 

• women 

• age 25 to 84 

• address on 

record with HMO

Exclusion 

criteria: 

• insufficient data 

to categorize 

Effective 

response, %: 

33.6 

32.5^ 

OAB: 

Per EPIQ* 

OAB-any: 

Includes urgency 

and frequency, 

with or without 

incontinence 

OAB-wet: 

Includes urgency 

and frequency, 

with incontinence 

SUI: 

Per EPIQ* 

Prevalence of 

OAB-any, % (95% 

CI):

13.3 (12.2, 14.4) 

Prevalence of 

OAB-any by age, 

%:† 

25-39: 5.9 

40-54: 10.9 

55-69:14.8 

70-84: 19.0 

P<0.01 

Prevalence of 

OAB, %:^

All: 13.4 

Nondiabetic: 12.5 

Diabetic: 21.4 

P<0.0001 for 

diabetic vs. non 

Prevalence of 

OAB by parity, % 

(95% CI): 

Nulliparous: 9 (7, 

11) 

Cesarean: 9 (7, 

13) 

Vaginal: 15 (14, 

16) 

P<0.05 both 

comparisons to 

vaginal 

Prevalence of 

OAB-wet, % (95% 

CI): † 

12.7 (11.7, 13.9) 

Prevalence of 

mixed OAB-wet 

and SUI, % (95% 

CI): † 

8.3 (7.5, 9.2) 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

34 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-35
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Lukacz et al., 

2006 

Lawrence et al., 

2007^ 

Lawrence et al., 

2008† 

(continued) 

Vaginally Parous, 

%:^

71.6 

**12,200 mailed, 4458 returned, 3962 evaluable = effective response of 3962/12,200 = 32.5% 

 C-36
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

MacDiarmid and 

Rosenberg, 2005 

Country: 

US 

Study period: 

September 2004 

Funding: 

Ortho-McNeil 

Author industry 

relationship 

disclosures: 

2 of 2 

GlaxoSmithKline 

(1) 

Lilly (1) 

Novartis (1) 

Odyssey (1) 

Ortho-McNeil (2) 

Pfizer (2) 

Reliant (1) 

Watson (1) 

Yamanouchi (1) 

Design: 

E-mailed invitation 

to online 

questionnaire 

Base population: 

Adult members of 

a multi-millionmember online 

panel 

Sampling frame: 

Random electronic 

mailing 

N eligible: 

2,951 

N respondents: 

2,951 

Age: 

NR for total N 

Race/ethnicity:

NR for total N 

BMI:

NR for total N 

Parity: 

NR for total N 

Inclusion criteria: 

• women 

• age ≥ 30 

Exclusion 

criteria: 

NR 

Effective 

response: 

NR 

UUI: 

ICS definition 

MUI: 

ICS definition 

Prevalence of 

UUI, %: 

9.2* 

Prevalence of 

MUI, %: 

13.2* 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

*Calculated from reported frequencies: 271/2,951 and 389/2,951 

 C-37
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

McGrother et al., 

2006^ 

Donaldson et al., 

2006* 

Country: 

UK 

Study period: 

Baseline 

questionnaires 

mailed in 1998* 

Funding: 

Medical Research 

Council 

Author industry 

relationship 

disclosures: 

None 

Design: 

Repeated 

measures mailed 

questionnaires at 

baseline and 1, 2*, 

and 3*-year followup 

Base population: 

Leicestershire 

Health Authority 

(108 general 

practices) 

Sampling frame: 

Random sample 

from 20,247 

women on 

registers at 

baseline 

N eligible: 

19,241 

N respondents: 

Baseline: 12,750 

Follow-up: NR 

Year 1: NR 

Year 2: NR 

Year 3: NR 

Age, mean ± SD: 

59.5 ± 13.0* 

Race/ethnicity, 

%: 

White: 85.5* 

BMI kg/m2

, %:^

< 20: 3.2 

> 20-25: 38.7 

> 25-30: 38.6 

> 30: 19.5 

Parity, %: 

87.2* 

Inclusion criteria: 

• women 

• age ≥ 40 

• community 

dwelling 

Exclusion 

criteria: 

NR^; 

• very elderly 

people in 

residential care;*

Effective 

Response, %:

Baseline: 65.3 

Follow-up: 79.7^ 

Year 1: 76.4* 

Year 2: 71.2* 

Year 3: 67.0* 

OAB: 

“a strong desire to 

pass urine 

resulting in 

leakage or

urgency occurring 

monthly or more.” 

(exclusive of SUI)^

Very strong or 

overwhelming 

urgency and UUI 

several times a 

month or more* 

UUI: 

strong desire to 

pass urine 

resulting in 

leakage before 

reaching toilet 

(exclusive of SUI) 

MUI:^ 

Not explicitly 

defined 

Annual incidence 

of MUI, %:^ 

4.5 

Annual incidence 

of OAB, %:^ 

5.4 

Year 1 Incidence 

of OAB, %:* 

6.9

Year 1 Incidence 

OAB by age, %:* 

40-49: 6.7 

50-59: 6.5 

60-69: 7.0 

70-79: 6.9 

80+: 9.5 

Year 1 Remission 

of OAB, %:* 

38.8 

Year 1 Remission 

OAB by age, %:* 

40-49: 36.3 

50-59: 32.9 

60-69: 45.4 

70-79: 39.7 

80+: 45.9 

Year 2 Incidence 

of OAB, %:* 

6.0 

Year 2 Remission 

of OAB, %:* 

38.9 

Year 3 Incidence 

of OAB, %:* 

6.8 

Year 3 Remission 

of OAB, %:* 

36.9 

Baseline 

prevalence of 

MUI, %:^ 

12.7 

Baseline 

prevalence of 

OAB, %:^ 

7.7 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: - 

Response Rate:* 

+ 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-38
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

McGrother et al., 

2006^ 

Donaldson et al., 

2006* 

(continued) 

Baseline 

prevalence of 

OAB by age, %:* 

40-49: 11.4 

50-59: 14.060-69: 

12.5 

70-79: 12.1 

80+: 15.5 

Prevalence, year 1 incidence and remission are reported by age in Table 2 on page 712; urgency is defined in Table 

1, but the threshold is only given for “When you need to pass urine, how strong is the urge usually?” 

 C-39
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Milsom et al., 

2001 

Country: 

France, Germany, 

Italy, Spain, 

Sweden, UK 

Study period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

telephone 

questionnaire, 

except Spain 

where in-person 

interviews were 

done 

Base population: 

Residents of 

France, Germany, 

Italy, Spain, 

Sweden, UK 

Sampling frame: 

Stratified random 

sample to obtain 

nationally 

representative 

respondents from 

telephone listings 

(or voter roles in 

Spain) 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

Total: 16,776 

Women: 9,728 

Age, %: 

40-44: 17.4 

45-49: 14.8 

50-54: 13.2 

55-59: 12.2 

60-64: 11.1 

65-69: 10.9 

70-74: 8.9 

≥ 75: 11.5 

Race/ethnicity:

NR 

Inclusion criteria: 

• adults 

• age ≥ 40 

Exclusion 

criteria: 

• voiding 

symptoms 

suggestive of 

stress 

incontinence, 

prostatic 

obstruction, or 

urinary tract 

infection 

Effective 

response: 

NR 

Frequency: 

> 8 voids/day 

Urgency: 

“Strong urge to go 

to toilet with no 

advance warning; 

have to hurry to 

toilet in time to 

urinate, have to 

keep running to 

toilet to urinate” 

UUI: 

“unable to get to 

bathroom in time; 

have wetting 

accidents at night 

when asleep; 

sudden and 

uncontrolled loss 

of urine; leak urine 

during the day 

without being able 

to control it” 

OAB: Frequency, 

urgency, and urge 

urinary 

incontinence alone 

or in any 

combination 

Prevalence of 

OAB, %: 

17.4 

Prevalence of 

OAB by age, %: 

40-44: 8.7 

45-49: 10.6 

50-54: 11.9 

55-59: 16.9 

60-64: 16.9 

65-69: 17.5 

70-74: 22.1 

75+: 31.3 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-40
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Møller et al., 2000 

Country: 

Denmark 

Study period: 

June 1996 

Funding: 

Coloplast A/S 

Pharmacia A/S 

Four Danish 

foundations 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross sectional 

mailed 

questionnaire 

Base population: 

Residents of 

Denmark 

Sampling frame: 

Random sampling 

of Danish Civil 

Registry System in 

age and urban vs. 

rural strata 

N screened: 

4,000 

N eligible: 

NR 

N respondents: 

3,204 

N included: 

2,860 

Age, %: 

40: 21.5 

45: 20.3 

50: 20.0 

55: 19.2 

60: 18.9 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age 40, 45, 50, 

55, or 60 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

71.7 

UUI: 

Do you leak urine 

if suddenly you 

need to void? 

Urgency: 

Do you rush to the 

toilet because of a 

sudden desire to 

void? 

Daytime 

frequency: 

Number of 

episodes exceeds 

10 voids daily.* 

Prevalence UUI, 

weekly or more, 

%:

7.2 (95% CI : 

6.2,8.2) 

Prevalence of 

urgency, weekly 

or more, %: 

7.1 (95% CI: 

6.1,8.1) 

Prevalence of 

daytime 

frequency, %: 

3.6 (95% CI: 

2.9,4.3) 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

71.7 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: 

Required 

frequency 

defined*: - 

^Data presented for women only. 

*More than 10 voids per day is categorized as “often” (and reported in Table III). 

 C-41
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Muller, 2005 

Country: 

US 

Study period: 

October 2000 to 

December 2000 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross sectional 

administered 

questionnaire (NS) 

Base population: 

US population 

Sampling frame: 

Unspecified 

sampling of 

shoppers in retail 

malls of 20 major 

urban areas 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

NR 

N included: 

Total: 1,001 

Women: NR 

Age: 

NR 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age 30 to 70 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response: 

NR 

Definitions: 

NR 

Prevalence of 

“sudden urge to 

urinate”, %: 

13 

Prevalence of 

“both urge and 

leakage”, %:

22 

Overall quality: 

Poor 

Internal validity 

score: 1, - 

External Validity 

Score: 1,- 

Sampling Method 

Described:+ 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: - 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: 

- 

Note: This is a report from the Executive Director of The National Association for Continence presenting for academic 

audiences consumer research done as part of pre- or post-marketing research by for profit entities. The Association 

assisted with formation and scope of questions included in the questionnaire. 

^Data presented for women only. 

 C-42
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Nuotio et al., 2002 

Country: 

Finland 

Study period: 

1979 to 1989 

Funding: 

Medical Research 

Fund of Tampere 

University 

Hospital, the 

Academy of 

Finland, and the 

Uulo Arhio 

Foundation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire with 

similar follow-up 

questionnaire 10 

years later 

Base population: 

Elderly residents 

of Tampere, 

Finland 

Sampling frame: 

Age and gender 

stratified random 

sample; part of the 

European 

Longitudinal Study 

on Aging (ELSA) 

N sampled: 

1,494 

N screened: 

NR 

N eligible: 

Baseline: 1,309 

Follow-up: 518 

N included: 

Total: 1,052 

Women: 528 

Follow-up: 435 

Women: 260 

Age, mean:^ 

73.2 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Adults 

• Age ≥ 60 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

Baseline: 82 

Follow-up: 84 

Urgency: 

“Do you ever have 

trouble getting to 

the lavatory in 

time?” 

UUI: 

Urgency and 

urinary leakage, 

regardless of the 

frequency of urine 

loss 

Prevalence of 

urgency, %: 

8 

Prevalence of 

UUI, %: 

6 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

82 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: 

^Data presented is for women only. 

 C-43
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Nygaard and 

Lemke, 1996 

Country: 

US 

Study period: 

1981 to 1988 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Repeated 

measures, inperson interviews 

Base population: 

Residents of two 

counties in rural 

Iowa 

Sampling frame: 

Age stratified 

random sample of 

women with 

address on record 

N sampled: 

NR 

N screened: 

NA 

N eligible: 

NR 

N respondents: 

2025 

Age, %: 

65-69: 25.6 

70-74: 25.9 

75-79: 23.0 

80-84: 15.9 

85-89: 7.5 

≥ 90: 2.1 

Race/ethnicity, 

%: 

Non-Hispanic 

white: 61.7 

Hispanic: 19.2 

Black: 9.6 

Asian-Pacific 

Islander: 8.2 

Other/unknown: 

1.3 

BMI, mean: 

25.4 

Inclusion criteria: 

• women 

• age ≥ 65 

• living in 

community 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

80 

UUI: 

“How often do you 

have difficulty 

holding your urine 

until you can get 

to a toilet?” 

For prevalence, 

incidence, and 

remission never 

and hardly ever = 

negative response

3-year incidence 

of UUI (first 

follow-up), %: 

20.4 

3-year remission 

of UUI (first 

follow-up), %: 

31.7 

3-year incidence 

of UUI (second 

follow-up), %: 

24.0* 

3-year remission 

of UUI (second 

follow-up), %: 

34.9* 

Baseline 

prevalence of 

UUI, %:

Total ever: 55 

Positive response: 

36.3 

Baseline 

prevalence of 

UUI by how 

often, %:

Hardly ever: 18.6 

Some of the time: 

27.8 

Most of the time: 

6.7 

All of the time: 1.6 

Overall quality: 

Fair 

Internal validity 

score: 3, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

80 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

*3-year incidence and remission in the second follow-up are calculated from those women without UUI at baseline. 

Effective response rate is reported on page 1050, but the number sampled is not reported. 

 C-44
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Odeyemi et al., 

2006 

Country: 

UK 

Study period: 

1987 to 2004 

Funding: 

Allergan 

Author industry 

relationship 

disclosures: 

1 of 6: 

Allergan (1) 

Design: 

Healthcare 

database 

Base population: 

Residents of the 

UK receiving care 

in one of 350 

general practices 

selected to be 

representative of 

the National 

Health Service 

Sampling frame: 

General Practice 

Research 

Database (4.6% 

representative 

sample with 

longitudinal data) 

N sampled: 

NR 

N screened: 

NA 

N eligible: 

68,910 

Age: 

NR for total N 

Race/ethnicity: 

NR for total N 

Inclusion criteria: 

• adults 

• in GPRD sample

Exclusion 

criteria: 

UTI within two 

weeks before or 

after visit meeting 

OAB criteria, renal 

dysfunction, 

diuretics use 

Effective 

response: 

NR 

OAB-related 

symptoms: 

Oxford Medical 

Index System and 

Read Clinical 

Classification 

codes for urgency, 

frequency, urge, 

urgency 

incontinence, 

nocturia, unstable 

bladder or irritable 

bladder 

Annual incidence 

of OAB-related 

symptoms (95% 

CI): 

2.60/1,000 (2.57, 

2.63) 

Prevalence of 

OAB-related 

symptoms:

3.64/1,000 

Overall quality: 

Fair 

Internal validity 

score: (+) 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: 

NA 

N eligible 

provided: NA 

N included 

respondents: NA 

Response Rate:* 

NA 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: - 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-45
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Perry et al., 2000 

Country: 

UK 

Study period: 

October 1996 to 

June 1997 

Funding: 

Medical Research 

Council 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Patients registered 

in any of 108 

general practices 

in Leicestershire 

Sampling frame: 

Random sample 

Leicestershire 

Health Authority 

registry 

N sampled: 

15,904 

N screened: 

NR 

N eligible: 

Total: 14,600 

Women: 7,659 

N respondents: 

Total: 10,226 

Women: NR 

N included: 

Total: 10,116 

Women: 5,544 

Age, %:^ 

40-49: 25.1 

50-59: 24.8 

60-69: 21.8 

70-79: 17.9 

≥ 80: 10.4 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age ≥ 40 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %:^ 

72.4 

Incontinence: 

Loss of urine 

several times a 

month or more 

Urgency: 

Experienced an 

overwhelming 

urge to pass urine 

or had difficulty 

holding urine most 

of the time or 

overwhelming 

Frequency: 

Voiding hourly or 

more often 

Prevalence of 

urgency, %: 

8.8 

Prevalence of 

frequency, %: 

9.1 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

72.4 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

^Data presented is for women only. 

 C-46
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Rohr et al., 2004 

Country: 

Denmark 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

telephone 

questionnaire 

Base population: 

Female residents 

of central Odense 

Sampling frame: 

Central Person 

Register listing of 

residents in postal 

district 5000 

N sampled: 

498 

N screened: 

498 

N eligible: 

421 

N respondents: 

223 

N included: 

223 

Age, median 

(range): 

82 (75, 96) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age ≥ 70 

Exclusion 

criteria: 

• need for proxy 

respondent 

Effective 

response, %: 

53 

UUI: 

Such a strong 

urge that it was 

impossible to get 

to the toilet in time

SUI: 

Involuntary loss of 

urine in 

connection with 

physical exertion 

in the past month 

MUI: 

Both UUI and SUI 

Prevalence of 

UUI, % (95% CI): 

16 (10.9, 20.5) 

Prevalence of 

MUI, % (95% CI): 

13 (8.2, 16.9) 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

53 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-47
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Schulman et al., 

1997 

Country: 

Belgium 

Study period: 

November 1994 to 

February 1995 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

1 of 3 

Marrion Merrell 

Dow (1) 

Design: 

Cross sectional 

written 

questionnaire in 

home 

Base population: 

Residents of 

Belgium 

Sampling frame: 

Two stage, 

random sampling, 

stratified by 

region, gender, 

age, and 

profession for 

nationally 

representative 

sample. 

N screened: 

8,000 

N eligible: 

NR 

N respondents: 

5,920 

N included: 

Total: 5,269 

Women: 2,770 

Age, %: 

30-34: 13.3 

35-49: 34.0 

50-64: 28.0 

≥ 65: 24.7 

Race/ethnicity: 

NR 

Inclusion criteria: 

• adults 

• age 30 and older

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

NR 

UUI: 

Arriving too late at 

the toilet 

Prevalence of 

UUI, %: 

2.7 

Overall quality: 

Poor 

Internal validity 

score: 3, - 

External Validity 

Score: 2, - 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

^Data presented for women only. 

The total number of UUI cases is 0.026*5,269=137, of which 55% (see page 317) are women. The prevalence of UUI 

can then be calculated as 137*0.55/2,770=75/2,770=2.7% 

 C-48
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Shakhatreh, 2005 

Country: 

Jordan 

Study period: 

July 2003 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Female residents 

of Southern 

Jordan in this age 

group 

Sampling frame: 

68 census blocks 

selected from 

among 228 to 

achieve 

representative 

sample; 

household and 

then individuals 

randomly selected 

within blocks 

N sampled: 

Households: 810 

N screened: 

NR 

N eligible: 

Women: 190* 

N respondents: 

182 

N included: 

182 

Age, %: 

50-54: 38.9 

55-59: 23.9 

60-65: 37.2 

Race/ethnicity: 

NR 

BMI kg/m2

, %: 

18.5-24: 20 

25-29: 32 

≥ 30: 48 

Parity, %: 

95.8 

Inclusion criteria: 

• women 

• age 50 to 65 

• community 

dwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

96* 

UUI: 

Inability to 

postpone urination 

with strong urge to 

void 

SUI: 

Involuntary 

leakage of urine 

on exertion as in 

coughing, 

sneezing, 

laughing, bending 

over, or with 

exercise as in 

jumping 

MUI:

Combination of 

UUI and SUI 

Prevalence of 

UUI, %: 

26.4 

Prevalence of 

MUI, %: 

18.1 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described:+ 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

96 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

* Authors report 96% of eligible women participated and 182 = respondents. 

 C-49
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Simeonova et al., 

1999 

Country: 

Sweden 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Female residents 

of the Central 

[primary care] 

District of 

Götenberg 

Sampling frame: 

Every fourth 

female resident 

(other detail NR) 

N sampled: 

2,911 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

2,248 

N included: 

2,176 

Age, %: 

20-29: 22.0 

30-39: 18.2 

40-49: 14.8 

50-59: 12.6 

60-69: 10.2 

70-79: 12.0 

≥ 80: 10.2 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age ≥ 20 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

74.8 

Incontinence: 

involuntary loss of 

urine at least 

1x/wk, considered 

by women to be 

hygienic or social 

problem

UUI: 

incontinence 

preceded by urge 

to void or 

uncontrollable 

voiding with little 

or no warning 

SUI: 

Incontinence 

precipitated by 

coughing, 

sneezing, or 

physical exertion 

Mixed: 

Both UUI and SUI 

Prevalence of 

UUI, %: 

5.1 

Prevalence of 

UUI by age, %: 

20-29: 0.8 

30-39: 1.5 

40-49: 4.4 

50-59: 4.9 

60-69: 7.7 

70-79: 10.0 

≥ 80: 13.7 

P < 0.01 for 

increase with age 

Prevalence of 

MUI, %: 

3.9 

Prevalence of 

MUI by age, %: 

20-29: 1.1 

30-39: 1.5 

40-49: 2.5 

50-59: 4.9 

60-69: 5.5 

70-79: 6.7 

≥ 80: 10.0 

P < 0.01 for 

increase with age 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

74.8 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

*Urge and mixed incontinence prevalence (overall and by age) computed from proportions of types of incontinence 

estimated from Figure 3. 

 C-50
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Siracusano et al., 

2003 

Country: 

Italy 

Study period: 

NR 

Funding: 

Associazione 

Progetto 

Continenza 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Female residents 

of Trieste 

Sampling frame: 

NR 

N sampled: 

10,000 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

3,557 

N included: 

2,900 

Age: 

NR for 

respondents 

Race/ethnicity: 

NR 

Inclusion criteria: 

• women 

• age 18 to 49 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

29 

UUI: 

NR 

Prevalence of 

UUI, %: 

8.7* 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 1, - 

Sampling Method 

Described: - 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

29% 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:- 

Operational 

definition 

provided*: - 

Required 

frequency 

defined*: - 

* Calculated: 43.5% of 581 women with incontinence had urge incontinence (Table 2) and denominator is 2900. 

 C-51
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Song et al., 2005 

Zhang et al., 2005 

Zhang et al., 

2006* 

Country: 

China 

Study period: 

April 2002 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

(BFLUTS) 

Base population: 

Residents of 

Fuzhou, China 

Sampling frame: 

Random sample 

(3%) of national 

census records for 

the city 

N sampled: 

6,066 

N screened: 

NA 

N eligible: 

4,745 

N respondents: 

4,684 

Age, mean ± SD: 

40.0 ± 11.1 

Race/ethnicity: 

Han Chinese: 100 

BMI, mean ± SD: 

21.9 ± 3.0 

Vaginally Parous, 

%: 

79.8 

Inclusion criteria: 

• women 

• age ≥ 20 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

77.2 

Incontinence: 

Any involuntary 

loss of urine in last 

month 

UUI: 

incontinence 

preceded by a 

sudden urge to 

void or 

uncontrollable 

voiding with little 

or no warning 

MUI: 

Symptoms of 

stress and urge 

incontinence 

OAB: 

OAB-wet or OABdry 

OAB-wet*: 

Urge incontinence 

with any 

combination of at 

least one of the 

following: urgency, 

frequency, 

nocturia, or mixed 

incontinence 

OAB-dry*: 

Urgency with 

either or both 

frequency and 

nocturia 

Frequency: 

≥ 8 voids a day 

Prevalence of 

UUI, %:

10.0 

Prevalence of 

MUI, %: 

7.7 

UUI and MUI 

Prevalence 

increases with 

age 

P<0.01 

Prevalence of 

OAB-wet*, %: 

5.6 

Prevalence of 

OAB-dry*, %: 

2.4 

Overall 

prevalence of 

OAB, %: 

8.0 

Prevalence of 

urgency, %: 

10.2 

Prevalence of 

frequency, %: 

16.4 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

77.2 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:+ 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

Note: differences between UUI and OAB-wet prevalence result from differences in operational definitions used in 

Zhang et al., 2006. 

 C-52
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Stewart et al., 

2003 

Wagner et al., 

2002 

Country: 

US 

Study period: 

November 2000 to 

January 2001 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

2 of 8 

Pharmacia (2) 

Design: 

Cross sectional 

telephone 

questionnaire 

Base population: 

US adults who are 

English speaking 

Sampling frame: 

Nationwide 

random sample by 

telephone to 

achieve 

representative 

sample by age, 

sex, and region 

N sampled: 

17,231 

N screened: 

11,740 

N eligible: 

6,201 

N respondents: 

6,201 

N included: 

Total: 5,204 

Women: 2,735 

Age, %:^ 

< 25: 11.2 

25-34: 15.3 

35-44: 22.2 

45-54: 16.5 

55-64: 14.1 

65-75: 11.1 

> 75: 8.6 

Race/ethnicity, 

%:^ 

White: 81.7 

Black: 9.1 

Hispanic: 4.2 

Other: 3.8 

BMI:^ 

< 22.0: 25.3 

22.0-23.9: 15.7 

24.0-25.9: 15.9 

26.0-29.9: 19.3 

≥ 30: 23.8 

Inclusion criteria: 

• adults 

• age 18 or older 

• English speaking

• residential 

phone 

• most recent 

birthday among 

eligibles 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

83.9 

OAB-wet: 

Per ICS 2002 

OAB-dry: 

Per ICS 2002 

Prevalence of 

OAB-wet, %: 

9.3 

Prevalence of 

OAB-dry, %: 

7.6 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

83.9 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-53
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Teloken et al., 

2006 

Country: 

Brazil 

Study period: 

November 2003 to 

August 2004 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross sectional, 

written 

questionnaire 

(King’s Health 

Questionnaire) 

Base population: 

Residents of Porto 

Alegre, Brazil 

Sampling frame: 

NR (“population 

based”) 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

913 

N included: 

Total: 848 

Women: 449 

Age, %: 

< 25: 59.3 

26-35: 21.4 

36-45: 13.2 

46-55: 6.1 

Race/ethnicity, 

%: 

White: 90.8 

Black: 3.9 

Other: 5.3 

Parity, %:^ 

39.9 

Inclusion criteria: 

• individuals 

• ages 15 to 55 

Exclusion 

criteria: 

• current 

pregnancy 

• UTI 

• Diabetes 

• SUI 

• diuretic use 

• urinary tract or 

gynecologic 

cancer 

• renal stones 

• previous 

urogenital tract 

surgery 

Effective 

response, %: 

NR 

OAB: 

Per ICS 2002 

Prevalence of 

OAB, %: 

23.2 

Overall quality: 

Poor 

Internal validity 

score: 1, - 

External Validity 

Score: 2, - 

Sampling Method 

Described: - 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-54
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Tikkinen et al., 

2008 

Country: 

Finland 

Study period: 

November 2003 to 

February 2004 

Funding: 

Competitive 

Research Funding 

of the Pirkanmaa 

Hospital District; 

Pfizer 

Author industry 

relationship 

disclosures: 

1 of 6 

Astellas (1) 

Orion (1) 

Design: 

Cross-sectional 

mailed 

questionnaire 

(DAN-PSS; AUASI) 

Base population: 

Women in Finland 

Sampling frame: 

Random sample 

with over-sampling 

in younger age 

strata from Finish 

Population 

Registry to 

achieve 

representative 

sample with good 

precision of 

estimates for all 

ages 

N sampled: 

3,000 

N screened: 

NR 

N eligible: 

2,989 

N respondents: 

2,002 

N included: 

1,728 

Age, mean ± SD: 

42.3 ± 15.6 

Race/ethnicity: 

NR 

Parity, %: 

64 

Inclusion criteria: 

• women 

• age 18 to 79 

Exclusion 

criteria: 

• pregnant or 

postpartum 

women 

• those reporting 

current UTI 

Effective 

response, %: 

57.6 

Urgency: 

An imperative 

(strong) urge to 

urinate, often or 

always 

Agestandardized 

prevalence of 

urgency, % (95% 

CI): 

10.2 (8.5, 11.9) 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

57.6 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

Prevalence of urgency by age in Figure 2 (no data). 

 C-55
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Danforth et al., 

2007* 

Townsend et al., 

2008 

Country: 

US 

Study period: 

Baseline 2000 

Follow-up 2002 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

None 

Design: 

Repeated 

measures 

mailed 

questionnaires 

at two time points, 

with supplement to 

some individuals 

with incident 1x/wk 

incontinence at 

follow-up 

Base population: 

Nurses Health 

Study (NHS) 

participants 

Sampling frame: 

Members of the 

NHS cohort 

N sampled/ 

screened: 

121,700 

Supplement: 

1,939 

N respondents: 

77,696 

Supplement: 

1,753 

N eligible: 

35,754 

Supplement: 

1,601 

Age, mean: 

65.3 

Race/ethnicity: 

White: 96.5 

Black: 1.6 

Hispanic: 0.9 

Asian: 0.8 

Other: 0.2 

BMI kg/m2

, %:

< 21: 12.6 

21-24: 36.3 

25-29: 33.9 

≥ 30: 17.1 

Parity, %: 

94.0 

Inclusion criteria: 

• women 

• NHS participants 

returning both 

baseline and 

follow-up 

• community 

dwelling 

Exclusion 

criteria: 

• missing data on 

BMI or UI 

• prevalent UI 

1x/mo at 

baseline 

• history of major 

neurologic 

conditions 

• significant 

functional 

limitations 

Effective 

response, %:

46.0 

Supplement: 82.6

Frequent 

incontinence: 

Leaking ≥ 1x/wk 

UUI: 

Frequent 

incontinence with 

a sudden feeling 

of bladder fullness 

or when a toilet 

was inaccessible 

SUI: 

Frequent 

incontinence with 

coughing or 

sneezing, lifting 

things, laughing, 

or doing exercise 

MUI: 

Reporting UUI and 

SUI symptoms 

equally 

2-year incidence 

of UUI , %:**

1.4 

2-year incidence 

of MUI, %:**

1.9 

Overall quality: 

Fair 

Internal validity 

score: 3, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: - 

Response Rate:* 

46 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:+ 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

* Incidence of UUI and MUI from Danforth et al., 2007 is 1.4% and 1.8%, respectively. 

** Incidence calculated as incidence of frequent UI (1x/wk) times estimated proportion with each type of UI, e.g. 

(2,416/35,754)*(342/1,601) = 1.4% 

 C-56
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Townsend et al., 

2007 

Country: 

US 

Study period: 

Baseline 2001 

Follow-up 2003 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Repeated 

measures 

mailed 

questionnaires 

at two time points, 

with supplemental 

questionnaire if ≥

1x/wk 

incontinence at 

follow-up 

Base population: 

Nurses Health 

Study (NHS) 

participants 

Sampling frame: 

Members of the 

NHSII cohort 

N sampled/ 

screened: 

115,713 

N respondents: 

Baseline: 85,994 

Follow-up: 70,712 

N eligible: 

Total: 64,650 

Age, mean: 

46.4 

Age, %: 

36-40: 13.2 

41-45: 29.1 

46-50: 34.8 

51-55: 22.9 

Race/ethnicity: 

“Largely 

Caucasian” 

BMI kg/m2

, %:

≥ 25: 50.3 

Parity, %: 

79.0 

Inclusion criteria: 

• women 

• age 35 to 54 at 

baseline 

• NHS participants 

returning both 

baseline and 

follow-up 

Exclusion 

criteria: 

• missing data 

• unclear 

continence 

status at 

baseline 

Response, %:

Baseline: 74 

Follow-up: 61 

Effective 

response, %:

Total: 57

Incontinence: 

“During last 12 

months, how often 

have you leaked 

or lost control of 

your urine?” 

(required ≥ 1x/wk) 

UUI: 

Predominance of 

urge symptoms in 

the Medical 

Epidemiological 

and Social 

Aspects of Aging 

questionnaire, per 

Diokno (1995) 

SUI: 

Predominance of 

stress symptoms 

MUI: 

Equal 

predominance of 

UUI and SUI 

symptoms 

2-year incidence 

of UUI , %:

0.4 

2-year incidence 

of UUI by age, %:

36-40: 0.4 

41-45: 0.4 

46-50: 0.5 

51-55: 0.4 

2-year incidence 

of MUI, %:

0.6 

2-year incidence 

of MUI by age, %:

36-40: 0.3 

41-45: 0.6 

46-50: 0.7 

51-55: 0.9 

Overall quality: 

Fair 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

61 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:+ 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-57
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Tseng et al., 2000 

Country: 

Taiwan 

Study period: 

March 1997 to 

April 1997 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Residents of 

Tungkang Town 

Sampling frame: 

Random sample 

stratified to obtain 

age and gender 

representation by 

city region 

N sampled: 

NR 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

NR 

N included: 

Total: 504 

Women: 256 

Age, %: 

65-70: 43.1 

71-75: 28.1 

76-80: 18.4 

> 80: 12.1 

Race/ethnicity: 

NR 

BMI, %: 

“Overweight”: 

47.3* 

Inclusion criteria: 

• adults 

• age ≥ 65 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

80 (per authors 

cannot calculate) 

UI: 

“ever experienced 

inappropriate loss 

of urine” 

UUI: 

Because of 

inability to delay 

voiding following 

micturition urge 

SUI: 

Loss associated 

with physical 

exertion 

(coughing, 

sneezing, lifting, or 

other physical 

activity) 

MUI: 

Features of UUI 

and SUI 

Prevalence of 

UUI, % : 

6.6 

Prevalence of 

MUI, %: 

6.3 

Overall quality: 

Poor 

Internal validity 

score: 2, - 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

^ Data presented for women only. 

 C-58
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Ueda et al., 2000 

Country: 

Japan 

Study period: 

NR 

Funding: 

LACADIA Health 

and Welfare 

Foundation; 

Social Department 

Foundation for 

Senior Citizens 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Residents of 

Shiga Prefecture 

Sampling frame: 

Random sample 

of individuals in 

seven towns 

N sampled: 

3,500 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,836 

N included: 

Total: 1,786 

Women: 968 

Age, %:^ 

40-49: 26.4 

50-59: 28.8 

60-69: 29.4 

≥ 70: 15.4 

Race/ethnicity: 

NR 

BMI: 

NR 

Inclusion criteria: 

• adults 

• age 40 to 80 

• communitydwelling 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

51.0 

Incontinence: 

involuntary loss of 

urine within prior 

year 

UUI: 

Often have 

difficulty holding 

urine until able to 

get to toilet 

SUI: 

Leak when cough, 

sneeze, or laugh? 

MUI: 

Both UUI and SUI 

Prevalence of 

UUI, %: 

6.9 

Prevalence of 

UUI by age, %: 

40-49: 5.1 

50-59: 4.3 

60-69: 8.8 

≥ 70: 11.4 

Prevalence of 

MUI, %: 

12.9 

Prevalence of 

MUI by age, %: 

40-49: 14.5 

50-59: 14.3 

60-69: 6.3 

≥ 70: 20.1 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

51 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-59
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

van der Vaart et 

al., 2002 

Country: 

Netherlands 

Study period: 

1999 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

(UDI) 

Base population: 

Female residents 

of the Central 

Netherlands 

Sampling frame: 

Random sample 

of women from the 

population registry 

office of a 

suburban area 

N sampled: 

1,393 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,029 

N included: 

933 

Age, mean ± SD: 

34.2 ± 3.2 

Race/ethnicity: 

NR 

BMI, mean ± SD: 

23.6 ± 4.2 

Inclusion criteria: 

• women 

• age 20 to 45 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

67 

UUI: 

Urine loss related 

to feeling of 

urgency 

OAB: 

Per ICS 

Urgency: 

Per ICS 

Frequency: 

Per ICS 

Prevalence of 

UUI, %: 

15.3 

Prevalence of 

OAB, %: 

11.9 

Prevalence of 

urgency, %: 

45.4 

Prevalence of 

frequency, %: 

34.0 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

67% 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described:+ 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-60
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Waetjen et al., 

2007 

Country: 

US 

Study period: 

1995 to 2001 

Funding: 

NIH, Univ. of 

California Davis 

Health Systems 

Research Award 

Author industry 

relationship 

disclosures: 

None 

Design: 

Repeated 

measures 

administered 

questionnaire and 

follow-up visits 

Base population: 

Women in six 

states near seven 

urban study 

centers 

Sampling frame: 

Random digit 

dialing, 

snowballing, and 

list sampling 

based on study 

center 

N sampled: 

16,065 

N screened: 

16,065 

N eligible: 

NR 

N respondents: 

16.065 baseline 

3,302 included in 

follow-up based 

on per center 

quotas 

Age, mean ± SD: 

45.8 ± 2.7 

Race/ethnicity, 

%: 

Caucasian: 47.0 

Black: 28.3 

Chinese: 7.6 

Japanese: 8.5 

Hispanic: 8.7 

BMI, mean ± SD: 

28.2 ± 7.2 

Parity, mean ± 

SD: 

2.0 ± 1.4 

Inclusion criteria: 

• women 

• age 42 to 52 

• self-identified as 

member of one 

of five 

race/ethnic 

groups 

Exclusion 

criteria: 

• inability to speak 

English, 

Spanish, 

Japanese, or 

Cantonese 

• no menstrual 

period in prior 3 

months 

• hysterectomy 

and/or 

oophorectomy 

prior to study 

• current use of 

hormones 

including birth 

control pills 

Effective 

response, %: 

NR 

UUI: 

at least monthly 

leakage when 

“urge to void and 

can’t reach the 

toilet fast enough.”

SUI: 

at least monthly 

leakage “with 

coughing, 

laughing, 

sneezing, jogging, 

jumping, or picking 

up an object from 

the floor.” 

MUI: 

Affirmative 

answers to both 

UUI and SUI at 

least monthly 

5-year incidence 

of UUI, %: 

15.9 

5-year incidence 

of MUI, %: 

11.9 

Baseline 

prevalence of 

UUI, %: 

7.6 

Baseline 

prevalence of 

MUI, %: 

12.4 

Overall quality: 

Fair 

Internal validity 

score: 3, - 

External Validity 

Score: 3, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

NR 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-61
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Wesnes et al., 

2007 

Country: 

Norway 

Study period: 

1999 to 2006 

Funding: 

Research Council 

of Norway 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

mailed 

questionnaire 

Base population: 

Pregnant women 

in Norway 

Sampling frame: 

Women receiving 

prenatal care in 

one of 52 

maternity units 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

46,262 

N included: 

43,279 

Age, mean 

(range): 

29.5 (14, 47) 

Race/ethnicity: 

NR 

Pre-pregnancy 

BMI, mean 

(range): 

24.1 (13, 59) 

Parity, %: 

53.8 

Inclusion criteria: 

• pregnant women

• read and write 

Norwegian 

• completion of 

questionnaire by 

30-week visit 

Exclusion 

criteria: 

• participated in 

prior pregnancy 

Effective 

response, %:

45 

UUI: 

Per ICS 2002 

MUI: 

Per ICS 2002 

Prevalence of 

UUI, before 

pregnancy, %:

3.8 

Prevalence of 

UUI during 

pregnancy, %: 

4.8 

Prevalence of 

MUI, before 

pregnancy, %:

5.5 

Prevalence of 

MUI during 

pregnancy, %: 

16.4 

Overall quality: 

Fair 

Internal validity 

score: 3, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: - 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

45 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

 C-62
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Yarnell et al., 1981 

Country: 

UK 

Study period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Female residents 

of South Wales 

Sampling frame: 

Random sample 

of electoral role 

from base 

population of 

38,000 

N sampled: 

1,140 

N screened: 

NR 

N eligible: 

1,060 

N respondents: 

1,022 

N included: 

1,000 

Age, %: 

17-24: 12 

23-34: 21 

35-44: 15 

45-54: 19 

55-64: 15 

65-74: 11 

≥ 75: 7 

Race/ethnicity: 

NR 

BMI: 

NR 

Inclusion criteria: 

• women 

• age ≥ 18 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

94.3 

UUI: 

Ever (12 months) 

have to rush to the 

toilet to pass water 

and ever loose 

water before 

reaching toilet 

SUI: 

Ever (12 months) 

loose urine when 

you cough, laugh, 

sneeze, etc. 

MUI: 

Both UUI and MUI

Prevalence of 

UUI, %: 

9.2 

Prevalence of 

UUI by age, %: 

17-24: 9 

23-34: 5 

35-44: 10 

45-54: 9 

55-64: 10 

65-74:13 

≥75: 14 

Prevalence of 

MUI, %: 

13.5 

Prevalence of 

MUI by age, %: 

17-24: 4 

23-34: 8 

35-44: 16 

45-54: 16 

55-64: 15 

65-74: 13 

≥ 75: 28 

Overall quality: 

Good 

Internal validity 

score: 5, ++ 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

94.3 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: + 

 C-63
Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence^ Quality Rating 

Author: 

Yu et al., 2006 

Country: 

Taiwan 

Study period: 

February 2003 to 

February 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

Base population: 

Residents of 

Matsu 

Sampling frame: 

100% of residents 

N sampled: 

5,456 

N screened: 

NR 

N eligible: 

NR 

N respondents: 

1,921 

N included: 

Total: 1,827 

Women: 925 

Age, %:^ 

30-39: 22.6 

40-49: 34.5 

50-59: 19.4 

60-69: 12.8 

70-79: 10.8 

Race/ethnicity: 

NR 

BMI kg/m2

, %:^ 

< 24.0: 70.9 

24.0-26.9: 20.5 

≥ 27.0: 8.5 

Parity, %: 

89.4 

Inclusion criteria: 

• adults 

• age ≥ 30 in 2000

Exclusion 

criteria: 

NR 

Effective 

response, %: 

33.5 

UUI: 

Urine loss 

associated with an 

urge to void 

OAB: 

Per ICS 2002 

Prevalence of 

OAB, %: 

18.3 

Prevalence of 

OAB by age, %: 

30-39: 14.4 

40-49: 14.7 

50-59: 19.6 

60-69: 25.4 

70-79: 31.0 

P = 0.001 for trend 

Overall quality: 

Fair 

Internal validity 

score: 4, + 

External Validity 

Score: 3, + 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: - 

N included 

respondents: + 

Response Rate:* 

33.5 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

^Data presented for women only. 

 C-64
 C-65

Evidence Table 1. KQ 1 Prevalence and Incidence of OAB (continued) 

Study 

Description 

Study Design 

and Sampling 

Inclusion/ 

Exclusion 

Criteria Study Definitions

Incidence/ 

Prevalence Quality Rating 

Author: 

Zhu et al., 2008 

Country: 

China 

Study period: 

April 2005 to July 

2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cross-sectional 

administered 

questionnaire 

(Chinese ICIQ) 

Base population: 

Female residents 

of Beijing 

Sampling frame: 

1.0% of female 

Beijing residents 

age ≥ 20 (2000 

national census 

data) 

N sampled: 

5,300 

N included: 

5,221 

Age, mean: 

46.4 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 20 

Exclusion 

criteria: 

NR 

Effective 

response, %: 

98.5 

Incontinence: 

Any leakage or 

involuntary loss of 

urine within the 

last month. 

SUI: 

A leak or loss of 

urine caused by 

sneezing, 

coughing, 

exercising, lifting, 

or physical 

activity. 

UUI: 

An urge to urinate 

but being unable 

to reach the toilet 

before leaking or 

having a strong 

sudden urge to go 

to the toilet to 

urinate with no 

advance warning. 

MUI: 

Experiencing at 

least one stress 

and one urge 

symptom. 

Prevalence of 

UUI, %: 

2.8 

Prevalence of 

UUI by menopausal status, %: 

Premenopause: 

1.9 

Menopause: 4.0 

Prevalence of 

MUI, %: 

12.4 

Prevalence of 

MUI by menopausal status, %: 

Premenopause: 

6.0 

Menopause: 20.4 

Overall quality: 

Good 

Internal validity 

score: 4, + 

External Validity 

Score: 4, ++ 

Sampling Method 

Described: + 

N sampled 

provided: + 

N eligible 

provided: + 

N included 

respondents: + 

Response Rate:* 

98.5 

Inclusion 

(Exclusion) 

Specified: + 

Age of population 

described: + 

Operational 

definition 

provided*: + 

Required 

frequency 

defined*: - 

Mean age and prevalence of UUI and MUI by menopausal status calculated from results reported. 

Prevalence of UUI and MUI by age groups in Figure 3 on page 567 (no results reported). 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Abrams et al., 

1998 

Country and 

setting: 

UK, Ireland, 

Sweden, 

Academic medical 

center 

Enrollment 

period: 

July 1995 to July 

1996 

Funding: 

Pharmacia 

Upjohn 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine vs. 

Oxybutynin vs. 

Placebo x 12 wks 

Groups: 

G1: Tolterodine 2 

mg b.i.d. (dose 

could be reduced 

to 1.0 mg b.i.d.) 

G2: Oxybutynin 5 

mg t.i.d. (dose 

could be reduced 

to 2.5 mg t.i.d.) 

G3: Placebo 

N at enrollment: 

G1: 118 

G2: 118 

G3: 57 

N at follow-up: 

G1: 118 

G2: 117 

G3: 56 

Women, n (%): 

G1: 91 (77.1) 

G2: 88 ( 74.5) 

G3: 43 (75.4) 

Age, mean 

(range): 

G1: 55 (19-80) 

G2: 58 (21-80) 

G3: 58 (26-78) 

Inclusion criteria: 

• Age ≥ 18 

• UDS confirmed 

bladder 

overactivity 

• ≥ 8 voids/day 

• ≥ 1 episode 

UUI/ day 

Exclusion 

criteria: 

• SUI 

• Detrusor 

hyperreflexia 

• Hepatic, renal, 

hematological 

disorders 

• Symptomatic or 

recurrent UTI 

• BOO 

• Bladder 

retraining 

• Electrical 

stimulation 

therapy 

• Indwelling 

catheter 

• CIC 

• Pregnant/ 

nursing 

• Women without 

reliable BC 

Incontinence 

episodes, n (%): 

G1: 93 (79)

G2: 88 (75)

G3: 40 (70)

Incontinence 

episodes/day, 

mean (range): 

G1: 2.9 (0.1-24.0)

G2: 2.6 (0.1-24.0)

G3: 3.3 (0.1-23.5)

Voids/day, mean 

(range): 

G1: 11.5 (6.3-

37.0) 

G2: 10.7 (5.3-

27.7) 

G3: 11.7 (6.9-

34.4) 

≥ 8 voids/day, n 

(%): 

G1: 112 (95) 

G2: 109 (92) 

G3: 53 (93) 

Voided volume 

(mL), mean 

(range): 

G1: 166 (55-426)

G2: 176 (57-423)

G3: 157 (59-276)

Previous OAB 

therapy, n (%): 

G1: 61 (52)

G2: 71 (60)

G3: 43 (75) 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -1.3 ± 3.2 

G2: -1.7 ± 3.1 

G3: -0.9 ± 1.5 

G1/G3: P = 0.22 

G2/G3: P = 0.023 

Voids/day, mean 

change ± SD: 

G1: -2.7 ± 3.8 

G2: -2.3 ± 2.7 

G3: -1.6 ± 3.6

G1/G3: P = 0.002 

G2/G3: P = 0.068 

Voided volume 

(mL), mean 

change ± SD: 

G1: 38 ± 54 

G2: 47 ± 58 

G3: 6 ± 42 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

Subjective 

improvement in 

bladder 

symptoms, %: 

G1: 50 

G2: 49 

G3: 47 

Dose reductions, 

n (%): 

G1: 9 (8) 

G2: 38 (32) 

G3: 1 (2) 

G2/G1: P < 0.001 

G2/G3: P < 0.001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-66 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Abrams et al., 

1998 

(continued)

Dry mouth, n (%): 

G1: 59 (50) 

G2: 102 (86) 

G3: 12 (21) 

G1/G3: P < 0.001 

G2/G1: P < 0.001

G2/G3: P < 0.001 

Dyspepsia, n (%): 

G1: 11 (9) 

G2: 27 (23) 

G3: 3 (5) 

Nausea, n (%): 

G1: 4 (3) 

G2: 7 (6) 

G3: 6 (11) 

Upper 

respiratory 

infection, n (%): 

G1: 12 (10) 

G2: 3 (3) 

G3: 8 (14) 

Adverse events 

reported, N: 

G1: 302 

G2: 412 

G3: 117 

Patients with ≥ 1 

AE, n (%): 

G1: 105 (89) 

G2: 114 (97) 

G3: 46 (81) 

G2/G1: P = 0.023 

G2/G3: P < 0.001 

Discontinued 

due to AEs, n 

(%): 

G1: 10 (8) 

G2: 20 (17) 

G3: 1 (2) 

C-67 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Abrams et al., 

2006 

Country and 

setting: 

UK, 8 sites 

Enrollment 

period: 

NR 

Funding: 

Pfizer

Author industry 

relationship 

disclosures: 

2 of 6 

Pfizer (2) 

Design: 

Crossover RCT

Intervention: 

8 weeks 

consisting of 2-

week run-in period 

followed by twoweek treatment 

period, 2 week 

washout, and 

additional 2 week 

treatment. 

Groups: 

G1: Propiverine 

20 mg qd 

G2: Propiverine 

15 mg t.i.d. 

G3: Oxybutynin 5 

mg t.i.d. 

G4: Placebo 

N at enrollment: 

Total: 77 

G1: 38 

G2: 42 

G3: 41 

G4: 24 

N at follow-up: 

Safety Analysis: 

77 

AUM parameter 

analysis: 69 

Women, n (%)*: 

59 (76.6) 

Age, range: 

47-56

Race/ethnicity: 

NR

Weight, range 

(kg): 

74-81

Inclusion criteria: 

• Age ≥ 18 

• Clinical 

diagnosis of 

idiopathic OAB 

with detrusor 

overactivity 

• Two or more of 

the following 

during 2-week 

run-in period: 

urinary 

frequency (≥ 7 

voids/ day), UUI 

(≥ 1 

episode/week 

requiring change 

of clothing or 

pad), urinary 

urgency (≥ 7 

episodes 

preceding week)

Exclusion 

criteria: 

• Hepatic, renal or 

cardiac 

abnormalities 

• SUI 

• Untreated 

narrow-angle 

glaucoma 

• Urinary or 

gastric retention 

• BOO > 40 

(Abrams-Griffiths 

number) 

• Indwelling 

catheter 

• Recent 

urogenital 

surgery 

• Use of 

investigational 

drugs in 30 days 

preceding the 

study 

Duration of OAB 

since diagnosis 

(years), range: 

5-15 

f 

IDC number, all 

activities, mean 

difference (SE): 

G2/G1: -1.3 (1.4)* 

G3/G1: -3.8 (1.4) 

P ≤ 0.01 

G3/G2: -2.6 (1.4)* 

IDC number, with 

concurrent 

symptoms, mean 

difference (SE): 

G2/G1: -0.9 (0.7)* 

G3/G1: -1.7 (0.7) 

P ≤ 0.05 

G3/G2: -0.8 (0.7)* 

IDC duration 

(sec), all 

activities, mean 

difference (SE): 

G2/G1: -133.6 

(88.0)* 

G3/G1: -244 

(91.3) 

P ≤ 0.01 

G3/G2: -110.4 

(88.9)* 

IDC duration 

(sec), with 

concurrent 

symptoms, mean 

difference (SE): 

G2/G1: -54.3 

(48.0)* 

G3/G1: 108.1 

(50.0) 

P ≤ 0.05 

G3/G2: 53.7 

(49.0)* 

AUC detrusor 

pressure vs time 

(cmH20 * s), all 

activities, mean 

difference (SE): 

G2/G1: -0.1 (0.5)* 

G3/G1: -0.3 (0.5)* 

G3/G2: -0.2 (0.5)* 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

^ gender accounted for in mixed-effects statistical model; * P = NS 

C-68 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Abrams et al., 

2006 

(continued) 

AUC detrusor 

pressure vs. time 

(cmH20 * s), with 

concurrent 

symptoms, mean 

difference (SE): 

G2/G1: -0.2 (0.8)* 

G3/G1: -1.3 (0.8)* 

G3/G2: -1.1 (0.8)* 

IDC max amplitude (cmH20), all 

activities, mean 

difference (SE): 

G2/G1: -3.8 (8.2)* 

G3/G1: -16.8 

(8.5)* 

G3/G2: 12.7 (8.3)* 

IDC max amplitude (cmH20), 

with concurrent 

symptoms, mean 

difference (SE): 

G2/G1: -5.0 (7.6)* 

G3/G1: -15.8 (7.9) 

P ≤ 0.05 

G3/G2: -10.7 

(7.7)* 

Salivary flow 

rate, mean 

difference (SE): 

G2/G1: 0.0 (0.7)* 

G3/G1: -0.6 (0.1) 

P < 0.0001 

G3/G2: -0.6 (0.1) 

P < 0.0001 

Visual near point, 

mean difference 

(SE): 

G2/G1: 1.6 (1.2)* 

G3/G1: 0.6 (1.2)* 

G3/G2: -1.0 (1.2)* 

Heart rate, mean 

difference (SE): 

G2/G1: 2.7 (1.4) 

P < 0.05 

G3/G1: -5.1 (1.4) 

P < 0.0001 

G3/G2: -7.8 (1.4) 

P < 0.0001 

^ gender accounted for in mixed-effects statistical model; * P = NS 

C-69 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Abrams et al., 

2006 

(continued)

PNN50, mean 

difference (SE): 

G2/G1: -3.6 (1.8) 

P < 0.05 

G3/G1: 6.2 (1.8) 

P < 0.0001 

G3/G2: 9.9 (1.8) 

P < 0.0001 

St. George’s 

index, mean 

difference (SE): 

G2/G1: -3.5 (1.9) 

P < 0.05 

G3/G1: 3.4 (1.9) 

P < 0.05 

G3/G2: 6.9 (1.9) 

P < 0.0001 

Dry mouth, n (%): 

G1: 13 (34) 

G2: 22 (52) 

G3: 34 (83) 

G4: 4 (17) 

Abnormal vision, 

n (%): 

G1: 9 (24) 

G2: 14 (33) 

G3: 9 (22) 

G4: 0 

Constipation, n 

(%): 

G1: 6 (16) 

G2: 10 (24) 

G3: 4 (10) 

G4: 0 

Headache, n (%): 

G1: 1 (3) 

G2: 3 (7) 

G3: 6 (15) 

G4: 0 

C-70 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Anderson et al., 

1999 

Country and 

setting: 

US, multi-center 

Enrollment 

period: 

NR 

Funding: 

Oros Oxybutynin 

Study group 

Alza Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin CR vs. 

Oxybutynin IR 

1 wk washout 

period prior to 

initiation of study 

Groups: 

G1: Oxybutynin 5, 

10, 15, 20, 25, or 

30 mg CR qd 

G2: Oxybutynin 5 

mg IR daily to qid 

N at enrollment: 

G1: 53 

G2: 52 

N at follow-up: 

G1: 46 

G2: 47 

Age, yrs ± SD: 

G1: 59.2 ± 10.6 

G2: 59.6 ± 10.0 

Race/ethnicity: 

NR 

Women, N (%): 

G1: 50 (94) 

G2: 47 (90) 

Inclusion criteria: 

• Community 

dwelling 

• Symptoms of 

urge 

incontinence or 

mixed 

incontinence 

with primary 

urge symptoms 

• ≥6 episodes 

UUI/ wk when 

not taking 

medications 

• Previous 

favorable 

response with 

oxybutynin 

Exclusion 

criteria: 

• Myasthenia 

gravis 

• Narrowing of GI 

tract 

• glaucoma 

• Pregnant/ 

lactating 

• Positive urine 

drug screen 

• Receiving meds 

other than 

oxybutynin, 

hyoscamine, or 

propantheline 

which was 

considered 

effective in UUI 

treatment 

• At risk for 

complete 

urinary retention 

caused by 

anticholinergic 

treatment 

• Prostate 

surgery in last 9 

mos 

• BOO 

• PVR>100 

UUI episodes/ 

week, mean ± 

SD: 

G1: 27.4 ± 24.0 

G2: 23.4 ± 16.3 

Total 

incontinence 

episodes, mean ± 

SD: 

G1: 29.3 ± 24.2 

G2: 26.3 ± 18.5 

Voids/ week, 

mean ± SD: 

G1: 48.3 ± 18.4 

G2: 51.5 ± 19.4 

Voided volume/ 

void (mL), mean 

± SD: 

G1: 134.2 ± 82 

G2: 161.2 ± 92 

PVR/ void (mL), 

mean ± SD: 

G1: 15.4 ± 21 

G2: 18.0 ± 24 

Total bladder 

volume/ void 

(mL), mean ± SD:

G1: 149.7 ± 90 

G2: 179.2 ± 95 

UUI episodes/ 

week, mean: 

G1: 4.8 

G2: 3.1 

P = 0.6 

Total 

incontinence 

episodes, mean: 

G1: 6 

G2: 3.8 

P = 0.7 

Percentage 

reduction in UUI 

episodes/ week 

(%): 

G1: 84

G2: 88

P = 0.7

No UUI episodes/ 

week, %: 

G1: 52

G2: 51 

P = 0.7 

Totally continent, 

%: 

G1: 41 

G2: 41 

P = 0.9 

Voided volume/ 

void (mL), mean 

± SD: 

G1: 176.6 ± 138 

G2: 194.5 ± 152 

P = 0.1 

PVR/ void (mL), 

mean ± SD: 

G1: 33.5 ± 77 

G2: 36.1 ± 59 

P = 0.2 

Total bladder 

volume/ void 

(mL), mean ± SD: 

G1: 210.1 ± 148 

G2: 230.6 ± 176 

P = 0.9

≥1 

anticholinergic 

event, n (%): 

G1: 46 (87) 

G2: 49 (94) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-71 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Anderson et al., 

1999 

(continued) 

Dry Mouth, n (%): 

G1: 36 (68) 

G2: 45 (87) 

P = 0.04 

Moderate-severe 

dry mouth, n (%): 

G1: 13 (25) 

G2: 24 (46) 

P = 0.03 

Somnolence, n 

(%): 

G1: 20 (38) 

G2: 21 (40) 

P = 0.8 

Blurred vision, n 

(%): 

G1: 15 (28) 

G2: 9 (17) 

P = 0.3 

Constipation, n 

(%): 

G1: 16 (30) 

G2: 16 (31) 

P = 1.0 

Dizziness, n (%): 

G1: 15 (28) 

G2: 20 (38) 

P = 0.3 

Impaired 

urination, n (%): 

G1: 13 (25) 

G2: 15 (29) 

P = 0.7 

Nervousness, n 

(%): 

G1: 13 (25) 

G2: 12 (23) 

P = 1.0 

Nausea, n (%): 

G1: 10 (19) 

G2: 9 (17) 

P = 1.0 

C-72 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Anderson et al., 

2006 

[See evidence 

table for Diokno et 

al. 2003] 

Country and 

setting: 

US, Multicenter 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

1 of 6 

ALZA Corp (1) 

Design: 

RCT 

Intervention: 

Extended release 

antimuscarinic 

medications in 

women with or 

without prior 

antimuscarinic 

treatment for OAB 

Groups: 

G1: Prior 

antimuscarinic 

G1a: Oxybutynin 

ER 10 mg po daily 

G1b: Tolterodine 

ER 4mg po daily 

G2: No prior 

anticholinergic 

treatment 

G2a: Oxybutynin 

ER 10 mg po daily 

G2b: Tolterodine 

ER 4mg po daily 

Ga: Oxybutynin 

ER 10 mg po daily 

Gb: Tolterodine 

ER 4mg po daily 

N at enrollment: 

Total: 790 

G1: 373 

G1a: 180 

G1b: 193 

G2: 417 

G2a: 211 

G2b: 206 

N at follow-up, 12 

weeks: 

G1: 341 

G1a: 165 

G1b: 176 

G2: 355 

G2a: 174 

G2b: 181 

Inclusion criteria:

• Women 

• Age ≥ 18 

• Mean of 21-60 

UUI episodes 

per week and 

mean of ≥ 10 

voids per 24 hr 

Exclusion 

criteria: 

NR 

UUI episodes/ 

wk, mean ± SD: 

G1a: 36.8 ± 16.4 

G1b: 37.4 ± 14.0 

G2a: 37.5 ± 14.0 

G2b: 36.2 ± 13.9 

Incontinence 

episodes/wk, 

mean ± SD: 

G1a: 41.5 ±19.0 

G1b: 43.0 ± 18.0 

G2a: 45.0 ±19.4 

G2b: 41.9 ± 17.9 

Voids/week, 

mean ± SD: 

G1a: 92.8 ± 23.7 

G1b: 94.6 ± 25.2 

G2a: 96.5 ± 27.1 

G2b: 97.9 ± 24.2 

UUI episodes/wk, 

mean ± SD: 

G1a: 11.4 ± 17.9 

G1b: 13.3 ± 15.1 

G2a: 10.2 ± 13.7 

G2b: 9.3 ± 13.3 

G1a/G1b: P = 0.3 

UUI episodes/wk, 

completed wk 12, 

mean ± SD: 

G1a: 9.9 ± 14.1 

G1b: 12.9 ± 14.9 

P = 0.049 

No UUI, 12 wk, 

%: 

G1a: 25.2 

G1b: 16.4 

G2a: 29.4 

G2b: 26.4 

G1a/G1b: P =

0.046 

G2a/G2b: P =

0.495 

Incontinence 

episodes/wk, 

mean ± SD: 

G1a: 12.7 ± 18.7 

G1b: 16.5 ± 19.8 

G2a: 11.9 ± 15.1 

G2b: 11.3 ± 16.0 

G1a/G1b: P =

0.09 for LOCF (P 

= 0.012 if 

completed wk 12)

G2a/G2b: P =

0.886 

Voids/week, 

mean ± SD: 

G1a: 68.4 ± 17.2 

G1b: 72.8 ± 25.4 

G2a: 64.8 ± 22.0 

G2b: 69.4 ± 21.3 

G1a/G1b: P =

0.05 for LOCF (P 

= 0.026 wk 12)

G2a/G2b: P =

0.035 for LOCF (P 

= 0.026 wk 12) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-73 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Anderson et al., 

2006 

(continued) 

Women, %: 

100 

Age, mean ± SD: 

G1a: 62.6 ± 12.9 

G1b: 62 ± 12.6 

G2a: 57.5 ± 13.4 

G2b: 58.8 ± 12.4 

Race/ethnicity, 

%: 

White: 

G1a: 87 

G1b: 88 

G2a: 82 

G2b: 84 

Black: 

G1a: 7 

G1b: 9 

G2a: 9 

G2b: 8.7 

Asian: 

G1a: 0.6 

G1b: 0 

G2a: 0 

G2b: 1 

Hispanic: 

G1a: 5.6 

G1b: 3.1 

G2a: 8.1 

G2b: 6.3 

Other 

G1a: 0 

G1b: 0.5 

G2a: 0.9 

G2b: 0 

Dry mouth, % 

G1a: 32 

G1b: 19 

G2a: 27.5 

G2b: 25.2 

G1a/G1b: P =

0.004 

G2a/G2b: P = 0.6

Constipation, %: 

G1a: 7.8 

G1b: 5.2 

G2a: 5.2 

G2b: 10.2 

Diarrhea, %: 

G1a: 7.8 

G1b: 5.7 

G2a: 8.1 

G2b: 6.8 

Headache, %: 

G1a: 4.4 

G1b: 5.2 

G2a: 6.6 

G2b: 6.8 

Discontinued 

due to AE, n (%): 

G1a: 7 (3.9) 

G1b: 6 (3.1) 

G2a: 13 (6.2) 

G2b: 13 (6.3) 

Withdrew, %: 

G1: 3.5 

G2: 6.2 

C-74 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Appell, Abrams et 

al., 2001 

Country and 

setting: 

Multinational, 

Multicenter 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Open-label 

extension study 

(after 12-wk RCT 

and 1 wk washout) 

Intervention: 

Tolterodine 2 mg 

b.i.d. with option 

for patients to selflower their dosage 

to 1 mg b.i.d. 

Groups: 

NA 

N at enrollment: 

854 

N at follow-up, n 

(%): 

594 (70) 

Age, yrs, mean 

(range): 

59.5 (19-89) 

Race/ethnicity: 

NR 

Women, %: 

76 

Previous drug 

therapy for OAB, 

n (%): 

472 (55) 

Previous lower 

urinary tract 

surgery, n (%): 

291 (34)

Inclusion criteria: 

• ≥18 years old 

• Cystometric 

evidence of 

detrusor 

overactivity 

(phasic detrusor 

contraction with 

amplitude 10+ 

cm H2O) 

• ≥ 8 voids/day 

• ≥ 1 urinary 

incontinence 

episode/day 

Exclusion 

criteria: 

• SUI 

• Hepatic or renal 

disease 

• Recurrent or 

symptomatic 

UTIs 

• Interstitial 

cystitis 

• Hematuria 

secondary to 

malignant 

disease 

• Contraindication 

to antimuscarinic 

therapy 

• Serious AE on 

oxybutynin 

• Clinically 

significant 

voiding difficulty 

w/ treatment of 

urinary retention

• Treatment in 14 

days prior to 

baseline visit 

• Initiation of 

antimuscarinic 

or any drug for 

UI during study 

• Electrostimulation or 

bladder training 

• Indwelling or 

intermittent 

catheter 

• Total voided 

volume >3L/day

Detrusor 

instability, %: 

93.7 

UUI episodes, n 

(%): 

724 (85) 

Symptom 

duration > 5 yrs, 

n (%): 

412 (48) 

Urgency, n (%): 

841 (98) 

Severe/very 

severe problems, 

n (%): 

384 (45) 

UUI episodes/ 

day, mean 

(range): 

3.5 (0.1-24.0) 

Voids/day, mean 

(range): 

11.4 (5.3-37.0) 

Voided volume 

(mL), mean 

(range): 

159 (25-423) 

Adverse events 

at end of 12-wk 

RCT, n (%): 

Any: 358 (76) 

ANS: 203 (43) 

CNS: 59 (12) 

GI: 125 (26) 

Respiratory: 68 

(14) 

Urinary: 50 (11) 

Dry mouth: 187 

(39) 

UTI: 26 (5) 

Headache: 49 (10)

Constipation: 31 

(7) 

Abdominal pain: 

36 (8) 

URI: 28 (6) 

UUI 

episodes/day, 3 

mos, mean 

(range): 

1.3 (0.0-24.0) 

UUI 

episodes/day, 

mean change 

(95% CI): 

-2.1 (-2.4, -1.9) 

P = 0.0001 

UUI 

episodes/day, 3 

mos, mean 

(range): 

1.5 (0.0-24.0) 

UUI 

episodes/day, 

mean change 

(95% CI): 

-2.0 (-2.2, -1.7) 

P = 0.0001 

UUI 

episodes/day, 

median % 

change: 

-76 

Voids/day, 3 

mos, mean 

(range) 

8.8 (2.0-23.4) 

Voids/day, 3 

months, mean 

change (95% CI): 

-2.6 (-2.8, -2.3) 

P = 0.0001 

Voids/day, 9 

mos, mean 

(range): 

8.9 (1.9-31.6) 

Voids/day, 9 

months, mean 

change (95% CI): 

-2.5 (-2.9, -2.4) 

P = 0.0001 

Voids/day, 9 

mos, median % 

change: 

-22 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-75 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Appell, Abrams et 

al., 2001 

(continued) 

Voided volume 

(mL), 3 mos, 

mean (range): 

201 (33-444) 

Voided volume 

(mL), 3 mos, 

mean change 

(95% CI): 41 (36, 

45) 

P = 0.0001 

Voided volume 

(mL), 9 mos, 

mean (range): 

199 (34-514) 

Voided volume 

(mL), 9 mos, 

mean change 

(95% CI): 

40 (35, 45) 

P = 0.0001 

Voided volume 

(mL), 9 mos, 

median % 

change: 

22 

Improvement, 9 

mos, %: 

65 

Any adverse 

event, n (%): 

652 (76) 

ANS, n (%): 

268 (31) 

General, n (%): 

219 (26) 

CNS/PNS, n (%): 

82 (10) 

GI, n (%) 

201 (24) 

Respiratory, n 

(%): 

139 (16) 

Urinary, n (%): 

165 (19) 

Dry mouth, n (%): 

236 (28) 

C-76 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Appell, Abrams et 

al., 2001 

(continued) 

Mild dry mouth, 

%: 

19 

Moderate dry 

mouth, %: 

7 

Severe dry 

mouth, %: 

2 

UTI, n (%): 

106 (12) 

Headache, n (%): 

57 (7) 

Constipation, n 

(%): 

57 (7) 

Abdominal pain, 

n (%): 

50 (6) 

Upper 

respiratory tract 

infection, n (%): 

45 (5) 

Serious adverse 

events, n: 

72 

Discontinued 

due to AE, n (%): 

73 (9) 

Reduced dosage 

to 1 mg b.i.d., n 

(%): 

108 (13) 

C-77 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Appell, Sand et 

al., 2001 

Country and 

setting: 

US, 37 sites 

Enrollment 

period: 

March 2000 to 

October 2000 

Funding: 

ALZA Corp 

Author industry 

relationship 

disclosures:

12 of 12 

ALZA (12) 

Pharmacia (9) 

Design: 

RCT stratified by 

UUI severity (mild 

≤ 21/wk, or 

moderate >21/wk) 

Intervention: 

Oxybuynin ER vs 

Tolterodine 

Groups: 

G1: Oxybutynin 

ER 10 mg 

G2: Tolterodine 

4mg (2mg b.i.d.) 

N at enrollment: 

G1: 185 

G2: 193 

N at follow-up: 

G1: 160 

G2: 172 

Women, %: 

G1: 82 

G2: 85 

Age, mean ± SD: 

G1: 58.6 ± 13.4 

G2: 59.6 ± 13.2 

Race/ethnicity, 

%: 

White: 

G1: 87.6 

G2: 86.0 

Black: 

G1: 5.4 

G2: 6.7 

Hispanic: 

G1: 3.8 

G2: 5.2 

Asian: 

G1: 2.2 

G2: 1.6 

Other: 

G1: 1.1 

G2: 0.5 

Follow-up: 

12 week 

Inclusion criteria:

• 7-50 urge 

urinary 

incontinence 

episodes per 

week 

• ≥ 10 voids/day 

• Majority of 

leakage urgerelated

Exclusion 

criteria: 

• Non-OAB cause 

for incontinence 

• Delivered baby < 

6 mos prior 

• PVR >150 mL 

• Significant 

medical 

comorbidities 

• Decreased 

hepatic function 

• Renal 

impairment 

• Myasthenia 

gravis 

• Gastroparesis 

• Hematuria 

• Narrow-angle 

glaucoma 

• POP to hymen 

• Known allergy 

• Pregnant or 

lactating 

UUI episodes/ 

week, mean ± 

SD: 

G1: 25.5 ± 14.6 

G2: 24.6 ± 15.1 

P = 0.36 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 28.4 ± 17.8 

G2: 28.0 ± 18.3 

P = 0.62 

Voids/week, 

mean ± SD: 

G1: 92.9 ± 23.0 

G2: 91.8 ± 20.0 

P = 0.77 

Received 

antimuscarinic 

med before 

study, n (%): 

G1: 75 (40.5) 

G2: 73 (37.8) 

UUI episodes/ 

week, mean ± SD 

(95% CI): 

G1: 6.1 ± 9.7 

(4.4, 7.3) 

G2: 7.8 ± 11.1 

(6.7, 9.5) 

P = 0.03 

Incontinence 

episodes/week, 

mean ± SD (95% 

CI): 

G1: 7.1 ± 12.0 

(5.2, 8.6) 

G2: 9.3 ± 13.4 

(8.0, 11.3) 

P = 0.02 

Voids/week, 

mean ± SD (95% 

CI): 

G1: 67.1 ± 22.1 

(64.6, 70.0) 

G2: 71.5 ± 20.5 

(69.1, 74.2) 

P = 0.02 

Discontinuation 

due to AE, n (%): 

G1: 14 (7.6) 

G2: 15 (7.8) 

P > 0.99 

Dry mouth, n (%): 

G1: 52 (28.1) 

G2: 64 (33.2) 

Constipation, n 

(%): 

G1: 13 (7) 

G2: 12 (6.2) 

Impaired 

urination/ 

retention, n (%): 

G1: 6 (3.2) 

G2: 6 (3.1) 

P ≥ 0.99 

Blurred vision, n 

(%): 

G1: 4 (2.2) 

G2: 2 (1.0) 

P = 0.44 

Dizziness, n (%): 

G1: 9 (4.9) 

G2: 8 (4.1) 

P = 0.81 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-78 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Appell, Sand et 

al., 2001 

(continued) 

Somnolence, n 

(%): 

G1: 8 (4.3) 

G2: 3 (1.6) 

P = 0.13 

Asthenia, n (%): 

G1: 3 (1.6) 

G2: 7 (3.6) 

P = 0.34 

Insomnia, n (%): 

G1: 1 (0.5) 

G2: 3 (1.6) 

P = 0.62 

Headache, n (%): 

G1: 15 (8.1) 

G2: 17 (8.8) 

P = 0.86 

Dyspepsia, n (%): 

G1: 11 (5.9) 

G2: 10 (5.2) 

P = 0.82 

Nausea, n (%): 

G1: 6 (3.2) 

G2: 3 (1.6) 

P = 0.33 

Vomiting, n (%): 

G1: 3 (1.6) 

G2: 3 (1.6) 

P > 0.99 

C-79 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Arruda et al., 

2008 

Country and 

setting: 

Brazil, community 

Enrollment 

period: 

August 2001 to 

September 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

None 

Design: 

RCT 

Intervention: 

Oxybutynin vs. 

functional 

electrostimulation 

vs. pelvic floor 

training

Groups: 

G1: Oxybutynin 5 

mg b.i.d. 

G2: Ambulatory 

stimulation applied 

vaginally 

G3: Pelvic floor 

exercises with a 

therapist and at 

home 

N Screened: 

81 

N at enrollment: 

G1: 22 

G2: 21 

G3: 21 

N at follow-up: 

G1: 22 

G2: 21 

G3: 21 

Age, range: 

35-80 

Race/ethnicity: 

NR 

Women, %: 

100 

Length of follow 

up: 12 weeks 

Inclusion criteria: 

• Communitydwelling 

• Dx of OAB and 

DO 

• Capable of 

completing a 

bladder diary 

and performing a 

pelvic muscle 

floor contraction 

• For those with 

MUI, urge was 

predominant 

Exclusion 

criteria: 

• Hx of psychiatric 

or neurologic 

illness 

• Persistent UTI 

• Inability to 

comply with 

regular follow-up 

visits 

• Current 

pregnancy 

• Postvoid 

residual volume 

> 100 ml 

• Contraindication

s to 

anticholinergic 

therapy 

• Cardiac 

pacemaker 

• Type III SUI 

• Uncontrolled 

metabolic 

conditions or 

indwelling 

catheterization 

• Using 

medications 

including 

anticholinergic 

drugs, calcium 

antagonists, 

beta agonists, 

dopamine 

agonists, striated 

muscle relaxants 

or estrogens 

• Any uterine 

prolapsed 

UUI episodes/ 

week, mean ± 

SD: 

G1: 13.8 ± 11.6 

G2: 13.5 ± 15.6 

G3: 16.4 ± 17.2 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 1.7 ± 1.5 

G2: 1.9 ± 1.9 

G3: 1.4 ± 1.2 

Pads/day, mean ± 

SD: 

G1: 2.6 ± 2.7 

G2: 2.3 ± 2.4 

G3: 2.7 ± 1.5 

Voids/day, mean 

± SD: 

G1: 7.7 ± 2.6 

G2: 8.6 ± 3.4 

G3: 6.8 ± 2.2 

Residual volume 

mean mL ± SD: 

G1: 3.2 ± 6.3 

G2: 1.0 ± 2.6 

G3: 1.8 ± 3.3 

Volume, first 

desire to void, 

mean mL ± SD: 

G1: 117.7 ± 68.9 

G2: 102.4 ± 51.1 

G3: 86.7 ± 38.9 

Maximal 

cystometric 

capacity, mean 

mL ± SD: 

G1: 410.4 ± 194.1 

G2: 350.0 ± 212.9

G3: 424.0 ± 149.0

UUI episodes/ 

week, mean ± 

SD: 

G1: 7.0 ± 10.6 

G2: 7.9 ± 13.7 

G3: 7.8 ± 15.3

G1/BL: P = 0.007 

G2/BL: P = 0.039 

G3/BL: P = 0.035 

Urgency 

resolved, n (%): 

G1: 14 (63.6) 

G2: 11 (52.4) 

G3: 12 (57.1) 

P = 0.754 

Satisfied, n (%):

G1: 17 (77.3) 

G2: 11 (52.4) 

G3: 16 (76.2) 

P = 0.142 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 0.9 ± 0.8 

G2: 1.2 ± 1.3 

G3: 1.0 ± 1.1

G1/BL: P = 0.003 

G2/BL: P = 0.036 

G3/BL: P = 0.086 

Pads/day, mean 

± SD: 

G1: 0.9 ± 1.5 

G2: 0.9 ± 1.7 

G3: 0.8 ± 1.3

G1/BL: P < 0.001 

G2/BL: P = 0.004 

G3/BL: P < 0.001 

Voids/day, mean 

± SD: 

G1: 6.4 ± 1.6 

G2: 7.9 ± 2.3 

G3: 7.1 ± 2.1

G1/BL: P = 0.014 

G2/BL: P = 0.291 

G3/BL: P = 0.441 

Residual volume, 

mean mL ± SD: 

G1: 4.7 ± 9.4 

G2: 1.1 ± 2.5 

G3: 2.1 ± 3.5

G1/BL: P = 0.425 

G2/BL: P = 0.760 

G3/BL: P = 0.297 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Method and 

blinding: - 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

+ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-80 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 

2008 

(continued) 

Involuntary 

detrusor 

contraction 

volume mean mL 

± SD: 

G1: 189.5 ± 114.1 

G2: 220.0 ± 127.2

G3: 239.3 ± 163.0

Involuntary 

detrusor 

contraction 

maximal 

pressure (mm 

H20): 

G1: 39.4 ± 26.1 

G2: 43.7 ± 22.9 

G3: 34.2 ± 19.8 

Volume first 

desire to void, 

mean mL ± SD: 

G1: 157.3 ± 63.8 

G2: 123.8 ± 59.0 

G3: 137.6 ± 76.7

G1/BL: P = 0.019 

G2/BL: P = 0.091 

G3/BL: P = 0.017 

Maximal 

cystometric 

capacity mean 

mL ± SD: 

G1: 517.3 ± 191.7 

G2: 436.6 ± 178.7 

G3: 489.0 ± 141.3

G1/BL: P = 0.001 

G2/BL: P = 0.017 

G3/BL: P = 0.113 

Involuntary 

detrusor 

contraction 

volume (mL): 

G1: 188.6 ± 183.2 

G2: 73.3 ± 112.4 

G3: 114.3 ± 154.2

G1/BL: P = 0.986 

G2/BL: P = 0.001 

G3/BL: P = 0.044 

Involuntary 

detrusor 

contraction 

maximal 

pressure, mm 

H20 ± SD: 

G1: 19.6 ± 20.9 

G2: 22.4 ± 30.1 

G3: 17.2 ± 25.5

G1/BL: P < 0.001 

G2/BL: P = 0.002 

G3/BL: P = 0.027 

Normal 

urodynamic 

evaluation, n (%):

G1: 8 (36.4) 

G2: 12 (57.1) 

G3: 11 (52.4) 

P = 0.358 

Persistent 

improvement at 1 

year: 

G1: 10/17 

G2: 4/11 

G3: 9/16 

C-81 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 

2008 

(continued)

Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty 

voiding, n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0

Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty 

voiding, n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

C-82 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Barkin et al., 2004 

Country and 

setting: 

Canada, 

Community 

Enrollment 

period: 

NR 

Funding: Purdue 

Pharma

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin CR 

versus Oxybutynin 

IR 

3 week washout 

period followed by 

2 weeks of dose 

titration plus 4 

weeks stable dose 

period 

Groups: 

G1: Oxybutynin 

CR 15 mg daily 

Final titration 

dose, n (%): 

5 mg: 3 (6) 

10mg: 10 (19) 

≥ 15mg: 40 (75) 

G2: Oxybutynin IR 

5 mg t.i.d. 

Final titration 

dose, n (%): 

5 mg: 6 (15) 

10mg: 14 (34) 

≥ 15mg: 21 (51) 

N at enrollment: 

G1: 65 

G2: 60 

N at follow-up: 

G1: 53 

G2: 41 

Women, n (%): 

G1: 48 (91) 

G2: 37 (90) 

Age, yrs ± SD: 

G1: 58.0 ± 12.4 

G2: 60.6 ± 14.8 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• ≥ 7 UUI/week 

during washout 

period 

• ≥ 8 voids/day 

during washout 

period 

Exclusion 

criteria: 

• PVR> 100mL 

• Unstable 

dosage of any 

drug with 

anticholinergic 

or diuretic/ 

antidiuretic side 

effects 

• Allergy or 

previous life 

threatening side 

effects with 

anticholinergic/ 

antispasmodic 

meds 

• SUI 

• Conditions 

contraindicating 

anticholinergic 

therapy 

• Daily fluid intake 

> 3 liters 

• Hepatic/ renal 

disease 

• IC/ painful 

bladder 

syndrome 

• Urinary 

retention 

• Hematuria 

• UTI 

• Recurrent UTI 

• Indwelling 

catheter 

• Bladder training 

within 14 days 

of screening 

• Drug/ alcohol 

abuse 

• Untreated 

psychiatric 

disease 

effecting 

completion of 

bladder diary 

Purdue Urgency 

Questionnaire, 

frequency, mean 

score ± SD: 

G1: 3.3 ± 1.1 

G2: 3.2 ± 0.9 

Purdue Urgency 

Questionnaire, 

severity, mean 

score ± SD: 

G1: 3.8 ± 1.1 

G2: 3.7 ± 1.1 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 24.3 ± 19.0 

G2: 23.0 ± 17.7 

Pads/day, mean: 

G1: 2.3 

G2: 2.4 

Voids/day, mean 

± SD: 

G1: 11.4 ± 2.9 

G2: 11.0 ± 3.1 

Voided volume 

(mL), mean ± SD:

G1: 177 ± 77 

G2: 221 ± 137 

Fluid intake 

(cups/day), 

mean: 

G1: 6.8

G2: 6.6

IIQ, mean score ± 

SD: 

G1: 2.6 ± 0.8

G2: 2.3 ± 0.8 

UDI, mean score 

± SD: 

G1: 2.6 ± 0.6

G2: 2.5 ± 0.4 

Purdue Urgency 

Questionnaire, 

frequency, mean 

± SD: 

G1: 2.3 ± 1.2 

G2: 1.9 ± 0.9 

G1/G2: P = 0.116 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Purdue Urgency 

Questionnaire, 

severity, mean ± 

SD: 

G1: 2.3 ± 1.0 

G2: 2.3 ± 1.3 

G1/G2: P = 0.255 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Incontinence 

episodes/ week, 

mean ± SD: 

G1: 10.4 ± 18.8 

G2: 6.1 ± 8.8 

G1/G2: P = 0.404 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Pads/day, mean: 

G1: 1.7 

G2: 1.9 

G1/G2: P = NS 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Voids/day, mean 

± SD: 

G1: 9.6 ± 2.6 

G2: 8.6 ± 2.8 

G1/G2: P = 0.286 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Voided volume 

(mL), mean ± SD: 

G1: 202 ± 80 

G2: 261 ± 119 

G1/G2: P = 0.533 

G1/BL: P = 0.064 

G2/BL: P = 0.077 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-83 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Barkin et al., 2004 

(continued) 

• Untreated 

constipation 

• BOO 

• Pregnant or 

breast feeding 

• Women using 

reliable method 

of birth control 

Fluid intake 

(cups/day), 

mean: 

G1: 7.0

G2: 7.7 

G1/G2: P = NS 

G1/BL: P = NS 

G2/BL: P = 0.032 

IIQ score, mean ± 

SD: 

G1: 1.9 ± 1.7

G2: 1.6 ± 0.6

G1/G2: P = NS 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

UDI scores, 

mean ± SD: 

G1: 2.0 ± 0.6 

G2: 1.8 ± 0.5 

G1/G2: P = NS 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Dry mouth, 

overall, n (%): 

G1: 44 (68) 

G2: 43 (72) 

Dry mouth, 

moderate/ 

severe, n (%): 

G1: 25 (38) 

G2: 27 (45) 

Dry throat, n (%): 

G1: 23 (35) 

G2: 24 (40) 

Dry skin, n (%): 

G1: 11 (17) 

G2: 7 (12) 

Diarrhea, n (%): 

G1: 9 (14) 

G2: 3 (5) 

Headache, n (%): 

G1: 8 (12) 

G2: 13 (22) 

UTI, n (%): 

G1: 8 (12) 

G2: 11 (18) 

Dizziness, n (%): 

G1: 7 (11) 

G2: 11 (18) 

C-84 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Barkin et al., 2004 

(continued)

Dyspepsia, n (%): 

G1: 7 (11) 

G2: 10 (17) 

Rhinitis, n (%): 

G1: 7 (11) 

G2: 9 (15) 

Abdominal pain, 

n (%): 

G1: 6 (9) 

G2: 6 (10) 

Asthenia, n (%): 

G1: 5 (18) 

G2: 9 (15) 

Constipation, n 

(%): 

G1: 5 (8) 

G2: 6 (10) 

Taste perversion, 

n (%): 

G1: 5 (8) 

G2: 7 (12) 

Cough 

increased, n (%): 

G1: 4 (6) 

G2: 8 (13) 

Dysphagia, n 

(%): 

G1: 4 (6) 

G2: 8 (13) 

Dry eyes, n (%): 

G1: 2 (3) 

G2: 9 (15) 

Nausea, n (%): 

G1: 3 (5) 

G2: 10 (17) 

Discontinued 

due to AEs, n 

(%): 

G1: 11 (17)

G2: 12 (20) 

C-85 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Bemelmans et al., 

2000 

Country and 

setting: 

Netherlands, 

Primary Care 

Enrollment 

period: 

May 1995 to 

September 1997 

Funding: 

Byk Nederland 

(Distributor 

Oxybutynin) 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective case 

series 

Intervention: 

Oxybutynin 

Run in study with 

all subjects 

enrolled in G1 with 

assessment at 2 

wks treatment with 

diary followed by 

movement to G2 if 

effect was 

unsatisfactory or 

capable of 

improvement 

Tx x 4 more wks 

followed by 

voiding diary. 

Groups: 

G1: Responders 

to oxybutynin 2.5 

mg t.i.d. 

G2: Non 

responders to 

oxybutynin 2.5 mg 

t.i.d. increased to 

xybutynin 5 mg 

t.i.d. 

N at enrollment: 

Total: 416

G1: 320 

G2: 96 

N at follow-up: 

350 

Women, N (%): 

346 (83.2) 

Age, mean 

(range): 

61.3 (16.4-91.5) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Complaint of 

involuntary 

urine loss 

• Score of ≥ 14 on 

symptom score 

questionnaire 

indicating UUI 

(determined by 

unvalidated 

questionnaire) 

Exclusion 

criteria: 

• Age ≤ 15 

• Concurrent use 

of bladder 

medication 

• Urinary 

retention 

• Hematuria 

• UTI 

• SUI 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 5.6 ± 3.5 

G2: 7.2 ± 3.9 

Voids/day, mean 

± SD: 

G1: 9.6 ± 3.5 

G2: 11.1 ± 3.9 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 1.5 ± 1.5 

G2: 2.3 ± 2.3 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Voids/day, mean 

± SD: 

G1: 5.8 ± 2.3 

G2: 6.8 ± 2.9 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Side effects, n 

(%): 

G1: 83 (26) 

G2: 40 (42) 

Severity of side 

effects, %: 

Mild: 72 

Severe: 21 

Extremely severe: 

4 

Side effects, %: 

Dry mouth: 23 

Blurred vision: 11 

Nausea/ vomiting: 

6 

Dizziness: 6 

Headache: 6 

Anorexia: 3 

Constipation: 3 

Drowsiness: 3 

Tachycardia: 1 

Urinary retention: 

<1 

Allergic Reaction: 

<1 

Discontinued 

due to AEs, n 

(%): 

66 (16) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-86 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Boone et al., 2002

Country and 

setting: 

US, Multicenter 

(86.0% of 

physicians in 

private-practice) 

Enrollment 

period: 

NR 

Funding: 

Alza 

Pharmaceuticals

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective 

observational 

Intervention: 

Non-specific/nonspecified 

pharmacologic 

therapy 

Groups: 

G1: persons who 

started drug 

therapy (any) at 

baseline and 

continued therapy 

for ≥ 3 mos 

G2: persons who 

started drug 

therapy (any) at 

baseline but did 

not continue for 3 

mos 

G3: persons who 

did not start drug 

therapy at 

baseline but were 

receiving it at 3 

mos 

G4: persons who 

did not start drug 

therapy at 

baseline and were 

not receiving 

therapy at 3 mos 

G5: persons who 

were on drugs at 3 

mos and 6 mos 

G6: persons who 

were on drugs at 3 

mos and not at 6 

mos 

G7: persons who 

were on not drugs 

at 3 mos and on 

drug at 6 mos 

G8: persons on no 

drugs at 3 mos 

and 6 mos 

N at enrollment:

Total: 213 

Inclusion criteria: 

• Age ≥ 18 

• Fluent in English

• US resident 

• Urgency and ≥ 1 

incontinence 

episodes/day 

• ≥ 8 voids/day 

• ≥ 3 nocturia 

episodes/day 

Exclusion 

criteria: 

• Neurogenic 

condition 

causing 

incontinence 

• Persistent or 

recurrent UTI 

• History of 

interstitial cystitis

• Bladder cancer 

• Previous bladder 

augmentation 

surgery 

• Spinal injury 

• Alzheimer’s 

disease 

• Other dementia 

• Obstruction of 

urinary tract 

• Primary 

diagnosis of SUI

• Enrolled in 

another study 

involving 

medication 

• Pharmacologic 

treatment for 

OAB during 

previous year 

Incontinence 

episodes/day, 

mean ± SD: 

Total: 2.2 ± 3.4 

G1-G2: 2.34 

G3-G4: 2.09 

Duration of 

symptoms (yrs), 

mean ± SD: 

Total: 8.1 ± 10.3 

G1-G2: 8.5 ± 12.0

G3-G4: 7.8 ± 9.1 

Symptom 

severity, n (%): 

Mild: 

G1-G2: 11 (22.0) 

G3-G4: 18 (25) 

Moderate 

G1-G2: 26 (52.0) 

G3-G4: 43 (59.7) 

Severe 

G1-G2: 13 (26.0) 

G3-G4: 11 (15.3) 

Symptom 

severity 

worsening, n (%):

G1-G2: 28 (56.0) 

G3-G4: 37 (51.4) 

U-UDI score, 

mean ± SD: 

G1-G2: 1.99 ± 

0.79 

G3-G4: 1.99 ± 

0.88 

Non-drug 

interventions, 

mean ± SD: 

G1-G2: 0.40 ± 

0.49 

G3-G4: 0.47 ± 

0.65 

Pads/week, mean 

± SD: 

G1-G2: 0.30 ± 

1.34 

G3-G4: 0.17 ± 

0.56 

Improvement in 

OAB sx, 3 mos, n 

(%): 

G1: 30 (76.9) 

G2: 7 (63.6) 

G3: 10 (52.6) 

G4: 19 (35.8) 

G1-G2/G3-G4: 

P < 0.001 

Moderate to 

great 

improvement in 

OAB sx, n (%): 

G1-G2: 26 (52.0) 

G3-G4: 21 (29.2)

G1-G2/G3-G4: 

P = 0.014 

Pads/week, 3 

mos, mean % 

change: 

G1-G2: -25.4 

G3-G4: 135.2 

Physician visits, 

mean: 

G1: 0.15 

G2: 0.64 

G3: 1.16 

G4: 0.26 

G1-G2/G3-G4: 

P = 0.096 

Patients prescribed nondrug 

intervention(s), 3 

mos, n (%): 

G1-G2: 5 (10.0) 

G3-G4: 16 (22.2)

G1-G2/G3-G4: 

P = 0.092 

Patients with 

improvement in 

OAB sx, 4-6 mos, 

n (%): 

G5: 35 (81.4) 

G6: 1 (12.5) 

G7: 2 (28.6) 

G8: 12 (28.6) 

Pads/week, 4-6 

mo, % change: 

G5: 23 

G6: 25 

G7: 0 

G8: 16 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: - 

C-87 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Boone et al., 2002 

(continued) 

N at follow-up: 

G1: 39 

G2: 11 

G3: 19 

G4: 53 

G5: 43 

G6: 8 

G7: 7 

G8: 42 

Women, n (%): 

G1-G2: 40 (80) 

G3-G4: 64 (88.9) 

Age, mean ± SD: 

G1-G2: 62.3 ± 

11.9 

G3-G4: 60.3 ± 

16.4 

Race/ethnicity, n 

(%): 

White: 94 (77.7) 

Black: 17 (14.0) 

Hispanic: 7 (5.8) 

Asian: 2 (1.7) 

Other: 1 (0.8)

Physician visits, 

4-6 mo, mean: 

G5: 0.16 

G6: 0.38 

G7: 0.43 

G8: 0.05 

Predictors of 

OAB symptom 

improvement, OR 

(95 %CI): 

Rx at baseline: 

4.3 (1.8-9.9) 

Incontinence 

episodes/day: 

3.2 (1.2-8.4) 

C-88 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 1998 

Country and 

setting: 

US, academic 

health center 

outpatient 

geriatric medicine 

clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National Institutes 

on Aging 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted 

behavioral vs. 

drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback 

added to 

behavioral training 

in absence of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2:

Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

G1: 65 

G2: 67 

G3: 65 

N at follow-up: 

G1: 61 

G2: 55 

G3: 53 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Duration of 

symptoms, mean 

yrs ± SD: 

G1: 9.4 ± 10.8 

G2: 9.8 ± 11.9 

G3: 12.7 ± 15.9 

Restricted 

activity, (%): 

G1: 30.8 

G2: 32.8 

G3: 38.5 

UUI only, %: 

G1: 49.2 

G2: 49.3 

G3: 47.7 

Accidents per 

week, mean ± 

SD: 

G1: 15.8 ± 14.5 

G2: 15.9 ± 14.1 

G3: 15.4 ± 13.4 

P = .98 

Severity 

classification, %:

Mild (<5 

accidents/wk) 

G1: 18.5 

G2: 17.9 

G3: 18.5 

Moderate (5-10 

accidents/wk) 

G1: 29.2 

G2: 29.9 

G3: 27.7 

Severe (>10 

accidents/wk) 

G1: 52.3 

G2: 52.2 

G3: 53.8 

Previous 

treatment with 

surgery, %: 

G1: 20.0 

G2: 26.9 

G3: 29.2 

Accidents per 

week, mean ± 

SD: 

G1: 2.8 ± 4.7 

G2: 5.7 ± 9.8 

G3: 8.2 ± 11.6 

P = .005 

Percent 

reduction, mean

± SD: 

G1: 80.7 ± 24.8 

G2: 68.5 ± 37.2 

G3: 39.4 ± 80.0 

P < 0.001 

Percent 

reduction, range: 

G1: -0.9 – 100 

G2: -85.7 – 100 

G3: -400.0 - 100 

Patient 

perceptions of 

progress in 

treatment, %: 

Much better 

G1: 74.1 

G2: 50.9 

G3: 226.9 

Better: 

G1: 25.9 

G2: 30.9 

G3: 38.5 

About the same: 

G1: 0.0 

G2: 16.4 

G3: 28.8 

Worse: 

G1: 0.0 

G2: 1.8 

G3: 5.8 

Estimate of % 

improvement, 

mean ± SD: 

G1: 81.6 ± 18.6 

G2: 66.4 ± 35.4 

G3: 45.1 ± 36.6 

Having fewer 

accidents, %: 

G1: 100.0 

G2: 87.3 

G3: 67.3 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-89 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 1998 

(continued)

Women, %: 

100 

Age, yrs ± SD: 

G1: 67.3 ± 7.6 

G2: 68.2 ± 7.5 

G3: 67.6 ± 7.6 

Race/ethnicity,: 

NR

Parity mean ± 

SD: 

G1: 2.8 ± 2.0 

G2: 2.1 ± 1.4 

G3: 2.7 ± 1.8 

P < 0.05 

Previous 

treatment with 

medication, %: 

G1: 27.7 

G2: 35.8 

G3: 30.8 

Using estrogen, 

%: 

G1: 32.3 

G2: 38.8 

G3: 35.4 

Using diuretics, 

%: 

G1: 20.0 

G2: 14.9 

G3: 12.3 

Accidents are 

smaller, %: 

G1: 87.3 

G2: 78.8 

G3: 54.0 

Able to wear less 

protection, %: 

G1: 76.0 

G2: 56.0 

G3: 334.1 

Comfortable 

enough with 

treatment to 

continue 

indefinitely, %: 

G1: 96.5 

G2: 54.7 

G3: 43.1 

Patient 

satisfaction with 

progress, %: 

Completely 

satisfied: 

G1: 77.6 

G2: 54.7 

G3: 43.1 

Somewhat 

satisfied: 

G1: 22.4 

G2: 40.0 

G3: 34.0 

Not at all satisfied: 

G1: 0.0 

G2: 10.9 

G3: 38.0 

Wish to receive 

another form of 

treatment, %: 

G1: 14.0 

G2: 75.5 

G3: 75.5 

P < 0.001 for all 

comparisons 

Adverse effects, 

p compared to 

placebo G3: 

Dry mouth, %: 

G1: 34.9 

G2: 96.9 

G3: 54.8 

P < 0.001 

C-90 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 1998 

(continued)

Inability to void, 

%: 

G1: 6.3 

G2: 21.5 

G3: 3.2 

P = 0.002 

Constipation, %: 

G1: 22.2 

G2: 38.5 

G3: 37.1 

P = 0.10 

Blurred vision, 

%: 

G1: 9.5 

G2: 15.4 

G3: 9.7 

P = 0.50 

Confusion, %: 

G1: 6.3 

G2: 7.7 

G3: 11.3 

P = 0.59 

C-91 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al. 2000 

[See Burgio et al., 

1998] 

Country and 

setting: 

US, University 

based 

Enrollment 

period: 

two weeks after 

completion of 

Burgio et al. 1998 

Funding: 

National Institute 

on Aging 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Modified 

crossover of RCT 

Intervention: 

Participants 

whose treatment 

was not 

completely 

successful were 

given the 

opportunity to 

switch or use 

combined 

treatment; further 

reductions in 

incontinence were 

measured.

Groups: 

Treatment 

Changes:

G1: Previous 

oxybutynin to 

behavioral 

modification alone 

G2: Previous 

behavior alone to 

2.5 mg oxybutynin 

t.i.d. + behavioral 

therapy 

G3: Previous 

oxybutynin alone 

to 2.5 mg 

oxybutynin t.i.d. + 

behavioral therapy 

G4: Placebo to 

behavioral 

G5: Placebo to 

oxybutynin 

N at enrollment 

G1: 19 

G2: 8 

G3: 27 

G4: 34 

G5: 10 

N at follow-up: 

G1: 18 

G2: 8 

G3: 26 

G4: NR 

G5: NR 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

• Not completely 

dry or satisfied 

with previous, 8-

wk treatment 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Incontinence, 

after previous 

study (at 

baseline), mean 

% reduction: 

G1: 59.1 

G2: 57.5 

G3: 72.7 

G4: 22.9 

G5: 44.8 

Incontinence, 

final mean % 

reduction: 

G1: 77.1, 

P = 0.109 

G2: 88.5, 

P = 0.034 

G3: 84.3 

P = 0.001 

G4: 63.9 

P = 0.002 

G5: 76.5 

P = 0.012 

Note: 29.2 of G3 

declined to 

continue with drug 

therapy once they 

received 

behavioral 

modification. 

Numbers were too 

low to compare 

across groups. 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-92 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 2001 

[See Burgio et al,. 

1998] 

Country and 

setting: 

US, University 

based 

Enrollment 

period: 

[See Burgio et al,. 

1998] 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Psychological 

distress 

associated with 

pharmacologic 

treatment vs. 

behavioral vs. 

placebo 

Groups: 

G1: Behavioral 

training with 

biofeedback, 4 

visits 

G2: Oxybutynin 

2.5 mg po t.i.d., up 

to a max of 5 mg 

t.i.d. 

G3: Placebo 

N at enrollment: 

197 women 

N treated: 

169 

N at follow-up: 

155 (completed 

both pre and posttreatment 

psychological 

assessment) 

Age yrs, mean ± 

SD: 

67.5 ± 7.2 

Women, %: 

100 

Race/ethnicity, 

%: 

White: 97 

African American: 

3 

Inclusion criteria:

• ≥ 55 yrs old 

• Ambulatory 

• UUI ≥2x/wk (2 

wk bladder 

diary), 

persisting x 3 

mo 

• Predominant 

UUI (vs. other 

forms 

incontinence) 

• Urodynamic 

evidence of 

bladder 

dysfunction (DI 

or maximal 

capacity ≤350 

mL) 

• Exclusion 

criteria: 

• Contraindication 

to oxybutynin or 

behavioral 

treatment 

• Continual 

leakage 

• PVR > 200 mL 

• Uterine 

prolapse 

beyond the 

introitus 

• Decompensated 

CHF 

• Hx of malignant 

arrhythmias 

• Impaired mental 

status (MMSE 

<20) 

SCL-90-R scores 

± SD: 

Somatization 

G1: 56.0 (10.6) 

G2: 51.4 (10.8) 

G3: 52.4 (11.1) 

ObsessiveCompulsive: 

G1: 56.5 (10.7) 

G2: 56.6 (11.4) 

G3: 57.7 (10.0) 

Interpersonal 

Sensitivity 

G1: 53.8 (11.0) 

G2: 51.4 (11.9) 

G3: 50.4 (12.0) 

Depression 

G1: 54.7 (10.0) 

G2: 52.5 (9.7) 

G3: 51.0 (11.9) 

Anxiety 

G1: 48.7 (13.9) 

G2: 46.8 (12.0) 

G3: 47.2 (12.8) 

Hostility 

G1: 49.3 (10.7) 

G2: 45.9 (10.1) 

G3: 48.3 (10.4) 

Phobia 

G1: 47.5 (10.2) 

G2: 46.7 (10.3) 

G3: 45.7 (8.5) 

Paranoid Ideation 

G1: 48.6 (12.4) 

G2: 49.3 (11.1) 

G3: 46.1 (12.8) 

Psychoticism 

G1: 54.1 (10.7) 

G2: 52.1 (10.3) 

G3: 50.5 (11.2) 

Global Severity 

G1: 54.2 (11.1) 

G2: 52.5 (10.3) 

G3: 52.4 (11.2) 

 

Reduction in 

incontinence 

episodes: 

G1: 83.3% 

G2: 74.4% 

G3: 41.4% 

P<0.001 

SCL-90-R scores 

± SD: 

Somatization 

G1: 51.8 (11.4) 

G2: 51.2 (9.8) 

G3: 49.8 (13.0) 

ObsessiveCompulsive: 

G1: 53.8 (13.9) 

G2: 53.9 (10.9) 

G3: 55.4 (11.0) 

Interpersonal 

Sensitivity 

G1: 49.5 (12.0) 

G2: 48.9 (11.2) 

G3: 49.2 (11.3) 

Depression 

G1: 51.5 (11.5) 

G2: 50.6 (10.7) 

G3: 51.4 (11.2) 

Anxiety 

G1: 46.1 (14.6) 

G2: 44.5 (12.3) 

G3: 45.8 (12.9) 

Hostility 

G1: 44.9 (10.8) 

G2: 44.6 (10.5) 

G3: 47.3 (11.2) 

Phobia 

G1: 47.1 (11.2) 

G2: 45.0 (8.3) 

G3: 45.1 (8.5) 

Paranoid Ideation 

G1: 45.8 (10.9) 

G2: 47.2 (11.6) 

G3: 47.2 (12.0) 

Psychoticism 

G1: 49.2 (11.7) 

G2: 50.4 (9.7) 

G3: 49.6 (10.3) 

Global Severity 

G1: 50.8 (12.8) 

G2: 50.4 (10.0) 

G3: 51.4 (10.9) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Methods and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-93 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2001 

(continued) 

155 participants 

were compared to 

the 42 who did not 

complete 

intervention and 

psychological 

assessment, 

higher scores 

(greater distress) 

on 6 of 10 SCL90-R scales 

(somatization, 

obsessive/compul

sive, depression, 

hostility, paranoid 

ideation, global 

severity index), all 

p values <0.05 

Normal range, 

score 0-63 

>75% in normal 

range (including 

dropouts) on 9 of 

10 scales 

Highest 

impairment rate: 

33% scored 

abnormal for 

obsessivecompulsive

Correlations 

between 

reduction of 

incontinence and 

changes in 

psychological 

symptoms 

Somatization 

G1: 0.28* 

G2: -0.09 

G3: 0.17 

ObsessiveCompulsive 

G1: 0.01 

G2: -0.14 

G3: 0.02 

Interpersonal 

Sensitivity 

G1: -0.09 

G2: 0.04 

G3: 0.13 

Depression 

G1:-0.04 

G2: 0.03 

G3: 0.07 

Anxiety 

G1: -0.10 

G2: -0.01 

G3: 0.34* 

Hostility 

G1: -0.10 

G2: 0.09 

G3: 0.11 

Phobic anxiety 

G1:-0.21 

G2: -0.17 

G3: 0.02 

Paranoid Ideation 

G1: 0.14 

G2: -0.04 

G3: -0.06 

Psychoticism 

G1: -0.01 

G2: -0.01 

G3: 0.13 

***P=0.001 

C-94 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2001 

(continued) 

Global Severity 

Index 

G1: 0.01 

G2: 0.06 

G3: 0.45*** 

*p<0.05 

C-95 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 2008 

Country and 

setting: 

US, Academic 

medical centers 

Enrollment 

period: 

July 2004 to 

January 2006 

Funding: 

NIH 

Pfizer 

Author industry 

relationship 

disclosures: 

20 of 29 

Allergan (3) 

Alza (1) 

Astellas Pharma 

(7) 

Bionovo (1) 

Bristol-Meyers 

Squibb (1) 

Dynogen (1) 

Elan (1) 

Ethicon (2) 

GSK (4) 

Johnson & 

Johnson (3) 

Lilly (7) 

Medtronic (1) 

Merck (1) 

Novartis (6) 

Ortho-McNeil (3) 

Pfizer (>10) 

Procter & Gamble 

(3) 

Q-Med (1) 

Renessa (1) 

Sanofi (1) 

Solace (1) 

Watson (1) 

Design: 

RCT 

Intervention: 

Pharmacologic vs. 

pharmacologic 

plus behavioral 

interventions for 

10 wks (Stage 1), 

followed by no 

drug therapy 

(Stage 2) with 

assessments at 10 

wks and 8 mos* 

Groups: 

G1: Tolterodine 

tartrate (ER 

capsules), 4 mg/d 

plus behavioral 

training: pelvic 

floor muscle 

control and 

exercises, 

behavioral 

strategies to 

diminish urgency, 

suppress bladder 

contractions and 

prevent both 

stress and urge 

incontinence; 

delayed voiding; 

fluid management; 

handout with hints 

G2: Tolterodine 

tartrate (ER 

capsules), 4 mg/d 

N at enrollment: 

4043 screened 

2612 not eligible 

870 declined 

561 consented 

254 excluded 

307 randomized 

G1: 153 

G2: 154 

Inclusion criteria: 

• Women 

• Communitydwelling 

• UUI only, or 

urgepredominant 

• ≥ 7 episodes of 

incontinence in 

a 7-day bladder 

diary

• Persistent 

incontinence for 

at least 3 mos 

• No current use 

of 

antimuscarinics 

or other 

medications that 

could affect UI 

• No evidence of 

neurogenic 

etiology

Exclusion 

criteria: 

• Age < 21 

• Pregnant, 

planning a 

pregnancy in 

next 8 mos, or 

not using birth 

control 

• < 6 mos 

postpartum or 

termination after 

20 wks 

gestation 

• Unable to 

contract pelvic 

floor muscles 

during 

evaluation 

• Behavioral 

therapy of > 2 

mos in past 2 

yrs 

• Continual 

leakage or 

always damp 

• Hypersensitive 

to study drug 

• Systemic 

disease that 

affects bladder 

function 

UUI, 7-13 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 2 (1.3) 

UUI, ≥ 14 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 4 (2.6) 

MUI, 7-13 

episodes/week, n 

(%): 

G1: 46 (29.9) 

G2: 46 (30.1) 

MUI, ≥ 14 

episodes/week, n 

(%): 

G1: 104 (67.5) 

G2: 101 (66.0) 

Adjusted 

incontinence 

episodes/week, 

mean: 

G1: 23.1 

G2: 23.2 

Previous nonsurgical 

treatment for 

incontinence, n 

(%): 

G1: 19 (12) 

G2: 22 (14) 

Success, n (%): 

G1: 43 (28) 

G2: 41 (27) 

Failure, n (%): 

G1: 75 (49) 

G2: 78 (51) 

Success rate, 8 

months, lifetable 

analysis, % (95% 

CI): 

G1: 41 (32, 50) 

G2: 41 (33, 50) 

G1/G2: 0 (-12, 12) 

Success rate, 8 

months, 

complete cases, 

% (95% CI): 

G1: 36 (27, 45) 

G2: 34 (25, 43) 

G1/G2: 2 (-10, 14) 

Success rate, 8 

mos, assuming 

missings were 

failures, % (95% 

CI): 

G1: 28 (21, 35) 

G2: 27 (20, 34) 

G1/G2: 1 (-9, 11) 

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean: 

G1: 2.7

G2: 4.7

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean change: 

G1: -20.4 

G2: -18.5 

G1/G2: -1.9 (-5.9, 

2.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-96 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

N at follow-up: 

G1: 153 

Completed 

treatment: 107 

Outcome known at 

8 mos: 119 

G2: 154 

Completed 

treatment: 101 

Outcome known at 

8 mos: 118 

Age, mean ± SD: 

G1: 55.8 ± 14.2 

G2: 58.0 ± 13.5 

Women, %: 

100

Race/ethnicity, n 

(%): 

Hispanic: 

G1: 13 (9) 

G2: 17 (11) 

NH White: 

G1: 105 (69) 

G2: 85 (56) 

NH Black: 

G1: 22 (14) 

G2: 35 (23) 

Other: 

G1: 13 (9) 

G2: 15 (10) 

BMI, kg/m2

 ± SD: 

G1: 33.2 ± 9.5 

G2: 32.3 ± 7.6

• Currently using 

catheter to 

empty bladder 

• Postvoid 

residual volume 

> 150mL 

• Treatment for 

prolapse with 

pessary < 3 

mos 

• Incontinence, 

vaginal, bladder 

or prolapse 

surgery in the 

past 6 mos 

• Urethral 

diverticulum 

• Previous 

augmentation 

cystoplasty or 

artificial 

sphincter 

• Neuromodulatio

n for pelvic 

indications 

• Using 

anticholinergic 

agents, 

cholinergic 

agonists, 

tricyclic 

antidepressants

, or duloxetine 

in ≤ 4 wks 

• Using diuretics 

with dosage 

change past 3 

mos 

• Uncontrolled 

medical 

problem 

• History of 

bladder or 

pelvic cancer or 

pelvic radiation 

therapy 

• Glaucoma 

• Gastric 

retention 

• Non-ambulatory 

• Participation in 

other 

intervention trial 

that might 

influence 

outcome 

Achieved 70% 

reduction in 

incontinence 

episodes, per 

bladder diary, 

10 weeks (%): 

G1: 69

G2: 58

G1/G2: 11 (-0.3, 

22.1) 

Totally dry, per 

bladder diary, 

10 weeks (%): 

G1: 21 

G2: 17 

Voids/day, mean 

change: 

G1: 0.5 

G2: -0.4 

G1/G2: 0.9 (0.3, 

1.5) 

Symptom 

Distress Scores: 

G1/G2: P <

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 1, mean 

change: 

G1: -36.7

G2: -30.4

G1/G2: P <

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 2, mean 

change: 

G1: -30.9 

G2: -20.4 

G1/G2: P <

0.0001 

Patient 

completely 

satisfied, Stage 

1, %: 

G1: 53

G2: 40 

G1/G2: 13 (1, 25) 

C-97 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

Patient 

completely 

satisfied, 8 

months, %: 

G1: 33 

G2: 20 

G1/G2: 13 (2, 24) 

Patient better or 

much better, 

Stage 1, %: 

G1: 90 

G2: 77 

G1/G2: 13 (4, 22) 

Patient better or 

much better, 8 

months, %: 

G1: 69 

G2: 43 

G1/G2: 26 (14 , 

38) 

Persistence in 

perceived 

improvement, 8 

mos, women with 

improvement at 

Stage 1: 

G1: 72 

G2: 54 

G1/G2: 17 (4, 30) 

Harms: 

G1: 3 participants 

1: blurred vision, 

syncope, night 

sweats, stomach 

cramping and 

weakness 

2: 2 episodes of 

small-bowel 

obstruction and an 

allergic reaction 

(pruritus and rash) 

3: tachycardia 

during stage 2 

G2: 3 participants 

1: small bowel 

obstruction 

2: peripheral 

edema 

3: renal cell 

carcinoma 

diagnosis during 

stage 2 

C-98 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Capo et al. 2008 

Country and 

setting: 

US, 207 centers 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, Inc., and 

GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

5 of 5 

Astellas (4) 

Boehringer 

Mannheim 

Pharmaceuticals 

(1) 

Cephalon Inc. (1) 

GlaxoSmithKline 

(3) 

Reliant 

Pharmaceuticals 

(1) 

Schering Plough 

Corporation (1) 

Abbott (1) 

Akros (1) 

AstraZenica (1) 

Johnson & 

Johnson (1) 

Lilly (1) 

Manking (1) 

Merck (1) 

Novartis (1) 

NovoNordisk (1) 

Pfizer Inc. (1) 

Solvay (1) 

Takeda & TAP (1) 

Pri Med (1) 

Lucente (1) 

Design: 

RCT 

Intervention: 

12-wk treatment 

with 5 mg 

solifenacin 

succinate. Dosage 

could be 

increased at wk 4 

and wk 8 to 10 

mg, maintained or 

decreased in 

response to pt 

perceived efficacy 

and tolerability 

Groups: 

G1: Hispanic 

subgroup of G2 

G2: full study 

population 

including G1 

N at enrollment: 

G1: 94 

G2: 2205 

N at follow-up, 

range:

G1: 47-80 

G2: 1254-2005 

Age, yrs ± SD: 

G1: 51.8 ± 12.8 

G2: 59.7 ± 14.4 

Weight in lbs, 

mean ± SD: 

G1: 171.1±36.4 

G2: 182.2±47.0 

Race/ethnicity, n 

(%): 

Hispanic: 

G1: 94 (100) 

G2: 94 (4.3)

White: 

G2: 1761 (79.9) 

Black: 

G2: 274 (12.4) 

Asian: 

G2: 59 (2.7) 

Other: 

G2: 17 (0.8) 

Women, N (%): 

G1: 74 (78.7) 

G2: 1813 (82.2) 

Inclusion criteria: 

• ≥ 18 yrs of age 

• OAB symptoms 

≥3 mos 

• Toilet without 

difficulty 

• Washout of 

other OAB 

meds ≥ 7 days 

• Non-drug 

treatment of 

OAB if 

established ≥ 4 

wks prior to 

study and 

continued 

Exclusion 

criteria: 

• SUI 

• Stress 

predominant 

MUI 

• UTI or chronic 

inflammation 

clinically 

significant 

outflow 

• Obstruction due 

to BPH 

• Narrow-angle 

glaucoma 

• Urinary or 

gastric retention

• Severe renal or 

hepatic 

impairment 

• Chronic severe 

constipation or 

gastrointestinal 

obstructive 

disease 

• Bladder cancer 

• Women not 

using a reliable 

contraceptive 

• Hypersensitivity 

to the study 

medication, any 

of its 

components, or 

to 

anticholinergic 

medication 

Urge 

incontinence, n 

(%): 

G1: 63 (67.0) 

G2: 1586 (71.9) 

Urinary urgency, 

n %: 

G1: 88 (93.6) 

G2: 2007 (91.0) 

Frequency, n, 

(%): 

G1: 86 (91.5) 

G2: 1969 (89.3) 

Nocturia, n (%): 

G1: 79 (84.0) 

G2: 1792 (81.3) 

Patient 

perception of 

bladder 

condition, mean 

score: 

G1: 4.0

G2: 4.0

Most bothersome 

OAB symptomfrequency, n %:

G1: 38 (40.4) 

G2: 619 (28.1) 

Most bothersome 

OAB symptomurinary urgency, 

n %: 

G1: 22 (23.4) 

G2: 508 (23.0) 

Most bothersome 

OAB symptomurge 

incontinence, n 

%: 

G1: 17 (18.1) 

G2: 602 (27.3) 

Most bothersome 

OAB symptomnocturia, n %: 

G1: 12 (12.8 

G2: 337 (15.3) 

Increased 

dosage 5 

mg/day, n (%)-Wk 

4: 

G1: 46 (48.9)

Increased 

dosage 10 

mg/day, n (%)-Wk 

4: 

G1: 37 (39.4) 

Discontinued, n 

Wk 4: 

G1: 1 

Increased 

dosage 5 

mg/day, n (%)-Wk 

8: 

G1: 31 (33.0)

Increased 

dosage 10 

mg/day, n (%)-Wk 

8: 

G1: 39 (41.5) 

Discontinued-Wk 

8, n: 

1 

Returned to 5 

mg/day-Wk 8, n: 

5 

Increased 

dosage to 10 

mg/day-Wk 8, n: 

12 

Patient 

Perception of 

Bladder, mean 

Wk 4: 

G1: 3.3* 

G2: 3.3* 

Patient 

Perception of 

Bladder, mean 

Wk 8: 

G1: 2.8* 

G2: 2.8* 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-99 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al., 2008 

(continued) 

Parity : 

NR 

Most bothersome 

OAB symptomnone specified, n 

%: 

G1: 5 (5.3) 

G2: 139 (6.3)

Patient 

Perception of 

Bladder, mean 

Wk 12: 

G1: 3.0* 

G2: 2.9* 

*P <0.001 

vs.baseline

Symptom bother 

from VAS, 

Change from 

Baseline, mean 

scores (mm), 

(95% CI) p-value: 

Urinary urgency: 

G1: -39.2 (-45.9, -

32.5) 

P < 0.001 

G2: -39.5 (-41.0, -

38.1) 

P < 0.001 

Urge 

Incontinence: 

G1: -37.7 (-46.0, -

29.4) 

P < 0.001 

G2: -40.1 (-41.8, -

38.4) 

P < 0.001 

Frequency: 

G1: -40.0 (-46.9, -

33.2) 

P < 0.001 

G2: -41.8 (-43.3, -

40.3) 

P < 0.0001 

Nocturia: 

G1: -43.2 (-50.4, -

36.1) 

P < 0.001 

G2: -36.9 (-38.4, -

35.4) p < 0.001 

OAB-q 

subscales, 

change from 

baseline, mean 

(95% CI) p-value: 

C-100 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al., 2008 

(continued) 

Symptom bother: 

G1: -29.1 (-34.8, -

23.4) 

P < 0.001, 

G2: -29.6 (-30.7, -

28.6) 

P < 0.001 

Coping: 

G1: 24.0 (18.0, 

30.1) 

P < 0.001 

G2: 27.4 (26.2, 

28.5) 

P < 0.001 

Concern: 

G1: 25.8 (19.5, 

32.2) 

P < 0.001 

G2: 29.6 (28.4, 

30.8) 

P < 0.001 

Sleep: 

G1: 25.7 (19.4, 

32.0) 

P < 0.001 

G2: 27.3 (26.1, 

28.5) 

P < 0.001 

Social Interaction 

G1: 15.9 (11.5, 

20.3) 

P < 0.001 

G2: 14.7 (13.7, 

15.6) 

P < 0.001 

Overall Healthrelated QoL: 

G1: 23.2 (18.0, 

28.5) 

P < 0.001 

G2: 25.4 (24.4, 

26.4) 

P < 0.001 

Any Adverse 

Event, n (%): 

G1: 48 (51.4) 

G2: 1321 (59.4) 

Dry mouth, n (%): 

G1: 17 (18.1) 

G2: 477 (21.4) 

C-101 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al., 2008 

(continued) 

Constipation, n 

(%): 

G1: 12 (12.8) 

G2: 295 (13.3) 

Headache, n (%): 

G1: 3 (3.2) 

G2: 76 (3.4) 

Dizziness, n (%): 

G1: 2 (2.1) 

G2: 27 (1.2) 

Blurred vision, n 

(%): 

G1: 4 (4.3) 

G2: 57 (2.6) 

Palpitations, n 

(%): 

G1: 2 (2.1) 

G2: 6 (0.3) 

Upper 

respiratory tract 

infection, n (%): 

G1: 3 (3.2) 

G2: 68 (3.1) 

UTI, n (%): 

G1: 3 (3.2) 

G2: 76 (3.4) 

Bronchitis, n (%): 

G1: 3 (3.2) 

G2: 31 (1.4) 

Nasopharyngitis, 

n (%): 

G1: 2 (2.1) 

G2: 50 (2.3) 

Influenza, n (%): 

G1: 2 (2.1) 

G2: 11 (0.5) 

Insomnia, n (%): 

G1: 2 (2.1) 

G2: 17 (0.8) 

Depression, n 

(%): 

G1: 2 (2.1) 

G2: 19 (0.9) 

Hypertension, n 

(%): 

G1: 2 (2.1) 

G2: 16 (0.7) 

C-102 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Cardozo et al., 

1993

Country and 

setting: 

UK, Denmark, 

Germany, 

Netherlands, 4 

centers 

Enrollment 

period: 

NR

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Oral oestriol vs. 

placebo

Groups: 

G1: 3 mg oral 

estradiol 3mg qd x 

12 wks 

G2: placebo x 12 

wks 

N at enrollment: 

G1: 34 

G2: 30 

N at follow-up: 

G1: 31 

G2: 25 

Women, %: 

100 

Age, mean ± SD: 

G1: 58.9 ± 10.4 

G2: 60.2 ± 9.8 

Race/ethnicity: 

NR

Height (cm), 

mean ± SD: 

G1: 161.9 ± 7.1 

G2: 162.9 ± 6.6 

Weight (kg), 

mean ± SD: 

G1: 70.9 ± 11.6 

G2: 69.1 ± 12.6 

Inclusion criteria:

• Women 

• Ambulant 

• Postmenopausa

l 

• Sensory and/or 

motor urge 

incontinence 

(confirmed by 

urodynamics) 

Exclusion 

criteria: 

• Symptoms 

present for > 3 

years before 

menopause 

• Voiding difficulty

• Pelvic 

anatomical 

defect requiring 

surgery 

• Neurological 

disease 

• Recent 

estrogen usage 

(< 6 mos) 

• Medication use 

that could affect 

bladder or 

urethral function

• Contraindication 

to estrogen 

Daytime 

incontinence 

episodes/day, 

mean ± SD: 

G1: 3.4 ± 4.2 

G2: 3.2 ± 4.7 

Nocturnal 

incontinence 

episodes/day, 

mean ± SD: 

G1: 1.6 ± 6.0 

G2: 1.0 ± 2.3 

Daytime voids/ 

day, mean ± SD: 

G1: 10.2 ± 5.0 

G2: 10.6 ± 5.4 

Nocturia s/day, 

mean ± SD: 

G1: 2.0 ± 1.4 

G2: 2.6 ± 2.2 

Diurnal 

frequency, %: 

G1: 26 

G2: 20 

Nocturia, %: 

G1: 25 

G2: 20 

Urgency, %: 

G1: 29 

G2: 25 

Dysuria, %: 

G1: 9 

G2: 4 

SUI, %: 

G1: 11 

G2: 10 

UUI, %: 

G1: 25 

G2: 23 

Urgency severity, 

mean score ± SD:

G1: 2.6 ± 0.5 

G2: 2.5 ± 0.8 

Nocturia severity 

mean score ± SD:

G1: 1.6 ± 0.8 

G2: 1.7 ± 1.1 

Daytime 

incontinence 

episodes/day, 1 

mo, mean ± SD: 

G1: 3.0 ± 3.5 

G2: 2.1 ± 2.6 

Daytime 

incontinence 

episodes/day, 3 

mos, mean ± SD: 

G1: 2.7 ± 3.5 

G2: 1.3 ± 2.3 

Nocturnal 

incontinence 

episodes/day, 1 

mo, mean ± SD: 

G1: 0.6 ± 1.2 

G2: 0.7 ± 2.0 

Nocturnal 

incontinence 

episodes/day, 3 

mos, mean ± SD: 

G1: 0.3 ± 0.7 

G2: 0.3 ± 0.8 

Daytime voids/ 

day, 1 mo, mean 

± SD: 

G1: 8.9 ± 3.0 

G2: 10.6 ± 5.4 

Daytime voids/ 

day, 3 mos, mean 

± SD: 

G1: 8.6 ± 3.4 

G2: 7.2 ± 2.2 

G1/BL: P < 0.05 

G2/BL: P < 0.01 

Nocturia 

episodes/day, 1 

mo, mean ± SD: 

G1: 2.0 ± 1.6 

G2: 1.5 ± 1.2 

Nocturia 

episodes/day, 3 

mos, mean ± SD: 

G1: 1.5 ± 1.1 

G2: 1.4 ± 1.3 

G2/BL: P < 0.05 

Diurnal 

frequency, cure 

%: 

G1: 6 

G2: 9 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-103 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

1993

(continued) 

Bladder volume 

(mL), first desire 

to void, mean ± 

SD: 

G1: 161 ± 74 

G2: 163 ± 86 

Detrusor 

pressure (cm 

H2O), mean ± SD: 

G1: 17 ± 12 

G2: 17 ± 17 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 328 ± 125 

G2: 322 ± 113 

Max pressure 

(cm H2O), mean ± 

SD: 

G1: 31 ± 27

G2: 21 ± 79 

Nocturia, cure %: 

G1: 10

G2: 8 

P < 0.01 

Urgency, cure %: 

G1: 7

G2: 9 

P < 0.01 

Dysuria, cure %: 

G1: 5

G2: 4 

SUI, cure %: 

G1: 6

G2: 6 

UUI, cure %:

G1: 11

G2: 7 

P < 0.01 

Urgency severity, 

1 mo, mean 

score ± SD: 

G1: 1.8 ± 0.8 

G2: 1.6 ± 1.0 

Urgency severity, 

3 mos, mean 

score ± SD: 

G1: 1.5 ± 1.1 

G2: 1.4 ± 1.1 

G1/BL: P < 0.01 

G2/BL: P < 0.01

Nocturia 

severity, 1 mo, 

mean score ± 

SD: 

G1: 1.3 ± 0.8 

G2: 1.3 ± 1.0 

Nocturia 

severity, 3 mos, 

mean score ± 

SD: 

G1: 1.0 ± 0.8 

G2: 1.0 ± 1.1 

G1/BL: P < 0.01 

Bladder volume 

(mL), first desire 

to void, 3 mos, 

mean ± SD: 

G1: 206 ± 142 

G2: 202 ± 142 

G1/BL: P < 0.05 

C-104 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

1993

(continued) 

Detrusor 

pressure (cm 

H2O), 3 months, 

mean ± SD: 

G1: 17 ± 15 

G2: 22 ± 39 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 333 ± 163 

G2: 365 ± 136 

Max pressure 

(cm H2O), mean ± 

SD: 

G1: 25 ± 20

G2: 32 ± 65 

G1/BL: P < 0.05 

C-105 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Cardozo et al., 

2004 

[See evidence 

table for Kelleher 

et al., 2005] 

Country and 

setting: 

84 centers in 

Denmark, UK, 

Czech Republic, 

Australia, 

Netherlands, 

Russia, US 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Solifenacin 5 mg 

vs. solifenacin 10 

mg vs. placebo, 

12 weeks once 

daily therapy

Groups: 

G1: Solifenacin 5 

mg qd 

G2: Solifenacin 10 

mg qd 

G3: Placebo 

N at enrollment: 

911 

N treated: 

G1: 299 

G2: 307 

G3: 301

N at follow-up, 

first visit: 

G1: 286 

G2: 290 

G3: 281 

N at follow-up, 

study 

completion: 

G1: 277 

G2: 283 

G3: 270 

Women, n (%): 

G1: 237 (82.9) 

G2: 238 (82.1) 

G3: 227 (80.8) 

Age, mean ± SD 

(range): 

G1: 55.4 ± 13.8 

(19-85) 

G2: 55.9 ± 14.2 

(18-83) 

G3: 56.1 ± 13.3 

(18-82) 

Race/ethnicity, n 

(%): 

White: 

G1: 280 (97.9) 

G2: 281 (96.9) 

G3: 274 (97.5)

Inclusion criteria: 

• Age ≥ 18 

• Symptoms of 

OAB (including 

urinary 

frequency with 

urgency and/or 

UUI) for ≥3 

months 

• ≥ 8 voids/day 

• ≥ 3 episodes 

urinary 

incontinence 

during 3-day 

diary period 

Exclusion 

criteria: 

• BOO 

• PVR volume 

>200 mL 

• Stress 

predominant 

MUI 

• Neurological 

cause for 

detrusor 

overactivity 

• UTI or bladder 

stones 

• Previous pelvic 

irradiation 

• Malignant 

disease of 

pelvic organs 

• Contraindication 

to 

antimuscarinic 

medication 

• Narrow-angle 

glaucoma 

• Urinary or 

gastric retention

• Non drug 

treatment for 

OAB 2 wks 

before study 

• Diabetic 

neuropathy 

• Drugs to treat 

incontinence 

• Drugs with 

cholinergic or 

anticholinergic 

side-effects 

UUI, n (%): 

405 (47) 

Urinary 

incontinence, n 

(%): 

491 (57) 

Voids/day, range:

12.05-12.31 

Duration of 

symptoms 

(months), median 

(range): 

G1: 27.0, 4-383) 

G2: 28.0, 4-314) 

G3: 29.0, 5-327) 

Prior drug 

therapy, n (%): 

G1: 101 (35.3) 

G2: 94 (32.5) 

G3: 95 (33.8) 

Any other nondrug therapy, n 

(%): 

G1: 64 (22.4) 

G2: 77 (26.6) 

G3: 94 (33.5) 

UUI 

episodes/day, 

mean change (% 

change): 

G1: -1.3 (-62.7) 

G2: -1.21 (-57.1) 

G3: -0.91 (-42.5) 

G1/BL: P = 0.014* 

G2/BL: P = 0.042* 

Urgency 

episodes/day, 

mean change 

(95% CI for 

difference): 

G1: -2.84 (-1.44, 

-0.28) 

G2: -2.90 (-1.49, 

-0.35) 

G3: -1.98 

G1/G3: P = 0.003 

G2/G3: P = 0.002 

Incontinence 

episodes/day, 

mean change 

(% change): 

G1: -1.63 (-60.7) 

G2: -1.57 (-51.9) 

G3: -1.25 (-27.9) 

G1/BL: P = 0.002* 

G2/BL: P = 0.016* 

Incontinent 

patients with no 

incontinence at 

end of study, %: 

G1: 50.3 

G2: 49.7 

Voids/day, mean 

change (95% CI 

for difference): 

G1: -2.37 (-1.27, 

-0.29) 

G2: -2.81 (-1.71, 

-0.72) 

G3: -1.59 

G1/G3: P =

0.0018 

G2/G3: P =

0.0001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-106 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

2004 

(continued) 

Black: 

G1: 2 (0.7)

G2: 2 (0.7) 

G3: 3 (1.1) 

Asian: 

G1: 4 (1.4) 

G2: 6 (2.1) 

G3: 2 (0.7) 

Other: 

G1: 0 

G2: 1(0.3) 

G3: 2 (0.7) 

Weight (kg), 

mean ± SD: 

G1: 74.1 ± 15.0 

G2: 74.6 ± 15.4 

G3: 74.1 ± 14.4 

• Participation in 

a clinical trial 

within 30 days 

• Childbearing 

potential, 

pregnant or 

nursing or not 

using reliable 

contraceptive 

methods 

Nocturia 

episodes/day, 

mean change 

(95% CI for 

difference): 

G1: -0.58 

G2: -0.71 (-0.38, 

-0.01) 

P = 0.005 

G3: -0.52 

G1/G3: P = 0.48

G2/G3: P = 0.036 

KHQ, general 

health 

perception, mean 

change: 

G1: -5.8

G2: -4.5 

G3: -2.3 

KHQ, incontinence impact, 

mean change: 

G1: -27.0 

G2: -30.3 

G3: -20.1 

G1/BL: P < 0.01 

G2/BL: P < 0.001 

KHQ, role 

limitations, mean 

change: 

G1: -21.9 

G2: -24.4 

G3: -15.9 

G1/BL: P < 0.01 

G2/BL: P < 0.001 

KHQ, physical 

limitations, mean 

change: 

G1: -19.2 

G2: -22.3 

G3: -15.4 

G2/BL: P < 0.001 

KHQ, social 

limitations, mean 

change: 

G1: -12.1 

G2: -11.7 

G3: -9.0 

C-107 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

2004 

(continued) 

KHQ, personal 

relationships, 

mean change: 

G1: -8.5

G2: -8.3 

G3: -9.4 

KHQ, emotions, 

mean change: 

G1: -16.4 

G2: -16.6 

G3: -12.2 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

KHQ, sleep/ 

energy, mean 

change: 

G1: -15.4 

G2: -15.9 

G3: -11.4 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

KHQ, severity 

measures, mean 

change: 

G1: -9.6

G2: -11.8 

G3: -7.2 

G2/BL: P < 0.01 

KHQ, symptom 

severity, mean 

change: 

G1: -3.4 

G2: -3.4 

G3: -2.4 

G1/BL: P < 0.01 

G2/BL: P < 0.01 

Voided volume 

(mL), mean 

change (95% CI 

for difference): 

G1: 30.8 (12.4-

27.2) 

G2: 36.0 (17.7-

33.0) 

G3: 10.67 

G1/G3: P =

0.0001

G2/G3: P =

0.0001 

Dry mouth, n (%): 

G1: 23 (7.7) 

G2: 71 (23.1) 

G3: 7 (2.3) 

C-108 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

2004 

(continued) 

Dry mouth, mild, 

n (%): 

G1: 18 (6.0) 

G2: 55 (17.9) 

G3: 5 (1.7) 

Dry mouth, 

moderate, n (%): 

G1: 5 (1.7) 

G2: 15 (5.2) 

G3: 1 (0.3) 

Dry mouth, 

severe, n (%): 

G1: 0 

G2: 0 

G3: 1 (0.3) 

Constipation, n 

(%): 

G1: 11 (3.7) 

G2: 28 (9.1) 

G3: 6 (2.0) 

Constipation, 

mild, n (%): 

G1: 9 (3.0) 

G2: 16 (5.2) 

G3: 5 (1.7) 

Constipation, 

moderate, n (%): 

G1: 5 (1.7) 

G2: 15 (5.2) 

G3: 1 (0.3) 

Constipation, 

severe, n (%): 

G1: 0 

G2: 2 (0.7) 

G3: 0 

Blurred vision, n 

(%): 

G1: 12 (4.0) 

G2: 18 (5.9) 

G3: 7 (2.3) 

Blurred vision, 

mild, n (%): 

G1: 7(2.3) 

G2: 14 (4.6) 

G3: 6 (2.0) 

Blurred vision, 

moderate, n (%): 

G1: 4 (1.3) 

G2: 4 (1.3) 

G3: 1 (0.3) 

C-109 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

2004 

(continued) 

Blurred vision, 

severe, n (%): 

G1: 1 (0.3) 

G2: 0 

G3: 0 

Discontinued 

due to AEs, n 

(%): 

G1: 7 (2.3) 

G2: 12 (3.9) 

G3: 10 (3.3) 

C-110 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Cardozo et al., 

2008 

Country and 

setting: 

Europe, 

Community 

Enrollment 

period: 

April 2004 to 

October 2005 

Funding: 

Astellas Pharma 

Europe Ltd 

Author industry 

relationship 

disclosures: 

9 of 9 

Apogepha (1) 

Astellas (9) 

BARD (1) 

Bayer-Schering 

(1) 

Boston Scientific 

(1) 

Cook (1) 

Gynecare (1) 

J&J (1) 

Lilly (3) 

Merckle Recordati 

(1) 

Organon (1) 

Pfizer (3) 

Plethora (1) 

Recordati (1) 

Sanofi-Aventis (1) 

UCB (1) 

Design: 

Multicenter 

randomized 

double blind 

placebo-controlled 

2 week run in 

Intervention: 

Solifenacin 5 or 10 

mg daily (pts 

requesting dose 

increase to 10 mg 

at 8 weeks were 

randomized in a 

1:1 ratio to 5 mg 

or 10 mg)

Groups: 

G1: Solifenacin 

5 or 10 mg daily 

G2: Placebo 

N at enrollment: 

G1: 640 

G2: 223 

N at follow-up: 

G1: 505 

G2: 223 

Women, %: 

G1: 89.1 

G2: 85.7 

Age, mean: 

G1: 57.7 

G2: 57.9 

Race/ethnicity, 

%: 

White: 

G1: 98.4 

G2: 99.1

Black: 

G1: 0.4 

G2: 0.4 

Asian: 

G1: 0.8 

G2: 0

Other: 

G1: 0.4 

G2: 0.4 

Follow-up: 

16 weeks 

Inclusion criteria:

• Age ≥ 18 

• Male or female 

• OAB symptoms 

of urgency, 

frequency, urge 

incontinence ≥ 3 

months 

• ≥ 3 episodes of 

urgency with or 

without 

incontinence in 

last 3 days 

• Mean of ≥ 8 

voids/day 

Exclusion 

criteria: 

• Clinically 

significant BOO 

• PVR > 200 mL 

• UTI 

• Bladder stones 

• IC 

• Previous 

irradiation 

• Malignant pelvic 

disease 

• Sexually active 

women 

practicing an 

unreliable 

method of birth 

control 

• Pregnancy/ 

lactation 

• Conditions 

contraindicating 

anticholinergic 

medication 

UUI episodes/ 

day, mean: 

G1: 1.63 

G2: 2.01 

Severe urgency 

episodes (PPIUS 

3+4)/day, mean: 

G1: 5.11 

G2: 5.54 

Urgency 

episodes (PPIUS 

1-4)/day, mean: 

G1: 10.72 

G2: 10.81 

Maximum 

urgency intensity 

(PPIUS)/day, 

mean: 

G1: 3.53 

G2: 3.59 

Incontinence 

episodes/day, 

mean: 

G1: 1.58 

G2: 1.96 

Voids/day, mean:

G1: 11.10 

G2: 11.14 

PPBC score, 

mean:

G1: 5 

G2: 5 

Urgency bother 

score, VAS (mm), 

mean: 

G1: 68 

G2: 69 

Treatment 

satisfaction 

score, VAS (mm), 

mean: 

G1: 29 

G2: 29 

UUI 

episodes/day, 

mean change ± 

SD: 

G1: -1.7 ± 2.2 

(N=326) 

G2: -1.3 ± 2.0 

(N=158) 

P = 0.0002 

Severe urgency 

episodes (PPIUS 

3+4)/day, mean ± 

SD: 

G1: -2.6 ± NR 

(N=503) 

G2: -1.8 ± NR 

(N= 216) 

P < 0.0001 

Urgency 

episodes (PPIUS 

1-4)/day, mean ± 

SD: 

G1: -2.3 ± 3.0 

(N=503) 

G2: -1.6 ± 3.3 

(N=216) 

P = 0.0006 

Maximum 

urgency intensity 

(PPIUS)/day, 

mean change ± 

SD: 

G1: -0.8 ± 0.9 

(N=503) 

G2: -0.6 ± 0.9 

(N=216) 

P = 0.0006 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -1.7 ± 2.2 

(N=329) 

G2: -1.4 ± 2.0 

(N=158) 

P = 0.0003 

Voids/day, mean 

change ± SD: 

G1: -2.1 ± 2.6 

(N= 502) 

G2: -1.3 ± 2.7 

(N= 216) 

P < 0.0001 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: + 

Method and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-111 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Cardozo et al., 

2008 

PPBC score, 

median % 

change: 

G1: -33 

G2: -20 

P < 0.0001 

Urgency bother 

score, VAS (mm), 

median % 

change: 

G1: -59 

G2: -35 

P < 0.0001 

Treatment 

satisfaction 

score, VAS (mm), 

median % 

change: 

G1: 66 

G2: 34 

P < 0.0001 

Withdrawn due 

to AEs, n: 

G1: 17

G2: 6

Dry mouth, %: 

G1: 15.8 

G2: 2.7 

P < 0.001 

Constipation, %: 

G1: 6.9 

G2: 2.2 

P = NS 

Blurred Vision, 

%: 

G1: 0.8 

G2: 0.9 

P = NS 

C-112 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chancellor et al., 

2000

Country and 

setting: 167 

centers in Europe, 

North America, 

Australia 

Enrollment 

period: 

NR 

Funding: 

Pharmacia & 

Upjohn 

Author industry 

relationship 

disclosures: 

NR 

Design: 

randomized, 

double-blind, 

placebocontrolled, 

parallel-group 

Intervention: 

tolterodine vs. 

placebo

Groups: 

G1: tolterodine 2 

mg b.i.d. x 12 wks 

G2: placebo x 12 

wks 

N at enrollment: 

G1: 514 

G2: 508 

N at follow-up: 

G1: 514 

G2: 508 

Age, mean yrs 

(range): 

G1: 60 (22-92) 

G2: 61 (21-93) 

Women, N (%): 

818 (80%) 

Race/ethnicity: 

NR 

Inclusion criteria:

• ≥18 years 

• ≥5 incontinence 

episodes/wk 

• Average ≥8 

voids/24 hr 

• OAB symptoms 

≥6 mos 

Exclusion 

criteria: 

• Stress 

incontinence 

• Total daily urine 

volume >3L 

• Contraindications to 

antimuscarinic 

therapy 

• Hepatic/renal 

disorders 

• Symptomatic or 

history of 

recurrent UTI 

• BOO 

• Haematuria 

• Interstitial 

cystitis 

• Receiving 

bladder training, 

electrostimulation 

therapy 

• Indwelling or 

intermittent 

catheter 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Concomitant 

treatment for 

OAB (other than 

ERT for at least 

2 mos) 

• Use of agents 

or drugs with 

potential to 

inhibit 

cytochrome 

P4503A4 

isoform 

Previous drug 

therapy for OAB, 

%: 

G1: 54 

G2: 52 

Good efficacy 

response, %: 

G1: 62 

G2: 59 

Incontinence 

episodes/week, 

mean (range): 

G1: 23.2 (0-168) 

G2: 23.3 (0-168) 

≥5 incontinence 

episodes/week, n 

(%): 

G1: 494 (97) 

G2: 498 (97) 

Voids/day, mean 

(range): 

G1: 11.1 (2-48.6) 

G2: 11.3 (2-37.4) 

≥8 voids/day, n 

(%): 

G1: 469 (91) 

G2: 467 (92) 

Voided volume 

(mL), mean 

(range): 

G1: 137 (38-283) 

G2: 136 (21-374) 

Pads/day, mean 

(range): 

G1: 1.4 (0-25) 

G2: 1.5 (0-22) 

Incontinence 

episodes/week, 

mean change ± 

SD: 

G1: -10.6 ± 16.9 

G2: -6.9 ± 15.4 

P = 0.0005* 

Voids/day, mean 

change ± SD: 

G1: -1.7 ± 3.3 

G2: -1.2 ± 2.9 

P = 0.0079* 

Voided volume 

(mL), mean 

change ± SD: 

G1: +29 ± 47 

G2: +14 ± 41 

P = 0.0001* 

Pads/day, mean 

change ± SD: 

G1: -0.5 ± 1.8 

G2: -0.2 ± 1.4 

P = 0.0035* 

Improvement, n 

(%): 

G1: 313 (61) 

G2: 218 (43) 

No change, n 

(%): 

G1: 158 (31) 

G2: 225 (44) 

Deterioration, n 

(%): 

G1: 43 (8) 

G2: 65 (13) 

Mild dry mouth, n 

(%): 

G1: 93 (18) 

G2: 31 (6) 

Moderate dry 

mouth, n (%): 

G1: 50 (10) 

G2: 8 (2) 

Severe dry 

mouth, n (%): 

G1: 12 (2) 

G2: 0 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-113 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chancellor et al., 

2000 

(continued)

Constipation, n 

(%): 

G1: 35 (7) 

G2: 22 (4) 

Headache, n (%): 

G1: 19 (4) 

G2: 23 (5) 

C-114 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chancellor, 

Kianifard, et al., 

2008 

Country and 

setting: 

US 

Enrollment 

period: 

May 2005 to 

February 2006 

Funding: 

NR 

Author industry 

relationship 

disclosures:

6 of 7 

Genaera (1) 

Novartis (6) 

Design: 

Randomized 

open-label 

Intervention: 

Behavioral 

modification in 

addition to 

darifenacin 

(allowed to 

increase dose 

from darifenacin 

7.5 mg to 15 mg 

daily after 2 

weeks) 

Groups:* 

G1: Darifenacin 

G2: Darifenacin 

and behavioral 

modification 

N at enrollment: 

G1: 190 

G2: 205 

N at follow-up, 12 

weeks: 

G1: 173 

G2: 175 

Age, mean ± SD: 

G1: 57.4 ± 13.1 

G2: 58.4 ± 14.6 

Race/ethnicity: 

White: 

G1: 90 

G2: 88.3 

Other (nonwhite): 

G1: 10 

G2: 11.7 

Women, %: 

G1: 90 

G2: 88.3 

Inclusion criteria:

• ≥ 8 voids/ day 

• ≥ 2 UUI 

episodes/ day 

• ≥ 2 episodes of 

urgency/day 

Exclusion 

criteria: 

• Any drug with 

bladder effects 

for 2 weeks prior 

to study 

participation 

• Participation in 

any formal 

bladder-training 

program within 

30 days of 

screening 

• Predominant 

SUI 

• Bladder or 

neurologic 

condition that 

could affect 

bladder function 

or in which use 

of 

anticholinergics 

was contraindicated

UUI episodes/ 

day, mean ± SD:

G1: 2.78 ± 2.57 

G2: 3.00 ± 2.56 

UUI episodes/ 

day, median:

G1: 2.33 

G2: 2.58 

Mean UUI 

episodes/day, 

total population, 

n (%): 

0 episodes: 

G1: 36 (19.1) 

G2: 29 (14.2) 

1-6 episodes: 

G1: 138 (73.0) 

G2: 155 (76.0) 

7-13 episodes: 

G1: 15 (7.9) 

G2: 20 (9.8) 

≥14 episodes 

G1: 0 (0.0) 

G2: 0 (0.0) 

Mean UUI 

episodes/day, 

age ≥ 65, n (%) 

0 episodes 

G1: 9 (17.0) 

G2: 8 (9.9) 

1-6 episodes 

G1: 40 (75.5) 

G2: 63 (77.8) 

7-13 episodes 

G1: 4 (7.5) 

G2: 10 (12.3) 

Urgency 

episodes/day, 

mean ± SD: 

G1: 10.88 ± 3.80 

G2: 10.58 ± 4.00 

Urgency 

episodes/day, 

median: 

G1: 10.67 

G2: 10.33 

Voids/day, mean 

± SD: 

G1: 11.92 ± 3.03 

G2: 11.75 ± 3.37 

UUI episodes/day 

mean change ± 

SD:

G1: -1.89 ± 2.29 

G2: -2.10 ± 2.32 

G1/G2: P = 0.268 

UUI episodes/day 

median change 

(95% CI):

G1: -1.33 

(-2.00, -1.00) 

G2: -2.00 

(-2.00, -1.33) 

Urgency 

episodes/day 

mean change ± 

SD: 

G1: -2.87 ± 3.59 

G2: -2.68 ± 3.54 

G1/G2: P = 0.882 

Urgency 

episodes/day 

median change 

(95% CI): 

G1: -2.33 

(-3.00, -1.67) 

G2: -2.67 

(-3.00, -2.00) 

Voids/day, mean 

change ± SD: 

G1: -2.96 ± 2.91 

G2: -2.82 ± 2.87 

G1/G2: P = 0.681 

Voids/day, 

median change 

(95% CI): 

G1: -2.67 

(-3.33, -2.00) 

G2: -2.67 

(-3.00, -2.33) 

Nocturia 

episodes/day, 

mean change ± 

SD: 

G1: -0.65 ± 1.26 

G2: -0.67 ± 1.21 

G1/G2: P = 0.315 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-115 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chancellor, 

Kianifard, et al., 

2008 

(continued) 

Voids/day, 

median: 

G1: 11.33 

G2: 11.33 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.77 ± 1.43 

G2: 1.87 ± 1.35 

Nocturia 

episodes/day, 

median: 

G1: 1.67 

G2: 1.67 

Pads used/day, 

mean ± SD:

G1: 1.12 ±1.93 

G2: 0.99 ± 1.67 

Pads used/day, 

median:

G1: 0 

G2: 0 

Nocturia 

episodes/day, 

median change 

(95% CI): 

G1: -0.67 

(-0.67, -0.33) 

G2: -0.67 

(-0.67, -0.33) 

Pads used/day 

mean change ± 

SD:

G1: -0.72 ±1.54 

G2: -0.61 ± 1.28 

G1/G2: P = 0.978 

Pads used/day 

median change 

(95% CI):

G1: 0 (0,0) 

G2: 0 (0,0) 

Side effects, %: 

Constipation: 18.5 

Dry mouth 25 

UTI: 4.8 

Headache: 3.8 

Discontinued 

due to adverse 

event(s), n (%) 

G1: 6 (3.2) 

G2: 21 (10.25) 

Discontinued 

due to 

constipation, %: 

2 

Discontinued 

due to dry 

mouth, %: 

1.8 

C-116 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chancellor, Zinner 

et al., 2008 

Country and 

setting: 

USA, multicenter 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

12 of 12 

Abbot (1) 

AEterna Zentaris 

(1) 

Akros (1) 

Allergan (3) 

American Medical Systems (2) 

Amgen (1) 

Astellas (10) 

AstraZeneca (1) 

Bard (1) 

Bayer (1) 

Boehringer 

Ingelheim (3) 

Cephalon (1) 

Coloplast (1) 

Cook (1) 

CooperSurgical 

(1) 

Eli Lilly (2) 

Ferring 

GSK (6) 

Gynecare (1) 

Indevus (2) 

J&J (1) 

Mankind (1) 

Medtronic (1) 

Merck (1) 

Novartis (3) 

Novo Nordisk (1) 

Ortho-McNeil (1) 

Design: 

Prospective 

cohort, open 

label, flexibledose, 14 day 

washout 

Intervention: 

Solifenacin 5-10 

mg daily

Groups: 

G1: Solifenacin 5-

10 mg daily 

N at enrollment: 

G1: 440 

N at follow-up 

(%): 

G1: 390 (88.4) 

Age, mean ± SD: 

G1: 61.4 ± 13.8 

Race/ethnicity, n 

(%): 

White: 

G1: 392 (88.9) 

Women, N (%): 

G1: 389 (88.2) 

BMI, kg/m2

 ± SD: 

G1: 30.1 ± 7.1 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

> 3 months 

• Treatment with 

tolterodine ER 4 

mg, solifenacin, 

darifenacin, or 

trospium x ≥ 4 

weeks 

• Desired change 

in therapy 

• ≥ 3 mean UUI 

episodes/day 

Exclusion 

criteria: 

• Treatment < 4 

weeks with 

tolterodine, 

solifenacin, 

darifenacin, or 

trospium 

• SUI 

• MUI with primary 

stress 

• UTI 

• Chronic bladder 

inflammation 

• Bladder cancer 

• Severe 

constipation 

• Elevated PVR 

• Neurological 

deficit 

• Renal/ hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary retention

• Gastric retention

• Hypersensitivity 

to drugs 

• BOO 

• Women of 

childbearing 

age/ lactation 

Urgency 

episodes/day, 

mean change: 

G1: 6.9 ± 4.4 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 3.8 ± 3.6 

Voids/day, mean 

± SD: 

G1: 11.3 ± 3.8 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.9 ± 1.2 

PPBC score, 

mean: 

G1: 4.2 

OAB-q score, 

mean: 

Symptom bother: 

57.3 

Coping: 52.2 

Concern: 51.3 

Sleep: 50.6 

Social Interaction: 

77.7 

Total score: 56.7 

Urgency 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -4.2 ± 4.2 

(-4.6, -3.8) 

G1/BL: P < 0.001 

Incontinence 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -2.6 ± 3.2 

(-3.0, -2.3) 

G1/BL: P < 0.001 

Voids/day, mean 

change ± SD 

(95% CI): 

G1: -2.3 ± 3.2 

(-2.6, -2.0) 

G1/BL: P< 0.001 

Nocturia 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -0.8 ± 1.0 

(-0.9,-0.6) 

G1/BL: P < 0.001 

PPBC score, 

mean change 

(95% CI): 

G1: -1.2 (-1.3, -

1.0) 

G1/BL: P < 0.001

OAB-q score, 

mean: 

Symptom bother: 

27.8 

Coping: 80.1 

Concern: 81.1 

Sleep: 75.1 

Social Interaction: 

92.7 

Total score: 81.9 

G1/BL: P < 0.001 

all domains and 

total score 

Dry Mouth, n (%): 

G1: 77 (17.5) 

Constipation, n 

(%): 

G1: 51 (11.6)

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: -

Method and 

blinding: NA 

Pt selection 

criteria: + 

Loss to followup: 

+ 

Drop-out rates: +

Power 

calculation: + 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: 

++ 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-117 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chancellor, 

Zinner, et al., 

2008 (continued) 

Author industry 

relationship 

disclosures: 

Pfizer (7) 

Pharmacia (1) 

Pri Med (1) 

Reliant (1) 

Solvay (1) 

Sanofi-Aventis (1) 

Schering-Plough 

(1) 

Takeda (1) 

TAP (1) 

Watson (1) 

Blurred vision, n 

(%): 

G1: 10 (2.3)

UTI, n (%): 

G1: 19 (4.3)

Headache, n (%): 

G1: 13 (2.9)

URI, n (%): 

G1: 11 (2.5) 

C-118 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al., 

2004 

Country and 

setting: 

98 centers – 

United States, 

United Kingdom, 

Poland, Russia, 

New Zealand, 

Belgium, 

Netherlands 

Enrollment 

period: 

NR 

Funding: 

Yamanouchi 

Pharmaceutical 

Co., Ltd, Tokyo, 

Japan 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, double-blind 

placebo 

controlled, with 2-

wk placebo run-in 

period 

Intervention: 

Tolterodine vs. 

solifenacin vs. 

placebo

Groups: 

G1: Tolterodine 2 

mg b.i.d. 

G2: Solifenacin 5 

mg qd 

G3: Solifenacin 

10 mg qd 

G4: Placebo qd 

N at enrollment: 

G1: 279 

G2: 269 

G3: 266 

G4: 267 

N at follow-up: 

G1: 250 

G2: 266 

G3: 264 

G4: 253 

Female, n (%) 

G1: 200 (80.0) 

G2: 188 (71.2) 

G3: 194 (72.9)

G4: 193 (76.3)

Age, yrs ± SD: 

G1: 56.9 +/-12.8 

G2: 58.1± 13.4 

G3: 57.2 ±13.4 

G4: 57.8 ± 13.7 

<65 years of age, 

n (%) 

G1: 169 (63.5) 

G2: 172 (65.2) 

G3: 172 (68.8) 

G4: 168 (66.4) 

≥65 years of age, 

n (%) 

G1: 97 (36.5) 

G2: 92 (34.8) 

G3: 78 (31.2) 

G4: 85 (33.6) 

Inclusion criteria: 

• Age ≥ 18 

• Symptoms of 

OAB (including 

urinary 

frequency with 

urgency and/or 

UI) for ≥ 3 

months 

• ≥ 8 voids per 24 

hr 

• ≥ 3 episodes 

UUI during 3-

day diary period

Exclusion 

criteria: 

• Clinically 

significant BOO 

• Postvoid 

residual volume 

>200 mL 

• Stress 

predominant 

factor 

• Neurological 

cause for 

detrusor 

overactivity 

• UTI or bladder 

stones 

• Previous pelvic 

irradiation 

• Malignant 

disease of 

pelvic organs 

• Contraindication 

to 

antimuscarinic 

medication 

(including 

narrow-angle 

glaucoma, 

urinary or 

gastric 

retention) 

• Non pharmacological 

treatment for 

OAB 2 wks 

before study 

• Diabetic 

neuropathy 

• Use of drugs 

intended to treat 

incontinence 

UUI only, n (%):

G1: 142 (56.8) 

G2: 162 (61.4) 

G3: 172 (64.7) 

G4: 177(70.0)

MUI, n (%):

G1: 90 (36.0) 

G2: 81 (30.7) 

G3: 79 (29.7) 

G4: 59(23.3) 

No incontinence, 

n (%):

G1: 18 (7.2) 

G2: 20 (7.6) 

G3: 15 (5.6) 

G4: 17 (6.7) 

UUI episodes/ 

day, mean ± SD: 

G1: 2.33 ± 2.50 

G2: 2.14 ± 2.44 

G3: 1.86 ± 1.54 

G4: 2.02 ± 2.50 

Urgency 

episodes/day, 

mean ± SD: 

G1: 5.77 ± 4.89 

G2: 5.82 ± 4.45 

G3: 5.45 ± 3.87 

G4: 5.30 ± 3.92 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.64 ± 2.55 

G2: 2.59 ± 2.88 

G3: 2.32 ± 1.94 

G4: 2.71 ± 2.83 

Voids/day, mean 

± SD: 

G1: 12.08 ± 3.86 

G2: 12.32 ± 3.95 

G3: 12.08 ± 3.43 

G4: 12.20 ± 4.11 

Voided volume 

(mL), mean ± SD:

G1: 149.6 ± 54.6 

G2: 147.2 ± 51.2 

G3: 147.0 ± 50.3 

G4: 143.8 ± 53.6 

UUI 

episodes/day, 

mean change ± 

SD:

G1: -0.91 (2.01) 

G2: -1.41 (1.74) 

G3: -1.36 (2.13) 

G4: -0.62 (1.96)

G1/G4: P = 0.239 

G2/G4: P = 0.002 

G3/G4: P =

0.0028 

UUI 

episodes/day, 

mean % change:

G1: -58 

G2: -65 

G3: -63 

G4: -40 

UUI 

episodes/day, 

estimated 

difference vs. 

tolterodine 

(95% CI): 

G2: -0.487 (-

0.988, 0.014) 

G3: -0.436 (-

0.921, 0.048) 

Urgency 

episodes/day, 

mean change ± 

SD: 

G1: -2.05 ± 3.58 

G2: -2.85 ± 3.74 

G3: -3.07 ± 3.90 

G4: -1.41 ± 3.67 

G1/G4: P =

0.0511 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Urgency 

episodes/day, 

mean % change:

G1: -38 

G2: -55 

G3: -52 

G4: -33 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-119 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2004 

(continued) 

<75 years of age, 

n (%) 

G1: 236 (88.7) 

G2: 241 (91.3) 

G3: 233 (93.2) 

G4: 225 (88.9) 

≥75 years of age, 

n (%) 

G1: 30 (11.3) 

G2: 23 (8.7) 

G3: 17 (16.8) 

G4: 28 (11.1) 

Weight, mean kg 

± SD 

G1: 74.8 +/-14.8 

G2: 74.6±14.3 

G3: 75.5±14.2 

G4: 72.6±14.4 

Race/ethnicity, n 

(%): 

White 

G1: 261(98.1) 

G2: 260 (98.5) 

G3: 247(98.8) 

G4: 248 (98.0) 

Black 

G1: 2 (0.8) 

G2: 0 

G3: 1 (0.4) 

G4: 1 (0.4) 

Asian 

G1: 2 (0.8) 

G2: 0 

G3: 2(0.8) 

G4: 1 (0.4) 

Other 

G1: 1 (0.4) 

G2: 4 (1.5) 

G3: 0 

G4: 3 (1.2) 

• Use of drugs 

with cholinergic 

or 

anticholinergic 

side-effects 

• Participation in 

a clinical trial 

within 30 days 

• Childbearing 

potential, 

pregnant or 

nursing or not 

using reliable 

contraceptive 

methods 

Time from start 

of symptoms 

(months), mean ± 

SD: 

G1: 57.4 ± 60.5

G2: 72.6 ± 105.4 

G3: 62.9 ± 82.5 

G4: 61.0 ± 83.9

Prior drug 

therapy, n (%):

G1: 93 (34.9) 

G2: 106 (40.1) 

G3: 77 (30.8) 

G4: 83 (32.8) 

Any non drug 

therapy, n (%):

G1: 92 (34.6) 

G2: 92 (34.8) 

G3: 88 (35.2) 

G4: 76 (30.0) 

Urgency 

episodes/day, 

estimated 

difference vs. 

tolterodine (95% 

CI): 

G2: -0.791 (-

14.34, -0.148) 

G3: -1.015 (-

1.659, -0.370) 

Incontinence 

episodes/day, 

mean change ± 

SD:

G1: -1.42 ± 1.82 

G2: -1.45 ± 2.24 

G3: -1.14 ± 2.15 

G4: -0.76 ± 2.26

G1/G4: P =

0.1122 

G2/G4: P = 0.008 

G3/G4: P =

0.0038 

Incontinence 

episodes/24 h ∆

from baseline, %:

G1: -59 

G2: -47 

G3: -59 

G4: -29 

Incontinence 

episodes/day, 

estimated 

difference vs. 

tolterodine (95% 

CI): 

G2: -0.276 (-

0.761, 0.208) 

G3: -0.316 (-

0.786, 0.154) 

Voids/day, mean 

change ± SD: 

G1: -1.88 ± 3.00 

G2: -2.19 ± 2.87 

G3: -2.61 ± 3.24 

G4: -1.20 ± 3.26

G1/G4: P =

0.0145 

G2/G4: P = 0.003 

G3/G4: P < 0.001 

C-120 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2004 

(continued) 

Voids/day, mean 

% change:

G1: -15 

G2: -20 

G3: -17 

G4: -18 

Voids/day, 

estimated 

difference vs. 

tolterodine (95% 

CI): 

G2: -0.312 (-

0.844, 0.219) 

G3: -0.737 (-

1.269, -0.204) 

Voided volume 

(mL), mean 

change ± SD: 

G1: 24.4 ± 49.2 

G2: 32.9 ± 47.7 

G3: 39.2 ± 50.4 

G4: 07.4 ± 36.3

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Voided volume 

(mL), mean % 

change:

G1: 20 

G2: 25 

G3: 29 

G4: 9 

Voided volume 

(mL), estimated 

difference vs. 

tolterodine (95% 

CI): 

G2: 8.4 (0.496, 

16.34) 

G3: 14.8 (6.855, 

22.72) 

Discontinued 

due to AEs, n 

(%): 

G1: 5 (1.9) 

G2: 9 (3.2) 

G3: 7 (2.6) 

G4: 10 (3.7) 

Dry mouth, n (%): 

G1: 49 (18.6) 

G2: 39 (14.0) 

G3: 57 (21.3) 

G4: 13 (4.9) 

C-121 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2004 

(continued) 

Constipation, n 

(%): 

G1: 7 (2.6) 

G2: 20 (7.2) 

G2: 21 (7.8) 

G4: 5 (1.9) 

Blurred Vision, n 

(%): 

G1: 4 (1.5) 

G2: 10 (3.6) 

G3: 15 (5.6) 

G4: 7 (2.6) 

C-122 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al., 

2005* 

Chapple, FianuJonsson et al., 

2007† 

Country and 

setting: 

European, 

Multicenter 

Enrollment 

period: 

May 2003 to 

October 2004 

Funding: 

Yamanouchi (now 

Astellas) 

Author industry 

relationship 

disclosures: 

NR* 

1 of 9† 

Astellas (1) 

Novartis (1) 

Pfizer (1) 

Schwartz (1) 

UCB (1) 

Design: 

RCT

Intervention: 

Solifenacin 5 mg 

vs. tolterodine ER 

4 mg 

Groups: 

G1: Solifenacin 

5mg

G2: Tolterodine 

ER 4mg 

G1a: G1 who 

elected not to 

increase dose at 4 

weeks 

G2a: G2 who 

elected not to 

increase dose at 4 

weeks 

N at enrollment: 

G1: 578 

G2: 599 

N at follow-up: 

G1a: 297 

G2a: 267 

Age, mean: 

G1: 56.5 

G2: 56.4 

G1a: 56.5 

G2a: 56.9 

Race/ethnicity, 

%: 

White: 

G1: 99.3 

G2: 99.5 

G1a: 99.3 

G2a: 99.3 

Women, %: 

G1: 85.3 

G2: 88.3 

G1a: 87.5 

G2a: 87.1 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

for ≥ 3 months 

• Outpatient 

treatment 

• ≥ 8 voids/day 

• ≥ 1 incontinence 

episode/day or 

≥ 1 urgency 

episode/day 

Exclusion 

criteria: 

NR 

UUI episodes/ 

day, mean ± SD:*

G1: 2.31 ± 2.35 

G2: 2.12 ± 2.14 

UUI episodes/ 

day, mean:† 

G1a: 1.97 

G2a: 1.66 

Urgency 

episodes/day, 

mean ± SD:* 

G1: 6.01 ± 4.66 

G2: 5.84 ± 4.12 

Urgency 

episodes/day, 

mean:† 

G1a: 5.67 

G2a: 5.30 

Incontinence 

episodes/day, 

mean ± SD:* 

G1: 2.77 ± 2.65 

G2: 2.55 ± 2.37 

Incontinence 

episodes/day, 

mean:† 

G1a: 2.32 

G2a: 2.01 

Voids/day, mean 

± SD:* 

G1: 11.78 ± 3.58 

G2: 11.66 ± 3.25 

Voids/day, 

mean:† 

G1: 11.10 

G2: 11.36 

Nocturia, 

episodes/day, 

mean ± SD:* 

G1: 2.02 ± 1.33 

G2: 1.92 ± 1.22 

Nocturia, 

episodes/day, 

mean:† 

G1a: 1.83 

G2a: 1.84 

UUI 

episodes/day, 4 

wks, mean 

change:† 

G1: -1.22 

G2: -0.91 

P = NS 

UUI 

episodes/day, 12 

wks, mean 

change:* 

G1: -1.42 

G2: -0.83 

P = 0.001 

UUI 

episodes/day, 12 

wks, mean 

change:† 

G1a: -1.46 

G2a: -1.03 

Urgency 

episodes/day, 

4 wks, mean 

change:† 

G1: -1.98 

G2: -1.67 

P = NS 

Urgency 

episodes/day, 

12 wks, mean 

change:* 

G1: -2.85 

G2: -2.42 

P = 0.035 

Urgency 

episodes/day, 

12 wks, mean 

change:† 

G1a: -3.08 

G2a: -2.62 

Incontinence 

episodes/day, 4 

wks, mean 

change:† 

G1: -1.30 

G2: -0.90 

P = 0.0181 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-123 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

Incontinence 

episodes/day, 12 

wks, mean 

change:* 

G1: -1.60 

G2: -1.11 

P = 0.006 

Incontinence 

episodes/day, 12 

wks, mean 

change:† 

G1a: -1.56 

G2a: -1.23 

Voids/day, 4 wks, 

mean change:† 

G1: -1.71 

G2: -1.47 

P = NS 

Voids/day, 12 

wks, mean 

change:* 

G1: -2.45 

G2: -2.24 

P = 0.004 for noninferiority 

Voids/day, 12 

wks, mean 

change:† 

G1a: -2.47 

G2a: -2.49 

Nocturia, 

episodes/day, 4 

wks, mean 

change:† 

G1: -0.51 

G2: -0.44 

P = NS 

Nocturia, 

episodes/day, 12 

wks, mean 

change:* 

G1: -0.71 

G2: -0.63 

P = NS 

Nocturia 

episodes/day, 12 

wks, mean 

change:† 

G1a: -0.72 

G2a: -0.69 

C-124 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

Perception of 

bladder 

condition, 4 wks, 

mean change:† 

G1: -0.96 

G2: -0.88 

P = NS

Perception of 

bladder 

condition, 12 

wks, mean 

change:* 

G1: -1.51 

G2: -1.33 

P < 0.0061 

Perception of 

bladder 

condition, 12 

wks, mean 

change:† 

G1a: -1.72 

G2a: -1.62 

Pad use, 4 wks, 

mean change:† 

G1: -1.21 

G2: -0.80 

P = 0.0089 

Pad use, 12 wks, 

mean change:* 

G1: -1.72 

G2: -1.19 

P < 0.0023 

Pad use, 12 wks, 

mean change:† 

G1a: -1.55 

G2a: -1.40 

Dry rate, 4 wks, 

mean % 

change:† 

G1: 39 

G2: 34 

P = NS 

Dry rate, 12 wks, 

mean % 

change:† 

G1a: 65.4 

G2a: 58.3 

P = NS 

C-125 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

Voided volume 

(mL), 12 wks, 

mean change:* 

G1: 38 

G2: 31 

P = 0.010

Voided volume 

(mL), 12 wks, 

mean change:† 

G1a: 39.95 

G2a: 37.84 

Dry mouth, mild, 

%:*† 

G1: 17.5 

G2: 14.8 

G1a: 6.5 

G2a: 5.0 

Dry mouth, 

moderate, %:*† 

G1: 10.8 

G2: 7.7 

G1a: 10.4 

G2a: 7.0 

Dry mouth, 

severe, %:*† 

G1: 1.7 

G2: 1.5 

G1a: 0.7 

G2a: 2.1 

Constipation, 

mild, %:*† 

G1: 3.2 

G2: 1.3 

G1a: 2.0 

G2a: 1.0 

Constipation, 

moderate, %:*† 

G1: 2.7 

G2: 1.0 

G1a: 1.7 

G2a: 1.4 

Constipation, 

severe, %:*† 

G1: 0.5 

G2: 0.2 

G1a: 0.3 

G2a: 0.0 

C-126 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

Blurred vision, 

mild, %:*† 

G1: 0.7 

G2: 0.7 

G1a: 0.3 

G2a: 0.7

Blurred vision, 

moderate, %:*† 

G1: 0.0 

G2: 1.0 

G1a: 0.0 

G2a: 1.7 

Blurred vision, 

severe, %:*† 

G1: 0.0 

G2: 0.0

G1a: 0.0 

G2a: 0.0 

C-127 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple, Van 

Kerrebroeck et al., 

2007 

Country and 

setting: 

Multicenter study 

in Europe, Africa, 

and Oceania 

(academic and 

private), 150 sites 

in 19 countries 

Enrollment 

period: 

NR

Funding: 

Schwarz 

BioSciences 

GmbH, Pfizer Inc. 

Author conflicts 

of interest: 

9 of 9: 

Astellas 

(Yamanouchi) (2) 

Eli-Lilly (1) 

Ferring (1) 

GlaxoSmithKline 

(1) 

Novartis (3) 

Pfizer (5) 

Schwarz (4) 

UCB (1) 

Design: 

RCT

Intervention: 

Fesoterodine (8 

mg or 4 mg) vs. 

tolterodine ER 4 

mg 

Groups: 

G1: Tolterodine 

ER 4mg 

G2: Fesoterodine 

8mg 

G3: Fesoterodine 

4mg 

G4: Placebo 

N at enrollment: 

G1: 290 

G2: 288 

G3: 272 

G4: 285 

N at follow-up: 

G1: 253 

G2: 252 

G3: 231 

G4: 252 

Age, mean ± SD: 

G1: 57.7 ± 14.6 

G2: 55.6 ± 14.1 

G3: 57.1 ± 13.2 

G4: 56.0 ± 13.7 

Women, %: 

G1: 78 

G2: 82 

G3: 81 

G4: 81 

Race/ethnicity, 

%: 

White: 

G1: 98 

G2: 98 

G3: 96 

G4: 98 

Black: 

G1: 0 

G2: 1 

G3: 0 

G4: <1 

Asian: 

G1: 2 

G2: 1 

G3: 2 

G4: 2 

Inclusion criteria: 

• OAB symptoms 

with urinary 

urgency for ≥ 6 

mos 

• Age ≥ 18 

• ≥ 8 voids per 

day 

• ≥ 6 urgency 

episodes or ≥ 3 

UUI 

episodes/day 

• At least 

moderate 

problems 

recorded via a 

Likert scale 

• Negative 

pregnancy test 

• Adequate 

contraception 

Exclusion 

criteria: 

• SUI 

• Bladder stones 

• Interstitial cystitis

• Urothelial tumors

• Grade III or 

higher pelvic 

prolapse 

• BOO 

• Polyuria (>3L/d) 

• UTIs 

• PVR urine 

volume >100mL 

• Use of 

antimuscarinic ≤

2 weeks 

• Treatment with 

electrostimulatio

n ≤ 4 weeks 

• Neurological 

disease 

• Clinically 

relevant cardiac 

arrhythmia 

• Unstable angina

• QTcB interval > 

500ms 

UUI episodes/ 

day, mean ± SD: 

G1: 3.8 ± 3.1 

G2: 3.7 ± 3.0 

G3: 3.8 ± 3.1 

G4: 3.7 ± 3.1 

Urgency 

episodes/day 

mean ± SD: 

G1: 11.0 ± 3.4 

G2: 11.5 ± 4.2 

G3: 11.0 ± 3.4 

G4: 11.4 ± 4.0 

Incontinence, %: 

G1: 79 

G2: 81 

G3: 75 

G4: 76 

Continent days/ 

wk, mean ± SD: 

G1: 0.6 ± 1.3 

G2: 0.6 ± 1.3 

G3: 0.8 ± 1.6 

G4: 0.8 ± 1.5 

Voids/day, mean 

± SD: 

G1: 11.5 ± 2.9 

G2: 11.9 ± 3.8 

G3: 11.6 ± 3.2 

G4: 12.0 ± 3.7 

Daytime voids/ 

day, mean ± SD: 

G1: 2.0 ± 1.2 

G2: 2.0 ± 1.6 

G3: 1.9 ± 1.3 

G4: 1.8 ± 1.2 

Duration of OAB 

symptoms (yrs), 

mean ± SD: 

G1: 8.7 ± 10.1 

G2: 7.6 ± 8.4 

G3: 9.0 ± 11.2 

G4: 7.9 ± 9.6 

Previous drug 

treatment, n (%): 

G1: 135 (47) 

G2: 118 (41) 

G3: 102 (38) 

G4: 112 (40) 

UUI 

episodes/day, LS 

mean change 

(SE): 

G1: -1.74 (0.16) 

G2: -2.22 (0.16) 

G3: -1.95 (0.17) 

G4: -1.14 (0.16) 

G1/G4: P = 0.008 

G2/G4: P < 0.001 

G3/G4: P = 0.001 

UUI 

episodes/day, 

median % 

change: 

G1: -70.0 

G2: -87.5 

G3: -80.0 

G4: -50.0 

G1/G4: P = 0.105 

G2/G4: P < 0.001 

G3/G4: P = 0.001 

Urgency 

episodes/day 

mean change 

(SE): 

G1: -2.03 (0.19) 

G2: -2.36 (0.20) 

G3: -1.88 (0.20) 

G4: -1.07 (0.19) 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P = 0.003 

Urgency 

episodes/day 

median change, 

%: 

G1: -16.0 

G2: -19.1 

G3: -17.6 

G4: -11.1 

G1/G4: P = 0.004 

G2/G4: P < 0.001 

G3/G4: P = 0.002

Continent 

days/wk mean 

change (SE): 

G1: 2.48 (0.20) 

G2: 3.32 (0.19) 

G3: 2.84 (0.21) 

G4: 2.07 (0.20) 

G1/G4: P = 0.139 

G2/G4: P < 0.001 

G3/G4: P = 0.007 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-128 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple, Van 

Kerrebroeck et al., 

2007 

(continued) 

Other: 

G1: <1 

G2: 0 

G3: 3 

G4: <1 

BMI, kg/m2

 ± SD: 

G1: 27.5 ± 5.2 

G2: 27.1 ± 5.2 

G3: 27.5 ± 5.5 

G4: 27.2 ± 5.2 

Voided volume 

(mL), mean ± SD:

G1: 154.3 ± 52.9 

G2: 153.9 ± 56.9 

G3: 160.0 ± 59.5 

G4: 150.2 ± 52.0 

Voids/day, LS 

mean change 

(SE): 

G1: -1.73 (0.16) 

G2: -1.88 (0.16) 

G3: -1.76 (0.17) 

G4: -0.95 (0.16) 

G1/G4: P = 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Voids/day, 

median % 

change: 

G1: -13.8 

G2: -18.6 

G3: -16.7 

G4: -11.1 

G1/G4: P = 0.005 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Daytime voids/ 

day, LS mean 

change (SE): 

G1: -0.40 (0.06) 

G2: -0.39 (0.06) 

G3: -0.39 (0.06) 

G4: -0.32 (0.06) 

Daytime voids/ 

day, median % 

change: 

G1: -25.0 

G2: -23.1 

G3: -28.6 

G4: -26.8 

Treatment 

Response, % 

yes: 

G1: 72 

G2: 79 

G3: 75 

G4: 53 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

C-129 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple, Van 

Kerrebroeck et al., 

2007 

(continued) 

Maximum voided 

volume, mean 

change (SE): 

G1: 23.64 (3.31) 

G2: 33.62 (3.35) 

G3:27.72 (3.41) 

G4: 9.37 (3.33) 

G1/G4: (P = 

0.003) 

G2/G4: (P <0.001) 

G3/G4: (P = 

0.001)

Adverse events, 

n (%): 

G1: 144 (50) 

G2: 167 (58) 

G3: 135 (50) 

G4: 107 (38) 

Dry mouth, n (%): 

G1: 49 (16.9) 

G2: 97 (33.8) 

G3: 59 (21.7) 

G4: 20 (7.1) 

Constipation, n 

(%): 

G1: 8 (2.8) 

G2: 13 (4.5) 

G3: 9 (3.3) 

G4: 4 (1.4) 

Headache, n (%): 

G1: 14 (4.8) 

G2: 7 (2.4) 

G3: 12 (4.4) 

G4: 14 (4.9) 

Dry eye, n (%): 

G1: 1 (<1) 

G2: 12 (4.2) 

G3: 6 (2.2) 

G4: 0 

Nasopharyngitis, 

n (%): 

G1: 10 (3.4) 

G2: 5 (1.7) 

G3: 8 (2.9) 

G4: 7 (2.5) 

Fatigue, n (%): 

G1: 10 (3.4) 

G2: 1 (<1) 

G3: 1 (<1) 

G4: 1 (<1) 

C-130 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple, Van 

Kerrebroeck et al., 

2007 

(continued) 

Influenza, n (%): 

G1: 2 (<1) 

G2: 2 (<1) 

G3: 9 (3.3) 

G4: 6 (2.1) 

Dry throat, n (%): 

G1: 3 (1) 

G2: 8 (2.8) 

G3: 1 (<1) 

G4: 0 

Dizziness, n (%): 

G1: 4 (1.4) 

G2: 3 (1.0) 

G3: 4 (1.5) 

G4: 7 (2.5) 

Alanine 

aminotransferase

, n (%): 

G1: 0 

G2: 6 (2.1) 

G3: 2 (<1) 

G4: 1 (<1) 

Nausea, n (%): 

G1: 6 (2.1) 

G2: 4 (1.4) 

G3: 1 (<1) 

G4: 1 (<1) 

Mean change in 

heart rate (bpm): 

G1: 2.89 

G2: 3.9 

G3: 3.3 

G4: 0.8 

C-131 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple, DuBeau 

et al., 2007 

Country and 

setting: 

US, Poland, 

South Africa, 

Hungary, 

Sweden, United 

Kingdom, 

Germany; 73 

centers 

Enrollment 

period: 

NR 

Funding: 

Novartis

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Darifenacin 7.5 

mg qd versus 

placebo x 12 

weeks, with 

optional uptitration offered (to 

15 mg qd) after 2 

weeks of 

treatment 

Groups: 

G1: Darifenacin

G2: Placebo

N at enrollment: 

G1: 266 

G2: 133

N at follow-up 

(%): 

G1: 244 (91.7)

G2: 117 (87.3)

Age, mean ± SD 

(range): 

G1: 72 ± 5 (64-89) 

G2: 73 ± 5 (64-87) 

Women, n (%): 

G1: 206 (77.4)

G2: 100 (75.2) 

Race/ethnicity: 

NR 

Follow-up: 

12 weeks 

Inclusion criteria: 

• Age ≥ 65 

• OAB sx for ≥ 6 

months 

• Capable of 

independent 

toileting 

• Able to complete 

the diary 

independently 

• Completed at 

least 5 days of 

the 7-day diary 

during the 

baseline period 

• ≥ 1 UUI 

episodes/day 

• ≥ 10 micturitions/ 

day 

Exclusion 

criteria: 

• Treatment w/ 

drugs known to 

effect urinary 

bladder function 

or the external 

urethral 

sphincter 

• Total urinary 

volume ≥ 3L 

• Mean voided 

volume > 300 ml

• Clinically 

significant SUI or 

BOO 

• PVR > 100mL by 

ultrasound 

• Women with 

marked 

cystocele or 

other clinically 

significant Stage 

3 or Stage 4 

pelvic prolapsed

• Participated in a 

bladder-training 

program or 

received 

electrical 

stimulation 

therapy w/in 3 

mos of 

screening 

• Serious or 

intermittent UTI 

UUI episodes/ 

week, median 

(range): 

G1: 19.8 (4.0-

142.0) 

G2: 21.0 (7.0-

155.4) 

Urgency 

episodes/day, 

median (range): 

G1: 7.6 (1.0-24.4) 

G2: 7.4 (1.3-22.2) 

Voids/day, 

median (range): 

G1: 11.8 (7.1-

25.1) 

G2: 12.0 (7.6-

27.6) 

UUI episodes/ 

week, median 

change (% 

change): 

G1: -14.0 (-88.6) 

G2: -13.0 (-77.9) 

UUI episodes/ 

week, median 

change (95% CI): 

G1/G2: -1.0 (-

2.83, 1) 

P = 0.328 

Urgency 

episodes/day, 

median change 

(% change): 

G1: -3.3 (-69.6) 

G2: -3.1 (-55.5) 

Urgency 

episodes/day, 

median change 

(% change): 

G1/G2: -0.5 (-1.2, 

0.2) 

P = 0.174 

Voids/day, 

median change 

(% change): 

G1: -3.0 (-25.3) 

G2: -2.2 (-18.5) 

Voids/day, 

median change 

(95% CI): 

G1/G2: -0.7 (-1.1, 

-0.2) 

P = 0.006 

OAB-q, total 

score, mean 

change: 

G1: 22.9 

G2: 16.8 

P < 0.001 

OAB-q, symptom 

severity score, 

mean change: 

G1: -27.9 

G2: -20.7 

P < 0.001 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: + 

Method and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-132 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple, DuBeau 

et al., 2007 

(continued)

• Clinically 

significant 

congenital or 

acquired 

disorder of the 

urinary tract 

• Any urinary 

bladder 

dysfunction 

other than OAB 

• Hx of chronic 

pain syndrome 

of the lower 

urinary tract 

Other significant 

medical 

conditions that 

made participant 

unfit (cognitive 

impairment, 

uncontrolled 

severe HTN, 

uncontrolled 

severe heart 

failure, recent MI, 

uncontrolled 

thyroid disease 

OAB-q, coping 

score, mean 

change: 

G1: 27.4 

G2: 19.2 

P < 0.001 

OAB-q, concern 

score, mean 

change: 

G1: 26.5 

G2: 18.6 

P < 0.001 

OAB-q, sleep 

score, mean 

change: 

G1: 21.1 

G2: 16.8 

P = 0.015 

OAB-q, social 

score, mean 

change: 

G1: 12.5 

G2: 10.4 

P = 0.047 

PVR (mL), wk 12, 

mean change 

(95% CI) : 

G1: 11.9 (1.7, 

22.1) 

G2: 17.3 (-18.1, 

52.8) 

P = NS 

Adverse Event, n 

(%) 

G1: 149 (56.0) 

G2: 60 (45.1) 

AEs attributed to 

treatment, n (%) 

G1: 99 (37.2) 

G2: 24 (18.0) 

Dry mouth, n (%) 

G1: 59 (22.2) 

G2: 5 (3.8) 

Constipation, n 

(%) 

G1: 41 (15.4) 

G2: 11 (8.3) 

Discontinued 

due to AEs, n (%) 

G1: 4 (1.6) 

G2: 1 (0.8) 

C-133 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al., 

2008 

Country and 

setting: 

European, 

multicenter 

(academic and 

private) 

Enrollment 

period: 

NR 

Funding: 

Pfizer, 

Schwarz 

BioSciences 

Author industry 

relationship 

disclosures: 

4 of 5 

Pfizer (4) 

Design: 

Multicenter 

randomized 

placebo-controlled 

Intervention: 

Tolterodine 4 mg 

ER vs. 

fesoterodine 8 mg

Groups: 

G1: Tolterodine 

ER 4mg 

G2: Fesoterodine 

8mg 

G3: Placebo 

N at enrollment: 

G1: 290 

G2: 287 

G3: 283 

Age, mean ± SD: 

Total: 57 ± 14 

Race/ethnicity, 

%: 

White: 

Total: >95 

Women, %: 

Total: 80 

Follow-up: 

12 weeks 

Inclusion criteria: 

• Age ≥ 18 

• OAB sx w/ 

urinary urgency 

for ≥6 mos 

• ≥ 8 voids/day 

• ≥ 6 urgency 

episodes or ≥ 3 

UUI 

episodes/day 

• At least 

moderate 

problems 

recorded via a 

Likert scale 

• Negative 

pregnancy test 

• Adequate 

contraception 

throughout trial 

Exclusion 

criteria: 

• LUT pathology: 

SI, bladder 

stones, 

interstitial 

cystitis, 

urothelial tumors

• Grade III or 

higher pelvic 

prolapsed 

• Bladder-outlet 

obstruction 

• Polyuria (>3L/d) 

• Symptomatic or 

recurrent UTIs 

• PVR urine 

volume >100 mL

• Antimuscarinic 

agent w/in 2 wks

• Electrostimulatio

n for bladder 

training in prior 4 

wks 

• Active UTI 

• Underlying 

neurological dz 

• Clinically 

relevant cardiac 

arrhythmia 

• Unstable angina

• QTcB interval > 

500ms 

Time since first 

diagnosis or 

onset of OAB 

(years), mean: 

Total: 8-9 

Incontinent at 

BL, n: 

G1: 213 

G2: 217 

G3: 203 

KHQ severity 

score, mean 

change: 

G1: -12.6 

G2: -14.0 

G3: -9.0 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ severity 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -14.9 

G2: -15.8 

G3: -10.8 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ emotions 

score, mean 

change: 

G1: -16.3 

G2: -17.4 

G3: -10.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ emotions 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -17.3 

G2: -18.6 

G3: -11.3 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ role 

limitations score, 

mean change: 

G1: -22.1 

G2: -21.7 

G3: -11.8 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Method and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: NR 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-134 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

KHQ role 

limitations score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -23.2 

G2: -23.7 

G3: -12.4 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ physical 

limitations score, 

mean change: 

G1: -19.7 

G2: -21.7 

G3: -11.4 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ Physical 

limitations score, 

patients 

incontinent at 

BL, mean 

change:

G1: -20.5 

G2: -23.3 

G3: -11.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ social 

limitations score, 

mean change: 

G1: -14.1 

G2: -15.4 

G3: -8.7 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ social 

limitations score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -15.7 

G2: -16.2 

G3: -9.5 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

C-135 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

KHQ 

sleep/energy 

score, mean 

change: 

G1: -11.7G2: -

13.6

G3: -9.6 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ 

sleep/energy 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -12.5 

G2: -15.3 

G3: -10.4 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ personal 

relationship 

score, mean 

change: 

G1: -10.4 

G2: -11.9 

G3: -6.2 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ personal 

relationship 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -12.7 

G2: -12.3 

G3: -6.8 

G1/G3: P < 0.05

G2/G3: P = NS 

KHQ 

incontinence 

impact score, 

mean change: 

G1: -23.3 

G2: -24.6 

G3: -16.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

C-136 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

KHQ 

incontinence 

impact score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -23.8 

G2: -26.5 

G3: -17.7 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ general 

health score, 

mean change: 

G1: -4.3 

G2: -4.0 

G3: -3.8 

G1/G3: P = NS 

G2/G3: P = NS 

KHQ general 

health score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -4.3 

G2: -4.5 

G3: -5.5 

G1/G3: P = NS 

G2/G3: P = NS 

ICIQ-SF total 

score, mean: 

G1: -3.95 

G2: -4.41 

G3: -2.55 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

ICIQ-SF total 

score, patients 

incontinent at 

BL, mean: 

G1: -4.56 

G2: -5.29 

G3: -3.12 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

C-137 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

Major improvement in severity 

of bladderrelated problems, 

%: 

G1: 34 

G2: 39 

G3: 25

G1/G3: P = 0.01 

G2/G3: P = 0.01 

Dry mouth, n (%): 

G1: 49 (17) 

G2: 97 (34) 

G3: 20 (7) 

Constipation, n 

(%): 

G1: 8 (3) 

G2: 13 (5) 

G3: 4 (1) 

Nasopharyngitis, 

n (%): 

G1: 10 (3) 

G2: 5 (2) 

G3: 7 (3) 

Dry eye, n (%): 

G1: 1 (1) 

G2: 12 (4) 

G3: 0 (0) 

Nausea, n (%): 

G1: 6 (2) 

G2: 4 (1) 

G3: 1 (1) 

Fatigue, n (%): 

G1: 10 (3) 

G2: 1 (1) 

G3: 1 (1) 

Dry throat, n (%): 

G1: 3 (1) 

G2: 8 (3) 

G3: 0 (0) 

C-138 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Choo et al., 2008 

Country and 

setting: 

Korea, Academic 

hospital 

Enrollment 

period: 

July 2005 to 

March 2006 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

None 

Design: 

Prospective cohort 

Intervention: 

Tolterodine ER 4 

mg qd x 12 wks 

Groups: 

NA 

N at enrollment: 

60 

N at follow-up: 

56

Women, %: 

100 

Age, mean ± SD: 

54.8 ± 11.5

Race/ethnicity: 

NR 

Inclusion 

criteria: 

• Age ≥ 18 

• OAB for ≥ 3 

mos 

• ≥ 8 frequency 

episodes/d and 

≥ 2 urgency 

episodes/d

Exclusion 

criteria: 

• Total 24-h 

micturition 

volume > 3L 

• PVR > 30% of 

voided volume 

or ≥ 150 mL 

• Stress UI 

• Hx of urinary 

retention 

• Active UTI 

• Indwelling 

catheter 

• Intermittent selfcatheterisation 

• Neurological dz 

• Any condition 

for which 

antimuscarinic 

agents are 

contraindicated 

UUI episodes/ 

day, mean ± SD: 

1.4 ± 2.7 

UUI episodes/ 

day, mean ± SD: 

PGA < 80%: 2.4 ± 

3.4 

PGA ≥ 80%: 2.9 ± 

4.1 

Urgency 

episodes/day, 

mean ± SD: 

9.6 ± 6.8 

Urgency 

episodes/day, 

mean ± SD: 

PGA < 60%: 12.6 

± 7.7 

PGA ≥ 60%: 7.1 ± 

4.9 

P < 0.01 

Total of all 

urgency scales/ 

day, mean ± SD: 

94.4 ± 43.0 

Voids/day, mean 

± SD: 

12.6 ± 5.3 

Voids/day, mean 

± SD: 

PGA < 60%: 14.9 

± 6.2 

PGA ≥ 60%: 10.5 

± 2.9 

P < 0.01 

Nocturia 

episodes/day, 

mean ± SD: 

1.6 ± 0.9 

Nocturia 

episodes/day, 

mean ± SD: 

PGA < 50%: 1.9 ± 

0.8 

PGA ≥ 50%: 1.6 ± 

0.7 

UUI episodes 

/day, 12 wks, 

mean ± SD: 

0.4 ± 0.9 

P < 0.01 

UUI severity, 12 

wks, median % 

change (95% CI): 

-71 (-76.8, -39.2) 

UUI, PGA median 

rate, % (95% CI): 

80 (34.2, 80.0) 

UUI episodes 

/day, 12 wks, 

mean change ± 

SD: 

PGA < 80%: -0.9 

± 1.6 

PGA ≥ 80%: -2.8 ± 

4.3 

UUI, PPBC, mean 

change ± SD: 

PGA < 80%: -1.6 

± 1.1 

PGA ≥ 80%: -2.2 ± 

1.5 

UUI, GII, %: 

PGA < 80%: 

No: 1 (11.1) 

Little: 5 (55.6) 

Much: 3 (33.3) 

PGA ≥ 80%: 

No: 0 (0) 

Little: 4 (40.0) 

Much: 6 (60.0) 

UUI, continue 

treatment, n (%): 

PGA < 80%: 5 

(55.6) 

PGA ≥ 80%: 8 

(80.0) 

Urgency 

episodes /day, 12 

wks, mean ± SD: 

5.4 ± 4.5 

P < 0.01 

Urgency severity, 

12 wks, median 

% change (95% 

CI): 

-55 (-60.4, -40.1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Methods and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-139 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Choo et al., 2008 

(continued) 

Most 

troublesome 

symptoms, n (%):

UUI: 9 (16.1) 

Urgency: 6 (10.7) 

Frequency: 28 

(50) 

Nocturia: 10 (17.9)

Tenesmus: 3 (5.4)

Voided volume, 

(mL), mean ± SD:

157.0 ± 70.3 

Total of all 

urgency scales/ 

day, 12 wks, 

mean ± SD: 

66.3 ± 31.2 

P < 0.01 

Urgency, PGA 

median rate, %

(95% CI): 

60 (46.2, 64.9) 

Urgency 

episodes /day, 12 

wks, mean 

change ± SD: 

PGA < 60%: -4.2 

± 6.8 

PGA ≥ 60%: -4.3 ± 

4.7

P < 0.01 

Urgency, PPBC, 

mean change ± 

SD: 

PGA < 60%: -1.5 

± 1.0 

PGA ≥ 60%: -2.3 ± 

1.1 

P < 0.01 

Urgency, GII, %: 

PGA < 60%: 

No: 4 (16.0) 

Little: 15 (60.0) 

Much: 6 (24.0) 

P < 0.01 

PGA ≥ 60%: 

No: 0 (0) 

Little: 7 (22.6) 

Much: 24 (77.4)

P < 0.01 

Urgency, pts 

want to continue 

treatment, n (%): 

PGA < 60%: 16 

(64.0) 

PGA ≥ 60%: 25 

(80.6) 

Voids/day, 12 

wks, mean ± SD: 

9.9 ± 4.2 

P < 0.01 

C-140 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Choo et al., 2008 

(continued)

Frequency 

severity, 12 wks, 

median % 

change (95% CI): 

-45 (-54.4, -36.2) 

Frequency, PGA 

median rate, % 

(95% CI): 

60 (46.9, 63.6) 

Voids/day, 12 

wks, mean 

change ± SD: 

PGA < 60%: -2.6 

± 2.9 

PGA ≥ 60%: -2.7 ± 

2.2 

P < 0.01 

Frequency, 

PPBC, mean 

change ± SD: 

PGA < 60%: -1.4 

± 1.1 

PGA ≥ 60%: -2.4 ± 

1.0 

P < 0.01 

Frequency, GII, 

%: 

PGA < 60%: 

No: 4 (14.8) 

Little: 16 (59.3) 

Much: 7 (25.9) 

P < 0.01 

PGA ≥ 60%: 

No: 0 (0) 

Little: 6 (20.7) 

Much: 23 (79.3) 

P < 0.01 

Frequency, 

continue 

treatment, n (%): 

PGA < 60%: 18 

(66.7) 

PGA ≥ 60%: 23 

(79.3) 

Nocturia 

episodes /day, 12 

wks, mean ± SD: 

0.9 ± 0.8 

P < 0.01 

C-141 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Choo et al., 2008 

(continued)

Nocturia 

severity, 12 wks, 

median % 

change (95% CI): 

-52 (-59.7, -40.2) 

Nocturia, PGA 

median rate, % 

(95% CI): 

50 (39.4, 57.6) 

Nocturia 

episodes /day, 12 

wks, mean 

change ± SD: 

PGA < 50%: -0.6 

± 1.1 

PGA ≥ 50%: -1.4 ± 

0.9 

Nocturia, PPBC, 

mean change ± 

SD: 

PGA < 50%: -1.3 

± 0.9 

PGA ≥ 50%: -2.3 ± 

1.1 

P < 0.01 

Nocturia, GII, %: 

PGA < 50%: 

No: 4 (20.0) 

Little: 13 (65.0) 

Much: 3 (15.0) 

P < 0.01 

PGA ≥ 50%: 

No: 0 (0) 

Little: 6 (20.7) 

Much: 23 (79.3) 

P < 0.01 

Nocturia, pts 

want to continue 

treatment, n (%): 

PGA < 50%: 9 

(45.0) 

PGA ≥ 50%: 26 

(89.7) 

P < 0.01 

Nocturia 

severity, 12 wks, 

median % 

change (95% CI): 

-52 (-59.7, -40.2)

C-142 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Choo et al., 2008 

(continued)

Tenesmus 

severity, 12 wks, 

median % 

change (95% CI): 

-26 (-50.4, -16.9) 

Tenesmus, PGA 

median rate, % 

(95% CI): 

30 (25.4, 52.2) 

Tenesmus, 

PPBC, mean 

change ± SD: 

PGA < 30%: -1.4 

± 0.9 

PGA ≥ 30%: -2.1 ± 

1.1 

Tenesmus, GII, 

%: 

PGA < 30%: 

No: 2 (15.4) 

Little: 9 (69.2) 

Much: 2 (15.4) 

P < 0.01 

PGA ≥ 30%: 

No: 0 (0) 

Little: 5 (31.3) 

Much: 11 (68.8) 

P < 0.01 

Tenesmus, pts 

want to continue 

treatment, n (%): 

PGA < 30%: 8 

(61.5) 

PGA ≥ 30%: 14 

(87.5) 

Most 

troublesome 

symptom 

severity, median 

% change: 

UUI: -64.5 

Urgency: -32 

Frequency: -42.5 

Nocturia: -56.5 

Voided volume 

(mL), 12 wks, 

mean ± SD: 

189.3 ± 111.5 

P = 0.05 

Dry mouth, n (%): 

13 (21.7) 

C-143 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Choo et al., 2008 

(continued) 

Constipation/ 

indigestion, n 

(%): 

6 (10) 

Headache, n (%): 

3 (5) 

UTI, n (%): 

2 (3.3) 

Peripheral 

oedema, n (%): 

1 (1.7) 

C-144 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Colombo et al., 

1995 

Country and 

setting: 

Italy; Setting 

Enrollment 

period: 

May 1990 to 

March 1993 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, 

Computer 

generated random 

assignment 

Intervention: 

Oxybutynin vs. 

Bladder training 

for 6 weeks

Groups: 

G1: Oxybutynin, 3 

daily doses of 5 

mg each for 6 

weeks (dose 

reduced to half if 

substantial AEs) 

G2: Bladder 

training 

N at enrollment: 

G1: 42 

G2: 39 

N at 6 wk followup: 

G1: 38 

G2: 37 

N at 6 mo followup: 

G1: 28 

G2: 27 

Age, yrs ± SD: 

G1: 48 (31 – 65) 

G2: 49 (24 – 65) 

Race/ethnicity: 

NR 

Women, N (%): 

G1: 42 (100) 

G2: 39 (100) 

Postmenopausal 

n (%): 

G1: 16 (38) 

G2: 20 (51) 

Inclusion criteria: 

• Socially 

embarrassing 

(severe) urinary 

urge 

incontinence 

• On cystometry: 

detrusor 

instability, or 

low-compliance 

bladder (LCB), 

or sensory 

bladder 

Exclusion 

criteria: 

• Stable bladder 

at cystometry 

• Neurologic 

disease 

• Detrusor 

hyperreflexia 

• Age greater 

than 65 y 

• Coexisting 

genuine SUI 

• Genital prolapse

• Postvoid 

residual volume 

>50mL 

• Previous 

gynecologic or 

urogynecologic 

surgery 

• Prior use of any 

drug to treat 

UUI 

• Urethral 

diverticula 

• Fistulas 

• Urinary tract 

neoplasia 

• Cystitis 

• Bladder stones 

• Previous pelvic 

radiotherapy 

Detrusor 

instability, n (%): 

G1: 14 (37) 

G2: 13 (35) 

Low compliance 

bladder, n (%): 

G1: 9 (24) 

G2: 8 (22) 

Sensory bladder, 

n (%): 

G1: 15 (39) 

G2: 16 (43) 

Daily UUI 

episodes, range 

9 – 17 

Diurnal 

frequency, n (%):

G1: 32 (84) 

G2: 29 (78) 

Nocturia, n (%): 

G1: 11 (29) 

G2: 18 (49) 

Volume at first 

desire (mL): 

G1: 120 ± 59 

G2: 134 ± 61 

Volume at very 

strong desire 

(mL): 

G1: 317 ± 92 

G2: 332 ± 87 

Clinically cured 

overall, n (%): 

G1: 28 (74) 

G2: 27 (73) 

Cured among DI, 

(%): 

G1: 13 (93) 

G2: 8 (62) 

P = 0.07 

Cured among 

LCB: 

G1: 6 (67) 

G2: 6 (75) 

P = 0.56 

Cured among 

sensory bladder: 

G1: 9 (60) 

G2: 13 (81) 

P = 0.18 

Cured among 18 

G1 patients 

requiring dosage 

halving: 

12 (67%) 

Diurnal 

frequency 

resolved, n (%): 

G1: 18 (56) 

G2: 20 (69) 

Nocturia 

resolved n (%): 

G1: 3 (27) 

G2: 11 (61) 

Volume at first 

desire (mL), 

mean ± SD: 

G1: 179 ± 32 

P = .0009 

G2: 178 ± 49 

P = .001 

Volume at very 

strong desire 

(mL) mean ± SD: 

G1: 408 ± 76 

P = .00001 

G2: 403 ± 69 

P = .0002 

Patients still 

cured at 6 mos,n: 

G1: 16

G2: 26 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-145 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Colombo et al., 

1995 

(continued) 

Patients still 

cured at 6 mos 

among DI, n: 

G1: 8

G2: 8

Patients still 

cured at 6 mos 

among LCB, n: 

G1: 4

G2: 6

Patients still 

cured at 6 mos 

among sensory 

bladder, n: 

G1: 4

G2: 12 

Treatment 

discontinued in 6 

cases: 

G1: 4 (3 cases of 

severe dry mouth, 

1 case of 

previously 

unknown 

glaucoma) 

G2: 2 (treatment 

was time 

consuming) 

Other adverse 

effects 

G1: 18 (47%) with 

AE requiring 

halving of dosage: 

-dry mouth (n=15) 

-constipation (n=6) 

-nausea (n=5) 

-dizziness (n=2) 

- decrease in 

visual acuity (n=1) 

- tachycardia 

(n=1) 

C-146 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Davila, et al., 

2001 

Country and 

setting: 

US, Specialty 

treatment centers 

Enrollment 

period: 

6 weeks 

Funding: 

Watson 

Laboratories, Inc 

Author industry 

relationship 

disclosures: 

2 of 3 

Pharmadigm (1) 

Watson 

Laboratories (2) 

Design: 

RCT 

Intervention: 

Transdermal 

Oxybutynin vs. 

Oral Oxybutynin 

2 week washout

Groups: 

G1: Transdermal 

OXY 1.3mg/day 

G2: OXY 2.5mg 

b.i.d./t.i.d. 

N at enrollment: 

G1: 38 

G2: 38 

N at follow-up: 

G1: 38 

G2: 36 

Women, n (%): 

G1: 33 (87)

G2: 37 (97)

Age, mean ± SD: 

G1: 64 ± 15 

G2: 63 ± 13 

Race/ethnicity, n, 

(%): 

White: 72 (95) 

Black: 4 (5) 

Inclusion criteria: 

• Age ≥ 18 

• History of UUI 

or MUI with 

predominant 

urge symptoms 

• ≥ 3 episodes UI/ 

day with ≥ 30% 

increase in UUI 

episodes/ day 

during 2 week 

washout 

• Diagnosis of 

motor urge 

incontinence 

• Improvement 

during ≥ 6 wks 

with oral 

oxybutynin 

• UDS confirmed 

motor urge 

incontinence 

Exclusion 

criteria: 

• Allergy to 

oxybutynin 

• Intolerability of 

transdermal 

system 

• Pregnancy or 

breastfeeding 

• Overflow 

incontinence 

secondary to 

underactive or 

non-contractile 

detrusor 

• BOO 

• Impaired 

bladder 

compliance 

including tonic 

increase in 

pressure> 15 

cmH2O during 

filling 

cystometry 

• Medical 

conditions or 

drug therapies 

that could cause 

incontinence 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 7.2 ± 4.5 

G2: 7.2 ± 4.1 

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

G1: 165 ± 158 

G2: 267 ± 187 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 244 ± 168 

G2: 342 ± 167 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.4 ± 2.4 

G2: 2.6 ± 3.3 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

G1/G2: P = NS 

Patient assessment of efficacy, 

VAS score, mean 

change ± SD: 

G1: 5.8 ± 4.2 

G2: 6.0 ± 3.3 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

G1/G2: P = 0.9 

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

G1: 229 ± 189 

G2: 302 ± 198

G1/BL: P =

0.0055 

G2/BL: P =

0.1428 

G1/G2: P = 0.57 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 297 ± 176 

G2: 387 ± 162

G1/BL: P =

0.0011 

G2/BL: P =

0.0538 

G1/G2: P = NR 

Dry mouth, n (%): 

G1: 15 (39) 

G2: 31 (82) 

Constipation, n 

(%): 

G1: 8 (21) 

G2: 19 (50) 

Somnolence, n 

(%): 

G1: 7 (18) 

G2: 14 (37) 

Nausea, n (%): 

G1: 3 (8) 

G2: 10 (26) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-147 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Davila et al. 2001 

(continued) 

• Medical 

conditions that 

could be 

worsened by 

oxybutynin 

Dizziness, n (%): 

G1: 6 (16) 

G2: 10 (26) 

Blurred vision, n 

(%): 

G1: 7 (18) 

G2: 9 (24) 

Urinary retention, 

n (%): 

G1: 9 (24) 

G2: 13 (34) 

Impaired vision, 

n (%): 

G1: 9 (24) 

G2: 9 (24) 

Palpitation, n 

(%): 

G1: 3 (8) 

G2: 5 (13) 

Dry mouth by 

unvalidated 

questionnaire, %: 

G1: 38 

G2: 94 

P < 0.001 

C-148 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al., 

1995 

Country and 

setting: 

US, private clinic 

Enrollment 

period: 

January 1992 to 

December 1992 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohorts with 

comparison; 

(Series of patients 

self selected into 

two groups) 

Intervention: 

Bladder training 

vs. anticholinergic 

or antispasmodic

Groups: 

G1: Bladder 

training 

G2: oxybutynin 

2.5-5.0 mg b.i.d. 

or t.i.d. 

N at enrollment: 

G1: 39 

G2: 33 

N at follow-up: 

G1: 26 

G2: 28 

Age, mean 

(range): 

64 (20-93) 

Race/ethnicity: 

NR

Women, N (%): 

72 (100) 

Inclusion criteria: 

• Incontinent by 

AHCPR 

guidelines* 

• Incontinence 

persisted after 

treatment for 

transient 

incontinence 

Exclusion 

criteria: 

• Post-void 

residual of more 

than 150 mL 

UUI, n (%): 

G1: 27 (49) 

G2: 28 (51) 

MUI with 

predominant 

urge, n (%): 

G1: 12 (71) 

G2: 5 (29) 

Continent, n (%): 

G1: 1 (4) 

G2: 1 (4) 

Improved, n (%): 

G1: 22 (85) 

G2: 19 (68) 

No Change, n 

(%): 

G1: 3 (11) 

G2: 8 (28) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-149 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al., 

2002 

Country and 

setting: 

US, Communitydwelling 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

1 of 7 

ALZA Corp (1) 

Design: 

Multicenter, openlabel, prospective 

cohort with 12 

mos follow-up 

Intervention: 

Oxybutynin 

chloride ER

Groups: 

NA 

N at enrollment: 

1,067 

N at follow-up: 

493 

Women, n (%): 

904 (84.7) 

Age, mean ± SD: 

64 ± 14.4 

Age, n (%): 

< 40: 65 (6.1) 

40-65: 415 (38.9) 

>65-74: 313 (29.3) 

≥ 75: 274 (25.7) 

Race/ethnicity, n 

(%): 

White: 950 (89.0) 

Black: 82 (7.7) 

Hispanic: 28(2.6) 

Asian: 2 (0.2) 

Native American: 

5 (0.5) 

Follow-up: 

12 months 

Inclusion criteria: 

• Communitydwelling 

• Urge or mixed 

incontinence 

• Age ≥ 18 

• Generally in 

good health 

Exclusion 

criteria: 

• UTI 

• Prostatitis 

• Urinary tract 

obstruction 

• Bladder tumor 

• Bladder stone 

• Prostate cancer

• Contraindication 

to study drug 

• Current drug or 

alcohol abuse 

• Pregnant or 

breastfeeding 

• Pre-existing 

severe GI 

narrowing 

• Taken an 

investigational 

drug ≤ 1 mo 

• Known allergy 

or 

hypersensitivity 

to oxybutynin 

chloride 

• Not able to 

swallow 

medication 

whole 

Incontinence 

impact, mean 

score ± SD: 

1.4 ± 0.72 

Sleep impact, 

mean score ± SD:

3.3 ± 1.67 

Bother score, 

estimated from 

figure, mean: 

72 

Incontinence 

impact, end of 

dose adjustment, 

mean change ± 

SD: 

-0.5 ± 0.70 

P < 0.001 

Incontinence 

impact, 90 days, 

mean change ± 

SD: 

-0.6 ± 0.76 

P < 0.001 

Incontinence 

impact, final 

measure, mean 

change ± SD: 

-0.5 ± 0.77 

P < 0.001 

Sleep impact, 

end of dose 

adjust-ment, 

mean change ± 

SD: 

-1.0 ± 1.73 

P < 0.001 

Sleep impact, 90 

days, mean 

change ± SD: 

-1.2 ± 1.82 

P < 0.001 

Sleep impact, 

final measure, 

mean change ± 

SD: 

-1.1 ± 1.81 

P < 0.001 

Bother score, 

end of dose 

adjust-ment, 

estimated from 

figure, mean: 

44 

P < 0.001 

Bother score, 90 

days, estimated 

from figure, 

mean: 

42 

P < 0.001 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-150 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2002 (continued) 

Bother score, 

12 mos, 

estimated from 

figure, mean: 

39 

P < 0.001 

Headache, %: 

1-90 days: 6.2 

91-180 days: 0.6 

181-270 days: 0.4 

271-364 days: 0.4 

Total: 7.6 

Dizziness, %: 

1-90 days: 5.0 

91-180 days: 0.4 

181-270 days: 0.2 

271-364 days: 0 

Total: 5.6 

Blurred vision, 

%: 

1-90 days: 2.8 

91-180 days: 0.4 

181-270 days: 0.1 

271-364 days: 0 

Total: 3.3 

Somnolence, %: 

1-90 days: 2.8 

91-180 days: 0 

181-270 days: 0.2 

271-364 days: 0 

Total: 3.0 

Confusion, %: 

1-90 days: 1.1 

91-180 days: 0.1 

181-270 days: 0.2 

271-364 days: 0 

Total: 1.4 

Discontinued 

due to AEs, n 

(%): 

256 (24) 

Discontinued 

due to lack of 

efficacy, n (%): 

108 (10.1) 

Discontinued 

due to 

administrative 

reasons, n (%): 

90 (8.4) 

C-151 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al., 

2003* 

Chu et al., 2005† 

Country and 

setting: 

US, Academic 

medical center 

Enrollment 

period: 

November 2000 

to October 2001 

Funding: 

ALZA 

Corporation, 

Ortho-McNeil 

Pharmaceuticals 

Author industry 

relationship 

disclosures: 

5 of 7* 

ALZA (1) 

Indevus (1) 

Ortho-McNeil (4) 

Pharmacia (1) 

Watson (1) 

NR† 

Design: 

RCT 

Intervention: 

Oxybutynin ER vs 

Tolterodine ER 

12 week treatment 

period

Groups: 

G1: Oxybutynin 

ER 10 mg daily 

G2: Tolterodine 

ER 4mg daily 

N at enrollment: 

G1: 391 

G2: 399 

N at follow-up: 

G1: 339 

G2: 357 

Age, mean 

(range) : 

G1: 60 (23-92) 

G2: 60 (18-85) 

Race/ethnicity, N 

(%): 

White: 

G1: 329 (84) 

G2: 342 (86) 

Black: 

G1: 32 (8) 

G2: 35 (9) 

Hispanic: 

G1: 27 (7) 

G2: 19 (5) 

Other: 

G1: 3 (1) 

G2: 3 (1) 

Women, N (%): 

G1: 391 (100) 

G2: 399 (100) 

Inclusion criteria: 

• Age ≥ 18 

• ≥ 21 episodes 

UUI/ week 

• ≥ 10 voids/ day 

• Urge > non-urge 

incontinence 

Exclusion 

criteria: 

• Treatable GU 

conditions 

causing 

incontinence 

• PVR > 150 mL 

by ultrasound x 

2 

• Risk of 

developing 

complete 

urinary retention

• Medical 

problems 

worsened by 

anticholinergic 

effects 

• Hematuria 

• Uncontrolled 

narrow angle 

glaucoma 

• Obstructive 

uropathy 

• Reduced GI 

motility 

• Hypersensitivity 

to medications 

UUI episodes/ 

wk, mean ± SD: 

G1: 37.2 ± 15.2 

G2: 36.9 ± 14.1 

Total 

incontinence 

episodes/wk, 

mean ± SD: 

G1: 43.3 ± 19.3 

G2: 42.6 ± 18.2 

Voids/wk, mean ± 

SD: 

G1: 94.8 ± 25.4 

G2: 96.2 ± 24.5 

UUI episodes/wk, 

mean: 

G1: 10.8 

G2: 11.2 

P = 0.28 

Incontinence 

episodes/wk, 

mean: 

G1: 12.3 

G2: 13.8 

P = 0.08 

Voids/wk, mean: 

G1: 66.4 

G2: 71.1 

P = 0.03 

UUI episodes/wk, 

% reduction ± 

SD: 

G1: 72.0 ± 34.0 

G2: 70.2 ± 33.2 

P = 0.13 

Incontinent 

episodes/wk, % 

reduction ± SD: 

G1: 72.8 ± 31.0 

G2: 69.1 ± 34.9 

P = 0.08 

Voids/wk, % 

reduction ± SD: 

G1: 27.7 ± 19.7 

G2: 24.9 ± 18.9 

P = 0.05 

Total dryness, %: 

G1: 23 

G2: 16.8 

P = 0.03 

No UUI episodes, 

%: 

G1: 26.7 

G2: 20.9 

P = 0.06 

Dry mouth, any 

degree, n (%): 

G1: 116 (29.7) 

G2: 89 (22.3) 

P = 0.02 

Dry Mouth, mild, 

n (%): 

G1: 87 (22.3) 

G2: 69 (17.3) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-152 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

Dry mouth, 

moderate-severe, 

n (%): 

G1: 29 (7.4) 

G2: 20 (5.0) 

Constipation, n 

(%): 

G1: 25 (6.4) 

G2: 31 (7.8) 

Diarrhea, n (%): 

G1: 31 (7.9) 

G2: 25 (6.3) 

Headache, n (%): 

G1: 22 (5.6) 

G2: 24 (6.0) 

UTI, n (%): 

G1: 20 (5.1) 

G2: 13 (3.3) 

CNS AE, n (%):† 

G1: 35 (9.0) 

G2: 33 (8.3) 

Dizziness, n 

(%):† 

G1: 15 (3.8) 

G2: 10 (2.5) 

Dizziness, mild,** 

%:† 

G1: 1.8 

G2: 1.5 

Dizziness, 

moderate,** %:† 

G1: 0.8 

G2: 0.3 

Somnolence, n 

(%):† 

G1: 4 (1.0) 

G2: 9 (2.3) 

Somnolence, 

mild,** %:† 

G1: 0.5 

G2: 1.5 

Somnolence, 

moderate,** %:† 

G1: 0.3 

G2: 0.5 

Insomnia, n (%):† 

G1: 7 (1.8) 

G2: 3 (0.8) 

C-153 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

Insomnia, mild** 

%:† 

G1: 0.8 

G2: 0 

Insomnia, 

moderate,** %:† 

G1: 0.5 

G2: 0 

Depression, n 

(%):† 

G1: 5 (1.3) 

G2: 3 (0.8) 

Hypertonia, n 

(%):† 

G1: 2 (0.5) 

G2: 4 (1.0) 

Hypertonia, 

mild,** %:† 

G1: 0 

G2: 0 

Hypertonia, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Anxiety, mild,** 

%:† 

G1: 0.5 

G2: 0 

Anxiety, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Nervousness, 

mild,** %:† 

G1: 0 

G2: 0 

Nervousness, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Tremor, mild,** 

%:† 

G1: 0.3 

G2: 0.3 

Tremor, 

moderate,** %:† 

G1: 0 

G2: 0 

C-154 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

Confusion, 

mild,** %:† 

G1: 0.3 

G2: 0.3 

Confusion, 

moderate,** %:† 

G1: 0 

G2: 0 

C-155 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et 

al., 2002 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

2 week washout 

12 week 

treatment period 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

7 of 7 

Abbot (1) 

Alza (3) 

Amgen (1) 

AstraZeneca (1) 

Bayer (1) 

Bioform (1) 

Genyx (1) 

Glaxo (1) 

Interneuron (2) 

Lilly (2) 

Merck (1) 

Otsulta (1) 

Pharmacia (3) 

Pfizer (1) 

Praecis (2) 

Roche (1) 

Seprecor (1) 

Surx (1) 

Synthelabo (1) 

Vivus (1) 

Watson (7) 

Yamanouchi (1) 

Design: 

RCT 

Followed by: 

12 week open 

label dose titration 

Intervention: 

Oxybutynin TDS 

vs. placebo

Groups: 

G1: OXY TDS 1.3 

mg 

G2: OXY TDS 2.6 

mg 

G3: OXY TDS 3.9 

mg 

G4: placebo 

N at enrollment: 

G1: 130 

G2: 133 

G3: 125 

G4: 132 

N at follow-up: 

G1: 128 

G2: 131 

G3: 123 

G4: 130 

Women, N (%): 

G1: 120 (92.3) 

G2: 123 (92.5) 

G3: 114 (91.2) 

G4: 121 (91.7)

Age, mean ± SD: 

G1: 61.5 ± 11.8 

G2: 61.9 ± 13.5 

G3: 59.4 ± 14.5 

G4: 62.7 ± 13.1 

Race/ethnicity, n 

(%): 

White: 

G1: 119 (91.5) 

G2: 118 (88.7) 

G3: 118 (94.4)

G4: 118 (89.4) 

Black: 

G1: 7 (5.4) 

G2: 10 (7.5) 

G3: 3 (2.4)

G4: 11 (8.3) 

Inclusion criteria: 

• Age ≥ 18 

• History of OAB 

• ≥ 10 episodes 

UUI either pure 

urge or 

predominant 

urge on 7 day 

voiding diary 

• ≥ 56 voids/ 7 

day diary 

• Average 

recorded urinary 

volume of ≤ 350 

mL 

Exclusion 

criteria: 

• Incontinence 

related to 

chronic illness 

• Concomitant 

medications 

• History of lower 

urinary tract 

surgery in ≤ 6 

mos 

• IC 

• Urethral 

syndrome 

• Painful bladder 

syndrome 

• Overflow urinary 

incontinence 

• Alcohol/drug 

abuse 

• Known 

hypersensitivity 

to oxybutynin, 

similar 

compounds or 

transdermal 

systems 

• Active skin 

disorder 

• Narrow angle 

glaucoma 

• Excessive 

caffeine intake > 

5 cups/day 

Incontinence 

episodes/week, 

median: 

G1: 31.0 

G2: 30.0 

G3: 31.0 

G4: 30.0 

Voids/day, mean 

± SD: 

G1: 12.4 ± 2.9 

G2: 12.1 ± 3.3 

G3: 12.3 ± 3.3 

Voided volume 

(mL), mean: 

G1: 175 

G2: 165 

G3: 156 

G4: 170

Open Label: 

Incontinence 

episodes/week, 

open label, 

median: 

G1: 30.0 

G2: 29.0 

G3: 37.0 

G4: NA

Prior years 

incontinent, 

years, mean ±

SD: 

G1: 9.1 ± 10.3

G2: 8.9 ± 8.8

G3: 9.9 ± 9.8

G4: 9.1 ± 9.1 

IIQ (QoL), total 

score, mean: 

G1: 167 

G2: 161 

G3: 144 

G4: 160 

Prior 

anticholinergic 

treatment, n, (%):

G1: 30 (23.1) 

G2: 28 (21.1) 

G3: 28 (22.4) 

G4: 27 (20.5 

Incontinence 

episodes/ week, 

median change: 

G1: -16.0 

G2: -14.0 

G3: -19.0 

G4: -14.5

G3/G4: P <

0.0165 

Voids/day, mean 

change ± SD: 

G1: -1.8 ± 2.6 

G2: -1.8 ± 2.4 

G3: -2.3 ± 2.5 

G4: -1.7 ± 3.0 

G3/G4: P =

0.0457 

Voided volume, 

mL, mean 

increase ± SD: 

G1: -2 

G2: 19 

G3: 24 

G4: 6 

G3/G4: P =

0.0063 

G2/G4: P =

0.0157 

Open Label: 

Incontinence 

episodes/week, 

median change: 

G1: -18.0 

G2: -17.0 

G3: -19.0 

G4: NA

IIQ (QoL), total 

score, mean 

change: 

G1: 119 

G2: 104 

G3: 89 

G4: 113 

G3/G4: P =

0.0327 

UDI (QoL), total 

score, mean ± 

SD: 

G1: NR 

G2: NR 

G3: 78.8 ± 51.9 

G4: 94.7 ± 50.0 

G3/G4: P =

0.0266 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-156 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2002 

(continued) 

Other: 

G1: 4 (3.1) 

G2: 5 (3.8) 

G3: 4 (3.2) 

G4: 3 (2.3) 

Dry mouth, n (%): 

G1: 6 (4.6) 

G2: 9 (6.8) 

G3: 12 (9.6) 

G4: 11 (8.3) 

Dizziness, n (%): 

G1: 2 (1.5) 

G2: 4 (3.0) 

G3: 5 (4.0) 

G4: 5 (3.8) 

Dysuria, n (%): 

G1: 1 (0.8) 

G2: 3 (2.3) 

G3: 3 (2.4) 

G4: 0 (0) 

Somnolence, n 

(%): 

G1: 1 (0.8) 

G2: 0 (0) 

G3: 2 (1.6) 

G4: 1 (0.8) 

Nausea, n (%): 

G1: 6 (4.6) 

G2: 5 (3.8) 

G3: 2 (1.6) 

G4: 7 (5.3) 

Constipation, 

(%): 

G1: 7 (5.4) 

G2: 3 (2.3) 

G3: 1 (0.8) 

G4: 4 (3.0) 

Palpitations, n 

(%): 

G1: 1 (0.8) 

G2: 0 (0) 

G3: 1 (0.8) 

G4: 0 (0) 

Vision abnormal, 

n (%): 

G1: 3 (2.3) 

G2: 2 (1.5) 

G3: 0 (0) 

G4: 2 (1.5) 

Localized 

application site 

reactions, n (%): 

G1: 32 (26.4) 

G2: 7 (5.7) 

G3: 8 (6.9) 

C-157 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2002 

(continued) 

Application site 

erythema, n (%): 

G1: 23 (19) 

G2: 29 (23.6) 

G3: 14 (12.0) 

Application site 

erythema, mild, 

double blind 

period, n (%): 

G1: 79 (31.5) 

G2: 29 (36.2) 

G3: NA 

Application site 

erythema, 

moderate, double 

blind period, n 

(%): 

G1: 46 (18.3) 

G2: 46 (18.1) 

G3: NA 

Application site 

erythema, 

severe, double 

blind period, n 

(%): 

G1: 6 (2.4) 

G2: 8 (3.1) 

G3: NA 

Application site 

erythema, mild, 

open label, n (%): 

G1: 18 (34.6) 

G2: 58 (38.4) 

G3: 87 (43.9) 

Application site 

erythema, 

moderate, open 

label, n (%): 

G1: 7(13.5) 

G2: 23 (15.2) 

G3: 24 (12.1) 

Application site 

erythema, 

severe, open 

label, n (%): 

G1: 0 (0) 

G2: 2 (1.3) 

G3: 0 (0) 

C-158 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et 

al., 2003 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

2 week washout 

12 week 

treatment period 

Funding: 

Watson Pharma 

Author industry 

relationship 

disclosures: 

6 of 6 

Watson Pharma 

(6) 

Design: 

RCT 

Intervention: 

Oxybutynin TDS 

vs. Tolterodine ER 

vs. placebo, 2 

week washout 

plus 12 weeks 

treatment period; 

drug/placebo 

applied 

transdermally 

twice weekly to 

the abdomen and 

oral capsule 

ingested once 

daily

Groups: 

G1: OXY TDS 3.9 

mg/day 

G2: Tolterodine 

ER 4 mg daily 

G3: placebo 

N at enrollment: 

G1: 121 

G2: 123 

G3: 117 

Total: 361 

N at follow-up: 

G1: NR 

G2: NR 

G3: NR 

Total: 320 (89%) 

Age, mean yrs ± 

SD: 

G1: 63.1 ± 12.0 

G2: 62.9 ± 13.5 

G3: 64.5 ± 12.3 

Race/ethnicity, n 

(%): 

White: 

G1: 111 (91.7) 

G2: 120 (97.6) 

G3: 110 (94.0) 

Black: 

G1: 8 (6.6) 

G2: 1(0.8) 

G3: 4 (3.4) 

Inclusion criteria: 

• ≥ 18yo men and 

women 

• Current 

pharmacological 

treatment for 

OAB with 

beneficial 

response 

• ≥4 episodes 

UUI episodes 

either pure urge 

or predominant 

urge on 3 day 

voiding diary 

• ≥ 24 voids/ 3 

day diary 

• Average 

recorded urinary 

volume of ≤350 

mL 

Exclusion 

criteria: 

• History of lower 

urinary tract 

surgery in 

previous 6 

months 

• IC 

• Urethral 

syndrome 

• Painful bladder 

syndrome 

• Overflow urinary 

incontinence 

Incontinence 

episodes/ day, 

mean ± SD: 

G1: 4.7 ± 2.9 

G2: 5.0 ± 2.9 

G3: 5.0 ± 3.2 

Incontinence 

episodes/day, 

median: 

G1: 4 

G2: 4 

G3: 4 

Voids/day, mean 

± SD: 

G1: 12.4 ± 2.9 

G2: 12.1 ± 3.3 

G3: 12.3 ± 3.3 

Voids/day, 

median: 

G1: 12 

G2: 12 

G3: 12 

Voided volume 

(mL), mean ± SD:

G1: 165 ± 62 

G2: 165 ± 61 

G3: 175 ± 68 

Voided volume, 

mL, median: 

G1: 160 

G2: 150 

G3: 171 

Global 

assessment of 

disease, QOL, 

mean ± SD: 

G1: 65 ± 19

G2: 63 ± 20

G3: 65 ± 20 

IIQ (QOL), travel 

domain, mean ± 

SD: 

G1: 49 ± 28 

G2: 47 ± 29 

G3: 43 ± 29 

Incontinence 

episodes/ day, 

mean ± SD: 

G1: 1.9 ± 2.7 

G2: 1.9 ± 3.0 

G3: 2.9 ± 3.8 

G1/G3: P = 

0.0137 

G2/G3: P = 

0.0011 

G1/G2: P = 

0.5878 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: 2.9 ± 3.0 

G2: 3.2 ± 2.8 

G3: 2.1 ± 3.0 

Incontinence 

episodes/day, 

median 

G1: 1 

G2: 1 

G3: 2 

Incontinence 

episodes/day, 

median change 

G1: 3 

G2: 3 

G3: 2 

Voids/day, mean 

± SD: 

G1: 10.4 ± 3.2 

G2: 9.9 ± 3.1 

G3: 10.9 ± 3.8 

G1/G3: P = 0.101 

G2/G3: P = 

0.0025 

G1/G2: P = 0.276 

Voids/day, mean 

change ± SD: 

G1: -1.9 ± 2.7 

G2: -2.2 ± 2.6 

G3: -1 ± 1.4 

Voids/day, 

median: 

G1: 10 

G2: 10 

G3: 10 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-159 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2003 

(continued) 

Other: 

G1: 2 (1.6) 

G2: 2 (1.6) 

G3: 3 (2.6) 

Women, N (%): 

G1: 109 (90.1) 

G2: 117 (95.1) 

G3: 109 (93.2) 

Prior 

antimuscarinic 

treatment, 

Tolterodine, n, 

(%): 

G1: 57 (47)

G2: 60 (49) 

G3: 54 (46) 

Prior 

antimuscarinic 

treatment, 

Oxybutynin, n, 

(%): 

G1:61 (51)

G2: 59 (48) 

G3: 59 (50)

Prior 

antimuscarinic 

treatment, Other, 

n, (%): 

G1: 7 (6)

G2: 6 (5)

G3: 6 (5)

UDI (QOL), 

irritative 

symptoms, mean 

± SD: 

G1: 62 ± 20 

G2: 66 ± 18 

G3: 63 ± 20

Voids/day, 

median change: 

G1: 2 

G2: 2 

G3: 1 

Voided volume, 

(mL), mean ± 

SD: 

G1: 198 ± 84 

G2: 193 ± 75 

G3: 182 ± 84 

G1/G3: P = 

0.0010 

G2/G3: P = 

0.0017 

G1/G2: P = 

0.7690 

Voided volume 

(mL), mean 

change ± SD: 

G1: 32 ± 55 

G2: 29 ± 57 

G3: 9 ± 63 

Voided volume 

(mL), median: 

G1: 188 

G2: 189 

G3: 165 

Voided volume 

(mL), median 

change: 

G1: 24 

G2: 29 

G3: 5.5 

Global 

assessment of 

disease, QOL, 

change ± SD: 

G1: 30 ± 30

G2: 33 ± 28

G3: 21 ± 31

G1/G3: P = 

0.0106 

G2/G3: P = 0.001 

G1/G2: P = 

0.1861 

 

C-160 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2003 

(continued) 

IIQ (QOL) travel 

domain, change 

± SD: 

G1: 23 ± 25 

G2: 22 ± 29 

G3: 11 ± 30 

G1/G3: P = 

0.0018 

G2/G3: P = 

0.0045 

UDI (QOL), 

irritative 

symptoms, 

change ± SD: 

G1: 25 ± 26 

G2: 28 ± 26 

G3: 18 ± 24 

G1/G3: P = 

0.0156 

G2/G3: P = 

0.0010 

Treatment 

compliance with 

assigned dosage 

regimen: 92%: 

Frequency 

decreased to a 

greater extent for 

patients with > 

14 micturations 

per day at 

baseline 

G1: -2.9/day, P = 

0.0036 (data for 

other groups not 

reported) 

Adverse effects: 

Dry mouth, %: 

G1: 4.1 

G2: 7.3 

G3: 1.7 

G1/G3: P = 

0.2678 

G2/G3: P = 

0.0379 

Constipation, 

(%): 

G1: 3.3 

G2: 5.7 

G3: NR 

C-161 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2003 

(continued) 

Mild systemic 

adverse effects, 

n (%): 

G1: 15 (12.4) 

G2: 13 (10.6) 

G3: 6 (5.1) 

Moderate 

systemic adverse 

effects, n (%) 

G1: 7 (5.8) 

G2: 13 (10.6) 

G3: 7 (6.0)

Severe systemic 

adverse effects, 

n (%) 

G1: 1 (0.8)

G2: 3 (2.4) 

G3: 1 (0.9)Mild 

localized 

application site 

reactions, n (%): 

G1: 9 (7.4) 

G2: 2 (1.6) 

G3: 5 (4.3) 

Moderate 

localized 

application site 

reactions, n (%): 

G1: 17 (14.0) 

G2: 4 (3.3) 

G3: 2 (1.7) 

Severe localized 

application site 

reactions, n (%): 

G1: 6 (5.0) 

G2: 1 (0.8) 

G3: 1 (0.9) 

Treatment 

discontinuation 

due to adverse 

effects, n (%): 

G1: 13 (10.7) (12 

due to application 

site reactions, 1 

due to hot flushes) 

G2: 2 (1.6) (1 due 

to fatigue and 1 

due to dizziness) 

G3: NR 

C-162 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2003 

(continued) 

Postvoid 

residual>150 mL 

at end of 

treatment: 

G1: 4 

G2: 4 

G3: 3 

No reports of 

symptomatic 

urinary retention 

Withdraw due to 

AEs: 

 23 

C-163 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et 

al., 2007 

Country and 

setting: 

International, 

multicenter 

Enrollment 

period: 

NR 

Funding: 

Pfizer Inc. 

Author industry 

relationship 

disclosures: 

5 of 5 

Astellas (2) 

Esprit (1) 

Lilly (1) 

Merck (1) 

Novartis (2) 

Ortho-McNeil (1) 

Pfizer (5) 

Watson (1) 

Design: 

RCT (subanalysis) 

Intervention: 

Tolterodine ER vs. 

placebo 

Groups: 

G1: Tolterodine 

ER 4mg po qAM 

G2: Placebo qAM 

N at enrollment: 

Total: 1015 

G1: 507 

G2: 508 

N at follow-up: 

G1: 507 

G2: 507 

Age, yrs (range): 

G1: 60 (20-89) 

G2: 61 (22-93) 

Race/ethnicity, 

%: 

White: 

G1: 95 

G2: 94 

Black: 

G1: 3 

G2: 4 

Other: 

G1: 1 

G2: 2 

Women, %: 

81 

Follow-up: 

12 wks 

Inclusion criteria:

• Age ≥18 

• ≥ 8 voids/day 

and ≥ 5 

episodes/wk UUI 

x 6 mos 

Exclusion 

criteria: 

• Hepatic, renal 

disease 

• UTI, recurrent 

UTIs 

• SUI 

• BOO 

• Indwelling 

catheter 

• Self 

catheterization 

• Taking 

anticholinergic 

medication 

• Mean voided 

volume > 200 

mL or total daily 

voided volume > 

3000 mL 

UUI episodes/ 

wk, mean ± SD:

G1: 22.1 ± 22.3 

G2: 23.3 ± 20.7 

UUI episodes/ 

wk, 24:00-06:00, 

mean ± SD:

G1: 3.5 ± 5.0 

G2: 3.9 ± 5.0 

UUI episodes/ 

wk, 06:00-12:00, 

mean ± SD:

G1: 6.9 ± 8.1 

G2: 6.7 ± 6.7 

UUI episodes/ 

wk, 12:00-18:00, 

mean ± SD:

G1: 6.9 ± 8.2 

G2: 7.2 ± 6.9 

UUI episodes/ 

wk, 18:00-24:00, 

mean ± SD:

G1: 5.3 ± 8.1 

G2: 5.5 ± 5.8 

Voids/day, mean 

± SD: 

G1: 10.9 ± 4.2 

G2: 11.3 ± 3.8 

Voids/day, 24:00-

06:00, mean ± 

SD: 

G1: 1.7 ± 1.0 

G2: 1.8 ± 1.1 

Voids/day, 06:00-

12:00, mean ± 

SD: 

G1: 3.3 ± 1.4 

G2: 3.4 ± 1.3 

Voids/day, 12:00-

18:00, mean ± 

SD: 

G1: 3.1 ± 1.4 

G2: 3.2 ± 1.3 

Voids/day, 18:00-

24:00, mean ± 

SD: 

G1: 2.8 ± 1.3 

G2: 2.9 ± 1.1 

UUI episodes/wk, 

mean change ± 

SD:

G1: -11.8 ± 17.8 

G2: -6.9 ± 15.4 

P ≤ 0.001 

Benefit ratio 1.71 

UUI episodes/wk, 

24:00-06:00, 

mean change ± 

SD:

G1: -1.6 ± 4.0 

G2: -1.0 ± 3.5 

P ≤ 0.001 

Benefit ratio 1.53 

UUI episodes/wk, 

06:00-12:00, 

mean change ± 

SD:

G1: -3.7 ± 7.1 

G2: -2.0 ± 5.4 

P ≤ 0.001 

Benefit ratio 1.82 

UUI episodes/wk, 

12:00-18:00, 

mean change ± 

SD:

G1: -3.9 ± 7.1 

G2: -2.2 ± 5.7 

P ≤ 0.001 

Benefit ratio 1.82 

UUI episodes/wk, 

18:00-24:00, 

mean change ± 

SD:

G1: -3.0 ± 6.9 

G2: -1.6 ± 4.5 

P ≤ 0.001 

Benefit ratio 1.89 

Voids/day, mean 

change ± SD: 

G1: -1.8 ± 3.4 

G2: -1.2 ± 2.9 

P ≤ 0.001 

Benefit ratio 1.46 

Voids/day, 24:00-

06:00, mean 

change ± SD: 

G1: -0.22 ± 0.7 

G2: -0.17 ± 0.8 

P ≤ 0.05 

Benefit ratio 1.29 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-164 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2007 

(continued) 

Voided volume 

(mL), mean ± SD:

G1: 141 ± 43 

G2: 136 ± 42 

Voided volume 

(mL), 24:00-

06:00, mean ± 

SD: 

G1: 201± 99 

G2: 190 ± 96 

Voided volume 

(mL), 06:00-

12:00, mean ± 

SD: 

G1: 141 ± 52 

G2: 139 ± 55 

Voided volume 

(mL), 12:00-

18:00, mean ± 

SD: 

G1: 126 ± 49 

G2: 119 ± 45 

Voided volume 

(mL), 18:00-

24:00, mean ± 

SD: 

G1: 129 ± 50 

G2: 123 ± 47

Voids/day, 06:00-

12:00, mean 

change ± SD: 

G1: -0.57 ± 1.2 

G2: -0.35 ± 1.0 

P ≤ 0.001 

Benefit ratio 1.60 

Voids/day, 12:00-

18:00, mean 

change ± SD: 

G1: -0.55 ± 1.2 

G2: -0.39 ± 1.0 

P ≤ 0.001 

Benefit ratio 1.42 

Voids/day, 18:00-

24:00, mean 

change ± SD: 

G1: -0.43 ± 1.1 

G2: -0.30 ± 0.8 

P ≤ 0.002 

Benefit ratio 1.43 

Voided volume 

(mL), mean 

change ± SD: 

G1: 34.1 ± 50.5 

G2: 14. 0± 41.3 

P ≤ 0.001 

Benefit ratio 2.44 

Voided volume 

(mL), 24:00-

06:00, mean 

change ± SD: 

G1: 33.8± 105.5 

G2: 16.7 ± 87.7 

P ≤ 0.002 

Benefit ratio 2.03 

Voided volume 

(mL), 06:00-

12:00, mean 

change ± SD: 

G1: 38.2 ± 63.9 

G2: 15.5± 58.6 

P ≤ 0.001 

Benefit ratio 2.47 

Voided volume 

(mL), 12:00-

18:00, mean 

change ± SD: 

G1: 31.5 ± 59.4 

G2: 12.4 ± 42.4 

P ≤ 0.001 

Benefit ratio 2.55 

C-165 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2007 

(continued) 

Voided volume 

(mL), 18:00-

24:00, mean 

change ± SD: 

G1: 29.2 ± 55.0 

G2: 12.0 ± 49.6 

P ≤ 0.001 

Benefit ratio 2.44 

C-166 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et 

al., 2008 

Country and 

setting: 

US, 62 sites 

Enrollment 

period: 

September 2005 

to June 2006 

Funding: 

Esprit Pharma 

and Indevus 

Pharmaceuticals 

Inc. 

Author industry 

relationship 

disclosures: 

4 of 4 

Allergan (4) 

Astellas (3) 

Eli Lilly (1) 

Esprit Pharma (4) 

GSK (2) 

Indevus (4) 

Medtronics (1) 

Novartis (3) 

Ortho (2) 

Pfizer (2) 

Schwarz 

Pharma (1) 

Watson (4) 

Design: 

RCT 

Intervention: 

Trospium vs. 

placebo 

Groups: 

G1: Trospium 60 

mg qd 

G2: Placebo 

N at enrollment: 

G1: 280 

G2: 284 

N at follow-up: 

G1: 267 

G2: 276 

Women, n (%): 

G1: 230 (82.1) 

G2: 249 (87.7) 

Age, mean (SE): 

G1: 61.2 (0.7) 

G2: 58.4 (0.7) 

Race/ethnicity, n 

(%): 

White: 

G1: 245 (87.5)

G2: 234 (82.4)

Black: 

G1: 18 (16.4) 

G2: 28 (9.9) 

Hispanic: 

G1: 12 (4.3) 

G2: 14 (4.9) 

Asian: 

G1: 2 (0.7) 

G2: 3 (1.1) 

Other: 

G1: 3 (1.1) 

G2: 5 (1.8) 

Inclusion criteria: 

• Age ≥ 18 

• Symptoms of 

OAB ≥ 6 mos 

duration 

• Urinary 

frequency 

(mean of ≥ 10 

toilet voids per 

day) 

• Urgency (1 or 

more episodes 

of severe 

urgency 

associated with 

a toilet void) 

• UUI (a mean of 

1 or more UUI 

episodes per 

day) 

Exclusion 

criteria: 

• Total voided 

volumes > 3000 

mL/day 

• Mean voided 

volume > 250 

mL 

• Predominantly 

SUI 

• Insensate, or 

overflow 

incontinence 

• Neurogenic 

bladder 

• Indwelling or 

intermittent 

catheterization 

• Renal disease 

(serum 

creatinine >1.5 

mg/dL) 

• Uninvestigated 

hematuria 

• UTI 

• History of > 3 

UTIs in the 

previous 12 

mos 

• Urinary 

retention (PVR 

> 100 mL) 

• Cancer 

• Interstitial 

cystitis 

UUI episodes/ 

day, mean (SE): 

G1: 4.0 (0.2) 

G2: 4.0 (0.2) 

Urgency severity, 

mean (SE): 

G1: 1.82 (0.03) 

G2: 1.83 (0.03) 

Voids/day, mean 

(SE): 

G1:12.8 (0.2) 

G2: 12.9 (0.2) 

Prior 

anticholinergic 

use for OAB, 

mean (SE): 

G1: 142 (50.7) 

G2: 156 (54.9) 

Voided volume 

(mL), mean (SE): 

G1: 149.1 (2.9) 

G2: 151.8 (2.8) 

UUI 

episodes/day, 12 

wks, mean 

change (SE): 

G1: -2.4 (0.2) 

G2: -1.6 (0.2) 

G1/BL: P ≤ 0.001 

Urgency severity, 

12 wks, mean 

change (SE): 

G1: -0.28 (0.03) 

G2: -0.13 (0.03)

G1/BL: P ≤ 0.001 

Voids/day, 12 

wks, mean 

change (SE): 

G1: -2.5 (0.2) 

G2: -1.8 (0.2)

G1/BL: P ≤ 0.001 

Voided volume 

(mL), 12 wks, 

mean change 

(SE): 

G1: 31.5 (3.4) 

G2: 17.8 (3.3)

G1/BL: P ≤ 0.01 

Treatment 

emergent AE, n 

(%): 

G1: 154 (55) 

G2: 130 (45.8) 

Mild to Moderate 

AEs, %: 

G1: 87% 

G2: 91.5% 

Dry mouth, n (%): 

G1: 36 (12.9) 

G2: 12 (4.6) 

Constipation, n 

(%): 

G1: 21 (7.5) 

G2: 5 (1.8) 

Headache, n (%): 

G1: 5 (1.8) 

G2: 6 (2.1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-167 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2008 

(continued) 

• PSA > greater 

than 4 ng/mL 

• Prostate cancer, 

or chronic 

prostatitis 

C-168 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Drutz et al., 1999

Country and 

setting: 

25 centers United 

States and 

Canada

Enrollment 

period: 

NR 

Funding: 

Pharmacia & 

Upjohn AB, 

Uppsala, Sweden 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Tolterodine vs. 

oxybutynin vs. 

placebo 

Groups: 

2 wk washout/runin period

G1: Tolterodine 2 

mg b.i.d. x 12 wks

G2: Oxybutynin 5 

mg t.i.d. x 12 wks

G3: placebo

N at enrollment: 

G1: 109

G2: 112

G3: 56 

N at follow-up: 

Protocol correct 

G1: 70 

G2: 41 

G3: 36 

Age, mean 

range: 

G1: 63.0 (31-88) 

G2: 66.3 (23-91) 

G3: 62.1 (26-87) 

Women, %:

G1: 81 

G2: 91 

G3: 80 

Inclusion criteria:

• Age≥18 yrs 

• Provided written 

informed 

consent 

• Postmenopausal 

• Surgically sterile

• Adequate 

contraception 

• Detrusor 

overactivity on 

subtracted 

cystometry 

• Urinary 

frequency (58 

voids on 

average per 24 

hrs) and either 

urge 

incontinence 

(51 

incontinence 

episode on 

average per 24 

hrs 

Exclusion 

criteria: 

• SUI 

• Hepatic or renal 

disease 

• Recurrent UTIs 

• Interstitial 

cystitis 

• Hematuria or 

hematuria 

secondary to 

malignant 

disease 

• Indwelling 

catheter or 

intermittent 

catheterization 

• Treatment with 

investigational 

drug in ≤ 2 mos 

• Treatment with 

tolterodine or 

electrostimulation 

therapy or BT ≤

14 days 

Duration of 

symptoms >5 

years (%): 

G1: 47 (43) 

G2: 41 (37) 

G3: 25 (45) 

Instability 

hyperreflexia (%):

G1: 101:8 (93:7) 

G2: 100:8 (89:7) 

G3: 53:3 (95:5) 

Urgency (%): 

G1: 104 (95) 

G2: 111 (99) 

G3: 55 (98) 

Previous drug 

therapy for urge 

incontinence, 

(%): 

G1: 49 (45) 

G2: 50 (45) 

G3: 31 (55) 

Good response 

to previous drug 

therapy, n (%): 

G1: 20 (41) 

G2: 20 (40) 

G3: 12 (39) 

Previous surgery 

affecting the 

lower urinary 

tract (%): 

G1: 29 (27) 

G2: 50 (45)* 

G3: 19 (34) 

Patients with 

incontinence 

episodes, n (%): 

G1: 90 (83) 

G2: 103 (92) 

G3: 50 (89) 

Incontinence 

episodes/day, 

mean (range): 

G1: 3.7 (0.1-19.9) 

G2: 3.4 (0.1-13.4) 

G3: 3.5 (0.1-14.9) 

 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -1.7 ± 2.0 

G2: -1.7 ± 1.7 

G3: -1.0 ± 2.2 

G1/G3: P = 0.063 

Mean difference 

(SEM): 

G1/G2: 0.0 (0.4) 

(95% CI) 

G1/G2: -0.7 to 0.7 

Voids/day, mean 

change ± SD: 

G1: -2.0 ± (2.5) 

G2: -2.0 ± (2.3) 

G3: -1.1 ± (2.9) 

G1/G3: P = 0.036 

Mean difference 

(SEM): 

G1/G2: 0.0 (0.4) 

(95% CI) 

G1/G2: -0.8 to 0.8 

Voided volume 

(mL), mean 

change ± SD: 

G1: 34 ± 41 

G2: 50 ± 43 

G3: 12 ± 41 

G1/G3: P =

0.0075 

Mean difference 

(SEM): 

G1/G2: NA 

(95% CI) 

G1/G2: NA 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-169 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Drutz et al., 1999

(continued) 

Race/ethnicity, 

%: 

Caucasian: 

G1: 87 

G2: 94 

G3: 93 

BMI, mean kg/m2

(range):

G1: 29.0 (18.3-

56.2) 

G2: 28.0 (16.0-

51.4) 

G3: 29.1 (17.2-

52.8) 

• Treatment with 

anticholinergic 

drug, or any 

drug for urinary 

urge 

• Incontinence ≤

14 days 

• Unstable 

dosage of any 

anticholinergic 

• Serious adverse 

effects on 

oxybutynin 

• Average total 

voided 

volume/24 

hours of >3000 

mL 

• Clinically 

significant 

voiding difficulty 

with risk of 

urinary retention 

(such as 

residual volume 

>200 mL or 

urine flow rate 

<10 mL/s) 

Patients with ≥ 8 

voids/day, n (%): 

G1: 108 (99) 

G2: 110 (98) 

G3: 55 (98) 

Voids/day, mean 

(range): 

G1: 11.6 (7.7-

22.0) 

G2: 11.5 (7.1-

31.4) 

G3: 11.6 (6.6-

21.9) 

Volume 

voided/void, 

mean mL (range):

G1: 155 (48–290) 

G2: 149 (42–315) 

G3: 160 (33–371) 

*P <0.05 vs. 

placebo and 

tolterodine 

treatment groups. 

C-170 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dwyer et al., 2008 

Country and 

setting: 

Multinational, 

multicenter 

(academic and 

private) 

Enrollment 

period: 

NR 

Funding: 

Novartis Pharma 

AG 

Author industry 

relationship 

disclosures: 

6 of 7 

Allergan (1) 

Amgen (1) 

AMS (1) 

Astellas (1) 

Bayer (1) 

GSK (1) 

Hospira Australia 

(1) 

Novartis (5) 

Ocean Spray (1) 

Ono (1) 

Pfizer (2) 

Spectrum (1) 

Sunumoto (1) 

Design: 

Multicenter 

open label 

extension 

Intervention: 

Darifenacin 7.5 

mg or 15 mg (all 

pts received 7.5 

mg dose for 2 

weeks followed by 

individual dose 

adjustments)

Groups: 

G1: Darifenacin 

continuation group 

7.5 or 15 mg daily 

N at enrollment: 

G1: 303 

N at follow-up: 

G1: 300 

Women, N (%): 

G1: 262 (86.5) 

Age, mean 

(range): 

G1: 57.1 (22-89) 

Race/ethnicity: 

NR 

Follow-up: 

12 weeks followed 

by 2 year 

extension 

Inclusion criteria: 

• Successful 

completion of 

one of 2 

previous, 12-wk 

feeder studies 

with no major 

protocol violation

• “wet OAB” 

(urgency, 

frequency, and 

incontinence) x 6 

months 

• Adequate 

contraception if 

of childbearing 

potential 

• Able to complete 

patient diaries 

independently 

• Capable of 

independent 

toileting 

Exclusion 

criteria: 

• Certain 

concomitant 

medications (see 

previous studies)

• Max darifenacin 

dose of 7.5 mg 

qd for patients 

taking potent 

inhibitors of 

CYP450 3A4 

and pts w/ 

moderate 

hepatic 

impairment 

(Child Pugh B) 

• Other active 

management 

strategies of 

OAB (bladder 

training) 

Incontinence 

episodes/week, 

mean ± SD:

G1: 20.8 ± 13.6

Incontinence 

episodes/week, 

median:

G1: 17.0 

KHQ incontinence impact 

score, mean: 

G1: 78.56 

KHQ severity 

score, mean:

G1: 52.56 

KHQ role 

limitations score, 

mean:

G1: 62.72 

KHQ physical 

limitations score, 

mean:

G1: 62.67 

KHQ social 

limitations score, 

mean:

G1: 34.28 

KHQ emotions 

score, mean:

G1: 43.85 

KHQ sleep/ 

energy score, 

mean:

G1: 52.50 

KHQ personal 

relationship 

score, mean:

G1: 26.94 

KHQ general 

health score, 

mean:

G1: 27.25 

Incontinence 

episodes/week, 

median % 

change:

G1: -83.3 

P < 0.001 

KHQ 

incontinence 

impact score, 

mean change: 

G1: -25.25 

P < 0.001 

KHQ severity 

score, mean 

change: 

G1: -13.53 

P < 0.001 

KHQ role 

limitations score, 

mean change: 

G1: -26.77 

P < 0.001 

KHQ physical 

limitations score, 

mean change: 

G1: -26.35 

P < 0.001 

KHQ social 

limitations score, 

mean change: 

G1: -15.51 

P < 0.001 

KHQ emotions 

score, mean 

change: 

G1: -12.79 

P < 0.001 

KHQ 

sleep/energy 

score, mean 

change: 

G1: -11.59 

P < 0.002 

KHQ personal 

relationship 

score, mean 

change: 

G1: -8.68 

P < 0.001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Method and 

blinding: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-171 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dwyer et al., 2008 

(continued)

KHQ general 

health score, 

mean change: 

G1: 2.05 

P = NS 

C-172 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Elinoff et al., 

2006^ 

Roberts et al., 

2006 

Country and 

setting: 

US, 82 Primary 

care & Ob-Gyn 

offices 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

6 of 6 

Pfizer (6) 

Astellas (1) 

Novartis (1) 

Design: 

Open-label, 

single-arm cohort 

Intervention: 

Tolterodine ER 4 

mg qd for 12 wks

Groups: 

NA 

N at enrollment: 

896 

N at follow-up: 

758 

Age, yrs ± SD: 

56 ± 15 

Race/ethnicity, n 

(%): 

White: 691 (80) 

Black: 94 (11) 

Asian: 22 (3) 

Other: 53 (6) 

Women, N (%): 

708 (82) 

Parity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

for ≥3 mos 

• ≥ 8 voids/day 

• 2+ episodes of 

urgency or UUI 

in a 3-d period 

• 3+ on the OAB 

Bother Rating 

Scale 

Exclusion 

criteria: 

• Stress, 

functional, or 

overflow 

incontinence 

• Acute UTI 

• Clinically 

significant LUT 

pathology 

• Indwelling 

catheter 

• Intermittent selfcatherization 

• Use of 

anticholinergics, 

antimuscarinics 

for OAB, drugs 

to treat UUI, 

potent 

cytochrome 

P450 3A4 

inhibitors, or 

investigational 

drugs 

Duration of OAB 

(yrs), mean ± 

SD: 

6 ± 8 

Duration on 

study drug 

(days), mean ± 

SD: 

80 ± 19 

Daytime voids/ 

day, mean ± SD: 

9.3 ± 2.8 

Nocturia 

episodes/day, 

mean ± SD: 

3.0 ± 1.7 

UUI episodes/ 

day, mean ± SD: 

2.7 ± 3.2 

Urgency 

episodes/day, 

mean ± SD: 

5.0 ± 3.8 

OAB-q scores: 

Symptom bother: 

60.0 

Coping: 50.0 

Concern: 51.4 

Sleep: 44.4 

Social Interaction: 

84.0 

Total HRQL: 55.2 

AUA-SI: 

Total: 18 

Irritative: 10 

Obstructive: 8 

Most bothersome 

symptom, n (%) 

Daytime 

frequency: 256 

(30) 

Nocturnal 

frequency: 241 

(28) 

UUI: 206 (24) 

Urgency: 154 (18) 

UUI 

episodes/day, 

week 12, mean % 

change (95% 

CI):^ 

-86.1 (-91.7, -

80.0)* 

UUI 

episodes/day, 

week 12, UUI 

most 

bothersome, 

mean % change 

(95% CI):^ 

-80.0 (-85.7, -

69.2)* 

Urgency 

episodes/day, 

week 12, mean % 

change (95% 

CI):^ 

-75.0 (-80.0, -

71.4)* 

Urgency 

episodes/day, 

week 12, urgency 

most 

bothersome, 

mean % change 

(95% CI):^ 

-78.4 (-83.3, -

72.2)* 

Nocturia 

episodes/day, 

week 12, mean % 

change (95% 

CI):^ 

-37.5 (-40.0, -

33.3)* 

Nocturia 

episodes/day, 

week 12, nocturia 

most 

bothersome, 

mean % change 

(95% CI):^ 

-40.0 (-42.9, -

33.3)* 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-173 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Elinoff et al., 

2006 

Roberts et al., 

2006 

(continued) 

Daytime voids/ 

day, week 12, 

mean % change 

(95% CI):^ 

-29.0 (-31.0, -

27.3)* 

Daytime voids/ 

day, week 12, 

daytime voids 

most 

bothersome, 

mean % change 

(95% CI):^ 

-30.4 (-33.3, -

27.3)* 

OAB-q scores, 12 

weeks, median 

change (95% 

CI):* 

Symptom bother: 

-37.5 (-37.5 , -

35.0) 

Coping: 32.5 

 (30.0, 35.0) 

Concern: 34.3 

(31.4, 37.1) 

Sleep: 28.0 

(28.0, 32.0) 

Social Interaction: 

12.0 (12.0, 16.0) 

Total HRQL: 28.9 

(27.2, 31.2) 

AUA-SI, Median 

change from 

baseline to 12 

wks (95% CI):* 

Total: -9 (-9, -8) 

Irritative: -5 (-5, -5) 

Obstructive: -4 

(-4, -3) 

*P < 0.0001 vs. 

baseline 

All-cause AE, %: 

51 

Discontinued 

treatment, n %: 

15 (7) 

C-174 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Elinoff et al., 

2006 

Roberts et al., 

2006 

(continued) 

Trt-related AE, 

%: 

23 

Dry mouth, %: 

10.0 

Constipation, %: 

 3.7 

Headache, %: 

3.0 

UTI, %: 

2.7 

C-175 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Fantl et al.,1981 

Country and 

setting: 

US, University 

Enrollment 

period: 

N/A 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Retrospective 

chart review 

Intervention: 

Bladder retraining 

drill (BRD) and 

anticholinergics 

when BRD not 

satisfactory

Groups: 

G1: Detrusor 

muscle contraction 

approximately 5 

seconds after a 

cough 

G2: Detrusor 

muscle contracts 

spontaneously 

without prior 

provocation 

G3: Both cough 

contraction and 

spontaneous 

contraction 

N at enrollment: 

G1: 39 

G2: 4 

G3: 49 

N at follow-up: 

NA 

Women, %: 100

Age, mean ± SD: 

42.7 ± 10:3 

Race/ethnicity:

NR

Parity, mean: 3.5 

Inclusion criteria: 

• Cystometric 

tracings showed 

a rise of 15 cm 

water or more in 

intravesical 

pressure when 

recorded 

independently 

and calculated 

by subtraction 

from intraabdominal 

transrectal 

pressures 

Exclusion 

criteria: 

• Neuropathic 

conditions 

• UTI 

Urgency and 

frequency, n (%):

72 (78.2) 

Urinary 

incontinence, n 

(%): 

65 (70.6) 

Sensation of 

incomplete 

voiding, n (%) 

59 (64.1) 

Nocturia, n (%): 

66 (71.7) 

Dysuria, n (%): 

3 (3.2) 

MUI, n (%): 

6 (6.5) 

Enuresis in 

childhood, n (%):

5 (5.4) 

Previously 

operated on for 

similar urologic 

symptoms, n (%):

34 (36.9) 

Cured, n (%): 

G1: 32 (82.1)

G2: 1 (25)

G3: 41 (83.7) 

Cured by BRD 

alone, n (%): 

44 (78.6) 

Cured by BRD + 

anticholinergics, 

n (%):* 

30 (83.5) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

NA 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: - 

C-176 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Garely et al., 2006 

Country and 

setting: 

US, 207 centers 

Enrollment 

period: 

June 2004 to April 

2005 

Funding: 

Astellas Pharma 

US, Inc. and 

GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

2 of 5 

Astellas (2) 

 

Design: 

Phase IIIb trial 

Intervention: 

Treatment with 5 

mg solifenacin 

succinate. Dosage 

could be 

increased to 10 

mg, maintained or 

decreased in 

response to pt 

perceived efficacy 

and tolerability 

N at enrollment: 

2,205 

N at follow-up: 

1,743 

Women, N (%): 

1813 (82.2) 

Age, mean ± SD: 

59.7 ± 14.4 

Race/ethnicity, n 

(%): 

White: 1,761 

(79.9) 

Black: 274 (12.4) 

Other: 170 (7.7) 

Weight, mean ± 

SD: 

182.2 ± 47.0 

Follow-up: 

12 weeks 

Inclusion criteria: 

• ≥ 18 yrs 

• OAB symptoms 

≥ 3 months 

• Toilet without 

difficulty 

• Other OAB 

meds with 

washout period 

≥ 7 days 

• Non-drug 

treatment of 

OAB if 

established ≥ 4 

wks prior to 

study and 

continued 

Exclusion 

criteria: 

• SUI 

• Stress 

predominant 

MUI 

• UTI or chronic 

inflammation 

• Outflow 

obstruction due 

to benign 

prostatic 

hyperplasia 

• Uncontrolled 

narrow-angle 

glaucoma 

• Urinary or 

gastric retention

• Severe renal or 

hepatic 

impairment 

• Chronic severe 

constipation or 

diagnosed 

gastrointestinal 

obstructive 

disease 

• Bladder cancer 

• Pregnant or not 

using reliable 

method of birth 

control 

UUI, physician 

assessment, n 

(%): 

1,586 (71.9) 

Urgency, 

physician 

assessment, n 

(%): 

2,007 (91.0) 

Frequency, 

physician 

assessment, n 

(%): 

1,969 (89.3) 

Nocturia, 

physician 

assessment, n 

(%): 

1,792 (81.3) 

Perception of 

bladder 

condition, mean: 

4.4 

Most bothersome OAB 

symptom, n (%): 

Frequency:

619 (28.1) 

UUI: 602 (27.3) 

Urgency: 508 

(23.0) 

Nocturia: 337 

(15.3) 

None: 139 (6.3) 

Duration of OAB, 

n (%): 

3 mo to 1 year: 

349 (15.8) 

> 1 to 5 years: 

1,124 (51.0) 

> 5 years: 732 

(33.2) 

 

Flexible drug 

admin dose, wk 

4, n (%): 

Remained at 5 

mg/d: 941 (45.3) 

5 mg/d to 10 mg/d: 

1,076 (51.8) 

Discontinued: 60 

(2.9) 

Flexible drug 

admin dose, wk 

8, n (%): 

Remained at 5 

mg/d: 782 (43.3) 

5 mg/d to 10 mg/d: 

166 (17.6) 

Remained at 10 

mg/d: 1,018 (56.4) 

10 mg/d to 5 

mg/d: 491 (8.5) 

Discontinued: 4 

(0.2) 

Perception of 

bladder 

condition, wk 4, 

mean: 

3.3 

P < 0.001 

Perception of 

bladder 

condition, wk 12 

early termination, mean: 

2.9 

P < 0.001 

Perception of 

bladder 

condition, 

endpoint, mean: 

2.9 

P < 0.001 

Urgency bother, 

VAS score (mm), 

mean (n): 

29.1 (1,781) 

UUI bother, VAS 

score (mm), 

mean (n): 

24.0 (1,504) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-177 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 2006 

(continued)

• Known 

hypersensitivity 

to study 

medication, its 

components, or 

to 

anticholinergic 

medication 

Frequency 

bother, VAS 

score (mm), 

mean (n): 

28.3 (1,751)

Nocturia bother, 

VAS score mean 

mm (n): 

28.3 (1,659) 

OAB-q symptom 

severity 

subscale, mean 

change (95% CI): 

-29.6 (-30.7, -28.6) 

P < 0.001 

OAB-q coping 

subscale, mean 

change (95% CI): 

27.4 (26.2, 28.5) 

P < 0.001 

OAB-q concern 

subscale, mean 

change (95% CI): 

29.6 (28.4, 30.8) 

P < 0.001 

OAB-q sleep 

subscale, mean 

change (95% CI): 

27.3 (26.1, 28.5) 

P < 0.001 

OAB-q social 

interaction 

subscale, mean 

change (95% CI): 

14.7 (13.7, 15.6) 

P < 0.001 

OAB-q overall 

health-related 

QoL subscale, 

mean change 

(95% CI): 

25.4 (24.4, 26.4) 

P < 0.001 

Adverse events, 

n (%): 

1,321 (59.4) 

Any treatmentrelated AE, n (%): 

928 (41.7) 

C-178 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 2006 

(continued)

Dry mouth, n (%): 

Mild: 352 (15.8) 

Moderate: 100 

(4.5) 

Severe: 25 (1.1) 

Constipation, n 

(%): 

Mild: 190 (8.5) 

Moderate: 85 (3.8) 

Severe: 20 (0.9) 

Headache, n (%): 

76 (3.4) 

Blurred vision, n 

(%): 

Mild: 41 (1.8) 

Moderate: 15 (0.7) 

Severe: 1 (0) 

Dry eye, n (%): 

29 (1.3) 

C-179 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

Country and 

setting: 

US, multicenter

(207 sites)

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US 

Glaxo-SmithKline 

Author industry 

relationship 

disclosures: 

4 of 4* 

Astellas (4) 

Pfizer (1) 

Novartis (1) 

4 of 4^ 

Astellas (3) 

GlaxoSmthKline 

(2) 

Novartis (1) 

Watson (1) 

Yamanouchi (1) 

Design: 

Prospective case 

series 

Intervention: 

Flexibly dosed, 

once daily 

solifenacin 

(started on 5 

mg/d; option of 

increasing to 10 

mg/d at week 4; 

option to maintain 

10 mg dose or 

decrease to 5 mg 

at wk 8); for 12 

weeks of 

treatment 

10 mg dose, %: 

4 wks: 

G1: 55 

8 wks: 

G1: 59 (8% went 

back to 5mg; 19% 

increased to 10 

mg) 

Groups:

G1: Urge 

incontinence as 

most bothersome 

symptom 

G2: Black 

participants 

G3: Full study 

population 

N at enrollment: 

G1:582 

G2: 274 

G3: 2205 

Age, mean yrs ± 

SD: 

G1: 60.9 ± 13.1 

G2: 54.7 ± 13.6 

G3: 59.7 ± 14.4 

Race/ethnicity, n 

(%): 

White: 

G1: 493 (84.7) 

G3: 1761 (79.9) 

African 

American: 

G1: 62 (10.7) 

G3: 274 (12.4) 

Inclusion criteria:

• Age ≥ 18 

• Symptoms of 

OAB for ≥ 3 mos

• Ambulatory 

• Able to use the 

toilet without 

difficulty 

• Urgency, UUI, 

frequency or 

nocturia ≥ 3 mos

Exclusion 

criteria: 

• Previous use of 

solifenacin 

UUI, n (%): 

G1: 582 (100%) 

G2: NR 

G3: 1596 (71.9%) 

Urgency, n (%): 

G1: 534 (91.8) 

G2: NR 

G3: 2007 (91.0) 

Frequency, n (%):

G1: 488 (83.8) 

G2: NR 

G3: 1969 (89.3) 

Nocturia, n (%): 

G1: 438 (75.3) 

G2: NR 

G3: 1792 (81.3) 

Most bothersome 

OAB symptom

Urgency, n (%): 

G2: 48 (17.5) 

G3: 508 (23.0) 

UUI, n (%): 

G1: 582 (100) 

G2: 63 (23.0) 

G3: 602 (27.3) 

Frequency, n (%):

G2: 106 (38.7) 

G3: 619 (28.1) 

Nocturia, n (%): 

G2: 34 (12.4) 

G3: 337 (15.3) 

None specified, n 

(%): 

G2: 23 (8.4) 

G3: 139 (6.3) 

OAB for 3 mos -1 

yr, n (%):

G1: 57 (9.8) 

G3: 349 (15.8%) 

OAB for 1-5 yrs, 

n (%):

G1: 294 (50.5) 

G3: 1124 (51.0) 

OAB for >5 yrs: 

G1: 231 (39.7) 

G3: 732 (33.2) 

Patient 

perception of 

bladder 

condition scale, 

4 wks, mean:

G1: 3.3* 

G2: 3.1* 

G3: 3.3* 

Patient 

Perception of 

Bladder 

Condition Scale, 

8 wks, mean:

G1: 3.0* 

G2: 2.7* 

G3: 2.9* 

Patient 

Perception of 

Bladder 

Condition Scale, 

12 wks or early 

termination, 

mean:

G1: 2.9* 

G2: 2.6* 

G3: 2.9* 

Symptom 

severity, mean 

VAS, wk 4: 

Urinary urgency: 

G1: 40.9 

G2: 39.7 

G3: 40.6 

UUI: 

G1: 36.9 

G2: 29.9 

G3: 32.8 

Frequency: 

G1: 34.5 

G2: 39.3 

G3: 39.9 

Nocturia: 

G1: 30.4 

G2: 35.4 

G3: 38.2

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: 

NR 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-180 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

Other: 

G1: 27 (4.6) 

G3: 170 (7.7) 

Women, n (%): 

G1: 536 (92.1) 

G2: 213 (77.7) 

G3: 1813 (82.2) 

Weight (lbs), 

mean ± SD 

(range): 

G2: 198 ± 51.6 

(100-400) 

G3: 182.2 ± 47.0 

(80-413) 

Perception of 

bladder condition

scale (mean): 

G1: 4.6 

G2: 4.2 

G3: 4.4 

Symptom 

severity, mean 

VAS: 

Urinary urgency: 

G1: 72.3 

G2: 70.8 

G3: 68.7 

UUI: 

G1: 78.5 

G2: 70.8 

G3: 64.1 

Frequency: 

G1: 65.7 

G2: 70.8 

G3: 70.6 

Nocturia: 

G1: 57.9 

G2: 66.5 

G3: 65.2 

OAB-q, symptom 

severity, mean 

(SE):

G1: 63.1 (0.84) 

G2: 59.4 (NR) 

G3: 56.9 (NR) 

OAB-q, coping, 

mean (SE): 

G1: 48.9 (1.18)

G2: 46.5 (NR) 

G3: 53.1 (NR) 

OAB-q, concern, 

mean (SE) : 

G1: 43.1 (1.12) 

G2: 46.6 (NR) 

G3: 50.8 (NR) 

OAB-q, sleep, 

mean (SE): 

G1: 55.2 (1.22) 

G2: 43.8 (NR) 

G3: 49.2 (NR) 

OAB-q, social, 

mean (SE): 

G1: 73.6 (1.14) 

G2: 68.9 (NR) 

G3: 76.0 (NR) 

Symptom 

severity, mean 

VAS, wk 8: 

Urinary urgency: 

G1: 31.1 

G2: 29.4 

G3: 30.0 

UUI: 

G1: 28.9 

G2: 22.1 

G3: 24.5 

Frequency: 

G1: 24.9 

G2: 27.0 

G3: 28.6 

Nocturia: 

G1: 25.4 

G2: 36.4 

G3: 29.0 

Symptom 

severity, mean 

VAS, wk 12 (or 

early 

termination): 

Urinary urgency: 

G1: 27.5 

G2: 25.3 

G3: 28.0 

UUI: 

G1: 24.3 

G2: 20.0 

G3: 22.7 

Frequency: 

G1: 21.6 

G2: 24.5 

G3: 27.4 

Nocturia: 

G1: 22.0 

G2: 21.4 

G3: 27.2 

C-181 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

OAB-q, HRQoL, 

mean (SE): 

G1: 53.4 (1.01) 

G2: 50.5 (NR) 

G3: 56.3 (NR) 

Symptom 

severity, VAS, 

mean change 

from baseline 

(95% CI) p-value: 

Urinary urgency*: 

G1: -43.1 (-45.8, -

40.4) p < 0.001 

G2: -43.0 (-47.6, 

-38.5) 

G3: -39.5 (-41.0, 

-38.1) p < 0.001

UUI*: 

G1: -51.7 (-54.5, -

49.0) p < 0.001 

G2: -42.3 (-47.8, 

-36.8) 

G3: -40.1 (-41.8, 

-38.4) p < 0.001

Frequency*: 

G1: -42.0 (-45.0, -

39.0) p < 0.001 

G2: -44.2 (-48.8, 

-39.6) 

G3: -41.8 (-43.3, 

-40.3) p < 0.001

Nocturia*: 

G1: -34.4 (-37.3, -

31.5) p < 0.001 

G2: -42.6 (-47.5, 

-37.8) 

G3: -36.9 (-38.4, 

-35.4) p < 0.001

OAB-q, symptom 

severity, mean 

change (+ SE or 

95% CI)*: 

G1: -35.9 ± 1.08 

G2: -33.6 (-37.0, 

-30.3) 

G3: -29.6 (-30.7, 

-28.6) 

OAB-q, coping, 

mean change (+

SE or 95% CI)*: 

G1: 32.5 ± 1.16 

G2: 32.9 (29.3, 

36.6) 

G3: 27.4 (26.2, 

28.5) 

C-182 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

OAB-q, concern, 

mean change (+

SE or 95% CI)*: 

G1: 37.0 ± 1.21 

G2: 34.0 (30.4, 

37.6) 

G3: 29.6 (28.4, 

30.8) 

OAB-q, sleep, 

mean change (+

SE or 95% CI)*:

G1: 26.0 ± 1.19

G2: 33.8 (29.7, 

37.9) 

G3: 27.3 (26.1, 

28.5) UUI*: 

G1: -51.7 (-54.5, -

49.0) p < 0.001 

G2: -42.3 (-47.8, 

-36.8) 

G3: -40.1 (-41.8, 

-38.4) p < 0.001

Frequency*: 

G1: -42.0 (-45.0, -

39.0) p < 0.001 

G2: -44.2 (-48.8, 

-39.6) 

G3: -41.8 (-43.3, 

-40.3) p < 0.001

Nocturia*: 

G1: -34.4 (-37.3, -

31.5) p < 0.001 

G2: -42.6 (-47.5, 

-37.8) 

G3: -36.9 (-38.4, 

-35.4) p < 0.001

OAB-q, symptom 

severity, mean 

change (+ SE or 

95% CI)*: 

G1: -35.9 ± 1.08 

G2: -33.6 (-37.0, 

-30.3) 

G3: -29.6 (-30.7, 

-28.6) 

OAB-q, coping, 

mean change (+

SE or 95% CI)*: 

G1: 32.5 ± 1.16 

G2: 32.9 (29.3, 

36.6) 

G3: 27.4 (26.2, 

28.5) 

C-183 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

OAB-q, concern, 

mean change (+

SE or 95% CI)*: 

G1: 37.0 ± 1.21 

G2: 34.0 (30.4, 

37.6) 

G3: 29.6 (28.4, 

30.8) 

OAB-q, sleep, 

mean change (+

SE or 95% CI)*:

G1: 26.0 ± 1.19

G2: 33.8 (29.7, 

37.9) 

G3: 27.3 (26.1, 

28.5) 

OAB-q, social, 

mean change (+

SE or 95% CI)*:

G1: 17.7 ± 1.03

G2: 20.1 (16.7, 

23.5) 

G3: 14.7 (13.7, 

15.6) 

OAB-q, HRQoL, 

mean change (+

SE or 95% CI)*:

G1: 29.6 ± 1.02

G2: 30.8 (27.5, 

34.1) 

G3: 25.4 (24.4, 

26.4) 

Side effects, n 

(%): 

G1: 357 (61.3) 

G2: 128 (46.4) 

G3: 1321 (59.4) 

Dry mouth, n (%): 

G1: 104 (17.9) 

G2: 36 (13.0) 

G3: 477 (21.4) 

Constipation, n 

(%): 

G1: 85 (14.6) 

G2: 19 (6.9) 

G3: 295 (13.3) 

Nausea, n (%): 

G1: NR 

G2: 7 (2.5) 

G3: 39 (1.8) 

C-184 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

Headache, n (%): 

G1: 21 (3.6) 

G2: 9 (3.3) 

G3: 76 (3.4) 

Blurred vision, n 

(%): 

G1: 20 (3.4) 

G2: 7 (2.5) 

G3: 57 (2.6) 

Upper 

respiratory tract 

infection, n (%): 

G1: 27 (4.6) 

G2: 7 (2.5) 

G3: 69 (3.10) 

UTI, n (%) 

G1: 21 (3.6%) 

G2: NR 

G3: NR 

Rash, n (%): 

G1: NR 

G2: 6 (2.2) 

G3: 22 (0.99) 

Nasopharyngitis, 

n (%) 

G1: 13 (2.2%) 

G2: NR 

G3: NR 

Cough, n (%) 

G1: 12 (2.1%) 

G2: NR 

G3: NR 

Withdrew, n (%): 

G1: NR 

G2: 21 (7.6) 

G3: 216 (9.7) 

C-185 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Ghei et al., 2006 

Country and 

setting: 

UK, Primary care 

Enrollment 

period: 

NR 

Duration 16 

weeks 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Observational 

cohort 

Intervention: 

Bladder retraining 

vs. Bladder 

retraining + 

antimuscarinic 

(oxybutynin IR/ 

ER, tolterodine 

IR/ER, or 

imipramine 

combined with 

either oxybutynin 

or tolterodine as 

combination 

therapy) 

Groups: 

G1: Bladder 

retraining alone 

G2: Antimuscarinic therapy+ 

bladder retraining 

N at enrollment: 

G1: 52 

G2: 656 

N at Follow-up: 

G1: 46 

G2: 501 

Women, n (%): 

G1: 45 (86) 

G2: 618 (94) 

Age, mean ± SD: 

G1: 52 ± 14 

G2: 54 ± 23 

Race/ethnicity: 

NR

Inclusion criteria: 

• Frequency 

• Urgency with or 

without UUI 

Exclusion 

criteria: 

• SUI 

• Symptoms of 

BOO 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 0.47 ± 1.2 

G2: 1.12 ± 1.7 

P < 0.001 

Voids/day, mean 

± SD: 

G1: 14 ± 6 

G2: 11 ± 6 

P = 0.001 

Incontinence 

episodes/day, 

mean change 

difference 

(95% CI): 

G2/G1: -0.60 

(-0.93, -0.27) 

P = 0.024 

Voids/day, mean 

change 

difference 

(95% CI): 

G2/G1: 2.35 (1.4, 

3.3) 

P < 0.001 

Nocturia 

episodes/day, 

mean change 

difference 

(95% CI): 

G2/G1: 0.57 (0.15, 

0.99) 

Attendance 

visits, n (%) 

Failed follow-up: 

G1: 6 (12) 

G2: 155 (23) 

1 follow-up visit: 

G1: 10 (19) 

G2: 15 (2) 

2 follow-up visits: 

G1: 18 (35) 

G2: 86 (13) 

3 follow-up visits: 

G1: 9 (17) 

G2: 225 (35) 

4 follow-up visits: 

G1: 9 (17) 

G2: 175 (27) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-186 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Giannitsas et al., 

2004 

Country and 

setting: 

Greece, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized for 

which drug to 

receive first 

two-way 

crossover, table of 

random numbers 

Intervention: 

Oxybutynin 15 mg 

t.i.d. vs. 

Tolterodine 4mg 

b.i.d.; 6 weeks 

treatment with 3-4 

weeks washout 

Groups: 

G1: Oxybutynin 15 

mg t.i.d. 

G2: Tolterodine 

4mg b.i.d. 

Stratified by UDS 

findings: 

a: high volume (> 

250mL); low 

pressure (< 

25cmH2O)

b: high volume 

(≥ 250mL); 

high pressure 

(> 25cmH2O) 

C: low volume 

(< 250mL); low 

pressure (< 

25cmH2O) 

d: low volume 

(< 250mL); 

high pressure 

(> 25cmH2O) 

N at enrollment: 

Total: 128 

N at follow-up: 

Total: 107 

Ga: 6 

Gb: 25 

Gc: 36 

Gd: 40 

Women, %: 

100 

Inclusion criteria: 

• Age ≥ 18 

• DO on 

urodynamics 

Exclusion 

criteria: 

• Symptomatic or 

recurrent UTI 

• BOO 

• Neurologic 

disease 

• History of 

previous pelvic 

surgery 

• Narrow angle 

glaucoma 

• SUI 

• History of 

anticholinergic 

side effects 

• Interstitial 

cystitis 

• Child-bearing 

age without BC 

Voids/day, mean 

± SD: 

Total: 8.5 ± 2.63 

Ga: 7.2 ± NR 

Gb: 8.0 ± 2.40 

Gc: 8.3 ± 2.31 

Gd: 9.3 ± 2.91 

Volume (mL)/day, 

mean ± SD: 

Total: 1568.5 ± 

398.64 

Ga: 1756 ± NR 

Gb: 1594.6 ± 

326.12 

Gc: 1678.8 ± 

402.15 

Gd: 1420.5 ± 

384.96 

Voided volume 

(mL), mean ± SD:

Total: 196.1 ± 

60.19 

Ga: 253 ± NR 

Gb: 213.5 ± 53.57

Gc: 209.8 ± 57.43

Gd: 163.4 ± 51.97

Bladder volume 

(mL), first desire 

void, mean ± SD:

Total: 105.6 ± 

39.38 

Ga: 109 ± NR 

Gb: 128.0 ± 41.78

Gc: 94.3± 35.40 

Gd: 101.1 ± 38.14

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

Total: 172 ± 98.4 

Ga: 258 ± NR 

Gb: 303.3 ± 60.51

Gc: 111.9 ± 48.11

Gd: 124.4 ± 56.66

Voids/day, mean 

± SD: 

G1: 7.7 ± 1.87 

G2: 7.6 ± 2.18 

G1a: 6.1 ± NR 

G2a: 6.3 ± NR 

G1b: 7.3 ± 1.69 

G2b: 7.0 ± 1.87 

G1c: 7.5 ± 1.41 

G2c: 7.2 ± 1.58 

G1d: 8.3 ± 2.23 

G2d: 8.4 ± 2.53

Volume (mL)/day, 

mean ± SD: 

G1: 1764.4 ± 

333.03 

G2: 1670.7 ± 

338.6

G1a: 1862 ± NR 

G2a: 1720 ± NR

G1b: 1715.6 ± 

292.54 

G2b: 1665.8 ± 

251.19

G1c: 1847.9 ± 

333.81 

G2c: 1808.1 ± 

317.59

G1d: 1694.7 ± 

331.33 

G2d: 1550.3 ± 

373.65 

Voided volume 

(mL), mean ± SD: 

G1: 239.9 ± 64.98 

G2: 236.7 ± 63.03

G1a: 321 ± NR 

G2a: 286 ± NR 

G1b: 243.3 ± 

59.56 

G2b: 248.3 ± 

53.91

G1c: 252.9 ± 

55.75 

G2c: 258.6 ± 

60.63

G1d: 217.6 ± 

67.07 

G2d: 203.1 ± 

55.43 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-187 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Age, mean ± SD: 

Total: 56 ±16.3 

Ga: 53 ± 17.2 

Gb: 57 ± 16.2 

Gc: 57 ± 16.3 

Gd: 54 ± 16.6 

Weight (kg), 

mean ± SD: 

Total: 63 ± 5.6 

Ga: 63 ± 5.6 

Gb: 70 ± 9.1 

Gc: 67 ± 8.8 

Gd: 69 ± 7.5 

Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

Total: 34.8 ± 21.97

Ga: 17.4 ± NR 

Gb: 37.7 ± 14.03 

Gc: 18.5 ± 4.60 

Gd: 50.3 ± 25.14 

Overactivity 

index, mean ± 

SD: 

Total: 36.8 ± 31.36

Ga: 15.3 ± NR 

Gb: 24.8 ± 19.66 

Gc: 26.3 ± 16.14 

Gd: 57.0 ± 38.85 

Cystometric 

capacity (mL), 

mean ± SD: 

Total: 362.8 ± 

119.10

Ga: 403 ± NR 

Gb: 410.0 ± 97.78

Gc: 357.6 ± 

127.52 

Gd: 331.4 ± 

114.17 

Bladder volume 

(mL), first desire 

void, mean ± SD: 

G1: 129.0 ± 30.14 

G2: 117.9 ± 27.62

G1a: 144 ± NR 

G2a: 140 ± NR

G1b: 153.5 ± 

25.72 

G2b: 132.0 ± 

31.01

G1c: 120.8 ± 

25.07 

G2c: 113.2 ± 

23.16

G1d: 119.4 ± 

29.43 

G2d: 110.1 ± 

26.15 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

G1: 212.9 ± 

106.10 

G2: 206.9 ± 

103.56

G1a: 382 ± NR 

G2a: 364 ± NR

G1b: 355.28 ± 

74.79

G1c: 142.4 ± 

43.51 

G2c: 144.6 ± 

48.43

G1d: 173.3 ± 

57.37 

G2d: 162.7 ± 

53.87 

G1d/BL: P < 0.01 

G2d/BL: P < 0.01 

C-188 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

G1: 30.9 ± 22.63 

G2: 30.9 ± 19.01

G1a: 14.0 ± NR 

G2a: 17.4 ± NR

G1b: 35.6 ± 12.86 

G2b: 29.6 ± 13.56

G1c: 17.2 ± 6.80 

G2c: 17.9 ± 6.69

G1d: 42.9 ± 28.91 

G2d: 44.1 ± 20.75 

Overactivity 

index, mean ± 

SD: 

G1: 24.4 ± 22.61 

G2: 24.7 ± 23.46

G1a: 7.0 ± NR 

G2a: 9.5 ± NR

G1b: 14.1 ± 12.09 

G2b: 14.1 ± 12.71

G1c: 18.3 ± 15.89 

G2c: 16.9 ± 16.84

G1d: 38.9 ± 26.50 

G2d: 40.7 ± 26.58 

Cystometric 

capacity (mL), 

mean ± SD: 

G1: 419.3 ± 

120.86 

G2: 415.63 ± 

114.06

G1a: 465 ± NR 

G2a: 453 ± NR

G1b: 449.6 ± 

106.23 

G2b: 459.4 ± 

101.17

G1c: 409.9 ± 

130.22 

G2c: 411.05 ± 

132.49

G1d: 401.8 ± 

118.34 

G2d: 386.7 ± 

96.53 

Dry mouth, n (%): 

G1: 52 (40.6) 

G2: 20 (15.6) 

C-189 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Constipation, n 

(%): 

G1: 11 (10.3) 

G2: 3 (2.8) 

Discontinued 

due to AEs, n: 

Dry mouth: 12 

Palpitations: 1 

C-190 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Gleason et al. 

1999 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

12 week follow up 

Funding: 

Alza Corporation 

Author industry 

relationship 

disclosures: 

NR

Design: 

Multicenter 

Open label 

Single treatment 

Intervention: 

Oxybutynin ER 

Groups: 

G1: Oxybutynin 

ER 5- 30 mg/ day 

(dose adjustment 

period) 

N at enrollment: 

G1: 256 

N at follow-up: 

G1: 219 

37 missing data 

20 from AEs 

4 dc’d lack of 

effectiveness, 

included in 

analysis 

Age, yrs ± SD: 

NR 

38.8% were 65+ 

Race/ethnicity, n 

(%): 

White: 

G1: 235 (91.8) 

Women, N (%): 

G1: 234 (91.4) 

Inclusion criteria: 

• ≥ adult men and 

women 

• Idiopathic urge 

incontinence 

• Mixed 

incontinence 

with clinically 

significant urge 

component 

Exclusion criteria: 

• Uncontrolled 

medical 

condition 

• PVR > 100 mL 

• Significant 

bacteruria 

• Significant 

pyuria 

UUI episodes/ 

week, mean ± 

SD: 

G1: 18.8 ± 1.2 

Total incontinent 

episodes/ week, 

mean ± SD: 

G1: 22.2 ± 1.3 

Voids/ week, 

mean ± SD: 

G1: 81.1 ± 1.8 

PVR, mL, mean ± 

SD: 

G1: 17.4 ± 1.3 

Voided volume, 

mL, ± SD: 

G1: 121 ± 79.1 

UUI episodes/ 

week, mean ± 

SD: 

G1: 2.8 ± 0.6 

P < 0.001 

Total incontinent 

episodes/ week, 

mean ± SD: 

G1: 4.0 ± 0.7 

P < 0.001 

Voids/ week, 

mean ± SD: 

G1: 66.8 ± 1.4 

Reduction 

Voids/week, 

mean ± SD: 

G1: 14.3 ± 1.3 

95%CI: 11.7-16.8

PVR, mL, mean ± 

SD: 

G1: 21.0 ± 2.2

P = NR

Voided volume, 

mL, ± SD: 

G1: 113.4 ± 84.6

P = NR

Participants free 

UUI episodes, %: 

55.7 

Dry Mouth, n (%): 

G1: 128 (58.6) 

Discontinuation 

d/t AE, n (%): 

20 (7.8) 

Nausea (%): 

2.3 

Dry Mouth (%): 

1.6 

Somnolence (%): 

1.2 

Urinary retention, 

n (%): 

2 (0.8) 

Increased PVR, 

n, (%): 

1 (0.4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-191 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Goode et al., 

2002 

Country and 

setting: 

US, academic 

health center 

outpatient 

geriatric medicine 

clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National Institutes 

on Aging 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted 

behavioral vs. 

drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback 

added to 

behavioral training 

in absence of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2:

Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

105 had pre and 

post treatment 

urodynamics 

G1: 33 

G2: 35 

G3: 37 

N at follow-up: 

NA 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• History of 

malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Voids per day, 

mean ± SD: 

G1: 10.0 

G2: 10.9

G3: 10.0 

Cystometric 

volume (mL), first 

desire to void, 

mean ± SD: 

G1: 97.1 ± 50.7 

G2: 101.1 ± 62.1 

G3: 124.6 ± 73.7 

Cystometric 

volume (mL), 

strong desire to 

void mean ± SD:

G1: 188.5 ± 93.1 

G2: 212.1 ± 86.7 

G3: 222.3 ± 87.0 

Cystometric 

volume (mL), 

bladder capacity, 

mean ± SD: 

G1: 288.3 ± 117.0

G2: 308.7 ± 93.7 

G3: 328.9 ± 107.6

Voids per day, 

mean ± SD: 

G1: 8.2 

G2: 8.8

G3: 9.7 

DI on UDS, n (%): 

+Baseline DI/ 

+DI posttreatment: 

G1: 7 (21.2) 

G2: 1 (2.9) 

G3: 5 (13.5) 

+Baseline DI/ -

DI post-treatment: 

G1: 1 (3.0) 

G2: 7 (20.0) 

G3: 7 (18.9) 

-Baseline DI/ +DI 

post-treatment: 

G1: 3 (9.1) 

G2: 3 (8.6) 

G3: 3 (8.1) 

-Baseline DI/-DI 

post-treatment: 

G1: 22 (66.7) 

G2: 24 (68.6) 

G3: 22 (59.5) 

Cystometric 

volume (mL), 

first desire to 

void, mean ± SD: 

G1: 115.9 ± 64.9 

G2: 145.6 ± 74.0 

G3: 133.5 ± 59.6 

Cystometric 

volume (mL), 

strong desire to 

void mean ± SD: 

G1: 228.9 ± 106.4 

G2: 282.0 ± 93.2 

G3: 230.1 ± 

78.8Cystometric 

volume (mL), 

bladder capacity, 

mean ± SD: 

G1: 305.6 ± 117.9 

G2: 377.6 ± 92.1 

G3: 323.0 ± 109.0 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-192 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Goode et al., 

2002 

(continued) 

Age, yrs ± SD: 

G1: 65.3 ± 4.5 

G2: 67.9 ± 7.9 

G3: 67.6 ± 7.7 

Race/ethnicity, 

%: 

Black: 2 

White: 98 

Women: 

100% 

Parity mean ± 

SD: 

G1: 3.1 ± 1.7 

G2: 2.1 ± 1.3 

G3: 2.3 ± 1.5 

Cystometric, 

volume (mL), 

first desire to 

void, mean 

change:

G1: 18.8 

G2: 44.4 

G3: 8.9 

P = 0.149 

Cystometric, 

volume (mL), 

strong desire to 

void, mean 

change:

G1: 40.5 

G2: 69.9 

G3: 7.8 

P = 0.018 

Cystometric, 

volume (mL), 

bladder capacity, 

mean change:

G1: 17.3 

G2: 68.9 

G3: -6.0 

P = 0.000 

Standardized 

estimates of 

direct and 

mediated effects 

of treatment: 

G1/G3: 

Total effect: 0.28* 

Direct effect: 0.23 

Mediated Effect: 

0.05 

G2/G3: 

Total Effect: 0.34* 

Direct Effect: 0.30* 

Mediated Effect: 

0.04 

*P < 0.01 

C-193 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Haab et al., 2005 

Country and 

setting: 

Multinational, 

Community 

Enrollment 

period: 

NR 

52 week open 

enrollment 

Funding: 

Yamanouchi 

Author industry 

relationship 

disclosures: 

1 of 4 

Yamanouchi (1) 

Design: 

Cohort open-label 

extension 

Intervention: 

Solifenacin 5mg 

for 4 weeks, then 

pt-selected dose 

of either 5 or 10 

mg daily for 

remainder of study

Groups: 

NA 

N at enrollment: 

1,637 

N at follow-up: 

1,329 

Women, n (%): 

1,280 (78) 

Age, mean ± SD: 

56.4 ± 13.5 

Race/ethnicity, n 

(%): 

Black: 

8 (0.5) 

White: 

1,602 (98.1) 

Asian 

13 (0.8) 

Other: 

10 (0.6) 

Weight (kg), 

mean ± SD: 

74.5 ± 14.6 

Height (cm), 

mean ± SD: 

165.3 ± 8.4 

Inclusion criteria: 

• Age ≥ 18 

• Symptoms of 

OAB ≥ 3 months

• ≥ 8 voids per 

day 

• ≥ 1 urgency 

episode / day 

• ≥ 1 UUI 

episodes / day 

• Completed 

treatment in 

previous RCT ≤

14 days prior to 

extension study 

entry 

Exclusion 

criteria: 

• BOO 

• PVR > 200 mL 

• Persistent or 

recurrent UTI 

• Bladder stones 

• IC 

• Previous pelvic 

radiation 

• Previous or 

current pelvic 

organ 

malignancy 

• Narrow angle 

glaucoma 

• Gastric retention

• Urinary retention

• Pregnant/nursin

g 

• Non-reliable BC 

in childbearing 

woman 

Urgency 

episodes/day, 

mean ± SD: 

5.76 ± 4.46 

Incontinence 

episodes/day, 

mean ± SD: 

2.66 ± 2.51 

Voids/day, mean 

± SD: 

12.16 ± 3.79 

Nocturia 

episodes/day, 

mean ± SD: 

1.95 ± 1.22 

Voided volume 

(mL), mean ± SD:

147.6 ± 53.8 

Urgency 

episodes/day, 

mean ± SD (% 

change): 

2.28 ± 3.59 

(-63) 

Incontinence 

episodes/day, 

mean ± SD (% 

change): 

0.93 ± 2.06 

(-66) 

Voids/day, mean 

± SD (% change): 

9.18 ± 3.33 

(-23) 

Nocturia 

episodes/day, 

mean ± SD (% 

change): 

1.25 ± 1.26 

(-32) 

Voided volume 

(mL), mean ± SD 

(% change): 

187.4 ± 75.4 

(31) 

Dry mouth, n (%): 

339 (20.7) 

Constipation, n 

(%): 

157 (9.6) 

Blurred vision, n 

(%): 

113 (6.9) 

Discontinuation 

rate due to AE, 

%: 

4.7 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-194 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Haab et al., 2006 

[See evidence 

table for Hill et al., 

2007] 

Country and 

setting: 

France, Denmark, 

Sweden, 

Australia, 

Canada, US 

Enrollment 

period: 

NR 

Funding: 

Novartis Pharma 

AG (educational 

grant) 

Author industry 

relationship 

disclosures: 

8 of 9 

Astellas (1) 

Novartis (8) 

Pfizer (1) 

Design: 

2-year, noncomparative, 

open-label 

extension study 

Intervention: 

Darifenacin 

following 2 feeder 

studies of 

darifenacin 

3.75/7.5/15 mg qd 

or placebo x 12 

wks

Groups: 

NA 

N at enrollment: 

719 

N at follow-up 

(%): 

475 (66.3) 

Women, n (%): 

 609 (85.1) 

Age, mean 

(range): 

 57.3 (19-89) 

Age ≥ 65, %: 

29.9 

Race/ethnicity:

NR 

Received 

treatment ≥ 365 

days, n (%): 

532 (74.3) 

Inclusion criteria: 

• Successful 

completion of 

one of two 

previous, 12-wk 

feeder studies 

with no major 

protocol 

violation 

Exclusion 

criteria: 

NR

Urgency 

episodes/day, 

median (IQR): 

8.1 (5.7-10.3) 

Urgency severity, 

VAS score, 

median (IQR): 

54.7 (43.7-66.1) 

Incontinence 

episodes/week, 

median (IQR): 

16.8 (10.0-27.0) 

Significant 

leaks/week, 

median (IQR): 

7.0 (2.3-14.0) 

Voids/day, 

median (IQR): 

10.1 (8.9-12.1) 

Nocturia 

episodes/week, 

median (IQR): 

11.0 (7.0-16.0)

Voided volume 

(mL), median 

(IQR): 

163 (121-217) 

Primary 

diagnosis, n (%) 

Idiopathic: 674 

(94.1) 

Neurogenic: 42 

(5.9) 

Previous OAB 

drug treatment, n 

(%): 

163 (22.8) 

Urgency 

episodes/day, 

median change 

(median % 

change): 

-3.9 (-56.4) 

P < 0.001 

Urgency severity, 

median change 

(median % 

change): 

-15.4 (-28.8) 

P < 0.001 

Incontinence 

episodes/week, 

median change 

(median % 

change): 

-11.0 (-84.4) 

P < 0.001 

Significant 

leaks/week, 

median change 

(median % 

change): 

-4.7 (-100.0) 

P < 0.001 

Incontinence 

episodes, 

responders, 

reduction, %: 

≥ 50%: 77.2 

≥ 70%: 62.3 

≥ 90%: 43.8 

Voids/day, 

median change 

(median % 

change): 

-1.4 (-13.9) 

P < 0.001 

Nocturia 

episodes/week, 

median change 

(median % 

change): 

-1.5 (-14.3) 

P < 0.001 

Increased dose 

to 15 mg at 2 wks 

and maintained, 

n (%): 

363 (50.7) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-195 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Haab et al., 2006 

(continued) 

Remained on 7.5 

mg dose, n (%): 

182 (25.4) 

Dose adjusted at 

other times, n 

(%): 

171 (23.9) 

Compliance, ≥

80% of doses, %: 

>85 

Voided volume 

(mL), median 

change (median 

% change): 

19.0 (11.9) 

P < 0.001 

Adverse events, 

all causality, n 

(%): 

Any: 572 (79.9) 

Serious: 84 (11.7) 

Dry mouth: 167 

(23.3) 

Constipation: 150 

(20.9) 

UTI: 82 (11.5) 

Respiratory d/o: 

76 (10.6) 

Dyspepsia: 65 

(9.1) 

Accidental injury: 

57 (8.0) 

‘Flu’ syndrome: 49 

(6.8) 

HA: 42 (5.9) 

HTN: 39 (5.4) 

Arthritis: 36 (5.0) 

Bronchitis: 34 

(4.7) 

Arthralgia: 33 (4.6) 

Back pain: 30 

(4.2) 

Increased cough: 

26 (3.6) 

Arthrosis: 25 (3.5) 

Pain: 23 (3.2) 

Sinusitis: 22 (3.1) 

C-196 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Haab et al., 2006 

(continued) 

Adverse events, 

treatment 

related, n (%): 

Any: 343 (47.9) 

Serious: 1 (0.1) 

Dry mouth: 166 

(23.2) 

Constipation: 142 

(19.8) 

UTI: 8 (1.1) 

Respiratory d/o: 2 

(0.3) 

Dyspepsia: 36 

(5.2) 

Accidental injury: 

1 (0.1) 

‘Flu’ syndrome: 0 

HA: 14 (2.0) 

HTN: 3 (0.4) 

Arthritis: 1 (0.1) 

Bronchitis: 0 

Arthralgia: 1 (0.1) 

Back pain: 4 (0.6) 

Increased cough: 

1 (0.1) 

Arthrosis: 0 

Pain: 1 (0.1) 

Sinusitis: 1 (0.1) 

Days of bowel 

motions, mean 

change*: 

-0.04 

Days of hard or 

lumpy bowel 

motions, mean 

change:* 

0.13 

Days of 

straining, mean 

change:* 

0.22 

C-197 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Haab et al., 2006 

(continued) 

Days of 

incomplete 

bowel openings:* 

0.39 

Days on which 

patient felt life 

was affected by 

bowel habits:* 

0.17 

Extent to which 

life affected by 

bowel habits in 

previous 2 wks, 

mean score:* 

0.31 

C-198 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Halaska et al., 

2003 

Country and 

setting: 

Europe and Asia, 

Academic medical 

center 

Enrollment 

period: 

May 1996 to May 

1999 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized 

controlled 

double blind 

crossover 

Intervention: 

Trospium vs. 

Oxybutynin

Groups: 

G1: Trospium 20 

mg b.i.d. 

G2: Oxybutynin 5 

mg b.i.d. 

N at enrollment: 

G1: 268 

G2: 90 

N at follow-up: 

G1: 200 

G2: 66 

Women, n (%): 

G1: 228 (85) 

G2: 78 (87) 

Age, mean 

(range): 

G1: 54.2 (19, 89) 

G2: 52.2 (19, 85) 

Weight (kg), 

mean (range): 

G1: 72.3 (50-120) 

G2: 70.4 (50-90) 

Height (cm), 

mean (range): 

G1: 164.8 (144-

185) 

G2: 165.5 (145-

183) 

Smokers, n (%): 

G1: 38 (14) 

G2: 10 (11) 

Previous illness, 

n (%): 

G1: 184 (69) 

G2: 66 (73) 

Previous 

medication, n 

(%): 

G1: 101 (38) 

G2: 46 (51) 

Inclusion criteria: 

• Age ≥ 18 yrs 

• Urge syndrome 

• Urge 

incontinence 

• UUI as one 

component of 

MUI 

• UUI due to 

neurologic 

condition 

(detrusor 

hyperreflexia) 

Exclusion 

criteria: 

• Absolute 

tachycardia 

• Closed angle 

glaucoma 

• Myasthenia 

gravis 

• Arteriosclerosis 

of cerebral 

vessels 

• SUI 

• Heart or renal 

failure 

• Frequency from 

diuretics 

• BOO 

• Acute UTI 

• Hiatus hernia 

with reflux 

esophagitis 

• Stenosis of GI 

tract 

• Megacolon 

• Colonic 

ulceration 

• Allergy to study 

medications 

• Anticholinergics, 

TCAs, alpha 

blockers, beta 

sympathomimetics ≤ 7 

days 

• Urological or 

gynecologic 

surgery ≤ 3 mos

• Pregnant or 

lactating 

• In another study

Urgency 

episodes/day, 

mean: 

G1: 10.2 

G2: 11.0 

Incontinence 

episodes/ day, 

mean: 

G1: 1.5 

G2: 2.1 

Voids/day, mean:

G1: 11.4 

G2: 12.5 

Max cystometric 

capacity (mL), 

mean: 

G1: 205 

G2: 205 

Urgency 

episodes/day, 

mean: 

G1: 6.7 

G2: 7.4 

Incontinence 

episodes/ day, 

mean: 

G1: 0.5 

G2: 1.1 

Voids/day, mean: 

G1: 7.9 

G2: 8.3 

Max cystometric 

capacity (mL), 26 

wks, mean 

change: 

G1: 92.0 

G2: 117.0 

G1/BL: P ≤ 0.001 

G2/BL: P ≤ 0.001 

Max cystometric 

capacity (mL), 52 

wks, mean 

change: 

G1: 115.0 

G2: 119.4 

G1/BL: P ≤ 0.001 

G2/BL: P ≤ 0.001 

Bladder volume 

(mL), first 

contraction, 26 

wks, mean 

change: 

G1: 63.5 

G2: 61.2 

Bladder volume 

(mL), first 

contraction, 52 

wks, mean 

change: 

G1: 46.1 

G2: 36.7 

Bladder volume 

(mL), first 

sensation, 26 

wks, mean 

change: 

G1: 73.6 

G2: 76.93 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-199 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Halaska et al., 

2003 

(continued) 

Bladder volume 

(mL), first 

sensation, 26 

wks, mean 

change: 

G1: 78.6 

G2: 70.2 

Abnormal EKG, n 

(%): 

G1: 4 (0.1) 

G2: 2 (0.2) 

Any adverse 

event, n (%): 

G1: 10 (3.7) 

G2: 6 (6.7) 

Poor efficacy, n 

(%): 

G1: 8 (3) 

G2: 2 (2.2) 

Poor compliance, 

n (%): 

G1: 15 (15.6) 

G2: 6 (6.7) 

Abdominal pain, 

n (%): 

G1: 5 (2) 

G2: 0 (0) 

Constipation, n 

(%): 

G1: 18 (7) 

G2: 4 (4) 

Diarrhea, n (%): 

G1: 2 (1) 

G2: 2 (2) 

Dyspepsia, n (%): 

G1: 13 (5) 

G2: 3 (3) 

Dysphagia, n 

(%): 

G1: 9 (3) 

G2: 3 (3) 

Dry mouth, n (%): 

G1: 87 (33) 

G2: 45 (50) 

P < 0.001 

Nausea, n (%): 

G1: 6 (2) 

G2: 2 (2) 

C-200 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Halaska et al., 

2003 

(continued)

UTI, n (%): 

G1: 33 (12) 

G2: 10 (11) 

Headache, n (%): 

G1: 11 (4) 

G2: 8 (9) 

Visual 

disturbances, n 

(%): 

G1: 9 (3) 

G2: 5 (6) 

Virus infection, n 

(%): 

G1: 9 (3) 

G2: 4 (4) 

Abnormal EKG, n 

(%): 

G1: 4 (0.1) 

G2: 2 (0.2) 

Sleeplessness, n 

(%): 

G1: 10 (4) 

G2: 2 (2) 

C-201 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Herschorn et al., 

2004 

Country and 

setting: 

Canada, Family 

medicine and 

urology clinics 

Enrollment 

period: 

June 2000 to 

December 2001 

Funding: 

Pharmacia Pfizer 

Canada 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Health education 

with tolterodine vs. 

tolterodine alone

Groups: 

G1: Health 

education with 

tolterodine 

G2: tolterodine 

alone 

N at enrollment: 

G1: 39 

G2: 45 

N at follow-up, 5 

weeks: 

G1: 37 

G2: 40 

N at follow-up, 10 

weeks: 

G1: 35 

G2: 32 

N at follow-up, 16 

weeks: 

G1: 34 

G2: 31 

Age, yrs ± SD: 

G1: 65.7 ± 14.5 

G2: 63.1 ± 15.7 

Race/ethnicity: 

NR 

Women, %: 

G1: 92.3 

G2: 84.4 

Parity: 

NR 

Inclusion criteria: 

• Age ≥ 50 

• Symptoms of 

OAB 

• Attend 

investigators’ 

practice 

• Normal 

cognitive 

function 

• Able to read 

English 

Exclusion 

criteria: 

• Enrollment in 

another clinical 

trial 

• Interstitial 

cystitis 

• UTI 

• Already taking 

tolterodine 

OAB duration 

(yrs), mean ± 

SD: 

G1: 8.7 ± 11.0 

G2: 8.7 ± 10.8 

Mild bladder 

problems, n (%): 

G1: 13 (33.3) 

G2: 13 (28.9) 

Moderate bladder 

problems, n (%): 

G1: 19 (48.7) 

G2: 28 (62.2) 

Severe bladder 

problems, n (%): 

G1: 7 (18.0) 

G2: 4 (8.9) 

Obtained 

prescription, n 

(%): 

G1: 38 (97.4) 

G2: 37 (82.2) 

P < 0.05 

Intends to fill 

prescription, (%):

G1: 0 (0) 

G2: 6 (7.5) 

Incontinence 

episodes/week, 

mean change ± 

SD: 

G1: -7.72 ± 21.16 

G2: -10.24 ± 

19.56† 

Voids/day, mean 

change ± SD: 

G1: -1.82 ± 3.41 

G2: -2.18 ± 4.89 

P = NR 

Nocturia 

episodes/day, 

mean change ± 

SD: 

G1: -0.44 ± 1.13† 

G2: -0.07 ± 0.91 

No change in 

bladder problem 

severity, n (%): 

G1: 14 (42.4) 

G2: 20 (66.7) 

Improved 

bladder problem 

severity, n (%): 

G1: 15 (45.4)† 

G2: 6 (20) 

Worsened 

bladder problem 

severity, n (%): 

G1: 4 (12.1) 

G2: 4 (13.3) 

Compliance, 10 

weeks, %: 

G1: 41 

G2: 38 

P > 0.05 

Compliance, 16 

weeks, %: 

G1: 39 

G2: 31 

P > 0.05 

Continued or 

started non-drug 

OAB treatment, 

16 weeks, %: 

G1: 82 

G2: 53 

P > 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-202 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Herschorn et al., 

2004 

(continued) 

Stopped nondrug OAB 

treatments, %: 

G1: 12.8 

G2: 28.9 

C-203 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Hill et al., 2006 

Country and 

setting: 

MultinationalEuropean; 

Community; 62 

centers 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Novartis 

Thomson 

ACUMED 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Darifenacin vs. 

placebo 

Groups: 

G1: Darifenacin 

7.5 mg daily 

G2: Darifenacin 

15 mg daily 

G3: Darifenacin 

30 mg daily 

G4: placebo 

N at enrollment: 

G1: 108 

G2: 107 

G3: 115 

G4: 109 

N at follow-up: 

G1: 99 

G2: 93 

G3: 96 

G4: 101 

Total 50 (11.4%) 

discontinued 

study- AE and 

withdrawal of 

consent 

Age, mean 

(range): 

G1: 56.1 (23-88) 

G2: 55.1 (24-82) 

G3: 54.0 (23-79) 

G4: 53.7 (21-85) 

Race/ethnicity: 

NR 

Women, N (%): 

G1: 94 (87) 

G2: 92 (86) 

G3: 99 (86) 

G4: 90 (83) 

Parity : 

NR 

Previous drug 

therapy, n (%): 

G1: 21 (19.4)

G2: 22 (20.6) 

G3: 33 (28.7)

G4: 24 (22.0) 

Inclusion criteria: 

• Male and 

female 

• Age ≥18 

• ≥ 10 episodes 

UUI over 14 

days 

• ≥ 8 voids/ day 

• ≥ 1 episode of 

urinary urgency 

• Symptoms OAB 

≥ 6 months 

Exclusion 

criteria: 

• SUI 

• > 2 UTI/ year 

• BOO 

• PVR> 200 

• IC 

• Bladder stones 

• Severe 

constipation 

• History of 

intermittent UTI 

• Urogenital 

surgery within 

previous 6 

months 

• Cystoscopy 

within previous 

30 days 

• Indwelling 

catheter 

• CIC 

• Clinically 

significant 

systemic 

disease 

• Bladder training

• CI to 

antimuscarinic 

therapy 

• Pregnant/ 

lactating 

• Concomitant 

treatment with 

anticholinergic/ 

antispasmodics, 

opioids, HRT, 

drugs that 

inhibit 

cytochrome 

P450, 2D6, and 

3A4 

isoenzymes 

Urgency 

episodes/day, 

median (95% CI):

G1: 8.5 (7.0, 8.7) 

G2: 8.6 (7.8, 9.4) 

G3: 8.4 (7.8, 8.8) 

G4: 8.1 (7.4, 8.7) 

Severity of 

urgency, visual 

analog scale 

(0=mild, 100= 

severe), (range): 

G1: 53.2 (50.1-

56.5 

G2: 55.8 (51.5-

59.8) 

G3: 53.5 (50.0- 

57.9) 

G4: 53.5 (51.2- 

57.0) 

Incontinence 

episodes/week, 

median (95% CI):

G1: 13.7 (11.8, 

17.8) 

G2: 17.3 (13.5, 

21.5) 

G3: 19.1 (15.8, 

22.8) 

G4: 16.1 (14.0, 

19.4) 

Voids/day, 

median (95% CI):

G1: 10.3 (9.8, 

10.9) 

G2: 11.0 (10.4, 

12.1) 

G3: 10.4 (9.8, 

11.4) 

G4: 10.1 (9.8, 

10.8) 

Number OABrelated nocturnal 

awakenings/ 

week, median (95 

%CI): 

G1: 12.4 (10.2, 

12.9) 

G2: 11.7 (9.8, 

14.5) 

G3: 12.4 (10.5, 

14.0) 

G4: 10.4 (9.2, 

12.9) 

Urgency 

episodes/ day, 

median change 

(%): 

G1: -1.8 (-29.2) 

G2: -2.3 (-26.9) 

G3: -3.0 (-33.1) 

G4: -1.2 (-15.7) 

G1/G4: P = 0.196 

G2/G4: P = 0.013 

G3/G4: P < 0.001 

Severity of 

urgency, visual 

analog scale 

(0=mild, 100= 

severe), median 

change (range): 

G1: -7.0 (-14.2) 

G2: -7.0 (-11.6) 

G3: -9.4 (-19.9) 

G4: -3.9 (-8.0) 

G1/G4: P = 0.177 

G2/G4: P = 0.045 

G3/G4: P = 0.011 

Incontinence 

episodes/wk, 

median change 

(%): 

G1: -8.1 (-68.7) 

G2: -10.4 (-76.5) 

G3: -11.4 (-77.3) 

G4: -5.9 (-46.0) 

G1/G4: P = 0.007 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Leaks/week, 

median change 

(%): 

G1: -4.3 (-67.0) 

G2: -5.3 (-76.7) 

G3: -6.0 (-73.7) 

G4: -2.4 (-43.2) 

G1/G4: P = 0.012 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-204 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Hill et al., 2006 

(continued) 

Voided volume 

(mL), median (95 

%CI): 

G1: 162 (153, 

181) 

G2: 157 (143, 

173) 

G3: 156 (144, 

168) 

G4: 162 (149, 

174) 

Patients 

achieving ≥7 

consecutive days 

“dry”, (%): 

G1: NR 

G2: 28 

G3: 30 

G4: 17 

G2/G4: P = 0.29 

G3/G4: P = 0.011 

Voids/day, 

median change 

(%): 

G1: -1.7 (-16.7) 

G2: -1.9 (-17.9) 

G3: -2.2 (-21.2) 

G4: -1.1 (-9.6) 

G1/G4: P = 0.06 

G2/G4: P = 0.033 

G3/G4: P < 0.001 

Number OABrelated nocturnal 

awakenings/ 

week, median 

change (%): 

G1: -1.9 (-22.1) 

G2: -1.7 (-22.7) 

G3: -2.0 (-19.2) 

G4: -0.4 (-3.6) 

G1/G4: P = 0.028 

G2/G4: P = 0.022 

G3/G4: P = 0.008 

Voided volume 

(mL), median 

change (%): 

G1: 17 (10.3) 

G2: 24 (15.6) 

G3: 44 (26.0) 

G4: 7 (4.1) 

G1/G4: P = 0.079 

G2/G4: P = 0.001 

G3/G4: P < 0.001 

Dry mouth, n (%): 

G1: 25 (23.1) 

G2: 43 (40.2) 

G3: 68 (59.1) 

G4: 6 (5.5) 

C-205 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Hill et al., 2006 

(continued) 

Constipation, n 

(%): 

G1: 17 (15.7) 

G2: 27 (25.2) 

G3: 32 (27.8) 

G4: 5 (4.6) 

Dyspepsia, n (%): 

G1: 4 (3.7) 

G2: 9 (8.4) 

G3: 10 (8.7) 

G4: 1 (0.9) 

Headache, n (%): 

G1: 7 (6.5) 

G2: 7 (6.5) 

G3: 7 (6.1) 

G4: 2 (1.8) 

Respiratory tract 

infection, n (%): 

G1: 4 (3.7) 

G2: 6 (5.6) 

G3: 1 (0.9) 

G4: 6 (5.5) 

Urinary tract 

disorder, n (%): 

G1: 0 (0) 

G2: 6 (5.6) 

G3: 1 (0.9) 

G4: 0 

UTI, n (%): 

G1: 3 (2.8) 

G2: 3 (2.8) 

G3: 5 (4.3) 

G4: 2 (1.8) 

Flu syndrome, n 

(%): 

G1: 3 (2.8) 

G2: 2 (1.9) 

G3: 0 

G4: 5 (4.6) 

Back pain, n (%): 

G1: 3 (2.8) 

G2: 1 (0.9) 

G3: 5 (4.3) 

G4: 3 (2.8) 

Abdominal pain, 

n (%): 

G1: 1 (0.9) 

G2: 3 (2.8) 

G3: 4 (3.5) 

G4: 1 (0.9) 

C-206 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Hill et al., 2006 

(continued) 

Abnormal vision, 

n (%): 

G1: 2 (1.9) 

G2: 0 

G3: 4 (3.5) 

G4: 0 

C-207 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Hill et al., 2007 

[See evidence 

table for Haab et 

al., 2006] 

Country and 

setting: 

France, Denmark, 

Sweden, 

Australia, 

Canada, US, 

Multicenter 

Enrollment 

period: 

NR 

Funding: 

Novartis Pharma 

AG (educational 

grant) 

Author industry 

relationship 

disclosures: 

NR 

Design: 

2-yr, noncomparative, 

open-label 

extension study 

Intervention: 

Darifenacin 

following 2 feeder 

studies of 

darifenacin 

3.75/7.5/15 mg qd 

or placebo x 12 

wks

Groups: 

NA 

N at enrollment: 

214 

N at follow-up 

(%): 

137 (64.0) 

Patient years of 

exposure: 

308 

Women, n (%): 

172 (80.4) 

Age, n (%): 

65-74 years: 166 

(77.6) 

75-89 years: 48 

(22.4) 

Race/ethnicity: 

NR 

Menopausal, n 

(%): 

13 (6.1) 

Inclusion criteria: 

• Age ≥ 65 

• Successful 

completion of 

one of 2 

previous, 12-wk 

feeder studies 

with no major 

protocol 

violation 

Exclusion 

criteria: 

NR

Urgency 

episodes/day, 

median: 

8.1 

Urgency severity, 

median VAS 

score: 

51.8 

Incontinence 

episodes/week, 

median: 

18.7 

Voids/day, 

median: 

10.1 

Voided volume 

(mL), median: 

156 

Concomitant 

drug treatment, n 

(%): 

210 (98.1) 

Urgency 

episodes/day, 

median change 

(median % 

change): 

-3.7 (-52.0) 

P < 0.05 

Urgency severity, 

VAS score, 

median change 

(median % 

change): 

-12.6 (-23.3) 

P < 0.05 

Incontinence 

episodes/week, 

median change 

(median % 

change): 

-11.0 (-83.7) 

P < 0.05 

Significant leaks/ 

week, median 

change (median 

% change): 

-4.9 (-100.0) 

P < 0.05 

Incontinence 

episodes, 

responders, % 

reduction, %: 

≥ 50%: 74.1 

≥ 70%: 60.0 

≥ 90%: 44.4 

Voids/day, 

median change 

(median % 

change): 

-1.2 (-12.4) 

P < 0.05 

Normalization of 

voiding 

frequency (< 8 

voids/day) after 

darifenacin 

treatment, %: 

3 months: 34 

2 years: 33.8 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-208 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Hill et al., 2007 

(continued) 

Nocturia 

episodes/week, 

median change 

(median % 

change): 

-1.4 (-10.9) 

G1/BL: P < 0.05 

Increased dose 

to 15 mg at 2 wks 

and maintained, 

n (%): 

110 (51.4) 

Remained on 7.5 

mg dose, n (%): 

55 (25.7) 

Dose adjusted at 

other times, n 

(%): 

49 (22.9) 

Compliance, ≥

80% of doses, n 

(%): 

214 (84) 

Voided volume 

(mL), median 

change (median 

% change): 

11.1 (6.3) 

Dry mouth, n (%):

50 (23.4) 

Constipation, n 

(%): 

48 (22.4) 

CVD, %: 

1.4 

Peripheral/CNS, 

%: 

3.3 

C-209 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Homma and 

Koyama, 2006 

Country and 

setting: 

Japan, 

Community 

Enrollment 

period: 

NR 

9 weeks 

1 week wash out 

8 week treatment 

Funding: 

Sanyko Company 

Author industry 

relationship 

disclosures: 

1 of 2 

Sanyko (1) 

Design: 

RCT 

Intervention: 

Oxybutynin 

Transdermal 

(TDS) patch vs 

placebo

Groups: 

G1: OXY TDS 26 

cm2

G2: OXY TDS 39 

cm2

 

G3: OXY TDS 52 

cm2 

G4: placebo 

N at enrollment: 

G1: 160 

G2: 164 

G3: 152 

G4: 161 

N at follow-up: 

G1: 160 

G2: 164 

G3: 152 

G4: 161 

Women, n (%): 

G1: 122 (76.3) 

G2: 132 (80.5) 

G3: 119 (78.3) 

G4: 117 (72.7) 

Age, mean ± SD: 

G1: 63.5 ± 11.5 

G2: 62.7 ± 12.4 

G3: 62.0 ± 13.6 

G4: 62.9 ± 12.3 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Adult with OAB 

syndrome 

• ≥ 1 episodes 

UUI per day 

• ≥ 8 voids per 

day 

Exclusion 

criteria: 

NR 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 21.1 ± 13.9 

G2: 20.8 ± 14.6 

G3: 20.4 ± 14.1 

G4: 21.1 ± 16.6 

KHQ, general 

health, mean ± 

SD: 

G1: 36.9 ± 21.0 

G2: 38.6 ± 20.3 

G3: 36.0 ± 21.4 

G4: 36.0 ± 20.5 

KHQ, 

incontinence 

impact, mean ± 

SD: 

G1: 54.6 ± 27.1 

G2: 54.9 ± 26.7 

G3: 57.1 ± 27.4 

G4: 54.0 ± 25.5 

KHQ, role 

limitation, mean 

± SD: 

G1: 42.5 ± 24.6 

G2: 40.7 ± 24.5 

G3: 41.8 ± 26.5 

G4: 43.0 ± 25.1 

KHQ, physical 

limitation, mean 

± SD: 

G1: 48.6 ± 26.0 

G2: 45.8 ± 26.0 

G3: 48.9 ± 29.6 

G4: 46.9 ± 26.2 

KHQ, social 

limitation, mean 

± SD: 

G1: 27.4 ± 23.7 

G2: 25.2 ± 24.3 

G3: 26.1 ± 24.5 

G4: 26.3 ± 25.7 

KHQ, personal 

relationship, 

mean ± SD: 

G1: 17.9 ± 21.6 

G2: 13.2 ± 20.7 

G3: 16.4 ± 23.4 

G4: 17.0 ± 24.7 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 10.3 ± 17.8 

G2: 6.3 ± 10.4 

G3: 8.9 ± 15.8 

G4: 11.0 ± 15.4 

G2/G4: P = 0.014 

KHQ domain, 

general health, 

mean ± SD: 

G1: 33.4 ± 20.3 

G2: 30.9 ± 22.2 

G3: 33.9 ± 21.6 

G4: 33.0 ± 22.7 

G2/G4: P < 0.05 

KHQ domain, 

incontinence 

impact, mean ± 

SD: 

G1: 34.6 ± 23.2 

G2: 32.7 ± 23.6 

G3: 34.0 ± 24.4 

G4: 39.7 ± 26.0 

G2/G4: P < 0.05 

KHQ domain, 

role limitation, 

mean ± SD: 

G1: 24.8 ± 22.0 

G2: 22.0 ± 20.3 

G3: 26.5 ± 24.7 

G4: 31.9 ± 24.1 

G2/G4: P < 0.05 

KHQ domain, 

physical 

limitation, mean 

± SD: 

G1: 29.7 ± 25.6 

G2: 26.6 ± 22.8 

G3: 29.7 ± 27.3 

G4: 36.5 ± 27.5 

G2/G4: P < 0.05 

KHQ domain, 

social limitation, 

mean ± SD: 

G1: 16.3 ± 21.3 

G2: 13.2 ± 17.1 

G3: 18.4 ± 22.8 

G4: 21.6 ± 24.2 

G2/G4: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: NA 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-210 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Homma and 

Koyama, 2006 

(continued) 

KHQ, emotions, 

mean ± SD: 

G1: 45.3 ± 28.9 

G2: 46.5 ± 27.3 

G3: 46.1 ± 28.1 

G4: 46.2 ± 26.2 

KHQ, sleep/ 

energy, mean ± 

SD: 

G1: 32.0 ± 25.4 

G2: 35.3 ± 24.9 

G3: 33.4 ± 28.5 

G4: 32.5 ± 26.3 

KHQ domain, 

personal 

relationship, 

mean ± SD: 

G1: 10.4 ± 17.3 

G2: 8.4 ± 16.8 

G3: 11.6 ± 22.1 

G4: 12.0 ± 20.2 

G2/G4: P < 0.05 

KHQ domain, 

emotions, mean 

± SD: 

G1: 28.2 ± 25.8 

G2: 24.9 ± 21.6 

G3: 29.3 ± 26.7 

G4: 35.2 ± 28.4 

G2/G4: P < 0.05 

KHQ domain, 

sleep/ energy, 

mean ± SD: 

G1: 18.2 ± 19.2 

G2: 17.9 ± 18.9 

G3: 21.1 ± 22.8 

G4: 26.0 ± 25.6 

G2/G4: P < 0.05 

C-211 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jacquetin and 

Wyndaele, 2001 

Country and 

setting: 

France (22 

centers) and 

Belgium (10 

centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Double-blind, 

placebocontrolled, 

parallel-group, 

multicenter phase 

III study w/ 2-wk 

washout period 

Intervention: 

Tolterodine vs 

placebo for 4 

weeks

Groups: 

G1: Tolterodine 

2mg b.i.d. 

G2: Tolterodine 1 

mg b.i.d. 

G3: placebo 

(frequency NR) 

N at enrollment: 

NR 

N at follow-up: 

G1: 103 

G2: 97 

G3: 51 

Women, n (%): 

G1: 84 (82) 

G2: 74 (76) 

G3: 41 (80) 

Age, mean 

(range): 

G1: 58 (21-88) 

G2: 53 (18-85) 

G3: 56 (19-89) 

Race/ethnicity:

NR 

BMI, kg/m2

(range): 

G1: 26.4 (17.7-

39.7) 

G2: 25.5 (16.7-

46.3) 

G3: 24.8 (17.6-

36.9) 

Inclusion criteria: 

• Age ≥ 18 

• UDS-verified 

detrusor 

overactivity 

• ≥ 1 UUI 

episode/ day 

• ≥ 8 voids/day 

Exclusion 

criteria: 

• SI 

• Hepatic or renal 

dz 

• +UTI or 

recurrent UTIs 

• Interstitial 

cystitis 

• Hematuria 

• Clinically 

significant 

voiding difficulty

• Pts receiving 

bladder training, 

electrostimulation therapy 

• Indwelling 

catheter 

• Intermittent cath

• Pregnant or 

nursing 

• Women of 

childbearing 

age w/o reliable 

contraception 

UUI, n (%) 

G1: 75 (73)

G2: 75 (77)

G3: 39 (76)

UUI episodes/ 

day, mean 

(range): 

G1: 3.2 (0.1-24.0) 

G2: 2.7 (0.1-24.0) 

G3: 2.4 (0.1-8.4) 

Voids/day, mean 

(range): 

G1: 10.8 (6.2-

34.7) 

G2: 10.7 (4.9-

26.4) 

G3: 11.7 (6.3-

26.3) 

≥ 8 voids/day, n 

(%): 

G1: 96 (93) 

G2: 89 (92) 

G3: 49 (96) 

Urinary 

symptoms > 5 

years, n (%): 

G1: 46 (45) 

G2: 42 (43) 

G3: 17 (33) 

Previous lower 

urinary tract 

surgery, n (%): 

G1: 36 (35)

G2: 29 (30)

G3: 16 (31)

Previous drug 

therapy for OAB, 

n (%): 

G1: 66 (64) 

G2: 59 (61) 

G3: 36 (71) 

Previous poor 

efficacy 

response, n (%): 

G1: 50 (76) 

G2: 45 (76) 

G3: 26 (72) 

UUI episodes/ 

day, mean 

change ± SD: 

G1: -1.3 ± 1.8

G2: -1.1 ± 2.2

G3: -0.4 ± 1.9

G1/G3: P =

0.0089

G2/G3: P = 0.045

Voids/day, mean 

change ± SD: 

G1: -1.4 ± 4.3

G2: -1.4 ± 2.8

G3: -1.2 ± 2.7 

G1/G3: P = NS

G2/G3: P = NS 

Good efficacy 

response in 

current study, 

previous poor 

efficacy 

response, n/N 

(%)

G1: 20/39 (51) 

G2: 18/37 (49) 

G3: 7/19 (37) 

G1/G3: P = NS 

G2/G3: P = NS 

Voided volume 

(mL), mean 

change ± SD: 

G1: 19 ± 46

G2: 20 ± 42

G3: 7 ± 40

G1/G3: P = 0.056

G2/G3: P = 0.055 

Dry mouth, n (%): 

G1: 35 (34) 

G2: 20 (21) 

G3: 3 (6) 

G1/G2: P < 0.05 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

Abdominal pain, 

n (%): 

G1: 4 (4) 

G2: 6 (6) 

G3: 2 (4) 

Constipation, n 

(%): 

G1: 2 (2) 

G2: 4 (4) 

G3: 2 (4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-212 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Jacquetin and 

Wyndaele, 2001 

(continued) 

Voided volume 

(mL), mean 

(range): 

G1: 158 (43-382) 

G2: 150 (46-320) 

G3: 148 (23-284)

Headache, n (%): 

G1: 3 (3) 

G2: 3 (3) 

G3: 2 (4) 

Total AEs 

reported, n: 

G1: 84 

G2: 78 

G3: 26 

Any AE, n (%): 

G1: 55 (53) 

G2: 39 (40) 

G3: 16 (31) 

G1/G3: P < 0.05 

Discontinued 

due to AEs, n 

(%):* 

G1: 2 (2) 

G2: 3 (3) 

G3: 1 (2) 

C-213 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jarvis et al., 1981

Country and 

setting: 

UK, Academic 

medical center

Enrollment 

period: 

NR

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Inpatient bladder 

drill vs outpatient 

drug therapy 

Groups: 

G1: inpatient 

bladder drill 

G2: flavoxate 

hydrochloride 200 

mg tds and 

imipramine 25 mg 

tds x 4 wks 

N at enrollment: 

G1: 25 

G2: 25 

N at follow-up: 

G1: 25 

G2: 25 

Women, %: 

100 

Age, mean ± SD 

(range): 

G1: 47 ± 15.4 (17-

78) 

G2: 46 ± 12.8 (17-

65) 

Inclusion criteria: 

• Women 

• UDS-diagnosed 

detrusor 

instability 

Exclusion 

criteria: 

• DM 

• Neurological 

abnormalities 

• UTIs 

• Taking a drug 

suspected of 

affecting lower 

urinary tract 

function 

• Genuine stres 

incontinence 

UUI, n: 

G1: 25 

G2: 25 

SUI, n: 

G1: 19 

G2: 17 

Urgency, n: 

G1: 25 

G2: 25 

Frequency, n: 

G1: 25 

G2: 25 

Nocturia, n: 

G1: 21 

G2: 19 

Duration of 

symptoms 

(years), mean ± 

SD (range): 

G1: 4.3 ± 2.7 (1-

15) 

G2: 5.4 ± 3.2 (1-

20) 

Bladder volume 

(mL), first 

sensation, mean:

G1: 87 

G2: 79 

Max cystometric 

capacity (mL), 

mean: 

G1: 381 

G2: 353 

UUI, n: 

G1: 4 

G2: 11 

SUI, n: 

G1: 1 

G2: 9 

Urgency, n: 

G1: 4 

G2: 11 

Frequency, n: 

G1: 6 

G2: 12 

Nocturia, n: 

G1: 4 

G2: 13 

Continent, n (%): 

G1: 21 (84) 

G2: 14 (56) 

P < 0.05 

Symptom-free, n 

(%): 

G1: 19 (76) 

G2: 12 (48) 

P < 0.05 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 152 

G2: 140 

Max cystometric 

capacity (mL), 

mean: 

G1: 470 

G2: 446 

Adverse events, 

drug therapy, n:* 

Dizziness: 8 

Headache: 6 

Dry mouth: 6 

Nausea: 4 

Drowsiness: 2 

Vomiting: 1 

Discontinued 

due to AEs, n: 

Dizziness: 1 

Headache: 1 

Vomiting: 1 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

- 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: - 

C-214 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jonas et al., 1997 

Country and 

setting: 

Austria, Germany, 

Sweden, 

Academic medical 

center 

Enrollment 

period: 

NR 

1-2 week 

washout-run in to 

total 4 weeks 

efficacy/ 

tolerability 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine 1 mg 

b.i.d. vs 

tolterodine 2 mg 

b.i.d. vs placebo

Groups: 

G1: Tolterodine 1 

mg b.i.d. 

G2: Tolterodine 

2mg b.i.d. 

G3: placebo 

N at enrollment: 

G1: 99 

G2: 99

G3: 44 

N at follow-up: 

G1: 98 

G2: 99 

G3: 44 

Women, n (%): 

G1: 73 (74) 

G2: 76 (77) 

G3: 33 (75) 

Age, mean 

(range): 

G1: 59 (21, 81) 

G2: 57 (20, 83) 

G3: 57 (23, 92) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥18 

• Detrusor 

overactivity 

(phasic activity 

of amplitude of ≥

10 cm H20 or 1 

strong detrusor 

contraction that 

caused end of 

infusion) 

• ≥ 8 voids/ day 

and ≥ 1 

incontinence 

episode/ day, 

urinary urgency, 

or both 

Exclusion 

criteria: 

• SUI 

• Hepatic disease 

• Renal disease 

• Any condition 

contraindicating 

anticholinergic 

activity 

• Indwelling 

catheter 

• Recurrent UTI 

• IC 

• Uninvestigated 

hematuria 

• Voiding difficulty 

at risk for urinary 

retention 

• Patients on 

anticholinergic 

therapy 

• Electrostimulatio

n therapy or 

bladder training 

within 14 days 

prior to 

enrollment 

Urinary 

incontinence, n 

(%): 

G1: 79 (80) 

G2: 83 (84) 

G3: 38 (86) 

Voids/day, mean 

(range): 

G1: 11.7 (0.0, 

25.9) 

G2: 11.2 (4.1, 

23.4) 

G3: 12.2 (7.3, 

22.0) 

≥ 8 voids/day, n 

(%): 

G1: 94 (95) 

G2: 91 (92) 

G3: 42 (96) 

Volume (mL), 

first contraction, 

mean ± SD: 

G1: 142 ± 102 

G2: 141 ± 102 

G3: 140 ± 86 

Maximal height 

of wave (cmH2O), 

mean ± SD: 

G1: 41 ± 34 

G2: 52 ± 43 

G3: 47 ± 34 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 276 ± 142 

G2: 272 ± 136 

G3: 264 ± 116 

Postvoid residual 

volume (mL), 

mean ± SD: 

G1: 25 ± 45 

G2: 28 ± 47 

G3: 38 ± 53 

DO ≥ 10 cmH2O, 

n (%): 

G1: 99(100) 

G2: 97 (98) 

G3: 44 (100) 

Volume (mL), 

first contraction, 

mean ± SD: 

G1: 210 ± 163 

G2: 230 ± 160 

G3: 181 ± 142

G1/G3: P = 0.22 

G2/G3: P = 0.030 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

G3/BL: P = 0.11 

Maximal height 

of wave (cmH2O), 

mean ± SD: 

G1: 35 ± 36 

G2: 37 ± 38 

G3: 40 ± 36 

G1/G3: P = 0.97 

G2/G3: P = 0.17 

G1/BL: P = 0.007 

G2/BL: P < 0.001 

G3/BL: P = 0.11 

Max cystometric 

capacity (mL), 

mean ± SD: 

G1: 294 ± 151 

G2: 316 ± 156 

G3: 268 ± 135

G1/G3: P = 0.43 

G2/G3: P = 0.034 

G1/BL: P = 0.36 

G2/BL: P < 0.001 

G3/BL: P = 0.80 

Postvoid residual 

volume (mL), 

mean ± SD: 

G1: 35 ± 52 

G2: 46 ± 70 

G3: 41 ± 62 

G1/G3: P = 0.034 

G2/G3: P = 0.042 

G1/BL: P = 0.063 

G2/BL: P =

0.0076 G3/BL: P 

= 0.99 

Dry mouth, n (%): 

G1: 8 (8) 

G2: 10 (10) 

G3: 1 (2) 

Dry mouth, mild, 

n (%): 

G1: 5 (5) 

G2: 7 (7) 

G3: 1 (2) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-215 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Jonas et al., 1997 

(continued) 

Dry mouth, 

moderate, n (%): 

G1: 3 (3) 

G2: 2 (2) 

G3: 0 (0) 

Dry mouth, 

severe, n (%): 

G1: 0 (0) 

G2: 1 (1) 

G3: 0 (0)

UTI, n (%): 

G1: 5 (5) 

G2: 2 (2) 

G3: 2 (5) 

Accomodation 

abnormal, n (%): 

G1: 3 (3) 

G2: 5 (5) 

G3: NA 

Constipation, n 

(%): 

G1: 2 (2) 

G2: 3 (3) 

G3: 2 (5) 

Headache, n (%): 

G1: 3 (3) 

G2: 3 (3) 

G3: 1 (2) 

C-216 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Karram et al., 

2009 

Country and 

setting: 

USA, multicenter 

(61 sites) 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Solifenacin 5 or 10 

mg daily

Groups: 

G1: solifenacin 5 

mg daily (with 

dose adjustment 

at weeks 4 and 8) 

G2: placebo 

N at enrollment: 

G1: 372 

G2: 367 

N at follow-up 

(%): 

G1: 357 

G2: 350 

Age, mean: 

Total: 57 

Race/ethnicity, 

%: 

White: 

Total: 83.5 

Women, %: 

Total: 84.2 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

• ≥ 1 Urgency 

episode/day with 

or without 

leakage 

• >8 voids/day 

• ± nocturia 

Exclusion 

criteria: 

• SUI 

• MUI with primary 

stress 

• UTI 

• Chronic bladder 

inflammation 

• Bladder stones 

• Bladder cancer 

• Severe 

constipation 

• Narrow angle 

glaucoma 

• Urinary retention

• Gastric retention

• Hypersensitivity 

to drugs 

• BOO 

Urgency 

episodes/day, 

mean ± SD: 

G1: 6.15 ± 3.92

G2: 6.03 ± 3.90 

Warning time 

(sec), mean ± SD:

G1: 136.4 ± 224.2

G2: 161.6 ± 333.9

Incontinence 

episodes/ day, 

mean ± SD: 

G1: 2.82 ± 2.70 

G2: 2.56 ± 2.72 

Voids/day, mean 

± SD 

G1: 11.65 ± 3.72

G2: 11.70 ± 3.62 

Urgency 

episodes/day, 

mean ± SD: 

G1: 2.24 ± 3.04

G2: 3.30 ± 3.84

Urgency 

episodes/day, 

mean change ± 

SD: 

G1: -3.91 ± 3.54

G2: -2.73 ± 3.84

P < 0.0001 

Warning time 

(sec), mean 

change ± SD:

G1: 186.4 ± 600.7

G2: 54.7 ± 393.5

P = 0.008 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 0.72 ± 1.45 

G2: 1.32 ± 2.65

Incontinence 

episodes, mean 

change ± SD: 

G1: -2.10 ± 2.39 

G2: -1.24 ± 2.30 

P < 0.0001 

Voids/day, mean 

± SD: 

G1: 8.98 ± 3.26 

G2: 9.76 ± 3.50 

Voids/day, mean 

change ± SD: 

G1: -2.67 ± 3.31

G2: -1.94 ± 3.30 

P = 0.0014 

Dry Mouth, %: 

G1: 25.3

G2: 9.0 

Constipation, %: 

G1: 14.8

G2: 9.3

Blurred vision, 

%: 

G1: 3.8 

G2: 1.1 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Method and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-217 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Karram et al., 

2009 (continued) 

Headache, %: 

G1: 4.6 

G2: 5.2

Dizziness, %: 

G1: 3.2 

G2: 1.9 

Fatigue, %: 

G1: 2.7 

G2: 1.1 

C-218 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kelleher, Reese 

et al., 2002* 

Kelleher, Kreder, 

et al., 2002 

[See evidence 

table for Van 

Kerrebroeck, et 

al., 2001] 

Country and 

setting: 

Multinational: 

Europe 

North America 

Australia/New 

Zealand 

Russia/Ukraine, 

Community 

Enrollment 

period: 

NR 

12 week 

12 month† 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized 

placebo-controlled 

double blind 

parallel-group; 

Open label 

uncontrolled 

non-randomized 

extension† 

Intervention: 

Tolterodine ER vs 

placebo

Groups: 

G1: Tolterodine 

ER 4mg daily 

G2: placebo 

G3: Tolterodine IR 

2mg b.i.d.* 

N at enrollment: 

G1: 507 

G2: 508 

G3: 514 

N at follow-up: 

G1: 450 

G2: 440 

G3: 447 

Women, n (%): 

Total: 827 (81.5) 

G1: 417 (82.2) 

G2: 410 (80.7)* 

G3: 408 (79.4)* 

Age, mean ± SD: 

G1: 60.3 ± 14.4 

G2: 61.1 ± 13.9

G3: 60.0 ± 14.3* 

Race/ethnicity: 

NR 

Extension:† 

Tolterodine ER 

4mg daily 

Groups:† 

G4: KHQ 

G5: SF-36 

N at enrollment:† 

Total: 1077 

Inclusion criteria:

• Age ≥ 18 

• ≥ 8 voids/day on 

7 day voiding 

diary 

• ≥ 5 UUI 

episodes/ week 

• OAB symptoms 

for at least 6 

months 

Exclusion 

criteria: 

NR 

NR Patient rating of 

bladder 

condition, 

improvement, %: 

G1: 43 

G2: 58 

P = 0.001

Patient rating of 

bladder 

condition, 

deterioration, %: 

G1: 13 

G2: 7 

P = 0.004 

KHQ, incontinence impact, 

mean change ± 

SD: 

G1: -15.68 ± 

29.36 

G2: -8.86 ± 26.65 

P = 0.001 

KHQ, incontinence impact, 12 

months, mean 

change (SE):† 

G4: -23.1 (1.1) 

P = 0.002 

KHQ, role 

limitations, mean 

change ± SD: 

G1: -17.93 ± 

30.58 

G2: -10.26 ± 

29.20 

P = 0.001 

KHQ, role 

limitations, 12 

months, mean 

change (SE):† 

G4: -23.8 (1.1) 

P = 0.002 

KHQ, physical 

limitations, mean 

change ± SD: 

G1: -15.60 ± 

29.98 

G2: -8.73 ± 27.90 

P = 0.001 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-219 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher, Reese 

et al., 2002 

Kelleher, Kreder, 

et al., 2002 

(continued) 

N at follow-up:† 

G4: 838 

G5: 961 

Women, n (%):† 

G4: 678 (80.9)

G5: 793 (82.5) 

Age, yrs ± SD:† 

G4: 61.1 ± 13.5 

G5: 60.2 ± 13.7 

Race/ethnicity, n, 

(%):† 

White: 

G4: 800 (95.5) 

G5: 927 (96.5) 

Black: 

G4: 28 (3.3) 

G5: 25 (2.5) 

Asian or Pacific: 

G4: 6 (0.7) 

G5: 6 (0.6) 

Mixed: 

G4: 4 (0.5) 

G5: 4 (0.4) 

KHQ, physical 

limitations, 12 

months, mean 

change (SE):† 

G4: -19.9 (1.1) 

P = 0.002 

KHQ, social 

limitations, mean 

change ± SD: 

G1: -8.49 ± 23.24 

G2: -6.25 ± 22.76 

P = 0.062 

KHQ, social 

limitations, 12 

months, mean 

change (SE):† 

G4: -11.5 (0.8) 

P = 0.002 

KHQ, personal 

relationships, 

mean change ± 

SD: 

G1: -5.66 ± 26.74 

G2: -3.44 ± 23.15 

P = 0.446 

KHQ, personal 

relationships, 12 

months, mean 

change (SE):† 

G4: -8.4 (1.2) 

P = 0.002 

KHQ, emotions, 

mean change ± 

SD: 

G1: -9.31 ± 24.85 

G2: -6.52 ± 23.98 

P = 0.106 

KHQ, emotions, 

12 months, mean 

change (SE):† 

G4: -13.8 (0.9) 

P = 0.002 

KHQ, sleep and 

energy, mean 

change ± SD: 

G1: -9.82 ± 24.45 

G2: -5.08 ± 21.06 

P = 0.006 

C-220 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher, Reese 

et al., 2002 

Kelleher, Kreder, 

et al., 2002 

(continued) 

KHQ, sleep and 

energy, 12 

months, mean 

change (SE):† 

G4: -11.7 (0.8) 

P = 0.002 

KHQ, severity 

(coping) 

measures, mean 

change ± SD: 

G1: -11.98 ± 

22.04 

G2: -6.12 ± 20.39 

P = 0.001 

KHQ, severity 

(coping) 

measures, 12 

months, mean 

change (SE):† 

G4: -13.8 (0.8) 

P = 0.002 

KHQ, general 

health 

perception, mean 

change ± SD: 

G1: -0.41 ± 17.55 

G2: -0.12 ± 17.49 

P = 0.900 

KHQ, general 

health 

perception, 12 

months, mean 

change ± SD:† 

G4: -0.1 (0.6) 

P = 0.8302 

KHQ, symptom 

severity, mean 

change ± SD: 

G1: -2.90 ± 4.10 

G2: -1.42 ± 3.99 

P = 0.001 

KHQ, symptom 

severity, 12 

months, mean 

change (SE):† 

G4: -11.7 (0.5) 

P = 0.002 

C-221 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher, Reese 

et al., 2002 

Kelleher, Kreder, 

et al., 2002 

(continued)

SF-36, physical 

summary, mean 

change ± SD: 

G1: 0.97 ± 7.34 

G2: 0.72 ± 6.57 

P = 0.451 

SF-36, mental 

summary, mean 

change ± SD: 

G1: 0.67 ± 8.63 

G2: 0.10 ± 8.43 

P = 0.684 

C-222 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kelleher et al., 

2005 

[See evidence 

table for Chapple 

et al., 2004 and 

Cardozo et al. 

2004] 

Country and 

setting: 

Multinational, 

multicenter 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

1 of 5 

Pfizer (1) 

Yamanouchi (1) 

Lilly (1) 

Novartis (1) 

Q Med (1) 

Design: 

Pooled analysis 

from the 40-wk 

open-label 

extension studies 

of 2 12-wk 

multinational, 

multicentre, 

double-blind RCTs 

Intervention: 

Solifenacin 5 mg 

vs solifenacin 10 

mg vs placebo

Groups: 

G1: solifenacin 5 

mg qd 

G2: solifenacin 10 

mg qd 

G2: placebo qd 

N at enrollment: 

1637 

N at follow-up: 

1347 

Inclusion criteria: 

[See evidence 

table for Chapple 

et al., 2004 and 

Cardozo et al. 

2004] 

Exclusion 

criteria: 

[See evidence 

table for Chapple 

et al., 2004 and 

Cardozo et al. 

2004] 

[See evidence 

table for Chapple 

et al., 2004 and 

Cardozo et al. 

2004] 

KHQ, general 

health 

perception, 12 

weeks, mean 

change: 

G1: -4.3 

G2: -4.0 

G3: -2.3 

G1/G3: P < 0.001 

G2/G3: P = 0.031 

KHQ, 

incontinence 

impact, 12 

weeks, mean 

change: 

G1: -24.7 

G2: -27.3 

G3: -18.2 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

KHQ, role 

limitations, 12 

weeks, mean 

change: 

G1: -20.6 

G2: -22.7 

G3: -15.4 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

KHQ, physical 

limitations, 12 

weeks, mean 

change: 

G1: -17.7 

G2: -20.3 

G3: -13.7 

G1/G3: P = 0.002 

G2/G3: P < 0.001 

KHQ, social 

limitations, 12 

weeks, mean 

change: 

G1: -11.3 

G2: -11.7 

G3: -7.8 

G1/G3: P = 0.003 

G2/G3: P = 0.015 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-223 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher et al., 

2005 

(continued) 

KHQ, personal 

relationships, 12 

weeks, mean 

change: 

G1: -8.7 

G2: -9.3 

G3: -9.7 

G1/G3: P = 0.650 

G2/G3: P = 0.747 

KHQ, emotions, 

12 weeks, mean 

change: 

G1: -16.0 

G2: -17.7 

G3: -12.3 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

KHQ, sleep/ 

energy, 12 

weeks, mean 

change: 

G1: -13.8 

G2: -14.4 

G3: -10.0 

G1/G3: P = 0.002 

G2/G3: P = 0.001 

KHQ, severity 

measures, 12 

weeks, mean 

change: 

G1: -10.5 

G2: -13.2 

G3: -7.3 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

KHQ, symptom 

severity, 12 

weeks, mean 

change: 

G1: -3.4 

G2: -3.6 

G3: -2.6 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

KHQ, general 

health 

perception, 40 

weeks, mean 

change: 

G1: -6.0 

G2: -7.1 

G3: -7.8 

C-224 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher et al., 

2005 

(continued) 

KHQ, 

incontinence 

impact, 40 

weeks, mean 

change: 

G1: -33.5 

G2: -35.3 

G3: -32.9 

KHQ, role 

limitations, 40 

weeks, mean 

change: 

G1: -29.1 

G2: -28.9 

G3: -30.8 

KHQ, physical 

limitations, 40 

weeks, mean 

change: 

G1: -25.7 

G2: -27.0 

G3: -26.0 

KHQ, social 

limitations, 40 

weeks, mean 

change: 

G1: -15.6 

G2: -18.1 

G3: -15.7 

KHQ, personal 

relationships, 40 

weeks, mean 

change: 

G1: -14.1 

G2: -15.0 

G3: -13.2 

KHQ, emotions, 

40 weeks, mean 

change: 

G1: -22.2 

G2: -24.8 

G3: -21.0 

KHQ, sleep/ 

energy, 40 

weeks, mean 

change: 

G1: -17.9 

G2: -19.5 

G3: -18.8 

C-225 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kelleher et al., 

2005 

(continued) 

KHQ, severity 

measures, 40 

weeks, mean 

change: 

G1: -15.3 

G2: -17.2 

G3: -14.7 

KHQ, symptom 

severity, 40 

weeks, mean 

change: 

G1: -4.4 

G2: -4.7 

G3: -4.7 

C-226 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Koonings et al., 

1991 

Country and 

setting: 

US, Academic 

medical center 

Enrollment 

period: 

January 1986 to 

October 1987 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohort 

Intervention: 

Oxybutynin 

chloride 5 mg t.i.d. 

x 4 wks

Groups: 

NA 

N at enrollment: 

126 

N at follow-up: 

114 

Women, %: 

100 

Age, mean 

(range): 

39 (21-74) 

Race/ethnicity: 

NR 

Menopausal, n: 

44 

Parity, mean 

(range): 

2 (0-12) 

Inclusion criteria: 

• Confirmed 

diagnosis of 

detrusor 

instability 

• Uninhibited 

detrusor 

contraction > 15 

cm H2O on 

standing 

provocative 

urethra 

cystometry 

Exclusion 

criteria: 

• Urethritis (on 

urethroscopy) 

• Cystitis (on 

cystoscopy) 

• Neurologic 

findings on 

screening test of 

S2-S4 lower 

voiding center 

• MUI 

• Glaucoma

Uninhibited 

detrusor 

contraction 

starting prior to 

urethral pressure 

change, n (%): 

73 (64%) 

Urethral pressure 

drop (≥ 20 

cmH2O) prior to 

detrusor 

contraction, n 

(%): 

41 (6) 

Good response, n 

(%): 

66 (58) 

Poor response, n 

(%): 

48 (42) 

Response, 

women with 

uninhibited 

detrusor 

contraction 

starting prior to 

urethral pressure, 

n (%): 

Good: 61 (81) 

Poor: 5 (12) 

P < 0.01 

Response, 

women with 

urethral pressure 

drop (≥ 20 

cmH2O) prior to 

detrusor 

contraction, n 

(%): 

Good: 12 (16) 

Poor: 36 (88) 

P < 0.01 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-227 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kreder et al., 

2002 

[See evidence 

table for Van 

Kerrebroeck, et 

al., 2001] 

Country and 

setting: 

Multinational; 

open label 

extension x 12 

months 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective case 

series 

Open label, 

uncontrolled, nonrandomized 

extension study of 

Phase III 

Intervention: 

Tolterodine ER 4 

mg daily

Groups: 

 Tolterodine ER 4 

mg daily 

N at enrollment: 

 1077 

N at follow-up 

(%): 

 759 (70.6) 

Age, mean 

(range): 

 60.3 (19.6-93.2) 

Race/ethnicity: 

NR 

Women, N (%): 

 883 (82) 

Inclusion criteria: 

[See evidence 

table for Van 

Kerrebroeck, et 

al., 2001] 

Exclusion 

criteria: 

[See evidence 

table for Van 

Kerrebroeck, et 

al., 2001] 

Frequency ≥ 8 

voids/day, n (%): 

1041 (96.7) 

UUI episodes/ 

day ≥ 5, n (%): 

1056 (98.1) 

Voided volume ≤

200 mL, n (%): 

1032 (95.8) 

Incontinence 

episodes/week, n 

(range): 

21.6 (0.0-168.0) 

Voids/day, n 

(range): 

10.9 (2.3-48.6) 

Voided volume 

(mL), mean 

(range): 

137.7 (21.1-373.5)

Previous 

treatment for 

OAB, n (%): 

591 (54.9) 

Previous 

treatment for 

OAB with poor 

efficacy, n (%): 

231 (39.1) 

Incontinence 

episodes/week, 

3 months, mean 

change ± SD: 

-13.4 ± 19.3 

P = 0.297 

Incontinence 

episodes/week, 

12 months, mean 

change ± SD: 

-12.5 ± 19.9 

P = 0.5888 

Voids/day, 3 

months, mean 

change ± SD: 

-2.4 ± 3.2 

P = 0.0077 

Voids/day, 12 

months, mean 

change ± SD: 

-2.3 ± 3.4 

P = 0.0661 

Voided volume 

(mL), 3 months, 

mean change ± 

SD: 

42.9 ± 55.6 

P = 0.6319 

Voided volume 

(mL), 12 months, 

mean change ± 

SD: 

43.2 ± 60.3 

P = 0.6426 

Dry mouth, n (%): 

139 (12.9) 

Constipation, n 

(%): 

35 (3.3) 

Dyspepsia, n (%): 

24 (2.2) 

Upper 

Respiratory Tract 

Infection, n (%): 

43 (4.0) 

Bronchitis, n (%): 

28 (2.6) 

UTI, n (%): 

44 (4.1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-228 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kreder et al., 

2002 

(continued)

Cystitis, n (%): 

23 (2.1) 

Headache, n (%): 

26 (2.4) 

Back pain, n (%): 

35 (3.3) 

Flu-like illness, n 

(%): 

28 (2.6) 

Serious adverse 

events related to 

tolterodine, n: 

Urinary retention: 1 

Aggravated MS: 1 

Med error: 1 

Withdrawal due to 

AEs (N= 107), n 

(%): 

Dry Mouth: 19 (1.8) 

Headache: 9 (0.8) 

Abd pain: 9 (0.8) 

Dizziness: 7 (0.7) 

UTI: 7 (0.7) 

Dyspepsia: 6 (0.6) 

Constipation: 6 

(0.6) 

Xerophthalmia: 5 

(0.5) 

Voiding disorder: 5 

(0.5) 

C-229 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kreder et al., 

2003 

Country and 

setting: 

US and Canada, 

Community 

Enrollment 

period: 

NR 

16 week follow up 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Subgroup analysis 

of multicenter, 

single blind cohort 

Intervention: 

Tolterodine 1-2 

mg b.i.d.

Groups: 

G1: MUI with 

primary urge 

G2: UUI 

N at enrollment: 

G1: 171 

G2: 552 

N at follow-up: 

G1: 170 

G2: 551 

Women, n (%): 

G1: 165 (96.5) 

G2: 464 (84) 

Age, median 

(range): 

G1: 62 (21, 88) 

G2: 65 (20, 88) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 65 

• History, PE, 

UDS consistent 

with urge 

incontinence 

• ≥ 4 episodes UI 

on 5 day voiding 

diary 

• ≥ 8 voids/day 

• Either urgency 

or ≥ 1 UI 

episodes / day 

Exclusion 

criteria: 

• MUI with 

predominate 

stress 

component 

• Contraindication

s to 

antimuscarinic 

therapy 

• Hepatic/renal 

disease 

• Symptomatic or 

recurrent UTI 

• Hematuria 

• IC 

• Voiding difficulty 

with risk of 

retention 

• Concurrent 

bladder training 

• Electrostimulatio

n therapy 

• Indwelling 

catheter 

• CIC 

• Women with 

reproduction 

potential 

• Pregnant/ 

nursing 

• Concomitant 

anticholinergic 

meds/ treatment

Incontinence 

episodes/day, 

median (range): 

G1: 3 (1, 19) 

G2: 3 (1, 15) 

≥ 2 nocturia 

episodes/day, n 

(%): 

G1: 100 (58.5) 

G2: 334 (60.5) 

Using pads, n 

(%): 

G1: 122 (71) 

G2: 342 (62) 

Voided volume 

(mL), median 

(range): 

G1: 169 (62, 506) 

G2: 164 (31, 524) 

Duration of 

symptoms > 5 

years, n (%): 

G1: 91 (53) 

G2: 259 (47) 

Previous drug 

therapy for OAB, 

n (%): 

G1: 85 (50) 

G2: 275 (50) 

Incontinence 

episodes/day, 

median % 

change: 

G1: -67 

G2: -75 

P = NS 

Cure rate, 

achieved 

dryness, n (%): 

G1: 66 (39) 

G2: 243 (44) 

P = NS 

Voids/day, 

median % 

change: 

G1: -15 

G2: -17 

P = NS 

Cure rate, ≤ 8 

voids/day 

dryness, n (%): 

G1: 40 (23.5) 

G2: 130 (24) 

P = NS 

Nocturia 

episodes/day, 

median % 

change: 

G1: -50 

G2: -33 

P = NS 

Cure rate, 

achieving ≤ 2 

nocturnal voiding 

episodes/day, n 

(%): 

G1: 83 (83) 

G2: 254 (76) 

P = NS 

Cure rate, 

achieved no pad 

usage, n (%): 

G1: 26 (21) 

G2: 93 (27) 

P = NS 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-230 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Kreder et al., 

2003 (continued) 

Voided volume 

(mL), median 

change (range): 

G1: 26.5 (-261, 

195) 

G2: 27 (-345, 389) 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

C-231 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Landis et al., 

2004 

[See evidence 

table for van 

Kerrebroeck et 

al., 2001] 

Country and 

setting: 

Multinational, 

Community 

Enrollment 

period: 

NR 

12 weeks 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

2 of 4 

ALZA (1) 

Bristol-Myers 

Squibb (1) 

Pharmacia (2) 

Design: 

RCT 

Intervention: 

Tolterodine ER vs 

placebo 

1 week run-in 

period with 12 

weeks treatment 

Groups: 

G1: Tolterodine 

ER 4 mg daily 

G2: placebo 

Stratified: 

a: 5-20 UUI 

episodes/week 

b: ≥ 21 UUI 

episodes/week 

N at enrollment: 

G1: 492 

G1a: 321 

G1b: 171 

G2: 494 

G2a: 284 

G2b: 210 

N at follow-up: 

G1a: 321 

G1b: 171 

G2a: 284 

G2b: 210 

Women, N (%): 

G1a: 262 (81.6) 

G1b: 143 (83.6) 

G2a: 223 (78.5) 

G2b: 178 (84.8) 

Age, mean ± SD: 

G1a: 60.86 ± 

14.45 

G1b: 60.04 ± 

14.10 

G2a: 60.61 ± 

13.59 

G2b: 61.84 ± 

13.85 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• ≥ 5 UUI 

episodes/ week 

• ≥ 8 voids/day 

• Symptoms of 

OAB x 5 months

Exclusion 

criteria: 

NR 

UUI episodes/ 

week, median 

(range): 

G1: 16 (5-168) 

G1a: 11 (5-20)

G1b: 34 (21-168) 

G2: 18 (5-168) 

G2a: 11 (5-20)

G2b: 31.5 (21-

168) 

Voids/day, 

median (range): 

G1a: 9.57 (2.57- 

34.85) 

G1b: 10.71 (2.28- 

51.28) 

G2a: 10.28 (2.28-

28.42) 

G2b: 11.14 (2-

37.42) 

Voided volume 

(mL), median 

(range): 

G1a: 142.72 

(36.19-338) 

G1b: 135.12 

(51.45-270.52) 

G2a: 136.25 

(32.51-237.5) 

G2b: 126.94 

(21.16-373.46) 

Number prior Tx 

for OAB, n (%): 

G1a: 162 (50.6) 

G1b: 100 (58.5) 

G2a: 139 (49.1) 

G2b: 117 (55.7) 

Number prior Tx 

for OAB w/ good 

efficacy, n (%): 

G1a: 85 (52.8) 

G1b: 63 (63.0) 

G2a: 84 (60.4) 

G2b: 68 (58.6) 

UUI episodes/ 

week, median 

change: 

G1: -9.0 

G1a: -6.0 

G1b: -21 

G2: -5.0 

G2a: -4.0 

G2b: -9.5 

G1/G2: P < 0.0001 

G1a/G2a: P <

0.0001 

G1b/G2b: P <

0.0001 

UUI episodes/ 

week, median % 

change: 

G1a: -71.42 

G1b: -67.56 

G2a: -38.46 

G2b: -29.81 

G1a/G2a: P =

0.0264 (adjusted) 

G1b/G2b: P =

0.0221 (adjusted) 

Voids/day, 

median change: 

G1a: -1.22 

G1b: -1.9 

G2a: -0.85

G2b: -0.4 

G1a/G2a: P < 0.04 

G1b/G2b: P < 0.02 

Voided volume 

(mL), median 

change: 

G1a: 24.0 

G1b: 27.0 

G2a: 4.0 

G2b: 2.9 

G1a/G2a: P <

0.0001 

G1a/G2a: P <

0.0001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-232 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lauti et al., 2008 

Country and 

setting: 

New Zealand, 

Academic 

Enrollment 

period: 

February 2003 to 

July 2003 

Funding: 

University of 

Otago 

Author industry 

relationship 

disclosures: 

None 

Design: 

RCT pilot study, 

unmasked 

Intervention: 

Oxybutynin vs. 

bladder retraining 

vs. combination 

therapy

Groups: 

G1: Oxybutynin 

2.5 mg/day (daily 

dose could be 

increased by 2.5 

mg every 5 days

to a maximum of 

15 mg/day) 

G2: Bladder 

retraining 

G3: Combination 

therapy 

N screened: 

120 

N at enrollment: 

G1: 21 

G2: 16 

G3: 19 

N at 3 month 

follow-up: 

G1: 18 

G2: 16 

G3: 12 

N at 12 month 

follow-up: 

G1: 16 

G2: 14 

G3: 12 

Age, mean ± SD: 

G1: 53.8 ± 14.8 

G2: 63.9 ± 17.2 

G3: 47.6 ± 16.3 

Race/ethnicity: 

NR 

Women, %: 

Total: 100 

Parrous, %: 

G1: 81 

G2: 62.5 

G3: 73.7 

Inclusion criteria: 

• Age > 18 

• Predominant 

UUI 

Exclusion 

criteria: 

• Predominant 

SUI 

• Contraindication

s to 

anticholinergic 

drugs 

• Current UTI 

• Neurological 

disease 

• Psychiatric 

disorder 

• Untreated coexisting pelvic 

organ prolapse 

below the 

hymenal ring 

• Obstructed 

voiding 

• Functionalreversible cause 

of incontinence 

• Inability to toilet 

independently 

• Limited fluency 

of 

written/spoken 

English 

• Current or recent 

use of any of the 

trial 

interventions 

Urgency 

episodes/day, 

mean ± SD: 

G1: 3.8 ± 2.7 

G2: 3.1 ± 2.2 

G3: 3.5 ± 2.0 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.2 ± 1.5 

G2: 1.0 ± 1.1 

G3: 1.8 ± 1.6 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.1 ± 1.0 

G2: 1.4 ± 1.0 

G3: 0.8 ± 0.7 

Voids per day, 

mean ± SD: 

G1: 7.8 ± 2.8 

G2: 8.0 ± 1.7 

G3: 8.4 ± 2.5 

OAB-q total 

HRQL, mean ± 

SD: 

G1: 73.1 ± 17.4 

G2: 69.5 ± 24.6 

G3: 71.6 ± 21.5 

OAB-q severity, 

mean ± SD: 

G1: 47.0 ± 16.2 

G2: 42.3 ± 17.7 

G3: 45.9 ± 18.7 

OAB-q coping, 

mean ± SD: 

G1: 72.0 ± 21.6 

G2: 66.2 ± 31.7 

G3: 73.8 ± 26.2 

OAB-q concern, 

mean ± SD: 

G1: 68.2 ± 19.0 

G2: 68.8 ± 27.6 

G3: 63.8 ± 29.2 

OAB-q sleep, 

mean ± SD: 

G1: 63.1 ± 28.7 

G2: 59.8 ± 29.9 

G3: 55.1 ± 27.6 

Urgency 

episodes/day, 3 

mos, mean ± SD: 

G1: 2.2 ± 1.8 

G2: 1.5 ± 2.1 

G3: 1.7 ± 1.8 

Urgency 

episodes/day, 12 

mos, mean ± SD: 

G1: 2.3 ± 2.5 

G2: 1.9 ± 2.1 

G3: 2.0 ± 1.1 

Incontinence 

episodes/day, 3 

mos, mean ± SD: 

G1: 0.8 ± 0.8 

G2: 0.1 ± 0.3 

G3: 0.6 ± 0.8 

Incontinence 

episodes/day, 12 

mos, mean ± SD: 

G1: 0.9 ± 0.0 

G2: 0.9 ± 1.0 

G3: 0.8 ± 0.7 

Nocturia 

episodes/day, 3 

mos, mean ± SD: 

G1: 1.0 ± 0.5 

G2: 0.8 ± 0.7 

G3: 0.6 ± 0.5 

Nocturia 

episodes/day, 12 

mos, mean ± SD: 

G1: 1.0 ± 0.9 

G2: 1.2 ± 0.6 

G3: 0.7 ± 0.7 

Voids/day, 3 mos, 

mean ± SD: 

G1: 6.7 ± 1.8 

G2: 6.3 ± 1.6 

G3: 6.7 ± 2.2 

Voids/day, 12 

mos, mean ± SD: 

G1: 7.2 ± 1.1 

G2: 6.8 ± 1.4 

G3: 7.6 ± 1.5 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Method and 

blinding: - 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-233 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

OAB-q social, 

mean ± SD: 

G1: 92.5 ± 14.6 

G2: 85.4 ± 19.9 

G3: 92.8 ± 18.6 

SF-12 quality of 

life, physical, 

mean ± SD: 

G1: 49.0 ± 9.6 

G2: 41.7 ± 11.5 

G3: 46.2 ± 10.6 

SF-12 quality of 

life, mental, 

mean ± SD: 

G1: 49.1 ± 9.3 

G2: 53.1 ± 8.8 

G3: 46.3 ± 8.3 

OAB-q total 

HRQL, 3 mos, 

mean ± SD: 

G1: 82.3 ± 16.1 

G2: 89.6 ± 9.4 

G3: 91.8 ± 7.4 

OAB-q total 

HRQL, 12 mos, 

mean ± SD: 

G1: 87.9 ± 11.6 

G2: 81.6 ± 19.3 

G3: 88.9 ± 9.9 

OAB-q severity, 3 

mos, mean ± SD: 

G1: 37.2 ± 22.0 

G2: 16.8 ± 12.0 

G3: 21.6 ± 10.9 

OAB-q severity, 

12 mos, mean ± 

SD: 

G1: 24.6 ± 10.6 

G2: 33.1 ± 16.6 

G3: 21.9 ± 14.8 

OAB-q coping, 3 

mos, mean ± SD: 

G1: 79.2 ± 22.1 

G2: 91.6 ± 9.5 

G3: 92.7 ± 9.4 

OAB-q coping, 12 

mos, mean ± SD: 

G1: 89.2 ± 13.7 

G2: 81.5 ± 23.7 

G3: 90.5 ± 10.0 

OAB-q concern, 3 

mos, mean ± SD: 

G1: 78.6 ± 18.0 

G2: 87.7 ± 14.5 

G3: 90.2 ± 12.4 

OAB-q concern, 

12 mos, mean ± 

SD: 

G1: 85.3 ± 15.5 

G2: 81.7 ± 19.7 

G3: 85.2 ± 13.4 

OAB-q sleep, 3 

mos mean ± SD: 

G1: 77.7 ± 24.9 

G2: 81.3 ± 14.6 

G3: 85.0 ± 19.6 

C-234 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

OAB-q sleep, 12 

mos, mean ± SD: 

G1: 79.9 ± 18.3 

G2: 72.0 ± 24.5 

G3: 83.2 ± 18.4 

OAB-q social, 3 

mos, mean ± SD: 

G1: 96.4 ± 9.7 

G2: 95.6 ± 7.0 

G3: 98.9 ± 1.9 

OAB-q social, 12 

mos, mean ± SD: 

G1: 97.3 ± 7.1 

G2: 91.9 ± 14.2 

G3: 97.3 ± 6.9 

SF-12 quality of 

life, physical 

G1: 50.6 ± 8.0 

G2: 42.1 ± 12.7 

G3: 48.4 ± 10.8 

SF-12 quality of 

life, physical, 12 

mos, mean ± SD: 

G1: 50.0 ± 7.3 

G2: 45.1 ± 13.9 

G3: 45.3 ± 13.4 

SF-12 quality of 

life, mental, 3 

mos, mean ± SD: 

G1: 50.4 ± 9.6 

G2: 51.2 ± 9.5 

G3: 46.7 ± 7.6 

SF-12 quality of 

life, mental, 12 

mos, mean ± SD: 

G1: 49.6 ± 7.5 

G2: 50.1 ± 10.7 

G3: 50.6 ± 8.4 

Dry mouth, n (%): 

G1: 3 (21) 

G2: 5 (46) 

G3: 5 (42) 

Headaches, n (%): 

G1: 6 (43) 

G2: 1 (11) 

G3: 7 (58) 

Dizziness, n (%): 

G1: 4 (29) 

G2: 2 (20) 

G3: 3 (25) 

C-235 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

Constipation, n 

(%): 

G1: 3 (21) 

G2: 3 (27) 

G3: 3 (27) 

Fatigue, n (%): 

G1: 9 (64) 

G2: 5 (46) 

G3: 7 (64) 

C-236 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Layton et al., 

2001 

Country and 

setting: 

England, 

Community 

Enrollment 

period: 

November 1998 

to May 1999 

Funding: 

Pharmacia 

Upjohn 

Author industry 

relationship 

disclosures: 

NR

Design: 

Prospective 

observational 

cohort 

Intervention: 

Tolterodine 

prescription event 

monitoring in UK

Groups: 

NA 

N at enrollment: 

35,295 had 

commenced 

treatment 

26,991 green 

forms mailed out 

14,526 returned 

forms 

Response rate: 

53.8% 

Age, mean ± SD: 

62.7 ± 16.4 

Women, N (%): 

9965 (68.6) 

Parity: 

NR 

Inclusion criteria: 

• Patients 

prescribed 

tolterodine in 

general practice 

in UK 

Exclusion 

criteria: 

• None 

Dry mouth, n: 

250 

Unspecified 

adverse effects, 

n: 

168 

Headache, n: 

123 

Constipation, n: 

78 

General malaise, 

n: 

78 

Hallucinations, n: 

23 

Palpitations/tachy

cardia, n: 

42 

Other cardiac 

arrhythmias, n: 

29 

Chest pains, n: 

87 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

NA 

Drop-out rates: NA 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: - 

C-237 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lee et al., 2002 

Country and 

setting: 

South Korea, 

University 

Enrollment 

period: 

NR 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine 2mg 

b.i.d. vs 

Oxybutynin 5mg 

b.i.d. 

Groups: 

G1: Tolterodine 

2mg b.i.d. 

G2: Oxybutynin 

5mg b.i.d. 

N at enrollment: 

G1: 112 

G2: 116 

N at follow-up: 

G1: 97 

G2: 90 

Women, n (%): 

G1: 84 (74) 

G2: 92 (79) 

Age, mean 

(range): 

G1: 52 (27, 82) 

G2: 52 (20, 86) 

Race/ethnicity 

(%): 

Asian: 

G1: 100 

G2: 100 

BMI, kg/m2

(range): 

G1: 23 (17, 32.5) 

G2: 23.5 (16, 38) 

Previous drug 

therapy: N (%) 

G1: 36 (32) 

G2: 26 (22) 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

> 6 mos 

• ≥ 8 voids/day, 

with or without 

incontinence 

(measured by 

diary) 

Exclusion 

criteria: 

• SUI 

• Women not 

using reliable 

contraception 

• Pregnant or 

nursing 

• Prior treatment 

with 

anticholinergic < 

2 wks 

• Renal or hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary 

retention 

• Gastric 

retention 

• Hypersensitivity 

to drugs 

• UTI 

• IC 

• Hematuria 

• BOO 

• Concomitant 

bladder training, 

e-stim treatment

• Indwelling 

catheter 

• CIC 

• Concomitant 

treatment for 

OAB ≤ 2 mos 

Incontinence 

episodes/day, 

mean (range): 

G1: 2.6 (0.3, 9.3) 

G2: 2.4 (3.0, 14.7)

Patients with 

incontinence 

episodes, n (%): 

G1: 46 (41) 

G2: 42 (36) 

Voids/day, mean 

(range): 

G1: 12.2 (8.0, 

23.7) 

G2: 12.4 (7.7, 

29.7) 

Incontinence 

episodes/day, 

mean change ± 

SD (% change): 

G1: -2.2 ± 2.3 (-85) 

G2: -1.4 ± 1.8 (-58) 

G1/BL: P = 0.0001 

G1/BL: P = 0.0001 

G1/G2: P = 0.10 

Voids/ day, mean 

change ± SD (% 

change): 

G1: -2.6 ± 2.9 (-21) 

G2: -1.8 ± 4.2 (-15) 

G1/BL: P = 0.0001 

G1/BL: P = 0.0001 

G1/G2: P = 0.14 

Benefit of Tx, %: 

G1: 45 

G2: 46 

G1/G2: P = NS 

Patients reporting 

adverse events, n 

(%): 

G1: 62 (55) 

G2: 94 (82) 

Discontinued due 

to AEs, n (%): 

G1: 11 

G2: 18 

Dry mouth, n (%): 

G1: 39 (35) 

G2: 72 (63) 

G1/G2: P = 0.001 

Dry mouth, mild, 

n (%): 

G1: 29 (26) 

G2: 40 (35) 

Dry mouth, 

moderate, n (%): 

G1: 9 (8) 

G2: 26 (23) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-238 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lee et al., 2002 

(continued) 

Dry mouth, 

severe, n (%): 

G1: 1 (1) 

G2: 6 (5) 

Voiding disorder, 

n (%): 

G1: 10 (9) 

G2: 16 (14) 

Dyspepsia, n (%): 

G1: 8 (7) 

G2: 6 (5) 

Abdominal pain, 

n (%): 

G1: 6 (5) 

G2: 6 (5) 

Headache, n (%): 

G1: 4 (4) 

G2: 6 (5) 

C-239 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Leung et al., 2002

Country and 

setting: 

Hong Kong, 

Academic, urogynecology 

centers

Enrollment 

period: 

April 2000 to 

December 2000 

Funding: 

Pharmacia 

Limited 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

oral tolterodine 2 

mg vs. oxybutynin 

5 mg b.i.d. for 10 

weeks 

Groups: 

G1: tolterodine 2 

mg 

G2: oxybutynin 5 

mg b.i.d. 

N at enrollment: 

G1: 53 

G2: 53 

N at follow-up: 

G1: 44 

G2: 45 

Women, %: 

100 

Age, median 

(IQR): 

G1: 51 (44, 67) 

G2: 49 (43, 57) 

Race/ethnicity, 

%: 

Hong Kong 

Chinese: 100 

Menopausal, %: 

G1: 66.0 

G2: 45.3 

G1/G2: P = 0.073 

Inclusion criteria:

• UDS-confirmed 

detrusor 

instability 

• Age ≥ 18 

• Diagnosis of 

OAB (phasic 

detrusor 

contraction with 

an amplitude ≥

15 cmH2O by 

ICS criteria 

• ≥ 8 voids/day 

• ≥ 1 incontinent 

episodes/day 

Exclusion 

criteria: 

• Genuine SUI 

• Voiding difficulty 

(max flow rate < 

10mL/s with a 

residual volume 

of > 200mL) 

• Recurrent or 

acute UTIs 

• Intermittent or 

indwelling 

catheter 

• Hematuria or 

bladder cancer 

• Currently on 

treatment for 

OAB or on 

anticholinergic 

medications 

• Psychiatric 

disease or 

cognitive 

impairment (by 

history or 

MMSE) 

• Cardiac, hepatic, 

renal, or 

hematologic 

disorder 

• Contraindication

s for 

antimuscarinic 

agents 

• Pregnant or 

lactating 

• Women not 

using reliable 

contraception 

Overall severity, 

VAS score, wk 0, 

median (IQR): 

G1: 5.2 (5.0,7.85) 

G2: 5.7 (5.0, 8.0) 

Peak flow rate 

(mL/s), median 

(IQR) 

G1: 13.1 (10.0, 

17.4) 

G2: 13.9 (11.2, 

21.2) 

Max cystometric 

capacity (mL), 

median (IQR): 

G1: 333 (263.3, 

400.8) 

G2: 373 (293, 

416.8) 

Overall severity, 

VAS score, wk 4, 

median (IQR): 

G1: 5.0 (5.0, 7.0) 

G2: 5.0 (3.0, 6.0) 

Overall severity, 

VAS score, wk 10, 

median (IQR): 

G1: 5.0 (3.5, 6.0) 

G2: 5.0 (4.0, 6.0) 

P < 0.005 for 

change with duration of treatment, 

P < 0.005 for linear 

pattern 

Perceived change 

in symptoms, 

double-sided VAS 

score, wk 4, 

median (IQR): 

G1: 1.0 (0.0, 2.5) 

G2: 2.0 (0.0, 3.0) 

Perceived change 

in symptoms, 

double-sided VAS 

score, wk 10, 

median (IQR): 

G1: 1.0 (0.0, 2.0) 

G2: 2.0 (0.0, 3.0) 

G1/G2: P = 0.053 

ITT analysis 

G1/G2: P = 0.047 

per-protocol 

analysis 

Urinary pad 

weight (g), ITT 

analysis, median 

change (IQR): 

G1: -5.0 (-54.75, 0) 

G2: 0.0 (-4.5, -

0.75) 

G1/G2: P = 0.019 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-240 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Leung et al., 2002 

(continued)

Urinary pad 

weight (g), perprotocol analysis, 

median change 

(IQR): 

G1: -5.0 (-54.75, 0) 

G2: 0.0 (-5.0, 0) 

G1/G2: P = 0.031 

Drug compliance, 

%: 

G1: 75 

G2: 87.5 

Significance of 

variables, change 

with duration of 

treatment, ITT 

analysis: 

XQ overall 

dryness: 

P < 0.001 

XQ uncomfortable: 

P < 0.001 

XQ sleep: 

P = 0.020 

XQ speak: 

P = 0.042 

XQ swallow: 

P = 0.002 

XQ liquid: 

P = 0.005 

XQ dentures: 

P = 0.361 

Diary frequency: 

P < 0.001 

Diary urgency 

episodes: 

P = 0.109 

Diary incontinence 

episodes: 

P = 0.203 

Diary pad use: 

P = 0.593 

C-241 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Leung et al., 2002 

(continued)

Significance of 

variables, 

between groups, 

ITT analysis: 

XQ overall 

dryness: 

P = 0.062 

XQ uncomfortable: 

P = 0.285 

XQ sleep: 

P = 0.626 

XQ speak: 

P = 0.652 

XQ swallow: 

P = 0.197 

XQ liquid: 

P = 0.451 

XQ dentures: 

P = 0.480 

Diary frequency: 

P = 0.965 

Diary urgency 

episodes: 

P = 0.672 

Diary incontinence 

episodes: 

P = 0.993 

Diary pad use: 

P = 0.665 

Drug compliance 

rate (IQR): 

G1: 75.0 (8.9, 

98.8) 

G2: 87.5 (11.4, 

99.3) 

Withdrawal rate, 

%: 

G1: 17.0 

G2: 15.1 

Side effects, %: 

G1: 60.4 

G2: 49.1 

C-242 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lose et al., 2000 

Country and 

setting: 

Denmark, 26 

clinics in the Dept 

of Obstetrics & 

Gynaecology 

Outpatient Clinic 

Enrollment 

period: 

September 1994 

to April 1996 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT parallel 

group with active 

control, sequential 

numbers 

Intervention: 

oestradiolreleasing vaginal 

ring vs. oestriol 

vaginal pessaries 

(DANUGA study)

Groups: 

G1: 7.5 mg 

oestradiol per 24 h 

oestradiolreleasing vaginal 

ring x 12 wks 

G2: 1-0.5 mg 

oestriol vaginal 

pessaries per day 

x 3 wks followed 

by 1 every 2 days 

for 21 wks 

N at enrollment: 

G1: 134 

G2: 117 

N at follow-up: 

G1: 129 

G2: 114 

Age, yrs ± SD: 

G1: 65.6±9.5 

G2: 66.8 ± 9.1 

Race/ethnicity: 

NR 

Women, N (%): 

G1: 134 (100) 

G2: 117 (100) 

Height (cm) 

mean ± SD: 

G1: 164 ± 5.9 

G2: 164 ± 6.4 

Body weight (kg) 

mean ± SD: 

G1: 69.8 ± 12.7 

G2: 68.1 ± 12.4 

Inclusion criteria: 

• Women who 

reported at 

least one 

bothersome 

lower urinary 

tract symptom 

appearing at 

least two years 

after 

spontaneous 

or surgical 

postmenopaus

e 

Exclusion 

criteria: 

• known or 

suspected 

oestrogendependent 

neoplasia or 

mammary, 

ovarian 

endometrioid) 

or corpus uteri 

malignancies 

• vaginal 

bleeding of 

unknown origin

• clinically 

significant liver 

disease 

• acute or 

intermittent 

porphyria, 

uterovaginal 

prolapse of 

grade II or III 

• sex hormone 

treatment 

within the last 

6 mos 

• previous 

participation in 

clinical trials 

within 3 mos 

prior to 

inclusion 

Persistence of 

symptoms 

(months), mean 

± SD: 

G1: 74 ± 88 

G2: 80 ± 101 

Urgency %: 

G1: 84 

G2: 91 

Frequency %: 

G1: 75 

G2: 73 

Urge 

Incontinence %: 

G1: 66 

G2: 64 

Stress 

Incontinence %: 

G1: 67 

G2: 58 

Nocturia %: 

G1: 60 

G2: 66 

Dysuria %: 

G1: 25 

G2: 23 

Mucusal atrophy, 

n (%): 

G1: 127 (95) 

G2: 115 (98) 

Vaginal pH, 

mean: 

G1: 6.0 

G2: 6.0 

Urinary 

symptoms 

measured by 

VAS, mean: 

G1: 21.1 

G2: 23.2 

Concimitant 

medication n (%):

G1: 54 (41) 

G2: 50 (42) 

Responder rate, 

24 weeks, %: 

Urgency : 

G1: 51 

G2: 56 

Frequency : 

G1: 61 

G2: 58 

UUI: 

G1: 58 

G2: 58 

SUI: 

G1: 53 

G2: 59 

Nocturia: 

G1: 51 

G2: 54 

Dysuria: 

G1: 76 

G2: 63 

G1/G2: P = 0.282 

Vaginal dryness: 

G1: 77 

G2: 89 

Dyspareunia: 

G1: 75 

G2: 78 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-243 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lose et al., 2000 

(continued) 

• signs of 

vaginal 

irritation other 

than atrophy 

derived or 

signs of 

vaginal 

ulceration 

Symptom free 

rate, 24 weeks, %: 

Urgency : 

G1: 27 

G2: 33 

Frequency : 

G1: 34 

G2: 44 

G1/G2: P = 0.203

UUI: 

G1: 33 

G2: 34 

SUI: 

G1: 34 

G2: 41 

Nocturia : 

G1: 31 

G2: 35 

Dysuria : 

G1: 67 

G2: 52 

G1/G2: P = 0.244 

Vaginal dryness: 

G1: 57 

G2: 83 

G1/G2: P = 0.019 

Dyspareunia : 

G1: 61 

G2: 71 

Vaginal pH at 24 

weeks, mean: 

G1: 4.8 

G2: 4.8 

Subjective 

judgement of 

administration 

form, %: 

Excellent: 

G1: 60 

G2: 14 

Good: 

G1: 27 

G2: 34 

Acceptable: 

G1: 6 

G2: 48 

Bad: 

G1: 2 

G2: 3 

C-244 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lose et al., 2000 

(continued) 

Unacceptable: 

G1: 3 

G2: 2 

P = 0.0001 

At least 1 adverse 

events, n (%): 

49 (19.5) 

difference between 

groups = NS 

Vaginal 

discomfort, n : 

G1: 6 

G2: 13 

Leukorrhea, n : 

G1: 7 

G2: 7 

Vaginal itching, n: 

G1: 1 

G2: 4 

Breast pain, n: 

G1: 2 

G2: 3 

Vaginal 

haemorrhage, n: 

G1: 2 

G2: 2 

Weight increase, 

n: 

G1: 2 

G2: 3 

Breast discharge, 

n: 

G1: 1 

G2: 3 

Abdominal pain, 

n: 

G1: 2 

G2: 0 

Nausea, n: 

G1: 2 

G2: 0 

Headache, n: 

G1: 1 

G2: 1 

Pruritus, n: 

G1: 1 

G2: 1 

C-245 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lose et al., 2000 

(continued) 

Flushing, n: 

G1: 1 

G2: 0 

Urinary urgency, 

n: 

G1: 1 

G2: 0 

Change in body 

smell, n: 

G1: 0 

G2: 1 

Malaise, n: 

G1: 0 

G2: 1 

Hypertrichosis, n: 

G1: 0 

G2: 1Stranguria, 

n: 

G1: 1 

G2: 0 

Oedema, n: 

G1: 1 

G2: 0 

Palpitation, n: 

G1: 1 

G2: 0 

Increased 

sweating, n: 

G1: 1 

G2: 0 

Uterine 

discomfort, n: 

G1: 0 

G2: 1 

Amnesia, n: 

G1: 0 

G2: 1 

Pelvic 

inflammation, n: 

G1: 1 

G2: 0 

C-246 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Macaulay et al., 

1987 

Country and 

setting: 

UK, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

Wellcome Trust, 

trustees of St. 

George’s Hospital 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

(randomization not 

specified) 

Intervention: 

Brief eclectic 

psychotherapy, 

bladder training or 

medication 

Groups: 

G1: psychotherapy 

G2: bladder drill 

G3: Propantheline 

N at enrollment: 

G1: 19 

G2: 16 

G3: 15 

N at follow-up: 

G1: 18 

G2: 15 

G3: 14 

Women, %: 

100 

Age: 

NR 

Race/ethnicity: 

NR 

Follow-up: 

3 months 

Inclusion criteria:

• Previous 

completion of 

survey on psych 

conditions w/ 

OAB 

• Detrusor 

instability on 

UDS or sensory 

urgency 

Exclusion 

criteria: 

NR 

Detrusor 

instability, n: 

G1: 10 

G2: 8 

G3: 8 

Sensory 

urgency, n: 

G1: 9 

G2: 8 

G3: 7 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 10.8 

Bladder capacity 

(mL), mean: 

G1: 393 

G2: NR 

G3: 323 

Bladder volume 

(mL), first 

sensation, mean:

G1: 107 

G2: 110 

G3: 70 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 45.5 

G3: NR 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 8.3 

G3/BL: P < 0.005 

Bladder capacity 

(mL), mean:

G1: 414 

G2: NR 

G3: 368 

G1/BL: P = NS 

G3/BL: P = NS 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 142 

G2: 150 

G3: 137 

G1/BL: P = NS 

G2/BL: P < 0.05 

G3/BL: P = 0.06 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 29.5 

G3: NR 

G2/BL: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

- 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-247 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Malone-Lee et al., 

2003

Country and 

setting: 

UK, Hospital 

Enrollment 

period: 

1993-1999

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR

Design: 

Prospective 

observational 

Intervention: 

Oxybutynin 2.5mg 

b.i.d. and bladder 

retraining 

Groups: 

G1: urinary 

frequency and 

urgency w/ 

detrusor instability 

G2: urinary 

frequency and 

urgency w/o 

detrusor instability 

N at enrollment: 

G1: 266 

G2: 86 

N at follow-up: 

Total: 347 

G1: NR 

G2: NR 

Age, mean 

(range): 

G1: 54.8 (20, 90) 

G2: 51.8 (21, 88) 

Race/ethnicity: 

NR

Inclusion criteria:

• Women 

• Age ≥ 18 

• ≥ 8 voids/day 

Exclusion 

criteria: 

• Neurological 

disease 

• Significant stress 

incontinence 

• Symptomatic 

UTI 

• Interstitial cystitis 

Incontinence 

episodes/day, 

median (95% CI):

G1: 2 (0, 7) 

G2: 2 (0, 6.3) 

Voids/day 

median (95% CI):

G1: 14 (8, 24) 

G2: 12 (8, 22) 

Incontinence 

episodes/day, 

median change 

(95% CI): 

G1: 0 (2, 6) 

G2: 0 (2, 6) 

G1/G2: P = 0.73 

Voids/day, 

median change 

(95% CI): 

G1: -5 (1.9-14) 

G2: -5 (1-12.3) 

G1/G2: P = 0.61 

Dry mouth, n (%): 

G1: 219 (84) 

G2: 69 (70) 

Constipation, n 

(%): 

G1: 84 (32) 

G2: 19 (22) 

Heartburn, n (%): 

G1: 71 (27) 

G2: 20 (23) 

Dry skin, n (%): 

G1: 46 (18) 

G2: 4 (5) 

G1/G2: P = 0.01 

Headache, n (%): 

G1: 25 (10) 

G2: 3 (3.5) 

Dry eyes, n (%): 

G1: 12 (5) 

G2: 1 (1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: NR 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-248 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Mattiason et al., 

2003 

Country and 

setting: 

Sweden, 

Denmark, Norway 

(Tolterodine 

Scandinavian 

Study Group) 

Enrollment 

period: 

October 1999 to 

December 2000 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, singleblinded (balanced 

blocks of 4, 

computerized 

randomization list) 

Intervention: 

Pharmacologic ± 

behavioral 

therapy; 

Tolterodine 2mg 

b.i.d. ± bladder 

training (BT); 

Tolterodine 

dosage could be 

decreased to 1mg 

po b.i.d. during the 

first 2 wks if 

intolerable SE; 

BT taught with a 

written handout 

Groups: 

G1: Tolterodine + 

BT x 24 wks 

G2: Tolterodine x 

24 wks 

N at enrollment: 

Total: 505 

N at follow-up: 

G1: 244 

G2: 257 

N Completed 

treatment: 

G1: 77% 

G2: 79% 

Total: 74% 

Women, n (%) 

G1: 177 (73) 

G2: 201 (78) 

Age, median 

(range): 

G1: 62 (19, 86) 

G2: 63 (22, 86) 

Race/ethnicity: 

NR 

Follow-up: 

24 weeks 

Inclusion criteria:

• Age ≥ 18 

• ≥ 8 voids/day 

and urinary 

urgency (± UUI) 

as determined 

by 1 wk bladder 

diary 

• With or without 

UUI 

• Women of 

reproductive age 

had to be using 

reliable birth 

control 

Exclusion 

criteria: 

• Contraindication 

to antimuscarinic 

therapy 

• Use of 

electrostimulatio

n therapy or BT 

within prior 3 mo

• Indwelling 

catheter or 

intermittent 

catheterization 

• Pregnancy or 

lactation 

• Use of 

anticholinergic 

agents or 

concomitant 

treatment for 

OAB (estrogen 

permitted) 

Urgency 

episodes/day, 

mean (range): 

G1: 6.0 (0, 23.0) 

G2: 6.6 (0, 34.3) 

Incontinence 

episodes/day, 

mean (range): 

G1: 2 (0.3, 20.3) 

G2: 2.3 (0.3, 16.3)

Voids/day, mean 

(range):

G1: 10.3 (7.3, 

27.6) 

G2: 10.6 (7.7, 

24.6) 

Duration of 

symptoms > 5 

years, n (%): 

G1: 120 (49) 

G2: 124 (48) 

Previous drug 

therapy for OAB, 

n (%): 

G1: 40 (160 

G2: 35 (14) 

Previous surgery affecting 

lower urinary 

tract, n (%): 

G1: 28 (11.5) 

G2: 30 (12) 

Symptoms

caused at least 

moderate 

problems, %: 

G1: 92 

G2: 93 

 

Urgency 

episodes/day, 

median % change 

(IQR): 

G1: -38 (-76.7, 

-14.1) 

G2: -38 (-68.7, 

-8.0) 

G1/G2: P = 0.75 

Incontinence 

episodes/day, 

median IQR% 

change; n=301: 

G1: -87 (-100, -20) 

G2: -81 (-100, 

-41.8) 

G1/G2: P = 0.28 

Voids/day, 

median % change 

(IQR): 

G1: -33 (-42.3, 

21.3) 

G2: -25 (-38.8, 

-13.0) 

G1/G2: P < 0.001 

Voided volume 

(mL), median % 

change (IQR): 

G1: 31.5 (13.3, 

56.2) 

G2: 20 (3.1, 45.4) 

G1/G2: P < 0.001 

Symptoms are 

“minor or less”, 

%: 

G1: 66.5 

G2: 61.5 

Overall improvement in 

symptoms, %: 

G1: 76 

G2: 71 

Worsening of 

symptoms, %: 

G1: 3 

G2: 5 

Dry mouth, n (%):

G1: 76 (31) 

G2: 90 (35) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-249 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Mattiason et al., 

2003 

(continued) 

Headache, n (%): 

G1: 15 (6) 

G2: 21 

(8)Constipation, n 

(%): 

G1: 7 (3) 

G2: 14 (5) 

≥ 1 SE, n (%): 

G1: 158 (65) 

G2: 177 (69) 

G1/G2: P = NS 

Withdrawal due 

to, %: 

AE: 15 

Withdrawal due to 

lack of efficacy: 

3 

Withdrawal of 

consent : 

2 

Protocol 

violations: 

1 

Completed 

treatment: 

G1: 77% 

G2: 79% 

C-250 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Messelink, 1999 

Country and 

setting: 

NR 

Enrollment 

period: 

NR 

Funding: 

Pharmacia & 

Upjohn 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Compilation of 

findings from four 

Phase II and eight 

Phase III studies 

with open label 

follow-up; not all 

trials have been 

previously 

published* 

Intervention: 

Tolterodine 2mg 

b.i.d. 

Groups: 

G1: tolterodine 

2mg b.i.d. 

previously in 4 

week placebo 

controlled trial; 

continued for 12 

months open label 

G2: tolterodine 

2mg b.i.d. 

previously in 12 

week placebo 

controlled trial 

continued for 9 

months open label

N at enrollment: 

G1: 135 

G2: 121 

N at follow-up: 

G1: 135 

G2: 121 

Age, yrs (range): 

G1: 60 (18, 92) 

G2: 61 (18, 88) 

Race/ethnicity: 

NR 

Women, %: 

G1: 68 

G2: 76 

Parity: 

NR 

Inclusion criteria: 

• Participants in 

prior trials 

(details NR) 

• Proceeded into 

long term open 

label study 

Exclusion 

criteria: 

• NR 

Incontinence 

episodes/day, 

mean: 

G1: 2.9 

G2: 3.5 

Voids/day, mean:

G1: 10.9 

G2: 11.4 

Voided volume 

(mL), mean: 

G1: 159 

G2: 159 

Incontinence 

episodes/day, 3 

months, mean: 

G1: ND 

G2: 1.4 

Incontinence 

episodes/day, 

6 months, mean: 

G1: 1.4 

G2: ND 

Incontinence 

episodes/day, 9 

months, mean: 

G1: ND 

G2: 1.5 

Incontinence 

episodes/day, 12 

months, mean: 

G1: 1.6 

G2: ND 

Voids/day, 3 

months, mean: 

G1: ND 

G2: 8.8 

Voids/day, 6 

months, mean: 

G1: 8.6 

G2: ND 

Voids/day, 9 

months, mean: 

G1: ND 

G2: 8.9 

Voids/day, 12 

months, mean: 

G1: 8.6 

G2: ND 

Voided volume 

(mL), 3 months, 

mean: 

G1: ND 

G2: 201 

Voided volume, 

(mL), 6 months, 

mean: 

G1: 193 

G2: ND 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-251 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Messelink, 1999 

(continued) 

Voided volume 

(mL), 9 months, 

mean: 

G1: ND 

G2: 199 

Voided volume 

(mL), 12 months, 

mean: 

G1: 190 

G2: ND 

C-252 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Michel et al., 

2002 

Country and 

setting: 

Germany, 

Community 

Enrollment 

period: 

NR 

12 week follow up 

Funding: 

Pharmacia GmbH

Author industry 

relationship 

disclosures: 

1 of 4 

Pharmacia(1) 

SanofiSynthelabo(1) 

Design: 

Open-label 

observational 

post-marketing 

surveillance 

Intervention: 

Tolterodine 

Groups: 

Tolterodine 

Median dose: 2 

mg daily 

Dose (mg), mean 

± SD: 

3.81 ± 1.16 

N at enrollment: 

2,250 

N at follow-up: 

1,979 

Women, n (%): 

1,730 (76.9) 

Age, mean ± SD: 

61.1 ± 13.8 

Race/ethnicity: 

NR 

BMI, kg/m2

 ± SD: 

73.2 ± 11.3 

Inclusion criteria: 

• Physician 

medical 

judgement 

Exclusion 

criteria: 

NR 

Urgency 

episodes/day, 

mean ± SD: 

8.4 ± 5.1 

Incontinence 

episodes/day, 

mean ± SD: 

3.4 ± 4.2 

Voids/day, mean 

± SD: 

12.4 ± 4.3 

Urgency 

episodes/day, 

mean ± SD: 

2.0 ± 3.0 

P = NR 

Incontinence 

episodes/day, 

mean ± SD: 

 0.8 ± 2.0 

P = NR 

Voids/day, mean 

± SD: 

 7.7 ± 2.7 

P = NR 

Urgency, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

0.764 

(0.583, 1.001) 

P = 0.0508 

Age, years: 0.981 

(0.973, 0.990) 

P < 0.001 

Frequency, BL 

episodes/day: 

1.038 

(0.997- 1.080) 

P = 0.0724 

Urgency, BL 

episodes/day: 

0.851 

(0.823, 0.880) 

P < 0.001 

Incontinence, BL 

episodes/day: 

0.979 

(0.950, 1.000) 

P = 0.1735 

Tolterodine dose, 

mg/day: 0.913 

(0.830, 1.005) 

P = 0.0623 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-253 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2002 

(continued) 

Incontinence, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

1.453 (1.062, 

1.990) 

P = 0.0196 

Age, years: 0.978 

(0.968, 0.987) 

P < 0.001 

Frequency, BL 

episodes/day: 

1.034 

(0.993, 1.076) 

P = 0.1036 

Urgency, BL 

episodes/day: 

1.053 

(1.018, 1.088) 

P = 0.0027 

Incontinence, BL 

baseline 

episodes/day: 

0.744 

(0.716, 0.774) 

P < 0.001 

Tolterodine dose, 

mg/day: 0.866 

(0.784, 0.956) 

P = 0.0043 

C-254 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2002 

(continued) 

Frequency, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

0.745 

(0.552, 1.004) 

P = 0.0532 

Age, years: 0.981 

(0.971, 0.991) 

P = 0.001 

Frequency, BL 

episodes/day: 

0.735 

(0.701, 0.771) 

P < 0.001 

Urgency, BL 

episodes/day: 

1.008 

(0.975, 1.041) 

P = 0.6526 

Incontinence, BL 

episodes/day: 

0.969 

(0.937, 1.002) 

P = 0.0644 

Tolterodine dose, 

mg/day: 1.070 

(0.957, 1.196) 

P = 0.2335 

C-255 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2002 

(continued) 

Effect on Global 

efficacy, OR (95% 

CI): 

Gender, M/F: 

0.656 (0.526, 

0.818) 

P = 0.0002 

Age, years: 0.986 

(0.980, 0.993) 

P < 0.001 

Frequency, BL 

epsidoes/day: 

1.002 

(0.972, 1.033) 

P = 0.8896 

Urgency, BL 

episodes/day: 

1.009 

(0.984, 1.033) 

P = 0.4906 

Incontinence, BL 

episodes/day: 

0.963 

(0.939, 0.987) 

P <

0.0026Tolterodine 

dose, mg/day: 

1.000 (0.926, 

1.080) 

P = 0.9971 

C-256 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2002 

(continued) 

Effect on global 

tolerability of 

Tolterodine, OR 

(95% CI):

Gender, M/F: 

0.993 (0.790, 

1.249) 

P = 0.9519 

Age, years: 0.995 

(0.988, 1.002) 

P = 0.1915 

Frequency, BL 

episodes/day: 

1.002 

(0.971, 1.034) 

P = 0.8995 

Urgency, BL 

episodes/day: 

1.022 

(0.997, 1.048) 

P = 0.08 

Incontinence, BL 

episodes/day: 

0.990 

(0.965, 1.016) 

P < 0.459 

Tolterodine dose, 

mg/day: 1.114 

(1.028, 1.206) 

P = 0.008589 

C-257 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Michel et al., 

2007* 

Michel et al., 

2005 

Country and 

setting: 

Germany, NR 

Enrollment 

period: 

November 2001 

to June 2003 

Funding: 

Pharmacia 

(became Pfizer 

before 

publication) 

Author industry 

relationship 

disclosures: 

5 of 5* 

4SC (1) 

Astellas (1) 

Boehringer 

Ingelheim (2) 

Eli Lilly (2) 

Pfizer (4) 

Theravance (1) 

Anformed (1) 

Design: 

Retrospective 

cohort, open label 

Intervention: 

Tolterodine ER 

Groups: 

G1: Incontinent 

G2: Continent 

N at enrollment: 

Total: 3,824 

G1: 2,571 

G2: 1,253 

N at follow-up: 

Total: 3,416 

Women, %: 

Total: 75.8

G1: 81.7 

G2: 62.6 

P < 0.001 

Age, mean ± SD: 

Total: 64.8 ± 13.3 

G1: 66.3 ± 12.6 

G2: 61.4 ± 14.1 

P < 0.001 

Race/ethnicity: 

NR 

Follow-up: 

9 months 

Inclusion criteria:

NR 

Exclusion 

criteria: 

NR 

Urgency 

episodes/day, 

mean ± SD: 

Total: 7.9 ± 5.2 

G1: 8.0 ± 5.2 

G2: 7.7 ± 5.2 

P = 0.1937 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 4.8 ± 3.7 

G2: NA 

Voids/day, mean 

± SD: 

Total: 14.0 ± 4.6 

G1: 14.1 ± 4.6 

G2: 13.5 ± 4.4 

P < 0.001 

Daytime voids/ 

day, mean ± SD: 

Total: 10.7 ± 3.7 

G1: 10.8 ± 3.7 

G2: 10.4 ± 3.4 

P = 0.0128 

Frequency ≥ 8 

voids/day, %: 

G1: 95.7 

G2: 95.2 

Nocturia 

episodes/day, 

mean ± SD: 

Total: 3.4 ± 1.7 

G1: 3.5 ± 1.8 

G2: 3.2 ± 1.6 

P < 0.001 

Pad use/day, 

mean ± SD: 

G1: 3.4 ± 2.8 

G2: 0.1 ± 0.6 

P < 0.001 

Duration of 

symptoms (mos), 

mean ± SD: 

G1: 50 ± 53 

G2: 40 ± 46 

P < 0.001 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -3.8 ± 3.5 

G2: NA 

Urgency 

episodes/day, 

mean ± SD: 

Total: 1.6 ± 2.8 

No urgency, %: 

G1: 53.4 

G2: 63.2 

Voids/day, mean 

± SD: 

Total: 7.5 ± 3.0 

Daytime voids/ 

day, mean ± SD: 

Total: 6.2 ± 2.3 

Frequency ≥ 8 

voids/day, %: 

G1: 43.7 

G2: 39.1 

Nocturia 

episodes/day, 

mean ± SD: 

Total: 1.4 ± 1.1 

Pad use/day, 

mean change ± 

SD: 

G1: -2.4 ± 2.5 

Limitation of daily 

activities, score 

change ± SD: 

G1: 4.49 ± 2.65 

G2: 4.10 ± 2.51 

Limitations in 

daily life caused 

by bladder problems, score ± SD: 

G1: 7.59 ± 1.65

G2: 6.66 ± 1.69

P < 0.001 

Total adverse 

events, n (%): 

Total: 496 (13.0) 

Dry mouth, n (%): 

299 (7.8) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: 

NR 

Drop-out rates: NA 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-258 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2007* 

Michel et al., 

2005 

(continued) 

Previous 

treatment, %: 

G1: 50.8 

G2: 44.8 

P = 0.0007

Withdrew: 11% 

Unable to 

tolerate 

medication: 2.8% 

Administrative 

reasons: 2.6% 

Lack of efficacy :

2.4% 

Patient request:

1.2% 

C-259 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Michel et al,, 

2008 

Country and 

setting: 

Germany, 50% of 

office-based 

urologists 

Enrollment 

period: 

September 2004 

to November 

2005 

Funding: 

Astellas Pharma 

GmbH

Author industry 

relationship 

disclosures:

3 of 4 

Astellas (3) 

Bayer (1) 

Boehringer (1) 

Elbion (1) 

Eli Lilly (1) 

Pfizer (1) 

Design: 

Case series 

Intervention: 

Solifenacin 5-10 

mg qd x 12 wks 

(initial dose could 

be adjusted at first 

and second 

follow-up visits) 

Groups: 

NA 

N at enrollment: 

4,450 

N at follow-up: 

4,146 

Age, mean ± SD: 

63.6 ± 13.1 

Weight (kg), 

mean ± SD: 

75.5 ± 12.3 

Height (cm), 

mean ± SD: 

167 ± 7 

Race/ethnicity: 

”the vast majority 

of OAB patients in 

Germany are 

Caucasian”

Women, %: 

83.5 

Follow-up: 

12 weeks 

Inclusion criteria:

• Age ≥ 18 

Exclusion 

criteria: 

NR

Duration of OAB 

(years), mean ± 

SD: 

2.9 ± 3.7 

Duration of OAB 

(years), median 

(range): 

1.5 (0-34.6) 

Previous OAB 

drug treatment, 

%:

Herbal drugs: 28 

Oxybutynin: 23 

Trospium chloride: 

20 

Tolterodine: 13 

Topical estrogens: 

12 

No treatment: 30 

Previous nonpharma OAB 

treatment, %:

Absorbent 

products: 51 

Pelvic floor 

exercises: 41 

Bladder training: 

22 

No treatment: 30 

Initial solifenacin 

dose, %: 

5 mg: 93.4 

10 mg: 6.1 

Final solifenacin 

dose, %: 

5 mg: 78.7 

10 mg: 20.8 

Heart rate 

(beats/min), 

mean ± SD:

75.2 ± 8.2 

Blood pressure 

(mm Hg), mean ± 

SD:

137 ± 15 / 82 ± 7 

Mult regression 

analysis of the 

presence of trtemergent AEs, 

OR (95% CI): 

Male sex: 0.840 

(0.559,1.265) 

P = 0.4042 

Age: NA 

P = 0.0019 

Age 41-50: 1.144 

(0.363, 3.608) 

P = 0.8180 

Age 51-60: 1.773 

(0.614, 5.119) 

P = 0.2900 

Age 61-70: 1.941 

(0.682, 5.524) 

P = 0.2137 

Age 71-80: 1.816 

(0.627, 5.262) 

P = 0.2715 

Age > 80: 3.902 

(1.327, 11.472) 

P = 0.0133 

BMI (kg/m2

): NA 

P = 0.9052 

Comedication 

present: 1.768 

(1.219, 2.564) 

P = 0.0027 

CHD/MI present: 

0.997 

(0.667, 1.491) 

P = 0.9892 

CHF present: 

1.243 

(0.774, 1.997) 

P = 0.3684 

Diabetes mellitus 

present: 1.083 

(0.762, 1.541) 

P = 0.6557 

Heart rate (beats/ 

min), mean ± SD:

74.5 ± 7.6 

Blood pressure 

(mm Hg), mean ± 

SD:

134 ± 13 / 81 ± 8 

Treatmentemergent AEs, n 

(%): 

215 (4.8) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: NA

Method and 

blinding: NA 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

 

C-260 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2008 (continued) 

Leukocyturia, n 

(%): 

48 (1.1)

Dry mouth, n (%): 

31 (0.7)

Haematuria, n 

(%): 

26 (0.6)

Constipation, n 

(%): 

20 (0.4)

Proteinuria, n (%): 

17 (0.4)

UTI, n (%): 

15 (0.3)

Nausea, n (%): 

14 (0.3)

Nitrate present in 

urine, n (%): 

13 (0.3)

Bacteriuria, n (%): 

9 (0.2)

Glycosuria, n (%): 

7 (0.2)

Discontinued dt 

AEs, n (%): 

62 (1.4) 

C-261 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Millard et al., 

1999 

Country and 

setting: 

Australia & US, 

Academic 

medical centers 

Enrollment 

period: 

NR 

Funding: 

Pharmacia and 

Upjohn AB 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine 1 mg 

vs. tolterodine 2 

mg vs. placebo 

Groups: 

G1: tolterodine 1 

mg x 12 wks 

G2: tolterodine 2 

mg x 12 wks 

G3: placebo x 12 

wks 

N at enrollment: 

G1: 129 

G2: 123 

G3: 64 

N at follow-up: 

G1: 114 

G2: 116 

G3: 61 

Women, %: 

G1: 78 

G2: 77 

G3: 66 

Age, mean 

(range): 

G1: 60.1 (24-89) 

G2: 60.2 (24-83) 

G2: 60.5 (25-84) 

BMI, kg/m2

(range): 

G1: 28.0 (17.2-

47.2) 

G2: 27.3 (16.6-

51.4) 

G2: 26.8 (19.9-

47.1) 

Inclusion criteria: 

• Age ≥ 18 

• Cystometrically 

proved DO 

• Average urinary 

frequency ≥8 

voids/day 

• UI (≥ 1 

incontinence 

episodes/day) 

and/or urinary 

urgency 

• Adequate 

contraception 

Exclusion 

criteria: 

• SUI 

• Voiding difficulty 

(max flow rate < 

10 mL/second 

with post-void 

residual volume 

> 200 mL) 

• Recurrent UTI 

• Interstitial 

cystitis 

• Hematuria 

• Bladder cancer 

• Intermittent 

catheterization 

or indwelling 

catheter 

• Hepatic or renal 

disease 

• Narrow angle 

glaucoma 

• Electrostimulation for 

bladder training 

• Started primarily 

anticholinergic 

drug ≤ 14 days 

• Unstable dose 

of any treatment 

with 

anticholinergic 

side effects 

• Average total 

voided volume 

>3 L/24 h 

Urgency, %: 

G1: 100 

G2: 100 

G3: 98 

Incontinence, %: 

G1: 88 

G2: 90 

G3: 86 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 3.9 ± 4.0 

G2: 3.6 ± 4.0 

G3: 3.5 ± 3.2 

Incontinence 

episodes/day, 

mean (range): 

G1: 3.9 (0.1-24.0) 

G2: 3.6 (0.3-24.0) 

G3: 3.5 (0.1-18.4) 

≥ 8 voids/day, %:

G1: 99 

G2: 98 

G3: 98 

Voids/day, mean 

± SD: 

G1: 11.5 ± 3.7 

G2: 11.2 ± 3.1 

G3: 11.3 ± 3.4 

Voids/day, mean 

(range): 

G1: 11.5 (7.0-

26.3) 

G2: 11.2 (6.3-

22.0) 

G3: 11.3 (7.1-

21.7) 

Duration of 

symptoms > 5 

yrs, %: 

G1: 44 

G2: 49 

G3: 47 

Detrusor 

instability, %: 

G1: 87 

G2: 88 

G3: 91 

Incontinence 

episodes/day, 

mean change ± 

SD (mean % 

change): 

G1: -1.7 ± 2.8 (-43) 

G2: -1.7 ± 2.5 (-50) 

G3: -1.3 ± 2.5

G1/G3: P = 0.27 

G2/G3: P < 0.19 

Voids/day, mean 

change ± SD: 

G1: -2.3 ± 3.0 (-20) 

G2: -2.3 ± 2.1 (-25) 

G3: -1.4 ± 2.3

G1/G3: P = 0.0029 

G2/G3: P = 0.045 

Patients 

achieving 

normalized 

voiding 

frequency, %: 

G1: 26 

G2: 43 

G3: 26 

G2/G3: P = 0.012 

G2/G1: P = 0.022 

Complete cure, 

%: 

G1: 19 

G2: 11 

G3: 10

Compliance (12 of 

14 wks), %: 

G1: 87 

G2: 89 

Perceived 

improvement, %: 

G1: 41 

G2: 59 

G3: 38 

G2/G3: P = 0.015 

G2/G1: P = 0.018 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-262 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard et al., 

1999 

(continued)

• Treatment with 

any 

investigational 

drug during or 2 

mos before 

study 

Hyper reflexia, 

%:

G1: 13 

G2: 12 

G3: 9 

Severe problems, patient 

perception, %: 

G1: 42 

G2: 50 

G3: 36 

Previous therapy 

for UI, %: 

G1: 50 

G2: 47 

G3: 48 

Previous therapy 

for UI, good 

efficacy 

response, %: 

G1: 39 

G2: 48 

G3: 45 

Previous lower 

urinary tract 

surgery, %: 

G1: 35 

G2: 33 

G3: 30

Voided volume 

(mL), mean ± SD:

G1: 151 ± 56 

G2: 155 ± 52 

G3: 158 ± 53 

Voided volume 

(mL), mean 

(range): 

G1: 151 (34-334) 

G2: 155 (32-304) 

G3: 158 (47-299) 

Bladder volume 

(mL), initial 

contraction, 

mean (range): 

G1: 167 (4-600) 

G2: 188 (7-520) 

G3: 212 (6-600) 

Voided volume 

(mL), mean 

change ± SD:

G1: 27 ± 41 

G2: 36 ± 50 

G3: 10 ± 47 

G1/G3: P = 0.0059 

G2/G3: P < 0.0001 

Minor 

noncholinergic 

and cholinergic 

AEs, %: 

G1: 74 

G2: 73 

G3: 78 

AEs per patient, 

mean: 

G1: 1.9 

G2: 2.2 

G3: 2.0 

Autonomic 

nervous system 

disorders, %: 

G1: 29 

G2: 43 

G3: 17 

Dry mouth, %: 

G1: 24 

G2: 39 

G3: 13 

Dry mouth, 

severe, %: 

G1: 1 

G2: 2 

G3: 2 

Dry eyes, %: 

G1: 2 

G2: 6 

G3: 2 

Serious AEs, n 

(%): 

G1: 5 (4) 

G2: 7 (5) 

G3: 5 (4) 

G3: 2 

C-263 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard et al., 

1999 

(continued) 

Post voiding 

residual volume 

(mL), mean 

(range): 

G1: 28 (0-180) 

G2: 25 (0-178) 

G3: 33 (0-200) 

Max flow rate, 

(mL/sec), mean 

(range): 

G1: 18 (2-56) 

G2: 20 (3-70) 

G3: 19 (5-57) 

Detrusor 

overactivity ≥ 10 

cm, %: 

G1: 98 

G2: 98 

G3: 98 

Max wave height 

(cm), mean 

(range): 

G1: 44 (2-144) 

G2: 45 (2-165) 

G3: 52 (4-188) 

Severe AEs 

possibly 

indicating cardiac 

dysfunction, %: 

G1: 0 

G2: 2 

Nonserious 

cardiac AEs, %: 

G1: 3 

G2: 3 

G3: 6 

Discontinued due 

to AEs, n (%): 

G1: 2 (2) 

G2: 8 (6) 

G3: 0 

C-264 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Millard, 2004 

Country and 

setting: 

International, 

Multicenter study, 

54 sites

Enrollment 

period: 

NR

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Tolterodine ± 

simplified pelvicfloor exercise 

regimen for 24 

weeks 

Groups: 

G1: tolterodine 2 

mg b.i.d. and 

simple pelvic floor 

muscle exercise 

(PFME) program 

G2: tolterodine 2 

mg b.i.d. daily 

N at enrollment: 

G1: 227 

G2: 253 

N at follow-up, 12 

weeks, n (%): 

G1: 181 (79.7) 

G2: 205 (81.0) 

N at follow-up, 24 

weeks, n (%): 

G1: 164 (72.2) 

G2: 190 (75.1) 

Women, n (%): 

G1: 169 (75.4) 

G2: 190 (75.4) 

Age, mean ± SD: 

G1: 53.6 ± 16.9 

G2: 53.2 ± 17.4 

Race/ethnicity: 

Asian: 

G1: 176 (78.6) 

G2: 203 (80.6) 

White/mixed: 

G1: 48 (21.4) 

G2: 49 (19.4) 

Inclusion criteria: 

• Age 18-90 

• ≥ 8 voids/day 

• Urgency 

• ≥ 1 UI episode/d

• sx for ≥ 6 

months 

Exclusion 

criteria: 

• Symptomatic SI 

• Significant PVR 

volume 

• Neuropathy 

• Glaucoma 

• UTI 

• + urine cytology 

• Use of 

concomitant 

anticholinergic 

therapy w/in 14 

days of 

randomization 

Urgency 

episodes/day, 

mean ± SD: 

G1: 4.2 ± 3.6 

G2: 4.1 ± 4.0 

Urgency 

episodes/day, 

median (IQR): 

G1: 3.6 (1.3-6.0) 

G2: 3.0 (1.3-6.0) 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 3.44 ± 3.4 

G2: 3.21 ± 3.4 

Incontinence 

episodes/day, 

median (IQR): 

G1: 2.3 (1.3-4.0) 

G2: 2.9 (1.3-3.7) 

Voids/day, mean 

± SD: 

G1: 11.87 ± 4.3 

G2: 12.78 ± 5.6 

Voids/day, 

median (IQR): 

G1: 10.7 (9.0-

13.7) 

G2: 11.3 (9.0-

15.0) 

Voided volume 

(mL), mean ± SD:

G1: 146.1 ± 67.7 

G2: 146.0 ± 83.3 

Voided volume 

(mL), median 

(IQR): 

G1: 137 (98-186) 

G2: 132 (99-189) 

Duration of 

symptoms, n (%):

≤ 5 years: 

G1: 166 (74.1) 

G2: 173 (68.7) 

> 5 years: 

G1: 56 (25) 

G2: 78 (31) 

Urgency 

episodes/day, 

wk 12, mean 

change ± SD (% 

change): 

G1: -1.9 ± 4.0 

(-64.5) 

G2: -2.2 ± 3.6 

(-69.8) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Urgency 

episodes/day, 

wk 12, median 

change: 

G1: -1.6 

G2: -1.3 

G1/G2: P = 0.7658 

Urgency 

episodes/day, 

wk 24, mean 

change ± SD (% 

change): 

G1: -2.2 ± 3.6 

(-78.7) 

G2: -2.7 ± 3.5 

(-83) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Urgency 

episodes/day, 

wk 24, median 

change: 

G1: -1.9 

G2: -2.0 

G1/G2: P = 0.3029 

Incontinence 

episodes/day, 

wk 12, mean 

change ± SD: 

G1: -2.15 ± 3.0 

G2: -2.15 ± 2.7 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 0.2215 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-265 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

Previous UT 

surgery, n (%): 

G1: 44 (19.6) 

G2: 43 (17.1) 

Prev anticholinergics, n (%): 

G1: 19 (8.5) 

G2: 14 (5.6) 

Prev UUI drug, n 

(%): 

G1: 101 (45.1) 

G2: 91 (36.1) 

Patient subjective rating of 

UI symptoms as 

“severe” or 

“many severe”, 

%: 

G1: 54.0 

G2: 56.8 

Incontinence 

episodes/day, 

wk 12, median 

change: 

G1: -1.6 

G2: -1.6 

G1/G2: P = 0.8251 

Incontinence 

episodes/day, 

wk 24, mean 

change ± SD (% 

change): 

G1: -2.23 ± 3.0 

(-64) 

G2: -2.26 ± 3.0 

(-70) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Incontinence 

episodes/day,

wk 24, median 

change: 

G1: -1.6 

G2: -1.6 

G1/G2: P = 0.8341 

Voids/day, wk 12, 

mean change ± 

SD (% change): 

G1: -2.68 ± 3.8 

(-22) 

G2: -3.42 ± 4.6 

(-26) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 0.9478 

Voids/day, wk 24, 

mean change ± 

SD (% change): 

G1: -2.58 ± 5.0 

(-22) 

G2: -3.58 ± 5.2 

(-26) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 0.3549 

C-266 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

Voided volume 

(mL), wk 12, 

median change 

(% change):

G1: 20.4 (17.2) 

G2: 17.5 (15.8) 

Voided volume 

(mL), wk 12, 

median change 

(% change): 

G1: 21.1 (18.1) 

G2: 19.1 (15.4) 

Patient subjective 

report of improvement in bladder 

condition, wk 12, 

%: 

G1: 82.6 

G2: 83.9 

Patient subjective 

report of improvement in bladder 

condition, wk 24, 

%: 

G1: 81.7 

G2: 85.9 

Adverse events, n 

(%): 

G1: 22 (9.7) 

G2: 23 (9.1) 

Mild dry mouth, 

%: 

G1: 18.1

G2: 21.3

Moderate dry 

mouth, %: 

G1: 7.5

G2: 5.1

Severe dry 

mouth, %: 

G1: 4.0

G2: 3.2 

Headache, %: 

6 

Constipation, %: 

4.8

Nausea, %: 

2.7 

C-267 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

Dry eyes, %: 

2.5 

Dizziness, %: 

2.4 

C-268 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Minassian et al., 

2007

Country and 

setting: Canada, 

Tertiary care 

center

Enrollment 

period: 

February 2003 to 

December 2005

Funding: 

Janssen-Ortho 

Inc.

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention:

Oxybutynin XL vs 

oxybutynin IR 

Groups: 

G1: oxybutynin XL 

5 mg qd after 4 

weeks non 

responders to 

oxybutynin XL 10 

mg qd 

G2: oxybutynin IR 

2.5 mg t.i.d. after 

4 weeks non 

responders to 

oxybutynin 5 mg 

t.i.d. 

N at enrollment: 

G1: 39 

G2: 33 

N at follow-up: 

G1: 35 

G2: 27 

Age, mean ± SD:

G1: 75 ± 6 

G2: 73 ± 5

Women, %: 

G1: 100 

G2: 100 

Race/ethnicity: 

NR 

Height, cm ± SD: 

G1: 158 ± 6 

G2: 159 ± 5 

Weight, kg ± SD: 

G1: 73 ± 14 

G2: 76 ± 14 

BMI, kg/m2

 ± SD: 

G1: 29 ± 5 

G2: 30 ± 5 

Parous, %:

G1: 85 

G2: 88 

Inclusion criteria: 

• Symptoms of 

OAB (ICS) 

• Female 

• Age > 65 

• Communitydwelling 

• OAB main 

presenting 

symptom, 2-

week washout if 

on 

anticholinergic 

medication 

Exclusion 

criteria: 

• Bedridden 

• Permanent 

indwelling 

catheter 

• MMSE score 

<24 

• Glaucoma 

• Gastric retention 

or bowel 

obstruction 

• History of allergy 

to anticholinergic 

medications 

• Taking tricyclic 

antidepressants 

or anticholinesterase 

inhibitors 

• Post-void 

residual bladder 

volume >100 mL

• History of 

neurologic 

disorder 

UUI, %: 

G1: 95 

G2: 94 

SUI, %: 

G1: 67 

G2: 52 

Urgency, %: 

G1: 100 

G2: 97 

Incontinence 

episodes/day, 

median (IQR): 

G1: 2 (0, 4) 

G2: 1 (0, 3) 

Frequency 

episodes/day, 

median (IQR): 

G1: 9 (7, 11) 

G2: 10 (8, 12) 

Voids/day, 

median (IQR): 

G1: 13 (10, 16) 

G2: 14 (11, 16) 

Nocturia 

episodes/day, 

median (IQR): 

G1: 2 (2, 3) 

G2: 3 (2, 4) 

Pads/day, 

median (IQR): 

G1: 1 (0, 3) 

G2: 1 (0, 3) 

Mini-mental state 

exam, median 

score (IQR): 

G1: 29 (29, 30) 

G2: 30 (28, 30) 

U-IIQ, activities 

score ± SD: 

G1: 2.7 ± 0.9 

G2: 3.1 ± 1.1 

U-IIQ, travel 

score ± SD: 

G1: 2.4 ± 1.3 

G2: 2.8 ± 1.6 

Incontinence 

episodes/day, 

12 wks, median 

(IQR): 

G1: 1 (0, 2) 

G2: 0 (0, 1) 

P = 0.05 

Frequency 

episodes/day, 

wk 1-12, median 

change (IQR): 

G1: -1.4 (-3.3, 0.4) 

G2: -1.3 (-4.1, 0.3) 

P = 0.65 

Voids/day, wk 12, 

median (IQR): 

G1: 11 (9, 13) 

G2: 11 (9, 14) 

P = 0.35 

Pads/day, 12 wks, 

median (IQR): 

G1: 0 (0, 2) 

G2: 0 (0, 1) 

P = 0.53 

U-IIQ, activities 

score ± SD: 

G1: 2.2 ± 1.0 

G2: 2.1 ± 1.2 

P = 0.73 

U-IIQ, travel score 

± SD: 

G1: 2.0 ± 1.1 

G2: 1.9 ± 1.2 

P = 0.79 

U-IIQ, physical 

activities score ± 

SD: 

G1: 2.3 ± 1.3

G2: 1.9 ± 1.2 

P = 0.45 

U-IIQ, feelings 

score ± SD: 

G1: 2.0 ± 1.1 

G2: 1.9 ± 1.3 

U-IIQ, 

relationships 

score ± SD: 

G1: 1.4 ± 0.9 

G2: 1.5 ± 1.0 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-269 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Minassian et al., 

2007 

(continued) 

U-IIQ, physical 

activities score ± 

SD: 

G1: 2.4 ± 1.2 

G2: 2.6 ± 1.5 

U-IIQ, feelings 

score ± SD: 

G1: 2.5 ± 1.2 

G2: 2.7 ± 1.5 

U-IIQ, 

relationships 

score ± SD: 

G1: 1.7 ± 0.6 

G2: 2.0 ± 1.4 

U-UDI, mean 

score ± SD: 

G1: 2.9 ± 0.6 

G2: 2.7 ± 0.8 

Voided volume 

(mL), median 

(IQR): 

G1: 142 (109, 

192) 

G2: 138 (108, 

165) 

Postvoid residual 

volume (mL), 

median (IQR): 

G1: 0 (0, 23) 

G2: 0 (0, 22) 

Urine culture 

positive, % 

G1: 8 

G2: 9 

Previous 

prolapse/ 

incontinence 

surgery, %: 

G1: 13 

G2: 49 

Positive cough 

test, lying, %: 

G1: 26 

G2: 15 

U-UDI, mean 

score ± SD: 

G1: 2.1 ± 1.0 

G2: 1.7 ± 1.0 

P = 0.10 

Voided volume 

(mL), 12 wks, 

median (IQR): 

G1: 164 (129, 187) 

G2: 161 (114, 109) 

P = 0.78 

Postvoid residual 

volume (mL), 12 

wks, median 

(IQR): 

G1: 0 (0, 29) 

G2: 4 (0, 87) 

P = 0.33 

Remained on 

med, 12 wks, %: 

G1: 70 

G2: 61 

P = 0.42 

Experienced side 

effects, %: 

G1: 51 

G2: 57 

Dry mouth, n: 

G1: 14 

G2: 16 

Gastro-intestinal, 

n: 

G1: 6 

G2: 2 

C-270 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Minassian et al., 

2007 

(continued) 

Positive cough 

test, standing, %:

G1: 33 

G2: 15 

C-271 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Molander et al., 

1991 

Country and 

setting: Sweden, 

Academic 

hospital 

Enrollment 

period: 

NA 

Funding: 

Goteborg Medical 

Society, 

University of 

Goteborg 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Case series

Intervention: 3mg 

estriol qd for 1 mo, 

then 1-2 mg estriol 

qd for 2 mos 

Groups: 

G1: Intervention 

among SUI 

G2: Intervention 

among UUI 

G3: Intervention 

among MUI 

N at enrollment: 

G1: 91 

G2: 113 

G3: 142 

N at follow-up: 

G1: 55 

G2: 69 

G3: 82 

Women, %: 

100 

Age, mean (SE): 

G1: 70.1 (1.9) 

G2: 73.5 (1.2) 

G3: 72.6 (1.3) 

Race/ethnicity: 

NR 

Parity, mean 

(SE): 

G1: 2.0 (0.2) 

G2: 1.7 (0.1) 

G3: 1.9 (0.1) 

Menopausal age, 

mean (SE): 

G1: 49.6 (0.4) 

G2: 49.1 (0.4) 

G3: 48.8 (0.5) 

Inclusion criteria: 

• Self-reported UI 

(with UUI 

defined as

involuntary urine 

loss preceded 

by the urge to 

void or 

uncontrollable 

voiding with little 

or no warning; 

SUI definded as 

involuntary 

urinary loss 

precipitated by 

coughing, 

sneezing, or 

physical 

exertion; and 

MUI defined as 

a combination of 

UUI+SUI) 

Exclusion 

criteria: 

NR 

Total leakage/48 

hours (mL), 

mean (SEM): 

G1: 25.2 (6.1) 

G2: 44.4 (9.8) 

G3: 65.1 (11.5) 

Max single 

leakage/48 

hours, mean 

(SE): 

G1: 14.0 (3.1) 

G2: 21.7 (3.6) 

G3: 31.5 (3.1) 

Voids/day, mean 

(SE): 

G1: 6.9 (0.3) 

G2: 8.4 (0.3) 

G3: 7.6 (0.3) 

Total voided 

volume/day (mL), 

mean (SE): 

G1: 1405 (68) 

G2: 1515 (71) 

G3: 1497 (68) 

Max voided 

volume (mL)/day, 

mean (SE): 

G1: 401 (22) 

G2: 396 (23) 

G3: 383 (18) 

Total leakage/48 

hours (mL), mean 

(SEM): 

G1: 19.7+/-6.1 

G2: 37.3+/-11.9 

G3: 26.2+/-6.8 

G3/BL: P < 0.01 

Max single 

leakage/48 hours, 

mean (SE): 

G1: 11.3 (3.1) 

G2: 19.2 (4.6) 

G3: 16.1 (4.2) 

G3/BL: P < 0.05 

Voids/day, mean 

(SE): 

G1: 7.1 (0.4) 

G2: 7.9 (0.4) 

G3: 7.4 (0.4) 

G2/BL: P < 0.05 

Total voided 

volume/day (mL), 

mean (SE): 

G1: 1539 (67) 

G2: 1481 (74) 

G3: 1483 (88) 

Max voided 

volume (mL)/day, 

mean (SE): 

G1: 438 (24) 

G2: 399 (27) 

G3: 392 (26) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-272 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Moore et al., 1990 

Moore and 

Sutherst, 1990* 

Country and 

setting: 

UK, academic 

health center

Enrollment 

period: 

NR

Funding: 

Tillots 

Laboratories 

NR*

Author industry 

relationship 

disclosures: 

NR 

Design: RCT with 

crossover

Intervention: 

oxybutynin 

hydrochloride vs 

placebo 

Groups: 

G1:oxybutynin 

hydrochloride 3 

mg t.i.d. 

G2:placebo 

N at enrollment: 

53

N at follow-up: 

G1: 27 

G2: 22 

Age, mean ± SD: 

G1: 46.0 ± 11.7 

G2: 46.4 ± 12.4 

Race/ethnicity: 

NR 

Parity, mean: 

G1: 2.3 

G2: 2.2 

Inclusion criteria: 

• UDS-defined 

idiopathic detrusor 

instability 

• Involuntary 

detrusor 

contractions > 30 

cm H2O during 

filling phase of 

cystometry 

Exclusion 

criteria: 

• Neurological 

disorder 

• Urologic 

disorder 

• Age > 75 years 

• Genuine SI 

• Low-compliance 

bladder 

• Bacterial or 

interstitial 

cystitis 

• Previous 

treatment with 

oxybutynin 

Voids/day, mean 

± SD: 

G1: 11.1 ± 7.9 

G2: 12.1 ± 5.7 

Volume at first 

desire to void 

mean mL ± SD: 

G1: 94.2 ± 66 

G2: 107.4 ± 101 

Max detrusor 

filling pressure 

mean cm H2O, 

±SD: 

G1: 55.3 ± 23 

G2: 59.2 ± 26 

Max cystometric 

capacity (mL) 

G1: 275 ± 164 

G2: 290 ± 168 

Residual urine 

volume mean mL 

± SD: 

G1: 23.1 ± 34.2 

G2: 22.7 ± 34.0 

Duration of OAB, 

mean yrs ± SD): 

G1: 7.5 ± 7.9 

G2: 8.9 ± 9.0 

Change in volume 

at first desire to 

void, period 1, 

mean mL ± SD 

(95% CI) 

G1: 70.0 ± 103 

G2: 7.7 ± 76 

G1/G2: P = 0.02 

95% CI: (10, 113) 

Change in 

maximum 

detrusor filling 

pressure, mean ± 

SD: 

G1:-16.9 ± 19.5 

G2:1.0 ± 28.7 

G1/G2: P = 0.02 

95% CI: (-32.5, -

3.2) 

Change in 

maximum 

cystometric 

capacity, mean ± 

SD: 

G1:104.0 ± 131 

G2:7.0 ± 103 

G1/G2: P = 0.006 

95% CI: (29, 165) 

Change in 

residual urine 

Volume, period 1: 

G1: 22.4 (79.3) 

G2: 7.7 (45.7) 

P = 0.42 

Change in 

residual urine 

Volume, period 2: 

G1: 10.0 ± 27.1 

G2: 25.7 ± 55.6 

P = 0.33 

Dry mouth on 

oxybutynin, %: 

88 

Dry mouth on 

placebo, %: 

33 

Mouth ulcers on 

oxybutynin, %: 

16 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-273 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Moore et al., 1990 

Moore and 

Sutherst, 1990 

(continued)

Mouth ulcers on 

placebo, %: 

0 

Constipation on 

oxybutynin, % 

12.5 

Constipation on 

placebo, % 

0 

Drowsiness on 

oxybutynin, %: 

12.5 

Drowsiness on 

placebo, %: 

7 

Nausea on 

oxybutynin, %: 

8.3 

Nausea on 

placebo, %: 

2.3 

Initial hesitancy 

on oxybutynin, %: 

4.2 

Initial hesitancy 

on placebo, %: 

2.3 

Dizziness on 

oxybutynin, %: 

4.2 

Dizziness on 

placebo, %: 

7.0 

Metallic taste on 

oxybutynin, %: 

2.4 

Metallic taste on 

placebo, %: 

2.3 

Crown Crisp 

Experimental 

Index, >50% 

improvement:*

Free floating 

anxiety: 

6.4 

C-274 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Moore et al., 1990 

Moore and 

Sutherst, 1990 

(continued)

Phobic anxiety: 

5.3Obsessionalis

m: 

6.2 

Somatic 

complaints: 

6.2 

Depression: 

4.0 

Hysteria: 

2.6 

Total: 

30.7 

Crown Crisp 

Experimental 

Index, <49% 

improvement:* 

Free floating 

anxiety: 

8.8 

Phobic anxiety: 

6.8 

Obsessionalism: 

8.1 

Somatic 

complaints: 

8.9 

C-275 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Nitti et al.,2007 

Country and 

setting: 

US, 83 center 

Enrollment 

period: 

October 2003 to 

February 2005 

Funding: 

Schwarz 

BioSciences 

GmbH and Pfizer, 

Inc 

Author industry 

relationship 

disclosures: 

9 of 9 

Allergan (3) 

Astellas (3) 

Gynecare (1) 

Novartis (2) 

Pfizer (5) 

Boston Scientific 

(1) 

Espirit (4) 

Ortho (1) 

Watson (1) 

Indevus (1) 

GlaxoSmithKline 

(1) 

Schwarz 

Biosciences (3) 

Design: 

RCT 

Intervention: 

Placebo, 

Fesoteorine 4 or 8 

mg, bladder diary 

before 

randomization, 2, 

8, 12 wks 

Groups: 

G1: Placebo 

G2: Fesoterodine 

4 mg/d 

G3: Fesoterodine 

8 mg/d 

N at enrollment: 

Total: 836 

G1: 274 

G2: 283 

G3: 279 

N at follow-up: 

G1: 266 

G2: 267 

G3: 267 

Age, mean 

(range): 

Total: 59 (21, 91) 

G1: 59 (24, 88) 

G2: 59 (21, 85) 

G3: 59 (23, 91) 

Women, %: 

Total: 76 

G1: 74 

G2: 76 

G3: 78 

Race/ethnicity: 

White: 

Total: 82% 

G1: 80% 

G2: 82% 

G3: 84% 

Black: 

G1: 10% 

G2: 9% 

G3: 8% 

Asian: 

G1: 2% 

G2: 1% 

G3: 1% 

Inclusion criteria:

• Age ≥ 18 

• Urinary 

frequency ≥8 

voids/day 

• Urgency ≥ 6 for 

3 days or UUI ≥

3 episodes/3 

day diary 

• At least 

moderate 

bladder 

problems on a 

Likert scale 

Exclusion 

criteria: 

• Pregnant 

• Women of 

reproductive age 

not on adequate 

contraception 

• Lower urinary 

tract pathology 

(SUI, 

urolithiasis, 

interstitial 

cystitis, 

urothelial 

tumors, ≥ grade 

3 pelvic organ 

prolapse, BOO, 

postvoid 

residual > 100 

mL, polyuria >3 

L/24 h, rec UTI) 

• Current 

antimuscarinic 

• Neurogenic 

cause for OAB 

• Arrhythmia 

• Unstable angina 

or corrected QT 

interval > 500 

ms 

• Electrostimulatio

n or bladder 

training in past 4 

weeks or 

currently 

UUI episodes/ 

day, mean ± SD: 

G1: 3.7 ± 3.3 

(n=205) 

G2: 3.9 ± 3.5 

(n=228) 

G3: 3.9 ± 3.3 

(n=218) 

Urgency 

episodes/day, 

mean ± SD: 

G1: 11.4 ± 3.8 

G2: 12.5 ± 4.1 

G3: 11.6 ± 3.7 

Incontinence, n 

(%): 

G1: 205 (77) 

G2: 228 (85) 

G3: 218 (82) 

Continent days/ 

wk, mean ± SD: 

G1: 0.6 ± 1.3 

G2: 0.7 ± 1.5 

G3: 0.7 ± 1.4 

Voids/day, mean 

± SD: 

G1: 12.2 ± 3.7 

G2: 12.9 ± 3.9 

G3: 12.0 ± 3.3 

Daytime voids/ 

day, mean ± SD: 

G1:10.2 ± 3.3 

G2: 10.7 ± 3.4 

G3: 10.1 ± 2.9 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 2.0 ± 1.3 

G2: 2.2 ± 1.6 

G3: 1.9 ± 1.4 

Voided volume 

(mL), mean ± SD:

G1: 159 ± 69 

G2: 152 ± 60 

G3: 156 ± 58 

UUI episodes/day, 

LS mean change 

(SE): 

G1: -0.96 (0.17) 

G2: -1.65 (0.16)* 

G3: -2.28 (0.16)* 

UUI episodes/day, 

median % 

change: 

G1: -40.0 (n=205) 

G2: -67.4* (n=228) 

G3: -81.8* (n=218) 

Urgency 

episodes/day, LS 

mean change 

(SE): 

G1: -0.79 (0.20) 

G2: -1.91 (0.20) 

G3: -2.30 (0.20) 

Urgency 

episodes/day, 

median % 

change: 

G1:-3.3 

G2: -16.3* 

G3: -18.4* 

Continent days/ 

wk, LS mean 

change (SE): 

G1: 1.31 (0.20) 

G2: 2.33 (0.19)* 

G3: 2.80 (0.19)* 

Voids/day, LS 

mean change 

(SE): 

G1: -1.08 (0.18) 

G2: -1.61 (0.18)* 

G3: -2.09 (0.18)* 

Voids/day, mean 

% change: 

G1: -6.9 

G2: -14.9* 

G3: -16.0* 

Daytime voids/ 

day, LS mean 

change (SE): 

G1: -0.69 (0.16) 

G2: -1.04 (0.16) (P 

= 0.107) 

G3: -1.54 (0.16)* 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-276 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Nitti et al., 2007 

(continued) 

Years since OAB 

diagnosis, mean 

± SD: 

G1: 9.8 ± 10.3 

G2: 9.1 ± 10.3 

G3: 10.1 ± 11.5 

Previous 

tolterodine use, n 

(%): 

G1: 90 (33) 

G2: 88 (31) 

G3: 95 (34) 

Previous 

oxybutynin use, 

n (%): 

G1: 101 (37) 

G2: 94 (33) 

G3: 97 (35) 

Previous 

trospium 

chloride use, n 

(%): 

G1: 7 (2.6) 

G2: 6 (2.1) 

G3: 3 (1.1) 

Daytime voids/ 

median % 

change: 

G1: -5.9 

G2: -11.1 (P =

0.008) 

G3: -15.6* 

Nocturia 

episodes/day, LS 

mean change 

(SE): 

G1: -0.39 (0.07) 

G2: -0.58 (0.17) 

(P = 0.042) 

G3: -0.55 (0.17) 

(P = 0.09) 

Nocturia 

episodes/day, 

median % 

change: 

G1: -25.0 

G2: -33.3 

(P = 0.013) 

G3: -25.0 

(P = 0.267) 

Treatment 

response, n (% 

yes) 

G1: 266 (45) 

G2: 267 (64)* 

G3: 267 (74)* 

Voided volume 

(mL), LS mean 

change (SE): 

G1: 8.38 (4.06) 

G2: 16.5 (4.00) 

(P = 0.15) 

G3: 33.6 (4.04)* 

Side effects, n 

(%): 

G1: 149 (55) 

G2: 171 (61) 

G3: 193 (69) 

Dry mouth, n (%): 

G1: 19 (7) 

G2: 45 (16) 

G3: 99 (36) 

Constipation, n 

(%): 

G1: 7 (3) 

G2: 14 (5) 

G3: 21 (8) 

C-277 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Nitti et al., 2007 

(continued) 

UTI, n (%): 

G1: 11 (4) 

G2: 10 (4) 

G3: 15 (5) 

Headache, n (%): 

G1: 9 (3) 

G2: 12 (4) 

G3: 8 (3) 

Withdrew, %: 

Total: 19 

G1: 41 

G2: 58 

G3: 56 

Withdrew due to 

AE, %: 

G1: 4 

G2: 6 

G3: 9 

*P < 0.001 

C-278 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Preik et al., 2004 

[See evidence 

table for 

Anderson et al. 

1999] 

Country and 

setting: Germany 

& US, Multiple 

academic 

hospitals 

Enrollment 

period: 

NR

Funding: 

ALZA Corporation 

Author industry 

relationship 

disclosures: 

4 of 5 

ALZA Corp (2) 

Ditropan XL (1) 

Janssen-Cilag 

GmbH (1) 

Johnson and 

Johnson (1) 

Ortho-McNeil (1) 

Design: 

RCT

Intervention:

Oxybutynin

Groups: 

daily dose 

increased in 5 mg 

increments each 

4-7 days until 

reaching the 

minimum effective 

dose, maximum 

tolerated dose, or 

maximum 

allowable dose. 

Once participant 

reached titrated 

dose, maintained 

for 1 week confirmation period 

and 1 week 

maintenance 

period. 

G1: Controlledrelease 

oxybutynin 

(OROS-O) 

G2: Immediate 

release 

oxybutynin (IR-O) 

N at enrollment: 

105 

N at follow-up: 

Total: 93 

G1: 46 

G2: 47 

Women, n (%): 

G1: 50 (94.3) 

G2: 47 (90.4) 

Age, mean (SE): 

G1: 59.2 (10.6) 

G2: 59.6 (10.0) 

Race/ethnicity:

NR 

Weight (kg), 

mean (SE): 

G1: 78.0 (18.3) 

G2: 80 (20.2) 

Inclusion criteria:

• Communitydwelling men & 

women age 40-

75 

• Urge or mixed UI

• ≥ 6 UUI 

episodes per 

week recorded 

on the run-in 

diary after 

washout of 

anticholinergic 

• Previous 

response to 

anticholinergic 

• Urge 

predominant SUI

Exclusion 

criteria: 

• Known treatable 

GU disorders 

that could cause 

incontinence 

• Men who had 

had prostate 

surgery < 9 mos 

before study 

enrollment or 

with a PSA level 

of >10 ng/mL 

• PVR of > 100mL

• Estimated Cr 

clearance of < 

50 mL/min 

• Glaucoma or 

untreated 

anterior 

chamber angles 

• Hgb < 100g/L 

• Known hypersensitivity to 

oxybutynin 

• History of drug 

or alcohol abuse

• Positive urine 

drug screen 

• Pregnant or 

breastfeeding 

• Myasthenia 

gravis 

UUI episodes/ 

wk, mean (SE): 

G1: 27.6 (24.0) 

G2: 23.4 (16.3) 

Duration of 

incontinence, n 

(%): 

1-5 years: 

G1: 26 (49) 

G2: 22 (42) 

> 5 years: 

G1: 23 (43) 

G2: 22 (42) 

Dose-titration 

endpoint, MED, 

n/N (%): 

G1: 29/46 (63) 

G2: 26/47 (55) 

Dry mouth, MED, 

n/N (%): 

G1: 3/29 (10) 

G2: 7/26 (27) 

Dose-titration 

endpoint, MTD, 

n/N (%): 

G1: 11/46 (24) 

G2: 19/47 (41) 

Dry mouth, MTD, 

n/N (%): 

G1: 7/11 (64) 

G2: 13/19 (68) 

Dose-titration 

endpoint, MAD, 

n/N (%): 

G1: 6/46 (13) 

G2: 2/47 (4) 

Dry mouth, MAD, 

n/N (%): 

G1: 1/6 (17) 

G2: 1/2 (50) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-279 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Rentzhog et al., 

1993 

Country and 

setting: 

Sweden & UK, 17 

academic 

hospitals

Enrollment 

period: NR

Funding: 

Pharmacia & 

Upjohn AB 

Author industry 

relationship 

disclosures: 

NR 

Design: RCT, 

double blind, 

placebo controlled

Intervention: 

tolterodine vs 

placebo 

Groups: 

G1: tolterodine 

1mg/d 

G2: tolterodine 2 

mg/d 

G3: tolterodine 

4mg/d 

G4: tolterodine 

8mg/d 

G5: placebo 

N at enrollment: 

G1: 21 

G2: 16 

G3: 14 

G4: 16 

G5: 13 

N at follow-up: 

G1: 17 

G2: 15 

G3: 11 

G4: 11 

G5: 10 

Women, n: 

G1: 14 

G2: 10 

G3: 12 

G4: 15 

G5: 10 

Age, mean: 

G1: 56 

G2: 59 

G3: 56 

G4: 58 

G5:58 

Race/ethnicity: 

NR 

Body weight, kg, 

mean: 

G1: 73 

G2: 76 

G3: 72 

G4: 76 

G5: 73 

Inclusion criteria:

• age 18-75 

• urinary urgency, 

8+ 

micturitions/d, 

and/or UI (1+ 

episode/d) 

• UDS-confirmed 

detrusor 

instabililty 

(phasic increase 

in detrusor 

pressure in the 

presence of 

typical sx) 

• max urinary flow 

rate of >15 mL/s

• sterile or 

clinically 

insignificant 

bacteriuria 

• normal routine 

laboratory tests 

Exclusion 

criteria: 

• antimuscarinic 

agents or drugs 

w/ 

antimuscarinic 

side effects 

• other drugs for 

UI (except 

estrogens) 

• clinically 

significant 

cardiac, hepatic, 

renal, or heme 

disorders 

• contraindications 

to antimuscarinic 

agents 

• pregnant or 

lactating 

• women not using 

reliable 

contraception 

Frequency of 

micturitions/d: 

G1: 10.3 

G2: 11.2 

G3: 12.8 

G4: 10.2 

G5: 10.2 

Incontinence 

episodes/d: 

G1: 2.1 

G2: 1.7 

G3: 1.8 

G4: 2.7 

G5: 4.1 

Previous drug 

therapy: 

G1: 9 

G2: 10 

G3: 9 

G4: 9 

G5: 4 

Frequency, n: 

G1: 7 

G2: 7 

G3: 4 

G4: 5 

G5: 4 

Leakage, n: 

G1: 2 

G2: - 

G3: 2 

G4: 1 

G5: 3 

Leakage and 

frequency, n: 

G1: 11 

G2: 9 

G3: 7 

G4: 9 

G5: 6 

Volume at first 

contraction (mL), 

mean mL ± SD 

G1: 243 ± 220 

G2: 274 ± 129 

G3: 171 ± 109 

G4: 297 ± 123 

G5: 295 ± 16723 (

Volume at first 

contraction (mL), 

mean change 

(% change): 

G1: 74 (63) 

G2: 17 (17) 

G3: 89 (114) 

G4: 115 (119) 

G5: -23 (-4) 

Linear regression 

of change: P = 

0.0459 

Residual urinary 

volume (mL), 

mean change 

(% change): 

G1: 6 (2) 

G2: 10 (57) 

G3: 30 (122) 

G4: 143 (225) 

G5: 4 (126) 

Linear regression 

of change: P = 

0.0003 

Max cystometric 

capacity (mL), 

mean change 

(% change): 

G1: 15 (20) 

G2: -25 (5) 

G3: 2 (10) 

G4: 76 (30) 

G5: -17 (3) 

Linear regression 

of change: P = 

0.0921 

Bladder 

compliance 

(mL/cmH2O), 

mean change 

(% change): 

G1: -29 (-9) 

G2: 10 (164) 

G3: 2 (72) 

G4: 18 (355) 

G5: -6 (11) 

Linear regression 

of change: P = 

0.1646 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Methods and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-280 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rentzhog et 

al.,1993 

(continued)

Residual urinary 

volume, mean 

mL ± SD: 

G1: 24 ± 31 

G2: 51 ± 94 

G3: 25 ± 18 

G4: 52 ± 130 

G5: 26 ± 35 

Max cystometric 

capacity, mean 

mL ± SD: 

G1: 381 ± 200 

G2: 397 ± 197 

G3: 284 ± 195 

G4: 335 ± 145) 

G5: 377 ± 181) 

Bladder 

compliance, 

mean mL/cmH2O 

± SD: 

G1: 65 ± 105 

G2: 50 ± 44 

G3: 36 ± 43 

G4: 44 ± 46 

G5: 44 ± 28 

# detrusor 

contractions >10 

cmH20, mean ± 

SD: 

G1: 4.1 ± 3.3 

G2: 2.3 ± 1.8 

G3: 3.4 ± 2.5 

G4: 3.3 ± 2.7 

G5: 3.1 ± 3.0 

Detrusor contractions >10 cmH20, 

mean change 

(% change): 

G1: -1.6 (-34) 

G2: -1.2 (-38) 

G3: -2.0 (-33) 

G4: -0.3 (-32) 

G5: 0.0 (48) 

Linear regression 

of change: P = 

0.7284 

Max urinary flow 

(mL/s), mean 

change (% 

change): 

G1: 1.2 (9) 

G2: 1.3 (18) 

G3: -2.4 (-3) 

G4: -0.3 (-32) 

G5: -2.0 (28) 

Linear regression 

of change: P = 

0.3072 

Volume at normal 

desire to void 

(mL), mean 

change (% 

change): 

G1: -1 (2) 

G2: -18 (1) 

G3: 32 (25) 

G4: 66 (45) 

G5: -18 (15) 

Linear regression 

of change: P = 

0.0492 

Patients reporting 

1+ adverse event, 

n: 

G1: 8 

G2: 6 

G3: 7 

G4: 12 

G5: 6 

C-281 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rentzhog et 

al.,1993 

(continued)

Max urinary flow, 

mean mL/s ± SD:

G1: 21.0 ± 7.5 

G2: 2.33 ± 9.9 

G3: 19.2 ± 9.8 

G4: 20.5 ± 8.2 

G5: -2.0 ± 28 

Volume at 

normal desire to 

void, mean mL ± 

SD: 

G1: 235 ± 128 

G2: 273 ± 121 

G3: 143 ± 83 

G4: 211 ± 128 

G5: 255 ± 157 

Concomitant dz, 

n: 

G1: 11 

G2: 11 

G3: 7 

G4: 11 

G5: 9 

Total AE 

reported: 

G1: 10 

G2: 14 

G3: 10 

G4: 25 

G5: 10 

Dry mouth 

G1: 2 

G2: 2 

G3: 5 

G4: 9 

G5: 2 

Constipation 

G1: 1 

G2: 3 

G3: 1 

G4: 2 

G5: 0 

Abnormal vision 

G1: 0 

G2: 3 

G3: 1 

G4: 1 

G5: 1 

Urinary retention 

G1:0 

G2: 0 

G3: 0 

G4: 1 

G5: 0 

Other 

G1: 7 

G2: 6 

G3: 3 

G4: 12 

G5: 7 

C-282 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Robinson et al., 

2007

Country and 

setting: 

12 countries in 

Europe, 39 study 

sites 

Enrollment 

period: 

July 2002 to 

December 2002

Funding: 

Astellas

Author industry 

relationship 

disclosures: 

2 of 4 

Astellas (2) 

Design: 

RCT

Intervention: 

tamsulosin OCAS 

(0.25, 0.5, 1.0, 1.5 

mg) qd vs 

tolterodine ER qd 

vs placebo qd 

Groups: 

G1: 0.25 mg tamsulosin OCAS qd 

G2: 0.5 mg tamsulosin OCAS qd 

G3: 1.0 mg tamsulosin OCAS qd 

G4: 1.5 mg tamsulosin OCAS qd 

G5: tolterodine ER 

qd 

G6: placebo qd 

N at enrollment: 

G1: 58 

G2: 65 

G2: 63 

G4: 60 

G5: 61 

G6: 61

N at follow-up: 

G1: 52 

G2: 61 

G3: 55 

G4: 46 

G5: 53 

G6: 59

Women, %: 

100 

Age, range: 

18-70 

Race/ethnicity: 

NR

Inclusion criteria: 

• Symptoms of 

OAB ≥ 3 months

Exclusion 

criteria: 

• SUI or MUI 

where stress 

symptoms 

predominant and 

neurogenic 

Urgency 

episodes/day, 

mean: 

G1: 5.83 

G2: 5.58 

G3: 5.82 

G4: 6.28 

G5: 6.78 

G6: 5.58 

Incontinence 

episodes/day, 

mean: 

G1: 3.22 

G2: 2.17 

G3: 3.33 

G4: 2.98 

G5: 2.33 

G6: 2.90 

Voids/day, mean:

G1: 12.20 

G2: 11.09 

G3: 12.96 

G4: 12.46 

G5: 13.22 

G6: 11.90 

Nocturia 

episodes/day, 

mean: 

G1: 1.97 

G2: 1.76 

G3: 1.82 

G4: 2.10 

G5: 2.34 

G6: 1.87 

Voided volume 

(mL), mean: 

G1: 135.5 

G2: 148.6 

G3: 135.1 

G4: 131.4 

G5: 148.9 

G6: 145.5 

Urgency 

episodes/day, 

mean change: 

G1: -1.51 

G2: -1.66 

G3: -1.83 

G4: -1.91 

G5: -2.49 

G6: -1.86 

G4/G6: P = 0.901 

G5/G6: P = 0.632

Incontinence 

episodes/day, 

mean change: 

G1: -1.40 

G2: -0.93

G3: 0.02 

G4: -0.66 

G5: -1.66 

G6: -0.66 

G4/G6: P = 0.945 

G5/G6: P = 0.025

Voids/day, mean 

change: 

G1: -1.60 

G2: -1.01 

G3: -1.38 

G4: -1.18 

G5: -2.59 

G6: -1.81 

G4/G6: P = 0.189 

G5/G6: P = 0.353

Nocturia 

episodes/day, 

mean change: 

G1: -0.35 

G2: -0.36 

G3: -0.33 

G4: -0.34 

G5: -0.74 

G6: -0.41 

G4/G6: P = 0.495 

G5/G6: P = 0.353

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: + 

Baseline 

characteristics: - 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-283 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Robinson et al., 

2007 

(continued)

Void volume 

(mL), mean 

change: 

G1: 13.9 

G2: 9.7 

G3: 12.6 

G4: 12.9 

G5: 24.3 

G6: 11.4 

G4/G6: P = 0.992 

G5/G6: P = 0.092 

C-284 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Rogers et al., 

2008 

Country and 

setting: 

USA, multicenter 

(54 outpatient 

sites) 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

7 of 7 

Bayer (1) 

Boeringer 

Ingelheim(1) 

Duramed (1) 

J&J (1) 

P&G (1) 

Novartis (1) 

Novo-Nordisk (1) 

Pfizer (7) 

Wyeth (1) 

Design: 

Multicenter 

randomized 

placebo-controlled 

double-blind 

Intervention: 

Tolterodine 4 mg 

ER vs placebo 

within 4 hours of 

bedtime

Groups: 

G1: Tolterodine 

4mg ER daily 

G2: Placebo 

N at enrollment: 

G1: 202 

G2: 211 

N at follow-up: 

G1: 163 

G2: 167 

Women, %: 

Total: 100 

Age, yrs ± SD: 

G1: 49 ± 12 

G2: 47 ± 12 

Race/ethnicity, n 

(%): 

White: 

G1: 139 (69) 

G2: 138 (66) 

Black: 

G1: 37 (18) 

G2: 45 (21) 

Asian: 

G1: 3 (2) 

G2: 4 (2) 

Other: 

G1: 22 (11) 

G2: 23 (11) 

Parrous, %: 

G1: 86 

G2: 91 

Follow-up: 

12 weeks 

Premenopausal, 

n (%): 

G1: 71 (35) 

G2: 95 (45) 

Inclusion criteria: 

• Age ≥ 18 

• Women 

• ≥ 0.6 UUI 

episodes/day 

• ≥ 8 voids/day 

• ≥ 3 OAB voids/ 

day (urgencyassociated 

voids) 

• “some moderate 

problems” on 

PPBC 

• OAB symptoms 

≥ 3 months 

• Stable, sexually 

active 

relationship with 

man ≥ 6 months 

Exclusion 

criteria: 

• POP Stage 3 or 

greater 

• History of lower 

urinary tract 

surgery 

• Lifelong sexual 

dysfunction 

unrelated to 

lifelong UUI 

• Predominate 

SUI 

UUI episodes/ 

day, mean ± SD: 

G1: 2.5 ± 2.1 

G2: 2.2 ± 1.8 

Voids/ day, mean 

± SD: 

G1: 13.0 ± 4.1 

G2: 12.5 ± 3.9 

OAB voids/ day, 

mean ± SD: 

G1: 10.6 ± 4.4 

G2: 9.9 ± 4.2 

Pads/ day, mean 

± SD: 

G1: 2.9 ± 2.7 

G2: 2.9 ± 3.1 

SQOL-F total 

score, mean± 

SD: 

G1: 69.6 ± 23.1 

G2: 69.2 ± 23.0 

PISQ total score, 

mean ± SD: 

G1: 88.7 ± 13.9 

G2: 88.9 ± 14.2 

PISQ Behavioral/ 

emotive score, 

mean ± SD: 

G1: 38.0 ± 8.9 

G2: 38.0 ± 9.0 

PISQ Physical 

score, mean ± 

SD: 

G1: 31.7 ± 5.9 

G2: 31.8 ± 6.0 

PISQ partner 

related score, 

mean ± SD: 

G1: 19.0 ± 2.8 

G2: 19.0 ± 2.5 

HAD Anxiety 

score, mean ± 

SD: 

G1: 8.3 ± 4.0 

G2: 8.2 ± 4.0 

HAD Depression 

score, mean ± 

SD: 

G1: 5.1 ± 3.3 

G2: 5.4 ± 3.4 

UUI episodes/day, 

mean change 

(SE): 

G1: 1.8 (0.1) 

G2: 1.4 (0.1) 

P = 0.0029 

(P = 0.0525 when 

a single statistical 

outlier is excluded) 

UUI episodes/day, 

median % 

change: 

G1: -100.0 

G2: -82.5 

P = 0.0003

No UUI events, 

week 12, %: 

G1: 57 

G2: 42 

P < 0.004 

OAB voids/day, 

mean change 

(SE): 

G1: -4.7 (0.3) 

G2: -3.0 (0.3) 

P < 0.0001 

Pads/day, mean 

change (SE): 

G1: -1.5 (0.1) 

G2: -1.0 (0.1) 

P = 0.0024 

Voids/day, mean 

change (SE): 

G1: -3.3 (0.2) 

G2: -2.3 (0.2) 

P = 0.0006 

SQOL-F score, 

mean change 

(SE): 

G1: 6.4 (1.2) 

G2: 1.5 (1.2) 

P = 0.004 

PISQ total score, 

mean change 

(SE): 

G1: 4.9 (0.7) 

G2: 2.3 (0.7) 

P = 0.009 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Method and 

blinding: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-285 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rogers et al., 

2008 (continued) 

Perimenopausal, 

n (%): 

G1: 18 (9) 

G2: 16 (8) 

Postmenopausal, n (%): 

G1: 112 (56) 

G2: 99 (47) 

PISQ behavioral/ 

emotive score, 

mean change 

(SE): 

G1: 1.6 (0.4) 

G2: 0.5 (0.4) 

P = NS 

PISQ physical 

score, mean 

change (SE): 

G1: 2.6 (0.3) 

G2: 1.6 (0.3) 

P ≤ 0.01 

PISQ partner 

related score, 

mean change 

(SE): 

G1: 0.6 (0.1) 

G2: 0.3 (0.1) 

P = NS 

HAD anxiety 

score, mean 

change (SE): 

G1: -1.9 (0.3) 

G2: -1.1 (0.3) 

P = 0.03 

HAD depression 

score, mean 

change (SE): 

G1: -1.2 (0.2) 

G2: -0.8 (0.2) 

P = NS

Subjects with 

adverse events, n 

(%): 

G1: 114 (57)

G2: 111 (53)

Withdrawn due to 

AEs, n (%): 

G1: 9 (5)

G2: 6 (3)

Dry mouth, n (%): 

G1: 26 (13) 

G2: 19 (9) 

Constipation, n 

(%): 

G1: 7 (4) 

G2: 8 (4) 

C-286 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rogers et al., 

2008 (continued) 

Nasopharyngitis, 

n (%): 

G1: 9 (5) 

G2: 10 (5) 

Sinusitis, n (%): 

G1: 8 (4) 

G2: 9 (4) 

URI, n (%): 

G1: 9 (4) 

G2: 9 (5) 

UTI, n (%): 

G1: 12 (6) 

G2: 5 (2) 

Headache, n (%): 

G1: 7 (4) 

G2: 6 (3) 

Depression, n 

(%): 

G1: 5 (3) 

G2: 0 (0) 

Insomnia, n (%): 

G1: 5 (3) 

G2: 0 (0) 

C-287 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Rudy et al., 2006 

Rudy et al., 2006* 

Staskin and 

Harnett, 2004† 

Country and 

setting: 

US, 52 sites 

Enrollment 

period: 

NR 

Funding: 

Indevus 

NR†

Author industry 

relationship 

disclosures: 

5 of 5 

Indevus (5) NR†

Design: 

RCT 

Intervention: 

Trospium chloride 

vs placebo x 12 

wks

Groups: 

G1: trospium 

chloride 20 mg 

b.i.d. 

G2: matching 

placebo 

N at enrollment: 

G1: 329 

G2: 329 

N at follow-up: 

G1: 323 

G2: 325 

Age, mean (SE): 

G1: 61.1 (0.69) 

G2: 61.0 (0.70) 

Women, N (%): 

G1: 269 (81.8) 

G2: 267 (81.2) 

Race/ethnicity, n 

(%): 

Black: 

G1: 26 (7.9)

G2: 21 (6.4) 

White: 

G1: 284 (86.3) 

G2: 300 (91.2) 

Hispanic: 

G1: 13 (4.0) 

G2: 5 (1.5) 

Asian: 

G1: 5 (1.5) 

G2: 3 (0.9) 

Parity: 

NR 

Inclusion criteria: 

• Age ≥18 

• ≥ 6 mos of OAB 

sx 

• ≥10 voids/day 

• Sx of urgency 

• ≥ 7 UUI 

episodes/wk 

Exclusion 

criteria: 

• Predominantly 

SUI, insensate 

UI, or overflow 

UI 

• Neurogenic 

bladder d/o’s 

• Significant renal 

dz 

• Uninvestigated 

hematuria 

• UTI at washout 

or more than 2x 

during the prior 

12 mos 

• PVR >100mL 

• Use of any 

anticholinergic 

drug or other 

drug therapy for 

OAB w/in 21 

days before 

randomization 

• Bladder surgery 

w/in 6 mos 

before 

randomization 

• Cancer 

• Interstitial 

cystitis 

• PSA >10ng/mL 

• Diuretic use 

• Estrogen 

therapy 

• Nonmedical 

bladder therapy 

not part of a 

stable, longterm program 

(ie, timed voids 

and straight 

caths; Kegels 

were allowed) 

• Pregnancy 

UUI episodes/ 

day, median: 

G1: 2.86 

G2: 2.86 

P = 0.9849 

Urgency severity 

score associated 

with toilet voids, 

median: 

G1: 1.79 

G2: 1.75 

P = 0.4100 

Voids/day, mean:

G1: 12.94 

G2: 13.17 

P = 0.3169 

Nocturia 

episodes/day, 

median: 

G1: 2.00 

G2: 2.00 

P = 0.9048 

Nocturnal 

urgency severity 

score associated 

with toilet voids, 

mean: 

G1: 2.03 

G2: 2.01 

P = 0.6863 

OAB-SCS, 

median: 

G1: 36.56 

G2: 36.88 

P = 0.7176 

Stanford 

Sleepiness 

Scale, mean 

G1: 1.98 

G2: 1.94 

Stanford 

Sleepiness 

Scale, age group

< 65 years: 

G1: 1.99 

G2: 2.09 

UUI episodes/day, 

day 1, median 

change: 

G1: -1.00 

G2: -0.57 

P = 0.042 

UUI episodes/day, 

day 2, median 

change: 

G1: -1.29 

G2: -0.86 

P = 0.0022 

UUI episodes/day, 

day 3, median 

change: 

G1: -1.57 

G2: -0.86 

P < 0.0001 

UUI episodes/day, 

day 4, median 

change: 

G1: -1.57 

G2: -1.00 

P < 0.0001 

UUI episodes/day, 

day 5, median 

change: 

G1: -1.57 

G2: -1.00 

P < 0.0001 

UUI episodes/day, 

day 6, median 

change: 

G1: -1.71 

G2: -1.00 

P < 0.0001 

UUI episodes/day, 

day 7, median 

change: 

G1: -1.71 

G2: -1.00 

P < 0.0001 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-288 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

• Contraindication 

to 

antimuscarinic 

therapy 

Stanford 

Sleepiness 

Scale, age group 

> 65 years:

G1: 1.96 

G2: 1.71 

Stanford 

Sleepiness 

Scale, age group

< 75 years: 

G1: 2 

G2: 1.97 

Stanford 

Sleepiness 

Scale, age group 

>75 years: 

G1: 1.86 

G2: 1.79 

Voided volume 

(mL), mean: 

G1: 154.80 ± NR 

G2: 154.64 ± NR 

P = 0.9667 

Prior OAB 

medications, n 

(%): 

G1: 162 (49.2) 

G2: 169 (51.4) 

Prior hx of 

pelvic-floor 

training, n (%): 

G1: 62 (18.8) 

G2: 76 (23.1) 

Currently 

practice 

undergarment 

change d/t 

incontinence, n 

(%): 

G1: 227 (69.0) 

G2: 239 (72.6) 

UUI episodes/day, 

week 1, median 

change:*

G1: -1.43 

G2: -0.86 

P < 0.0001 

UUI episodes/day, 

week 4, median 

change:* 

G1: -1.71 

G2: -1.14 

P < 0.0001 

UUI episodes/day, 

week 12, median 

change:* 

G1: -1.86 

G2: -1.29 

P < 0.0001 

Urgency severity 

score, day 1, 

mean change: 

G1: 0.00 

G2: 0.02 

P = 0.47 

Urgency severity 

score, day 2, 

mean change: 

G1: -0.08 

G2: -0.03 

P = 0.13 

Urgency severity 

score, day 3, 

mean change: 

G1: -0.11 

G2: -0.04 

P = 0.015 

Urgency severity 

score, day 4, 

mean change: 

G1: -0.12 

G2: -0.05 

P = 0.031 

Urgency severity 

score, day 5, 

mean change: 

G1: -0.13 

G2: -0.05 

P = 0.021 

C-289 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Urgency severity 

score, day 6, 

mean change: 

G1: -0.08 

G2: 0.04 

P < 0.0001 

Urgency severity 

score, day 7, 

mean change: 

G1: -0.09 

G2: 0.03 

P < 0.0001 

Urgency severity 

score, week 1, 

mean change:* 

G1: -0.09 

G2: -0.01 

P = 0.0023 

Urgency severity 

score, week 4, 

mean change:* 

G1: -0.19 

G2: -0.04 

P < 0.0001 

Urgency severity 

score, week 12, 

mean change:* 

G1: -0.21 

G2: -0.02 

P < 0.0001 

Voids/day, day 1, 

mean change: 

G1: -0.66 

G2: -0.35 

P = 0.14 

Voids/day, day 2, 

mean change: 

G1: -1.11 

G2: -0.75 

P = 0.09 

Voids/day, day 3, 

mean change: 

G1: -1.30 

G2: -0.77 

P = 0.012 

Voids/day, day 4, 

mean change: 

G1: -1.33 

G2: -0.95 

P = 0.086 

C-290 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Voids/day, day 5, 

mean change: 

G1: -1.73 

G2: -1.12 

P = 0.0037 

Voids/day, day 6, 

mean change: 

G1: -1.80 

G2: -1.28 

P = 0.017 

Voids/day, day 7, 

mean change: 

G1: -1.99 

G2: -1.44 

P = 0.011 

Voids/day, week 

1, mean change:* 

G1: -1.42 

G2: -0.96 

P = 0.0039 

Voids/day, week 

4, mean change:* 

G1: -2.34 

G2: -1.55 

P < 0.0001 

Voids/day, week 

12, mean 

change:* 

G1: -2.67 

G2: -1.76 

P < 0.0001 

Nocturia 

episodes/day, 

week 1, median 

change:* 

G1: -0.29 

G2: -0.29 

P = 0.8454 

Nocturia 

episodes/day, 

week 4, median 

change:* 

G1: -0.43 

G2: -0.29 

P = 0.0299 

Nocturia 

episodes/day, 

week 12, median 

change:* 

G1: -0.57 

G2: -0.29 

P = 0.0026 

C-291 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Nocturnal 

urgency severity 

score, week 1, 

mean change:* 

G1: -0.05 

G2: 0.03 

P = 0.0442 

Nocturnal 

urgency severity 

score, week 4, 

mean change:* 

G1: -0.13 

G2: =0.01 

P = 0.0062 

Nocturnal 

urgency severity 

score, week 12, 

mean change:* 

G1: -0.17 

G2: 0.01 

P = 0.0005 

OAB-SCS, day 1, 

median change: 

G1: -2.50 

G2: -0.14 

P = 0.014 

OAB-SCS, day 2 

median change: 

G1: -3.86 

G2: -2.14 

P = 0.015 

OAB-SCS, day 3, 

median change: 

G1: -4.71 

G2: -2.71 

P = 0.0019 

OAB-SCS, day 4, 

median change: 

G1: -4.86 

G2: -3.36 

P = 0.011 

OAB-SCS, day 5, 

median change: 

G1: -6.43 

G2: -3.36 

P < 0.0001 

OAB-SCS, day 6, 

median change: 

G1: -5.43 

G2: -2.93 

P < 0.0001 

C-292 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

OAB-SCS, day 7, 

median change: 

G1: -6.29 

G2: -3.00 

P < 0.0001 

OAB-SCS, week 

1, median 

change:* 

G1: -4.71 

G2: -2.29 

P < 0.0001 

OAB-SCS, week 

4, median 

change:* 

G1: -8.14 

G2: -3.86 

P < 0.0001 

OAB-SCS, week 

12, median 

change:* 

G1: -8.43 

G2: -4.62 

P < 0.0001 

Stanford 

Sleepiness Scale, 

week 1, mean 

change:† 

G1: -0.2 

G2: -0.12 

Stanford 

Sleepiness Scale, 

week 4, mean 

change:† 

G1: -0.17 

G2: -0.14 

Stanford 

Sleepiness Scale, 

week 12, mean 

change:† 

G1: -0.16 

G2: -0.11 

Stanford 

Sleepiness Scale, 

including T-max 

time point values 

only (G1=93, 

G2=97), week 1, 

mean change:† 

G1: -0.42 

G2: -0.2 

C-293 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Stanford 

Sleepiness Scale, 

including T-max 

time point values 

only (G1=144, 

G2=148), week 4, 

mean change:† 

G1: -0.2 

G2: -0.19 

Stanford 

Sleepiness Scale, 

including T-max 

time point values 

only (G1=182, 

G2=179), week 12, 

mean change:† 

G1: -0.17 

G2: -0.18 

Mean Stanford 

Sleepiness Scale, 

age group < 65 

years, week 1, 

mean change:† 

G1: -0.27 

G2: -0.19 

Mean Stanford 

Sleepiness Scale, 

age group < 65 

years, week 4, 

mean change:† 

G1: -0.14 

G2: -0.27 

Mean Stanford 

Sleepiness Scale, 

age group < 65 

years, week 12, 

mean change:† 

G1: -0.14 

G2: -0.22 

Mean Stanford 

Sleepiness Scale, 

age group >65 

years, week 1, 

mean change:† 

G1: -0.04 

G2: -0.03 

C-294 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Mean Stanford 

Sleepiness Scale, 

age group >65 

years, week 4, 

mean change:† 

G1: -0.23 

G2: 0.03 

Mean Stanford 

Sleepiness Scale, 

age group >65 

years, week 12, 

mean change:† 

G1: -0.22 

G2: 0.03 

Mean Stanford 

Sleepiness Scale, 

age group < 75 

years, change 

from baseline to 

week 1:† 

G1: -0.21 

G2: -0.14 

Mean Stanford 

Sleepiness Scale, 

age group < 75 

years, change 

from baseline to 

week 4:† 

G1: 0.14 

G2: -0.16 

Mean Stanford 

Sleepiness Scale, 

age group < 75 

years, week 12, 

mean change:† 

G1: 0.15 

G2: -0.14 

Mean Stanford 

Sleepiness Scale, 

age group > 75 

years, change 

from baseline to 

week 1:†

G1: -0.02 

G2: 0 

C-295 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Mean Stanford 

Sleepiness Scale, 

age group > 75 

years, change 

from baseline to 

week 4:†

G1: -0.49 

G2: -0.09 

Mean Stanford 

Sleepiness Scale, 

age group > 75 

years, week 12, 

mean change:†

G1: -0.33 

G2: 0.02 

Clinically 

significant 

increase (> 3 

points) from 

baseline to week 

12 in SSS score, 

n (%):† 

G1: 5 (1.5) 

G2: 8 (2.5) 

Voided volume 

(mL), week 1, 

mean change:* 

G1: 29.23 

G2: 6.05 

P < 0.0001 

Voided volume 

(mL), week 4, 

mean change:* 

G1: 39.50 

G2: 9.45 

P < 0.0001 

Voided volume 

(mL), week 12, 

mean change:* 

G1: 35.59 

G2: 9.44 

P < 0.0001 

Adverse events 

Any, n (%) 

G1: 196 (59.6) 

G2: 153 (46.5) 

Dry mouth: 

G1: 65 (19.8) 

G2: 17 (5.2) 

C-296 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Constipation: 

G1: 36 (10.9) 

G2: 19 (5.8) 

Headache not 

otherwise 

specified:

G1: 18 (5.5) 

G2: 15 (4.6) 

UTI not otherwise 

specified: 

G1: 16 (4.9) 

G2: 8 (2.4) 

Nasopharyngitis: 

G1: 13 (4.0) 

G2: 12 (3.6) 

Cough: 

G1: 8 (2.4) 

G2: 1 (0.3) 

Diarrhea: 

G1: 7 (2.1) 

G2: 13 (4.0) 

AEs leading to 

treatment 

discontinuation, 

%: 

G1: 7.3 

G2: 4.6 

Most common 

AEs leading to 

discontinuation: 

Constipation: 

G1: 1.8% 

G2: 0.6% 

Dry mouth: 

G1: 1.5% 

G2: 0.0% 

At least one CNS 

event: 

G1: 5.8% 

G2: 5.2% 

Somnolence 

G1: 0.3% 

G2: 0.6% 

Sedation: 

G1: 0 

G2: 0.3% 

C-297 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Salvatore et al., 

2005 

Country and 

setting: 

UK, 

Urogynecology 

specialty 

Enrollment 

period: 

1 year with phone 

questionnaire at 2 

years 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective 

randomized phone 

questionnaire 

Intervention: 

Oxybutynin with 

incremental 

increase in 

dosage to 5mg 

t.i.d. over 6 weeks 

at 14 day intervals

Groups: 

G1: Oxybutynin 

2.5 mg b.i.d. 

G2: Oxybutynin 5 

mg at night 

N at enrollment: 

G1: 42 

G2: 44 

N at follow-up: 

G1: 27 

G2: 39 

Women, %: 

100 

Age, yrs ± SD: 

G1: 59.2 ± 12.6 

G2: 53.3 ± 14.4 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Women 

• Videourodynamic 

diagnosis of DO 

or low bladder 

capacity 

• DO- ≥ 1 

contractions on 

filling 

cystometry 

associated with 

urgency 

• Low bladder 

compliance = 

linear detrusor 

pressure rise 

during filling 

cystometry > 15 

cmH2O at 

500mL 

associated with 

urgency or 

leakage 

• Exclusion 

criteria: 

NR 

Stopped 

treatment, n (%) 

G1: 16 (59.3) 

G2: 28 (71.8) 

SUI episdes/day, 

mean ± SD: 

G1: 0.85 ± 0.78

G2: 1.27 ± 1.17 

P = 0.04 

Nocturia 

episodes/ day, 

mean ± SD: 

G1: 1.21 ± 1.17

G2: 2.04 ± 1.45 

P = 0.01

Oxybutynin 

compliance, 2 

yrs, n (%) : 

G1: 11 (40.7) 

G2: 11 (28.2) 

Time on drug, n: 

1 month:

G1: 6 

G2: 12 

1-2 months: 

G1: 6 

G2: 11 

1-2 months: 

G1: 2 

G2: 3 

3-4 months: 

G1: 2 

G2: 2 

Duration of 

treatment: 

G1: NR

G2: NR

P = 0.08 

General 

perception of 

improvement: 

P = 0.58 

Max dose of 

oxybutynin 

reached: 

P = 0.31 

Present dose of 

oxybutynin: 

P = 0.45 

Present overall 

severity of 

symptom: 

P = 0.12 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-298 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Salvatore et al., 

2005 

(continued) 

Daytime

frequency: 

P = 0.78 

Urgency: 

P = 0.78 

Urge 

incontinence: 

P = 0.18 

Pad usage: 

P = 0.24 

Side effects, n: 

G1: 3 

G2: 4 

Dry Mouth, n: 

G1: 1 

G2: 4 

Dry Throat, n: 

G1: 2 

G2: 0 

Dry nose, n: 

G1: 0 

G2: 1 

Dry eyes, n: 

G1: 0 

G2: 1 

Nausea, n: 

G1: 0 

G2: 4 

Tachycardia, n: 

G1: 0 

G2: 1 

Dizziness, n: 

G1: 0 

G2: 2 

Constipation, n: 

G1: 0 

G2: 0 

Headache. N: 

G1: 0 

G2: 1 

C-299 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Salvatore et al., 

2007

Country and 

setting: 

Italy, 

Urogynecology 

outpatient clinic

Enrollment 

period: 

January 2004 to 

October 2005

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohort

Intervention: 

Tolterodine SR 4 

mg qd 

Groups: 

G1: vaginal 

profile stage 0a 

or Ia 

G2: anterior 

prolapse ≥ stage 

IIa 

N at enrollment: 

G1: 184 

G2: 51 

N at follow-up: 

NR 

Women, %: 

100 

Age, median 

(range): 

G1: 59 (20, 85) 

G2: 59 (35, 82) 

Race/ethnicity: 

NR 

Parity, mean 

(range): 

G1: 2 (0-6) 

G2: 2 (0-6) 

Menopausal, n 

(%): 

G1: 132 (72) 

G2: 7 (18) 

Inclusion 

criteria: 

• Women 

• Urodynamicall

y proven OAB 

who had no 

prolapse or 

pure anterior 

vaginal 

prolapse 

• Proven 

detrusor 

overactivity 

Exclusion 

criteria: 

• All symptoms 

or signs 

related to 

voiding 

difficulties 

• Prolapse 

Previous 

surgery, n (%): 

G1: 52 (28) 

G2: 11 (22) 

HRT, n (%) 

G1: 35 (26) 

G2: 7 (18) 

Improvement in 

condition or 

cured, n (%): 

G1: 158 (85.9) 

G2: 31 (60.8)* 

P = 0.0002 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

NR 

Drop-out rates: 

NR 

Power 

calculation: - 

Statistical 

issues: - 

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: + 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-300 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Salvatore et al., 

2008 

Country and 

setting: 

Italy, academic 

health center 

Enrollment 

period: 

January 2005 to 

August 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

None 

Design: 

prospective cohort 

Intervention: 

tolterodine ER 4 

mg qd for 12 wks 

Groups: 

G1: Involuntary 

detrusor 

contractions 

during filling 

G2: Involuntary 

detrusor 

contractions after 

p 

N at enrollment: 

111 

N at follow-up: 

109 

G1: 84 

G2: 25 

Age, mean yrs: 

G1: 54.5 

G2: 52 

BMI 

G1: 25.5 (19-36) 

G2: 25 (18-38) 

Inclusion criteria: 

• UDS+ detrusor 

overactivity

Exclusion 

criteria: 

• UTI 

• DM 

• neurological dz 

• genital prolapse 

>/= POP-Q 

stage II 

• previous antiincontinence or 

prolapse surgery

• previous trt w/ 

antimuscarinics 

Indications, N: 

Menopause, n(%)

G1: 53 (63) 

G2: 16 (64) 

HRT, n(%) 

G1: 13 (24.5) 

G2: 6 (37.5) 

Reported in 

relation to 

urodynamic 

findings 

1. women who 

experienced 

involuntary 

detrusor 

contractions 

during the filling 

phase 

spontaneously 

N=84 

2. women who 

experienced 

involuntary 

detrusor 

contractions after 

provocative 

maneuvers such 

as listening to 

running water or 

washing hands in 

cold water N=25 

Non-response to 

trt, proportion 

(%): 

G1: 12/84 (14) 

G2: 12/25 (48) 

G1<G2 (P = 

0.0008) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

- 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-301 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 2004 

Country and 

setting: 

US, Specialty 

clinic 

Enrollment 

period: 

Subanalysis of 

OBJECT trial, 

women only 

Funding: 

ALZA Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

10mg ER 

Oxybutynin daily 

vs 4mg 

Tolterodine (2mg 

b.i.d.)

Groups: 

G1: 10mg ER 

Oxybutynin daily x 

12 wks 

G2: 4mg 

Tolterodine (2mg 

b.i.d.) x 12 wks 

Stratified by age: 

a: Age ≤ 64 

b: Age 65-74 

c: Age ≥ 75 

N at enrollment: 

G1: 152 

G2: 163 

N at follow-up: 

G1: 132 

G2: 146 

Women, %: 

100 

Age, yrs ± SD: 

G1: 58.4 

G2: 58.8 

Race/ethnicity: 

NR

Inclusion criteria: 

• ≥ 7 and ≤ 50 

UUI 

episodes/week 

• ≥ 10 voids/day 

• MUI included if 

predominant 

UUI 

Exclusion 

criteria: 

• UTI 

• IC 

• Urethral 

diverticulum 

• Bladder tumor 

• Bladder stone 

• Delivery within 6 

mos 

• Pelvic, bladder, 

vaginal surgery 

in ≤ 6 mos 

• PVR ≥ 150 mL 

• Cardiovascular, 

renal, 

pulmonary, 

gastrointestinal, 

endocrine, 

neurologic, 

autoimmune, 

hematological, 

urological, 

psychiatric, or 

hepatic disease

• Hematuria 

• Positive urine 

culture 

• Narrow angle 

glaucoma 

• Obstructive 

uropathy 

• Myasthenia 

gravis 

• POP to hymenal 

ring 

• Gastrointestinal 

obstruction 

• Decreased GI 

motility 

• GI narrowing 

• GI retention 

UUI episodes/ 

week, mean: 

G1: 25.2 

G2: 25.1 

Incontinence 

episodes/week, 

mean: 

G1: 28.1 

G2: 28.9 

Voids/week, 

mean: 

G1: 91.7 

G2: 91.6 

Naïve to anticholinergics, %: 

G1: 60.5 

G2: 60.7 

UUI episodes/ 

week, %: 

G1: 6.2 

G2: 8.5 

G1a: 5.0 

G2a: 8.4 

G1b: 5.5 

G2b: 7.5 

G1c: 8.5

G2c: 11.1 

G1/G2: P = 0.038 

G1a/G2a: P =

0.005 

G1b/G2b: P =

0.337 

G1c/G2c: P =

0.568 

Incontinence 

episodes/week, 

mean: 

G1: 7.3

G2: 10.1 

G1a: 5.8 

G2a: 10.0 

G1b: 6.1 

G2b: 9.2 

G1c: 10.5

G2c: 12.5 

G1/G2: P = 0.030 

G1a/G2a: P =

0.005 

G1b/G2b: P =

0.164 

G1c/G2c: P =

0.714 

Voids/week, 

mean: 

G1: 68.0 

G2: 71.2 

G1a: 63.7 

G2a: 71.2 

G1b: 73.8 

G2b: 71.9 

G1c: 66.8

G2c: 65.5 

G1/G2: P = 0.272 

G1a/G2a: P =

0.024 

G1b/G2b: P =

0.706 

G1c/G2c: P =

0.838 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-302 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2004 

(continued)

• Investigational 

drugs within 1 

month of 

screening 

• Hypersensitivity 

to drugs 

• Current drug/ 

EtOH abuse 

• Pregnant 

• Breastfeeding 

• Inability to 

follow protocol 

Dry mouth, %: 

G1: 28.3 

G2: 33.7 

Constipation, %: 

G1: 8.6 

G2: 6.7 

Retention, %: 

G1: 4.0 

G2: 1.2 

Blurred vision, %: 

G1: 2.6 

G2: 0.6 

Dizziness, %: 

G1: 3.9 

G2: 4.3 

Insomnia, %: 

G1: 0.7 

G2: 1.8 

Somnolence, %: 

G1: 3.3 

G2: 1.8 

Nervousness, %: 

G1: 0 

G2: 1.2 

Headache, %: 

G1: 9.2 

G2: 10.4 

Dyspepsia, %: 

G1: 5.3 

G2: 6.1 

Nausea, %: 

G1: 3.3 

G2: 1.8 

Vomiting, %: 

G1: 2.0 

G2: 1.8 

C-303 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 2006 

[See evidence 

table for Sand et 

al., 2007] 

Country and 

setting: 

US, 327 centers 

Enrollment 

period: 

NR 

Funding: 

Watson 

Laboratories, Inc 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin 

transdermal 

system 3.9 

mg/day, twice 

weekly patch for 

up to 6 months 

with “standard 

instruction” or with 

“educational 

intervention”. 

Evaluate changes 

in HRQoL using 

Kings Health 

Questionnaire 

(KHQ) and Beck 

Depression 

Inventory II (BDIII) 

Groups: 

G1: Standard 

instructions 

G2: Educational 

intervention 

(educational 

booklet, OAB 

newsletters, 

dosing reminders, 

calendar 

reminders, 

bladder diary) 

N at enrollment: 

Total: 2878 

G1: 

G2:1596 

N at follow-up: 

NR 

Age, mean yrs ± 

SD: 

62.5 ± 14.8 

Women, %: 

87.2 

Inclusion criteria:

• ≥18 years old 

• UUI, urinary 

urgency or 

frequency 

• Willing to 

discontinue all 

prescription and 

OTC 

medications for 

OAB 

• Capable of 

completing QOL 

questionnaires 

without 

assistance 

• Negative 

pregnancy test 

& medically 

acceptable 

contraceptive 

Exclusion 

criteria: 

• Contraindications to 

oxybutynin 

• Reversible 

etiologies for 

OAB 

• Prior treatment 

with Oxytrol 

• Long-term care 

facilities and 

nursing homes 

History of OAB, 

years, %:

<1 yr: 12.0% 

1-2 yr: 18.5% 

2-4 yr: 23.1% 

≥ 4 yr: 46.4% 

Sexually active: 

Yes: 1500 (59.2%)

No: 1034 (40.8%) 

Coital 

incontinence, n 

(%): 

Omitted or NA: 

1924 (77.2) 

A little: 324 (13) 

Moderately: 137 

(5.5) 

A lot: 108 (4.3) 

Total with 

incontinence: 569 

(22.8%) 

KHQ, 

embarrassed by 

bladder 

problems:

Yes: (1845/2571) 

71.8% 

OAB affects sex 

life:

586 (39% of 1500 

who answered; 

23.1% of total 

population) 

OAB affects 

relationship with 

partner: 

Yes: 622 (37.3% 

of 1666 who 

answered, 24.4% 

of total population)

Coital 

incontinence, n 

(%): 

Omitted or NA: 

1831 (80.7) 

A little: 260 (11.5) 

Moderately: 116 

(5.1) 

A lot: 62 (2.7) 

Total with 

incontinence: 438 

(19.3%) 

Coital 

incontinence, n 

(%): 

Improved: 277 

(12.6%) 

Worsened: 165 

(7.5%) 

P < 0.0001 

Embarrassed by 

OAB:

Improved: 828 

(35.5%) 

Worsened: 251 

(11.1%) 

P < 0.0001 

Effect of OAB on 

sex life:

Improved: 429 

(19.1%) 

Worsened 251 

(11.1%) 

P < 0.0001 

Effect of OAB on 

relationship with 

partners:

Improved: 444 

(19.6%) 

Worsened: 271 

(11.9%) 

P < 0.0001 

Interest in sex: 

Improved: 472 

(23.4%) 

Worsented: 246 

(12.2%) 

P < 0.0001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-304 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2006 

(continued) 

Race/ethnicity, 

%: 

White: 83.6 

African American: 

9.9 

Hispanic: 4.8 

Asian: 1.2 

Other: 0.5 

Follow-up: 

6 months 

Decreased 

interest in sex: 

Total: 1219 

(52.1%) 

Less interest: 589 

(25.2%) 

Much less interest: 

228 (9.7%) 

Complete loss of 

interest: 402 

(17.2%) 

Improvement in 

all KHQ domains 

and BDI-II 

summary scores 

(P < 0.0001) 

No difference 

between G1 and 

G2 in baseline 

sexual symptoms 

or improvement

C-305 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 2007 

Country and 

setting: 

US, Multicenter, 

327 sites (141 

Urology 141, 96 

Primary care, 43 

Ob-Gyn, 17 

Geriatric Med) 

Enrollment 

period: 

NR 

Funding: 

Watson 

Laboratiories, Inc 

Author industry 

relationship 

disclosures: 

7 of 7 

Allergan (1) 

Astellas (1) 

Esprit (1) 

GlaxoSmithKline 

(2) 

GSK (1) 

GTx (1) 

Indevus-Esprit (1) 

Lilly (1) 

Novartis (3) 

Ortho-McNeil (1) 

Ortho Urology (1) 

Pfizer (4) 

Sanofi (1) 

USB (1) 

Watson (6) 

Design: 

RCT, open-label 

(case series for 

drug, RCT for 

educational 

materials) 

Intervention: 

Oxybutynin 

transdermal 

system 3.9 

mg/day, twice 

weekly patch for 

up to 6 months 

with “standard 

instruction” or with 

“educational 

intervention”. 

Evaluate changes 

in HRQoL using 

KHQ 

Groups: 

G1: Standard 

instructions 

G2: Educational 

intervention 

(educational 

booklet, OAB 

newsletters, 

dosing reminders, 

calendar 

reminders, 

bladder diary) 

N at enrollment: 

Total: 2,878 

G1: 1,282 

G2: 1,596 

Women, %: 

87.2 

Age, yrs ± SD: 

62.5 ± 14.8 

Race/ethnicity, 

%: 

White: 83.6 

African American: 

9.9 

Hispanic: 4.8 

Asian: 1.2 

Other: 0.5 

Follow-up: 

6 months 

Inclusion criteria:

• Age ≥18 

• UUI, urinary 

urgency or 

frequency 

• Willing to 

discontinue all 

prescription and 

OTC 

medications for 

OAB 

• Capable of 

completing QOL 

questionnaires 

without 

assistance 

• Negative 

pregnancy test & 

medically 

acceptable 

contraceptive 

Exclusion 

criteria: 

• Contraindication

s to oxybutynin 

• Reversible 

etiologies for 

OAB 

• Prior treatment 

with Oxytrol 

• Long-term care 

facilities and 

nursing homes 

KHQ, UUI 

severity item 

score, %: 

A lot: 38.1 

Moderately: 31.3 

A little: 20.5 

Omitted, N/A: 10.1

KHQ, urgency 

severity item 

score, %: 

A lot: 49.2 

Moderately: 30.3 

A little: 14.8 

Omitted, N/A: 5.6 

KHQ, frequency 

severity item 

score, %: 

A lot: 59.3 

Moderately: 32.5 

A little: 7.2 

Omitted, N/A:1.0 

KHQ, nocturia 

severity item 

score, %: 

A lot: 47.3 

Moderately: 33.5 

A little: 16.7 

Omitted, N/A: 2.4 

History of OAB, 

years, %:

<1 year: 12.0 

1-2 years: 18.5 

2-4 years: 23.1 

≥ 4 years: 46.4 

OAB Severity:

No problem: 1.8 

Very minor: 4.6 

Minor: 15.5 

Moderate: 33.0 

Severe: 28.4 

Many severe 

problems: 16.7 

Previous OAB 

treatments, n 

(%):

0: 43.4 

1: 38.7 

2: 13.1 

3: 2.9 

4: 1.9 

KHQ, UUI 

severity item 

score, %: 

A lot: 21.3 

Moderately: 29.5 

A little: 31.6 

Omitted, N/A: 17.7 

KHQ, urgency 

severity item 

score, %: 

A lot: 27.3 

Moderately: 33.8 

A little: 27.3 

Omitted, N/A: 11.5 

KHQ, frequency 

severity item 

score, %: 

A lot: 33.5 

Moderately: 45.2 

A little: 18.7 

Omitted, N/A: 2.6 

KHQ, nocturia 

severity item 

score, %: 

A lot: 27.5 

Moderately: 35.4 

A little: 31.3 

Omitted, N/A: 5.7 

KHQ, general 

health perception, 

mean ± SD (% 

improvement): 

-1.2 ± 17.4 (-4.3) 

KHQ, 

incontinence 

Impact, mean ± 

SD (% 

improvement): 

-13.5 ± 29.5 (-19.5) 

KHQ, symptom 

severity, mean ± 

SD (% 

improvement): 

-12.4 ± 24.8 

(-22.2)*** 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-306 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2007 

(continued) 

KHQ, general 

health 

perception, mean 

± SD: 

28.2 ± 19.8 

KHQ, 

incontinence 

Impact, mean ± 

SD: 

69.3 ± 27.4 

KHQ, symptom 

severity, mean ± 

SD: 

55.9 ± 20.5* 

KHQ, role 

limitations, mean 

± SD: 

45.1 ± 31.0 

KHQ, physical 

limitations, mean 

± SD: 

46.7 ± 31.6 

KHQ, social 

limitations, mean 

± SD: 

25.6 ± 28.3 

KHQ, emotions, 

mean ± SD: 

30.0 ± 29.2 

KHQ, personal 

relationships, 

mean ± SD: 

20.6 ± 29.5*** 

KHQ, sleep/ 

energy, mean ± 

SD: 

54.2 ± 27.3 

KHQ, severity 

(coping) 

measures, mean 

± SD: 

47.9 ± 26.4 

KHQ, role 

limitations, mean 

± SD (% 

improvement): 

-13.3 ± 29.2 (-29.5) 

KHQ, physical 

limitations, mean 

± SD (% 

improvement): 

-11.7 ± 29.9 (-25.1) 

KHQ, social 

limitations, mean 

± SD (% 

improvement): 

-6.7 ± 23.7 (-26.2) 

KHQ, emotions, 

mean ± SD (% 

improvement): 

-8.8 ± 25.4 (-29.3) 

KHQ, personal 

relationships, 

mean ± SD (% 

improvement): 

-6.0 ± 23.5 

(-29.1)*** 

KHQ, 

sleep/energy, 

mean ± SD (% 

improvement): 

-11.2 ± 24.1 (-20.7) 

KHQ, severity 

(coping) 

measures, mean 

± SD (% 

improvement): 

-8.6 ± 21.3 (-18.0)

Side effects, 

application site, 

%: 

Total: 14.0 

Pruritis: 4.9 

Erythema: 4.6 

Dermatitis: 4.4 

Irritation: 3.2 

Other: 2.0 

Side effects, %: 

Rash: 3.0 

Dry mouth: 2.6 

Pruritis: 2.6 

Skin irritation: 2.1 

C-307 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2007 

(continued) 

Withdrew due to 

AEs, %: 

21.3 

Withdrew: 1452 

(50.5%) 

Adverse events 

21.3% 

Withdrawn 

consent: 7.5% 

Requirement for 

alternative therapy 

7.4% 

Loss to follow-up 

7.2% 

Noncompliance 

5.6% 

Administrative 

decision 0.7% 

Ineligible: 0.4% 

Death 0.1% 

No reason given 

0.3% 

C-308 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Song et al., 2006

Country and 

setting: 

Korea, Medical 

Center 

Enrollment 

period: 

May 2001 to April 

2002

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

bladder training 

(BT) vs. 

Tolterodine vs. BT 

+ Tolterodine 

Groups: 

G1: BT x 12 wks 

G2: Tolterodine 2 

mg b.i.d. x 12 wks 

G3:Tolterodine 2 

mg b.i.d. + BT x 

12 wks 

N at enrollment: 

G1: 46 

G2: 47 

G3: 46 

N at follow-up: 

G1: 26 

G2: 32 

G3: 31 

Women, %: 

100

Age, mean ± SD: 

G1: 45.73 ± 12.68 

G2: 48.41 ± 9.38 

G3: 45.42 ± 9.54 

Race/ethnicity, 

%: 

Korean: 100 

Inclusion criteria:

• Age ≥ 18

• ≥ 8 voids/day 

• Urge with or 

without 

incontinence 

• Symptom 

duration ≥ 3 

months 

• No prior history 

of treatment for 

OAB 

Exclusion 

criteria: 

• Active urinary 

tract infection 

• Clinically 

significant SUI 

• Bladder outlet 

obstruction 

• Interstitial cystitis

• Glaucoma 

• Megacolon 

• Maximal urine 

flow rate of < 10 

mL/sec 

• Postvoid 

residual volume 

> 30% of the 

total amount 

voided on 

uroflowmetry 

Voids/day, mean 

± SD: 

G1: 10.93 ± 2.14 

G2: 11.63 ± 2.57 

G3: 11.90 ± 1.51 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.45 ± 1.14 

G2: 1.72 ± 1.04 

G3: 1.96 ± 1.49 

Urgency, mean 

score ± SD: 

G1: 2.58 ± 1.30 

G2: 2.81 ± 0.74 

G3: 3.00 ± 1.10 

Maximum flow 

rate (mL/s), mean 

± SD: 

G1: 20.35 ± 8.44 

G2: 22.56 ± 4.94 

G3: 21.19 ± 4.96 

Residual urine 

(mL), mean ± SD:

G1: 9.08 ± 22.56 

G2: 7.59 ± 12.39 

G3: 6.42 ± 10.16 

Symptom 

duration (years), 

mean ± SD: 

G1: 6.44 ± 6.84 

G2: 4.54 ± 5.15 

G3: 4.10 ± 3.99 

Voids/day, mean 

(% decrease) 

G1: 8.1 (25.9%)* 

G2: 8.1 (30.2%)* 

G3: 7.9 (33.5%)* 

G3/G1: P < 0.05 

Nocturia 

episodes/day, 

mean (% 

reduction): 

G1: 0.6 (56.1%)* 

G2: 0.6 (65.4%)* 

G3: 0.6 (66.3%)* 

Urgency, mean 

score (% 

reduction): 

G1: 1.4 (44.8%)* 

G2: 1.1 (62.2%)* 

G3: 1.2 (60.2%)* 

G3/G1: P = 0.021 

G2/G1: P = 0.017 

G2/G3: P = NS 

Satisfaction, 

mean score (% 

improved): 

G1: 1.5 (53.9) 

G2: 1.4 (63.0) 

G3: 1.3 (71.0) 

Dry mouth, n (%): 

G1: 0 (0.0) 

G2: 7 (21.9) 

G3: 9 (28.9) 

Hesitancy, n (%) 

G1: 0 (0.0) 

G2: 3 (9.4) 

G3: 2 (6.5) 

Decreased 

appetite/constipat

ion, n (%): 

G1: 0 (0.0) 

G2: 2 (6.3) 

G3: 2 (6.5) 

Headache, n (%): 

G1: 0 (0.0) 

G2: 1 (3.1) 

G3: 0 (0.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-309 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Staskin et al., 

2007 

Country and 

setting: 

US, Multicenter

Enrollment 

period: 

August 2005 to 

May 2006

Funding: 

Esprit Pharma, 

Indevus 

Pharmaceuticals

Author industry 

relationship 

disclosures: 

4 of 4 

Allergan (3) 

Astellas (3) 

Eli Lilly (1) 

Esprit (4) 

GlaxoSmithKline 

(2) 

Indevus (3) 

Medtronics (1) 

Novartis (3) 

Ortho (1) 

Pfizer (2) 

Schwartz (1) 

Watson (4) 

Design: 

RCT

Intervention: 

Trospium chloride 

ER 

Groups: 

G1: trospium 

chloride ER 60mg 

qd 

G2: placebo 

N at enrollment: 

G1: 298 

G2: 303 

N at follow-up: 

G1: 263 

G2: 273 

Women, n (%): 

G1: 254 (85.2) 

G2: 256 (84.5) 

Age, mean (SE): 

G1: 59.6 (0.77) 

G2: 59.3 (0.70) 

Race/ethnicity, 

%: 

White: 

G1: 86.6 

G2: 85.5 

Black: 

G1: 8.7 

G2: 9.9 

Hispanic: 

G1: 3.0 

G2: 2.3 

Asian: 

G1: 1.0 

G2: 1.3 

Other 

G1: 0.7 

G2: 1.0 

Inclusion criteria:

• Age ≥18 

• OAB symptoms 

for ≥ 6 mos 

• ≥ 1 “severe” 

urgency severity 

rating per 3 

days, measured 

Indevus Urgency 

Severity Scale 

• ≥ 30 voids per 3 

days 

• ≥ 1 UUI 

episodes/day 

• Average total 

volume voided < 

3L per day and < 

250 per void 

Exclusion 

criteria: 

• SUI 

• Insensate 

incontinence or 

overflow 

incontinence 

• Neurogenic 

bladder 

• Significant renal 

disease 

• Hematuria 

• Current UTI 

• ≥ 3 UTIs during 

previous year 

• Significant 

bladder outlet 

obstruction 

• Indwelling 

catheter 

• Active IBD 

• Interstitial cystitis

• Bladder cancer 

• PSA > 4 ng/ml 

• Prostate cancer 

or chronic 

prostatitis 

• Undergoing or 

likely to undergo 

bladder 

retraining or drill 

program 

• Diuretic estrogen 

use outside of a 

long-term stable 

program 

• 

Prior OAB 

medications, n 

(%): 

G1: 159 (53.4) 

G2: 151 (49.8) 

UUI episodes/day, 

wk 1, mean 

change ± SD: 

G1: -1.86 ± 0.13 

G2: -1.24 ± 0.14 

P = .0003 

UUI episodes/day, 

wk 4, mean 

change ± SD: 

G1: -2.36 ± 0.17 

G2: -1.75 ± 0.15 

P = 0.0051 

UUI episodes/day, 

wk 12, mean 

change ± SD: 

G1: -2.48 ± 0.17 

G2: -1.93 ± 0.16 

P = 0.0022 

UUI episodes/wk, 

wk 1, mean 

change ± SD: 

G1: -13.03 ± 0.91 

G2: -8.66 ± 0.95 

P = 0.0003 

UUI episodes/wk, 

wk 4, mean 

change ± SD: 

G1: -16.50 ± 1.17 

G2: -12.24 ± 1.07 

P = 0.0054 

UUI episodes/wk, 

wk 12, mean 

change ± SD: 

G1: -17.34 ± 1.18 

G2: -13.49 ± 1.09 

P = 0.0024 

Urgencyassociated 

voids/day, wk 1, 

mean change ± 

SD: 

G1: -1.90 ± 0.16 

G2: -1.34 ± 0.16 

P = 0.0033 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

- 

Loss to followup: + 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-310 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Staskin et al., 

2007 

(continued) 

Urgencyassociated 

voids/day, wk 4, 

mean change ± 

SD: 

G1: -2.66 ± 0.17 

G2: -1.71 ± 0.18 

P = 0.0003 

Urgencyassociated 

voids/day, wk 12, 

mean change ± 

SD: 

G1: -3.11 ± 0.17 

G2: -2.12 ± 0.19 

P < 0.0001 

Voids/day, wk 1, 

mean change ± 

SD: 

G1: -1.66 ± 0.14 

G2: -1.24 ± 0.13 

P = 0.0092 

Voids/day, wk 4, 

mean change ± 

SD: 

G1: -2.44 ± 0.15 

G2: -1.58 ± 0.15 

P < 0.001 

Voids/day, wk 12, 

mean change ± 

SD: 

G1: -2.81 ± 0.15

G2: -1.99 ± 0.16 

P < 0.001 

Urgency severity 

score/void, wk 1, 

mean change ± 

SD: 

G1: -0.21 ± 0.02 

G2: -0.10 ± 0.02 

P = 0.0002 

Urgency severity 

score/void, wk 4, 

mean change ± 

SD: 

G1: -0.26 ± 0.03 

G2: -0.13 ± 0.03 

P = 0.0008 

C-311 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Staskin et al., 

2007 

(continued) 

Urgency severity 

score/void, wk 12, 

mean change ± 

SD: 

G1: -0.32 ± 0.03 

G2: -0.18 ± 0.03 

P = 0.0004 

OAB-SCS, wk 1, 

mean change ± 

SD: 

G1: -6.96 ± 0.51 

G2: -4.81 ± 0.55 

P = 0.0002 

OAB-SCS, wk 4, 

mean change ± 

SD: 

G1: -9.67 ± 0.56 

G2: -6.13 ± 0.64 

P < 0.0001 

OAB-SCS, wk 12, 

mean change ± 

SD: 

G1: -11.20 ± 0.55 

G2: -7.80 ± 0.67 

P < 0.0001 

Voided volume 

(mL), wk 1, mean 

change ± SD: 

G1: 21.61 ± 2.76 

G2: 12.07 ± 2.11 

P = 0.0036 

Voided volume 

(mL), wk 4, mean 

change ± SD: 

G1: 30.00 ± 3.14 

G2: 17.24 ± 2.47 

P = 0.0007 

Voided volume 

(mL), wk 12, mean 

change ± SD: 

G1: 29.77 ± 3.16 

G2: 18.89 ± 2.79 

P = 0.0039 

Subjects who 

achieved 

normalization, %: 

G1: 20.5 

G2: 11.3 

P < 0.01 

C-312 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Staskin et al., 

2007 

(continued)

At least 1 

treatment 

emergent AE, n 

(%): 

G1: 80 (26.8) 

G2: 53 (17.5) 

Dry mouth, n (%): 

G1: 26 (8.7) 

G2: 9 (3.0) 

Constipation, n 

(%): 

G1: 28 (9.4) 

G2: 4 (1.3) 

Headache, n (%): 

G1: 3 (1.0) 

G2: 8 (2.6) 

C-313 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Steers et al., 

2005 

Country and 

setting: 

US (49) and 

Canada (15), 

Multicenter 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

3 of 4 

Pfizer (3) 

Design: 

RCT 

Intervention: 

Darifenacin CR 

vs. placebo

Groups: 

G1: Darifenacin 

CR 7.5-15 mg qd 

G2: Placebo 

G3: Increased 

dose at 2 wks 

G4: No increased 

dose at 2 wks 

N at enrollment: 

G1: 269 

G2: 129 

N at follow-up: 

G1: 261 

G2: 123 

Women, N (%): 

G1: 227 (84.7) 

G2: 106 (83.5) 

Age, yrs (range): 

G1: 57.5 (27-89) 

G2: 58.5 (22-86) 

Aged < 65 years, 

n (%) 

G1: 183 (68.3) 

G2: 81 (63.8) 

Race/ethnicity:

NR 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

for ≥ 6 mos 

• Capable of 

independent 

toileting 

• ≥ 5 episodes of 

UI per wk 

• ≥ 8 voids/day 

• Strong desire to 

void ≥ 1 times 

per day 

• Adequate 

method of 

contraception 

Exclusion 

criteria: 

• BPH on a nonstable dose of 

finasteride for < 

6mos 

• Contraindications to 

anticholinergic 

medication 

• Clinically 

significant SUI 

• BOO 

• PVR of > 200 

mL 

• Pregnant or 

breastfeeding 

• GU conditions 

that could cause 

urinary 

symptoms 

• Fecal impaction 

or severe 

constipation (< 

3 BM/wk) 

• Urogenital 

surgery in past 

6 mos 

• Bladder biopsy 

in last 30 days 

• Indwelling 

catheter 

• Intermittent selfcatherization 

• Intention to start 

a bladdertraining program 

during study 

Urgency 

episodes/day, 

median (IQR): 

G1: 8.3 (6.4, 10.6)

G2: 8.0 (5.6, 10.3)

Severity of 

urgency, VAS 

score, median 

(IQR): 

G1: 53 (41-66) 

G2: 53 (39-66) 

Incontinence 

episodes/wk, 

median (IQR): 

G1: 16.3 (9.1, 

29.6) 

G2: 14.0 (9.0, 

26.0) 

Significant 

leaks/week, 

median (IQR): 

G1: 7.0 (2.0, 13.1)

G2: 5.3 (1.0, 11.2)

Voids/day, 

median (IQR): 

G1: 9.9 (8.6, 11.9)

G2: 10.4 (8.3, 

11.6) 

Nocturia 

episodes/week, 

median (IQR): 

G1: 12.0 (7.0-16) 

G2: 11.2 (6.1-16) 

Voided volume 

(mL), median 

(IQR): 

G1: 175 (125, 

253) 

G2: 177 (120, 

229) 

Idiopathic OAB, 

n (%): 

G1: 253 (94.4) 

G2: 123 (96.8) 

Urgency 

episodes/day, 

median change 

(%): 

G1: -2.3 (-28.2) 

G2: -0.9 (-11.0) 

G1/G2: P < 0.001 

Severity of 

urgency, VAS 

score, median 

change (%): 

G1: -9.1 (-16.8) 

G2: -3.2 (-5.6) 

G1/G2: P < 0.05 

Significant 

leaks/week, 

median change 

(%): 

G1: -3.0 (-67.3) 

G2: -1.8 (-42.9) 

G1/G2: P < 0.01 

Voids/day, 

median change 

(%): 

G1: -1.9 (-18.9) 

G2: -1.0 (-10.0) 

G1/G2: P < 0.001 

Nocturia 

episodes/week, 

median change 

(%): 

G1: -2.0 (-18.0) 

G2: -1.0 (-12.5) 

G1/G2: P = NS 

Voided volume 

(mL), median 

change (%): 

G1: 19 (10.5) 

G2: 7 (5.4) 

G1/G2: P < 0.05 

Constipation, n 

(%): 

G3: 24 (22.2)

G4: 32 (20.0) 

Dry Mouth, n (%): 

G3: 22 (20.4) 

G4: 28 (17.5)

Headache, n (%): 

G3: 5 (4.6) 

G4: 13 (8.1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-314 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 

2005 

(continued) 

• Concomitant 

use 

anticholinergics, 

antispasmodics, 

opioids, other 

drugs known to 

cause 

constipation, 

HRT (unless 

taken for ≥ 2 

months), and 

P450 3A4 

inhibitors 

Previous drug 

therapy for 

frequency, 

enuresis, or 

incontinence, n 

(%): 

G1: 62 (23.1) 

G2: 32 (25.2) 

C-315 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Steers et al., 

2007 

Country and 

setting: Australia, 

Canada, US; 

multicenter, 30 

centers 

Enrollment 

period: 

July 2001 to 

September 2003

Funding: 

Eli Lilly, 

Boehringer 

Ingelheim 

GmbH. 

Author industry 

relationship 

disclosures: 

7 of 7 

Eli Lilly (7) 

Design: RCT, 

placebocontrolled, doubleblind, stratified by 

urodynamic 

observation

Intervention: 

duloxetine vs 

placebo

Groups: 

G1: placebo x 2 

wks, duloxetine 

40 mg b.i.d. x 4 

wks, duloxetine 60 

mg b.i.d. x 8 wks 

G2: placebo b.i.d. 

x 14 wks 

N at enrollment: 

G1: 153 

G2: 153 

N at follow-up, N 

(%): 

G1: 90 (59) 

G2: 120 (78) 

Age, mean ± SD: 

G1: 56.0 ± 14.8 

G2: 53.3 ± 14.1 

Women, N (%): 

306 (100) 

BMI, mean kg/m2 

± SD: 

G1: 29.2 (7.4) 

G2: 30.2 (7.8) 

Inclusion criteria:

• women 

• >18 yoa 

• predominant 

symptoms of 

OAB ≥ 3 

months defined 

as bothersome 

urinary urgency 

and/or urge, 

abnormal 

voiding 

frequency (≤2 h 

mean daytime 

voiding interval)

• UDS 

observation of 

either detrusor 

OA or urgency 

that limited 

bladder capacity 

to <400mL 

Exclusion 

criteria: 

• -SUI 

• PVR >100 mL 

• Mean 24 h total 

volume voided 

of ≥ 3L 

• Urine culture 

• ≥4 UTIs in past 

yr 

• Regular use of 

meds for OAB 

w/in 4wks of 

enrollment 

• Previous use of 

duloxetine 

• Continence 

surgery ≤ 6 mos

• Any major 

surgery ≤ 3 mos

• Pelvic organ 

prolapse > ICS 

Stage II 

• Non-pharm 

intervention ≤ 3 

mos 

Incontinence 

episodes, all 

assessable pts, 

mean: 

G1: 1.70 

G2: 1.44 

Urinary 

incontinence 

episode (wet 

OAB): 

G1: 2.34 

G2: 2.07 

Pads/week, 

mean: 

G1: 7.81 

G2: 7.05 

Voids/day, mean:

G1: 10.76 

G2: 10.49 

Daytime voiding 

interval, mean: 

G1: 113.58 

G2: 119.63 

Nocturia 

episodes/day, 

mean: 

G1: 1.47 

G2: 1.63 

Voided volume 

(mL), mean: 

G1: 175.41 

G2: 183.40 

QoL Instrument 

score, mean ± 

SD: 

I-QOL: 

G1: 56.65 ± 24.80

G2: 57.11 ± 23.3 

U-IIQ: 

G1: 2.44 ± 1.18 

G2: 2.39 ± 1.15 

U-UDI: 

G1: 3.18 ± 0.58 

G2: 3.15 ± 0.71 

Bladder 

compliance 

(mL/cmH20) 

G1: 71.8 ± 85.7 

G2: 79.3 ± 91.0 

Incontinence 

episodes, all 

assessable pts, 

mean change: 

G1: -0.74 

G2: -0.14 

P = 0.006 

Incontinuence 

episodes, wet 

OAB pts, mean 

change: 

G1: -1.03 

G2: -0.24 

P = 0.032 

Pads/week, mean 

change: 

G1: -1.41 

G2: -0.53 

P = 0.143 

Voids/day, mean 

change: 

G1: -1.81 

G2: -0.62 

P < 0.001 

Daytime voiding 

interval, mean 

change: 

G1: 29.46 

G2: 6.51 

P < 0.001 

Nocturia 

episodes/day, 

mean change: 

G1: 0.05 

G2: -0.18 

P = 0.004 

Voided volume 

(mL), mean 

change: 

G1: 8.85 

G2: 5.07 

P = 0.171 

Condition 

improved, 80 

mg/day, %: 

G1: 59.9 

G2: 42.9 

P = 0.005 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-316 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 

2007 

(continued) 

• Pelvic-floormuscle training 

that had not 

been stable for 

3 mos or would 

not remain 

stable during 

the trial 

SUI: 

G1: 0 

G2: 0 

Maximum 

cystometric 

capacity mL 

G1: 318.3 ± 152.4

G2: 330.4 ± 135.4

Volume 

threshold for first 

detrusor 

contraction mL 

G1: 226.4 ± 141.8

G2: 250.6 ± 146.0

Moderate or 

severe bladder 

condition from 

PGI-I Scale (%): 

G1: 84.9 

G2: 88.8 

I-QOL total 

score, mean ± 

SD: 

G1: 56.6 (24.9) 

G2: 57.0 (23.2) 

UIE , mean ± SD: 

G1: 1.55 (2.08) 

G2: 1.41 (2.00) 

VE24 , mean ± 

SD: 

G1: 10.8 (3.3) 

G2: 10.6 (3.6) 

Symptom of 

bothersome 

urgency, %: 

G1: 99.3 

G2: 99.3 

Symptoms of 

urge UI, %: 

G1: 88.2 

G2: 88.9 

Symptoms of 

SUI: 

G1: 42.5 

G2: 50.3 

Urodynamic 

DOA 

G1: 42.5 

G2: 41.8 

Condition 

improved, 120 

mg/day, %: 

G1: 61.6 

G2: 42.1 

P = 0.008 

Condition 

improved, 

overall, %: 

G1: 53.4 

G2: 41.9 

P = 0.052 

Headache: 

G1: 13 (8.5) 

G2: 8 (5.2) 

P = 0.336 

Diarrhea: 

G1: 10 (6.5) 

G2: 5 (3.3) 

P = 0.289 

Cough: 

G1: 7 (4.6) 

G2: 6 (3.9) 

p>0.999 

Change in QOL 

Instrument score, 

mean ±: 

I-QOL 

G1: 8.37 ± 15.89 

G2: 4.87 ± 15.27 

G1>G2 (P = .035) 

U-IIQ 

G1: -0.44 ± 0.76 

G2: -0.22 ± 0.87 

P = 0.018 

U-UDI 

G1: -0.26± 0.67 

G2: -0.19 ± 0.59 

P = 0.440 

Bladder 

compliance 

(mL/cmH20) 

G1: 16.5 ±131.3 

G2: 1.0 ± 120.8 

P = 0.655 

Maximum 

cystometric 

capacity mL 

G1: 22.1 ± 116.4 

G2: 23.8 ± 108.5 

P = 0.619 

C-317 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 

2007 

(continued) 

Sensory 

urgency: 

G1: 57.5 

G2: 58.2 

Previous 

continence 

surgery, %: 

G1: 13.1 

G2: 11.8 

Current pelvicfloor muscle 

training, %: 

G1: 9.2 

G2: 11.8 

Previous 

behavioral 

therapy, %: 

G1: 3.3 

G2: 2.6 

Previous 

tolterodine 

therapy, %: 

G1: 10.5 

G2: 7.2 

Previous 

oxybutynin 

therapy, %: 

G1: 13.0 

G2: 9.2

Volume threshold 

for first detrusor 

contraction mL 

G1: 90.0 ± 200.6 

G2 : 13.9 ± 112.8 

P = 0.254 

PGI-I score 

Better 

4 wks (80 mg/day) 

G1: 59.9 

G2: 42.9 

P = 0.005 

TEAEs reported, 

% 

G1: 79.1 

G2: 55.6 

P < 0.001 

Appetite 

decreased 

G1: 6 (3.9) 

G2: 0 

G1>G2, P = 0.030 

Arthralgia 

G1: 6 (3.9) 

G2: 3 (2.0) 

P = 0.501 

Somnolence: 

G1: 6 (3.9) 

G2: 0 

P = 0.30 

Sweating 

increased: 

G1: 6 (3.9) 

G2: 2 (1.3) 

P = 0.283 

UTI: 

G1: 6 (3.9) 

G2: 6 (3.9) 

p>0.999 

Anorgasmia 

G1: 5 (3.3) 

G2: 0 

G1>G2, P = 0.060 

Anxiety: 

G1: 5 (3.3) 

G2: 0 

G1>G2, P = 0.060 

C-318 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 

2007 

(continued) 

Tremor: 

G1: 5 (3.3) 

G2: 0 

G1>G2, P = 0.060

Upper respiratory 

infection: 

G1: 5 (3.3) 

G2: 4 (2.6) 

P > 0.999 

Vomiting: 

G1: 5 (3.3) 

G2: 3 (2.0) 

P = 0.723 

Abdominal pain: 

G1: 4 (2.6) 

G2: 1 (0.7) 

P = 0.371 

Back pain: 

G1: 4 (2.6) 

G2: 1 (0.7) 

P = 0.371 

Note: mean 

change consistent 

at 4 wks 

(duloxetine 80 

mg/d) and 8 wks 

(duloxetine 120 

mg/d) 

Change in I-QOL 

total score, mean 

± SD: 

Discontinuation 

due to TEAEs, % 

G1: 28.1 

G2: 5.2 

P < 0.001 

Treatment 

emergent adverse 

events, n (%): 

Nausea: 

G1: 47 (30.7) 

G2: 7 (4.6) 

G1>G2, P < 0.001 

Dry mouth: 

G1: 25 (16.3) 

G2: 2 (1.3) 

G1>G2, P < 0.001 

C-319 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 

2007 

(continued) 

Dizziness: 

G1: 22 (14.4) 

G2: 1 (0.07) 

G1>G2, P < 0.001 

Constipation: 

G1: 21 (13.7) 

G2: 5 (3.3) 

G1>G2, P = 0.002 

Insomnia: 

G1: 20 (13.1) 

G2: 5 (3.3) 

G1>G2, P = 0.003 

Fatigue: 

G1: 16 (10.5) 

G2: 3 (2.0) 

G1>G2, P = 0.003 

C-320 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sussman and 

Garely, 2002 

Country and 

setting: 

US, 2 sites 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Multicenter RCT 

Intervention: 

Tolterodine ER vs. 

Oxybutynin ER

Groups: 

G1: Tolterodine 

ER 2 mg qd x 8 

wks 

G2: Tolterodine 

ER 4 mg qd x 8 

wks 

G3: Oxybutynin 

ER 5 mg qd x 8 

wks 

G4: Oxybutynin 

ER 10 mg qd x 8 

wks 

N at enrollment: 

G1: 333 

G2: 336 

G3: 313 

G4: 307 

N at follow-up: 

G1: 313 (86) 

G2: 316 (88) 

G3: 286 (81) 

G4: 285 (79) 

Age, yrs ± SD: 

G1: 63.8 ± 15.7 

G2: 63.4 ± 16.6 

G3: 59.8 ± 16.5 

G4: 63.2 ± 15.9 

Women, N (%): 

G1: 243 (73) 

G2: 254 (76) 

G3: 245 (78) 

G4: 222 (72) 

Race/ethnicity, n 

(%): 

White: 

G1: 278 (84) 

G2: 296 (88) 

G3: 256 (82) 

G4: 247 (81) 

Black: 

G1: 28 (8) 

G2: 23 (7) 

G3: 41 (13) 

G4: 42 (14) 

Inclusion criteria: 

• 18+ years old 

• OAB (urinary 

frequency + 

urgency) w/ or 

w/o UI 

Exclusion 

criteria: 

• Pure SI 

• Urinary 

retention 

• Gastric 

retention 

• Uncontrolled 

narrow-angle 

glaucoma 

• Significant 

hepatic or renal 

dysfunction 

• Symptomatic or 

recurrent UTI 

• Electrostimulati

on 

• Bladder training

• Pelvic floor 

exercise w/in 1 

wk of first study 

visit or expected 

to start during 

study 

• Indwelling 

catheter 

• Intermittent selfcath 

• Contraindication 

to 

antimuscarinic 

trt 

• Estrogen 

therapy started 

less than 2 mos 

prior to first visit

• Any trt for UI 

w/in 1 wk of first 

visit 

• Use of 

anticholinergic 

drug or potent 

inhibitors of 

cytochrome 

P450 3A4 

• Pregnant 

• Lactating 

Presence of UI, n 

(%): 

G1: 195 (59) 

G2: 214 (64) 

G3: 199 (64) 

G4: 195 (64) 

Duration of sx, n 

(%): 

< 6 months: 

G1: 38 (11) 

G2: 48 (14) 

G3: 62 (20) 

G4: 43 (14) 

6 months to 5 

years: 

G1: 226 (68) 

G2: 224 (67) 

G3: 183 (59) 

G4: 205 (67) 

> 5 years: 

G1: 68 (20) 

G2: 64 (19) 

G3: 67 (21) 

G4: 59 (19) 

Severity of 

bladder 

condition, % 

No problems: 

G1: 1.3 

G2: 0.3 

G3: 1.0 

G4: 0.7 

Some very minor 

problems: 

G1: 6 

G2: 5 

G3: 5 

G4: 5 

Some minor 

problems: 

G1: 18 

G2: 16 

G3: 21 

G4: 15 

Moderate 

problems 

G1: 45 

G2: 50 

G3: 41 

G4: 47 

Improvement in 

bladder 

condition, 8 wks, 

overall, %: 

G1: 60 

G2: 70 

G3: 59 

G4: 60 

G2/G3: P < 0.01 

G2/G4: P < 0.01 

Improvement in 

bladder 

condition, 8 wks, 

moderate or 

severe bladder 

condition, %: 

G2: 77 

G4: 65 

G2/G4: P < 0.01 

Improvement in 

bladder 

condition, 8 wks, 

treatment naïve, 

%: 

G1: 60 

G2: 69 

G3: 60 

G4: 61 

P = 0.11 for 

improvement rates 

P > 0.05 for overall 

difference btw trt 

arms 

Improvement in 

bladder 

condition, 8 wks, 

treatment 

experienced, %: 

G1: 57 

G2: 75 

G3: 59 

G4: 54 

P = 0.11 for 

improvement rates 

P > 0.05 for 

overall difference 

btw trt arms 

Withdrawal due to 

AE, (%): 

G2: 6 

G4: 13 

P = 0.001 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-321 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sussman and 

Garely, 2002 

(continued) 

Hispanic: 

G1: 19 (6) 

G2: 15 (5) 

G3: 15 (5) 

G4: 16 (5) 

Other, n (%): 

G1: 8 (2) 

G2: 2 (<1) 

G3: 1 (<1) 

G4: 2 (<1) 

Parity: 

NR 

• Childbearing 

potential w/o 

adequate 

contraception 

Severe problems: 

G1: 26 

G2: 21 

G3: 23 

G4: 25 

Many severe 

problems: 

G1: 4 

G2: 7 

G3: 8 

G4: 8

Mean change in 

severity of dry 

mouth (visual 

analogue scale): 

G1: 2.3 

G2: 6.0 

G3: 6.3 

G4: 11.3 

G1 vs G2: P = NS 

G3 vs G4: P = 0.05 

G2 vs G4: P = 0.03 

C-322 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Swift et al., 2003 

Country and 

setting: 

Europe (167 

centers), North 

America (74 

centers), Australia 

and New Zealand 

(4 centers), 

University 

Enrollment 

period: 

February 1999 to 

October 1999 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

double blind 

placebo-controlled 

double dummy, 

random permuted 

blocks of 6 

Intervention: 

Tolterodine ER vs. 

Tolterodine IR 

Groups: 

G1: Tolterodine 

ER 4 mg daily 

G2: Tolterodine IR 

2 mg b.i.d. 

G3: placebo 

N at enrollment: 

G1: 417 

G2: 408 

G3: 410 

N at follow-up: 

Total: 1092 

Women, %: 

100 

Age, yrs ± SD: 

G1: 59 ± 14 

G2: 59 ± 14 

G3: 60 ± 14 

Race/ethnicity, n 

(%): 

White: 

G1: 396 (95) 

G2: 389 (95) 

G3: 383 (93) 

Black: 

G1: 15 (4) 

G2: 12 (3) 

G3: 20 (5) 

Asian/Pacific: 

G1: 5 (1) 

G2: 4 (1) 

G3: 2 (1) 

Mixed: 

G1: 0 

G2: 3 (1) 

G3: 5 (1) 

Unknown: 

G1: 1 (<1) 

G2: 0 

G3: 0 

Inclusion criteria: 

• Women 

• Age ≥ 18 

• ≥ 8 voids/day 

• > 5 UUI/ week 

• Symptoms x ≥ 6 

months (per 

voiding diary) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 

liters 

• Hepatic/ renal 

disease 

• UTI 

• IC 

• Hematuria 

• BOO 

• Current e-stim 

• Current bladder 

training 

• Indwelling 

catheter 

• CIC 

• Pregnant/ 

nursing 

• Childbearing 

age without BC 

• Anticholinergic 

meds 

• Meds inhibit 

cytochromep45

0 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 22.1 ± 22.5 

G2: 22.9 ± 21.9 

G3: 23.9 ± 21.2 

Pads/day, mean 

± SD: 

G1: 1.6 ± 2.1 

G2: 1.5 ± 2.0 

G3: 1.7 ± 2.4 

Voids/day, mean 

± SD: 

G1: 10.8 ± 4.2 

G2: 11.1 ± 3.7 

G3: 11.2 ± 3.9 

Voided volume 

(mL), mean ± SD:

G1: 141.2 ± 43.1

G2: 137.2 ± 41.2

G3: 135.7 ± 43.2 

Previous drug 

therapy: n (%): 

G1: 235 (56) 

G2: 222 (54) 

G3: 225 (55) 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 10.3 ± 17.2 

G2: 12.8 ± 19.8 

G3: 16.7 ± 19.7 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Pads/day, mean ± 

SD: 

G1: 1.0 ± 1.8 

G2: 1.0 ± 1.5 

G3: 1.5 ± 2.2 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Voids/day, mean 

± SD: 

G1: 9.0 ± 3.2 

G2: 9.3 ± 4.0 

G3: 9.9 ± 3.8 

G1/G3: P = 0.001

G2/G3: P = 0.005 

Voided volume 

(mL), mean ± SD: 

G1: 179.1 ± 66.6

G2: 169.7 ± 65.6

G3: 149.0 ± 56.3 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Clinical effecttiveness*, dry 

mouth: 

G1: 0.53 

G2: 0.39 

G3: 0.30 

Dry mouth, n (%): 

G1: 105 (25.3) 

G2: 127 (31.2) 

G3: 33 (8.0) 

G1/G3: P < 0.01 

G2/G3: P < 0.01 

Abdominal pain, 

n (%): 

G1: 18 (4.3) 

G2: 12 (2.9) 

G3: 7 (1.7) 

G1/G3: P = 0.03 

Constipation, n 

(%): 

G1: 27 (6.5) 

G2: 27 (6.6) 

G3: 14 (3.4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: ++ 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-323 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

BMI, kg/m2

 ± SD: 

G1: 28.8 ± 13.8 

G2: 29.0 ± 11.0 

G3: 28.8 ± 6.7 

Dyspepsia, n (%): 

G1: 11 (2.7) 

G2: 14 (3.4) 

G3: 6 (1.5) 

Nausea, n (%): 

G1: 7 (1.7) 

G2: 9 (2.2) 

G3: 9 (2.2) 

Diarrhea, n (%): 

G1: 10 (2.4) 

G2: 14 (3.4) 

G3: 9 (2.2) 

Flatulence, n (%): 

G1: 8 (1.9) 

G2: 11 (2.7) 

G3: 6 (1.5) 

Xerophthalmia, n 

(%): 

G1: 16 (3.9) 

G2: 8 (2.0) 

G3: 8 (2.0) 

Abnormal vision, 

n (%): 

G1: 5 (1.2) 

G2: 4 (1.0) 

G3: 2 (0.5) 

Headache, n (%): 

G1: 29 (7.0) 

G2: 14 (3.4) 

G3: 19 (4.6) 

UTI, n (%): 

G1: 15 (3.6) 

G2: 11 (2.7) 

G3: 19 (4.6) 

Insomnia, n (%): 

G1: 7 (1.7) 

G2: 2 (0.5) 

G3: 9 (2.2) 

Somnolence, n 

(%): 

G1: 12 (2.9) 

G2: 11 (2.7) 

G3: 8 (2.0) 

Dizziness, n (%): 

G1: 7 (1.7) 

G2: 7 (1.7) 

G3: 4 (1.0) 

C-324 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

Hypertension, n 

(%): 

G1: 6 (1.4) 

G2: 4 (1.0) 

G3: 4 (1.0) 

Sinusitis, n (%): 

G1: 8 (1.9) 

G2: 2 (0.5) 

G3: 3 (0.7) 

Arthritis, n (%): 

G1: 1 (0.2) 

G2: 5 (1.2) 

G3: 1 (0.2) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 5 (1.2) 

G3: 1 (0.2) 

C-325 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics* Outcomes Quality Rating 

Author: 

Szonyi et al., 

1995 

Country and 

setting: 

UK 

Enrollment 

period: 

NR 

Funding: 

Smith & Nephew 

Pharmaceuticals 

Ltd 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin plus 

bladder training vs 

placebo plus 

bladder training 

Groups: 

G1: Oxybutynin 

2.5 mg b.i.d. with 

dose titration on 

days 29 and 43 

plus bladder 

training 

G2: placebo + 

bladder training 

N at enrollment: 

G1: 30 

G2: 30 

N at follow-up: 

G1:16 

G2: 23 

Women, n (%): 

56 (93) 

Age, mean ± SD: 

82.2 ± 6.06 

Race/ethnicity: 

NR 

Weight (kg),

mean ± SD:

67.4 ± 14.92

Inclusion criteria:

• Age > 70 

• Frequency, 

urgency and UUI

• Mobile 

• Able to keep 

diary 

Exclusion 

criteria: 

• UTI 

• Hepatic or renal 

disease 

• Glaucoma 

• Uncontrolled 

diabetes 

• Taking 

imipramine or 

propantheline 

Voids/2 weeks, 

median change 

(95% CI): 

G1/G2: 577 (-27.0, 

6.0) 

P = 0.0025 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -6 (-5, 7.0) 

Daytime 

incontinence 

episodes/2 

weeks, median 

change (95% CI): 

G1 vs. G2: -9.5 (-

11.0, 3.0) 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -1.0 (-3.0, 

2.0) 

Patient assessment of benefit, 

%: 

29 days: 

G1: 86

G2: 55

P = 0.02 

43 days: 

G1: 71

G2: 59

P = 0.41 

57 days: 

G1: 79

G2: 55

P = 0.09 

Patient response, 

29 days, n: 

Cure: 

G1: 1

G2: 0 

Significant 

improvement: 

G1: 15

G2: 8

Marginal 

improvement: 

G1: 7

G2: 8

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-326 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics* Outcomes Quality Rating 

Szonyi et al., 

1995 

(continued)

No change: 

G1: 5

G2: 13

Patient response, 

57 days, n: 

Cure: 

G1: 4

G2: 3

Significant 

improvement: 

G1: 14

G2: 8

Marginal 

improvement: 

G1: 3 

G2: 4

No change: 

G1: 7

G2: 14

Dry mouth, %: 

G1: 93

G2: 86

Blurred vision, %: 

G1: 50

G2: 59 

Heartburn, %: 

G1: 57

G2: 45

Constipation, %: 

G1: 50

G2: 45

Dry skin, %: 

G1: 50

G2: 59

Poor compliance 

(< 75% of tablets), 

%: 

G1: 20

G2: 20 

C-327 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Tseng et al., 2009 

Country and 

setting: 

Taiwan, 

University 

Enrollment 

period: 

January 2005 to 

November 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective cohort 

randomized 

Intervention: 

Tolterodine 2 mg 

b.i.d. vs. 

tolterodine 2 mg 

b.i.d. + conjugated 

equine estrogen 

0.625 mg twice 

per week

Groups: 

G1: tolterodine 2 

mg b.i.d. 

G2: tolterodine 2 

mg b.i.d. + 

conjugated equine 

estrogen 0.625 

mg twice per week 

N at enrollment: 

G1: 40 

G2: 40 

N at follow-up: 

G1: 40 

G2: 40 

Age, mean ± SD: 

G1: 64.5 ± 7.4 

G2: 66.2 ± 6.8 

Race/ethnicity:

NR 

Women, N (%): 

G1: 40 (100) 

G2: 40 (100) 

BMI, kg/m2

 ± SD: 

G1: 24.5 ± 3.9 

G2: 25.3 ± 3.8 

Previous 

antimuscarinic 

Rx, n (%): 

G1: 5 (12.5) 

G2: 6 (15) 

Prior hysterictomy, n (%): 

G1: 12 (30) 

G2: 14 (35) 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

• Amenorrheic 

Exclusion 

criteria: 

• Advanced POP 

> Stage 2 

• Women with 

storage and 

voiding 

dysfunction 

undiagnosed 

• Severe 

constipation 

• Elevated PVR 

• Neurological 

deficit 

• Renal/ hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary retention

• Gastric retention

• Hypersensitivity 

to drugs 

• BOO 

• Cardiac 

conduction 

disorders 

• Myasthenia 

gravis 

• History of CVA 

• History of VTE 

• Gallbladder 

disease 

• Known or 

suspected 

breast 

carcinoma 

• Undiagnosed 

genital bleeding 

• HRT within 3 

months of study 

enrollment 

UUI episodes/ 

day, mean ± SD: 

G1: 1.8 ± 0.7 

G2: 2.1 ± 1.1 

Urgency 

episodes/ day, 

mean ± SD: 

G1: 4.5 ± 0.8 

G2: 4.3 ± 0.7 

Nocturia 

episodes/ day, 

mean ± SD: 

G1: 3.5 ± 0.8 

G2: 3.3 ± 0.8 

Voids/day, mean 

± SD: 

G1: 14.1 ± 1.3 

G2: 14.8 ± 1.5 

UDI-6 score, 

mean ± SD: 

G1: 9.5 ± 3.9 

G2: 8.6 ± 3.8 

IIQ-7 score, mean 

± SD: 

G1: 10.2 ± 4.5 

G2: 9.4 ± 3.6 

Voided volume 

(mL), mean ± SD:

G1: 108.5 ± 14.0 

G2: 115.8 ± 15.1 

UUI episodes/day, 

mean ± SD: 

G1: 1.5 ± 0.5 

G2: 1.5 ± 0.5 

P = NS 

Urgency 

episodes/ day, 

mean ± SD: 

G1: 3.5 ± 0.5 

G2: 3.3 ± 0.6 

Nocturia 

episodes/ day, 

mean ± SD: 

G1: 2.9 ± 0.6 

G2: 2.6 ± 0.7 

Voids/day, mean 

± SD: 

G1: 6.4 ± 1.9 

G2: 5.8 ± 0.9 

P = 0.001 

UDI-6 score, 

mean ± SD: 

G1: 7.2 ± 2.9 

G2: 6.9 ± 2.7

P < 0.001 

IIQ-7 score, mean 

± SD: 

G1: 6.5 ± 2.7 

G2: 6.1 ± 2.5 

P < 0.001 

Voided volume 

(mL), mean ± SD: 

G1: 134.5 ± 15.8 

G2: 141.9 ± 16.1 

P = 0.007 

Adverse events: 

None 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: +

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: 

++ 

Power 

calculation: + 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: 

++ 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-328 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

Country and 

setting: 

North America 

(74 centers), 

Australasia (4 

centers), Europe 

(89 centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine ER vs 

Tolterodine IR vs 

placebo

Groups: 

G1: tolterodine ER 

4 mg qd 

G2: tolterodine IR 

2 mg b.i.d. 

G3: placebo 

N at enrollment: 

G1: 507 

G2: 514 

G3: 508 

N at follow-up: 

Total: 1442 

G1: 398 

G3: 374 

Women, n (%): 

G1: 417 (82) 

G2: 408 (79) 

G3: 410 (81) 

Age, mean 

(range): 

G1: 60 (20, 89) 

G2: 60 (22, 92) 

G3: 61 (22, 93) 

Race/ethnicity, 

%:* 

White: 

G1: 95.7 

G3: 94.7 

Black: 

G1: 3.0 

G3: 3.5 

Asian/Pacific 

Islander: 

G1: 1.0 

G3: 0.8 

Other: 

G1: 0.3 

G3: 1.1 

Inclusion criteria: 

• Age ≥ 18 

• Urinary 

frequency (≥ 8 

voids/day) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 L 

• Contraindications to 

antimuscarinic 

treatment 

• Hepatic or renal 

disease 

• UITs 

• Interstitial 

cystitis 

• Hematuria 

• BOO 

• Current 

electrostimulation or bladder 

training therapy 

• Indwelling 

catheter or 

intermittent selfcatheterization 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Being treated 

for OAB with 

other 

anticholinergic 

drugs or drugs 

that inhibit 

cytochrome 

P450 3A4 

isoenzymes 

• Estrogen 

therapy < 2 

months 

• Treatment w/ 

investigational 

drug < 2 months

Incontinence 

episodes/week, 

mean (range): 

G1: 22.1 (0, 

168.0) 

G2: 23.2 (0, 

168.0) 

G3: 23.3 (0, 

168.0) 

≥ 5 incontinence 

episodes/week, n 

(%): 

G1: 492 (97) 

G2: 498 (97) 

G3: 494 (97) 

Pads/day, mean 

(range): 

G1: 1.4 (0-18) 

G2: 1.4 (0-25) 

G3: 1.5 (0-22) 

Voids/day, mean 

(range): 

G1: 10.9 (2.3, 

51.3) 

G2: 11.1 (2.0, 

48.6) 

G3: 11.3 (2.0, 

37.4) 

≥ 8 voids/day, n 

(%): 

G1: 458 (90) 

G2: 469 (91) 

G3: 467 (92) 

Previous drug 

therapy, n (%): 

G1: 270 (53) 

G2: 276 (54) 

G3: 263 (52) 

Poor efficacy, %:

G1: 43 

G2: 38.4 

G3: 40.7 

Able to finish 

tasks before 

visiting a toilet, 

%:* 

G1: 5 

G3: 6 

Urgency, subjecttive assessment, 

12 wks, n (%):* 

Improvement:

G1: 173 (44) 

G3: 118 (32) 

G1/G3: P < 0.001 

No change: 

G1: 201 (51) 

G3: 212 (57) 

Deterioration: 

G1: 22 (6) 

G3: 44 (12) 

G1/G3: P < 0.002 

Urgency, 

improve-ment, 12 

wks, women only, 

%:* 

G1: 46.6 

G3: 26.6 

G1/G3: P = 0.001 

OR 1.81 (95% CI: 

1.31, 2.49) 

Not able to hold 

urine, 12 wks, %:* 

G1: 58 

G3: 32 

G1/G3: P < 0.001 

Incontinence 

episodes/week, 

mean change ± 

SD (%) 

G1: -11.8 ± 17.8 

G2: -10.6 ± 16.9 

G3: -6.9 ± 15.4 

G1/G3: P =

0.00001 

G2/G3: P = 0.0005 

G1/G2: P < 0.05 

Incontinence 

episodes/week, 

median % 

change: 

G1: -71 

G2: -60 

G3: -30 

G1/G2: P < 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-329 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

Voided volume 

(mL), mean 

(range): 

G1: 141 (36, 338) 

G2: 137 (38, 283) 

G3: 136 (31, 374) 

Pads/day, mean ± 

SD: 

G1: -0.5 ± 1.4 

G2: -0.5 ± 18 

G3: -0.2 ± 1.4 

G1/G3: P = 0.0145 

G2/G3: P = 0.0035 

Voids/day, mean 

± SD: 

G1: -3.5 ± 4.9 

G2: -3.3 ± 4.4 

G3: -2.2 ± 4.0 

G1/G3: P =

0.00001 

G2/G3: P = 0.0002 

Voluntary voids/ 

day, mean ± SD: 

G1: -1.8 ± 3.4 

G2: -1.7 ± 3.3 

G3: -1.2 ± 2.9 

G1 vs G3 

G1/G3: P =

0.00047 

G2/G3: P = 0.0079 

Bladder 

symptoms, 

improvement, 12 

wks, women only, 

%:* 

G1: 62.8 

G3: 48.4 

G1/G3: P = 0.001 

OR 1.78 (95% CI: 

0.34, 2.37) 

Treatment 

benefit, 12 wks, n 

(%):* 

Much benefit: 

G1: 172 (43.2) 

G3: 88 (23.5) 

G1/G3: P < 0.001 

Little benefit 

G1: 138 (34.7) 

G3: 118 (31.6) 

No benefit 

G1: 88 (22.1) 

G3: 168 (44.9) 

C-330 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

Able to finish 

tasks before 

visiting a toilet, 

12 wks, %:* 

G1: 33 

G3: 18 

G1/G3: P <

0.001Voided 

volume (mL), 

mean change ± 

SD: 

G1: +34 ± 51 

G2: +29 ± 47 

G3: +14 ± 41 

G1/G3: P =

0.00001 

G2/G3: P = 0.0001 

Discontinued due 

to AEs, n (%): 

G1: 27 (5) 

G2: 28 (5) 

G3: 33 (6) 

Reported serious 

adverse events, 

n: 

G1: 7 

G2: 12 

G3: 18 

Parasympathetic 

Dry mouth, n (%): 

G1: 118 (23) 

G2: 156 (30) 

G3: 39 (8) 

Xerophthalmia, n 

(%): 

G1: 17 (3) 

G2: 12 (2) 

G3: 10 (2) 

Abnormal vision, 

n (%): 

G1: 6 (1) 

G2: 4 (1) 

G3: 2 (0.5) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 6 (1) 

G3: 1 (0.5) 

C-331 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

Gastrointestinal 

Constipation, n 

(%): 

G1: 30 (6) 

G2: 35 (7) 

G3: 22 (4) 

Dyspepsia, n (%): 

G1: 15 (3) 

G2: 16 (3) 

G3: 7 (1) 

Abdominal pain, 

n (%): 

G1: 19 (4) 

G2: 13 (3) 

G3: 8 (2) 

Diarrhea, n (%): 

G1: 10 (2) 

G2: 16 (3) 

G3: 11 (2) 

Flatulence, n (%): 

G1: 10 (2) 

G2: 14 (3) 

G3: 9 (2) 

Nausea, n (%): 

G1: 7 (1) 

G2: 10 (2) 

G3: 10 (2) 

Headache, n (%): 

G1: 32 (6) 

G2: 19 (4) 

G3: 23 (5) 

Somnolence, n 

(%): 

G1: 14 (3) 

G2: 13 (3) 

G3: 9 (2) 

Dizziness, n (%): 

G1: 11 (2) 

G2: 9 (2) 

G3: 5 (1) 

Fatigue, n (%): 

G1: 11 (2) 

G2: 6 (1) 

G3: 4 (1) 

Insomnia, n (%): 

G1: 7 (1) 

G2: 2 (0.5) 

G3: 9 (2) 

C-332 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

Urinary tract 

infection, n (%):

G1: 16 (3) 

G2: 13 (3) 

G3: 20 (4) 

Dysuria, n (%): 

G1: 5 (1) 

G2: 8 (2) 

G3: 1 (0.5) 

Peripheral edema, 

n (%): 

G1: 7 (1) 

G2: 7 (1) 

G3: 4 (1) 

C-333 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Versi et al., 2000 

Country and 

setting: 

US, 20 Academic 

health centers 

Enrollment 

period: 

NR 

Funding: 

ALZA Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin CR vs 

Oxybutynin IR 

Doses were 

increased/ 

decreased in 5 

mg/d increments 

until optimal dose 

identified. Once 

identified the dose 

was maintained 

for 1 wk and 

urinary diary 

completed 

Groups: 

G1: Oxybutynin 

CR 5-20 mg/d 

G2: Oxybutynin IR 

5-20 mg/d 

N at enrollment: 

G1: 111 

G2: 115 

N at follow-up: 

G1: 107 

G2: 106 

Age, yrs ± SD: 

G1: 58.8 

G2: 59.6 

Race/ethnicity, 

%: 

White: 

G1: 86.5 

G2: 90.4 

Black: 

G1: 5.4 

G2: 3.5 

Hispanic 

G1: 5.4 

G2: 5.2 

Asian: 

G1: 0.9 

G2: 0 

Native American 

G1: 0 

G2: 0.9 

Inclusion criteria: 

• Known to be 

responsive to 

anticholinergic 

trt 

• 7-45 UI 

episodes per wk

• Adult 

• Communitydwelling 

• 4+ days of 

incontinence/wk

Exclusion 

criteria: 

• Clinically 

significant 

medical 

problems 

• PVR>100mL 

• Contraindication 

to oxybutynin 

UUI episodes/ 

week, mean: 

G1: 18.6 

G2: 19.8 

Incontinence 

episodes/week, 

mean: 

G1: 20.2 

G2: 22.4 

UUI episodes/ 

week, mean (%): 

G1: 2.9 (83) 

G2: 4.4 (76) 

P value for change 

from baseline: 

G1: P < 0.001 

G2: P < 0.001 

P = 0.36 for % 

reduction 

Incontinence 

episodes/week, 

mean (%): 

G1: 3.5 (81) 

G2: 5.4 (75) 

P value for change 

from baseline: 

G1: P < 0.001 

G2: P < 0.001 

P = 0.85 for % 

reduction 

Rates for Dry 

Mouth (%): 

G1: 47.7 

G2: 59.1 

P = 0.09 

Pts reporting any 

dry mouth, 

cumulative %: 

Dose of 5mg/day: 

G1: 18.9 

G2: 35.7 

Dose of 10mg/day: 

G1: 39.5 

G2: 61.2 

Dose of 15 

mg/day: 

G1: 56.8 

G2: 74.1 

Dose of 20 

mg/day: 

G1: 80.1 

G2: 82.7 

G1/G2: P = 0.003 

for all comparisons

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-334 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Versi et al., 2000 

(continued) 

Other 

G1: 2 

G2: 0 

Weight, mean kg: 

G1: 78.0 

G2: 79.0 

Height, mean 

cm: 

G1: 163.7 

G2: 165.1 

Women, %: 

G1: 88.3 

G2: 90.4 

Parity mean ± 

SD: 

NR 

C-335 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Wang et al., 2002 

Country and 

setting: 

US, Health care 

database 

Enrollment 

period: 

January 1991 to 

June 1995 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

NR 

 

Design: 

Healthcare 

database 

utilization claims 

analysis 

(retrospective 

cohort) 

Intervention: 

Urinary 

antispasmotics 

including 

flavoxate, 

oxybutynin, 

hyoscyamine and 

hyocyamine 

sulfate 

Groups: 

G1: Prescribed 

any urinary 

antispasmotic in 

interval 

G2: No 

prescriptions for 

urinary 

antispasmotic 

agents 

N in database: 

G1: 3,898 

G2: 10,740 

N at follow-up: 

NA 

Women, %: 

G1: 75.4 

G2: 67.0 

Age, mean: 

G1: 78.0 

G2: 80.3 

Race/ethnicity, 

%: 

White: 

G1: 82.9 

G2: 82.5 

Black: 

G1: 12.5 

G2: 13.0 

Other: 

G1: 4.6 

G2: 4.5 

Inclusion criteria: 

• New Jersey 

residents in 

Medicaid/ 

Medicare or 

Pharmacy 

Assistance for 

the Aged and 

Disabled with 

comprehensive 

prescription 

programs 

• Covered by 

programs from 

January 1990 to 

June 1995 

• Age ≥ 65 

• Diagnosis of 

urinary 

incontinence 

• Care utilization 

or prescription 

for any 

indication in the 

six months 

before and after 

the index date 

of the diagnosis 

of incontinence 

• Exclusion 

criteria: 

• No record of 

care utilization 

or prescriptions 

filled in the 

study interval 

Charlson 

comorbidity 

index, mean 

score: 

G1: 1.8 

G2: 2.6 

P < 0.001 

Hospital days in 

prior 180 days, 

mean: 

G1: 6.8 

G2: 12.5 

P < 0.001 

Physician visits 

in prior 180 days, 

mean: 

G1: 7.3 

G2: 5.4 

P < 0.001 

Nursing home 

days in prior 180 

days, mean: 

G1: 17.0 

G2: 36.8 

P < 0.001 

SES: Medicaid, 

%: 

G1: 51.5 

G2: 65.7 

P < 0.001 

SES: PAAD, %: 

G1: 48.5 

G2: 34.3 

P < 0.001 

Dx of CVD, %: 

G1: 18.2 

G2: 25.2 

P < 0.001 

Dx of CHF, %: 

G1: 16.9 

G2: 25.1 

P < 0.001 

Dx of conduction 

disturbance, %: 

G1: 3.0 

G2: 3.9 

P = 0.008 

Adjusted relative 

risk of ventricular 

arrhythmia, 

G1/G2 (95% CI): 

Urinary antispasmodic use: 

1.23 (0.87, 1.75) 

Nonsedating 

antihistamine use: 

0.95 (0.23, 3.84) 

Cytochrome P450 

3A4 inhibitor use: 

1.12 (0.60, 2.08) 

Concurrent 

nonsedating 

antihistamine/ 

cytochrome 

inhibitor use: 

5.47 (1.34, 22.26) 

Adjusted relative 

risk of sudden 

death, G1/G2 

(95% CI): 

Urinary antispasmodic use: 

0.70 (0.28, 1.74) 

Nonsedating 

antihistamine use: 

1.43 (0.20, 10.35) 

Cytochrome P450 

3A4 inhibitor use: 

1.80 (0.86, 3.76) 

Concurrent 

nonsedating 

antihistamine/ 

cytochrome 

inhibitor use: 

21.50 (5.23, 88.37) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: 

NA 

Drop-out rates: NA 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

NA 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-336 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Wang et al., 2002 

(continued) 

Dx of supraventricular 

dysrhythmia, %: 

G1: 7.8 

G2: 12.2 

P < 0.001 

Dx of HTN, %: 

G1: 44.8 

G2: 43.8 

P = 0.255 

Dx of Ischemic 

heart disease, %:

G1: 31.0 

G2: 36.7 

P < 0.001 

Dx of other CVD, 

%: 

G1: 28.0 

G2: 35.0 

P < 0.001 

Dx of electrolyte 

abnormalities, %:

G1: 6.4 

G2: 11.8 

P < 0.001

Incidence rate of 

ventricular 

arrhythmia with 

medication use, 

(95% CI): 

Urinary 

antispasmodics: 

1.08 (0.85, 1.37) 

Nonsedating 

antihistamines: 

1.00 (0.50, 1.99) 

Cytochrome P450 

3A4 inhibitors: 1.02 

(0.77, 1.34) 

Concurrent 

nonsedating 

antihistamine/cytoc

hrome inhibitor 

use: 3.45 (1.11, 

10.69) 

Incidence rate of 

sudden death 

with medication 

use, (95% CI): 

Urinary 

antispasmodics: 

0.69 (0.29, 1.66) 

Nonsedating 

antihistamines: 

1.14 (0.16, 8.06) 

Cytochrome P450 

3A4 inhibitors: 1.51 

(0.76, 3.02) 

Concurrent 

nonsedating 

antihistamine/ 

cytochrome 

inhibitor use: 24.35 

(6.09, 97.35) 

C-337 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Wang et al., 2006 

Country and 

setting: 

Taiwan; 

Academic 

medical center 

Enrollment 

period: 

July 2004 to 

November 2005 

Funding: 

National Science 

Council, Taiwan 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Electric 

Stimulation (ES) 

vs Oxybutynin vs 

Placebo for 12 

weeks

Groups: 

G1: ES: 

intravaginal 

electrode; 

biphasic 

symmetric pulsed 

current w/ a 10-Hz 

frequency, 400-

millisecond pulse 

width, 10/5 duty 

cycle, and varying 

intensity, 20 

min/session, twice 

weekly 

G2: Oxybutynin, 

2.5 mg 3 times 

daily 

G3: Placebo pill 3 

times daily 

N at enrollment: 

G1: 25 

G2: 26 

G3: 23 

N at follow-up: 

G1: 24 

G2: 23 

G3: 21 

Age: 

NR 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Female 

• OAB for ≥ 6 

mos 

• Age 16-80 

• Urgency ≥ 4 

times per day 

Exclusion 

criteria: 

• Use of 

anticholinergics 

or TCAs 

• Previous 

treatment with 

pelvic-floor 

muscle training, 

bladder training 

• Pelvic prolapse 

repair 

• Pregnancy 

• Neurologic 

disorders 

• DM 

• Demand cardiac 

pacemaker 

• IUD use 

• Genital prolapse 

greater than 

ICS Stage II 

• PVR>100 mL 

• Overt SI 

• Antiincontinence 

surgery 

• UTI 

UUI episodes/ 

day, median 

(range): 

G1: 1 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

Urgency 

episodes/day, 

median (range): 

G1: 11.4 (4.0-

16.0) 

G2: 12.1 (5-18) 

G3: 9.8 (4.2-15.5) 

Voids/day, 

median (range): 

G1: 12.8 (8.8-

16.0) 

G2: 11.5 (4.3-

19.5) 

G3: 11.5 (6.5-

22.8) 

Nocturia 

episodes/day, 

median (range): 

G1: 1.75 (0-6.5) 

G2: 0 (0-2.5) 

G3: 0.65 (0-3.1) 

Pads/day, 

median (range): 

G1: 1 (0-4.1) 

G2: 0 (0-3) 

G3: 1 (0-4) 

Warning time 

(sec), median 

(range): 

G1: 41.5 (8-105) 

G2: 44 (2-215) 

G3: 65 (26-265 

Max voided 

volume (mL), 

median (range): 

G1: 340 (120-450)

G2: 310 (130-800)

G3: 350 (120-600)

UUI episodes/day, 

median (range): 

G1: 0.5 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

G1/BL: P = 0.814 

G2/BL: P = 0 083 

G3/BL: P = 0.854 

G1-G3: P = 0.413 

Urgency 

episodes/day 

median (range): 

G1: 1.0 (0.0-12.3) 

G2: 6 (0.5-13) 

G3: 7.4 (3.9-13.4) 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

G3/BL: P = 0.003 

G1-G3: P < 0.001 

Voids/day, 

median (range): 

G1: 7.8 (1.8-13.0) 

G2: 7.4 (2-14) 

G3: 10 (3.9-13.4) 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

G3/BL: P = 0.070 

G1-G3: P = 0.002 

Nocturia 

episodes/day, 

median (range): 

G1: 0 (0-3.0) 

G2: 0 (0-2.5) 

G3: 1 (0-3.6) 

G1/BL: P = 0.001 

G2/BL: P = 0.394 

G3/BL: P = 0.176 

G1-G3: P = 0.002 

Pads/day, median 

(range): 

G1: 0 (0-2) 

G2: 0 (0-2.5) 

G3: 1 (0-3) 

G1/BL: P = 0.010 

G2/BL: P = 0.662 

G3/BL: P = 0.501 

G1-G3: P = 0.012 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-338 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Wang et al., 2006 

(continued) 

Total voided 

volume/day (mL), 

median (range):

G1: 2160 (1010-

2950) 

G2: 2106 (1560-

3153) 

G3: 2305 (1305-

3300) 

Warning time 

(sec), median 

(range):

G1: 72 (32-633) 

G2: 54.5 (138-850) 

G3: 66.5 (26-219) 

G1/BL: P = 0.002 

G2/BL: P = 0.001 

G3/BL: P = 0.532 

G1-G3: P < 0.001 

Max voided 

volume (mL), 

median (range): 

G1: 355 (150-550) 

G2: 336.5 (138-

850) 

G3: 340 (160-600)

G1/BL: P = 0.018 

G2/BL: P = 0.004 

G3/BL: P = 0.979 

G1-G3: P = 0.035 

Total voided 

volume/day (mL), 

median (range): 

G1: 2270 (1210-

3106) 

G2: 2100 (1619-

3200) 

G3: 2305 (1351-

3221) 

G1/BL: P = 0.024 

G2/BL: P = 0.728 

G3/BL: P = 0.627 

G1-G3: P = 0.050 

C-339 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Yamaguchi et al., 

2007 

Country and 

setting: 

Japan, 155 

academic health 

centers

Enrollment 

period: 

June 2003 to 

January 2004

Funding: Astellas 

Pharma Inc. 

Author industry 

relationship 

disclosures: 

2 of 12 

Astellas (2) 

Design: 

RCT, doubleblind, doubledummy, placebo 

controlled

Intervention: 

solifenacin vs 

propiverine vs 

placebo 

Groups: 

G1: solifenacin 5 

mg qd x 12 wks 

G2: solifenacin 10 

mg qd x 12 wks 

G3: propiverine 20 

mg qd x 12 wks 

G4: placebo qd x 

12 wks 

N at enrollment: 

G1: 398 

G2: 381 

G3: 400 

G4: 405 

N at follow-up: 

G1: 364 

G2: 349 

G3: 364 

G4: 371 

Women, n (%): 

G1: 318 (83.0) 

G2: 318 (85.7) 

G3: 321 (83.6) 

G4: 333 (84.3) 

Age, mean ± SD, 

(range): 

G1: 60.4 ± 13.3 

(20.0-89.0) 

G2: 59.9 ± 13.0 

(20.0-86.0) 

G3: 59.6 ± 13.6 

(23.0-94.0) 

G4: 60.8 ± 12.5 

(28.0-90.0) 

Age ≥ 65, N (%): 

G1: 161 (42.0) 

G2: 157 (42.3) 

G3: 166 (43.2) 

G4: 163 (41.3) 

Inclusion criteria: 

• Age ≥ 20 

• OAB sx for ≥ 6 

mos 

• ≥ 8 voids/day 

• ≥ 3 episodes of 

urgency or ≥ 3 

episodes of 

urgency 

incontinence 

over 72 hours 

Exclusion 

criteria: 

• PVR >100 mL 

• Significant BOO 

• Urinary retention

• SI 

• Bladder stones 

• UTI 

• Interstitial cystitis

• Previous or 

current 

malignant dz of 

the pelvic 

organs 

• Previous pelvic 

radiation 

• Current trt w/ 

anticholinergic 

meds 

• Known or 

suspected 

hypersensitivity 

to anticholinergic 

meds or lactose 

UUI episodes/ 

day, mean ± SD: 

G1: 1.95 ± 2.14 

G2: 1.89 ± 1.91 

G3: 1.82 ± 1.94 

G4: 1.67 ± 1.95 

Urgency 

episodes, n: 

G1: 383 

G2: 371 

G3: 384 

G4: 395 

Urgency 

episodes/day, 

mean ± SD: 

G1: 4.40 ± 3.38 

G2: 4.47 ± 3.30 

G3: 4.07 ± 3.19 

G4: 4.04 ± 3.11 

Incontinent, n:

G1: 274 

G2: 270 

G3: 295 

G4: 283 

Incontinence 

type, n (%): 

Urge: 

G1: 235 (61.4) 

G2: 213 (57.4) 

G3: 218 (56.8) 

G4: 244 (61.8) 

Mixed: 

G1: 130 (33.9) 

G2: 143 (38.5) 

G3: 144 (37.5) 

G4: 135 (34.2) 

None: 

G1: 18 (4.7) 

G2: 15 (4.0) 

G3: 22 (5.7) 

G4: 16 (4.1) 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.35 ± 2.45 

G2: 2.19 ± 2.04 

G3: 2.15 ± 2.31 

G4: 1.99 ± 2.11 

UUI episodes/day, 

mean change ± 

SD: 

G1: -1.45 ± 1.89 

G2: -1.52 ± 1.77 

G3: -1.19 ± 2.20 

G4: -0.69 ± 2.00 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.025 

Urgency free, n 

(%): 

G1: 126 (32.9) 

G2: 138 (37.2) 

G3: 128 (33.3) 

G4: 82 (20.8) 

Urgency 

episodes/day, 

mean change ± 

SD: 

G1: -2.41 ± 2.88 

G2: -2.78 ± 2.82 

G3: -2.30 ± 3.08 

G4: -1.28 ± 2.90 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

G2/G3: P = 0.012 

Continent, n (%): 

G1: 154 (56.2) 

G2: 161 (59.6) 

G3: 165 (55.9) 

G4: 105 (37.1) 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -1.59 ± 2.12 

G2: -1.60 ± 1.81 

G3: -1.25 ± 2.79 

G4: -0.72 ± 1.95 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.025 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-340 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Yamaguchi et al., 

2007 

(continued) 

Race/ethnicity: 

NR 

Weight (kg),

mean ± SD 

(range): 

G1: 56.3 ± 9.7 

(30.5-123.0) 

G2: 57.1 ± 10.5 

(35.0-117.4) 

G3: 56.6 ± 10.0 

(33.0-103.0) 

G4: 56.2 ± 9.4 

(36.0-90.0) 

Voids/day, mean 

± SD 

G1: 11.44 ± 2.94 

G2: 11.15 ± 2.76 

G3: 11.37 ± 2.71 

G4: 11.25 ± 2.73 

≥ 8 voids/day, n: 

G1: 383 

G2: 371 

G3: 384 

G4: 395 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.91 ± 1.22 

G2: 1.78 ± 1.04 

G3: 1.95 ± 1.29 

G4: 1.84 ± 1.10 

Duration of 

symptoms 

(years), n (%): 

≥ 0.5 to < 1: 

G1: 46 (12.0) 

G2: 36 (9.7) 

G3: 38 (9.9) 

G4: 39 (9.9) 

≥ 1 to < 3: 

G1: 89 (23.2) 

G2: 97 (26.1) 

G3: 85 (22.1) 

G4: 81 (20.5) 

≥ 3 to < 5: 

G1: 34 (8.9) 

G2: 45 (12.1) 

G3: 38 (9.9) 

G4: 40 (10.1) 

≥ 5 to < 10: 

G1: 24 (6.3) 

G2: 23 (6.2) 

G3: 22 (5.7) 

G4: 37 (9.4) 

≥ 10 

G1: 23 (6.0) 

G2: 14 (3.8) 

G3: 20 (5.2) 

G4: 24 (6.1) 

Unknown: 

G1: 167 (43.6) 

G2: 36 (9.7) 

G3: 38 (9.9) 

G4: 39 (9.9) 

Voids/day, mean 

change ± SD: 

G1: -1.93 ± 1.97 

G2: -2.19 ± 2.09 

G3: -1.87 ± 2.70 

G4: -0.94 ± 2.29 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

G1/G3: P = NS 

G2/G3: P = NS 

≥ 8 voids/day, n 

(%): 

G1: 109 (28.5) 

G2: 137 (36.9) 

G3: 101 (26.3) 

G4: 83 (21.0) 

Nocturia 

episodes/day, 

mean change ± 

SD: 

G1: -0.41 ± 0.96 

G2: -0.46 ± 0.90 

G1: -0.43 ± 1.21 

G4: -0.30 ± 0.91 

G1/G4: P = NS 

G2/G4: P < 0.025 

G3/G4: P = NS 

KHQ, general 

health:* 

G1/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, 

incontinence 

impact:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, role 

limitations:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, physical 

limitations:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

C-341 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Yamaguchi et al., 

2007 

(continued) 

Volume voided, 

mean mL ± SD: 

G1: 153.4 ± 52.91

G2: 154.4 ± 50.21

G3: 151.2 ± 49.38

G4: 152.8 ± 44.28

KHQ, social 

limitations:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, personal 

relationships:* 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, emotions:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, sleep/ 

energy:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

KHQ, severity:* 

G1/G4: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

G2/G3: P < 0.05 

Voided volume 

(mL), mean 

change ± SD: 

G1: 35.78 ± 43.49 

G2: 43.59 ± 44.52 

G3: 36.62 ± 37.99 

G4: 11.67 ± 33.74 

G1/G4: P < 0.001 

G2/G4: P < 0.001 

G3/G4: P < 0.001 

G2/G3: P = 0.009 

Discontinued due 

to AEs, n (%): 

G1: 20 (5.1) 

G2: 26 (6.8) 

G3: 26 (6.5) 

G4: 11 (2.7) 

Dry mouth, n (%): 

G1: 67 (16.9) 

G2: 130 (34.1) 

G3: 103 (25.8) 

G4: 23 (5.7) 

G1/G3: P = 0.003 

G2/G3: P = 0.012 

C-342 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Yamaguchi et al., 

2007 

(continued)

Dry mouth, mild, 

n (%): 

G1: 64 (16.2) 

G2: 124 (32.5) 

G3: 100 (25.0) 

G4: 23 (5.7) 

Dry mouth, 

moderate, n (%): 

G1: 3 (0..8) 

G2: 6 (1.6) 

G3: 3 (0.8) 

G4: 1 (0.2) 

Constipation, n 

(%): 

G1: 42 (10.6) 

G2: 72 (18.9) 

G3: 45 (11.3) 

G4: 16 (4.0) 

G2/G3: P = 0.004 

Blurred vision, n 

(%): 

G1: 7 (1.8) 

G2: 14 (3.7) 

G3: 15 (3.8) 

G4: 8 (2.0) 

C-343 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2002 

[See evidence 

table for Van 

Kerrebroeck et 

al., 2001] 

Country and 

setting: 

North America 

(74 centers), 

Australasia (4 

centers), Europe 

(89 centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine ER vs 

placebo

Groups: 

G1: tolterodine ER 

4 mg qd < 65 

years of age 

G2: placebo < 65 

years of age 

G3: tolterodine ER 

4 mg qd ≥ 65 

years of age 

G4: placebo ≥ 65 

years of age 

N at enrollment: 

G1: 293 

G2: 285 

G3: 214 

G4: 223 

N at follow-up: 

G1: 257 

G2: 246 

G3: 193 

G4: 194 

Women, n (%): 

G1: 255 (87)** 

G2: 247 (87)** 

G3: 162 (76) 

G4: 163 (73) 

Age, mean ± SD: 

G1: 51 ± 10.5 

G2: 51 ± 10 

G3: 74 ± 6 

G2: 74 ± 6 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• Urinary 

frequency (≥ 8 

voids/day) 

Exclusion 

criteria: 

• Demonstrable 

SUI 

• Total daily urine 

volume > 3 L 

• Contraindications to 

antimuscarinic 

treatment 

• Hepatic or renal 

disease 

• UTI 

• Interstitial 

cystitis 

• Hematuria 

• BOO 

• Current 

electrostimulation or bladder 

training therapy 

• Indwelling 

catheter or 

intermittent selfcatheterization 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Being treated 

for OAB with 

other 

anticholinergic 

drugs or drugs 

that inhibit 

cytochrome 

P450 3A4 

isoenzymes 

• Estrogen 

therapy < 2 

months 

• Treatment w/ 

investigational 

drug < 2 months

Not able to hold 

urine upon 

experiencing 

urgency, %: 

G1: 24.9 

G2: 29.1 

G3: 33.6 

G4: 34.5 

Able to complete 

tasks before 

toilet visit in 

response to 

urgency,%: 

G1: 6.5 

G2: 7.7 

G3: 5.1 

G4: 4.9 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 21.4 ± 22.1 

G2: 23.2 ± 22.0 

G3: 23.2 ± 22.7 

G4: 23.4 ± 18.9 

Voids/day, mean 

± SD: 

G1: 11.0 ± 3.9 

G2: 11.4 ± 4.2 

G3: 10.8 ± 4.5 

G4: 11.0 ± 3.2 

Voided volume 

(mL), mean ± SD:

G1: 140 ± 41 

G2: 137 ± 45 

G3: 141 ± 45 

G4: 134 ± 39 

Previous drug 

therapy, n (%): 

G1: 148 (50.5) 

G2: 146 (51.2)

G3: 121 (56.5) 

G4: 117 (52.5) 

Percentage with 

poor efficacy, %:

G1: 74 (50.0)** 

G2: 60 (41.1)**

G3: 40 (33.1) 

G4: 46 (39.3) 

Not able to hold 

urine upon 

experiencing 

urgency, %: 

G1: 11.3 

G2: 21.1 

G3: 15.9 

G4: 25.6 

G1/G2: P = 0.003 

G3/G4: P = 0.007 

No age-related 

difference 

Able to complete 

tasks before toilet 

visit in response 

to urgency,%: 

G1: 32.8 

G2: 16.8 

G3: 26.2 

G4: 14.8 

G1/G2: P = 0.001 

G3/G4: P = 0.003 

No age-related 

difference 

Incontinence 

episodes/week, 

mean ± SD 

G1: -12.0 ± 17.6 

G2: -7.4 ± 15.6 

G3: -11.5± 18.2 

G4: -6.3 ± 15.0 

G1/G2: P = 0.001 

G3/G4: P < 0.001 

No age-related 

difference 

Voids/day, mean 

± SD 

G1: -2.0 ± 3.1 

G2: -1.4 ± 3.1 

G3: -1.4± 3.7 

G4: -0.9 ± 2.6 

G1/G2: P = 0.26 

G3/G4: P = 0.92 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: NR 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-344 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2002 

(continued) 

Perception of 

bladder 

condition, 

improved, %:

G1: 60.1 

G2: 51.9 

G3: 54.2 

G4: 31.4 

G1/G2: P < 0.05 

G3/G4: P < 0.0001 

Perception of 

bladder 

condition, no 

change, %: 

G1: 32.4 

G2: 38.9 

G3: 38.3 

G4: 51.1 

G4/G2: P < 0.0001 

Perception of 

bladder 

condition, 

deterioration, %: 

G1: 7.2 

G2: 9.1 

G3: 7.5 

G4: 17.5 

Treatment 

beneficial, %: 

G1: 78.3 

G2: 58.3 

G3: 69.8 

G4: 46.9 

G1/G2: P = 0.001 

G3/G4: P = 0.001 

No age-related 

difference 

Voided volume 

(mL), mean ± SD: 

G1: 35 ± 53 

G2: 13 ± 41 

G3: 33± 47 

G4: 16 ± 41 

G1/G2: P < 0.001 

G3/G4: P < 0.001 

No age-related 

difference 

C-345 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2002 

(continued) 

Adverse events, 

%:

G1: 50.7 

G2: 50.5 

G3: 54.2 

G4: 46.0 

Dry mouth, 

severe, % 

G1-G2: 1.7 

G3-G4: 1.9 

Dry mouth, 

moderate, % 

G1-G2: 7.6 

G3-G4: 6.5 

Dry mouth, mild, 

% 

G1-G2: 13.4 

G3-G4: 15.9 

No dry mouth, % 

G1-G2: 77.3 

G3-G4: 75.7 

C-346 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2004 

Country and 

setting: 

US, 51 sites 

Enrollment 

period: 

NR 

Funding: 

Indevus 

Corporation 

Author industry 

relationship 

disclosures: 

4 of 5 

Alza (1) 

Indevus (4) 

Kyowa (1) 

Lilly (2) 

Merck (1) 

Ortho-McNeil (1) 

Pfizer (2) 

Pharma (1) 

Pharmacia (1) 

Schwarz (1) 

Watson (2) 

Yamanouchi (1) 

Design: 

RCT with 

2 wk washout 

period 

Intervention: 

Trospium chloride 

vs placebo

Groups: 

G1: Tropsium 

chloride 20 mg 

b.i.d.

G2: placebo 

N at enrollment: 

G1: 262 

G2: 261 

N at follow-up: 

G1: 256 

G2: 256 

Women, n (%): 

G1: 203 (77.5) 

G2: 186 (71.3) 

Age, mean ± SD: 

G1: 63 ± 0.8 

G2: 61.5 ± 0.8 

Race/ethnicity, n 

(%): 

White: 

G1: 222 (84.7) 

G2: 225 (86.2) 

Black: 

G1: 26 (9.9) 

G2: 20 (7.7) 

Hispanic: 

G1: 10 (3.8) 

G2: 13 (5.0) 

Other: 

G1: 4 (1.6) 

G2: 3 (1.1) 

Inclusion criteria:

• Age ≥18 years 

• OAB symptoms 

≥ 6 mos 

• Urinary urgency 

• ≥ 70 voids per 

week 

• ≥ 7 UUI 

episodes/week 

Exclusion 

criteria: 

• Stress 

predominant 

MUI 

• Insensate or 

overflow 

• Neurogenic 

bladder 

disorders 

• Significant renal 

disease 

• Hematuria 

hematuria and 

UTI at washout 

or ≥ twice in the 

prior year 

• BOO with PVR ≥

100 mL 

• Concurrent use 

of any 

anticholinergic 

drug or other 

drug therapy for 

OAB within 21 

days before 

randomization 

• Bladder surgery 

≤ 6 mos 

• Bladder cancer 

• Interstitial cystitis 

• PSA ≥ 10 ng/mL

• Diuretic use, 

estrogen therapy 

and nonmedical 

bladder therapy 

that was not part 

of a stable, longterm program. 

UUI episodes/ 

day, mean: 

G1: 3.9 

G2: 4.3 

Urgency 

episodes/day, 

mean: 

G1: 11.29 

G2: 11.72 

Urgency severity 

score, mean: 

G1: 1.8 

G2: 1.8 

Voids/day, mean:

G1: 12.7 

G2: 12.9 

Daytime voids/ 

day, mean: 

G1: 10.6 

G2: 10.9 

Nocturia 

episodes/day, 

mean: 

G1: 2.1 

G2: 2.0 

Voided volume 

(mL), mean: 

G1: 155.1 

G2: 156.1 

IIQ, mean score 

(SE): 

G1: 183.5 (5.6) 

G2: 195.4 (5.6) 

IIQ,, women only, 

mean score (SE):

G1: 191.2 (6.3)

G2: 201.9 (6.6) 

Incontinence 

Impact Questionnaire, travel 

subscale, score 

(SE): 

G1: 52.4 (1.7) 

G2: 55.6 (1.7) 

UUI episodes/ 

day, week 1, 

mean % change: 

G1: -40.1 

G2: -27.5 

G1/G2: P ≤ 0.001 

UUI episodes/ 

day, week 4, 

mean % change: 

G1: -58.5 

G2: -40.9 

G1/G2: P ≤ 0.0001 

UUI episodes/ 

day, week 12, 

mean % change: 

G1: -59.0 

G2: -44.2 

G1/G2: P ≤ 0.0001 

Urgency 

episodes/day, 

week 1, mean 

change: 

G1: -1.13 

G2: -1.08 

Urgency 

episodes/day, 

week 4, mean 

change: 

G1: -2.10 

G2: -1.00 

G1/G2: P ≤ 0.0001 

Urgency 

episodes/day, 

week 12, mean 

change: 

G1: -2.30 

G2: -1.08 

G1/G2: P ≤ 0.0001 

Urgency severity 

score, week 1, 

mean change: 

G1: -0.11 

G2: -0.01 

G1/G2: P ≤ 0.01 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-347 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

IIQ, social 

relationships, 

score (SE): 

G1: 37.8 (1.5) 

G2: 40.3 (1.5) 

IIQ, emotional 

health, mean 

score (SE): 

G1: 47.1 (1.6) 

G2: 49.6 (1.6) 

IIQ,, physical 

activity, mean 

score (SE): 

G1: 46.1 (1.6) 

G2: 50.2 (1.6) 

Prior OAB med, n 

(%): 

G1: 135 (51.5) 

G2: 142 (54.5) 

Urgency severity 

score, week 4, 

mean change: 

G1: -0.18 

G2: -0.06 

G1/G2: P ≤ 0.01 

Urgency severity 

score, week 12, 

mean change: 

G1: -0.22 

G2: -0.04 

G1/G2: P ≤ 0.001 

Voids/day, week 

1, mean change: 

G1: -1.18 

G2: -0.81 

G1/G2: P ≤ 0.05 

Voids/day, week 

4, mean change: 

G1: -2.20 

G2: -1.07 

G1/G2: P ≤ 0.0001 

Voids/day, week 

12, mean change: 

G1: -2.37 

G2: -1.29 

G1/G2: P ≤ 0.0001 

Daytime voids/ 

day, week 1, 

mean change: 

G1: -1.00 

G2: -0.68 

G1/G2: P ≤ 0.05 

Daytime voids/ 

day, week 4, 

mean change: 

G1: -1.77 

G2: -0.89 

G1/G2: P ≤ 0.0001 

Daytime voids/ 

day, week 12, 

mean change: 

G1: -1.90 

G2: -0.98 

G1/G2: P ≤ 0.0001 

C-348 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

Nocturia

episodes/day, 

week 1, mean 

change: 

G1: -0.18 

G2: -0.15 

Nocturia 

episodes/day, 

week 4, mean 

change:

G1: -0.43 

G2: -0.17 

G1/G2: P ≤ 0.001 

Nocturia 

episodes/day, 

week 12, mean 

change: 

G1: -0.47 

G2: -0.29 

G1/G2: P ≤ 0.05 

Voided volume 

(mL), week 1, 

mean change: 

G1: 19.9 

G2: 6.6 

G1/G2: P ≤ 0.0001 

Voided volume 

(mL), week 4, 

mean change: 

G1: 30.0 

G2: 8.5 

G1/G2: P ≤ 0.0001 

Voided volume 

(mL), week 12, 

mean change: 

G1: 32.1 

G2: 7.7 

G1/G2: P ≤ 0.0001 

IIQ, week 12, LS 

mean change 

(SE): 

G1: -54.0 (5.6) 

G2: -36.0 (5.6) 

G1/G2: P ≤ 0.05 

C-349 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

IIQ, women only, 

week 12, LS mean 

change (SE): 

G1: -59.1 (6.6) 

G2: -35.7 (6.9) 

G1/G2: P ≤ 0.05 

IIQ, travel 

subscale, week 

12, LS mean 

change (SE): 

G1: -14.9 (1.7) 

G2: -9.9 (1.7) 

G1/G2: P < ≤ 0.05 

IIQ, social 

relationsips, week 

12, LS mean 

change (SE): 

G1: -10.8 (1.4) 

G2: -6.3 (1.4) 

G1/G2: P ≤ 0.05 

IIQ, emotional 

health, 12 weeks, 

LS mean change 

(SE): 

G1: 14.1 (1.5) 

G2: -9.2 (1.5) 

G1/G2: P ≤ 0.05 

IIQ, physical 

activity, 12 

weeks, LS mean 

change (SE): 

G1: -13.5 (1.7) 

G2: -11.0 (1.7) 

Dry mouth, n (%): 

G1: 57 (21.8) 

G2: 17 (6.5) 

Constipation, n 

(%): 

G1: 25 (9.5) 

G2: 10 (3.8) 

Headache, n (%): 

G1: 17 (6.5) 

G2: 12 (4.6) 

C-350 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

Diarrhea, n (%): 

G1: 8 (3.1) 

G2: 14 (5.4) 

Abdominal pain, 

n (%): 

G1: 8 (3.1) 

G2: 3 (1.1) 

Discontinuation 

due to AE, %: 

G1: 8.8 

G2: 5.7 

C-351 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2005 

Country and 

setting: 

US, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Novartis Pharma 

Thomson 

ACUMED 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized 

double- blind 

placebocontrolled 

four way 

crossover 

Intervention: 

Darifenacin 15 mg 

qd vs darifenacin 

30 mg qd vs. 

Oxybutynin vs. 

placebo

Groups:* 

G1: Darifenacin 

15mg daily 

G2: Darifenacin 

30mg daily 

G3: Oxybutynin 5 

mg t.i.d. 

G4: placebo 

N at enrollment: 

G1-G4: 76

N included, 

tolerability: 

G1-G4: 61

N included, 

efficacy: 

G1-G4: 58

Women, n (%): 

G1-G4: 71 (93.4) 

Age, mean 

(range): 

G1-G4: 59.9 (33-

84) 

Race/ethnicity: 

NR 

Weight (kg), 

mean (range): 

G1-G4: 75.7 (42-

157) 

Inclusion criteria: 

• Age 18-85 

• ≥ 4 UUI 

episodes/week 

• ≥ 8 voids/day 

(from 14 day 

run in placebo 

voiding diary) 

Exclusion 

criteria: 

• Neurogenic 

bladder 

• SUI 

• Contraindication 

to 

antimuscarinic 

treatment 

• UTI 

• Bladder 

symptoms 

• Bladder stones 

• BOO 

• Concomitant 

disease 

• Concurrent 

bladder training 

• Concurrent 

thyroid or HRT 

• Other bladder 

meds 

• Pregnant or 

breastfeeding 

Urgency 

episodes/day, 

mean ± SD: 

G1-G 4: 9.3 ± 3.4 

Urgency severity, 

mean ± SD: 

G1-G4: 2.0 ± 0.4 

Incontinence 

episodes/week, 

mean ± SD: 

G1-G4: 20.4 ± 

17.7 

Voids/ day, mean 

± SD: 

G1-G4: 10.4 ± 3.0

Urgency 

episodes/day, 

mean: 

G1: 7.95 

G2: 7.59 

G3: 8.12 

G4: 8.71 

G1-G3/G4: P <

0.05 

Urgency severity, 

mean: 

G1: 1.93 

G2: 1.84 

G3: 1.89 

G4: 2.03 

G1-G3/G4: P <

0.05 

Incontinence 

episodes/week, 

mean: 

G1: 10.93 

G2: 8.82 

G3: 9.45 

G4: 14.64 

G1-G3/G4: P <

0.05 

Voids/day, mean 

± SD: 

G1: 9.33 

G2: 8.85 

G3: 9.24 

G4: 9.62 

G2/G4: P < 0.05 

Dry mouth, (%): 

G1: 13.1 

G2: 34.4 

G3: 36.1 

G4: 4.9 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

Constipation, (%): 

G1: 9.8 

G2: 21.3 

G3: 8.2 

G4: 3.3 

G2/G3: P < 0.05 

G2/G4: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-352 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2005 

(continued) 

Blurred vision, 

(%): 

G1: 0 

G2: 0 

G3: 3.3 

G4: 0 

Dizziness, (%): 

G1: 0 

G2: 0 

G3: 1.6 

G4: 0 

C-353 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2006 

Country and 

setting: 

NR, Multicenter 

Enrollment 

period: 

NR 

Funding: 

Novartis 

Author industry 

relationship 

disclosures: 

5 of 6 

Alza (1) 

Eli Lilly (2) 

Astellas (1) 

GSK (1) 

Indevus (1) 

Madaus (1) 

Novartis (5) 

Pfizer (2) 

Sanofi (1) 

Watson (2) 

Yamanouchi (1) 

Design: 

RCT 

Intervention: 

Darifenacin 15 mg 

controlled release 

once daily vs. 

placebo 

Groups: 

G1: Darifenacin 

15 mg controlled 

release once daily 

G2: Placebo 

N at enrollment: 

G1: 214 

G2: 225 

N at follow-up: 

G1: 185 

G2: 188 

Women, n (%): 

G1: 185 (86.4) 

G2: 198 (88.0) 

Age, mean 

(range): 

G1: 59.1 (20-93) 

G2: 59.1 (18-89) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Adults 

• Age ≥18 

• History of OAB 

for ≥ 6 mos 

• ≥ 1 urge 

incontinence 

episodes/day 

• ≥ 8 voids/day 

• ≥ 4 urgency 

episodes/day 

• Mean warning 

time of ≤ 15 min 

during 12 hrs 

Exclusion 

criteria: 

• SUI 

• Marked 

cystocele 

• Pelvic prolapse 

• Use of 

anticholinergics, 

antispasmodics, 

cholinergic 

agonists, potent 

cytochrome 

P450 3A4 

inhibitors, or 

opioids 2 wks 

prior to 

screening visit 

• Contraindication

s to drugs that 

cause significant 

constipation, 

clinically 

significant 

bladder outlet 

obstruction 

• Intention to start 

bladder training 

program 

• In-dwelling 

catheter 

• Intermittent selfcatheterization 

UUI episodes/ 

wk, median: 

G1: 18.73* 

G2: 21.00^ 

Urgency 

episodes/wk, 

median: 

G1: 82.60* 

G2: 85.40^ 

Warning time 

(min), mean: 

G1: 4.38* 

G2: 4.74* 

Warning time 

(min), median: 

G1: 2.57* 

G2: 3.04* 

Voids/day, 

median: 

G1: 11.00* 

G2: 11.20^ 

Duration of OAB 

(years), mean 

(range): 

G1: 7.8 (0, 45) 

G2: 8.3 (0, 58) 

Previous OAB 

therapy, n (%): 

G1: 112 (52.3) 

G2: 124 (55.1) 

Voided volume 

(mL), median: 

G1: 153.50* 

G2: 144.62^ 

UUI episodes/wk, 

wk 2, median 

change: 

G1: -9.1 

G2: -7.0 

P < 0.01 

UUI episodes/wk, 

wk 6, median 

change: 

G1: -11.2 

G2: -8.4 

P = 0.031 

UUI episodes/wk, 

wk 12, median 

change: 

G1: -12.60 

G2: -9.80 

P = 0.035 

Urgency 

episodes/wk, wk 

12, median 

change: 

G1: -18.20 

G2: -15.58 

P = 0.18 

Urgency-free 

time, (min), 

median: 

G1: 34.3 

G2: 25.0 

P = 0.003 

Warning time, 

median % 

change: 

G1: 41.8 

G2: 18.4 

Voids/day, wk 12, 

median change: 

G1: -2.20 

G2: -1.80 

P = 0.176 

Voided volume 

(mL), wk 12, mean 

change: 

G1: 22.62 

G2: 11.31 

P = 0.002 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-354 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2006 

(continued) 

Total OAB-q 

score, wk 6, mean 

change: 

G1: 24.5 

G2: 18.7 

P = 0.035 

Total OAB-q 

score, wk 12, 

mean change:

G1: 26.4G2: 19.1 

P < 0.001 

Incontinence 

Impact, wk 12, 

mean change: 

G1: -24.7 

G2: -17.8 

P = 0.022 

Severity 

measures, wk 12, 

mean change: 

G1: -24.3 

G2: -15.6 

P < 0.001 

Adverse events, 

%: 

G1: 63.6 

G2: 48.9 

Discontinuation, 

n (%): 

G1: 17 (7.9) 

G2: 9 (4) 

Dry mouth and 

constipation, n 

(%): 

G1: 29.0 (17.8) 

G2: 5.8 (4.9) 

Discontinuation 

due to dry mouth, 

%: 

G1: 2.3 

G2: 0 

Discontinuation 

due to 

constipation, %: 

G1: 2.3 

G2: 0 

Headaches, %: 

G1: 6.1 

G2: 2.2 

C-355 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2006 

(continued) 

Cardiac AEs, %: 

G1: 0.5 

G2: 0.9 

C-356 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al. 2008 

Country and 

setting: 

US, 89 sites 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, 

GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

5 of 5 

Astellas (5) 

Esprit (2) 

Watson (3) 

Allergan (2) 

Medtronics (1) 

GlaxoSmithKline 

(3) 

Indevus (1) 

Design: 

open label, noncomparative, 

flexible-dosing 

Intervention: 

solifenacin 5 or 10 

mg qd for 12 wks 

after washout from 

tolterodine, with 

dose adjustments 

at wk 4 and wk 8

Groups: 

NA 

N at enrollment: 

440 

N at follow-up: 

390 

Age, yrs ± SD: 

61.5 ± 13.69 

Age < 65, n (%): 

246 (55.9) 

Age ≥ 65-74, n 

(%): 

108 (24.5) 

Age ≥ 75, n (%): 

86 (19.5) 

Race/ethnicity, n 

(%): 

Caucasian 

391 (88.9) 

Black or African 

37 (8.4) 

Asian 

1 (0.2) 

Other 

11 (2.5) 

Women, N (%): 

388 (88.2) 

Women < 65 yrs, 

n (%): 

227 (58.5) 

Women Age ≥ 65-

74, n (%): 

92 (23.7) 

Women Age ≥ 75, 

(%): 

69 (17.8) 

Inclusion criteria: 

• Age ≥ 18 

• Symptoms of 

OAB ≥ 3 mos 

• Ambulatory and 

able to use toilet 

without difficulty

• Treated with 

tolterodine ER 4 

mg/day at least 

4 wks preceding 

study but failed 

to achieve 

satisfactory 

improvement in 

urgency 

episodes 

• ≥3 urgency 

episodes/24 hrs 

documented in 

3-day voiding 

diary while 

receiving 

tolterodine ER 4 

mg/d 

• Prior drug or 

other treatment 

for OAB with ≥ 4 

wks washout 

before 

screening 

Exclusion 

criteria: 

• Prior treatment 

with darifenacin

• SUI 

• Stress dominant 

MUI 

• UTI 

• Interstitial 

cystitis 

• Bladder stones 

• Outflow 

obstruction due 

to benign 

prostatic 

hyperplasia 

• Uncontrolled 

narrow-angle 

glaucoma 

• Urinary or 

gastric retention

• Severe renal or 

hepatic 

impairment 

Urgency 

episodes/day, 

mean: 

6.03 

Voids/day, mean:

10.59 

Incontinence 

episodes/day, 

mean: 

3.04 

Nocturia 

episodes/day, 

mean: 

1.83 

Nocturnal 

voids/day, mean:

2.32 

Pads or diapers/ 

week, mean: 

10.7 

Urgency 

episodes/day, 

mean change 

(95% CI): 

-3.41 (-3.79, -

3.04)* 

Voids/day, mean 

change (95% CI): 

-1.57 (-1.86, -

1.28)*

Incontinence 

episodes/day, 

mean change 

(95% CI): 

-1.86 (-2.19, -

1.53)*

Nocturia 

episodes/day, 

mean change 

(95% CI): 

-0.72 (-0.84, -

0.59)*

Nocturnal 

voids/day, mean 

change (95% CI): 

-0.79 (-0.95, -

0.62)* 

Pads or diapers/ 

week, mean 

change: 

7.9 

P = 0.0009 

Improvement in 

HRQL, mean (95% 

CI): 

21.1 (19.0, 23.1)*

Change in 

symptom bother 

score, mean (95% 

CI):^ 

-27.4 (-29.7, -

25.1)* 

Change in 

coping, score, 

mean (95% CI)^: 

23.1 (20.6, 25.6)* 

Change in 

concern score, 

mean (95% CI)^: 

25.2 (22.8, 27.5)* 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: NR 

Power calculation: -

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-357 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al. 2008 

(continued) 

Height, mean cm 

± SD: 

164.1 ± 8.39 

Weight, mean kg 

± SD: 

81.1 ± 20.56 

BMI, mean kg/m2

± SD: 

30.1 ± 7.12 

• Chronic severe 

constipation 

• Gastrointestinal 

obstructive 

disease 

• Bladder cancer 

• Pregnant or 

breast-feeding 

• Not using a 

reliable birth 

control method 

• Known 

hypersensitivity 

to solifenacin or 

to 

anticholinergic 

medicines 

• Participating in 

any clinical trial 

of any 

investigational 

drug within 30 

days 

Change in sleep, 

score, mean (95% 

CI)^: 

21.9 (19.5, 24.3)* 

Change in social 

interaction score, 

mean (95% CI)^: 

11.1 (9.4, 12.9)* 

Change in % work 

time missed, 

mean ± SD†: 

-1.84 ± 0.57 

P = 0.0017 

Change in % 

impairment while 

working, mean ± 

SD†: 

-11.64 ± 1.64 

P < 0.0001 

Change in % 

overall work 

impairment, mean 

± SD †: 

-12.14 ± 1.79 

P <0.0001 

Change in % 

activity 

impairment, mean 

± SD†: 

-13.21 ± 1.31 

P < 0.001 

Change in office 

visits, mean ± SD: 

-1.00 ± 0.08 

P < 0.001 

Change in UTI, 

mean ± SD: 

-0.12 ± 0.03 

P < 0.001 

Change in skin 

rash episodes, 

mean ± SD: 

-0.46 ± 0.34 

P = 0.1801 

C-358 
C-359 

Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al. 2008 

(continued) 

Change in 

number of falls, 

mean ± SD: 

0.04 ± 0.07 

P = 0.5561 

Change in 

number of 

pads/diapers/ wk, 

mean ± SD: 

-2.79 ± 0.83 

P = 0.0009 
Evidence Table 3. KQ2 Procedural and surgical treatments 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Enzelsberger et 

al. 1995 

Country and 

setting: Austria, 

Academic 

gynecology/ 

urology 

outpatient clinic 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Instillation of 

oxybutynin or 

sterile water into 

the bladder via a 

disposable 

catheter, 

administered over 

a period of 12 

days 

Groups: 

G1: instillation of 

20 mg oxybutynin 

in 40 mL sterile 

water 

G2: instillation of 

40 mL sterile 

water 

N at enrollment:

G1: 26 

G2: 26

N at follow-up: 

G1: 23 

G2: 20 

Women, %: 

100 

Age, median 

(range): 

G1: 61 (55, 66) 

G2: 59 (56, 64) 

Race/ethnicity:

NR 

Weight (kg), 

median (range):

G1: 68 (58, 74) 

G2: 70 (59, 77) 

Inclusion criteria: 

• Women 

• Presenting 

complaint of 

frequency (more 

than 5 times/ 

12hr), nocturia 

(more than twice 

per night), and 

urgency 

• Confirmed 

idiopathic 

detrusor 

instability 

Exclusion criteria: 

• Urodynamically 

assessed 

genuine stress 

incontinence 

• Neurologic 

disorders 

Daytime voids 

/day, median 

(range): 

G1: 7.5 (5, 15) 

G2: 8.2 (6, 12) 

Nocturia 

episodes/day, 

median (range): 

G1: 5.1 (3, 7) 

G2: 4.6 (3, 8) 

Voided volume 

(mL), first desire 

to void, median 

(range): 

G1: 95 (30, 140) 

G2: 90 (25, 170) 

Cystometric 

capacity (mL), 

median (range): 

G1: 205 (50, 340)

G2: 195 (40, 260)

Max pressure 

rise during 

filling (cmH20), 

median (range): 

G1: 16 (10, 22) 

G2: 14 (9, 19) 

Max contraction 

(cmH2O), median 

(range): 

G1: 32 (20, 44) 

G2: 29 (18, 42) 

Peak flow rate 

(mL/s), median 

(range): 

G1: 27 (15, 45) 

G2: 30 (17, 40) 

Residual urinary 

volume (mL), 

median (range): 

G1: 40 (10, 50) 

G2: 35 (12, 50) 

Duration of 

symptoms 

(months), 

median (range):

G1: 7 (2, 9) 

G2: 8 (3, 9) 

Daytime voids/ 

day, median 

(range): 

G1: 4.0 (2, 7) 

G2: 6.9 (5, 10) 

P < 0.05 

Nocturia 

episodes/day, 

median (range): 

G1: 1.8 (1, 3) 

G2: 3.5 (3, 6) 

P < 0.05 

Voided volume 

(mL), first desire 

to void, median 

(range): 

G1: 150 (80, 180) 

G2: 110 (30, 140) 

P < 0.05 

Cystometric 

capacity (mL), 

median (range: 

G1: 310 (100, 390) 

G2: 207 (43, 240) 

P < 0.05 

Max pressure rise 

during filling 

(cmH20), median 

(range): 

G1: 8 (5, 10) 

G2: 11 (6, 12) 

P < 0.05 

Max contraction 

(cmH2O), median 

(range): 

G1: 14 (10, 20) 

G2: 24 (11, 42) 

P < 0.05 

Peak flow rate 

(mL/s), median 

(range): 

G1: 22 (15, 40) 

G2: 32 (15, 45) 

Residual urinary 

volume (mL), 

median (range): 

G1: 81 (40, 140) 

G2: 38 (15, 60) 

P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-360 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Enzelsberger et 

al. 1995 

(continued) 

Previous 

operations for 

UI, n: 

G1: 11 

G2: 10 

Dry mouth, n (%): 

G1: 4 (17) 

G2: 2 (10) 

Blurred vision, n 

(%): 

G1: 2 (8) 

G2: 1 (5) 

Nausea, n (%): 

G1: 0 

G2: 0 

Constipation, n 

(%): 

G1: 2 (8) 

G2: 3 (15) 

Dizziness, n (%): 

G1: 3 (13) 

G2: 0 

Headache, n (%): 

G1: 1 (4) 

G2: 1 (5) 

UTI, n (%): 

G1: 4 (17) 

G2: 2 (10) 

C-361 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author:

Fossberg et al., 

1990 

Country and 

setting:

Norway, 

Denmark, 

Finland, 

Sweden, 

Academic 

medical center 

Enrollment 

period: 

NR 

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective case 

series 

Intervention: 

Treatment with a 

stimulation device 

including an anal 

and a vaginal 

plug electrode; 

stimulation 

provided at cyclic 

sweep within 5-10 

Hz, administered 

12 times for 20 

minutes each 

(frequency of 

treatment not 

indicated) 

Groups: 

NA 

N at enrollment: 

91

N at follow-up: 

74

Women, %: 

88

Age, mean 

(range): 

53 (20-78) 

Race/ethnicity: 

NR 

Menopausal, %: 

50 

Inclusion criteria: 

• Cystometrically 

proven detrusor 

instability, 

frequency and 

UUI 

Exclusion criteria: 

• UTI 

• Drugs affecting 

the lower urinary 

tract 

• Discontinued 

anticholinergic 

drugs < 6 weeks 

before study 

Voids/day, mean 

± SD (range): 

9.1 ± 3.5 (4-20) 

Nocturia 

episodes/day, 

mean ± SD 

(range): 

1.6 ± 1.1 (0-6)

Bladder volume 

(mL), mean ± SD 

(range): 

169 ± 68 (50-425)

Bladder volume 

(mL), first 

sensation, mean 

± SD (range): 

139 ± 81 (33-300)

Max cystometric 

capacity (mL), 

mean ± SD 

(range): 

270 ± 155 (25-

750) 

Previously 

treated with 

drugs for UUI, %

67 

Voids/day, before 

last treatment, 

mean ± SD 

(range): 

7.9 ± 2.9 (3-18) 

P = 0.001 

Voids/day, 6 

weeks after last 

treatment, mean ± 

SD (range): 

8.0 ± 2.8 (3-19) 

P = 0.003 

Nocturia 

epsides/day, 

before last treatment, mean ± SD 

(range): 

1.2 ± 1.2 (0-6) 

P = 0.002 

Nocturia 

epsides/day, 6 

weeks after last 

treatment, mean ± 

SD (range): 

1.1 ± 1.1 (0-4) 

P < 0.001 

Bladder volume 

(mL), before last 

treatment, mean ± 

SD (range): 

189 ± 82 (50-490) 

P = 0.002 

Bladder volume 

(mL), 6 weeks 

after last treatment, mean ± SD 

(range): 

194 ± 93 (50-500) 

P < 0.001 

Bladder volume 

(mL), first 

sensation, before 

last treatment, 

mean ± SD 

(range): 

164 ± 93 (35-410) 

P = 0.008 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-362 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Fossberg et al., 

1990 

(continued)

Bladder volume 

(mL), first sensation, 6 weeks after 

last treatment, 

mean ± SD 

(range): 

175 ± 114 (25-470) 

P = 0.003 

Max cystometric 

capacity (mL), 

before last treatment, mean ± SD 

(range): 

307 ± 159 (50-725) 

P = 0.009 

Max cystometric 

capacity (mL), 

before last treatment, mean ± SD 

(range): 

299 ± 174 (25-690) 

P = 0.12 

Patient evaluation 

of effect, before 

last treatment, n: 

Cured: 6 

Improved: 45 

Unchanged: 23 

Worse: 0 

P < 0.001 

Patient evaluation 

of effect, 6 weeks 

after last 

treatment, n: 

Cured: 8 

Improved: 32 

Unchanged: 34 

Worse: 0 

P < 0.001 

Adverse effects, 

n:* 

11 

Data analysis indicated no differences between males and females in any data recorded 

C-363 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Groenendijk et 

al. 2007 

[See evidence 

table for 

Hassouna et al. 

2000] 

Country and 

setting: 

US, Canada, 

and Europe;16 

centers 

Enrollment 

period: 

NR 

Funding:

Medtronic Inc. 

Author conflict 

of interest: 

Medtronic (6) 

Design: 

Cohort 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

Groups:

G1: urge 

incontinence and 

detrusor 

overactivity (DO) 

G2: urge 

incontinence 

without detrusor 

overactivity 

N at enrollment: 

G1: 67 

G2: 44 

N at follow-up: 

G1: 51 

G2: 32 

Age:

NR 

Race/ethnicity:

NR 

Women, n: 

G1: 59 

G2: 40 

Follow-up: 

6 months 

Inclusion criteria: 

• >16 years of age 

• refractory to 

standard medical 

therapy 

• Bladder capacity 

of at least 100mL

• -Normal upper 

urinary tract 

Exclusion criteria:

• Treatable 

etiologies for 

urinary/frequency 

symptoms 

• Neurologic 

conditions 

• -Primary stress 

incontinence 

• Pelvic pain 

symptoms 

First sensation 

of filling, mL ± 

SD: 

Overall: 

82.8 ± 64.7 

G1: NR 

G2: 122.2 ±78.8 

Bladder volume 

at first detrusor 

contraction, mL 

± SD: 

Overall: 104.7 ± 

111.0 

Bladder 

capacity, mL ± 

SD: 

Overall: 254 ± 

138 

G1: NR 

G2: 313 ± 117 

Detrusor 

pressure at 

capacity, cm 

water ± SD: 

Overall: 27.7 ± 

21.6 

First sensation of 

filling, mL ± SD: 

Overall: 

167.4 ± 109.3, 

p<0.001 

G1: NR 

G2: 192.4 ± 118.4 

p=0.001 

Bladder volume at 

first detrusor 

contraction, mL ± 

SD: 

Overall:133.7 ± 

125.9, p =0.30 

Bladder capacity, 

mL ± SD: 

Overall: 328 ± 148, 

p=0.001 

G1: NR 

G2: 365 ± 115, 

p=0.02 

Detrusor pressure 

at capacity, cm 

water ± SD: 

Overall: 17.7 ± 16.5

DO at 6 months, n 

(%): 

G1: 

-25 (49%) 

-stimulation was 

clinically successful 

in 19 (40%) 

-failed in 3 (6%) 

 - 26 (51%) were 

negative for DO 

 -stimulation was 

clinically successful 

in 20 (42%) 

- failed in 6 (12%) 

G2: 

-3 (9%)were 

positive for DO 

-stimulation was 

clinically successful 

in 2 (7%) 

- failed in 1 (4%) 

- 29 remained 

negative for DO 

-stimulation was 

successful in 23 

(82%) 

-failed in 2 (7%) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: + 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-364 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Hassouna et al., 

2000 

Country and 

setting: US, 

Canada, and 

Europe, 

12centers 

Enrollment 

period: 

Ended June 

1998 

Funding:

Medtronic Inc. 

Author conflict 

of interest: 

Medtronic 

Design: 

Prospective 

cohort 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

Groups: 

G1: 

Neurostimulation 

G2: control 

N at enrollment: 

G1: 25 

G2: 26 

N at follow-up: 

51 patients with 

urgency/ 

frequency 

Age, mean yrs ± 

SD: 

Total: 39.0 ±11.8 

Race/ethnicity:

NR 

Women, %: 

90 

Follow-up:

6 months 

Inclusion criteria:

• >16 years of age 

• refractory to 

standard medical 

therapy 

• Bladder capacity 

of at least 100mL

• -Normal upper 

urinary tract 

Exclusion criteria: 

• Treatable 

etiologies for 

urinary/frequency 

symptoms 

• Neurologic 

conditions 

• -Primary stress 

incontinence 

• Pelvic pain 

symptoms 

Mean voids/day:

16.0 ±8.2 

Mean mL 

voided/void: 

G1: 118±74 

G2: 124±66 

Mean max. 

voided volume: 

288 ±156 

Mean total 

voided 

volume/day: 

1693± 866 

Mean % 

indicating they 

felt empty: 

44 ±39 

Mean duration of 

urinary 

symptoms 

before 

enrollment: 

8.1 ± 9.2 years 

Mean pelvic/ 

bladder 

discomfort (0 

none-3 severe): 

2.1 ±0.8 

Degree urgency 

before voiding: 

G1: 2.2±0.6 

G2: 2.4±0.5 

Mean mL 

voided/void: 

G1: 226±124 

G2: 123±75 

P< 0.001 

Degree urgency 

before voiding: 

G1: 1.6±0.9 

G2: 2.3±0.5 

P = 0.01 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: 

NR 

Drop-out rates: NR 

Power calculation: -

Statistical issues: + 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: +

C-365 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Janknegt et al., 

2001 

 Country and 

setting: 15 

investigators in 

US, Canada, 

and Europe 

Enrollment 

period:

December 1993- 

September 1999 

Funding: NR. 

Author conflict 

of interest: NR 

Design: 

Prospective case 

series 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

Groups: 

NA 

N at enrollment: 

NA 

N at follow-up: 

96 patients with 

urge incontinence 

Age: 

NR 

Women, n (%): 

85 (89) 

Race/ethnicity: 

NR 

Follow-up: ≥12 

months 

Mean follow-up 

30.8 months 

(range 12-60) 

Inclusion criteria: 

• age > 16 years 

• refractory to 

standard medical 

therapy for UUI 

• 100 mL bladder 

capacity with 

normal upper 

urinary tract 

Exclusion criteria: 

• neurological 

conditions 

• stress urinary 

incontinence 

• rimary pelvic 

pain 

Duration of 

symptoms, 

mean yrs ± SD: 

9.1± 7.0. 

Leaking 

episodes/day: 

10.9 ±6.5 

Leak severity 

ranking: 

2.0 ±0.6 

Absorbent 

pad/diapers 

replaced/day: 

6.6 ±5.2 

Pads/diapers 

used daily, mean 

± SD: 

7.1 ± 5.1 

Leaking 

episodes per 

day, mean ± SD:

8.0± 4.8 

Heavy leaks per 

day, mean ± SD:

4.7 ± 4.2 

Leaking 

episodes/day: 

4.2 ± 4.9 

p<0.0001 

Completely dry, n 

(%): 

25 (26) 

> 50% reduction in 

frequency of 

incontinent 

episodes, n (%):

35 (36) 

Leak severity 

ranking: 

1.7±0.6 

P<0.0001 

Pads/diapers used 

daily mean ± SD: 

2.9 ± 3.8 

P<0.0001 

Stopped using 

pads, n (%): 

30 (33) 

Reduced pad use 

> 50%, n (%): 

25 (28) 

Heavy leaks per 

day, mean ± SD: 

2.8± 4.0 

P<0.0001 

Eliminated both 

moderate and 

heavy leaking 

episodes, n (%): 

38 (43) 

> 50% reduction in 

moderate/heavy 

leaking, n (%): 

18 (20) 

11 patients 

explanted due to 

lack of efficacy 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: ++

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-366 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

(n=9), chronic leg 

pain (n=1), or bowel 

dysfunction (n=1) 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

C-367 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kessler et al., 

2007

Country and 

setting: 

Switzerland, 

Swiss Registry 

database 

Enrollment 

period: 

July 2000 to 

December 2005

Funding: 

not described

Author conflict 

of interest: 

Authors Kessler, 

Buchser, and 

Burkhard have 

consultancy 

agreements with 

Medtronic; 

author Zrehen is 

a Medtronic 

employee; 

Metronic 

Switzerland was 

assigned to 

monitor and 

maintain the 

Swiss Registry.

Design: 

Prospective case 

series

Intervention: 

SNM testing and 

IPG implantation

Groups: 

A portion of this 

series is 

composed of 

patients with urge 

incontinence (not 

further defined). 

N at enrollment: 

209 evaluated: 

181 female, 28 

male. 

N at follow-up: 

209: all evaluated 

were considered 

for adverse 

events of SNM 

testing 

102 successful 

tests 

91 had 

implantation of 

implantable pulse 

generator (IPG). 

71 of these had 

urge 

incontinence. 

Age, median: 

58 yrs 

Race/ethnicity: 

NR

Follow-up, 

mean: 

24 months for 

UUI 

Inclusion criteria: 

• Tested for urge 

incontinence, 

nonobstructive 

chronic urinary 

retrention and 

chronic pain 

syndrome 

• Refractory to 

conventional 

therapies 

• Underwent 

urologic 

evaluation with 

medical history, 

physical exam, 

bladder and/or 

pain diary, urine 

analysis, urine 

culture and 

urodynamic 

studies before 

SNM. 

Exclusion criteria: 

NR 

Urge 

incontinence, n: 

Female: 137 

Male: 16 

Leakages per 24 

hrs, median: 

5 

Pads used per 

24 hrs, median: 

4 

Voids per 24 hrs, 

median: 

10 

Of 91 who 

underwent IPG 

implantation (11 

of the 102 with 

successful 

testing refused 

implantation): 

71 urge 

incontinence; 13 

nonobstructive 

chronic urinary 

retention and 7 

chronic pelvic 

pain syndrome. 

Median follow-up 

was 24 months. 

Primary outcome:

subjective symptom 

improvement, 

changes in 

bladder/pain diary 

variables. 

SNM was 

considered 

successful in 64 of 

91 implanted 

patients, including 

50 with urge 

incontinence. This 

group at last followup had a median of 

0 leakages per 24 

hours, 1 pad use 

per 24 hours, 6 

voids per 24 hours, 

and 80% subjective 

symptom 

improvement. 

Secondary 

outcome: 

Incidence and 

treatment of 

adverse events due 

to SNM: 

Adverse events 

were reported in 12 

of 209 patients who 

were initially tested, 

including lead 

migration in 9, 

wound infection in 

2, and refractory 

pain at tined lead 

site in 1. These 

were not broken 

down separately for 

urge incontinence 

group. 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: ++

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-368 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Kessler et al., 

2007 

(continued)

Adverse events 

with IPG 

implantation were 

reported in 10 of 91 

patients, including 

lead migration (2) 

broken lead (1), 

wound infection at 

IPG site (2), pain at 

IPG site (3), IPG 

migration (1), and 

IPG malfunction 

after MIR (1). 6 of 

these patients 

required surgical 

revision. These 

were not broken 

down separately for 

urge incontinence 

group. 

C-369 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author:

Koldewijn et al. 

1994 

Country and 

setting: 

The Netherlands

Enrollment 

period: 

June 1990 to 

August 1993 

Funding: 

NR

Design: 

Prospective case 

series

Intervention: 

percutaneous 

stimulation of the 

sacral root S3 on 

the left and right 

sides

Groups: 

NA 

N at enrollment:

NR 

N at follow-up: 

100 

Age (mean): 

42 years 

Women, n: 

86 

Race/ethnicity: 

NR 

Inclusion criteria: 

• failed previous 

treatment with 

medication, 

behavioral 

therapy, surgery, 

or combination 

therapy 

Exclusion criteria: 

• No other lower 

urinary tract 

conditions 

Urge 

incontinence, n: 

46 

Incomplete 

bladder emptying, 

n: 23 

Urgency and 

frequency, n: 13 

Mixed 

incontinence, n: 

10 

Dysuria or pelvic 

pain, n: 5 

Stress 

incontinence, n: 

3 

Detrusor 

overactivity, n: 

52 

Detrusor 

underactivity, n : 

24 

Urethral 

instability, n: 5 

No abnormalities 

by UDS, n: 19 

No neurophysiological 

abnormalities, n: 

18 

Central neurophysiological 

abnormality, n: 10

Peripheral neurophysiological 

abnormaility, n: 

16 

Perfect 

improvement

(>90%), n: 

22 

Moderate 

improvement (50-

90 %), n : 

8 

Slight 

improvement (10-

50%), n : 

10 

No response, n: 

17 

Pain in the area of 

puncture during 

stimulation, n: 

7 

Quality: 

Overall quality score: 

fair 

INTERNAL VALIDITY: 

fair 

Randomization: NA 

Masking: NA 

Pt selection criteria: + 

Loss to followup: NR 

Drop-out rates: NR 

Power calculation: - 

Statistical issues: + 

EXTERNAL VALIDITY: 

fair 

Age: + 

Baseline OAB status: + 

Baseline characteristics: 

++ 

Length of followup: - 

Measurement methods: 

+ 

Measurement reliability: 

- 

Intervention description: 

+ 

C-370 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

C-371 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Korda et al., 

1987 

Country and 

setting: 

Australia 

Enrollment 

period: 1983 - 

1984 

Funding: 

NR 

Design: 

Prospective case 

series 

Intervention: 

Bladder distention 

Groups: 

NA 

N at enrollment: 

50 

N at follow-up: 

50

Age: 

NR 

Race/ethnicity: 

NR 

Gender: 

100% F 

Follow-up: 

 3, 6 and 12 mo 

Inclusion criteria: 

• Diagnosis with 

detrusor instability 

and failure to 

respond to 

anticholinergic 

treatment 

Exclusion criteria: 

NR 

NR Extraperitoneal 

rupture: 

2 patients 

At 3 mos: 

Symptom free: 10 

Improved: 25 

Unchanged: 15 

At 12 mos: 

Symptom free: 9 

Improved: 15 

Unchanged: 26 

 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: ++

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-372 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Mundy 1983 

Country and 

setting: 

UK 

Enrollment 

period: 

NR 

Funding: 

NR

Design: 

retrospective 

case series 

Intervention:

bladder 

transection 

Groups, N: 

G1: 23; 

circumferential 

transection of the 

bladder wall just 

above the ureteric 

orifices 

G2: 81; 

transection of the 

posterior and 

posterolateral 

bladder wall from 

1 cm lateral to the 

right ureteric 

orifice to 1 cm 

lateral on the left 

side ureteric 

orifice 

N at enrollment:

104 

Duration of 

follow-up: 

at least 12 

months (range 

12-59 months; 

mean 35 months) 

N at follow-up: 

104 at year 1, 82 

at year 2, 49 at 

year 3, 25 at year 

4, and 6 at year 5 

Age mean yrs 

(range): 

37 (19-81 ) 

Women, n (%): 

91(87.5%) 

Race/ethnicity:

NR 

No separate 

analysis by 

Inclusion criteria:

• urodynamically 

proven detrusor 

instability 

• frequency, 

urgency and 

urge 

incontinence for 

at least 3 years 

• failure to 

respond to 

standard 

conservative 

treatment (e.g. 

bladder drill, 

probanthine 

therapy, 

imipramine 

therapy, 

emepromium 

bromide therapy, 

hydrostatic 

bladder 

dilatation, 

oxybutynin) 

Exclusion criteria: 

NR 

NR Initial postoperative 

evaluation (3-6 

months after 

operation): 

74% cured, 14% 

improved; 12% 

failures; authors 

note same results 

at year 1 

At last evaluation 

(in patients 

followed for 2-5 

years): 

53 (65% still cured), 

16 (19%) improved; 

13 (16%) failures 

9 participants with 

residual symptoms 

after operation later 

responded to other 

therapies 

Among 68 

patients with at 

least one 

postoperative 

urodynamic 

study: 

50 symptomatically 

cured; 14 of these 

reverted to stability 

and 26 showed a 

shift to the right of 

the urodynamic 

pattern 

28 were failures or 

showed partial 

response; 8 were 

no longer unstable, 

and 14 remained 

the same as before 

their operation; 

authors note 6 with 

genuine stress 

incontinence were 

successfully 

managed by 

appropriate surgical 

treatment 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: ++

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: - 

C-373 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

gender

C-374 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Mundy 1983 

(continued)

Adverse events: 

1 patient developed 

persistent urine 

leak from her 

bladder requiring 

reoperation. 

• Urodynamic 

evidence of 

vesicoureteric 

reflux 

postoperatively that 

had not been 

observed preoperatively in 14 

patients; none were 

symptomatic or 

developed acute 

pyelonephritis 

C-375 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

O’Reilly et al., 

2008 

Country and 

setting: 

Australia, 

Academic health 

centers 

Enrollment 

period: 

NR

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Trans-sacral 

nerve (S3-S4) 

stimulation vs 

sham 

Groups: 

G1: transsacral 

nerve magnetic 

stimulator of the 

S3 and S4 nerve 

roots x 20 min/ 

day x 12 wk 

G2: sham x 20 

min/day x 12 wk 

N at enrollment: 

G1: 33 

G2: 30

N at follow-up: 

G1: 33 

G2: 30 

Women, %: 

100 

Age, mean ± SD: 

G1: 62.6 ± 13.45 

G2: 59.8 ± 14.19

Inclusion criteria: 

• Women 

• Age ≥ 18 

• Ability to give 

informed consent

• Ability to comply 

w/ instructions to 

use the device 

• Ability to perform 

treatment over 

an 84-d period 

and attend for f/u 

• OAB symptoms 

for ≥ 6 mos 

• Unresponsive to 

behavioral 

measures or 

anticholinergic 

medication 

Exclusion criteria: 

• Pregnancy 

• Actively trying to 

conceive 

• Waking voiding 

frequency < 7 in 

12 hrs 

• Nocturia < 2 

• SUI symptoms 

• Benign or 

malignant 

bladder tumor 

• UTI 

• Previous 

irradiation or 

drug-induced 

cystitis 

• Symptomatic 

diverticulum 

• Vaginal infection 

• DM 

• Peripheral 

neuropathy 

• Cardiovascular 

disease 

• Cancer of the 

genital tract, 

urinary tract 

calculi 

• Cardiac 

arrhythmia 

Voids/day, mean 

± SD

G1: 10 ± 3.2 

G2: 9 ± 3.3 

Symptom 

impact, median 

VAS score (IQR):

G1: 80 (50-90) 

G2: 80 (70-90) 

AQoL, overall 

mean score ± 

SD: 

G1: 0.67 ± 0.22 

G2: 0.67 ± 0.26 

AQoL, illness, 

median score 

(IQR): 

G1: 0.42 (0.14-

0.87) 

G2: 0.40 (0.17-

0.87) 

AQoL, 

independent 

living, median 

score (IQR): 

G1: 1 (0.87-1) 

G2: 1 (0.88-1) 

AQoL, social 

relationships, 

median score 

(IQR): 

G1: 1 (0.90-1) 

G2: 0.97 (0.79-1) 

AQoL, physical 

senses, median 

score (IQR): 

G1: 0.94 (0.86-1) 

G2: 0.97 (0.92-1) 

AQoL, psychological wellbeing, median 

score (IQR): 

G1: 0.85 (0.85-

0.91) 

G2: 0.87 (0.85-

0.93) 

Voids/day, mean ±

SD: 

G1: 9 ± 2.7 

G2: 9 ± 3.2 

Symptom impact, 

median VAS score 

(IQR): 

G1: 70 (40-90) 

G2: 75 (50-80) 

AQoL, overall 

mean score ± SD:

G1: 0.69 ± 0.22 

G2: 0.72 ± 0.25 

AQoL, illness, 

median score 

(IQR): 

G1: 0.52 (0.19-

0.81) 

G2: 0.42 (0.17-

0.87) 

AQoL, 

independent 

living, median 

score (IQR): 

G1: 1 (0.9-1) 

G2: 1 (0.83-1) 

AQoL, social 

relationships, 

median score 

(IQR): 

G1: 0.94 (0.88-1) 

G2: 0.94 (0.86-1) 

AQoL, physical 

senses, median 

score (IQR): 

G1: 0.94 (0.86-1) 

G2: 0.94 (0.92-1) 

AQoL, psychological well-being, 

median score 

(IQR): 

G1: 0.85 (0.83-

0.93) 

G2: 0.90 (0.85-

0.98) 

KHQ, general 

health, median 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: ++

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-376 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

score (IQR): 

G1: 25 (0-50) 

G2: 25 (0-50) 

C-377 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

O’Reilly et al., 

2008 

(continued) 

KHQ, general 

health, median 

score (IQR): 

G1: 25 (0-25) 

G2: 25 (25-50) 

KHQ, incontinence Impact, 

median score 

(IQR): 

G1: 100 (66.6-

100) 

G2: 100 (66.6-

100) 

KHQ, role 

limitations, 

median score 

(IQR): 

G1: 66.6 (50-

83.3) 

G2: 58 (33.3-

83.3) 

KHQ, physical 

limitations, 

median score 

(IQR): 

G1: 50 (16.6-

83.3) 

G2: 50 (16.6-

66.6) 

KHQ, social 

limitations, 

median score 

(IQR): 

G1: 30 (10-70) 

G2: 30 (10-60) 

KHQ, personal 

relationships, 

median score 

(IQR): 

G1: 16.6 (0-66.6) 

G2: 16.6 (0-50) 

KHQ, emotions, 

median score 

(IQR): 

G1: 66.6 (33-100)

G2: 55.2 (22.2-

88.8) 

G2: 50 (33.3-

83.3) 

KHQ, incontinence Impact, 

median score 

(IQR): 

G1: 100 (33.3-100) 

G2: 100 (33.3-100) 

KHQ, role 

limitations, 

median score 

(IQR): 

G1: 33.3 (16.6-

83.3) 

G2: 33.3 (0-66.6) 

KHQ, physical 

limitations, 

median score 

(IQR): 

G1: 41.6 (16.6-

83.3) 

G2: 50 (16.6-66.6) 

KHQ, social 

limitations, 

median score 

(IQR): 

G1: 25 (10-60) 

G2: 20 (10-30) 

KHQ, personal 

relationships, 

median score 

(IQR): 

G1: 0 (0-33.3) 

G2: 0 (0-33.3) 

KHQ, emotions, 

median score 

(IQR): 

G1: 44.4 (22.2-

88.8) 

G2: 44.4 (22.2-

77.7) 

KHQ, sleep and 

energy, median 

score (IQR): 

G1: 50 (33.3-66.6) 

G2: 50 (33.3-66.6) 

KHQ, severity 

measures, median 

score (IQR): 

G1: 53.3 (33.3-

73.3) 

G2: 46.6 (40-66.6) 

C-378 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

O’Reilly et al., 

2008 

(continued) 

KHQ, sleep and 

energy, median 

score (IQR): 

G1: 66.6 (33.3-

83.3) 

KHQ, severity 

measures, 

median score 

(IQR): 

G1: 60 (46.6-

76.6) 

G2: 50 (40-66.6) 

Voided volume 

(mL), median 

(IQR): 

G1: 350 (250-

500) 

G2: 400 (300-

550) 

Total voided 

volume/day 

(mL), mean ± 

SD: 

G1: 1850 ± 715 

G2: 1800 ± 750 

Voided volume 

(mL), median 

(IQR): 

G1: 425 (250-550) 

G2: 375 (300-500) 

Total voided 

volume/ day (mL), 

mean ± SD: 

G1: 1780 ± 630 

G2: 1790 ± 710 

C-379 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics 

Outcomes Quality Rating 

Author: 

Rios et al., 2007 

Country and 

setting: 

Brazil, academic 

hospital

Enrollment 

period: 

NR

Funding: 

Departments of 

Urology of the 

Federal 

University of

São Paulo, 

Paulista School 

of Medicine and 

Hospital do 

Servidor Público 

Estadual de São 

Paulo

Author industry 

relationship 

disclosures: 

None 

Design: 

RCT

Intervention: 

intravesical 

resiniferatoxin 

(RTX)

Groups: 

G1: single dose 

100 ml 50 nM 

RTX 

G2: placebo 

N at enrollment: 

G1: 34 

G2: 24 

N at follow-up: 

G1: 33 

G2: 23 

Women, %: 

100

Age, mean ± SD: 

56 ± 12.09 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Urinary 

frequency, daily 

urgency & UUI, 

nocturia for > 6 

mos prior to study

• Involuntary 

detrusor 

contractions on 

cystometrogram 

Exclusion criteria:

• Use of 

anticholinergics 

or tricyclic 

antidepressants 

in last 2 mos 

• Neurologic 

conditions 

• UTI 

• Pelvic prolapse > 

grade 2 

• History of pelvic 

radiation or 

bladder tumor 

• Poor bladder wall 

compliance 

• Detrusor 

underactivity 

Incontinence 

episodes/day, 

per-protocol 

analysis, mean ± 

SD: 

G1: 3.11 ± 2.50 

G2: 5.76 ± 3.39 

P = 0.002 

Incontinence 

episodes/day, 

ITT analysis, 

mean ± SD: 

G1: 3.00 ± 2.46 

G2: 5.06 ± 3.37 

P = 0.015 

Voids/day, perprotocol analysis, mean ± SD: 

G1: 9.68 ± 2.92 

G2: 9.94 ± 2.76 

P = 0.756 

Voids/day, ITT 

analysis, mean ± 

SD: 

G1: 9.66 ± 2.88 

G2: 9.90 ± 2.58 

P = 0.746 

Enuretic 

episodes/wk, 

per-protocol 

analysis, mean ± 

SD: 

G1: 0.33 ± 0.53 

G2: 0.59 ± 0.80 

P = 0.340 

Enuretic 

episodes/wk, ITT 

analysis, mean ± 

SD: 

G1: 0.36 ± 0.53 

G2: 0.46 ± 0.72 

P = 0.864 

Nocturia 

episodes/day, 

per-protocol 

analysis, mean ± 

SD: 

G1: 2.22 ± 1.02 

Incontinence 

episodes/day, perprotocol analysis, 

mean ± SD: 

G1: 2.68 ± 3.08 

G2: 4.50 ± 3.83 

P = 0.012 

Incontinence 

episodes/day, ITT 

analysis, mean ± 

SD: 

G1: 2.72 ± 3.04 

G2: 4.20 ± 3.57 

P = 0.027 

Voids/day, perprotocol analysis, 

mean ± SD: 

G1: 9.03 ± 2.77 

G2: 9.10 ± 2.68 

P = 0.814 

Voids/day, ITT 

analysis, mean ± 

SD: 

G1: 9.03 ± 2.73 

G2: 9.21 ± 2.53 

P = 0.738 

Enuretic 

episoldes/wk, perprotocol analysis, 

mean ± SD: 

G1: 0.15 ± 0.34 

G2: 0.65 ± 1.06 

P = 0.140 

Enuretic 

episodes/wk, ITT 

analysis, mean ± 

SD: 

G1: 0.17 ± 0.36 

G2: 0.52 ± 0.98 

P = 0.321 

Nocturia 

episodes/day, perprotocol analysis, 

mean ± SD: 

G1: 1.73 ± 1.14 

G2: 1.82 ± 1.16 

P = 0.794 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection criteria: 

- 

Loss to followup: ++

Drop-out rates: NR 

Power calculation: -

Statistical issues: + 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-380 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

G2: 2.29 ± 1.26 

P = 0.827 

C-381 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Rios et al., 2007 

(continued)

Nocturia 

episodes/day, 

ITT analysis, 

mean ± SD: 

G1: 2.21 ± 1.02 

G2: 2.28 ± 1.19 

P = 0.796 

KHQ, general 

health perception, mean score 

± SD: 

G1: 37.88 ± 14.14

G2: 42.70 ± 21.61

KHQ, incontinence impact, 

mean score ± 

SD: 

G1: 77.78 ± 28.46

G2: 83.33 ± 22.94

KHQ, role 

limitations, 

mean score ± 

SD: 

G1: 62.63 ± 36.33

G2: 70.00 ± 35.29

KHQ, physical 

limitations, 

mean score ± 

SD: 

G1: 59.60 ± 34.37

G2: 60.00 ± 31.71

KHQ, social 

limitations, 

mean score ± 

SD: 

G1: 27.44 ± 25.23

G2: 29.90 ± 28.64

G2/G1: P < 0.05 

KHQ, personal 

relationship, 

mean score ± 

SD: 

G1: 34.92 ± 41.47

G2: 26.47 ± 34.89

KHQ, emotions, 

mean score ± 

SD: 

G1: 57.24 ± 35.59

G2: 66.11 ± 29.39

Nocturia 

episodes/day, ITT 

analysis, mean ± 

SD: 

G1: 1.77 ± 1.14 

G2: 1.89 ± 1.12 

P = 0.769 

KHQ, general 

health perception, 

mean score ± SD: 

G1: 34.85 ± 13.89 

G2: 43.75 ± 24.16 

KHQ, incontinence impact, 

mean score ± SD: 

G1: 60.61 ± 33.80 

G2: 65.00 ± 38.20 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

KHQ, role 

limitations, mean 

score ± SD: 

G1: 48.99 ± 35.09 

G2: 49.12 ± 37.46 

G2/BL: P < 0.05 

KHQ, physical 

limitations, mean 

score ± SD: 

G1: 45.45 ± 36.39** 

G2: 44.17 ± 39.84 

KHQ, social 

limitations, mean 

score ± SD: 

G1: 21.55 ± 25.30 

G2: 38.50 ± 31.91 

KHQ, personal 

relationship, mean 

score ± SD: 

G1: 27.08 ± 38.33 

G2: 37.50 ± 41.51 

KHQ, emotions, 

mean score ± SD: 

G1: 42.76 ± 35.80 

G2: 54.45 ± 37.10

G1/BL: P < 0.05 

KHQ, sleep and 

energy, mean 

score ± SD: 

G1: 28.79 ± 24.03 

G2: 38.33 ± 31.11

G1/BL: P < 0.05 

C-382 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Rios et al., 2007 

(continued)

KHQ, sleep and 

energy, mean 

score ± SD: 

G1: 43.43 ± 26.66

G2: 37.50 ± 24.71

KHQ, symptom 

severity, mean 

score ± SD: 

G1: 8.08 ± 7.59 

G2: 10.88 ± 13.55

Cystometric 

capacity, perprotocol 

analysis, mean ± 

SD: 

G1: 112.94 ± 

68.22 

G2: 124.15 ± 

76.05 

P = 0.581 

Cystometric 

capacity, ITT 

analysis, mean ± 

SD: 

G1: 114.62 ± 

67.89 

G2: 127.42 ± 

72.99 

P = 0.496 

Max cystometric 

capacity, perprotocol 

analysis, mean ± 

SD: 

G1: 285.8 ± 

183.20 

G2: 246.50 ± 

92.87 

P = 0.306 

Max cystometric 

capacity, ITT 

analysis, mean ± 

SD: 

G1: 287.47 ± 

180.64 

G2: 240.63 ± 

85.77 

P = 0.194 

KHQ, symptom 

severity, mean 

score ± SD: 

G1: 13.94 ± 9.91 

G2: 10.88 ± 11.80

G1/BL: P < 0.05 

Cystometric 

capacity, perprotocol analysis, 

mean ± SD: 

G1: 144.70 ± 93.41 

G2: 172.75 ± 

117.83 

P = 0.310 

Cystometric 

capacity, ITT 

analysis, mean ± 

SD: 

G1: 145.44 ± 92.08 

G2: 167.92 ± 

109.93 

P = 0.322 

Max cystometric 

capacity, perprotocol analysis, 

mean ± SD: 

G1: 298.03 ± 

161.48 

G2: 270.50 ± 

109.57 

P = 0.402 

Max cystometric 

capacity, ITT 

analysis, mean ± 

SD: 

G1: 299.26 ± 

159.18 

G2: 260.63 ± 

102.37 

P = 0.237 

Bladder volume, 

1st involuntary 

contraction, perprotocol analysis, 

mean ± SD: 

G1: 120.17 ± 68.98 

G2: 140.83 ± 84.34 

P = 0.093 

C-383 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Rios et al., 2007 

(continued)

Bladder volume, 

first involuntary 

contraction, perprotocol 

analysis, mean ± 

SD: 

G1: 89.31 ± 44.58

G2: 125.56 ± 

79.92 

P = 0.263 

Bladder volume, 

1st involuntary 

contraction, ITT 

analysis, mean ± 

SD: 

G1: 103.82 ± 

59.51 

G2: 124.38 ± 

73.01 

P = 0.243 

Max detrusor 

voiding 

pressure, perprotocol 

analysis, mean ± 

SD: 

G1: 35.90 ± 12.05

G2: 34.06 ± 12.86

P = 0.807 

Max detrusor 

voiding 

pressure, ITT, 

analysis, mean ± 

SD: 

G1: 33.59 ± 12.59

G2: 35.00 ± 11.67

P = 0.666 

Bladder volume, 

1st involuntary 

contraction, ITT 

analysis, mean ± 

SD: 

G1: 121.83 ± 68.39 

G2: 139.09 ± 79.83 

P = 0.102 

Max detrusor 

voiding pressure, 

per-protocol 

analysis, mean ± 

SD: 

G1: 33.83 ± 15.78 

G2: 32.33 ± 12.29 

P = 0.625 

Max detrusor 

voiding pressure, 

ITT analysis, 

mean ± SD: 

G1: 33.33 ± 15.74 

G2: 32.91 ± 11.50 

P = 0.819 

C-384 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Schmid et al. 

2006 

Country and 

setting:

Switzerland; 3 

clinics 

Enrollment 

period: 

January 2003 to 

October 2004 

Funding:

International 

Institute for 

Research in 

Paraplegia; 

Swiss National 

Science 

Foundation 

Author conflict 

of interest: 

NR 

Design: 

prospective case 

series 

Intervention:

1000 U Botox-A 

in 10 mL 0.9% 

normal saline 

injected into the 

detrusor muscle 

1-2 mm under the 

urothelium layer 

at 30 sites on the 

inner surface of 

the bladder wall 

(approx. 0.3 mL 

each injection) 

Groups: 

NA 

N at enrollment:

100 

N at follow-up: 

100 at 1 month; 

80 at 3 months; 

20 at 9 months

Age: mean 63 

years (range 24-

89) 

Race/ethnicity: 

NR 

Follow-up: 

patients followed 

4, 12, and 36 

weeks after 

treatment 

Mean follow-up: 

20 weeks (range 

4-36) 

No separate 

analysis by 

gender 

Inclusion criteria: 

• OAB syndrome 

(ICS) 

• Urodynamically 

demonstrable 

nonneurogenic 

detrusor 

overactivity or 

hypersensitive 

bladder with 

premature filling 

sensation 

• ≥ 8 voids per 24 

hours (with or 

without 

incontinence) 

• Not effectively 

treated with 

maximal doses 

of 

anticholinergics 

(or unable to 

tolerate those 

drugs) 

Exclusion criteria: 

• Renal 

dysfunction 

• Myasthenia 

gravis 

• Neurogenic 

bladder 

dysfunction 

• Serious illness 

• Pregnant or 

breastfeeding 

• Interstitial cystitis

• Radiocystitis 

• Bladder tumor 

• Chronic pelvic 

pain syndrome 

• Prostate 

hyperplasia 

• Infravesical 

obstruction 

• PVR > 150 mL 

• Hypocontractile/

acontractile 

detrusor 

• Prior SUI surgery 

and de novo 

Maximal 

cystometric 

bladder capacity 

(mL; mean +

SD): 

246 ±15 

Detrusor 

compliance 

(mL/cm H2O; 

mean + SD): 

24.5 ± 2.3

Reflex volume 

(mL; mean +

SD): 

169 ±14 (n=54) 

First desire to 

void (mL mean +

SD): 125 ±13 

Urgency to void 

(mL; mean +

SD): 

214 ±16 

Postvoid 

residual (mL; 

mean + SD): 

21 ±8 

Incontinence, n: 

84 

Voiding 

frequency/24 

hrs, n: 

9-15 times: 37 

16-23 times:41 

>24 times: 24

Voiding 

frequency/24 hrs: 

4-8 times: 69 

8-15 time : 24 

Maximal 

cystometric 

bladder capacity 

(mL; mean + SD): 

1 mo.: 381 ±19 

3 mos.: 384 ±19 

9 mos.: 325 ±55 

Detrusor 

compliance 

(mL/cm H2O; 

mean + SD): 

1 mo.: 40.5 ±2.9 

3 mos.: 45.1 ±2.9 

9 mos.: 37.1 ±8.4 

Reflex volume 

(mL; mean + SD): 

1 mo.: 229 ±25 

(n=14) 

3 mos.: 222 ±35 

(n=14) 

9 mos.: 195 ±57 

(n=6) 

First desire to 

void (mL mean +

SD): 

1 mo.: 212 ±16 

3 mos.: 208 ±16 

9 mos.: 178 ±40 

Urgency to void 

(mL; mean + SD): 

1 mo.: 309 ±20 

3 mos: 332 ±20 

9 mos: 210 ±57 

Postvoid residual 

(mL; mean + SD): 

1 mo: 75 ±10 

3 mos: 85 ±10 

9 mos: 14 ±28 

• Urgency 

disappeared in 

72 patients at the 

4 week 

assessment and 

in 66% at the 12 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-385 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

urge 

• Mixed 

incontinence 

week followup 

C-386 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Schmid et al., 

2006 

(continued)

• Incontinence 

disappeared in 

74% at 4 week 

follow-up and 

80% at 12 week 

followup 

• No improvement 

in 8 patients 

• 90% of patients 

experienced 

improvement in 

at least 1 quality 

of life category, 

increasing at 3 

month follow-up 

and decreasing 

at 9 months 

Adverse events: 

• 4 patients 

developed 

temporary (4 

week) urinary 

retention and 

postvoid residual 

> 400 mL at 1-2 

weeks after 

injection, 

requiring 

temporary 

intermittent clean 

selfcatheterization; 

PVR returned to 

baseline within 6-

9 months 

• 15 patients 

reported mild 

difficulty in 

voiding during 

the first moth with 

PVR 150-200 

mL; declined 

ICSC 

• 10 patients 

developed 

bladder infection 

successfully 

treated by 

antibiotics 

C-387 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Schmidt et al., 

1999 

Country and 

setting: 16 

centers in US, 

Canada, and 

Europe 

Enrollment 

period: 

1993- April 1997 

Funding:

Supported by 

Medtronics Inc. 

Author conflict 

of interest: 

Schmidt, Jonas, 

Oleson, 

Janknegt, 

Siegel: financial 

interest and/or 

other 

relationship with 

Medtronic Inc. 

Design: 

randomized 

controlled trial 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

Groups: 

G1: implantation 

with immediate 

stimulation (n=34 

for efficacy 

analysis) 

G2: control group 

receiving 

standard medical 

therapy for 6 

months; allowed 

to cross over at 6 

months if 

remained eligible 

for implantation 

(n=42 for efficacy 

analysis) 

N at enrollment: 

155 

N randomized: 

98 (the remaining 

57 did not 

respond to test 

stimulation so 

were not 

randomized) 

N at follow-up: 

76 at 6 months 

Age: mean 46.6 

±13.0 (range 20.2 

– 78.9) 

Gender: 125 F 

(80.6%), 30 M 

(19.4%) 

Inclusion criteria: 

• age > 16 years 

• refractory to 

standard medical 

therapy 

• ≥ 100 mL 

bladder 

capacdity with 

normal upper 

urinary tract 

• good surgical 

candidate 

• able to complete 

study 

documentation 

and return for 

follow-up 

evaluation 

Exclusion criteria: 

• neurological 

conditions 

• stress urinary 

incontinence 

• primary pelvic 

pain 

Duration of 

urinary symptoms 

before enrollment: 

mean 9.0±7.4 

(range 0.6-35.4) 

Mean number of 

daily incontinence 

episodes: 8.9± 

5.9 

G1: 9.7 ± 6.3 

G2: 9.3 ± 4.8 

Mean leak 

severity rating: 

1.9± 0.6 

G1: 2.0 ± 0.7 

G2: 1.8 ± 0.6 

Mean absorbent 

pads/diapers 

replaced daily 

4.8± 4.8 

G1: 6.2 ± 5.0 

G2: 5.0 ± 3.7 

Mean heavy 

incontinence 

episodes per day:

G1: 3.4 ±3.8 

G2: 2.6 ±3.5 

3-day diary data: 

90.3% of patients 

had at least 1 

moderate/heavy 

and 74.8% had at 

least 1 heavy 

incontinence 

episode 

Previous 

treatment for 

urinary 

problems: 153 

(89.7%), including 

pharmacological 

in 144 (92.5%, 

nonsurgical in 55 

(35.5%), and 

surgical in 88 

(56.8%) 

At 6 months: 

Mean number of 

daily incontinence 

episodes: 

G1: 2.6± 5.1 

(p<0.0001) 

G2: 11.3 ± 5.9 

(p=0.002) 

Mean leak severity 

rating: 

G1: 0.8 ± 0.9 

(p<0.0001) 

G2: 2.0± 0.6 

(p=0.006) 

Mean absorbent 

pads/diapers 

replaced daily 

G1: 1.1 ± 2.0 

(p<0.0001) 

G2: 6.3 ± 3.6 

(p=0.003) 

Mean heavy 

incontinence 

episodes per day: 

G1: 0.3 ±0.9 

(P<0.0001) 

G2: 3.9 ±3.8 

G1: 47% 

completely dry at 6 

months; 3 patients 

had no reduction in 

incontinence after 6 

months (one 

underwent device 

explantation and 2 

had increased 

frequency of 

urination and 

incontinence) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

 

C-388 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Race/ethnicity:

NR

C-389 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Schmidt et al., 

1999 

(continued) 

Safety data 

(pooled for 157 

patients): adverse 

events requiring 

surgical 

repositioning or 

replacement of 

implant devices 

document in 51 

(32.5%) 

168 post-implant 

events reported by 

83 patients, 

including pain at 

the neurostimulator 

site in 15.9%, pain 

at implant site in 

19.1, and lead 

migration in 7.0% 

Infection or skin 

irritation led to 

device explantation 

in 2 patients and 

templorary explant 

in 2 patients 

No permanent 

injuries or nerve 

damage reported. 

C-390 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Siegel et al. 

2000 

Country and 

setting: 

US, Canada, 

and Europe, 12 

centers in 

Enrollment 

period: 

1993- 999 

Funding:

partially funded 

through 

restricted 

research grants 

from Medtronics 

Inc. 

Author conflict 

of interest: 

NR 

Design: 

case series

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

N at enrollment: 

219 undergoing 

stimulator 

placement (from 

pool of 581 

patients 

evaluated)* 

UUI: 

 urge 

incontinence 

(n=41) 

Urgency/Freque

ncy: 

(n=29) 

N at follow-up: 

total=112; 23 

additional 

patients had 

undergone device 

explantation and 

an additional 84 

were not yet due 

for long-term 

follow-up 

Age, mean 

(range): 

43 (17-81) 

Women, %: 

78% 

Race/ethnicity:

NR 

Inclusion criteria: 

• patients who 

received 

implanted 

Interstim and 

were due for 

long-term followup 

Exclusion criteria: 

NA 

Indications, N: 

Urge incontinence: 

41 

Urgency/frequency: 

29 

Retention: 42 

UUI 

episodes/day, 

mean ± SD: 

11.6 ± 6.6 

Heavy episodes 

per day, mean ± 

SD: 

3.6 ±4.0 

Pads per day, 

mean ± SD: 

6.7 ±4.6 

Voids per day: 

17.7 ±8.6 

Average volume 

per void: 

132.5 ±93.6 

Average degree 

of urgency 

before voiding 

(scale 1 mild – 3 

severe): 

2.2. ±0.7 

Void volume per 

void, mean mL ± 

SD: 

343 ± 167 

UUI episodes/day, 

mean ± SD: 

5.0 ±6.1 

P<0.0001 

Heavy episodes 

per day, mean ± 

SD: 

1.3 ±3.5 

P<0.0001 

Pads per day, 

mean ± SD: 

3.4 ±4.9 

P<0.0001 

Voids per day: 

10.6 ±6.6 

P < 0.0001 

Void volume per 

void, mean mL ± 

SD: 

225 ±162 

P < 0.0001 

Improvement in 

degree of urgency 

before voiding was 

present in 69% of 

patients 

Eliminated use of 

catheterization, %: 

58 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-391 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Siegel et al. 

2000 

(continued) 

Adverse events: 

Pain at 

neurostimulator site 

(15.4%), new pain 

(9.0%), suspected 

lead migration 

(8.4%), infection 

(6.1%), transient 

electric shock 

(5.5%), pain at lead 

site (5.4%), 

adverse change in 

bowel function 

(3.0%), technical 

problems (1.7%), 

suspected device 

problems (1.6%), 

change in 

menstrual cycle 

(1.0%), adverse 

change in voiding 

function (0.6%), 

persistent skin 

irritation (0.5%), 

suspected nerve 

injury (0.5%), 

device rejection 

(0.5%), other 

(9.5%) 

Surgical revision 

rate: 

33% (73/219) 

C-392 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics 

Outcomes Quality Rating 

Author: 

Spinelli et al., 

2001 

Country and 

setting: 

Italy, Registry 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Case series 

Intervention: 

sacral 

neuromodulation 

with Itrel II or 

Interstim 

stimulation 

system 

Groups: 

G1: retrospective 

cases 

G2: prospective 

cases 

N at enrollment: 

G1: 93 

G2: 103 

N at follow-up: 

G1: 65 

G2: NR 

Age, mean 

(range): 

G1: 50.9 (17, 79) 

G2: 50.1 (17, 79) 

Race/ethnicity:

NR 

Women, %:

G1: 80.6 

G2: 72.8 

Follow-up:

G1: median 40 

months, range 

28-73 months 

G2: 3, 6, 9, 12, 18 

and 24 months 

Inclusion criteria: 

• placement of a 

sacral 

neurostimulator 

Exclusion criteria:

NR 

Incontinence 

episodes/day, 

mean ± SD: 

G2: 5.4 ± 3.9 

Detrusor 

instability QoL 

index, mean: 

G2: 33.1 

Urgency/ 

frequency QoL 

index, mean: 

G2: 40 

Detrusor 

instability, n (%):

G1: 44 (47.3) 

G2: 42 (40.8) 

Retention, n (%):

G1: 20 (21.5) 

G2: 25 (24.3) 

Neurogenic 

retention, n (%): 

G1: 0 

G2: 10 (9.7) 

Detrusor 

hyperreflexia, n 

(%): 

G1: 8 (8.6) 

G2: 15 (14.6) 

Urgency/frequency, n (%): 

G1: 5 (5.6) 

G2: 5 (4.9) 

Pelvic pain, n 

(%): 

G1: 9 (9.7) 

G2: 4 (3.9) 

Urethral 

instability, n (%):

G1: 4 (4.3) 

G2: 2 (1.9) 

Interstitial 

cystitis, n (%): 

G1: 3 (3.2) 

G2: 0 

Detrusor instaMean incontinence episodes/ 

day, UUI patients 

(including 

detrusor or 

urethral 

instability), %: 

Completely dry: 

G1: 39 

< 1 episode: 

G1: 23 

1-3 esisodes: 

G1: 23 

> 3 episodes: 

G1: 15 

Incontinence 

episodes/day, 12 

mo, mean ± SD: 

G2: 1.1 ± 1.6 

P < 0.001 

Completely dry, 3 

months, %: 

G2: 57 

P = NR 

Completely dry, 6 

months, %:: 

G2: 65 

P < 0.001 

Completely dry, 9 

months, %: 

G2: 55 

P < 0.003 

Completely dry, 

12 months, %: 

G2: 59 

P < 0.001 

Completely dry, 

18 months, %: 

G2: 43 

P < 0.04 

Mean voids/day, 

%: 

< 8 voids: 

G1: 42 

8-12 voids: 

G1: 42 

>12 voids: 

G1: 18 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: + 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-393 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

bility or urgency/ 

frequency, n 

(%): 

Total: 102 (52) 

C-394 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Spinelli et al., 

2001 

(continued) 

Detrusor 

instability QoL 

index, 3 months, 

mean: 

G2: 74.7 

P < 0.001 

Detrusor 

instability QoL 

index, 6 months, 

mean: 

G2: 80.5 

P < 0.001 

Detrusor 

instability QoL 

index, 12 months, 

mean: 

G2: 69.6 

P < 0.001 

Detrusor 

instability QoL 

index, 18 months, 

mean: 

G2: 73.7 

P = NR 

Urgency/ 

frequency QoL 

index, 3 months, 

mean: 

G2: 73 

P = NR 

Urgency/ 

frequency QoL 

index, 6 months, 

mean:

G2: 66 

P = NS 

Urgency/ 

frequency QoL 

index, 12 months, 

mean::

G2: 69.5 

P = NS 

Not requiring 

catheterization 

(but baseline 

catheterization), 

3 months, %: 

G2: 67 

P < 0.001 

C-395 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Spinelli et al., 

2001 

(continued) 

Not requiring 

catheterization 

(but baseline 

catheterization), 

6 months, %: 

G2: 67 

P < 0.001 

Not requiring 

catheterization 

(but baseline 

catheterization), 

9 months, %: 

G2: 50 

P < 0.001 

Not requiring 

catheterization 

(but baseline 

catheterization), 

12 months, %: 

G2: 50 

P < 0.003 

Any adverse 

events, %: 

G1: NR

G2: 15.5

Pain at implant 

site or extension 

cable connector, 

%: 

G2: 3.9

Hematoma/wound 

problem, %: 

G2: 1.9 

Surgical revision 

necessary, %: 

G2: 9.7 

Lead fracture, %: 

G2: 3.9 

Explant of 

stimulation 

system, %: 

G2: 3.9 

Lead 

repositioning, %: 

G2: 1.9 

Lead 

displacement, %: 

G1: 6.5 

 

C-396 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Spinelli et al., 

2001

(continued)

New lead required 

due to initial bad 

position, %: 

G1: 3.2 

Explantation of 

pulse generator 

due to infection, 

%: G1: 1 

Lead breakage, %: 

G1: 1 System 

removed due to 

treatment failure, 

%: 

G1: 3.2 

C-397 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author:

Sutherland et al. 

2007 

Country and 

setting: 

US continence 

and female 

urology clinic 

Enrollment 

period:

December 1993 

to December 

2004 

Funding:

funded in part by 

Medtronic, Inc. 

Author conflict 

of interest: 

3 authors 

received fees for 

educational 

speaking on 

OAB and 

incontinence 

from Pfizer, 

Indevus, 

Astellas, and 

Medtronic, and 

consulting fees 

from Medtronic 

Design: 

retrospective 

case series 

Intervention: 

implantable pulse 

generator for 

sacral nerve 

stimulation 

(device made by 

Medtronic)

N at enrollment: 

234 patients 

underwent the 

procedure 

N at follow-up: 

104 patients were 

consented 

Age, mean yrs ± 

SD: 

50 + 13.4 

Women, N: 

91 

Race/ethnicity: 

NR 

Gender: 

Mean follow-up

22 months (range 

3-162 months) 

Inclusion criteria: 

• Undergoing 

SNS 

Exclusion criteria:

NR 

Voids per 24 hrs, 

mean ± SD: 

12.4 ±5.1 

Nocturnal voids 

per 24 hrs, mean 

± SD: 

2.3 ±1.8 

Leaks per 24 

hrs, mean ± SD: 

5.0 ±4.7 

Pads used per 

24 hrs, mean ± 

SD: 

2.3 ±2.6 

Duration of 

symptoms, 

mean mos 

(range): 

116-130 (9-600) 

Urge 

incontinence: 

96% experienced 

reduction in pad 

use after SNS 

therapy; 50% 

completely dry; 

46% used fewer 

pads, and 4% had 

no change 

Voids per 24 hrs, 

mean ± SD: 

8.5 ±5.0 voids/24 hr 

P < 0.0001 

Nocturnal voids 

per 24 hrs, mean ± 

SD: 

1.6 ±2.2 

P = 0.0091

Leaks per 24 hrs, 

mean ± SD: 

1.0 ±1.4 leaks/24 hr 

P < 0.0001 

Pads used per 24 

hrs, mean ± SD: 

0.3 ±0.7 pads/24 hr 

P < 0.0001 

Subjective 

improvement: 

>50%: 69% 

>80%: 50% 

>90%: 35% 

Satisfaction: 

- satisfied: 60.5% 

- equivocal: 23.3% 

- dissatisfied: 

16.1% 

Adverse events:

- infection: 13 

events (4 severe 

requiring 

hospitalization for iv 

antibiotics) 

- hematoma: 2 

events 

- discomfort at 

component: 28 

events 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Method and 

blinding: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: NA 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: +

C-398 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

C-399 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Sutherland et 

al., 2007 

(continued) 

battery depletion: 5 

events 

- bowel complaints: 

4 events 

- pelvic pain: 1 

event 

- high impedance: 2 

events 

- malposition of 

component: 1 event 

- seizures: 2 events 

- herpes flare: 3 

events 

C-400 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

van Kerrebroeck 

et al., 2007 

Country and 

setting: 

US, Canada, 

and Europe, 17 

centers 

Enrollment 

period: 

NR 

Funding:

Medtronic Inc. 

Author conflict 

of interest: 

authors have 

financial interest 

and/or other 

relationship with 

Medtronic and 

other pharma 

and device 

companies 

(AMS, Astellas, 

Pfizer, 

Advanced 

Bionics, 

Uroplasty, 

Uromedica, J&J, 

Novartis, UCB, 

Bayer, 

Boehringer, 

Allergan, BioXell 

SpA, Alza, 

Solvay Pharma, 

Lilly Icos, 

SanofiSynthelabo, 

Janssen-Ortho, 

Purde Pharma, 

Negma Lerad, 

Laserscope, 

QLT, Lumenis, 

Schwarz, Glaxo, 

Eli Lilly, Boston 

Scientific) 

Design: 

Prospective case 

series 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

N at enrollment: 

163; 152 with 

implants 

N at follow-up, 

1 year 

79 

Age mean ± SD:

44.7 ± 11.2 

Women, n (%): 

141 (87) 

Race/ethnicity:

NR

Inclusion criteria: 

• patients 

receiving 

Interstim for 

management of 

voiding 

dysfunction 

Exclusion criteria: 

NR 

UUI: 

-average number 

of leaking 

episodes per day: 

9.6 ±6.0 

- number of heavy 

leaks per day: 

2.6± 3.3 

- number of pads 

per day: >5 

Frequency: 

- average number 

of voids per day 

19.3±7.0 

- average voided 

volume (mL): 

92.3±52.8 

-degree of 

urgency/day: 

2.3±0.6 

Urinary 

frequency: 28 

UUI: 87 

Urinary retention: 

31 *

UUI: 

-average number of 

leaking episodes 

per day: 4.7 ±4.9 at 

one year follow-up; 

maintained 

throughout followup with mean 3.9± 

4.0 at 5 years 

- number of heavy 

leaks per day: 1.2± 

2.7 at one year 

follow-up and 0.8± 

1.7 at 5 year followup 

- number of pads 

per day: 1.8 at 5 

years follow-up 

Frequency: 

- average number 

of voids per day 

13.0±7.9 at year 1 

and 14.8± 7.6 at 

year 5 

- average voided 

volume (mL): 

169.9±118.2 at 

year 1 and 165.2± 

147.7 at year 5 

-degree of 

urgency/day: 

1.9±0.8 at year 1, 

2.1±0.7 at year 5 

Adverse events: 

-110 events 

required surgery in 

60 patients 

- system explanted 

from 16 due to AE 

or lack of efficacy 

- 31 AEs were 

device related and 

240 were therapy 

related 

- new pain or 

undesirable change 

in stimulation: 43 

patients, 60 events 

Pain at PNE or 

implant site, INS: 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: ++

Drop-out rates: + 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-401 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

30 patients, 40 

events 

C-402 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

van Kerrebroeck 

et al., 2007 

(continued) 

-infection at PNE or 

implant site: 12 

patients, 14 events 

- pain at PNE or 

implant site, lead: 

12 patients, 13 

events 

- sensation of 

electric shock: 12 

patients, 14 events 

- undesirable 

change in voiding 

function 11 

patients, 12 events 

- lead migration: 13 

patients, 14 events 

- technical 

problems during 

PNE/implant: 8 

patients, 8 events 

- device problem: 

16 patients, 19 

events 

- Other: 51 patients, 

77 events 

-surgical 

intervention 

required for 

adverse events in 

60 patients (110 

events), including 

device exchange in 

36 patients, 

positioning of pulse 

generator in 12, 

reposition of lead 

and generator in 

10, reposition lead 

in 10, permanent 

explant in 9, 

temporary explant 

in 2, other 

intervention in 2, 

bilateral implant in 

1, and surgical 

wound care in 1 

C-403 
Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

van Voskuilen et 

al., 2006

Country and 

setting: 

Netherlands, 

academic 

medical center 

Enrollment 

period: 

1990 to 2003 

Funding: 

WAMU 

Foundation 

Author industry 

relationship 

disclosures: 

NR

Design: 

retrospective 

case series 

Intervention: 

sacral nerve 

stimulation with 

Itrel-I device 

(1990 – 1994), 

Itrel-II device 

(1994 – 1999), or 

Interstim device 

(1999-2003) 

Groups: 

NA 

N at enrollment: 

190 

N at follow-up: 

149 

Women, n (%): 

122 (81.9) 

Age, mean yrs ± 

SD: 

46.7 (10.0)

Race/ethnicity: 

NR

Follow-up, mean 

mos ± SD: 

64.2 (38.5) 

Inclusion criteria: 

• Receiving a 

neuromodulation 

system or 

revision surgery 

for urge 

incontinence or 

urgencyfrequency (with or 

without pelvic 

pain complaints), 

or nonobstructive 

urinary retention 

Exclusion criteria: 

• Percutaneous 

tined lead 

procedure 

• Receiving 

bilateral 

stimulation 

Overactive 

bladder, n (%): 

107 (71.8) 

Urinary 

retention, n (%): 

42 (28.2%) 

Idiopathic 

urgency/frequen

cy or retention, 

n (%): 

129 (86.6%) 

Neurologic 

urgency/frequen

cy or retention: 

42 (28.2%) 

Good result, n 

(%): 

89 (59.7) 

Insufficient 

results, n (%): 

44 (29.5) 

Reprogramming 

session at last 

visit, n (%): 

16 (10.7%) 

Good result after 

reprogramming, n 

(%): 

11 (68.8) 

Insufficient 

results after 

reprogramming, n 

(%): 

5 (31.3) 

Adverse events, 

n: 

194 in 106 patients 

Pain/undesirable 

change in 

stimulation, n: 

64 

Undesirable 

change in voiding 

function/loss of 

efficacy, n : 

42 

Pain at IPG 

implant site, n: 

41 

Adverse change 

in bowel function, 

n: 

15 

Suspected lead 

migration, n : 

10 

Suspected device 

problem 

(including lead 

breakage), n: 

6 

Infection, n: 

6 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

- 

Loss to followup: - 

Drop-out rates: NR 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-404 
C-405 

Evidence Table 3. KQ2 Procedural and surgical treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

van Voskuilen et 

al. 2006

(continued) 

Technical 

problem, n: 

5 

Suspected 

neuropraxia, n : 

2 

Other, n: 

3 

Requiring at least 

one reoperation 

due to AE, %: 

48.3 

Life span of 

replaced IPGs, 

mean mos 

(range): 

73.7 (28-127) 

IPG removed, n 

(%): 

21 (14.1) 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Arruda et al., 

2008 

Country and 

setting: 

Brazil, 

community 

Enrollment 

period: 

August 2001 to 

September 

2005 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

None 

Design: 

RCT 

Intervention: 

Oxybutynin vs. 

functional 

electrostimulation 

vs. pelvic floor 

training

Groups: 

G1: Oxybutynin 5 

mg b.i.d. 

G2: Ambulatory 

stimulation applied 

vaginally 

G3: Pelvic floor 

exercises with a 

therapist and at 

home 

N Screened: 

81 

N at enrollment: 

G1: 22 

G2: 21 

G3: 21 

N at follow-up: 

G1: 22 

G2: 21 

G3: 21 

Age, range: 

35-80 

Race/ethnicity: 

NR 

Women, %: 

100 

Length of follow 

up: 12 weeks 

Inclusion criteria: 

• Communitydwelling 

• Dx of OAB and 

DO 

• Capable of 

completing a 

bladder diary and 

performing a 

pelvic muscle 

floor contraction 

• For those with 

MUI, urge was 

predominant 

Exclusion 

criteria: 

• Hx of psychiatric 

or neurologic 

illness 

• Persistent UTI 

• Inability to 

comply with 

regular follow-up 

visits 

• Current 

pregnancy 

• Postvoid residual 

volume > 100 mL

• Contraindications 

to anticholinergic 

therapy 

• Cardiac 

pacemaker 

• Type III SUI 

• Uncontrolled 

metabolic 

conditions or 

indwelling 

catheterization 

• Using 

medications 

including 

anticholinergic 

drugs, calcium 

antagonists, beta 

agonists, 

dopamine 

agonists, striated 

muscle relaxants 

or estrogens 

• Any uterine 

prolapse 

UUI episodes/ 

week, mean ± SD:

G1: 13.8 ± 11.6 

G2: 13.5 ± 15.6 

G3: 16.4 ± 17.2 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 1.7 ± 1.5 

G2: 1.9 ± 1.9 

G3: 1.4 ± 1.2 

Pads/day, mean ± 

SD: 

G1: 2.6 ± 2.7 

G2: 2.3 ± 2.4 

G3: 2.7 ± 1.5 

Voids/day, mean 

± SD: 

G1: 7.7 ± 2.6 

G2: 8.6 ± 3.4 

G3: 6.8 ± 2.2 

Residual volume 

mean mL ± SD: 

G1: 3.2 ± 6.3 

G2: 1.0 ± 2.6 

G3: 1.8 ± 3.3 

Volume, first 

desire to void, 

mean mL ± SD: 

G1: 117.7 ± 68.9 

G2: 102.4 ± 51.1 

G3: 86.7 ± 38.9 

Maximal 

cystometric 

capacity, mean 

mL ± SD: 

G1: 410.4 ± 194.1 

G2: 350.0 ± 212.9 

G3: 424.0 ± 149.0 

Involuntary 

detrusor 

contraction 

volume mean mL 

± SD: 

G1: 189.5 ± 114.1 

G2: 220.0 ± 127.2 

G3: 239.3 ± 163.0 

UUI episodes/ 

week, mean ± SD: 

G1: 7.0 ± 10.6 

G2: 7.9 ± 13.7 

G3: 7.8 ± 15.3

G1/BL: P = 0.007 

G2/BL: P = 0.039 

G3/BL: P = 0.035 

Urgency 

resolved, n (%): 

G1: 14 (63.6) 

G2: 11 (52.4) 

G3: 12 (57.1) 

P = 0.754 

Satisfied, n (%):

G1: 17 (77.3) 

G2: 11 (52.4) 

G3: 16 (76.2) 

P = 0.142 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 0.9 ± 0.8 

G2: 1.2 ± 1.3 

G3: 1.0 ± 1.1

G1/BL: P = 0.003 

G2/BL: P = 0.036 

G3/BL: P = 0.086 

Pads/day, mean ± 

SD: 

G1: 0.9 ± 1.5 

G2: 0.9 ± 1.7 

G3: 0.8 ± 1.3

G1/BL: P < 0.001 

G2/BL: P = 0.004 

G3/BL: P < 0.001 

Voids/day, mean 

± SD: 

G1: 6.4 ± 1.6 

G2: 7.9 ± 2.3 

G3: 7.1 ± 2.1

G1/BL: P = 0.014 

G2/BL: P = 0.291 

G3/BL: P = 0.441 

Residual volume, 

mean mL ± SD: 

G1: 4.7 ± 9.4 

G2: 1.1 ± 2.5 

G3: 2.1 ± 3.5

G1/BL: P = 0.425 

G2/BL: P = 0.760 

G3/BL: P = 0.297 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

+ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-396 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 

2008 

(continued) 

Involuntary 

detrusor 

contraction 

maximal pressure 

(mm H20 ± SD): 

G1: 39.4 ± 26.1 

G2: 43.7 ± 22.9 

G3: 34.2 ± 19.8 

Volume first 

desire to void, 

mean mL ± SD: 

G1: 157.3 ± 63.8 

G2: 123.8 ± 59.0 

G3: 137.6 ± 76.7

G1/BL: P = 0.019 

G2/BL: P = 0.091 

G3/BL: P = 0.017 

Maximal 

cystometric 

capacity mean 

mL ± SD: 

G1: 517.3 ± 191.7 

G2: 436.6 ± 178.7 

G3: 489.0 ± 141.3

G1/BL: P = 0.001 

G2/BL: P = 0.017 

G3/BL: P = 0.113 

Involuntary 

detrusor 

contraction 

volume (mL): 

G1: 188.6 ± 183.2 

G2: 73.3 ± 112.4 

G3: 114.3 ± 154.2

G1/BL: P = 0.986 

G2/BL: P = 0.001 

G3/BL: P = 0.044 

Involuntary 

detrusor 

contraction 

maximal 

pressure, mm H20 

± SD: 

G1: 19.6 ± 20.9 

G2: 22.4 ± 30.1 

G3: 17.2 ± 25.5

G1/BL: P < 0.001 

G2/BL: P = 0.002 

G3/BL: P = 0.027 

Normal 

urodynamic 

evaluation, n (%):

G1: 8 (36.4) 

G2: 12 (57.1) 

G3: 11 (52.4) 

P = 0.358 

Persistent 

improvement at 1 

year: 

G1: 10/17 

G2: 4/11 

G3: 9/16 

C-397 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 

2008 

(continued)

Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty voiding, 

n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0

Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty voiding, 

n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

C-398 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Bryant et al., 

2002 

Country and 

setting: 

Australia, 

Specialty 

treatment 

centers 

Enrollment 

period: 

NR 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

RCT 

Intervention: 

Bladder training 

plus an 

educational 

intervention to 

reduce caffeine 

intake to less than 

100mg per day vs. 

bladder training 

alone 

Groups: 

G1: BT + caffeine 

reduction 

G2: BT 

N at enrollment: 

G1: 48 

G2: 47 

N at follow-up: 

G1: 36 

G2: 39 

Age, yrs ± SD: 

G1: 56 ± 18 

G2: 58 ± 16 

Women, %: 

G1: 94 

G2: 87 

Weight in kg, 

mean ± SD: 

G1: 69 ± 17

G2: 68 ± 20

Race/ethnicity: 

NR 

Parity 

NR 

Inclusion criteria: 

• Adult 

• Symptoms of 

urinary urgency, 

frequency and/or 

urge 

incontinence 

• Routinely 

ingested ≥

100mg 

caffeine/24 hrs 

Exclusion 

criteria: 

• Significant 

cognitive 

impairment 

• Pregnant 

• Symptoms of 

UTI 

Voids/24 hrs, 

mean ± SD: 

G1: 11.4 ± 4.0 

G2: 11.2 ± 3.5 

Urgency 

episodes/24 hrs, 

mean ± SD: 

G1: 4.8 ± 3.5 

G2: 4.6 ± 3.0 

Leakages/24 hrs, 

mean ± SD: 

G1: 2.8 ± 3.2 

G2: 3.1 ± 3.9 

Volume/void (mL) 

mean ± SD: 

G1: 178 ± 78 

G2: 177 ± 101 

Caffeine 

intake/day (mg) 

mean ± SD: 

G1: 238.7 ± 121 

G2: 272 ± 184 

Duration of 

urinary 

symptoms (yrs), 

mean ± SD: 

G1: 13.7 ± 14.9 

G2: 10.7 ± 15.5 

Leakages/24 hrs, 

mean ± SD: 

G1: 1.2 ± 1.9 

G2: 1.4 ± 1.7 

Mean reduction in 

leakages/24 hrs, 

%: 

G1: 55 

G2: 26 

P = 0.219 

Voids/24 hrs, 

mean ± SD: 

G1: 6.8 ± 2.0 

G2: 7.9 ± 2.6 

Urgency 

episodes per 24 

h, mean ± SD: 

G1: 1.6 ± 1.9 

G2: 3.2 ± 2.8 

Mean reduction in 

voids/24 hrs,%: 

G1: 35 

G2: 23 

P = 0.037 

Mean reduction in 

urgency 

episodes/24 hrs, 

%: 

G1: 61 

G2: 12 

P = 0.002 

Quality: 

Overall quality 

score: 

poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-399 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 

1998 

Country and 

setting: 

US, academic 

health center 

outpatient 

geriatric 

medicine clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National 

Institutes on 

Aging 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted behavioral 

vs. drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback added 

to behavioral 

training in absence 

of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2: Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

G1: 65 

G2: 67 

G3: 65 

N at follow-up: 

G1: 61 

G2: 55 

G3: 53 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline bladder 

diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL 

• Uterine prolapse 

past the 

entroitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive heart 

failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Duration of 

symptoms, mean 

yrs ± SD: 

G1: 9.4 ± 10.8 

G2: 9.8 ± 11.9 

G3: 12.7 ± 15.9 

Restricted 

activity, (%): 

G1: 30.8 

G2: 32.8 

G3: 38.5 

Urge UUI only, %:

G1: 49.2 

G2: 49.3 

G3: 47.7 

Accidents per 

week, mean ± SD:

G1: 15.8 ± 14.5 

G2: 15.9 ± 14.1 

G3: 15.4 ± 13.4 

P = .98 

Severity 

classification, %: 

Mild (<5 

accidents/wk)

G1: 18.5 

G2: 17.9 

G3: 18.5 

Moderate (5-10 

accidents/wk)

G1: 29.2 

G2: 29.9 

G3: 27.7 

Severe (>10 

accidents/wk) 

G1: 52.3 

G2: 52.2 

G3: 53.8 

Previous 

treatment with 

surgery, %: 

G1: 20.0 

G2: 26.9 

G3: 29.2 

Accidents per 

week, mean ± SD: 

G1: 2.8 ± 4.7 

G2: 5.7 ± 9.8 

G3: 8.2 ± 11.6 

P = 0.005 

Percent 

reduction, mean ± 

SD: 

G1: 80.7 ± 24.8 

G2: 68.5 ± 37.2 

G3: 39.4 ± 80.0 

P < 0.001 

Percent 

reduction, range: 

G1: -0.9 – 100 

G2: -85.7 – 100 

G3: -400.0 - 100 

Patient 

perceptions of 

progress in 

treatment

Much better 

G1: 74.1 

G2: 50.9 

G3: 226.9 

Better 

G1: 25.9 

G2: 30.9 

G3: 38.5 

About the same 

G1: 0.0 

G2: 16.4 

G3: 28.8 

Worse 

G1: 0.0 

G2: 1.8 

G3: 5.8 

Estimate of % 

improvement, 

mean ± SD: 

G1: 81.6 ± 18.6 

G2: 66.4 ± 35.4 

G3: 45.1 ± 36.6 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-400 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

1998 

(continued)

Women, %: 

100 

Age, yrs ± SD: 

G1: 67.3 ± 7.6 

G2: 68.2 ± 7.5 

G3: 67.6 ± 7.6 

Race/ethnicity: 

NR

Parity mean ± SD: 

G1: 2.8 ± 2.0 

G2: 2.1 ± 1.4 

G3: 2.7 ± 1.8 

P < 0.05 

Previous 

treatment with 

medication, %: 

G1: 27.7 

G2: 35.8 

G3: 30.8 

Using estrogen, 

%: 

G1: 32.3 

G2: 38.8 

G3: 35.4 

Using diuretics, 

%: 

G1: 20.0 

G2: 14.9 

G3: 12.3 

Having fewer 

accidents, %: 

G1: 100.0 

G2: 87.3 

G3: 67.3 

Accidents are 

smaller, %: 

G1: 87.3 

G2: 78.8 

G3: 54.0 

Able to wear less 

protection, %: 

G1: 76.0 

G2: 56.0 

G3: 334.1 

Comfortable 

enough with 

treatment to 

continue 

indefinitely, %: 

G1: 96.5 

G2: 54.7 

G3: 43.1 

Patient 

satisfaction with 

progress, %: 

Completely 

satisfied 

G1: 77.6 

G2: 54.7 

G3: 43.1 

Somewhat 

satisfied 

G1: 22.4 

G2: 40.0 

G3: 34.0 

Not at all satisfied 

G1: 0.0 

G2: 10.9 

G3: 38.0 

Wish to receive 

another form of 

treatment, %: 

G1: 14.0 

G2: 75.5 

G3: 75.5 

P < 0.001 for all 

comparisons 

C-401 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

1998 

(continued)

Adverse effects, 

%, p compared to 

placebo G3: 

Dry mouth, %: 

G1: 34.9 

G2: 96.9 

G3: 54.8 

P < 0.001 

Inability to void, 

%: 

G1: 6.3 

G2: 21.5 

G3: 3.2 

P = 0.002 

Constipation, %: 

G1: 22.2 

G2: 38.5 

G3: 37.1 

P = 0.10 

Blurred vision, %: 

G1: 9.5 

G2: 15.4 

G3: 9.7 

P = 0.50 

Confusion, %: 

G1: 6.3 

G2: 7.7 

G3: 11.3 

P = 0.59 

C-402 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al.. 

2000 

[See Burgio et 

al., 1998] 

Enrollment 

period: 

Two weeks 

after completion 

of Burgio et al. 

1998 

Funding: 

National 

Institute on 

Aging, grants 

AG 08010 and 

K04 00431 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Modified crossover 

of RCT 

Intervention: 

Participants whose 

treatment was not 

completely 

successful were 

given the 

opportunity to 

switch or use 

combined 

treatment; further 

reductions in 

incontinence were 

measured.

Groups: 

Treatment 

Changes:

G1: Previous 

oxybutynin to 

behavioral 

modification alone 

G2: Previous 

behavior alone to 

2.5 mg oxybutynin 

t.i.d. + behavioral 

therapy 

G3: Previous 

oxybutynin alone 

to 2.5 mg 

oxybutynin t.i.d. + 

behavioral therapy 

G4: Placebo to 

behavioral 

G5: Placebo to 

oxybutynin 

N at enrollment 

G1: 19 

G2: 8 

G3: 27 

G4: 34 

G5: 10 

N at follow-up: 

G1: 18 

G2: 8 

G3: 26 

G4: NR 

G5: NR 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline bladder 

diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

• Not completely 

dry or satisfied 

with previous, 8-

wk treatment 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL 

• Uterine prolapse 

past the introitus

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive heart 

failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

% Reduction of 

incontinence 

after previous 

study (at 

baseline), mean: 

G1: 59.1 

G2: 57.5 

G3: 72.7 

G4: 22.9 

G5: 44.8 

Final % 

Reduction of 

incontinence 

mean, p: 

G1: 77.1, 0.109 

G2: 88.5, 0.034 

G3: 84.3, 0.001 

G4: 63.9, .002 

G5: 76.5, .012 

Note: 29.2 of G3 

declined to 

continue with drug 

therapy once they 

received 

behavioral 

modification. 

Numbers were too 

low to compare 

across groups. 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-403 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 

2001 

[See Burgio et 

al,. 1998] 

Country and 

setting: 

US, University 

based 

Enrollment 

period: 

[See Burgio et 

al., 1998] 

Funding: 

NIH 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Psychological 

distress associated 

with pharmacologic 

treatment vs. 

behavioral vs. 

placebo 

Groups: 

G1: Behavioral 

training with 

biofeedback, 4 

visits 

G2: Oxybutynin 

2.5 mg po t.i.d., up 

to a max of 5 mg 

t.i.d. 

G3: Placebo 

N at enrollment: 

197 women 

N treated: 

169 

N at follow-up: 

155 (completed 

both pre and posttreatment 

psychological 

assessment) 

Age yrs, mean ± 

SD: 

67.5 ± 7.2 

Women, %: 

100 

Race/ethnicity, %: 

White: 97 

African American: 

3 

Inclusion criteria:

• ≥ 55 yrs old 

• ambulatory 

• UUI ≥2x/wk (2 

wk bladder 

diary), 

persisting x 3 

mos 

• Predominant 

UUI 

• Urodynamic 

evidence of 

bladder 

dysfunction (DI 

or maximal 

capacity ≤350 

mL) 

Exclusion 

criteria: 

• contraindication 

to oxybutynin or 

behavioral 

treatment 

• Continual 

leakage 

• Post void 

residual > 200 

mL 

• Uterine 

prolapse 

beyond the 

introitus 

• Decompensate

d CHF 

• Hx of malignant 

arrhythmias 

• Impaired mental 

status (MMSE 

<20)

SCL-90-R scores 

mean (SD): 

Somatization 

G1: 56.0 (10.6) 

G2: 51.4 (10.8) 

G3: 52.4 (11.1) 

ObsessiveCompulsive: 

G1: 56.5 (10.7) 

G2: 56.6 (11.4) 

G3: 57.7 (10.0) 

Interpersonal 

Sensitivity 

G1: 53.8 (11.0) 

G2: 51.4 (11.9) 

G3: 50.4 (12.0) 

Depression 

G1: 54.7 (10.0) 

G2: 52.5 (9.7) 

G3: 51.0 (11.9) 

Anxiety 

G1: 48.7 (13.9) 

G2: 46.8 (12.0) 

G3: 47.2 (12.8) 

Hostility 

G1: 49.3 (10.7) 

G2: 45.9 (10.1) 

G3: 48.3 (10.4) 

Phobia 

G1: 47.5 (10.2) 

G2: 46.7 (10.3) 

G3: 45.7 (8.5) 

Paranoid Ideation 

G1: 48.6 (12.4) 

G2: 49.3 (11.1) 

G3: 46.1 (12.8) 

Psychoticism 

G1: 54.1 (10.7) 

G2: 52.1 (10.3) 

G3: 50.5 (11.2) 

Global Severity 

G1: 54.2 (11.1) 

G2: 52.5 (10.3) 

G3: 52.4 (11.2) 

 

Reduced 

incontinence 

episodes: 

G1: 83.3% 

G2: 74.4% 

G3: 41.4% 

P < 0.001 

SCL-90-R scores 

(SD): 

Somatization 

G1: 51.8 (11.4) 

G2: 51.2 (9.8) 

G3: 49.8 (13.0) 

ObsessiveCompulsive: 

G1: 53.8 (13.9) 

G2: 53.9 (10.9) 

G3: 55.4 (11.0) 

Interpersonal 

sensitivity 

G1: 49.5 (12.0) 

G2: 48.9 (11.2) 

G3: 49.2 (11.3) 

Depression 

G1:51.5 (11.5) 

G2: 50.6 (10.7) 

G3: 51.4 (11.2) 

Anxiety 

G1: 46.1 (14.6) 

G2: 44.5 (12.3) 

G3: 45.8 (12.9) 

Hostility 

G1: 44.9 (10.8) 

G2: 44.6 (10.5) 

G3: 47.3 (11.2) 

Phobia 

G1: 47.1 (11.2) 

G2: 45.0 (8.3) 

G3: 45.1 (8.5) 

Paranoid ideation 

G1: 45.8 (10.9) 

G2: 47.2 (11.6) 

G3: 47.2 (12.0) 

Psychoticism 

G1: 49.2 (11.7) 

G2: 50.4 (9.7) 

G3: 49.6 (10.3) 

Global Severity 

G1: 50.8 (12.8) 

G2: 50.4 (10.0) 

G3: 51.4 (10.9) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: 

+ 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-404 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

2001 

(continued) 

155 participants 

were compared to 

the 42 who did not 

complete 

intervention and 

psychological 

assessment, 

higher scores 

(greater distress) 

on 6 of 10 SCL-90-

R scales 

(somatization, 

obsessive/compuls

ive, depression, 

hostility, paranoid 

ideation, global 

severity index), all 

p values <0.05 

Normal range, 

score 0-63 

>75% in normal 

range (including 

dropouts) on 9 of 

10 scales 

Highest 

impairment rate: 

33% scored 

abnormal for 

obsessivecompulsive

Correlations 

between 

reduction of 

incontinence and 

changes in 

psychological 

symptoms: 

Somatization 

G1: 0.28* 

G2: -0.09 

G3: 0.17 

ObsessiveCompulsive 

G1: 0.01 

G2: -0.14 

G3: 0.02 

Interpersonal 

Sensitivity 

G1: -0.09 

G2: 0.04 

G3: 0.13 

Depression 

G1: -0.04 

G2: 0.03 

G3: 0.07 

Anxiety 

G1: -0.10 

G2: -0.01 

G3: 0.34* 

Hostility 

G1: -0.10 

G2: 0.09 

G3: 0.11 

Phobic anxiety 

G1: -0.21 

G2: -0.17 

G3: 0.02 

Paranoid Ideation 

G1: 0.14 

G2: -0.04 

G3: -0.06 

Psychoticism 

G1: -0.01 

G2: -0.01 

G3: 0.13 

C-405 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

2001 

(continued) 

Global Severity 

Index 

G1: 0.01 

G2: 0.06 

G3: 0.45*** 

*P < 0.05 

***P = 0.001 

C-406 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 

2002 

Country and 

setting: 

US, Academic 

medical center 

Enrollment 

period: 

April 1995 to 

March 2001 

Funding: 

NIH 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention:

Behavioral training 

with or without 

biofeedback for 8 

wks compared to 

self-training, 

followed by 2 wks 

of post-treatment 

bladder diaries and 

a patient 

satisfaction 

questionnaire 

Groups: 

G1: Behavioral 

training with 

biofeedback 

G2: Behavioral 

training with verbal 

feedback 

G3: Selfadministered 

behavioral training 

N at enrollment: 

Evaluated: 474 

Excluded: 252 

Randomized: 222 

G1: 73 

G2: 74 

G3: 75 

N at follow-up: 

G1: 62 

G2: 65 

G3: 68 

Women, %: 

100 

Age, mean ± SD: 

G1: 64.8 ± 7.1 

G2: 65.8 ± 7.6 

G3: 65.8 ± 8.5 

Race/ethnicity, n 

(%): 

Black: 

G1: 11 (15.1) 

G2: 13 (17.6) 

G3: 11 (14.7) 

Inclusion 

criteria:* 

Women 

Age ≥ 55 

Communitydwelling 

Ambulatory 

Predominant urge 

incontinence ≥

2x/wk for at least 3 

mos 

Urodynamic 

evidence of 

bladder 

dysfunction

Exclusion 

criteria: 

• Continual 

leakage 

• PVR ≥ 150mL 

• Severe uterine 

prolapse past 

uterine introitus 

• Decompensated 

congestive heart 

failure 

• MMSE score 

<24 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 15.1 ± 13.5 

G2: 17.3 ± 16.3 

G3: 15.4 ± 14.2 

P = 0.62 

< 5 incontinence 

episodes/wk, n 

(%): 

G1: 14 (19.2) 

G2: 14 (18.9) 

G3: 16 (21.3) 

5-10 incontinence 

episodes/wk, n 

(%): 

G1: 20 (27.4) 

G2: 21 (28.4) 

G3: 21 (28.0) 

> 10 incontinence 

episodes/wk, n 

(%): 

G1: 39 (53.4) 

G2: 39 (52.7) 

G3: 38 (50.7) 

P > 0.99 

UUI, n (%): 

G1: 50 (68.5) 

G2: 50 (67.6) 

G3: 50 (66.7)

MUI, n (%): 

G1: 23 (31.5) 

G2: 24 (32.4) 

G3: 25 (33.3) 

P = 0.97 

Duration of 

symptoms (yrs), 

mean ± SD: 

G1: 7.1 ± 7.8 

G2: 6.6 ± 7.7 

G3: 6.6 ± 8.7 

Previous 

treatment with 

medication, n 

(%): 

G1: 16 (21.9) 

G2: 18 (24.3) 

G3: 21 (28.0) 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 6.1 ± 10.3 

G2: 6.0 ± 10.7 

G3: 6.7 ± 11.4 

P = 0.78 

Incontinence 

episodes/week, % 

change, mean ± 

SD: 

G1: -63.1 ± 42.7 

G2: -69.4 ± 32.7 

G3: -58.6 ± 38.8 

P = 0.23 

Incontinence 

episodes/week, % 

change, median 

(IQR): 

G1: -75.0 (-100, 

120.0) 

G2: -82.8 (-100, 0) 

G3: -70.4 (-100, 

29.4) 

Fewer 

incontinence 

episodes, n (%): 

G1: 51 (96.2) 

G2: 57 (100) 

G3: 58 (92.1) 

P = 0.09 

Smaller 

accidents, n (%): 

G1: 42 (79.2) 

G2: 49 (89.1) 

G3: 42 (67.7) 

G2/G3: P = 0.006 

G1/G2/G3: P = 

0.02 

Able to wear less 

protection, n (%): 

G1: 33 (71.7) 

G2: 40 (83.3) 

G3: 34 (70.8) 

P = .29 

Much better 

progress, n (%): 

G1: 33 (62.3) 

G2: 36 (63.2) 

G3: 20 (30.8) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-407 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

2002 

(continued) 

Parity, mean ± 

SD: 

G1: 2.5 ± 1.7 

G2: 3.0 ± 2.0 

G3: 2.7 ± 2.0 

Using estrogen, n 

(%): 

G1: 52 (72.2) 

G2: 51 (68.9) 

G3: 44 (59.5)

Previous 

treatment with 

surgery, n (%): 

G1: 16 (21.9) 

G2: 13 (17.6) 

G3: 12 (16.0) 

Bladder capacity 

(mL), mean ± SD: 

G1: 282 ± 117 

G2: 238 ± 100 

G3: 266 ± 105 

P = 0.04 

Better progress, 

n (%): 

G1: 18 (34.0) 

G2: 20 (35.1) 

G3: 36 (55.4) 

No Progress, n 

(%): 

G1: 2 (3.8) 

G2: 1 (1.8) 

G3: 8 (12.3) 

Worse, n (%): 

G1: 0 

G2: 0 

G3: 1 (1.5) 

G2/G3: P < 0.001 

G1/G3: P < 0.001

G1/G2/G3: P < 

0.001 

Comfortable 

enough to 

continue 

treatment 

indefinitely, n 

(%): 

G1: 49 (98.0) 

G2: 54 (100) 

G3: 54 (88.5) 

G2/G3: P = 0.01 

G1/G2/G3: P = 

0.009 

Completely 

satisfied with 

progress, n (%): 

G1: 39 (75.0) 

G2: 47 (85.5) 

G3: 34 (55.7) 

Somewhat 

satisfied with 

progress, n (%): 

G1: 12 (23.1) 

G2: 8 (14.5) 

G3: 24 (39.3) 

Not at all satisfied 

with progress, n 

(%): 

G1: 1 (1.9) 

G2: 0 

G3: 3 (4.9) 

G2/G3: P < 0.001 

G1/G3: P = 0.03

G1/G2/G3: P < 

0.001 

C-408 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 

2002 

(continued)

Incontinence 

restricts 

activities-not at 

all, n (%): 

Not at all: 

G1: 36 (69.2) 

G2: 43 (78.2) 

G3: 31 (50.8) 

Incontinence 

restricts 

activities- some 

or all, n (%): 

G1: 16 (30.8) 

G2: 12 (21.8) 

G3: 30 (49.2) 

G2/G3: P = 0.002 

G1/G3: P = 0.047

G1/G2/G3: P = 

0.007 

Not at all 

disturbed about 

incontinence, n 

(%) 

G1: 26 (49.1) 

G2: 32 (59.3) 

G3: 23 (39.0) 

Somewhat 

disturbed about 

incontinence, n 

(%): 

G1: 26 (49.1) 

G2: 22 (40.7) 

G3: 32 (54.2) 

Extremely 

disturbed about 

incontinence, n 

(%): 

G1: 1 (1.9) 

G2: 0 

G3: 4 (6.8) 

P = 0.18 

C-409 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 2008 

Country and 

setting: 

US, Academic 

medical centers 

Enrollment 

period: 

July 2004 to 

January 2006 

Funding: 

NIH 

Pfizer 

Author industry 

relationship 

disclosures: 

20 of 29 

Allergan (3) 

Alza (1) 

Astellas Pharma 

(7) 

Bionovo (1) 

Bristol-Meyers 

Squibb (1) 

Dynogen (1) 

Elan (1) 

Ethicon (2) 

GSK (4) 

Johnson & 

Johnson (3) 

Lilly (7) 

Medtronic (1) 

Merck (1) 

Novartis (6) 

Ortho-McNeil (3) 

Pfizer (>10) 

Procter & Gamble 

(3) 

Q-Med (1) 

Renessa (1) 

Sanofi (1) 

Solace (1) 

Watson (1) 

Design: 

RCT 

Intervention: 

Pharmacologic vs. 

pharmacologic 

plus behavioral 

interventions for 

10 wks (Stage 1), 

followed by no 

drug therapy 

(Stage 2) with 

assessments at 10 

wks and 8 mos* 

Groups: 

G1: Tolterodine 

tartrate (ER 

capsules), 4 mg/d 

plus behavioral 

training: pelvic 

floor muscle 

control and 

exercises, 

behavioral 

strategies to 

diminish urgency, 

suppress bladder 

contractions and 

prevent both 

stress and urge 

incontinence; 

delayed voiding; 

fluid management; 

handout with hints 

G2: Tolterodine 

tartrate (ER 

capsules), 4 mg/d 

N at enrollment: 

4043 screened 

2612 not eligible 

870 declined 

561 consented 

254 excluded 

307 randomized 

G1: 153 

G2: 154 

Inclusion criteria: 

• Women 

• Communitydwelling 

• UUI only, or 

urgepredominant 

• ≥ 7 episodes of 

incontinence in 

a 7-day bladder 

diary

• Persistent 

incontinence for 

at least 3 mos 

• No current use 

of 

antimuscarinics 

or other 

medications that 

could affect UI 

• No evidence of 

neurogenic 

etiology

Exclusion 

criteria: 

• Age < 21 

• Pregnant, 

planning a 

pregnancy in 

next 8 mos, or 

not using birth 

control 

• < 6 mos 

postpartum or 

termination after 

20 wks 

gestation 

• Unable to 

contract pelvic 

floor muscles 

during 

evaluation 

• Behavioral 

therapy of > 2 

mos in past 2 

yrs 

• Continual 

leakage or 

always damp 

• Hypersensitive 

to study drug 

• Systemic 

disease that 

affects bladder 

function 

UUI, 7-13 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 2 (1.3) 

UUI, ≥ 14 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 4 (2.6) 

MUI, 7-13 

episodes/week, n 

(%): 

G1: 46 (29.9) 

G2: 46 (30.1) 

MUI, ≥ 14 

episodes/week, n 

(%): 

G1: 104 (67.5) 

G2: 101 (66.0) 

Adjusted 

incontinence 

episodes/week, 

mean: 

G1: 23.1 

G2: 23.2 

Previous nonsurgical 

treatment for 

incontinence, n 

(%): 

G1: 19 (12) 

G2: 22 (14) 

Success, n (%): 

G1: 43 (28) 

G2: 41 (27) 

Failure, n (%): 

G1: 75 (49) 

G2: 78 (51) 

Success rate, 8 

months, lifetable 

analysis, % (95% 

CI): 

G1: 41 (32, 50) 

G2: 41 (33, 50) 

G1/G2: 0 (-12, 12) 

Success rate, 8 

months, 

complete cases, 

% (95% CI): 

G1: 36 (27, 45) 

G2: 34 (25, 43) 

G1/G2: 2 (-10, 14) 

Success rate, 8 

mos, assuming 

missings were 

failures, % (95% 

CI): 

G1: 28 (21, 35) 

G2: 27 (20, 34) 

G1/G2: 1 (-9, 11) 

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean: 

G1: 2.7

G2: 4.7

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean change: 

G1: -20.4 

G2: -18.5 

G1/G2: -1.9 (-5.9, 

2.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: - 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-410 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

N at follow-up: 

G1: 153 

Completed 

treatment: 107 

Outcome known at 

8 mos: 119 

G2: 154 

Completed 

treatment: 101 

Outcome known at 

8 mos: 118 

Age, mean ± SD: 

G1: 55.8 ± 14.2 

G2: 58.0 ± 13.5 

Women, %: 

100

Race/ethnicity, n 

(%): 

Hispanic: 

G1: 13 (9) 

G2: 17 (11) 

NH White: 

G1: 105 (69) 

G2: 85 (56) 

NH Black: 

G1: 22 (14) 

G2: 35 (23) 

Other: 

G1: 13 (9) 

G2: 15 (10) 

BMI, kg/m2

 ± SD: 

G1: 33.2 ± 9.5 

G2: 32.3 ± 7.6

• Currently using 

catheter to 

empty bladder 

• Postvoid 

residual volume 

> 150mL 

• Treatment for 

prolapse with 

pessary < 3 

mos 

• Incontinence, 

vaginal, bladder 

or prolapse 

surgery in the 

past 6 mos 

• Urethral 

diverticulum 

• Previous 

augmentation 

cystoplasty or 

artificial 

sphincter 

• Neuromodulatio

n for pelvic 

indications 

• Using 

anticholinergic 

agents, 

cholinergic 

agonists, 

tricyclic 

antidepressants

, or duloxetine 

in ≤ 4 wks 

• Using diuretics 

with dosage 

change past 3 

mos 

• Uncontrolled 

medical 

problem 

• History of 

bladder or 

pelvic cancer or 

pelvic radiation 

therapy 

• Glaucoma 

• Gastric 

retention 

• Non-ambulatory 

• Participation in 

other 

intervention trial 

that might 

influence 

outcome 

Achieved 70% 

reduction in 

incontinence 

episodes, per 

bladder diary, 

10 weeks (%): 

G1: 69

G2: 58

G1/G2: 11 (-0.3, 

22.1) 

Totally dry, per 

bladder diary, 

10 weeks (%): 

G1: 21 

G2: 17 

Voids/day, mean 

change: 

G1: 0.5 

G2: -0.4 

G1/G2: 0.9 (0.3, 

1.5) 

Symptom 

Distress Scores: 

G1/G2: P <

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 1, mean 

change: 

G1: -36.7

G2: -30.4

G1/G2: P <

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 2, mean 

change: 

G1: -30.9 

G2: -20.4 

G1/G2: P <

0.0001 

Patient 

completely 

satisfied, Stage 

1, %: 

G1: 53

G2: 40 

G1/G2: 13 (1, 25) 

C-411 
Evidence Table 2. KQ 2 Pharmacologic Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

Patient 

completely 

satisfied, 8 

months, %: 

G1: 33 

G2: 20 

G1/G2: 13 (2, 24) 

Patient better or 

much better, 

Stage 1, %: 

G1: 90 

G2: 77 

G1/G2: 13 (4, 22) 

Patient better or 

much better, 8 

months, %: 

G1: 69 

G2: 43 

G1/G2: 26 (14 , 

38) 

Persistence in 

perceived 

improvement, 8 

mos, women with 

improvement at 

Stage 1: 

G1: 72 

G2: 54 

G1/G2: 17 (4, 30) 

Harms: 

G1: 3 participants 

1: blurred vision, 

syncope, night 

sweats, stomach 

cramping and 

weakness 

2: 2 episodes of 

small-bowel 

obstruction and an 

allergic reaction 

(pruritus and rash) 

3: tachycardia 

during stage 2 

G2: 3 participants 

1: small bowel 

obstruction 

2: peripheral 

edema 

3: renal cell 

carcinoma 

diagnosis during 

stage 2 

C-412 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Colombo et al., 

1995 

Country and 

setting: 

Italy; Setting 

Enrollment 

period: 

May 1990 to 

March 1993 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin vs. 

Bladder training for 

6 weeks

Groups: 

G1: Oxybutynin, 3 

daily doses of 5 

mg each for 6 

weeks (dose 

reduced to half if 

substantial AEs) 

G2: Bladder 

training 

N at enrollment: 

G1: 42 

G2: 39 

N at 6 wk followup: 

G1: 38 

G2: 37 

N at 6 mo followup: 

G1: 28 

G2: 27 

Age, yrs ± SD: 

G1: 48 (31 – 65) 

G2: 49 (24 – 65) 

Race/ethnicity, 

mean ± SD: 

Black: 

NR 

Women, N (%): 

G1: 42 (100) 

G2: 39 (100) 

Postmenopausal 

n (%): 

G1: 16 (38) 

G2: 20 (51) 

Inclusion criteria: 

• Socially 

embarrassing 

(severe) urinary 

urge 

incontinence 

• On cystometry: 

detrusor 

instability, or 

low-compliance 

bladder (LCB), 

or sensory 

bladder 

Exclusion 

criteria: 

• Stable bladder 

at cystometry 

• Neurologic 

disease 

• Detrusor 

hyperreflexia 

• Age greater than 

65 yr 

• Coexisting 

genuine SUI 

• Genital prolapse

• Postvoid 

residual volume 

>50mL 

• Previous 

gynecologic or 

urogynecologic 

surgery 

• Prior use of any 

drug to treat UUI

• Urethral 

diverticula 

• Fistulas 

• Urinary tract 

neoplasia 

• Cystitis 

• Bladder stones 

• Previous pelvic 

radiotherapy 

Detrusor 

instability, n (%): 

G1: 14 (37) 

G2: 13 (35) 

Low compliance 

bladder, n (%): 

G1: 9 (24) 

G2: 8 (22) 

Sensory bladder, 

n (%): 

G1: 15 (39) 

G2: 16 (43) 

Daily UUI 

episodes, range 

9 – 17 

Diurnal 

frequency, n (%): 

G1: 32 (84) 

G2: 29 (78) 

Nocturia, n (%): 

G1: 11 (29) 

G2: 18 (49) 

Volume at first 

desire (mL): 

G1: 120 ± 59 

G2: 134 ± 61 

Volume at very 

strong desire 

(mL): 

G1: 317 ± 92 

G2: 332 ± 87 

Clinically cured 

overall, n (%): 

G1: 28 (74) 

G2: 27 (73) 

Cured among DI, 

(%): 

G1: 13 (93) 

G2: 8 (62) 

P = 0.07 

Cured among 

LCB: 

G1: 6 (67) 

G2: 6 (75) 

P = 0.56 

Cured among 

sensory bladder: 

G1: 9 (60) 

G2: 13 (81) 

P = 0.18 

Cured among 18 

G1 patients 

requiring dosage 

halving: 

12 (67%) 

Diurnal frequency 

resolved, n (%): 

G1: 18 (56) 

G2: 20 (69) 

Nocturia resolved 

n (%): 

G1: 3 (27) 

G2: 11 (61) 

Volume at first 

desire (mL), mean 

± SD: 

G1: 179 ± 32 

P = .0009 

G2: 178 ± 49 

P = .001 

Volume at very 

strong desire 

(mL) mean ± SD: 

G1: 408 ± 76 

P = .00001 

G2: 403 ± 69 

P = .0002 

Patients still 

cured at 6 mos, n: 

G1: 16

G2: 26 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: 

++ 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: - 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-413 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Colombo et al., 

1995 

(continued) 

Patients still 

cured at 6 mos 

among DI, n: 

G1: 8

G2: 8

Patients still 

cured at 6 mos 

among LCB, n: 

G1: 4

G2: 6

Patients still 

cured at 6 mos 

among sensory 

bladder, n: 

G1: 4

G2: 12 

Treatment 

discontinued in 6 

cases: 

G1: 4 (3 cases of 

severe dry mouth, 

1 case of 

previously 

unknown 

glaucoma) 

G2: 2 (treatment 

was time 

consuming) 

Other adverse 

effects 

G1: 18 (47%) with 

AE requiring 

halving of dosage: 

-dry mouth (n=15) 

-constipation (n=6) 

-nausea (n=5) 

-dizziness (n=2) 

- decrease in 

visual acuity (n=1) 

- tachycardia (n=1) 

C-414 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al., 

1995 

Country and 

setting: 

US; private 

clinic 

Enrollment 

period: 

January 1992 to 

December 1992 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Cohorts with 

comparison; 

(Series of patients 

self selected into 

two groups) 

Intervention: 

Bladder training vs. 

anticholinergic or 

antispasmodic

Groups: 

G1: Bladder 

training 

G2: oxybutynin 

2.5-5.0 mg b.i.d. or 

t.i.d. 

N at enrollment: 

G1: 39 

G2: 33 

N at follow-up: 

G1: 26 

G2: 28 

Age, mean yrs 

(range): 

64 (20-93) 

Race/ethnicity: 

NR

Women, N (%): 

72 (100)

Parity: 

NR 

Inclusion criteria: 

• Incontinent by 

AHCPR 

guidelines* 

• Incontinence 

persisted after 

treatment for 

transient 

incontinence 

Exclusion 

criteria: 

• Post-void 

residual of more 

than 150 mL 

UUI, n (%): 

G1: 27 (49) 

G2: 28 (51) 

MUI with 

predominant 

urge, n (%): 

G1: 12 (71) 

G2: 5 (29) 

Continent, n (%): 

G1: 1 (4) 

G2: 1 (4) 

Improved, n (%): 

G1: 22 (85) 

G2: 19 (68) 

No Change, n 

(%): 

G1: 3 (11) 

G2: 8 (28) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection 

criteria: - 

Loss to follow up: -

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: - 

EXTERNAL 

VALIDITY: poor 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of follow up: 

++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-415 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes* Quality Rating 

Author: 

Dorey et al., 

2006

Country and 

setting:

UK, 

Urogynecology 

clinic 

Enrollment 

period: 

January 2002 to 

July 2004 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

Retrospective 

review of cases 

Intervention: 

Physiotherapeutic 

treatment, avg. 3 

sessions, 

including: 

PFME 

Urge suppression 

techniques 

Fluid advice 

Dietary advice 

Groups: 

NA 

N at enrollment: 

87 

N at follow-up: 

66 

13 (15%) excluded 

for SUI 

7 (8%) LTFU 

1 (1%) selfcatherized 

Women, n (%): 

87 (100) 

Age, mean yrs 

(range): 

56 (29-79) 

Race/ethnicity: 

NR 

BMI >30, %: 

20 

Parous, n (%): 

79 (91) 

Prior pelvic 

surgery, n (%):

60 (69) 

Prior 

hysterectomy, n 

(%):

30 (35) 

Inclusion criteria: 

• Treated for UUI 

from Jan 2002 to 

Jul 2004 

Exclusion 

criteria: 

• Severe stress 

urinary 

incontinence 

• Selfcatherization 

Daily leakage, n 

(%): 

44 (67)

Strong pelvic 

floor muscles, %:

75 

Significant 

improvement in 

UUI, n (%): 

55 (83) 

Daily leakage, n 

(%): 

8 (12) 

100 % 

improvement, n 

(%): 

8 (12) 

≥80% 

improvement, n 

(%): 

24 (37) 

50-75% 

improvement, n 

(%): 

31(48) 

Slight 

improvement, n 

(%): 

6 (9) 

No improvement, 

n (%): 

4 (6) 

No UUI at 

discharge, n (%): 

5 (8) 

Mild UUI at 

discharge, n (%): 

46 (69) 

Moderate UUI at 

discharge, n (%): 

12 (18) 

Severe UUI at 

discharge, n (%): 

4 (6) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: - 

Loss to follow up: 

NR 

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: NA 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-416 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes^ Quality Rating 

Author: 

Dowd et. al., 

2003 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

Funding: 

Kidney 

Foundation of 

Ohio 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

Cohorts with 

comparison, 

patients alternately 

assigned to 3 

groups 

Intervention: 

G1: Pamphlet plus 

CS plus coaching

G2: Pamphlet plus 

cognitive strategies 

(CS) via audiotape 

daily for 4 wks then 

1x wk until 12 wks 

G3: Pamphlet on 

bladder health, etc. 

Groups: 

G1: Bladder health 

information + CS + 

coaching 

G2: Bladder health 

information + CS 

G3: Bladder health 

information 

N at enrollment: 

Total: 58 

N at follow-up: 

G1: 18

G2: 18 

G3: 14 

Women, n (%): 

G1: 17 (94)

G2: 18 (100) 

G3: 13 (93) 

P = 0.54 

Age, mean: 

G1: 68.7 

G2: 59.6

G3: 57.1 

P = 0.03 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Adults 

• Living 

independently 

• No major 

hearing problem, 

• Able to read and 

write English, 

• CUBS for 6 mos 

or more 

• MMSE score 

>20 

• Negative urine 

screen 

Exclusion 

criteria: 

See inclusion 

criteria 

UUI, %: 

G1: 26.7 

G2: 31.6 

G3: 33.3 

SUI or MUI, %: 

G1: 73.3 

G2: 68.4 

G3: 66.7 

Comfort (UFIQC): 

Persons in G1 and 

G3 saw modest 

gains over time; 

G2 did not. 

Significant groupby-type of UI 

interaction: G1 and 

G3 with urge had 

more improvement 

than participants 

with stress or other 

UI (F=3.61; P = 

.037) 

Bladder Function 

(BFQ):

Significant change 

for all groups 

(F=13.31; P = 

0.0001); No 

significant 

interactions by 

type of 

incontinence by 

significant main 

effect for urge 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: +

C-417 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Fantl et al., 

1981 

Country and 

setting: 

US, University 

Enrollment 

period: 

N/A 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Retrospective 

chart review 

Intervention: 

Bladder retraining 

drill (BRD) and 

anticholinergics 

when BRD not 

satisfactory

Groups: 

G1: Detrusor 

muscle contraction 

approximately 5 

seconds after a 

cough 

G2: Detrusor 

muscle contracts 

spontaneously 

without prior 

provocation 

G3: Both cough 

contraction and 

spontaneous 

contraction 

N at enrollment: 

G1: 39 

G2: 4 

G3: 49 

N at follow-up: 

NA 

Women, %: 

100

Age, mean ± SD: 

42.7 ± 10:3 

Race/ethnicity:

NR

Parity, mean: 3.5 

Inclusion criteria: 

• Cystometric 

tracings showed 

a rise of 15 cm 

water or more in 

intravesical 

pressure when 

recorded 

independently 

and calculated 

by subtraction 

from intraabdominal 

transrectal 

pressures 

Exclusion 

criteria: 

• Neuropathic 

conditions 

• UTI 

Urgency and 

frequency, n (%): 

72 (78.2) 

Urinary 

incontinence, n 

(%): 

65 (70.6) 

Sensation of 

incomplete 

voiding, n (%) 

59 (64.1) 

Nocturia, n (%): 

66 (71.7) 

Dysuria, n (%): 

3 (3.2) 

MUI, n (%): 

6 (6.5) 

Enuresis in 

childhood, n (%): 

5 (5.4) 

Previously 

operated on for 

similar urologic 

symptoms, n (%):

34 (36.9) 

Cured, n (%): 

G1: 32 (82.1)

G2: 1 (25)

G3: 41 (83.7) 

Cured by BRD 

alone, n (%): 

44 (78.6) 

Cured by BRD + 

anticholinergics, 

n (%):* 

30 (83.5) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to follow up: 

NR 

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: NA 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: - 

C-418 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Frewen, 1982 

Country and 

setting: 

UK; Outpatient 

clinic 

Enrollment 

period: 

NR 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Case series 

Intervention: 

Bladder training

Groups: 

NA 

N at enrollment: 

90 

N at follow-up: 

90 

Age, range: 

15-75 

Race/ethnicity: 

NR 

Women, N (%): 

90 (100) 

Parity mean ± SD: 

NR 

Inclusion criteria: 

• Consecutive 

patients 

presenting with 

frequency, 

urgency and/or 

urge 

incontinence 

Exclusion 

criteria: 

• NR 

Urgency 

incontinence, n 

(%): 

63 (70) 

Detrusor 

Instability, n (%): 

NR (63) 

Frequency, n: 

10 

Diurnal-nocturnal 

enuresis, n: 

20 

Duration of 

symptoms, yrs 

(range): 

stable: 4-5 

unstable: 12 

Results of 

cystometry in 82 

patients, n: 

Unstable: 40 

Cure, n (%):* 

78 (86.6) 

Free from 

incontinence (but 

residual 

urgency), n (%): 

12 (13.4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: - 

Loss to follow up: 

++ 

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of follow 

up: NA 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-419 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Ghei et al., 

2006 

Country and 

setting: 

UK, Primary 

care 

Enrollment 

period: 

NR 

Duration 16 

weeks 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Observational 

cohort 

Intervention: 

Bladder retraining 

vs. Bladder 

retraining + 

antimuscarinic 

(oxybutynin IR/ 

ER, tolterodine 

IR/ER, or 

imipramine 

combined with 

either oxybutynin 

or tolterodine as 

combination 

therapy) 

Groups: 

G1: Bladder 

retraining alone 

G2: Antimuscarinic 

therapy+ bladder 

retraining 

N at enrollment: 

G1: 52 

G2: 656 

N at follow-up: 

G1: 46 

G2: 501 

Women, n (%): 

G1: 45 (86) 

G2: 618 (94) 

Age, mean ± SD: 

G1: 52 ± 14 

G2: 54 ± 23 

Race/ethnicity: 

NR

Inclusion criteria: 

• Frequency 

• Urgency with or 

without UUI 

Exclusion 

criteria: 

• SUI 

• Symptoms of 

BOO 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 0.47 ± 1.2 

G2: 1.12 ± 1.7 

P < 0.001 

Voids/day, mean 

± SD: 

G1: 14 ± 6 

G2: 11 ± 6 

P = 0.001 

Incontinence 

episodes/day, 

mean change 

difference (95% 

CI): 

G2/G1: -0.60 

(-0.93, -0.27) 

P = 0.024 

Voids/day, mean 

change difference 

(95% CI): 

G2/G1: 2.35 (1.4, 

3.3) 

P < 0.001 

Nocturia 

episodes/day, 

mean change 

difference 

(95% CI): 

G2/G1: 0.57 (0.15, 

0.99) 

Attendance visits, 

n (%) 

Failed follow-up: 

G1: 6 (12) 

G2: 155 (23) 

1 follow-up visit: 

G1: 10 (19) 

G2: 15 (2) 

2 follow-up visits: 

G1: 18 (35) 

G2: 86 (13) 

3 follow-up visits: 

G1: 9 (17) 

G2: 225 (35) 

4 follow-up visits: 

G1: 9 (17) 

G2: 175 (27) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: +

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-420 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Goode et al., 

2002 

Country and 

setting: 

US; academic 

health center 

outpatient 

geriatric 

medicine clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National 

Institutes on 

Aging 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted behavioral 

vs. drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback added 

to behavioral 

training in absence 

of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2: Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

105 had pre and 

post treatment 

urodynamics 

G1: 33 

G2: 35 

G3: 37 

N at follow-up: 

NA 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline bladder 

diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL 

• Uterine prolapse 

past the introitus

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive heart 

failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Voids per day, 

mean ± SD: 

G1: 10.0 

G2: 10.9

G3: 10.0 

Cystometry at 

baseline: 

First desire to 

void, mL ± SD: 

G1: 97.1 ± 50.7 

G2: 101.1 ± 62.1 

G3: 124.6 ± 73.7 

Strong desire to 

void, mL ± SD: 

G1: 188.5 ± 93.1 

G2: 212.1 ± 86.7 

G3: 222.3 ± 87.0 

Bladder capacity, 

mL ± SD: 

G1: 288.3 ± 117.0 

G2: 308.7 ± 93.7 

G3: 328.9 ± 107.6 

Voids per day, 

mean ± SD: 

G1: 8.2 

G2: 8.8

G3: 9.7 

DI on UDS, n (%) 

+Baseline DI/+DI 

post-treatment 

G1: 7 (21.2) 

G2: 1 (2.9) 

G3: 5 (13.5) 

DI on UDS, n (%) 

+Baseline DI/-DI 

post-treatment 

G1: 1 (3.0) 

G2: 7 (20.0) 

G3: 7 (18.9) 

DI on UDS, n (%) 

-Baseline DI/+DI 

post-treatment 

G1: 3 (9.1) 

G2: 3 (8.6) 

G3: 3 (8.1) 

DI on UDS, n (%) 

-Baseline DI/-DI 

post-treatment 

G1: 22 (66.7) 

G2: 24 (68.6) 

G3: 22 (59.5) 

Cystometry posttreatment: 

First desire to 

void, mL ± SD: 

G1: 115.9 ± 64.9 

G2: 145.6 ± 74.0 

G3: 133.5 ± 59.6 

Strong desire to 

void, mL ± SD: 

G1: 228.9 ± 106.4 

G2: 282.0 ± 93.2 

G3: 230.1 ± 78.8 

Bladder capacity, 

mL ± SD: 

G1: 305.6 ± 117.9 

G2: 377.6 ± 92.1 

G3: 323.0 ± 109.0 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: 

+ 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-421 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Goode et al., 

2002 

(continued) 

Age, yrs ± SD: 

G1: 65.3 ± 4.5 

G2: 67.9 ± 7.9 

G3: 67.6 ± 7.7 

Race/ethnicity, %: 

Black: 2 

White: 98 

Women: 

100% 

Parity mean ± SD: 

G1: 3.1 ± 1.7 

G2: 2.1 ± 1.3 

G3: 2.3 ± 1.5 

Cystometry 

change: 

First desire to 

void, mL: 

G1: 18.8 

G2: 44.4 

G3: 8.9 

P = 0.149 

Strong desire to 

void, mL: 

G1: 40.5 

G2: 69.9 

G3: 7.8 

P = 0.018 

Bladder capacity, 

mL: 

G1: 17.3 

G2: 68.9 

G3: -6.0 

P = 0.000 

Standardized 

estimates of 

direct and 

mediated effects 

of treatment: 

G1 v G3: 

Total effect: 0.28* 

Direct effect: 0.23 

Mediated Effect: 

0.05 

G2 v G3: 

Total Effect: 0.34* 

Direct Effect: 0.30* 

Mediated Effect: 

0.04 

*P < 0.01 

C-422 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Herschorn et 

al., 2004 

Country and 

setting: 

Canada; Family 

medicine and 

urology clinics 

Enrollment 

period: 

June 2000 to 

December 2001 

Funding: 

Pharmacia 

Pfizer Canada 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Health education 

with tolterodine vs. 

tolterodine alone

Groups: 

G1: Health 

education with 

tolterodine 

G2: Tolterodine 

alone 

N at enrollment: 

G1: 39 

G2: 45 

N at follow-up, 5 

weeks: 

G1: 37 

G2: 40 

N at follow-up, 10 

weeks: 

G1: 35 

G2: 32 

N at follow-up, 16 

weeks: 

G1: 34 

G2: 31 

Age, yrs ± SD: 

G1: 65.7 ± 14.5 

G2: 63.1 ± 15.7 

Race/ethnicity: 

NR 

Women, %: 

G1: 92.3 

G2: 84.4 

Parity: 

NR 

Inclusion criteria: 

• Age ≥ 50 

• Symptoms of 

OAB 

• Attend 

investigators’ 

practice 

• Normal cognitive 

function 

• Able to read 

English 

Exclusion 

criteria: 

• Enrollment in 

another clinical 

trial 

• Interstitial 

cystitis 

• UTI 

• Already taking 

tolterodine 

Duration of OAB, 

yrs ± SD: 

G1: 8.7 ± 11.0 

G2: 8.7 ± 10.8 

Mild bladder 

problems, n (%): 

G1: 13 (33.3) 

G2: 13 (28.9) 

Moderate bladder 

problems, n (%): 

G1: 19 (48.7) 

G2: 28 (62.2) 

Severe bladder 

problems, n (%): 

G1: 7 (18.0) 

G2: 4 (8.9) 

Obtained 

prescription, n 

(%): 

G1: 38 (97.4) 

G2: 37 (82.2) 

P < 0.05 

Intends to fill 

prescription, (%):

G1: 0 (0) 

G2: 6 (7.5) 

Change in 

incontinence 

episodes/wk, 

mean ± SD: 

G1: -7.72 ± 21.16 

G2: -10.24 ± 

19.56† 

Change in 

voids/d, mean ± 

SD: 

G1: -1.82 ± 3.41 

G2: -2.18 ± 4.89 

P = NR 

Change in 

nocturnal voids, 

mean ± SD: 

G1: -0.44 ± 1.13† 

G2: -0.07 ± 0.91 

No change in 

bladder problem 

severity, n (%): 

G1: 14 (42.4) 

G2: 20 (66.7) 

Improved bladder 

problem severity, 

n (%): 

G1: 15 (45.4)† 

G2: 6 (20) 

Worsened 

bladder problem 

severity, n (%): 

G1: 4 (12.1) 

G2: 4 (13.3) 

Compliance, 10 

weeks, %: 

G1: 41 

G2: 38 

P > 0.05 

Compliance, 16 

weeks, %: 

G1: 39 

G2: 31 

P > 0.05 

Continued or 

started non-drug 

OAB treatment, 

16 weeks, %: 

G1: 82 

G2: 53 

P > 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: - 

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-423 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Herschorn et 

al., 2004 

(continued) 

Stopped nondrug OAB 

treatments, %: 

G1: 12.8 

G2: 28.9 

C-424 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jarvis et al., 

1980 

Country and 

setting: 

UK, Hospital 

Enrollment 

period: 

NR 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

RCT 

Intervention: 

Behavioral: 

1) rationale 

explained 

2) pt instructed to 

pass urine at 

specific intervals 

during the day 

3) pt encouraged 

to maintain usual 

fluid intake and 

chart fluid balance 

4) pt introduced to 

someone 

successfully 

treated by the drill 

Groups: 

G1: Bladder drill 

G2: Control (told 

they should now 

be able to hold 

urine 4 hrs and 

sent home) 

N at enrollment:

G1: 30 

G2: 30 

N at follow-up: 

G1: 30 

G2: 30 

Women, %: 

100 

Age, range: 

27-79 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Women 

• Diagnosis of DI 

by pressure flow 

studies 

• Not taking 

medications 

known to affect 

urinary tract 

function 

Exclusion 

criteria: 

• Co-existing 

genuine SUI 

UUI, n: 

G1: 30 

G2: 30 

SUI, n: 

G1: 21 

G2: 21 

Urgency, n: 

G1: 30 

G2: 30 

Diurnal 

frequency, n: 

G1: 30 

G2: 30 

Nocturnal 

frequency, n: 

G1: 27 

G2: 25 

Continent and 

symptom-free: 

G1: 27 

G2: 7 

P < 0.01 

UUI, n: 

G1: 3 

G2: 23 

P < 0.01 

SUI, n: 

G1: 3 

G2: 16 

P < 0.01 

Urgency, n: 

G1: 4 

G2: 23 

P < 0.01 

Diurnal 

frequency, n:

G1: 5 

G2: 23 

P < 0.01 

Nocturnal 

frequency: 

G1: 3 

G2: 20 

P < 0.01 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: - 

Loss to follow up: 

++ 

Drop-out rates: ++ 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of follow 

up: ++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description:- 

C-425 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jarvis et al., 

1981

Country and 

setting: 

UK, Academic 

medical center

Enrollment 

period: 

NR

Funding: 

NR

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Inpatient bladder 

drill vs. outpatient 

drug therapy 

Groups: 

G1: Inpatient 

bladder drill 

G2: Flavoxate 

hydrochloride 200 

mg t.i.d. and 

imipramine 25 mg 

t.i.d. x 4 wks 

N at enrollment: 

G1: 25 

G2: 25 

N at follow-up: 

G1: 25 

G2: 25 

Women, %: 

100 

Age, mean ± SD 

(range): 

G1: 47 ± 15.4 (17-

78) 

G2: 46 ± 12.8 (17-

65) 

Inclusion criteria: 

• Women 

• UDS-diagnosed 

detrusor 

instability 

Exclusion 

criteria: 

• DM 

• Neurological 

abnormalities 

• UTIs 

• Taking a drug 

suspected of 

affecting lower 

urinary tract 

function 

• Genuine stress 

incontinence 

UUI, n: 

G1: 25 

G2: 25 

SUI, n: 

G1: 19 

G2: 17 

Urgency, n: 

G1: 25 

G2: 25 

Frequency, n: 

G1: 25 

G2: 25 

Nocturia, n: 

G1: 21 

G2: 19 

Duration of 

symptoms 

(years), mean ± 

SD (range): 

G1: 4.3 ± 2.7 (1-

15) 

G2: 5.4 ± 3.2 (1-

20) 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 87 

G2: 79 

Max cystometric 

capacity (mL), 

mean: 

G1: 381 

G2: 353 

UUI, n: 

G1: 4 

G2: 11 

SUI, n: 

G1: 1 

G2: 9 

Urgency, n: 

G1: 4 

G2: 11 

Frequency, n: 

G1: 6 

G2: 12 

Nocturia, n: 

G1: 4 

G2: 13 

Continent, n (%): 

G1: 21 (84) 

G2: 14 (56) 

P < 0.05 

Symptom-free, n 

(%): 

G1: 19 (76) 

G2: 12 (48) 

P < 0.05 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 152 

G2: 140 

Max cystometric 

capacity (mL), 

mean: 

G1: 470 

G2: 446 

Adverse events, 

drug therapy, n:* 

Dizziness: 8 

Headache: 6 

Dry mouth: 6 

Nausea: 4 

Drowsiness: 2 

Vomiting: 1 

Discontinued due 

to AEs, n: 

Dizziness: 1 

Headache: 1 

Vomiting: 1 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: 

++ 

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-426 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lauti et al., 

2008 

Country and 

setting: 

New Zealand, 

Academic 

Enrollment 

period: 

February 2003 

to July 2003 

Funding: 

University of 

Otago 

Author 

industry 

relationship 

disclosures: 

None 

Design: 

RCT pilot study, 

unmasked 

Intervention: 

Oxybutynin vs. 

bladder retraining 

vs. combination 

therapy

Groups: 

G1: Oxybutynin 

2.5 mg/day (daily 

dose could be 

increased by 2.5 

mg every 5 days to 

a maximum of 15 

mg/day) 

G2: Bladder 

retraining 

G3: Combination 

therapy 

N screened: 

120 

N at enrollment: 

G1: 21 

G2: 16 

G3: 19 

N at 3 month 

follow-up: 

G1: 18 

G2: 16 

G3: 12 

N at 12 month 

follow-up: 

G1: 16 

G2: 14 

G3: 12 

Age, mean ± SD: 

G1: 53.8 ± 14.8 

G2: 63.9 ± 17.2 

G3: 47.6 ± 16.3 

Race/ethnicity: 

NR 

Women, %: 

Total: 100 

Parous, %: 

G1: 81 

G2: 62.5 

G3: 73.7 

Inclusion criteria: 

• Age > 18 

• Predominant UUI

Exclusion 

criteria: 

• Predominant SUI

• Contraindications 

to anticholinergic 

drugs 

• Current UTI 

• Neurological 

disease 

• Psychiatric 

disorder 

• Untreated coexisting pelvic 

organ prolapse 

below the 

hymenal ring 

• Obstructed 

voiding 

• Functionalreversible cause 

of incontinence 

• Inability to toilet 

independently 

• Limited fluency of 

written/spoken 

English 

• Current or recent 

use of any of the 

trial interventions

Urgency 

episodes/day, 

mean ± SD: 

G1: 3.8 ± 2.7 

G2: 3.1 ± 2.2 

G3: 3.5 ± 2.0 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.2 ± 1.5 

G2: 1.0 ± 1.1 

G3: 1.8 ± 1.6 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.1 ± 1.0 

G2: 1.4 ± 1.0 

G3: 0.8 ± 0.7 

Voids per day, 

mean ± SD: 

G1: 7.8 ± 2.8 

G2: 8.0 ± 1.7 

G3: 8.4 ± 2.5 

OAB-q total 

HRQoL, mean ± 

SD: 

G1: 73.1 ± 17.4 

G2: 69.5 ± 24.6 

G3: 71.6 ± 21.5 

OAB-q severity, 

mean ± SD: 

G1: 47.0 ± 16.2 

G2: 42.3 ± 17.7 

G3: 45.9 ± 18.7 

OAB-q coping, 

mean ± SD: 

G1: 72.0 ± 21.6 

G2: 66.2 ± 31.7 

G3: 73.8 ± 26.2 

OAB-q concern, 

mean ± SD: 

G1: 68.2 ± 19.0 

G2: 68.8 ± 27.6 

G3: 63.8 ± 29.2 

OAB-q sleep, 

mean ± SD: 

G1: 63.1 ± 28.7 

G2: 59.8 ± 29.9 

G3: 55.1 ± 27.6 

Urgency 

episodes/day, 3 

mos, mean ± SD: 

G1: 2.2 ± 1.8 

G2: 1.5 ± 2.1 

G3: 1.7 ± 1.8 

Urgency 

episodes/day, 12 

mos, mean ± SD: 

G1: 2.3 ± 2.5 

G2: 1.9 ± 2.1 

G3: 2.0 ± 1.1 

Incontinence 

episodes/day, 3 

mos, mean ± SD: 

G1: 0.8 ± 0.8 

G2: 0.1 ± 0.3 

G3: 0.6 ± 0.8 

Incontinence 

episodes/day, 12 

mos, mean ± SD: 

G1: 0.9 ± 0.0 

G2: 0.9 ± 1.0 

G3: 0.8 ± 0.7 

Nocturia 

episodes/day, 3 

mos, mean ± SD: 

G1: 1.0 ± 0.5 

G2: 0.8 ± 0.7 

G3: 0.6 ± 0.5 

Nocturia 

episodes/day, 12 

mos, mean ± SD: 

G1: 1.0 ± 0.9 

G2: 1.2 ± 0.6 

G3: 0.7 ± 0.7 

Voids/day, 3 mos, 

mean ± SD: 

G1: 6.7 ± 1.8 

G2: 6.3 ± 1.6 

G3: 6.7 ± 2.2 

Voids/day, 12 

mos, mean ± SD: 

G1: 7.2 ± 1.1 

G2: 6.8 ± 1.4 

G3: 7.6 ± 1.5 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-427 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 

2008 

(continued) 

OAB-q social, 

mean ± SD: 

G1: 92.5 ± 14.6 

G2: 85.4 ± 19.9 

G3: 92.8 ± 18.6 

SF-12 quality of 

life, physical, 

mean ± SD: 

G1: 49.0 ± 9.6 

G2: 41.7 ± 11.5 

G3: 46.2 ± 10.6 

SF-12 quality of 

life, mental, mean 

± SD: 

G1: 49.1 ± 9.3 

G2: 53.1 ± 8.8 

G3: 46.3 ± 8.3 

OAB-q total 

HRQoL, 3 mos, 

mean ± SD: 

G1: 82.3 ± 16.1 

G2: 89.6 ± 9.4 

G3: 91.8 ± 7.4 

OAB-q total 

HRQoL, 12 mos, 

mean ± SD: 

G1: 87.9 ± 11.6 

G2: 81.6 ± 19.3 

G3: 88.9 ± 9.9 

OAB-q severity, 3 

mos, mean ± SD: 

G1: 37.2 ± 22.0 

G2: 16.8 ± 12.0 

G3: 21.6 ± 10.9 

OAB-q severity, 

12 mos, mean ± 

SD: 

G1: 24.6 ± 10.6 

G2: 33.1 ± 16.6 

G3: 21.9 ± 14.8 

OAB-q coping, 3 

mos, mean ± SD: 

G1: 79.2 ± 22.1 

G2: 91.6 ± 9.5 

G3: 92.7 ± 9.4 

OAB-q coping, 12 

mos, mean ± SD: 

G1: 89.2 ± 13.7 

G2: 81.5 ± 23.7 

G3: 90.5 ± 10.0 

OAB-q concern, 3 

mos, mean ± SD: 

G1: 78.6 ± 18.0 

G2: 87.7 ± 14.5 

G3: 90.2 ± 12.4 

OAB-q concern, 

12 mos, mean ± 

SD: 

G1: 85.3 ± 15.5 

G2: 81.7 ± 19.7 

G3: 85.2 ± 13.4 

OAB-q sleep, 3 

mos mean ± SD: 

G1: 77.7 ± 24.9 

G2: 81.3 ± 14.6 

G3: 85.0 ± 19.6 

C-428 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 

2008 

(continued) 

OAB-q sleep, 12 

mos, mean ± SD: 

G1: 79.9 ± 18.3 

G2: 72.0 ± 24.5 

G3: 83.2 ± 18.4 

OAB-q social, 3 

mos, mean ± SD: 

G1: 96.4 ± 9.7 

G2: 95.6 ± 7.0 

G3: 98.9 ± 1.9 

OAB-q social, 12 

mos, mean ± SD: 

G1: 97.3 ± 7.1 

G2: 91.9 ± 14.2 

G3: 97.3 ± 6.9 

SF-12 quality of 

life, physical 

G1: 50.6 ± 8.0 

G2: 42.1 ± 12.7 

G3: 48.4 ± 10.8 

SF-12 quality of 

life, physical, 12 

mos, mean ± SD: 

G1: 50.0 ± 7.3 

G2: 45.1 ± 13.9 

G3: 45.3 ± 13.4 

SF-12 quality of 

life, mental, 3 

mos, mean ± SD: 

G1: 50.4 ± 9.6 

G2: 51.2 ± 9.5 

G3: 46.7 ± 7.6 

SF-12 quality of 

life, mental, 12 

mos, mean ± SD: 

G1: 49.6 ± 7.5 

G2: 50.1 ± 10.7 

G3: 50.6 ± 8.4 

Dry mouth, n (%): 

G1: 3 (21) 

G2: 5 (46) 

G3: 5 (42) 

Headaches, n 

(%): 

G1: 6 (43) 

G2: 1 (11) 

G3: 7 (58) 

Dizziness, n (%): 

G1: 4 (29) 

G2: 2 (20) 

G3: 3 (25) 

C-429 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 

2008 

(continued) 

Constipation, n 

(%): 

G1: 3 (21) 

G2: 3 (27) 

G3: 3 (27) 

Fatigue, n (%): 

G1: 9 (64) 

G2: 5 (46) 

G3: 7 (64) 

C-430 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Macaulay et al., 

1987 

Country and 

setting: 

UK, Specialty 

treatment 

center 

Enrollment 

period: 

NR 

Funding: 

Wellcome Trust, 

trustees of St. 

George’s 

Hospital 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

RCT 

Intervention: 

Brief eclectic 

psychotherapy, 

bladder training or 

medication 

Groups: 

G1: Psychotherapy 

G2: Bladder drill 

G3: Propantheline 

N at enrollment: 

G1: 19 

G2: 16 

G3: 15 

N at follow-up: 

G1: 18 

G2: 15 

G3: 14 

Women, %: 

100 

Age: 

NR 

Race/ethnicity: 

NR 

Follow-up: 

3 months 

Inclusion criteria:

• Previous 

completion of 

survey on psych 

conditions w/ 

OAB 

• Detrusor 

instability on 

UDS or sensory 

urgency 

Exclusion 

criteria: 

NR 

Detrusor 

instability, n: 

G1: 10 

G2: 8 

G3: 8 

Sensory urgency, 

n: 

G1: 9 

G2: 8 

G3: 7 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 10.8 

Bladder capacity 

(mL), mean: 

G1: 393 

G2: NR 

G3: 323 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 107 

G2: 110 

G3: 70 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 45.5 

G3: NR 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 8.3 

G3/BL: P < 0.005 

Bladder capacity 

(mL), mean: 

G1: 414 

G2: NR 

G3: 368 

G1/BL: P = NS 

G3/BL: P = NS 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 142 

G2: 150 

G3: 137 

G1/BL: P = NS 

G2/BL: P < 0.05 

G3/BL: P = 0.06 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 29.5 

G3: NR 

G2/BL: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: - 

Loss to follow up: 

++ 

Drop-out rates: ++ 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-431 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Mattiason et al., 

2003 

Country and 

setting: 

Sweden, 

Denmark, 

Norway 

(Tolterodine 

Scandinavian 

Study Group) 

Enrollment 

period: 

October 1999 to 

December 2000 

Funding: 

Pharmacia Corp 

Author 

industry 

relationship 

disclosures: 

NR

Design: 

RCT, singleblinded (balanced 

blocks of 4, 

computerized 

randomization list) 

Intervention: 

Tolterodine 2mg 

b.i.d. ± bladder 

training (BT); 

Tolterodine dosage 

could be 

decreased to 1 mg 

P.O. b.i.d. during 

the first 2 wks if 

intolerable SE; 

BT taught with a 

written handout 

Groups: 

G1: Tolterodine + 

BT x 24 wks 

G2: Tolterodine x 

24 wks 

N at enrollment: 

Total: 505 

N at follow-up: 

G1: 244 

G2: 257 

N Completed 

treatment: 

G1: 77% 

G2: 79% 

Total: 74% 

Women, n (%) 

G1: 177 (73) 

G2: 201 (78) 

Age, median 

(range): 

G1: 62 (19, 86) 

G2: 63 (22, 86) 

Race/ethnicity: 

NR 

Follow-up: 

24 weeks 

Inclusion criteria:

• Age ≥ 18 

• ≥ 8 voids/day 

and urinary 

urgency (± UUI) 

as determined by 

1 wk bladder 

diary 

• With or without 

UUI 

• Women of 

reproductive age 

had to be using 

reliable birth 

control 

Exclusion 

criteria: 

• Contraindication 

to antimuscarinic 

therapy 

• Use of 

electrostimulatio

n therapy or BT 

within prior 3 mo 

• Indwelling 

catheter or 

intermittent 

catheterization 

• Pregnancy or 

lactation 

• Use of 

anticholinergic 

agents or 

concomitant 

treatment for 

OAB (estrogen 

permitted) 

Urgency 

episodes/day, 

mean (range): 

G1: 6.0 (0, 23.0) 

G2: 6.6 (0, 34.3) 

Incontinence 

episodes/day, 

mean (range): 

G1: 2 (0.3, 20.3) 

G2: 2.3 (0.3, 16.3) 

Voids/day, mean 

(range): 

G1: 10.3 (7.3, 

27.6) 

G2: 10.6 (7.7, 

24.6) 

Duration of 

symptoms > 5 

years, n (%): 

G1: 120 (49) 

G2: 124 (48) 

Previous drug 

therapy for OAB, 

n (%): 

G1: 40 (160 

G2: 35 (14) 

Previous surgery 

affecting lower 

urinary tract, n 

(%): 

G1: 28 (11.5) 

G2: 30 (12) 

Symptoms

caused at least 

moderate 

problems, %: 

G1: 92 

G2: 93 

 

Urgency 

episodes/day, 

median % change 

(IQR): 

G1: -38 (-76.7, 

-14.1) 

G2: -38 (-68.7, 

-8.0) 

G1/G2: P = 0.75 

Incontinence 

episodes/day, 

median IQR% 

change; n=301: 

G1: -87 (-100, -20) 

G2: -81 (-100, 

-41.8) 

G1/G2: P = 0.28 

Voids/day, 

median % change 

(IQR): 

G1: -33 (-42.3, 

21.3) 

G2: -25 (-38.8, 

-13.0) 

G1/G2: P < 0.001 

Voided volume 

(mL), median % 

change (IQR): 

G1: 31.5 (13.3, 

56.2) 

G2: 20 (3.1, 45.4) 

G1/G2: P <0.001 

Symptoms are 

“minor or less”, 

%: 

G1: 66.5 

G2: 61.5 

Overall improvement in 

symptoms, %: 

G1: 76 

G2: 71 

Worsening of 

symptoms, %: 

G1: 3 

G2: 5 

Dry mouth, n (%):

G1: 76 (31) 

G2: 90 (35) 

Headache, n (%): 

G1: 15 (6) 

G2: 21 (8) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-432 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Mattiason et al., 

2003 

(continued) 

Constipation, n 

(%): 

G1: 7 (3) 

G2: 14 (5) 

≥ 1 SE, n (%): 

G1: 158 (65) 

G2: 177 (69) 

G1/G2: P = NS 

Withdrawal due 

to, %: 

AE: 15 

Withdrawal due 

to lack of 

efficacy: 

3 

Withdrawal of 

consent : 

2 

Protocol 

violations: 

1 

Completed 

treatment: 

G1: 77% 

G2: 79% 

C-433 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Millard et al., 

1983 

Country and 

setting: 

Australia, 

Hospital 

Enrollment 

period: 

NR 

Funding: 

NR 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

Report of hospitalbased results 

Intervention: 

All patients initially 

hospitalized for 5-

14 days then 

assigned to a 

Frewen-type 

bladder training 

program or 

biofeedback, each 

lasting 3 months. 

Adjunctive 

therapy* was used 

when patients did 

not show 

improvement. 

Groups: 

NR 

N at enrollment: 

59 

N at follow-up: 

59 

Women, %: 

100 

N at follow-up: 

39 

Age, mean 

(range): 

49 (14-74) 

Race/ethnicity: 

NR 

Inclusion 

criteria*: 

• Men, women or 

children with 

frequency, 

urgency, 

nocturia and 

urge 

incontinence 

Exclusion 

criteria: 

• Neurological 

lesions 

Frequency, n: 

59

Nocturia, n: 

37 

UUI, n: 

42 

MUI, n: 

24 

Enuresis, n: 

12 

Giggle, n: 

9 

Urodynamic 

status, n: 

Unstable bladder: 

38 

Unstable bladder & 

bladder neck 

incompetence: 

6 

Sensory urgency: 

12 

Sensory urgency & 

bladder neck 

incompetence: 

3 

Duration of 

symptoms 

(years), mean:

11.9 

Results, patients 

with unstable 

bladder, n: 

Cure: 18 

Significant 

improvement: 10 

Minor 

improvement: 2 

Failure: 8 

Results, patients 

with unstable 

bladder & bladder 

neck 

incompetence, n: 

Cure: 0 

Significant 

improvement: 3 

Minor 

improvement: 1 

Failure: 0 

Results, patients 

with sensory 

urgency, n: 

Cure: 7 

Significant 

improvement: 4 

Minor 

improvement: 1 

Failure: 0 

Results, patients 

with sensory 

urgency & 

bladder neck 

incompetence, n: 

Cure: 0 

Significant 

improvement: 0 

Minor 

improvement: 0 

Failure: 3 

Bladder Capacity 

(mL), by result, 

patients with 

unstable bladder, 

mean change: 

Cure: 149 

Significant 

improvement: 87 

Minor 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: 

NA 

Pt selection 

criteria: - 

Loss to follow up: 

++ 

Drop-out rates: NR

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: - 

Measurement 

reliability: + 

Intervention 

description: + 

C-434 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

improvement: 95 

Failure: 73 

C-435 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Millard et al., 

1983 

(continued) 

Bladder Capacity 

(mL) by result, 

patients with 

sensory urgency, 

mean change: 

Cure: 83 

Significant 

improvement: 115 

Minor 

improvement: 127 

Failure: NA 

Voiding 

frequency 

(hours), by result, 

patients with 

unstable bladder, 

initial/final: 

Cure: 1.9/4.8

Significant 

improvement: 

1.8/3.2 

Minor 

improvement: 

1.0/4.0 

Failure: 1.4/3.3 

Voiding 

frequency 

(hours), by result, 

patients with 

sensory urgency, 

initial/final: 

Cure: 1.7/3.8 

Significant 

improvement: 

1.0/3.4 

Minor 

improvement: 

3.3/4.0 

Fail: NA 

C-436 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 

2007 

Country and 

setting: 

US, Multicenter, 

327 sites (141 

Urology 141, 96 

Primary care, 

43 Ob-Gyn, 17 

Geriatric Med) 

Enrollment 

period: 

NR 

Funding: 

Watson 

Laboratories, 

Inc 

Author 

industry 

relationship 

disclosures: 

7 of 7 

Allergan (1) 

Astellas (1) 

Esprit (1) 

GlaxoSmithKlin

e (2) 

GSK (1) 

GTx (1) 

Indevus-Esprit 

(1) 

Lilly (1) 

Novartis (3) 

Ortho-McNeil 

(1) 

Ortho Urology 

(1) 

Pfizer (4) 

Sanofi (1) 

USB (1) 

Watson (6) 

Design: 

RCT, open-label 

(case series for 

drug, RCT for 

educational 

materials) 

Intervention: 

Oxybutynin 

transdermal 

system 3.9 

mg/day, twice 

weekly patch for 

up to 6 months 

with “standard 

instruction” or with 

“educational 

intervention”. 

Groups: 

G1: Standard 

instructions 

G2: Educational 

intervention 

(educational 

booklet, OAB 

newsletters, dosing 

reminders, 

calendar 

reminders, bladder 

diary) 

N at enrollment: 

Total: 2,878 

G1: 1,282 

G2: 1,596 

Women, %: 

87.2 

Age, yrs ± SD: 

62.5 ± 14.8 

Race/ethnicity, %: 

White: 83.6 

African American: 

9.9 

Hispanic: 4.8 

Asian: 1.2 

Other: 0.5 

Follow-up: 

6 months 

Inclusion criteria:

• Age ≥18 

• UUI, urinary 

urgency or 

frequency 

• Willing to 

discontinue all 

prescription and 

OTC medications 

for OAB 

• Capable of 

completing QoL 

questionnaires 

without 

assistance 

• Negative 

pregnancy test & 

medically 

acceptable 

contraceptive 

Exclusion 

criteria: 

• Contraindications 

to oxybutynin 

• Reversible 

etiologies for 

OAB 

• Prior treatment 

with Oxytrol 

• Long-term care 

facilities and 

nursing homes 

KHQ, UUI 

severity item 

score, %: 

A lot: 38.1 

Moderately: 31.3 

A little: 20.5 

Omitted, N/A: 10.1

KHQ, urgency 

severity item 

score, %: 

A lot: 49.2 

Moderately: 30.3 

A little: 14.8 

Omitted, N/A: 5.6 

KHQ, frequency 

severity item 

score, %: 

A lot: 59.3 

Moderately: 32.5 

A little: 7.2 

Omitted, N/A:1.0 

KHQ, nocturia 

severity item 

score, %: 

A lot: 47.3 

Moderately: 33.5 

A little: 16.7 

Omitted, N/A: 2.4 

History of OAB, 

years, %:

<1 year: 12.0 

1-2 years: 18.5 

2-4 years: 23.1 

≥ 4 years: 46.4 

OAB Severity:

No problem: 1.8 

Very minor: 4.6 

Minor: 15.5 

Moderate: 33.0 

Severe: 28.4 

Many severe 

problems: 16.7 

Previous OAB 

treatments, n (%):

0: 43.4 

1: 38.7 

2: 13.1 

3: 2.9 

KHQ, UUI 

severity item 

score, %: 

A lot: 21.3 

Moderately: 29.5 

A little: 31.6 

Omitted, N/A: 17.7 

KHQ, urgency 

severity item 

score, %: 

A lot: 27.3 

Moderately: 33.8 

A little: 27.3 

Omitted, N/A: 11.5 

KHQ, frequency 

severity item 

score, %: 

A lot: 33.5 

Moderately: 45.2 

A little: 18.7 

Omitted, N/A: 2.6 

KHQ, nocturia 

severity item 

score, %: 

A lot: 27.5 

Moderately: 35.4 

A little: 31.3 

Omitted, N/A: 5.7 

KHQ, general 

health perception, mean ± SD 

(% improvement): 

-1.2 ± 17.4 (-4.3) 

KHQ, 

incontinence 

Impact, mean ± 

SD (% 

improvement): 

-13.5 ± 29.5 (-19.5) 

KHQ, symptom 

severity, mean ± 

SD (% 

improvement): 

-12.4 ± 24.8 

(-22.2)*** 

KHQ, role 

limitations, mean 

± SD (% 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: - 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-437 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

4: 1.9 improvement): 

-13.3 ± 29.2 (-29.5) 

C-438 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 

2007 

(continued) 

KHQ, general 

health perception, mean ± SD: 

28.2 ± 19.8 

KHQ, incontinence Impact, 

mean ± SD: 

69.3 ± 27.4 

KHQ, symptom 

severity, mean ± 

SD: 

55.9 ± 20.5* 

KHQ, role 

limitations, mean 

± SD: 

45.1 ± 31.0 

KHQ, physical 

limitations, mean 

± SD: 

46.7 ± 31.6 

KHQ, social 

limitations, mean 

± SD: 

25.6 ± 28.3 

KHQ, emotions, 

mean ± SD: 

30.0 ± 29.2 

KHQ, personal 

relationships, 

mean ± SD: 

20.6 ± 29.5*** 

KHQ, sleep/ 

energy, mean ± 

SD: 

54.2 ± 27.3 

KHQ, severity 

(coping) 

measures, mean 

± SD: 

47.9 ± 26.4 

KHQ, physical 

limitations, mean 

± SD (% 

improvement): 

-11.7 ± 29.9 (-25.1) 

KHQ, social 

limitations, mean 

± SD (% 

improvement): 

-6.7 ± 23.7 (-26.2) 

KHQ, emotions, 

mean ± SD (% 

improvement): 

-8.8 ± 25.4 (-29.3) 

KHQ, personal 

relationships, 

mean ± SD (% 

improvement): 

-6.0 ± 23.5 

(-29.1)*** 

KHQ, sleep/ 

energy, mean ± 

SD (% 

improvement): 

-11.2 ± 24.1 (-20.7) 

KHQ, severity 

(coping) 

measures, mean 

± SD (% 

improvement): 

-8.6 ± 21.3 (-18.0)

Side effects, 

application site, 

%: 

Total: 14.0 

Pruritis: 4.9 

Erythema: 4.6 

Dermatitis: 4.4 

Irritation: 3.2 

Other: 2.0 

Side effects, %: 

Rash: 3.0 

Dry mouth: 2.6 

Pruritis: 2.6 

Skin irritation: 2.1 

Withdrew due to 

AEs, %: 

21.3 

C-439 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 

2007 

(continued) 

Withdrew: 

1452 (50.5%) 

Adverse events, 

%:

21.3 

Withdrawn 

consent, %: 

7.5 

Requirement for 

alternative 

therapy, %: 

7.4 

Loss to follow-up, 

%: 

7.2 

Noncompliance, 

%: 

5.6 

Administrative 

decision, %: 

0.7 

Ineligible, %: 

0.4 

Death, %: 

0.1 

No reason given, 

%: 

0.3 

C-440 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Song, et al., 

2006

Country and 

setting: 

Korea, Medical 

Center 

Enrollment 

period: 

May 2001 to 

April 2002

Funding: 

NR

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Bladder training 

(BT) vs. 

Tolterodine vs. BT 

+ Tolterodine 

Groups: 

G1: BT x 12 wks 

G2: Tolterodine 2 

mg bid x 12 wks 

G3:Tolterodine 2 

mg bid + BT x 12 

wks 

N at enrollment: 

G1: 46 

G2: 47 

G3: 46 

N at follow-up: 

G1: 26 

G2: 32 

G3: 31 

Women, %: 

100

Age, mean ± SD: 

G1: 45.73 ± 12.68 

G2: 48.41 ± 9.38 

G3: 45.42 ± 9.54 

Race/ethnicity, %: 

Korean: 100 

Inclusion criteria:

• Age ≥ 18

• ≥ 8 voids/day 

• Urge with or 

without 

incontinence 

• Symptom 

duration ≥ 3 

months 

• No prior history 

of treatment for 

OAB 

Exclusion 

criteria: 

• Active urinary 

tract infection 

• Clinically 

significant SUI 

• Bladder outlet 

obstruction 

• Interstitial cystitis

• Glaucoma 

• Megacolon 

• Maximal urine 

flow rate of < 10 

mL/sec 

• Postvoid residual 

volume > 30% of 

the total amount 

voided on 

uroflowmetry 

Voids/day, mean 

± SD: 

G1: 10.93 ± 2.14 

G2: 11.63 ± 2.57 

G3: 11.90 ± 1.51 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.45 ± 1.14 

G2: 1.72 ± 1.04 

G3: 1.96 ± 1.49 

Urgency, mean 

score ± SD: 

G1: 2.58 ± 1.30 

G2: 2.81 ± 0.74 

G3: 3.00 ± 1.10 

Maximum flow 

rate (mL/s), mean 

± SD: 

G1: 20.35 ± 8.44 

G2: 22.56 ± 4.94 

G3: 21.19 ± 4.96 

Residual urine 

(mL), mean ± SD: 

G1: 9.08 ± 22.56 

G2: 7.59 ± 12.39 

G3: 6.42 ± 10.16 

Symptom 

duration (years), 

mean ± SD: 

G1: 6.44 ± 6.84 

G2: 4.54 ± 5.15 

G3: 4.10 ± 3.99 

Voids/day, mean 

(% decrease) 

G1: 8.1 (25.9%)* 

G2: 8.1 (30.2%)* 

G3: 7.9 (33.5%)* 

G3/G1: P < 0.05 

Nocturia 

episodes/day, 

mean (% 

reduction): 

G1: 0.6 (56.1%)* 

G2: 0.6 (65.4%)* 

G3: 0.6 (66.3%)* 

Urgency, mean 

score (% 

reduction): 

G1: 1.4 (44.8%)* 

G2: 1.1 (62.2%)* 

G3: 1.2 (60.2%)* 

G3/G1: P = 0.021 

G2/G1: P = 0.017 

G2/G3: P = NS 

Satisfaction, 

mean score (% 

improved): 

G1: 1.5 (53.9) 

G2: 1.4 (63.0) 

G3: 1.3 (71.0) 

Dry mouth, n (%): 

G1: 0 (0.0) 

G2: 7 (21.9) 

G3: 9 (28.9) 

Hesitancy, n (%) 

G1: 0 (0.0) 

G2: 3 (9.4) 

G3: 2 (6.5) 

Decreased 

appetite/constipation, n (%): 

G1: 0 (0.0) 

G2: 2 (6.3) 

G3: 2 (6.5) 

Headache, n (%): 

G1: 0 (0.0) 

G2: 1 (3.1) 

G3: 0 (0.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-441 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

C-442 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Author: 

Szonyi et al., 

1995 

Country and 

setting: 

UK 

Enrollment 

period: 

NR 

Funding: 

Smith & 

Nephew 

Pharmaceutical

s Ltd 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin + 

bladder training vs. 

placebo + bladder 

training 

Groups: 

G1: Oxybutynin 

2.5 mg bid with 

dose titration on 

days 29 and 43 

plus bladder 

training 

G2: Placebo + 

bladder training 

N at enrollment: 

G1: 30 

G2: 30 

N at follow-up: 

G1:16 

G2: 23 

Women, n (%): 

56 (93) 

Age, mean ± SD: 

82.2 ± 6.06 

Race/ethnicity: 

NR 

Weight (kg),

mean ± SD:

67.4 ± 14.92

Inclusion criteria:

• Age > 70 

• Frequency, 

urgency and UUI

• Mobile 

• Able to keep 

diary 

Exclusion 

criteria: 

• UTI 

• Hepatic or renal 

disease 

• Glaucoma 

• Uncontrolled 

diabetes 

• Taking 

imipramine or 

propantheline 

Voids/2 weeks, 

median change 

(95% CI): 

G1/G2: 577 (-27.0, 

6.0) 

P = 0.0025 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -6 (-5, 7.0) 

Daytime 

incontinence 

episodes/2 

weeks, median 

change (95% CI): 

G1 vs. G2: -9.5 (-

11.0, 3.0) 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -1.0 (-3.0, 

2.0) 

Patient assessment of benefit, 

%: 

29 days: 

G1: 86

G2: 55

P = 0.02 

43 days: 

G1: 71

G2: 59

P = 0.41 

57 days: 

G1: 79

G2: 55

P = 0.09 

Patient response, 

29 days, n: 

Cure: 

G1: 1

G2: 0 

Significant 

improvement: 

G1: 15

G2: 8

Marginal 

improvement: 

G1: 7

G2: 8

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to follow up: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of follow 

up: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-443 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Szonyi et al., 

1995 

(continued)

No change: 

G1: 5

G2: 13

Patient response, 

57 days, n: 

Cure: 

G1: 4

G2: 3

Significant 

improvement: 

G1: 14

G2: 8

Marginal 

improvement: 

G1: 3 

G2: 4

No change: 

G1: 7

G2: 14

Dry mouth, %: 

G1: 93

G2: 86

Blurred vision, %: 

G1: 50

G2: 59 

Heartburn, %: 

G1: 57

G2: 45

Constipation, %: 

G1: 50

G2: 45

Dry skin, %: 

G1: 50

G2: 59

Poor compliance 

(< 75% of tablets), 

%: 

G1: 20

G2: 20 

C-444 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Wang et al., 

2004

Country and 

setting: 

Taiwan, NR 

Enrollment 

period: 

July 2001 to 

December 2002 

Funding: 

National 

Science 

Council, Taiwan

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Pelvic floor muscle 

training (PFMT), 

biofeedbackassisted PFMT 

(BAPFMT), 

electrical 

stimulation (ES) 

Groups: 

G1: PFMT per 

PERFECT score 

G2: BAPFMT per 

PERFECT score 

G3: ES using 

biphasic symmetric 

probe current w/ 

10-Hz freq, 400-

microsec pulse 

width, 10/5 duty 

cycle, varying 

intensity 

N at enrollment: 

G1: 40 

G2: 38 

G3: 42 

N at follow-up: 

G1: 34 

G2: 34 

G3: 35 

Women: 

100% 

Age, mean ± SD: 

G1: 50.09 ± 15.85 

G2: 52.32 ± 12.68 

G3: 55.74 ± 12.53 

Race/ethnicity: 

NR

BMI, kg/m2

 ± SD: 

G1: 22.69 ± 3.32 

G2: 23.70 ± 3.90 

G3: 23.93 ± 3.21 

Parity, mean ± 

SD: 

G1: 2.47 ± 1.44 

Inclusion criteria:

• Female 

• Age 16-75 

• OAB symptoms 

for > 6 months 

• Voids/day ≥ 8 

• UUI/day ≥ 1 

Exclusion 

criteria: 

• Anticholinergic 

medications 

• Tricyclic 

antidepressants 

• Treatment with 

pelvic-floor 

exercises 

• Treatment with 

bladder training 

• Repair of pelvic 

prolapse 

• Pregnancy 

• Deafness 

• Neurologic 

disorders 

• DM 

• Pacemaker or 

IUD use 

• Genital prolapse 

> stage II by ICS

• Residual urine > 

100 mL 

• UTI 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 0.86 ± 1.80 

G2: 0.92 ± 1.77 

G3: 2.09 ± 2.96

Urine leakage 

during former 

pregnancy, no 

(%): 

G1: 7 (20.59) 

G2: 3 (8.83) 

G3: 3 (8.57) 

UUI symptoms 

resolved, n (%): 

G1: 10 (30.3) 

G2: 13 (38.24) 

G3: 14 (40) 

UUI symptoms 

modified, n (%): 

G1: 3 (6.06) 

G2: 4 (11.76) 

G3: 4 (11.43) 

UUI symptoms 

unchanged, n 

(%): 

G1: 21 (63.64) 

G2: 17 (50) 

G3: 17 (48.6) 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 0.73±1.82

G2: 0.70±1.80 

G3: 1.95±2.84 

G1/G2/G3: P = 

0.016 

OAB symptom 

improvement/ 

cure, %: 

G1: 38.2 

G2: 50.0 

G3: 51.4 

G1/G2/G3: P = 

0.567 

Adherence to 

treatment, 

median % 

(range): 

G1: 0.833 (0.25-

1.00) 

G2: 0.791 (0.58-

1.99) 

G3: 0.750 (0.54-

1.00) 

G1/G2/G3: P = 

0.356 

Compliance with 

home program 

(days), median 

(range): 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: 

+ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-445 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

G2: 2.91 ± 1.86 

G3: 3.69 ± 1.75

G1: 8.5 (0-44) 

G2: 14.5 (0-44) 

G1/G2: P = 0.636 

C-446 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Wang et al., 

2004 

(continued) 

Menopausal, n 

(%)

G1: 21 (61.76) 

G2: 17 (50) 

G3: 8 (22.86) 

KHQ, general 

health 

perception, mean 

change ± SD:

G1: 14.66 ± 24.57 

G2: 12.10 ± 20.28 

G3: 16.96 ± 24.58 

G1/G2/G3: P = 

0.376 

KHQ, incontinence impact, 

mean change ± 

SD:

G1: 6.03 ± 120.82 

G2: 37.42 ± 37.11 

G3: 47.03 ± 35.45 

G1/G2/G3: P = 

0.067 

KHQ, role 

limitation, mean 

change ± SD:

G1: 25.86 ± 26.57 

G2: 30.64 ± 30.15 

G3: 34.52 ± 31.73

G1/G2/G3: P = 

0.376 

KHQ, physical 

limitation, mean 

change ± SD:

G1: 25.29 ± 26.58 

G2: 33.33 ± 33.88 

G3: 28.57 ± 28.99 

G1/G2/G3: P = 

0.693 

KHQ, social 

limitation, mean 

change ± SD:

G1: 17.05 ± 21.20 

G2: 22.76 ± 29.20 

G3: 20.84 ± 27.45 

G1/G2/G3: P = 

0.799 

KHQ, personal 

relationships, 

mean change ± 

SD:

G1: 2.30 ± 13.89 

G2: 10.75 ± 26.37 

G3: 3.57 ± 22.39 

G1/G2/G3: P = 

0.167 

C-447 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Wang et al., 

2004 

(continued)

KHQ, emotions, 

mean change ± 

SD:

G1: 19.31 ± 29.68 

G2: 22.22 ± 27.82 

G3: 46.83 ± 37.33 

G1/G2/G3: P = 

0.005 

G2/G3: P = 0.003 

G1/G3: P = 0.007 

G2/G1: P = 0.751 

KHQ, sleep/ 

energy, mean 

change ± SD:

G1: 18.83 ± 26.18 

G2: 26.88 ± 24.60 

G3: 38.10 ± 39.51 

G1/G2/G3: P = 

0.249 

KHQ, severity 

measures, mean 

change ± SD:

G1: 14.71 ± 20.27 

G2: 20.65 ± 31.19 

G3: 31.23 ± 23.83 

G1/G2/G3: P = 

0.004 

G2/G3: P = 0.029 

G1/G3: P = 0.001 

G2/G1: P = 0.587 

KHQ, total score, 

mean change ± 

SD:

G1: 50.27 ± 

171.42 

G2: 185.86 ± 

176.57 

G3: 180.08 ± 

176.03 

G1/G2/G3: P = 

0.003 

G2/G3: P = 0.952 

G1/G3: P = 0.004 

G2/G1: P = 0.003 

Pelvic muscle 

strength, scale of 

power: 

G2/G3: P < 0.001 

G1/G3: P < 0.001 

C-448 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Wang et al., 

2004

(continued) 

Times of fast 

contraction, 

mean ± SD: 

G1: -5.82 ± 5.05 

G2: -6.21 ± 4.56 

G3: -3.03 ± 4.98 

G2/G3: P = 0.007 

G1/G3: P = 0.012 

Degree of vaginal 

pressure, mean 

change ± SD: 

G1: -36.03 ± 21.79 

G2: -38.35 ± 29.62 

G3: -8.91 ± 12.83 

G2/G3: P < 0.001 

G1/G3: P < 0.01 

Vaginal pressure, 

mean % change 

(range): 

G1: -78.95 

(-522.22, -10.34) 

G2: -105.0 

(-2450 to 79.55) 

G3: -12.63 

(-138.46 to 50) 

G1/G2/G3: P < 

0.001 

Vaginal pressure, 

mean change ± 

SD: 

G1: -36.03 ± 21.79 

G2: -38.35 ± 29.62 

G3: -8.91 ± 12.83

G2/G3: P < 0.001 

G1/G3: P < 0.001 

G2/G1: P = NS 

C-449 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics* Outcomes Quality Rating 

Author: 

Wang et al., 

2006 

Country and 

setting: 

Taiwan; 

Academic 

medical center 

Enrollment 

period: 

July 2004 to 

November 2005 

Funding: 

National 

Science 

Council, Taiwan 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Electric Stimulation 

(ES) vs. 

Oxybutynin vs. 

Placebo for 12 

weeks

Groups: 

G1: ES: 

intravaginal 

electrode; biphasic 

symmetric pulsed 

current w/ a 10-Hz 

frequency, 400-

millisecond pulse 

width, 10/5 duty 

cycle, and varying 

intensity, 20 

min/session, twice 

weekly 

G2: Oxybutynin, 

2.5 mg t.i.d. 

G3: Placebo pill 

t.i.d. 

N at enrollment: 

G1: 25 

G2: 26 

G3: 23 

N at follow-up: 

G1: 24 

G2: 23 

G3: 21 

Age: 

NR 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Female 

• OAB for ≥ 6 mos

• Age 16-80 

• Urgency ≥ 4 

times per day 

Exclusion 

criteria: 

• Use of 

anticholinergics 

or TCAs 

• Previous 

treatment with 

pelvic-floor 

muscle training, 

bladder training 

• Pelvic prolapse 

repair 

• Pregnancy 

• Neurologic 

disorders 

• DM 

• Demand cardiac 

pacemaker 

• IUD use 

• Genital prolapse 

greater than ICS 

Stage II 

• PVR>100 mL 

• Overt SI 

• Antiincontinence 

surgery 

• UTI 

Warning time, s 

(range) 

G1: 41.5 (8-105) 

G2: 44 (2-215) 

G3: 65 (26-265 

MVV, mL/void 

(range): 

G1: 340 (120-450)

G2: 310 (130-800)

G3: 350 (120-600)

Daily voided 

volume, mL 

(range) 

G1: 2160 (1010-

2950) 

G2: 2106 (1560-

3153) 

G3: 2305 (1305-

3300) 

Pads per day 

(range): 

G1: 1 (0-4.1) 

G2: 0 (0-3) 

G3: 1 (0-4) 

Urgency (subj): 

G1: 11.4 (4.0-16.0)

G2: 12.1 (5-18) 

G3: 9.8 (4.2-15.5) 

Frequency (subj):

G1: 12.8 (8.8-16.0)

G2: 11.5 (4.3-19.5)

G3: 11.5 (6.5-22.8)

Nocturia (subj): 

G1: 1.75 (0-6.5) 

G2: 0 (0-2.5) 

G3: 0.65 (0-3.1) 

UI (subj): 

G1: 1 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

Warning time, s 

(range) 

G1: 72 (32-633) 

G2: 54.5 (138-850) 

G3: 66.5 (26-219) 

P(G1-G3) < 0.001 

MVV, 

mL/micturition 

(range): 

G1: 355 (150-550) 

G2: 336.5 (138-

850) 

G3: 340 (160-600) 

P(G1-G3) = 0.035 

Voided volume/d, 

mL (range) 

G1: 2270 (1210-

3106) 

G2: 2100 (1619-

3200) 

G3: 2305 (1351-

3221) 

P(G1-G3) = 0.050 

Pad count, pad/d 

(range): 

G1: 0 (0-2) 

G2: 0 (0-2.5) 

G3: 1 (0-3) 

P(G1-G3) = 0.012 

Urgency (subj) 

G1: 1.0 (0.0-12.3) 

G2: 6 (0.5-13) 

G3: 7.4 (3.9-13.4) 

P(G1-G3) < 0.001 

Frequency (subj) 

G1: 7.8 (1.8-13.0) 

G2: 7.4 (2-14) 

G3: 10 (3.9-13.4) 

P(G1-G3) = 0.002 

Nocturia (subj) 

G1: 0 (0-3.0) 

G2: 0 (0-2.5) 

G3: 1 (0-3.6) 

P(G1-G3) = 0.002 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

+ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-450 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Wang et al., 

2006 

(continued) 

UI (subj) 

G1: 0.5 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

P(G1-G3) = 0.413 

P values before 

vs. after 

treatment 

Warning time, s 

(range): 

G1: 0.002 

G2: 0.001 

G3: 0.532 

MVV, mL/void 

(range): 

G1: 0.018 

G2: 0.004 

G3: 0.979 

Daily voided 

volume, mL 

(range): 

G1: 0.024 

G2: 0.728 

G3: 0.627 

Pad per day 

(range): 

G1: 0.010 

G2: 0.662 

G3: 0.501 

Urgency (subj): 

G1: <0.001 

G2: <0.001 

G3: 0.003 

Frequency (subj): 

G1: <0.001 

G2: <0.001 

G3: 0.070 

Nocturia (subj): 

G1: 0.001 

G2: 0.394 

G3: 0.176 

UI (subj): 

G1: 0.814 

G2: 0 083 

G3: 0.854 

C-451 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Wyman et al. 

1998 

Country and 

setting: 

US, Academic 

medical center 

Enrollment 

period: 

NR 

Funding: 

NIH 

Author 

industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

12-wk program of 

patient education, 

self-monitoring of 

voiding behaviors, 

compliance 

assessment, and 

positivereinforcement 

techniques 

administered by 

trained RNs 

Groups: 

G1: Bladder 

Training (BT) 

G2: Pelvic muscle 

exercise (PME) 

G3: Combination 

therapy (CT) 

N at enrollment: 

Total: 204 

G1: 68 

G2: 69 

G3: 67

N at follow-up, 3 

mos: 

G1: 68 

G2: 64 

G3: 61 

Age, mean ± SD: 

G1: 60 ± 10 

G2: 62 ± 10 

G3: 61 ± 9 

Race/ethnicity, n 

(%): 

White: 

G1: 64 (94) 

G2: 62 (90) 

G3: 49 (91) 

Parity (vaginal 

births), mean ± 

SD: 

G1: 2.4 ± 1.7 

G2: 2.6 ± 1.9 

G3: 2.5 ± 1.7 

P = 0.846 

Inclusion criteria: 

• Age ≥ 45 

• Community 

dwelling 

• Mentally intact 

• Able to toilet 

independently 

• Urine loss 

≥1x/wk 

• Urodynamic 

evidence of GUI, 

DI or both 

Exclusion 

criteria: 

• Reversible 

cases of UI 

• Uncontrolled 

metabolic 

conditions 

• Residual urine 

volume after 

voiding > 100mL

• UTI 

• Genitourinary 

fistula 

• Indwelling 

catheterization 

• Inability to 

correctly perform 

a pelvic muscle 

contraction on 

digital exam 

Stress urinary 

incontinence, n 

(%): 

G1: 19 (28) 

G2: 35 (51) 

G3: 22 (33) 

P = 0.015 

Urge urinary 

incontinence, n 

(%): 

G1: 8(12) 

G2: 6(9) 

G3: 10(15) 

Mixed urinary 

incontinence, n 

(%): 

G1: 41 (60) 

G2: 27 (39) 

G3: 35 (52) 

P = 0.044 

Genuine stress 

incontinence by 

urodynamics, n 

(%): 

G1: 48 (71) 

G2: 48 (70) 

G3: 49 (73) 

Detrusor 

Instability by 

urodynamics, n 

(%): 

G1: 9 (13) 

G2: 10 (14) 

G3: 10 (15) 

DI + GSI by 

urodynamics, n 

(%): 

G1: 11 (16) 

G2: 11 (16) 

G3: 8 (12) 

Incontinence 

episodes/wk, 

mean ± SD: 

G1: 14.6 ± 11.2 

G2: 16.8 ± 17.1 

G3: 14.9 ± 13.8 

Incontinence 

episodes/wk, 

immediately after 

treatment, mean ± 

SD: 

G1: 10.6 ± 16.3 

G2: 9.6 ± 10.8 

G3: 6.8 ± 10.7 

P = 0.004 

G1/G2: P = 0.796

G1/G3: P = 0.006

G2/G3: P = 0.003 

Incontinence 

episodes/wk, 

immediately after 

treatment, DI ± 

GSI subgroup, 

mean ± SD: 

G1: 6.2 ± 9.1 

G2: 11.9 ± 12.7 

G3: 5.8 ± 9.5 

Incontinence 

episodes, % 

reduction, 

immediately after 

treatment, n (%): 

100%: 

G1: 12 (18) 

G2: 8 (13) 

G3: 19 (31) 

75-99%: 

G1: 11 (16) 

G2: 8 (13) 

G3: 14 (23) 

50-74%: 

G1: 12 (18) 

G2: 20 (31) 

G3: 10 (16) 

0-49%: 

G1: 14 (21) 

G2: 13 (20) 

G3: 10 (16) 

None/worse: 

G1: 19 (28) 

G2: 15(23) 

G3: 8 (13) 

P = 0.050 

Incontinence 

episodes/wk, 3 

mos, mean ± SD: 

G1: 10.0 ± 12.0 

G2: 9.4 ± 14.0 

G3: 8.1 ± 12.4 

P = 0.126

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-452 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Wyman et al. 

1998 

(continued) 

BMI, kg/m2

 ± SD: 

G1: 28.4 ± 6.6 

G2: 27.6 ± 5.8 

G3: 26.8 ± 5.6 

P = 0.288 

Incontinence 

episodes/wk, DI ± 

GSI subgroup, 

mean ± SD: 

G1: 14.3 ± 10.3 

G2: 20.7 ± 22.4 

G3: 16.2 ± 13.7 

Previous medical 

treatment for UI, 

n (%): 

G1: 14 (21) 

G2: 14 (21) 

G3: 16 (24) 

Previous surgical 

treatment for UI, 

n (%): 

G1: 15 (22) 

G2: 14 (21) 

G3: 22 (33) 

UDI QoL, mean ± 

SD: 

G1: 130.1 ± 48.8 

G2: 119.7 ± 49.9 

G3: 118.9 ± 46.9 

UDI QoL, DI ± GSI 

subgroup, mean 

± SD: 

G1: 143.2 ± 54.0 

G2: 133.2 ± 59.6 

G3: 115.4 ± 42.5 

IIQ-R incontinence impact, 

mean ± SD: 

G1: 93.7 ± 74.2 

G2: 75.6 ± 67.1 

G3: 84.6 ± 67.8 

IIQ-R incontinence impact, DI 

± GSI subgroup, 

mean ± SD: 

G1: 118.5 ± 84.4

G2: 93.7 ± 90.3 

G3: 84.0 ± 66.9 

Incontinence 

episodes, % 

reduction, 3 mos, 

n (%): 

100%: 

G1: 10 (16) 

G2: 13 (20) 

G3: 16 (27) 

75-99%: 

G1: 9 (15) 

G2: 12 (22) 

G3: 13 (22) 

50-74%: 

G1: 9 (15) 

G2: 9 (14) 

G3: 6 (10) 

0-49%: 

G1: 15 (24) 

G2: 12 (18) 

G3: 15 (25) 

None/worse: 

G1: 19 (31) 

G2: 17 (26) 

G3: 10 (17) 

P = 0.587 

UDI QoL, 

immediately after 

treatment, mean ± 

SD: 

G1: 95.5 ± 54.4 

G2: 90.8 ± 52.0 

G3: 64.4 ± 48.6 

UDI QoL, 

immediately after 

treatment, DI ± 

GSI subgroup, 

mean ± SD: 

G1: 86.8 ± 54.8 

G2: 114.8 ± 70.3 

G3: 67.6 ± 48.5 

P = 0.054 

G1/G2: P = 0.37

G1/G3: P = 0.956

G2/G3: P = 0.038 

UDI QoL, 3 

months, mean ± 

SD: 

G1: 91.7 ± 55.0 

G2: 85.0 ± 52.4 

G3: 72.8 ± 50.4 

P = 0.203 

C-453 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Wyman et al., 

1998 

(continued) 

IIQ-R incontinence impact, 

immediately after 

treatment, mean ± 

SD: 

G1: 72.1 ± 75.2 

G2: 56.8 ± 61.4 

G3: 46.6 ± 65.3 

IIQ-R incontinence impact, 

immediately after 

treatment, DI ± 

GSI subgroup, 

mean ± SD: 

G1: 81.2 ± 88.7 

G2: 89.9 ± 79.4 

G3: 31.8 ± 34.4 

P = 0.0301 

G1/G2: P = 0.357

G1/G3: P = 0.084

G2/G3: P = 0.009 

IIQ-R incontinence impact, 3 

months, mean ± 

SD: 

G1: 65.7 ± 80.2 

G2: 59.3 ± 67.7 

G3: 59.8 ± 83.9 

P = 0.850 

Patient 

perception of 

improvement, 

immediately after 

treatment, n (%):

Much: 

G1: 25 (38) 

G2: 19 (30) 

G3: 32 (52) 

Some: 

G1: 18 (27) 

G2: 29 (46) 

G3: 23 (38) 

None: 

G1: 20 (30) 

G2: 13 (21) 

G3: 4 (7) 

Worse: 

G1: 3 (5) 

G2: 2 (3) 

G3: 2 (3) 

P = 0.011 

C-454 
Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Wyman et al., 

1998 

(continued) 

Patient 

perception of 

improvement, 3 

mos, n (%): 

Much: 

G1: 21 (35) 

G2: 24 (37)

G3: 31 (53) 

Some: 

G1: 16 (27) 

G2: 21 (33) 

G3: 13 (22) 

None: 

G1: 19 (32) 

G2: 16 (25) 

G3: 12 (21) 

Worse: 

G1: 4 (7) 

G2: 3 (5) 

G3: 2 (4) 

P = 0.414 

Patient satisfaction, immediately 

after treatment, n 

(%): 

Very satisfied: 

G1: 42 (64) 

G2: 46 (73) 

G3: 50 (82) 

Slightly satisfied: 

G1: 6 (9) 

G2: 10 (16) 

G3: 7 (11) 

Neither 

G1: 12 (21) 

G2: 6 (10) 

G3: 3 (5) 

Dissatisfied: 

G1: 4 (6) 

G2: 1 (2) 

G3: 1 (2) 

Patient satisfaction, 3 mos, n 

(%): 

Very satisfied: 

G1: 36 (60) 

G2: 42 (66) 

G3: 45 (78) 

Slightly satisfied: 

G1: 11 (18) 

G2: 11 (17) 

G3: 6 (10) 

C-455 
C-456 

Evidence Table 4. KQ 2 Behavioral Treatment of OAB (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Wyman et al., 

1998 

(continued) 

Neither: 

G1: 8 (13) 

G2: 10 (16) 

G3: 5 (9) 

Dissatisfied: 

G1: 5 (8) 

G2: 1 (2) 

G3: 2 (3) 

P = 0.310 
Evidence Table 5. KQ2 Complementary and Alternative Therapies 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Emmons and 

Otto, 2005 

Country and 

setting: 

US, Academic 

medical center

Enrollment 

period: 

July 2000 to 

October 2002

Funding: 

Supported in 

part by grants 

from the Oregon 

Health Science 

Foundation and 

the Public 

Health Service 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Acupuncture 

Groups: 

G1: acupuncture 

with needles 

placed at sites 

intended to 

address 

overactive 

bladder with UUI; 

administered for 

20 minutes during 

4 weekly sessions 

G2: acupuncture 

with needles 

placed at sites 

intended to 

support 

relaxation; 

administered for 

20 minutes during 

4 weekly sessions 

N at enrollment: 

G1: 44 

G2: 41 

N at follow-up, 2-

4 weeks: 

G1: 38 

G2: 36 

Women, %: 

100 

Age, mean ± SD: 

G1: 53 ± 13 

G2: 51 ± 12 

Race/ethnicity: 

Minority, % 

Parity, mean ± 

SD: 

G1: 1.8 ± 1.6 

G2: 1.8 ± 1.6 

Menopausal, n: 

G1: 21 

G2: 20 

Inclusion criteria: 

• > 8 voids per day

• Subjective 

urgency to void 

• Urge-associated 

incontinence ≥

twice during a 3 

day period 

Exclusion criteria: 

• Current treatment 

with medications 

for OAB 

• Current treatment 

with acupuncture 

for other 

indications 

• Unable to walk 

• Unable to 

complete a 3-day 

voiding diary 

• Hematuria 

• Untreated UTI 

UUI episodes/3 

days, mean ± 

SD: 

G1: 16.2 ± 11.1 

G2: 15.4 ± 10.2 

P = 0.68 

Incontinence 

episodes/3 days, 

mean ± SD: 

G1: 6.3 ± 7.3 

G2: 8.9 ± 9.2 

P = 0.09 

Voids/3 days, 

mean ± SD: 

G1: 30.4 ± 7.8 

G2: 32.7 ± 11.5 

P = 0.40 

Urinary distress 

inventory score, 

mean ± SD: 

G1: 8.4 ± 3.6 

G2: 8.6 ± 5.5 

P = 0.87 

Incontinence 

impact 

questionnaire 

score, mean ± 

SD: 

G1: 8.9 ± 2.8 

G2: 9.1 ± 2.6 

P = 0.80 

Functional 

bladder capacity 

(mL), mean ± 

SD: 

G1: 210 ± 88 

G2: 199 ± 84 

P = 0.50 

Cystometric max 

capacity (mL), 

mean ± SD: 

G1: 371 ± 161 

G2: 341 ± 126 

P = 0.49 

Cystometric 

volume (mL), 

first urge to 

void, mean ± SD:

G1: 61 ±+/- 67 

G2: 69 ±+/- 52 

P = 0.84 

UUI episodes/3 

days, mean ± SD 

(% change): 

G1: 11.4 ± 8.8 (30) 

G2: 15.0 ± 9.4 (3) 

G1/BL: P < 0.003 

G1/G2: P = 0.016 

Incontinence 

episodes/3 days, 

mean ± SD (% 

change): 

G1: 2.6 ± 3.1 (59) 

G2: 5.3 ± 5.9 (40) 

G1/BL: P < 0.003 

G2/BL: P < 0.003 

G1/G2: P = 0.71 

Voids/3 days, 

mean ± SD (% 

change): 

G1: 26.2 ± 7.1 (14) 

G2: 33.1 ± 16.1 (4) 

G1/G2: P = 0.03 

Urinary distress 

inventory score, 

mean ± SD (% 

change): 

G1: 3.6 ± 3.2 (57) 

G2: 5.8 ± 4.8 (32) 

G1/BL: P < 0.003 

G2/BL: P < 0.003 

G1/G2: P = 0.05 

Incontinence 

impact 

questionnaire 

score, mean ± SD 

(% change): 

G1: 4.3 ± 2.7 (52) 

G2: 7.0 ± 3.5 (23) 

G1/BL: P < 0.003 

G2/BL: P < 0.003 

G1/G2: P = 0.004 

Functional 

bladder capacity 

(mL), mean ± SD 

(% change): 

G1: 236 ± 99 (12) 

G2: 196 ± 85 (-2) 

G1/BL: P < 0.03 

G1/G2: P = 0.01 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection criteria: 

+ 

Loss to followup: + 

Drop-out rates: ++ 

Power calculation: 

+ 

Statistical issues: + 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-453 
Evidence Table 5. KQ2 Complementary and Alternative Therapies (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Emmons and 

Otto, 2005 

(continued)

Cystometric 

volume (mL), 

strong urge to 

void, mean ± SD:

G1: 274 ± 144 

G2: 241 ± 100 

P = 0.26 

Detrusor contractions during 

cystometry, n: 

G1: 7 

G2: 11 

P = 0.22 

Incontinence 

surgery, n: 

G1: 8 

G2: 6 

Cystometric max 

capacity (mL), 

mean ± SD (% 

change): 

G1: 415 ± 205 (12) 

G2: 356 ± 193 (4) 

G1/G2: P = 0.049 

Cystometric 

volume (mL), first 

urge to void, 

mean ± SD (% 

change): 

G1: 65 ± 80 (6) 

G2: 57 ± 75 (-19) 

G1/G2: P = 0.47 

Cystometric 

volume (mL), 

strong urge to 

void, mean ± SD 

(% change): 

G1: 297 ± 167 (8) 

G2: 276 ± 156 (14) 

G1/BL: P < 0.03 

G2/BL: P < 0.03 

G1/G2: P = 0.75 

Detrusor contractions during 

cystometry, n 

(% change): 

G1: 6 (3) 

G2: 10 (3) 

G1/G2: P = 0.98 

Bleeding/bruising 

from the needles, 

%: 

23 

Minor discomfort 

with needle 

placement, %: 

25 

C-454 
Evidence Table 5. KQ2 Complementary and Alternative Therapies (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Freeman and 

Baxby, 1982 

Country and 

setting: 

UK, Academic 

medical center 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Case series 

Intervention: 

12 sessions of 

hypnotherapy

Groups: 

NA 

N at enrollment: 

63

N at follow-up: 

44

Women, %: 

100 

Age, mean ± SD: 

44.0 ± 15.6

Race/ethnicity: 

NR 

Follow-up: 

3-14 months

Inclusion criteria: 

• Women 

• Detrusor 

instability by 

urodynamics 

• Normal 

cystoscopy 

• Normal 

neurological 

findings 

• No drugs that 

affect the 

detrusor 

Exclusion criteria:

• Genuine stress 

incontinence 

• Flow rate < 15 

ml/s 

• Voiding pressure 

> 70 cm H2O 

Max cystometric 

capacity (mL), 

full study 

population, 

mean ± SD 

(range): 

410.0 ± 13.3 

(120-650) 

Max cystometric 

capacity (mL), 

urodynamic 

studies 

performed, 

mean ± SD: 

378 ± 126 

Height of 

unstable 

contraction (cm 

H2O), full study 

population, 

mean ± SD 

(range): 

43.6 ± 22.1 (15-

100) 

Height of 

unstable 

contraction (cm 

H2O), urodynamic studies 

performed, 

mean ± SD: 

57.5 ± 23.3 

Bladder volume 

(mL), first 

unstable 

contraction, full 

study 

population, 

mean ± SD 

(range): 

318.0 ± 14.4 (50-

650) 

Bladder volume 

(mL), first 

unstable 

contraction, urodynamic studies 

performed, 

mean ± SD: 

245 ± 159 

Max cystometric 

capacity (mL), 

mean ± SD: 

487 ± 117 

Max cystometric 

capacity (mL), 

mean change ± 

SD: 

92.3 ± 112.2 

P < 0.001 

Height of unstable 

contraction (cm 

H2O), mean ± SD: 

39.0 ± 13.2 

Height of unstable 

contraction 

difference (cm 

H2O), mean 

change ± SD: 

-18.5 ± 18.9 

P < 0.01 

Bladder volume 

(mL), first 

unstable 

contraction, mean 

± SD: 

337 ± 123 

Bladder volume 

(mL), first 

unstable 

contraction, mean 

change ± SD: 

92.2 ± 126 

P < 0.02 

Symptom free, n: 

29 

Considerably 

improved 

symptoms, n: 

14 

No change in 

symptoms, n: 

7 

Relapse, n: 

1 year: 3 

10 months: 1 

8 months: 1 

7 months: 1 

2 months: 1 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: - 

Power calculation: -

Statistical issues: - 

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-455 
Evidence Table 5. KQ2 Complementary and Alternative Therapies (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Mak et al., 2007 

Country and 

setting: 

Hong Kong, 

China, 

Gynecological 

hospital

Enrollment 

period: 

January 2003 to 

March 2003

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Foot reflexology 

vs nonspecific 

foot message

Groups: 

G1: foot 

reflexology for 45 

min 

G2: nonspecific 

foot massage for 

45 min 

N at enrollment: 

G1: 60 

G2: 60 

N at follow-up: 

G1: 54 

G2: 43 

Women, %: 

100

Age, mean ± SD: 

G1: 56.0 ± 13.4 

G2: 56.4 ± 9.1 

Race/ethnicity: 

NR 

Menopausal, n 

(%): 

G1: 33 (57.8) 

G2: 29 (67.4) 

P = 0.533 

BMI, kg/m2

, 

median (IQR): 

G1: 24.2 (21.6, 

27.4) 

G2: 24.7 (21.8, 

26.7) 

Inclusion criteria: 

• Majority of 

leakage related to 

UI 

• Taking 

antimuscarinics 

with required 3 

week washout 

Exclusion criteria: 

• SUI 

• UTI 

• Interstitial cystitis 

• Urinary tract 

obstruction 

• Organic disease 

of bladder or 

urethra 

• Pregnant 

• Breast-feeding 

• Pelvic, vaginal, or 

bladder surgery 

within 6 mos 

• Heart disease 

• Abnormal EKG 

UUI episodes, 

median (IQR): 

G1: 0.5 (0, 2) 

G2: 1.0 (0, 2) 

P = 0.86 

Urgency 

episodes, 

mean ± SD: 

G1: 2.22 ± 1.42 

G2: 2.14 ± 1.12 

P = 0.75 

Voids/day, mean 

± SD: 

G1: 11.3 ± 4.68 

G2: 10.23 ± 3.53 

P = 0.22 

Daytime voids/ 

day, mean ± SD:

G1: 9.07 ± 4.59 

G2: 8.09 ± 3.83 

P = 0.26 

Nocturia 

episodes, 

median (IQR): 

G1: 2 (1, 3) 

G2: 2 (1, 3) 

P = 0.94 

Perceived 

severity, median 

(IQR): 

G1: 5.6 (3.9, 7.1) 

G2: 5.3 (3.1, 7.0) 

P = 0.18 

KHQ, general 

health, mean 

score ± SD: 

G1: 56.0 ± 18.1 

G2: 55.8 ± 17.1 

P = 0.955 

KHQ, incontinence impact, 

mean score ± 

SD: 

G1: 68.5 ± 30.6

G2: 69.7 ± 27.9 

P = 0.836 

UUI episodes, 

median change 

(IQR): 

G1: 0 (-1, 0) 

G2: 0 (-1, 0) 

Urgency 

episodes, mean 

change ± SD: 

G1: 0.27 ± 0.94 

G2: 0.48 ± 1.12 

P = 0.32 

Voids/day, mean 

change ± SD: 

G1: 2.18 ± 2.80 

G2: 1.04 ± 2.92 

P = 0.055 

Daytime voids/ 

day, mean change 

± SD: 

G1: 1.90 ± 2.76 

G2: 0.55 ± 3.21 

P = 0.029 

Nocturia 

episodes, median 

change (IQR): 

G1: -1 (-1, 0) 

G2: -1 (-1, 0)* 

P = 0.46 

Frequency, 

change from > 8 

to ≤ 8 after 

treatment, n (%): 

G1: 11 (20.3) 

G2: 7 (16.2) 

P = 0.482 

Perceived 

severity, median 

change (IQR): 

G1: 1.5 (-0.65, 3.4) 

G2: 1.2 (-0.8, 3) 

P = 0.7 

Perceived change 

of bladder 

symptoms, 

median (IQR): 

G1: 1.5 (0.5, 3) 

G2: 1.1 (0, 2) 

P = 0.172 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection criteria: 

+ 

Loss to followup: - 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: + 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++ 

Length of followup: 

- 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-456 
Evidence Table 5. KQ2 Complementary and Alternative Therapies (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Mak et al., 2007 

(continued) 

KHQ, role 

limitations, 

mean score ± 

SD: 

G1: 39.8 ± 33.7 

G2: 41.4 ± 33.8 

P = 0.811 

KHQ, physical 

limitations, 

mean score ± 

SD: 

G1: 37.3 ± 35.0 

G2: 54.2 ± 78.6 

P = 0.160 

KHQ, social 

limitations, 

mean score ± 

SD: 

G1: 28.6 ± 30.2 

G2: 35.1 ± 30.5 

P = 0.294 

KHQ, personal 

limitations, 

mean score ± 

SD: 

G1: 17.2 ± 29.9 

G2: 24.4 ± 31.5 

P = 0.358 

KHQ, emotion, 

mean score ± 

SD: 

G1: 36.2 ± 33.5 

G2: 44.1 ± 35.9 

P = 0.262 

KHQ, sleep/ 

energy, mean 

score ± SD: 

G1: 36.1 ± 33.9 

G2: 33.3 ± 29.9 

P = 0.674 

KHQ, severity 

measures, 

mean score ± 

SD: 

G1: 25.8 ± 21.1 

G2: 25.5 ± 20.8 

P = 0.959 

Peak flow rate, 

ml/s ± SD: 

G1: 16.7 ± 9.75 

G2: 18.5 ± 7.69 

KHQ, general 

health, mean 

change ± SD: 

G1: -5.55 ± 19.8 

G2: -5.23 ± 19.3 

P = 0.936 

KHQ, incontinence impact, 

mean change ± 

SD: 

G1: -9.87 ± 32.7

G2: -14.72 ± 33.5 

P = 0.477 

KHQ, role 

limitations, mean 

change ± SD: 

G1: -3.08 ± 31.0 

G2: -2.32 ± 28.5 

P = 0.902 

KHQ, physical 

limitations, mean 

change ± SD: 

G1: -1.54 ± 27.9 

G2: -12.8 ± 71.9 

P = 0.337 

KHQ, social 

limitations, mean 

change ± SD: 

G1: -0.51 ± 29.1 

G2: -6.97 ± 27.6 

P = 0.267 

KHQ, personal 

limitations, mean 

change ± SD: 

G1: 2.15 ± 29.1 

G2: -10.1 ± 29.8 

P = 0.116 

KHQ, emotion, 

mean change ± 

SD: 

G1: 1.44 ± 30.4 

G2: -10.0 ± 31.6 

P = 0.074 

KHQ, sleep/ 

energy, mean 

change ± SD: 

G1: -5.8 ± 36.9 

G2: -6.2 ± 36.2 

P = 0.964 

C-457 
C-458 

Evidence Table 5. KQ2 Complementary and Alternative Therapies (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion Criteria

Symptom 

Characteristics Outcomes Quality Rating 

Mak et al., 2007 

(continued)

Max cystometric 

capacity, ml ± 

SD: 

G1: 378.1 ± 89.0 

G2: 347.8 ± 94.0 

P = 0.11 

Duration of 

symptoms, 

median (IQR): 

G1: 5 (3, 9) 

G2: 6 (3, 10) 

Previous 

treatment for 

idiopathic 

detrusor 

overactivity, n 

(%): 

G1: 27 (47.3) 

G2: 22 (44.9) 

Previous 

continence 

surgery, n (%): 

G1: 5 (8.8) 

G2: 7 (16.3) 

KHQ, severity 

measures, mean 

change ± SD: 

G1: -0.37 ± 8.8 

G2: -1.86 ± 21.3 

P = 0.720 

Believed to have 

received 

intervention, %: 

G1: 88.9 

G2: 67.4 

P = 0.012 
C-459 

Evidence Table 6. KQ 3 Comparison of Treatments 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Abrams et al., 

1998 

Country and 

setting: 

UK, Ireland, 

Sweden, 

Academic medical 

center 

Enrollment 

period: 

July 1995 to July 

1996 

Funding: 

Pharmacia 

Upjohn 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine vs. 

oxybutynin vs. 

placebo x 12 wks 

Groups: 

G1: Tolterodine 

2mg bid (dose 

could be reduced 

to 1.5 mg b.i.d.) 

G2: Oxybutynin 

5mg t.i.d. (dose 

could be reduced 

to 2.5 mg t.i.d.) 

G3: Placebo 

N at enrollment: 

G1: 118 

G2: 118 

G3: 57 

N at follow-up: 

G1: 118 

G2: 117 

G3: 56 

Women, n (%): 

G1: 91 (77.1) 

G2: 88 ( 74.5) 

G3: 43 (75.4) 

Age, mean 

(range): 

G1: 55 (19-80) 

G2: 58 (21-80) 

G3: 58 (26-78) 

Inclusion criteria: 

• Age ≥ 18 

• UDS confirmed 

bladder 

overactivity 

• ≥ 8 voids/day 

• ≥ 1 episode 

UUI/ day 

Exclusion 

criteria: 

• SUI 

• Detrusor 

hyperreflexia 

• Hepatic, renal, 

hematological 

disorders 

• Symptomatic or 

recurrent UTI 

• BOO 

• Bladder 

retraining 

• Electrical 

stimulation 

therapy 

• Indwelling 

catheter 

• Intermittent 

catherization 

• Pregnant/ 

nursing 

• Women without 

reliable BC 

Incontinence 

episodes, n (%): 

G1: 93 (79)

G2: 88 (75)

G3: 40 (70)

Incontinence 

episodes/day, 

mean (range): 

G1: 2.9 (0.1-24.0)

G2: 2.6 (0.1-24.0)

G3: 3.3 (0.1-23.5)

Voids/day, mean 

(range): 

G1: 11.5 (6.3-

37.0) 

G2: 10.7 (5.3-

27.7) 

G3: 11.7 (6.9-

34.4) 

≥ 8 voids/day, n 

(%): 

G1: 112 (95) 

G2: 109 (92) 

G3: 53 (93) 

Voided volume 

(mL), mean 

(range): 

G1: 166 (55-426)

G2: 176 (57-423)

G3: 157 (59-276)

Previous OAB 

therapy, n (%): 

G1: 61 (52)

G2: 71 (60)

G3: 43 (75) 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -1.3 ± 3.2 

G2: -1.7 ± 3.1 

G3: -0.9 ± 1.5 

G1/G3: P = 0.22 

G2/G3: P = 0.023 

Voids/day, mean 

change ± SD: 

G1: -2.7 ± 3.8 

G2: -2.3 ± 2.7 

G3: -1.6 ± 3.6

G1/G3: P = 0.002 

G2/G3: P = 0.068 

Voided volume 

(mL), mean 

change ± SD: 

G1: 38 ± 54 

G2: 47 ± 58 

G3: 6 ± 42 

G1/G3: P < 0.001 

G2/G3: P < 0.001 

Subjective 

improvement in 

bladder 

symptoms, %: 

G1: 50 

G2: 49 

G3: 47 

Dose reductions, 

n (%): 

G1: 9 (8) 

G2: 38 (32) 

G3: 1 (2) 

G2/G1: P < 0.001 

G2/G3: P < 0.001 

Dry mouth, n (%): 

G1: 59 (50) 

G2: 102 (86) 

G3: 12 (21) 

G1/G3: P < 0.001 

G2/G1: P < 0.001

G2/G3: P < 0.001 

Dyspepsia, n (%): 

G1: 11 (9) 

G2: 27 (23) 

G3: 3 (5) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-460 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Abrams et al., 

1998 

(continued)

 Nausea, n (%): 

G1: 4 (3) 

G2: 7 (6) 

G3: 6 (11) 

Upper 

respiratory 

infection, n (%): 

G1: 12 (10) 

G2: 3 (3) 

G3: 8 (14) 

Adverse events 

reported, N: 

G1: 302 

G2: 412 

G3: 117 

Patients with ≥ 1 

AE, n (%): 

G1: 105 (89) 

G2: 114 (97) 

G3: 46 (81) 

G2/G1: P = 0.023 

G2/G3: P < 0.001 

Discontinued 

due to AEs, n 

(%): 

G1: 10 (8) 

G2: 20 (17) 

G3: 1 (2) 
C-461 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Arruda et al., 2008 

Country and 

setting: 

Brazil, community 

Enrollment 

period: 

August 2001 to 

September 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

None 

Design: 

RCT 

Intervention: 

Oxybutynin vs. 

functional 

electrostimulation 

vs. pelvic floor 

training

Groups: 

G1: Oxybutynin 5 

mg b.i.d. 

G2: Ambulatory 

stimulation applied 

vaginally 

G3: Pelvic floor 

exercises with a 

therapist and at 

home 

N Screened: 

81 

N at enrollment: 

G1: 22 

G2: 21 

G3: 21 

N at follow-up: 

G1: 22 

G2: 21 

G3: 21 

Age, range: 

35-80 

Race/ethnicity: 

NR 

Women, %: 

100 

Length of follow 

up: 12 weeks 

Inclusion criteria: 

• Communitydwelling 

• Dx of OAB and 

DO 

• Capable of 

completing a 

bladder diary 

and performing a 

pelvic muscle 

floor contraction 

• For those with 

MUI, urge was 

predominant 

Exclusion 

criteria: 

• Hx of psychiatric 

or neurologic 

illness 

• Persistent UTI 

• Inability to 

comply with 

regular follow-up 

visits 

• Current 

pregnancy 

• Postvoid 

residual volume 

> 100 ml 

• Contraindication

s to 

anticholinergic 

therapy 

• Cardiac 

pacemaker 

• Type III SUI 

• Uncontrolled 

metabolic 

conditions or 

indwelling 

catheterization 

• Using 

medications 

including 

anticholinergic 

drugs, calcium 

antagonists, 

beta agonists, 

dopamine 

agonists, striated 

muscle relaxants 

or estrogens 

• Any uterine 

prolapse 

UUI episodes/ 

week, mean ± 

SD: 

G1: 13.8 ± 11.6 

G2: 13.5 ± 15.6 

G3: 16.4 ± 17.2 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 1.7 ± 1.5 

G2: 1.9 ± 1.9 

G3: 1.4 ± 1.2 

Pads/day, mean 

± SD: 

G1: 2.6 ± 2.7 

G2: 2.3 ± 2.4 

G3: 2.7 ± 1.5 

Voids/day, mean 

± SD: 

G1: 7.7 ± 2.6 

G2: 8.6 ± 3.4 

G3: 6.8 ± 2.2 

Residual volume 

mean mL ± SD: 

G1: 3.2 ± 6.3 

G2: 1.0 ± 2.6 

G3: 1.8 ± 3.3 

Volume, first 

desire to void, 

mean mL ± SD: 

G1: 117.7 ± 68.9 

G2: 102.4 ± 51.1 

G3: 86.7 ± 38.9 

Maximal 

cystometric 

capacity, mean 

mL ± SD: 

G1: 410.4 ± 194.1 

G2: 350.0 ± 212.9

G3: 424.0 ± 149.0

UUI episodes/ 

week, mean ± 

SD: 

G1: 7.0 ± 10.6 

G2: 7.9 ± 13.7 

G3: 7.8 ± 15.3

G1/BL: P = 0.007 

G2/BL: P = 0.039 

G3/BL: P = 0.035 

Urgency 

resolved, n (%): 

G1: 14 (63.6) 

G2: 11 (52.4) 

G3: 12 (57.1) 

P = 0.754 

Satisfied, n (%):

G1: 17 (77.3) 

G2: 11 (52.4) 

G3: 16 (76.2) 

P = 0.142 

Nocturia 

episodes/week, 

mean ± SD: 

G1: 0.9 ± 0.8 

G2: 1.2 ± 1.3 

G3: 1.0 ± 1.1

G1/BL: P = 0.003 

G2/BL: P = 0.036 

G3/BL: P = 0.086 

Pads/day, mean 

± SD: 

G1: 0.9 ± 1.5 

G2: 0.9 ± 1.7 

G3: 0.8 ± 1.3

G1/BL: P < 0.001 

G2/BL: P = 0.004 

G3/BL: P < 0.001 

Voids/day, mean 

± SD: 

G1: 6.4 ± 1.6 

G2: 7.9 ± 2.3 

G3: 7.1 ± 2.1

G1/BL: P = 0.014 

G2/BL: P = 0.291 

G3/BL: P = 0.441 

Residual volume, 

mean mL ± SD: 

G1: 4.7 ± 9.4 

G2: 1.1 ± 2.5 

G3: 2.1 ± 3.5

G1/BL: P = 0.425 

G2/BL: P = 0.760 

G3/BL: P = 0.297 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of 

followup: + 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 
C-462 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 2008 

(continued) 

 Involuntary 

detrusor 

contraction 

volume mean mL 

± SD: 

G1: 189.5 ± 114.1 

G2: 220.0 ± 127.2

G3: 239.3 ± 163.0

Involuntary 

detrusor 

contraction 

maximal 

pressure (mm 

H20): 

G1: 39.4 ± 26.1 

G2: 43.7 ± 22.9 

G3: 34.2 ± 19.8 

Volume first 

desire to void, 

mean mL ± SD: 

G1: 157.3 ± 63.8 

G2: 123.8 ± 59.0 

G3: 137.6 ± 76.7

G1/BL: P = 0.019 

G2/BL: P = 0.091 

G3/BL: P = 0.017 

Maximal 

cystometric 

capacity mean 

mL ± SD: 

G1: 517.3 ± 191.7 

G2: 436.6 ± 178.7 

G3: 489.0 ± 141.3

G1/BL: P = 0.001 

G2/BL: P = 0.017 

G3/BL: P = 0.113 

Involuntary 

detrusor 

contraction 

volume (mL): 

G1: 188.6 ± 183.2 

G2: 73.3 ± 112.4 

G3: 114.3 ± 154.2

G1/BL: P = 0.986 

G2/BL: P = 0.001 

G3/BL: P = 0.044 

Involuntary 

detrusor 

contraction 

maximal 

pressure, mm 

H20 ± SD: 

G1: 19.6 ± 20.9 

G2: 22.4 ± 30.1 

G3: 17.2 ± 25.5

G1/BL: P < 0.001 

G2/BL: P = 0.002 

G3/BL: P = 0.027 

Normal 

urodynamic 

evaluation, n (%):

G1: 8 (36.4) 

G2: 12 (57.1) 

G3: 11 (52.4) 

P = 0.358 

Persistent 

improvement at 1 

year: 

G1: 10/17 

G2: 4/11 

G3: 9/16 
C-463 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Arruda et al., 2008 

(continued)

 Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty 

voiding, n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0

Dry mouth, n (%): 

G1: 16 (72.7) 

G2: 0 

G3: 0 

Difficulty 

voiding, n (%): 

G1: 2 (9.1) 

G2: 0 

G3: 0 

Dizziness, n (%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Blurred vision, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 

Constipation, n 

(%): 

G1: 1 (4.5) 

G2: 0 

G3: 0 
C-464 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al. 1998 

Country and 

setting: 

US; academic 

health center 

outpatient geriatric 

medicine clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National Institutes 

on Aging 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted 

behavioral vs. 

drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback 

added to 

behavioral training 

in absence of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2:

Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

G1: 65 

G2: 67 

G3: 65 

N at follow-up: 

G1: 61 

G2: 55 

G3: 53 

Inclusion criteria: 

• Communitydwelling women 

≥ 55 years old 

• Ambulatory 

• ≥ 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Duration of 

symptoms, mean 

yrs ± SD: 

G1: 9.4 ± 10.8 

G2: 9.8 ± 11.9 

G3: 12.7 ± 15.9 

Restricted 

activity, (%): 

G1: 30.8 

G2: 32.8 

G3: 38.5 

Urge UUI only, 

%: 

G1: 49.2 

G2: 49.3 

G3: 47.7 

Accidents per 

week, mean n ± 

SD: 

G1: 15.8 ± 14.5 

G2: 15.9 ± 14.1 

G3: 15.4 ± 13.4 

P=.98 

Severity 

classification, %:

Mild (<5 

accidents/wk) 

G1: 18.5 

G2: 17.9 

G3: 18.5 

Moderate (5-10 

accidents/wk) 

G1: 29.2 

G2: 29.9 

G3: 27.7 

Severe (>10 

accidents/wk) 

G1: 52.3 

G2: 52.2 

G3: 53.8 

Previous 

treatment with 

surgery, %: 

G1: 20.0 

G2: 26.9 

G3: 29.2 

Accidents per 

week, mean ± 

SD: 

G1: 2.8 ± 4.7 

G2: 5.7 ± 9.8 

G3: 8.2 ± 11.6 

P=.005 

Percent 

reduction, mean

± SD: 

G1: 80.7 ± 24.8 

G2: 68.5 ± 37.2 

G3: 39.4 ± 80.0 

P<0.001 

Percent 

reduction, range: 

G1: -0.9 – 100 

G2: -85.7 – 100 

G3: -400.0 - 100 

Patient 

perceptions of 

progress in 

treatment 

Progress, %: 

Much better 

G1: 74.1 

G2: 50.9 

G3: 226.9 

Better 

G1: 25.9 

G2: 30.9 

G3: 38.5 

About the same 

G1: 0.0 

G2: 16.4 

G3: 28.8 

Worse 

G1: 0.0 

G2: 1.8 

G3: 5.8 

Estimate of % 

improvement, 

mean ± SD: 

G1: 81.6 ± 18.6 

G2: 66.4 ± 35.4 

G3: 45.1 ± 36.6 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-465 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al. 1998 

(continued)

Women, %: 

100 

Age, yrs ± SD: 

G1: 67.3 ± 7.6 

G2: 68.2 ± 7.5 

G3: 67.6 ± 7.6 

Race/ethnicity,: 

NR

Parity mean ± 

SD: 

G1: 2.8 ± 2.0 

G2: 2.1 ± 1.4 

G3: 2.7 ± 1.8 

 Previous 

treatment with 

medication, %: 

G1: 27.7 

G2: 35.8 

G3: 30.8 

Using estrogen, 

%: 

G1: 32.3 

G2: 38.8 

G3: 35.4 

Using diuretics, 

%: 

G1: 20.0 

G2: 14.9 

G3: 12.3 

Having fewer 

accidents, %: 

G1: 100.0 

G2: 87.3 

G3: 67.3 

Accidents are 

smaller, %: 

G1: 87.3 

G2: 78.8 

G3: 54.0 

Able to wear less 

protection, %: 

G1: 76.0 

G2: 56.0 

G3: 334.1 

Comfortable 

enough with 

treatment to 

continue 

indefinitely, %: 

G1: 96.5 

G2: 54.7 

G3: 43.1 

Patient 

satisfaction with 

progress, %: 

Completely 

satisfied 

G1: 77.6 

G2: 54.7 

G3: 43.1 

Somewhat 

satisfied 

G1: 22.4 

G2: 40.0 

G3: 34.0 

Not at all satisfied 

G1: 0.0 

G2: 10.9 

G3: 38.0 

Wish to receive 

another form of 

treatment, %: 

G1: 14.0 

G2: 75.5 

G3: 75.5 

p<0.001 for all 

comparisons 
C-466 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al. 1998 

(continued)

 Adverse effects, 

%, p compared to 

placebo G3: 

Dry mouth 

G1: 34.9 

G2: 96.9 

G3: 54.8 

p<0.001 

Inability to void 

G1: 6.3 

G2: 21.5 

G3: 3.2 

p=0.002 

Constipation 

G1: 22.2 

G2: 38.5 

G3: 37.1 

p=0.10 

Blurred vision 

G1: 9.5 

G2: 15.4 

G3: 9.7 

p=0.50 

Confusion 

G1: 6.3 

G2: 7.7 

G3: 11.3 

p=0.59 
C-467 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al. 2000 

[See Burgio et al., 

1998] 

Enrollment 

period: 

two weeks after 

completion of 

Burgio et al. 1998, 

#2440 

Funding: 

National Institute 

on Aging, grants 

AG 08010 and 

K04 00431 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Modified 

crossover of RCT 

Intervention: 

Participants 

whose treatment 

was not 

completely 

successful were 

given the 

opportunity to 

switch or use 

combined 

treatment; further 

reductions in 

incontinence were 

measured.

Groups: 

Treatment 

Changes:

G1: Previous 

oxybutynin to 

behavioral 

modification alone 

G2: Previous 

behavior alone to 

2.5 mg oxybutynin 

t.i.d. + behavioral 

therapy 

G3: Previous 

oxybutynin alone 

to 2.5 mg 

oxybutynin t.i.d. + 

behavioral therapy 

G4: Placebo to 

behavioral 

G5: Placebo to 

oxybutynin 

N at enrollment 

G1: 19 

G2: 8 

G3: 27 

G4: 34 

G5: 10 

N at follow-up: 

G1: 18 

G2: 8 

G3: 26 

G4: NR 

G5: NR 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

• not completely 

dry or satisfied 

with previous, 8-

wk treatment 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

% Reduction of 

incontinence 

after previous 

study (at 

baseline), mean: 

G1: 59.1 

G2: 57.5 

G3: 72.7 

G4: 22.9 

G5: 44.8 

Final % 

Reduction of 

incontinence 

mean, p: 

G1: 77.1, 0.109 

G2: 88.5, 0.034 

G3: 84.3, 0.001 

G4: 63.9, .002 

G5: 76.5, .012 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

Note: 29.2 of G3 declined to continue with drug therapy once they received behavioral modification. 
C-468 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 2001 

[See Burgio et al,. 

1998] 

Country and 

setting: 

US, University 

based 

Enrollment 

period: 

[See Burgio et al,. 

1998] 

Funding: 

NIH 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Psychological 

distress 

associated with 

pharmacologic 

treatment vs. 

behavioral vs. 

placebo 

Groups: 

G1: Behavioral 

training with 

biofeedback, 4 

visits 

G2: Oxybutynin 

2.5 mg P.O. t.i.d., 

up to a max of 5 

mg t.i.d. 

G3: Placebo 

N at enrollment: 

197 women 

N treated: 

169 

N at follow-up: 

155 (completed 

both pre and posttreatment 

psychological 

assessment) 

Age yrs, mean ± 

SD: 

67.5 ± 7.2 

Women, %: 

100 

Race/ethnicity, 

%: 

White: 97 

African American: 

3 

Inclusion criteria:

• ≥ 55 yrs old 

• Ambulatory 

• UUI ≥2x/wk (2 

wk bladder 

diary), 

persisting x 3 

mo 

• Predominant 

UUI 

• UDS evidence 

of bladder 

dysfunction (DI 

or maximal 

capacity ≤350 

mL) 

Exclusion 

criteria: 

• Contraindication 

to oxybutynin or 

behavioral 

treatment 

• Continual 

leakage 

• PVR > 200 mL 

• Uterine 

prolapse 

beyond the 

introitus 

• Decompensated 

CHF 

• Hx of malignant 

arrhythmias 

• Impaired mental 

status (MMSE 

<20) 

SCL-90-R scores 

± SD: 

Somatization 

G1: 56.0 (10.6) 

G2: 51.4 (10.8) 

G3: 52.4 (11.1) 

ObsessiveCompulsive: 

G1: 56.5 (10.7) 

G2: 56.6 (11.4) 

G3: 57.7 (10.0) 

Interpersonal 

Sensitivity 

G1: 53.8 (11.0) 

G2: 51.4 (11.9) 

G3: 50.4 (12.0) 

Depression 

G1: 54.7 (10.0) 

G2: 52.5 (9.7) 

G3: 51.0 (11.9) 

Anxiety 

G1: 48.7 (13.9) 

G2: 46.8 (12.0) 

G3: 47.2 (12.8) 

Hostility 

G1: 49.3 (10.7) 

G2: 45.9 (10.1) 

G3: 48.3 (10.4) 

Phobia 

G1: 47.5 (10.2) 

G2: 46.7 (10.3) 

G3: 45.7 (8.5) 

Paranoid Ideation 

G1: 48.6 (12.4) 

G2: 49.3 (11.1) 

G3: 46.1 (12.8) 

Psychoticism 

G1: 54.1 (10.7) 

G2: 52.1 (10.3) 

G3: 50.5 (11.2) 

Global Severity 

G1: 54.2 (11.1) 

G2: 52.5 (10.3) 

G3: 52.4 (11.2) 

 

Reduction in 

incontinence: 

G1: 83.3% 

G2: 74.4% 

G3: 41.4% 

P<0.001 

SCL-90-R scores 

± SD: 

Somatization 

G1: 51.8 (11.4) 

G2: 51.2 (9.8) 

G3: 49.8 (13.0) 

ObsessiveCompulsive: 

G1: 53.8 (13.9) 

G2: 53.9 (10.9) 

G3: 55.4 (11.0) 

Interpersonal 

Sensitivity 

G1: 49.5 (12.0) 

G2: 48.9 (11.2) 

G3: 49.2 (11.3) 

Depression 

G1: 51.5 (11.5) 

G2: 50.6 (10.7) 

G3: 51.4 (11.2) 

Anxiety 

G1: 46.1 (14.6) 

G2: 44.5 (12.3) 

G3: 45.8 (12.9) 

Hostility 

G1: 44.9 (10.8) 

G2: 44.6 (10.5) 

G3: 47.3 (11.2) 

Phobia 

G1: 47.1 (11.2) 

G2: 45.0 (8.3) 

G3: 45.1 (8.5) 

Paranoid Ideation 

G1: 45.8 (10.9) 

G2: 47.2 (11.6) 

G3: 47.2 (12.0) 

Psychoticism 

G1: 49.2 (11.7) 

G2: 50.4 (9.7) 

G3: 49.6 (10.3) 

Global Severity 

G1: 50.8 (12.8) 

G2: 50.4 (10.0) 

G3: 51.4 (10.9) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-469 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2001 

(continued) 

 155 participants 

were compared to 

the 42 who did not 

complete 

intervention and 

psychological 

assessment, 

higher scores 

(greater distress) 

on 6 of 10 SCL90-R scales 

(somatization, 

obsessive/compul

sive, depression, 

hostility, paranoid 

ideation, global 

severity index), all 

p values <0.05 

Normal range, 

score 0-63 

>75% in normal 

range (including 

dropouts) on 9 of 

10 scales 

Highest 

impairment rate: 

33% scored 

abnormal for 

obsessivecompulsive

Correlations 

between 

Reduction of 

Incontinence and 

Changes in 

Psychological 

Symptoms 

Somatization 

G1: 0.28* 

G2: -0.09 

G3: 0.17 

ObsessiveCompulsive 

G1: 0.01 

G2: -0.14 

G3: 0.02 

Interpersonal 

Sensitivity 

G1: -0.09 

G2: 0.04 

G3: 0.13 

Depression 

G1:-0.04 

G2: 0.03 

G3: 0.07 

Anxiety 

G1: -0.10 

G2: -0.01 

G3: 0.34* 

Hostility 

G1: -0.10 

G2: 0.09 

G3: 0.11 

Phobic anxiety 

G1:-0.21 

G2: -0.17 

G3: 0.02 

Paranoid Ideation 

G1: 0.14 

G2: -0.04 

G3: -0.06 

Psychoticism 

G1: -0.01 

G2: -0.01 

G3: 0.13 

Global Severity

Index 

G1: 0.01 

G2: 0.06 

G3: 0.45*** 

*p<0.05 

***P=0.001
C-470 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Burgio et al., 2008 

Country and 

setting: 

US, Academic 

medical centers 

Enrollment 

period: 

July 2004 to 

January 2006 

Funding: 

NIH 

Pfizer 

Author industry 

relationship 

disclosures: 

20 of 29 

Allergan (3) 

Alza (1) 

Astellas Pharma 

(7) 

Bionovo (1) 

Bristol-Meyers 

Squibb (1) 

Dynogen (1) 

Elan (1) 

Ethicon (2) 

GSK (4) 

Johnson & 

Johnson (3) 

Lilly (7) 

Medtronic (1) 

Merck (1) 

Novartis (6) 

Ortho-McNeil (3) 

Pfizer (>10) 

Procter & Gamble 

(3) 

Q-Med (1) 

Renessa (1) 

Sanofi (1) 

Solace (1) 

Watson (1) 

Design: 

RCT 

Intervention: 

Pharmacologic vs. 

pharmacologic 

plus behavioral 

interventions for 

10 wks (Stage 1), 

followed by no 

drug therapy 

(Stage 2) with 

assessments at 10 

wks and 8 mos* 

Groups: 

G1: tolterodine 

tartrate (ER 

capsules), 4 mg/d 

plus behavioral 

training: pelvic 

floor muscle 

control and 

exercises, 

behavioral 

strategies to 

diminish urgency, 

suppress bladder 

contractions and 

prevent both 

stress and urge 

incontinence; 

delayed voiding; 

fluid management; 

handout with hints 

G2: tolterodine 

tartrate (ER 

capsules), 4 mg/d 

N at enrollment: 

4043 screened 

2612 not eligible 

870 declined 

561 consented 

254 excluded 

307 randomized 

G1: 153 

G2: 154 

Inclusion criteria: 

• Women 

• Communitydwelling 

• UUI only, or 

urgepredominant 

incontinence 

• ≥ 7 episodes of 

incontinence in 

a 7-day bladder 

diary

• Persistent 

incontinence for 

at least 3 mos 

• No 

antimuscarinics 

or other 

medications that 

could affect UI 

• No evidence of 

neurogenic 

etiology

Exclusion 

criteria: 

• Age < 21 

• Pregnant, or 

planning a 

pregnancy in 

next 8 mos, or 

not using birth 

control 

• < 6 mos 

postpartum or 

termination after 

20 wks 

gestation 

• Unable to 

contract pelvic 

floor muscles 

• Behavioral 

therapy of > 2 

mos in past 2 

yrs 

• Continual 

leakage or 

always damp 

• Hypersensitive 

to study drug 

• Systemic 

disease that 

affects bladder 

function 

UUI, 7-13 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 2 (1.3) 

UUI, ≥ 14 

episodes/week, n 

(%): 

G1: 2 (1.3) 

G2: 4 (2.6) 

MUI, 7-13 

episodes/week, n 

(%): 

G1: 46 (29.9) 

G2: 46 (30.1) 

MUI, ≥ 14 

episodes/week, n 

(%): 

G1: 104 (67.5) 

G2: 101 (66.0) 

Adjusted 

incontinence 

episodes/week, 

mean: 

G1: 23.1 

G2: 23.2 

Previous nonsurgical 

treatment for 

incontinence, n 

(%): 

G1: 19 (12) 

G2: 22 (14) 

Success, n (%): 

G1: 43 (28) 

G2: 41 (27) 

Failure, n (%): 

G1: 75 (49) 

G2: 78 (51) 

8 month success 

rate, lifetable 

analysis, % (95% 

CI): 

G1: 41 (32, 50) 

G2: 41 (33, 50) 

G1/G2: 0 (-12, 12) 

8 mo success 

rate, complete 

cases, % (95% 

CI): 

G1: 36 (27, 45) 

G2: 34 (25, 43) 

G1/G2: 2 (-10, 14) 

8 mo success 

rate, assuming 

missings were 

failures, % (95% 

CI): 

G1: 28 (21, 35) 

G2: 27 (20, 34) 

G1/G2: 1 (-9, 11) 

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean: 

G1: 2.7

G2: 4.7

Adjusted 

incontinence 

episodes/week, 

after Stage 1, 

mean change: 

G1: -20.4 

G2: -18.5 

G1/G2: -1.9 (-5.9, 

2.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-471 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

N at follow-up: 

G1: 153 

Completed 

treatment: 107 

Outcome known at 

8 mos: 119 

G2: 154 

Completed 

treatment: 101 

Outcome known at 

8 mos: 118 

Age, mean ± SD: 

G1: 55.8 ± 14.2 

G2: 58.0 ± 13.5 

Women, %: 

100

Race/ethnicity, n 

(%): 

Hispanic: 

G1: 13 (9) 

G2: 17 (11) 

NH White: 

G1: 105 (69) 

G2: 85 (56) 

NH Black: 

G1: 22 (14) 

G2: 35 (23) 

Other: 

G1: 13 (9) 

G2: 15 (10) 

BMI, kg/m2

 ± SD: 

G1: 33.2 ± 9.5 

G2: 32.3 ± 7.6

• Currently using 

catheter to 

empty bladder 

• Postvoid 

residual volume 

> 150mL 

• Treatment for 

prolapse with 

pessary < 3 

mos 

• Incontinence, 

vaginal, bladder 

or prolapse 

surgery in the 

past 6 mos 

• Urethral 

diverticulum 

• Previous 

augmentation 

cystoplasty or 

artificial 

sphincter 

• Neuromodulatio

n for pelvic 

indications 

• Using 

anticholinergic 

agents, 

cholinergic 

agonists, 

tricyclic 

antidepressants

, or duloxetine 

in ≤ 4 wks 

• Using diuretics 

with dosage 

change past 3 

mos 

• Uncontrolled 

medical 

problem 

• History of 

bladder or 

pelvic cancer or 

pelvic radiation 

therapy 

• Glaucoma 

• Gastric 

retention 

• Non-ambulatory 

• Participation in 

other 

intervention trial 

that might 

influence 

outcome 

 Achieved 70% 

reduction in 

incontinence 

episodes, 10 wks 

(%): 

G1: 69

G2: 58

G1/G2: 11 (-0.3, 

22.1) 

Totally dry, per 

bladder diary, 10 

wks (%): 

G1: 21 

G2: 17 

Voids/day, mean 

change: 

G1: 0.5 

G2: -0.4 

G1/G2: 0.9 (0.3, 

1.5) 

Symptom 

Distress Scores: 

G1/G2: P < 

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 1, mean 

change: 

G1: -36.7

G2: -30.4

G1/G2: P < 

0.0001 

Symptom Bother 

Scores (OAB-q), 

Stage 2, mean 

change: 

G1: -30.9 

G2: -20.4 

G1/G2: P < 

0.0001 

Patient 

completely 

satisfied, Stage 

1, %: 

G1: 53

G2: 40 

G1/G2: 13 (1, 25) 
C-472 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Burgio et al., 2008 

(continued) 

 Patient 

completely 

satisfied, 8 

months, %: 

G1: 33 

G2: 20 

G1/G2: 13 (2, 24) 

Patient better or 

much better, 

Stage 1, %: 

G1: 90 

G2: 77 

G1/G2: 13 (4, 22) 

Patient better or 

much better, 8 

months, %: 

G1: 69 

G2: 43 

G1/G2: 26 (14 , 

38) 

Persistence in 

perceived 

improvement, 8 

months, women 

with 

improvement at 

Stage 1: 

G1: 72 

G2: 54 

G1/G2: 17 (4, 30) 

Harms: 

G1: 3 participants 

1: blurred vision, 

syncope, night 

sweats, stomach 

cramping and 

weakness 

2: 2 episodes of 

small-bowel 

obstruction and an 

allergic reaction 

(pruritus and rash) 

3: tachycardia 

during stage 2 

G2: 3 participants 

1: small bowel 

obstruction 

2: peripheral 

edema 

3: renal cell 

carcinoma 

diagnosis during 

stage 2 
C-473 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chancellor, 

Kianifard et al., 

2008 

Country and 

setting: 

US 

Enrollment 

period: 

May 2005 to 

February 2006 

Funding: 

NR 

Author industry 

relationship 

disclosures:

6 of 7 

Genaera (1) 

Novartis (6) 

Design: 

Randomized 

open-label 

Intervention: 

Behavioral 

modification in 

addition to 

darifenacin 

(allowed to 

increase dose 

from darifenacin 

7.5 mg to 15 mg 

daily after 2 

weeks) 

Groups:* 

G1: Darifenacin 

G2: Darifenacin 

and behavioral 

modification 

N at enrollment: 

G1: 190 

G2: 205 

N at follow-up, 12 

weeks: 

G1: 173 

G2: 175 

Age, mean ± SD: 

G1: 57.4 ± 13.1 

G2: 58.4 ± 14.6 

Race/ethnicity: 

White: 

G1: 90 

G2: 88.3 

Other (nonwhite): 

G1: 10 

G2: 11.7 

Women, %: 

G1: 90 

G2: 88.3 

Inclusion criteria:

• ≥ 8 voids/ day 

• ≥ 2 UUI 

episodes/ day 

• ≥ 2 episodes of 

urgency/day 

Exclusion 

criteria: 

• Any drug with 

bladder effects 

for 2 weeks prior 

to study 

participation 

• Participation in 

any formal 

bladder-training 

program within 

30 days of 

screening 

• Predominant 

SUI 

• Bladder or 

neurologic 

condition that 

could affect 

bladder function 

or in which use 

of 

anticholinergics 

was contraindicated

UUI episodes/ 

day, mean ± SD:

G1: 2.78 ± 2.57 

G2: 3.00 ± 2.56 

UUI episodes/ 

day, median:

G1: 2.33 

G2: 2.58 

Mean UUI 

episodes/day, 

total population, 

n (%): 

0 episodes: 

G1: 36 (19.1) 

G2: 29 (14.2) 

1-6 episodes: 

G1: 138 (73.0) 

G2: 155 (76.0) 

7-13 episodes: 

G1: 15 (7.9) 

G2: 20 (9.8) 

≥14 episodes 

G1: 0 (0.0) 

G2: 0 (0.0) 

Mean UUI 

episodes/day, 

age ≥ 65, n (%) 

0 episodes 

G1: 9 (17.0) 

G2: 8 (9.9) 

1-6 episodes 

G1: 40 (75.5) 

G2: 63 (77.8) 

7-13 episodes 

G1: 4 (7.5) 

G2: 10 (12.3) 

Urgency 

episodes/day, 

mean ± SD: 

G1: 10.88 ± 3.80 

G2: 10.58 ± 4.00 

Urgency 

episodes/day, 

median: 

G1: 10.67 

G2: 10.33 

Voids/day, mean 

± SD: 

G1: 11.92 ± 3.03 

G2: 11.75 ± 3.37 

UUI episodes/day 

mean change ± 

SD:

G1: -1.89 ± 2.29 

G2: -2.10 ± 2.32

G1/G2: P = 0.268 

UUI episodes/day 

median change 

(95% CI):

G1: -1.33 

(-2.00, -1.00) 

G2: -2.00 

(-2.00, -1.33) 

Urgency 

episodes/day 

mean change ± 

SD: 

G1: -2.87 ± 3.59 

G2: -2.68 ± 3.54 

G1/G2: P = 0.882 

Urgency 

episodes/day 

median change 

(95% CI): 

G1: -2.33 

(-3.00, -1.67) 

G2: -2.67 

(-3.00, -2.00) 

Voids/day, mean 

change ± SD: 

G1: -2.96 ± 2.91 

G2: -2.82 ± 2.87 

G1/G2: P = 0.681 

Voids/day, 

median change 

(95% CI): 

G1: -2.67 

(-3.33, -2.00) 

G2: -2.67 

(-3.00, -2.33) 

Nocturia 

episodes/day, 

mean change ± 

SD: 

G1: -0.65 ± 1.26 

G2: -0.67 ± 1.21 

G1/G2: P = 0.315 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-474 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chancellor, 

Kianifard et al., 

2008 

(continued) 

 Voids/day, 

median: 

G1: 11.33 

G2: 11.33 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.77 ± 1.43 

G2: 1.87 ± 1.35 

Nocturia 

episodes/day, 

median: 

G1: 1.67 

G2: 1.67 

Pads used/day, 

mean ± SD:

G1: 1.12 ±1.93 

G2: 0.99 ± 1.67 

Pads used/day, 

median:

G1: 0 

G2: 0 

Nocturia 

episodes/day, 

median change 

(95% CI): 

G1: -0.67 

(-0.67, -0.33) 

G2: -0.67 

(-0.67, -0.33) 

Pads used/day 

mean change ± 

SD:

G1: -0.72 ±1.54 

G2: -0.61 ± 1.28 

G1/G2: P = 0.978 

Pads used/day 

median change 

(95% CI):

G1: 0 (0,0) 

G2: 0 (0,0) 

Side effects, %:** 

Constipation: 18.5 

Dry mouth 25 

UTI: 4.8 

Headache: 3.8 

Discontinued 

due to adverse 

event(s), n (%) 

G1: 6 (3.2) 

G2: 21 (10.25) 

Discontinued 

due to 

constipation, %: 

2 

Discontinued 

due to dry 

mouth, %: 

1.8 
C-475 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chancellor, Zinner 

et al., 2008 

Country and 

setting: 

USA, multicenter 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

12 of 12 

Abbot (1) 

AEterna Zentaris 

(1) 

Akros (1) 

Allergan (3) 

American Medi-cal 

Systems (2) 

Amgen (1) 

Astellas (10) 

AstraZeneca (1) 

Bard (1) 

Bayer (1) 

Boehringer 

Ingelheim (3) 

Cephalon (1) 

Coloplast (1) 

Cook (1) 

CooperSurgical 

(1) 

Eli Lilly (2) 

Ferring 

GSK (6) 

Gynecare (1) 

Indevus (2) 

J&J (1) 

Mankind (1) 

Medtronic (1) 

Merck (1) 

Novartis (3) 

Novo Nordisk (1) 

Ortho-McNeil (1) 

Design: 

Prospective 

cohort, open label, 

flexible-dose, 14 

day washout 

Intervention: 

Solifenacin 5-10 

mg daily

Groups: 

G1: Solifenacin 5-

10 mg daily 

N at enrollment: 

G1: 440 

N at follow-up 

(%): 

G1: 390 (88.4) 

Age, mean ± SD: 

G1: 61.4 ± 13.8 

Race/ethnicity, n 

(%): 

White: 

G1: 392 (88.9) 

Women, N (%): 

G1: 389 (88.2) 

BMI, kg/m2

 ± SD: 

G1: 30.1 ± 7.1 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

> 3 months 

• Treatment with 

tolterodine ER 4 

mg, solifenacin, 

darifenacin, or 

trospium x ≥ 4 

weeks 

• Desired change 

in therapy 

• ≥ 3 mean UUI 

episodes/day 

Exclusion 

criteria: 

• Treatment < 4 

weeks with 

tolterodine, 

solifenacin, 

darifenacin, or 

trospium 

• SUI 

• MUI with primary 

stress 

• UTI 

• Chronic bladder 

inflammation 

• Bladder cancer 

• Severe 

constipation 

• Elevated PVR 

• Neurological 

deficit 

• Renal/ hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary retention

• Gastric retention

• Hypersensitivity 

to drugs 

• BOO 

• Women of 

childbearing 

age/ lactation 

Urgency 

episodes/day, 

mean change: 

G1: 6.9 ± 4.4 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 3.8 ± 3.6 

Voids/day, mean 

± SD: 

G1: 11.3 ± 3.8 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.9 ± 1.2 

PPBC score, 

mean: 

G1: 4.2 

OAB-q score, 

mean: 

Symptom bother: 

57.3 

Coping: 52.2 

Concern: 51.3 

Sleep: 50.6 

Social Interaction: 

77.7 

Total score: 56.7 

Urgency 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -4.2 ± 4.2 

(-4.6, -3.8) 

G1/BL: P < 0.001 

Incontinence 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -2.6 ± 3.2 

(-3.0, -2.3) 

G1/BL: P < 0.001 

Voids/day, mean 

change ± SD 

(95% CI): 

G1: -2.3 ± 3.2 

(-2.6, -2.0) 

G1/BL: P< 0.001 

Nocturia 

episodes/day, 

mean change ± 

SD (95% CI): 

G1: -0.8 ± 1.0 

(-0.9,-0.6) 

G1/BL: P < 0.001 

PPBC score, 

mean change 

(95% CI): 

G1: -1.2 (-1.3, -

1.0) 

G1/BL: P < 0.001

OAB-q score, 

mean: 

Symptom bother: 

27.8 

Coping: 80.1 

Concern: 81.1 

Sleep: 75.1 

Social Interaction: 

92.7 

Total score: 81.9 

G1/BL: P < 0.001 

all domains and 

total score 

Dry Mouth, n (%): 

G1: 77 (17.5) 

Constipation, n 

(%): 

G1: 51 (11.6)

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Method and 

blinding: NA 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-476 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chancellor, 

Zinner, et al., 2008 

(continued) 

Author industry 

relationship 

disclosures: 

Pfizer (7) 

Pharmacia (1) 

Pri Med (1) 

Reliant (1) 

Solvay (1) 

Sanofi-Aventis (1) 

Schering-Plough 

(1) 

Takeda (1) 

TAP (1) 

Watson (1) 

 Blurred vision, n 

(%): 

G1: 10 (2.3)

UTI, n (%): 

G1: 19 (4.3)

Headache, n (%): 

G1: 13 (2.9)

URI, n (%): 

G1: 11 (2.5) 
C-477 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al. 

2003 

Country and 

setting: 

98 centers – 

United States, 

United Kingdom, 

Poland, Russia, 

New Zealand, 

Belgium, 

Netherlands 

Enrollment 

period: 

NR 

Funding: 

Yamanouchi 

Pharmaceutical 

Co., Ltd, Tokyo, 

Japan 

Author industry 

relationship 

disclosures: 

Not reported 

Design: 

RCT, double-blind 

placebo 

controlled, with 2-

wk placebo run-in 

period 

Intervention: 

tolterodine vs. 

solifenacin vs. 

placebo

Groups: 

G1: tolterodine 2 

mg bid 

G2: solifenacin 5 

mg qd 

G3: solifenacin 10 

mg qd 

G4: placebo qd 

N at enrollment: 

G1: 279 

G2: 269 

G3: 266 

G4: 267 

N at follow-up: 

G1: 250 

G2: 266 

G3: 264 

G4: 253 

Female, n (%) 

G1: 200 (80.0) 

G2: 188 (71.2) 

G3: 194 (72.9)

G4: 193 (76.3)

Age, yrs ± SD: 

G1: 56.9 +/-12.8 

G2: 58.1± 13.4 

G3: 57.2 ±13.4 

G4: 57.8 ± 13.7 

<65 years of age, 

n (%) 

G1: 169 (63.5) 

G2: 172 (65.2) 

G3: 172 (68.8) 

G4: 168 (66.4) 

≥65 years of age, 

n (%) 

G1: 97 (36.5) 

G2: 92 (34.8) 

G3: 78 (31.2) 

G4: 85 (33.6) 

Inclusion criteria: 

• ≥ 18 years of 

age 

• symptoms of 

OAB (including 

urinary 

frequency with 

urgency and/or 

urge 

incontinence) 

for ≥3 months 

• ≥8 voids per 24 

hr 

• ≥3 episodes 

urinary 

incontinence 

during 3-day 

diary period 

Exclusion 

criteria: 

• BOO 

• PVR >200 mL 

• stress 

predominant 

factor 

• neurological 

cause for 

detrusor 

overactivity 

• UTI or bladder 

stones 

• previous pelvic 

irradiation 

• malignant 

disease of 

pelvic organs 

• contraindication 

to 

antimuscarinic 

medication 

(including 

narrow-angle 

glaucoma, 

urinary or 

gastric 

retention) 

• non 

pharmacologic 

treatment for 

OAB 2 wks 

before study 

• diabetic 

neuropathy 

UI only, n (%)

G1: 142 (56.8) 

G2: 162 (61.4) 

G3: 172 (64.7)

G4: 177(70.0)

Mixed SI/UI, n (%)

G1: 90 (36.0) 

G2: 81 (30.7) 

G3: 79 (29.7)

G4: 59(23.3) 

No incontinence, 

n (%)

G1: 18 (7.2) 

G2: 20 (7.6) 

G3: 15 (5.6)

G4: 17 (6.7) 

Urgency

episodes/24 h, 

mean ± SD 

G1: 5.77 ± 4.89 

G2: 5.82 ± 4.45 

G3: 5.45 ± 3.87 

G4: 5.30 ± 3.92 

UI/24 h, mean ± 

SD 

G1: 2.33 ± 2.50 

G2: 2.14 ± 2.44 

G3: 1.86 ± 1.54 

G4: 2.02 ± 2.50 

Incontinence 

episodes/24 h, 

mean ± SD: 

G1: 2.64 ± 2.55 

G2: 2.59 ± 2.88 

G3: 2.32 ± 1.94 

G4: 2.71 ± 2.83 

# Voids/24 h, 

mean ± SD: 

G1: 12.08± 3.86 

G2: 12.32 ±3.95 

G3: 12.08 ± 3.43 

G4: 12.20 ± 4.11

Volume 

voided/void, mL, 

mean ± SD: 

G1: 149.6 ± 54.6 

G2: 147.2 ±51.2 

G3: 147.0 ± 50.3 

G4: 143.8 ± 53.6 

Urgency 

episodes/24 h 

mean ∆ from 

baseline:

G1: -2.05 (3.58) 

G2: -2.85 (3.74) 

G3: -3.07 (3.90)

G4: -1.41 (3.67) 

Urgency 

episodes/24 h ∆

from baseline, %:

G1: -38 

G2: -55 

G3: -52 

G4: -33 

Urgency

episodes 

estimated 

difference vs. 

tolterodine 

(95%CI) 

G1: -0.791 (-

14.34, -0.148) 

p<0.001 

G2: -1.015 (-

1.659, -0.370) 

p<0.001 

G3: p=0.0511 

UI/24 h 

mean ∆ from 

baseline:

G1: -0.91 (2.01) 

G2: -1.41 (1.74) 

G3: -1.36 (2.13)

G4: -0.62 (1.96) 

UI/24 h ∆ from 

baseline, %:

G1: -58 

G2: -65 

G3: -63 

G4: -40 

UI estimated 

difference vs. 

tolterodine 

(95%CI) 

G1: -0.487 (-

0.988, 0.014) 

p=0.002 

G2: -0.436 (-

0.921, 0.048) 

p=0.0028 

G3: p=0.2390 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-478 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al. 

2003 

(continued) 

<75 years of age, 

n (%) 

G1: 236 (88.7) 

G2: 241 (91.3) 

G3: 233 (93.2) 

G4: 225 (88.9) 

≥75 years of age, 

n (%) 

G1: 30 (11.3) 

G2: 23 (8.7) 

G3: 17 (16.8) 

G4: 28 (11.1) 

Weight, mean kg 

± SD 

G1: 74.8 +/-14.8 

G2: 74.6±14.3 

G3: 75.5±14.2 

G4: 72.6±14.4 

Race, n (%) 

White 

G1: 261(98.1) 

G2: 260 (98.5) 

G3: 247(98.8) 

G4: 248 (98.0) 

Black 

G1: 2 (0.8) 

G2: 0 

G3: 1 (0.4) 

G4: 1 (0.4) 

Asian 

G1: 2 (0.8) 

G2: 0 

G3: 2(0.8) 

G4: 1 (0.4) 

Other 

G1: 1 (0.4) 

G2: 4 (1.5) 

G3: 0 

G4: 3 (1.2) 

• use of drugs 

intended to treat 

incontinence 

• use of drugs 

with cholinergic 

or 

anticholinergic 

side-effects 

• participation in a 

clinical trial 

within 30 days 

• childbearing 

potential, 

pregnant or 

nursing or not 

using reliable 

contraceptive 

methods 

Time from start 

of symptoms, 

mean months (%)

G1: 57.4 (60.5) 

G2: 72.6 (105.4) 

G3: 62.9 (82.5) 

G4: 61.0 (83.9)

Prior drug 

therapy, n (%)

G1: 93 (34.9) 

G2: 106 (40.1) 

G3: 77 (30.8) 

G4: 83 (32.8) 

Any non drug 

therapy, n (%)

G1: 92 (34.6) 

G2: 92 (34.8) 

G3: 88 (35.2) 

G4: 76 (30.0) 

Incontinence 

episodes/24 h 

mean ∆ from 

baseline:

G1: -1.42 (1.82) 

G2: -1.45 (2.24) 

G3: -1.14 (2.15) 

G4: -0.76 (2.26) 

Incontinence 

episodes/24 h ∆

from baseline, %:

G1: -59 

G2: -47 

G3: -59 

G4: -29 

Incontinence 

episodes 

estimated 

difference vs. 

tolterodine 

(95%CI) 

G1: -0.276 (-

0.761, 0.208) 

p=0.008 

G2: -0.316 (-

0.786, 0.154) 

p=0.0038 

G3: p=0.1122 

Voids/24 h 

mean ∆ from 

baseline:

G1: -1.88 (3.00) 

G2: -2.19 (2.87) 

G3: -2.61 (3.24)

G4: -1.20 (3.26) 

Voids/24 h ∆

from baseline, %:

G1: -15 

G2: -20 

G3: -17 

G4: -18 

Voids estimated 

difference vs. 

tolterodine 

(95%CI) 

G1: -0.312 (-

0.844, 0.219) 

p=0.003 

G2: -0.737 (-

1.269, -0.204) 

p<0.001 

G3: p=0.0145 
C-479 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al. 

2003 

(continued) 

 Volume voided, 

mL mean ∆ from 

baseline:

G1: 24.4 (49.2) 

G2: 32.9 (47.7) 

G3: 39.2 (50.4) 

G4: 07.4 (36.3) 

Volume voided, 

mL ∆ from 

baseline, %:

G1: 20 

G2: 25 

G3: 29 

G4: 9 

Volume voided, 

mL estimated 

difference vs. 

tolterodine 

(95%CI) 

G1: 8.4 (0.496, 

16.34) p,0.001 

G2: 14.8 (6.855, 

22.72) p<0.001 

G3: p<0.001 

Discontinued 

due to AEs, n 

(%): 

G1: 5 (1.9) 

G2: 9 (3.2) 

G3: 7 (2.6) 

G4: 10 (3.7) 

Dry mouth, n (%): 

G1: 49 (18.6) 

G2: 39 (14.0) 

G3: 57 (21.3) 

G4: 13 (4.9) 

Constipation, n 

(%): 

G1: 7 (2.6) 

G2: 20 (7.2) 

G2: 21 (7.8) 

G4: 5 (1.9) 

Blurred Vision, n 

(%): 

G1: 4 (1.5) 

G2: 10 (3.6) 

G3: 15 (5.6) 

G4: 7 (2.6) 
C-480 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al., 

2005 

Chapple et al., 

2007† 

Country and 

setting: 

European, 

Multicenter 

Enrollment 

period: 

May 2003 to 

October 2004 

Funding: 

Yamanouchi (now 

Astellas) 

Author industry 

relationship 

disclosures: 

NR* 

1 of 9† 

Astellas (1) 

Novartis (1) 

Pfizer (1) 

Schwartz (1) 

UCB (1) 

Design: 

RCT

Intervention: 

Solifenacin 5mg 

vs. tolterodine ER 

4mg 

Groups: 

G1: solifenacin 

5mg

G2: tolterodine ER 

4mg 

G1a: G1 who 

elected not to 

increase dose at 4 

weeks 

G2a: G2 who 

elected not to 

increase dose at 4 

weeks 

N at enrollment: 

G1: 578 

G2: 599 

N at follow-up: 

G1a: 297 

G2a: 267 

Age, mean: 

G1: 56.5 

G2: 56.4 

G1a: 56.5 

G2a: 56.9 

Race/ethnicity, 

%: 

White: 

G1: 99.3 

G2: 99.5 

G1a: 99.3 

G2a: 99.3 

Women, %: 

G1: 85.3 

G2: 88.3 

G1a: 87.5 

G2a: 87.1 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

for ≥ 3 months 

• outpatient 

treatment 

• ≥ 8 voids/day 

• ≥ 1 incontinence 

episode/day or 

≥ 1 urgency 

episode/day 

Exclusion 

criteria: 

NR 

UUI episodes/ 

day, mean ± SD:*

G1: 2.31 ± 2.35 

G2: 2.12 ± 2.14 

UUI episodes/ 

day, mean:† 

G1a: 1.97 

G2a: 1.66 

Urgency 

episodes/day, 

mean ± SD:* 

G1: 6.01 ± 4.66 

G2: 5.84 ± 4.12 

Urgency 

episodes/day, 

mean:† 

G1a: 5.67 

G2a: 5.30 

Incontinence 

episodes/day, 

mean ± SD:* 

G1: 2.77 ± 2.65 

G2: 2.55 ± 2.37 

Incontinence 

episodes/day, 

mean:† 

G1a: 2.32 

G2a: 2.01 

Voids/day, mean 

± SD:* 

G1: 11.78 ± 3.58 

G2: 11.66 ± 3.25 

Voids/day, 

mean:† 

G1: 11.10 

G2: 11.36 

Nocturia, 

episodes/day, 

mean ± SD:* 

G1: 2.02 ± 1.33 

G2: 1.92 ± 1.22 

Nocturia, 

episodes/day, 

mean:† 

G1a: 1.83 

G2a: 1.84 

UUI 

episodes/day, 4 

wks, mean 

change:† 

G1: -1.22 

G2: -0.91 

P = NS 

UUI 

episodes/day, 12 

wks, mean 

change:* 

G1: -1.42 

G2: -0.83 

P = 0.001 

UUI 

episodes/day, 12 

wks, mean 

change:† 

G1a: -1.46 

G2a: -1.03 

Urgency

episodes/day, 4 

wks, mean 

change:† 

G1: -1.98 

G2: -1.67 

P = NS 

Urgency 

episodes/day, 

12 wks, mean 

change:* 

G1: -2.85 

G2: -2.42 

P = 0.035 

Urgency 

episodes/day, 

12 wks, mean 

change:† 

G1a: -3.08 

G2a: -2.62 

Incontinence 

episodes/day, 4 

wks, mean 

change:† 

G1: -1.30 

G2: -0.90 

P = 0.0181 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-481 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

 Incontinence 

episodes/day, 12 

wks, mean 

change:* 

G1: -1.60 

G2: -1.11 

P = 0.006 

Incontinence 

episodes/day, 12 

wks, mean 

change:† 

G1a: -1.56 

G2a: -1.23 

Voids/day, 4 wks, 

mean change:† 

G1: -1.71 

G2: -1.47 

P = NS 

Voids/day, 12 

wks, mean 

change:* 

G1: -2.45 

G2: -2.24 

P = 0.004 for noninferiority 

Voids/day, 12 

wks, mean 

change:† 

G1a: -2.47 

G2a: -2.49 

Nocturia, 

episodes/day, 4 

wks, mean 

change:† 

G1: -0.51 

G2: -0.44 

P = NS 

Nocturia, 

episodes/day, 12 

wks, mean 

change:* 

G1: -0.71 

G2: -0.63 

P = NS 

Nocturia 

episodes/day, 12 

wks, mean 

change:† 

G1a: -0.72 

G2a: -0.69 
C-482 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

 Perception of 

bladder 

condition, 4 wks, 

mean change:† 

G1: -0.96 

G2: -0.88 

P = NS

Perception of 

bladder 

condition, 12 

wks, mean 

change:* 

G1: -1.51 

G2: -1.33 

P < 0.0061 

Perception of 

bladder 

condition, 12 

wks, mean 

change:† 

G1a: -1.72 

G2a: -1.62 

Pad use, 4 wks, 

mean change:† 

G1: -1.21 

G2: -0.80 

P = 0.0089 

Pad use, 12 wks, 

mean change:* 

G1: -1.72 

G2: -1.19 

P < 0.0023 

Pad use, 12 wks, 

mean change:† 

G1a: -1.55 

G2a: -1.40 

Dry rate, 4 wks, 

mean % 

change:† 

G1: 39 

G2: 34 

P = NS 

Dry rate, 12 wks, 

mean % 

change:† 

G1a: 65.4 

G2a: 58.3 
C-483 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

 Voided volume 

(mL), 4 wks, 

mean change:† 

G1: 28.51 

G2: 24.29 

P = NS 

Voided volume 

(mL), 12 wks, 

mean change:* 

G1: 38 

G2: 31 

P = 0.010

Voided volume 

(mL), 12 wks, 

mean change:† 

G1a: 39.95 

G2a: 37.84 

Dry mouth, mild, 

%:*† 

G1: 17.5 

G2: 14.8 

G1a: 6.5 

G2a: 5.0 

Dry mouth, 

moderate, %:*† 

G1: 10.8 

G2: 7.7 

G1a: 10.4 

G2a: 7.0 

Dry mouth, 

severe, %:*† 

G1: 1.7 

G2: 1.5 

G1a: 0.7 

G2a: 2.1 

Constipation, 

mild, %:*† 

G1: 3.2 

G2: 1.3 

G1a: 2.0 

G2a: 1.0 

Constipation, 

moderate, %:*† 

G1: 2.7 

G2: 1.0 

G1a: 1.7 

G2a: 1.4 
C-484 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2005* 

Chapple et al., 

2007† 

(continued) 

 Constipation, 

severe, %:*† 

G1: 0.5 

G2: 0.2 

G1a: 0.3 

G2a: 0.0 

Blurred vision, 

mild, %:*† 

G1: 0.7 

G2: 0.7 

G1a: 0.3 

G2a: 0.7

Blurred vision, 

moderate, %:*† 

G1: 0.0 

G2: 1.0 

G1a: 0.0 

G2a: 1.7 

Blurred vision, 

severe, %:*† 

G1: 0.0 

G2: 0.0

G1a: 0.0 

G2a: 0.0 
C-485 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Chapple et al., 

2008 

Country and 

setting: 

European, 

multicenter 

(academic and 

private) 

Enrollment 

period: 

NR 

Funding: 

Pfizer, 

Schwarz 

BioSciences 

Author industry 

relationship 

disclosures: 

4 of 5 

Pfizer (4) 

Design: 

Multicenter 

randomized 

placebo-controlled 

Intervention: 

Tolterodine 4 mg 

ER vs. 

fesoterodine 8 mg

Groups: 

G1: Tolterodine 

ER 4mg 

G2: Fesoterodine 

8mg 

G3: Placebo 

N at enrollment: 

G1: 290 

G2: 287 

G3: 283 

Age, mean ± SD: 

Total: 57 ± 14 

Race/ethnicity, 

%: 

White: 

Total: >95 

Women, %: 

Total: 80 

Follow-up: 

12 weeks 

Inclusion criteria: 

• Age ≥ 18 

• OAB sx w/ 

urinary urgency 

for ≥6 mos 

• ≥ 8 voids/day 

• ≥ 6 urgency 

episodes or ≥ 3 

UUI 

episodes/day 

• At least 

moderate 

problems 

recorded via a 

Likert scale 

• Negative 

pregnancy test 

• Adequate 

contraception 

throughout trial 

Exclusion 

criteria: 

• LUT pathology: 

SI, bladder 

stones, 

interstitial 

cystitis, 

urothelial tumors

• Grade III or 

higher pelvic 

prolapsed 

• Bladder-outlet 

obstruction 

• Polyuria (>3L/d) 

• Symptomatic or 

recurrent UTIs

• PVR urine 

volume >100 mL

• Antimuscarinic 

agent w/in 2 wks

• Electrostimulatio

n for bladder 

training in prior 4 

wks 

• Active UTI 

• Underlying 

neurological 

disease 

• Clinically 

relevant cardiac 

arrhythmia 

• Unstable angina

• QTcB interval > 

500ms 

Time since first 

diagnosis or 

onset of OAB 

(years), mean: 

Total: 8-9 

Incontinent at 

BL, n: 

G1: 213 

G2: 217 

G3: 203 

KHQ severity 

score, mean 

change: 

G1: -12.6 

G2: -14.0 

G3: -9.0 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ severity 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -14.9 

G2: -15.8 

G3: -10.8 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ emotions 

score, mean 

change: 

G1: -16.3 

G2: -17.4 

G3: -10.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ emotions 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -17.3 

G2: -18.6 

G3: -11.3 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ role 

limitations score, 

mean change: 

G1: -22.1 

G2: -21.7 

G3: -11.8 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Method and 

blinding: + 

Pt selection 

criteria: + 

Loss to followup: 

NR 

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

 
C-486 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

 KHQ role

limitations score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -23.2 

G2: -23.7 

G3: -12.4 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ physical 

limitations score, 

mean change: 

G1: -19.7 

G2: -21.7 

G3: -11.4 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ Physical 

limitations score, 

patients 

incontinent at 

BL, mean 

change:

G1: -20.5 

G2: -23.3 

G3: -11.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ social 

limitations score, 

mean change: 

G1: -14.1 

G2: -15.4 

G3: -8.7 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ social 

limitations score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -15.7 

G2: -16.2 

G3: -9.5 

G1/G3: P < 0.05 

G2/G3: P < 0.05 
C-487 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

 KHQ

sleep/energy 

score, mean 

change: 

G1: -11.7G2: -

13.6

G3: -9.6 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ 

sleep/energy 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -12.5 

G2: -15.3 

G3: -10.4 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ personal 

relationship 

score, mean 

change: 

G1: -10.4 

G2: -11.9 

G3: -6.2 

G1/G3: P = NS 

G2/G3: P < 0.05 

KHQ personal 

relationship 

score, patients 

incontinent at 

BL, mean 

change: 

G1: -12.7 

G2: -12.3 

G3: -6.8 

G1/G3: P < 0.05

G2/G3: P = NS 

KHQ 

incontinence 

impact score, 

mean change: 

G1: -23.3 

G2: -24.6 

G3: -16.1 

G1/G3: P < 0.05 

G2/G3: P < 0.05 
C-488 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

 KHQ 

incontinence 

impact score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -23.8 

G2: -26.5 

G3: -17.7 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

KHQ general 

health score, 

mean change: 

G1: -4.3 

G2: -4.0 

G3: -3.8 

G1/G3: P = NS 

G2/G3: P = NS 

KHQ general 

health score, 

patients 

incontinent at 

BL, mean 

change: 

G1: -4.3 

G2: -4.5 

G3: -5.5 

G1/G3: P = NS 

G2/G3: P = NS 

ICIQ-SF total 

score, mean: 

G1: -3.95 

G2: -4.41 

G3: -2.55 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

ICIQ-SF total 

score, patients 

incontinent at 

BL, mean: 

G1: -4.56 

G2: -5.29 

G3: -3.12 

G1/G3: P < 0.05 

G2/G3: P < 0.05 
C-489 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Chapple et al., 

2008 

(continued) 

 Major improvement in severity 

of bladderrelated problems, 

%: 

G1: 34 

G2: 39 

G3: 25

G1/G3: P = 0.01 

G2/G3: P = 0.01 

Dry mouth, n (%): 

G1: 49 (17) 

G2: 97 (34) 

G3: 20 (7) 

Constipation, n 

(%): 

G1: 8 (3) 

G2: 13 (5) 

G3: 4 (1) 

Nasopharyngitis, 

n (%): 

G1: 10 (3) 

G2: 5 (2) 

G3: 7 (3) 

Dry eye, n (%): 

G1: 1 (1) 

G2: 12 (4) 

G3: 0 (0) 

Nausea, n (%): 

G1: 6 (2) 

G2: 4 (1) 

G3: 1 (1) 

Fatigue, n (%): 

G1: 10 (3) 

G2: 1 (1) 

G3: 1 (1) 

Dry throat, n (%): 

G1: 3 (1) 

G2: 8 (3) 

G3: 0 (0) 
C-490 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Colombo et al., 

1995 

Country and 

setting: 

Italy; Setting 

Enrollment 

period: 

May 1990 to 

March 1993 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, 

Computer 

generated random 

assignment 

Intervention: 

Oxybutynin vs. 

Bladder training 

for 6 weeks

Groups: 

G1: Oxybutynin, 3 

daily doses of 5 

mg each for 6 

weeks (dose 

reduced to half if 

substantial AEs) 

G2: Bladder 

training 

N at enrollment: 

G1: 42 

G2: 39 

N at 6 wk followup: 

G1: 38 

G2: 37 

N at 6 mo followup: 

G1: 28 

G2: 27 

Age, yrs ± SD: 

G1: 48 (31 – 65) 

G2: 49 (24 – 65) 

Race/ethnicity, 

mean ± SD: 

Black: 

NR 

Women, N (%): 

G1: 42 (100) 

G2: 39 (100) 

Postmenopausal 

n (%): 

G1: 16 (38) 

G2: 20 (51) 

Inclusion criteria: 

• Socially 

embarrassing 

(severe) urinary 

urge 

incontinence 

• On cystometry: 

detrusor 

instability, or 

LCB, or sensory 

bladder 

Exclusion 

criteria: 

• Stable bladder 

at cystometry 

• Neurologic 

disease 

• Detrusor 

hyperreflexia 

• Age greater 

than 65 y 

• Coexisting 

genuine SUI 

• Genital prolapse

• Postvoid 

residual volume 

>50mL 

• Previous 

gynecologic or 

urogynecologic 

surgery 

• Prior use of any 

drug to treat 

UUI 

• Urethral 

diverticula 

• Fistulas 

• Urinary tract 

neoplasia 

• Cystitis 

• Bladder stones 

• Previous pelvic 

radiotherapy 

Detrusor 

instability, n (%):

G1: 14 (37) 

G2: 13 (35) 

Low compliance 

bladder, n (%): 

G1: 9 (24) 

G2: 8 (22) 

Sensory bladder, 

n (%): 

G1: 15 (39) 

G2: 16 (43) 

Daily UUI 

episodes, range 

9 – 17 

Diurnal 

frequency, n (%):

G1: 32 (84) 

G2: 29 (78) 

Nocturia, n (%): 

G1: 11 (29) 

G2: 18 (49) 

Volume at first 

desire (mL): 

G1: 120 ± 59 

G2: 134 ± 61 

Volume at very 

strong desire 

(mL): 

G1: 317 ± 92 

G2: 332 ± 87 

Clinically cured 

overall, n (%): 

G1: 28 (74) 

G2: 27 (73) 

Cured among DI, 

(%): 

G1: 13 (93) 

G2: 8 (62) 

P=0.07 

Cured among 

LCB: 

G1: 6 (67) 

G2: 6 (75) 

P=0.56 

Cured among 

sensory bladder: 

G1: 9 (60) 

G2: 13 (81) 

P=0.18 

Cured among 18 

G1 patients 

requiring dosage 

halving: 

12 (67%) 

Diurnal 

frequency 

resolved, n (%): 

G1: 18 (56) 

G2: 20 (69) 

Nocturia 

resolved n (%): 

G1: 3 (27) 

G2: 11 (61) 

Volume at first 

desire (mL), 

mean ± SD: 

G1: 179 ± 32 

P=.0009 

G2: 178 ± 49 

P=.001 

Volume at very 

strong desire 

(mL) mean ± SD: 

G1: 408 ± 76 

P=.00001 

G2: 403 ± 69 

P=.0002 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 
C-491 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Colombo et al. 

1995 

(continued) 

 Patients still 

cured at 6 mos, 

n: 

G1: 16

G2: 26

Patients still 

cured at 6 mos 

among DI, n: 

G1: 8

G2: 8

Patients still 

cured at 6 mos 

among LCB, n: 

G1: 4

G2: 6

Patients still 

cured at 6 mos 

among sensory 

bladder, n: 

G1: 4

G2: 12 

Treatment 

discontinued in 6 

cases: 

G1: 4 (3 cases of 

severe dry mouth, 

1 case of 

previously 

unknown 

glaucoma) 

G2: 2 (treatment 

was time 

consuming) 

Other adverse 

effects 

G1: 18 (47%) with 

AE requiring 

halving of dosage: 

-dry mouth (n=15) 

-constipation (n=6) 

-nausea (n=5) 

-dizziness (n=2) 

- decrease in 

visual acuity (n=1) 

- tachycardia (n=1) 
C-492 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al. 1995 

Country and 

setting: 

US; private clinic 

Enrollment 

period: 

January 1992 to 

December 1992 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohorts with 

comparison; 

(Series of patients 

self selected into 

two groups) 

Intervention: 

Bladder training 

vs. anticholinergic 

or antispasmodic

Groups: 

G1: Bladder 

training 

G2: oxybutynin 

2.5-5.0 mg bid or 

t.i.d. 

N at enrollment: 

G1: 39 

G2: 33 

N at follow-up: 

G1: 26 

G2: 28 

Age, mean yrs 

(range): 

64 (20-93) 

Race/ethnicity: 

NR

Women, N (%): 

72 (100)

Parity mean ± 

SD: 

NR 

Inclusion criteria: 

• Incontinent by 

AHCPR 

guidelines* 

• Incontinence 

persisted after 

treatment for 

transient 

incontinence 

Exclusion 

criteria: 

• Post-void 

residual of more 

than 150 mL 

UUI, n (%): 

G1: 27 (49) 

G2: 28 (51) 

MUI with 

predominant 

urge, n (%): 

G1: 12 (71) 

G2: 5 (29) 

Continent, n (%): 

G1: 1 (4) 

G2: 1 (4) 

Improved, n (%): 

G1: 22 (85) 

G2: 19 (68) 

No Change, n 

(%): 

G1: 3 (11) 

G2: 8 (28) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: - 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: poor 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: ++ 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 
C-493 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Diokno et al., 

2003* 

Chu et al., 2005† 

Country and 

setting: 

US, Academic 

medical center 

Enrollment 

period: 

November 2000 to 

October 2001 

Funding: 

ALZA Corporation, 

Ortho-McNeil 

Pharmaceuticals 

Author industry 

relationship 

disclosures: 

5 of 7* 

ALZA (1) 

Indevus (1) 

Ortho-McNeil (4) 

Pharmacia (1) 

Watson (1) 

NR† 

Design: 

RCT 

Intervention: 

Oxybutynin ER vs. 

Tolterodine ER 

12 week treatment 

period

Groups: 

G1: Oxybutynin 

ER 10 mg daily 

G2: Tolterodine 

ER 4mg daily 

N at enrollment: 

G1: 391 

G2: 399 

N at follow-up: 

G1: 339 

G2: 357 

Age, mean 

(range) : 

G1: 60 (23-92) 

G2: 60 (18-85) 

Race/ethnicity, N 

(%): 

White: 

G1: 329 (84) 

G2: 342 (86) 

Black: 

G1: 32 (8) 

G2: 35 (9) 

Hispanic: 

G1: 27 (7) 

G2: 19 (5) 

Other: 

G1: 3 (1) 

G2: 3 (1) 

Women, N (%): 

G1: 391 (100) 

G2: 399 (100) 

Inclusion criteria: 

• Age ≥ 18 

• ≥ 21 episodes 

UUI/ week 

• ≥ 10 voids/ day 

• Urge > non-urge 

incontinence 

Exclusion 

criteria: 

• Treatable GU 

conditions 

causing 

incontinence 

• PVR > 150 mL 

by ultrasound x 

2 

• Risk of 

developing 

complete 

urinary retention

• Medical 

problems 

worsened by 

anticholinergic 

effects 

• Hematuria 

• Uncontrolled 

narrow angle 

glaucoma 

• Obstructive 

uropathy 

• Reduced GI 

motility 

• Hypersensitivity 

to medications 

UUI episodes/ 

wk, mean ± SD: 

G1: 37.2 ± 15.2 

G2: 36.9 ± 14.1 

Total 

incontinence 

episodes/wk, 

mean ± SD: 

G1: 43.3 ± 19.3 

G2: 42.6 ± 18.2 

Voids/wk, mean ± 

SD: 

G1: 94.8 ± 25.4 

G2: 96.2 ± 24.5 

UUI episodes/wk, 

mean: 

G1: 10.8 

G2: 11.2 

P = 0.28 

Incontinence 

episodes/wk, 

mean: 

G1: 12.3 

G2: 13.8 

P = 0.08 

Voids/wk, mean: 

G1: 66.4 

G2: 71.1 

P = 0.03 

UUI episodes/wk, 

% reduction ± 

SD: 

G1: 72.0 ± 34.0 

G2: 70.2 ± 33.2 

P = 0.13 

Incontinent 

episodes/wk, % 

reduction ± SD: 

G1: 72.8 ± 31.0 

G2: 69.1 ± 34.9 

P = 0.08 

Voids/wk, % 

reduction ± SD: 

G1: 27.7 ± 19.7 

G2: 24.9 ± 18.9 

P = 0.05 

Total dryness, %: 

G1: 23 

G2: 16.8 

P = 0.03 

No UUI episodes, 

%: 

G1: 26.7 

G2: 20.9 

P = 0.06 

Dry mouth, any 

degree, n (%): 

G1: 116 (29.7) 

G2: 89 (22.3) 

P = 0.02 

Dry Mouth, mild, 

n (%): 

G1: 87 (22.3) 

G2: 69 (17.3) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-494 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

 Dry mouth, 

moderate-severe, 

n (%): 

G1: 29 (7.4) 

G2: 20 (5.0) 

Constipation, n 

(%): 

G1: 25 (6.4) 

G2: 31 (7.8) 

Diarrhea, n (%): 

G1: 31 (7.9) 

G2: 25 (6.3) 

Headache, n (%): 

G1: 22 (5.6) 

G2: 24 (6.0) 

UTI, n (%): 

G1: 20 (5.1) 

G2: 13 (3.3) 

CNS AE, n (%):† 

G1: 35 (9.0) 

G2: 33 (8.3) 

Dizziness, n 

(%):† 

G1: 15 (3.8) 

G2: 10 (2.5) 

Dizziness, mild,** 

%:† 

G1: 1.8 

G2: 1.5 

Dizziness, 

moderate,** %:† 

G1: 0.8 

G2: 0.3 

Somnolence, n 

(%):† 

G1: 4 (1.0) 

G2: 9 (2.3) 

Somnolence, 

mild,** %:† 

G1: 0.5 

G2: 1.5 

Somnolence, 

moderate,** %:† 

G1: 0.3 

G2: 0.5 

Insomnia, n (%):† 

G1: 7 (1.8) 

G2: 3 (0.8) 
C-495 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

 Insomnia, mild** 

%:† 

G1: 0.8 

G2: 0 

Insomnia, 

moderate,** %:† 

G1: 0.5 

G2: 0 

Depression, n 

(%):† 

G1: 5 (1.3) 

G2: 3 (0.8) 

Hypertonia, n 

(%):† 

G1: 2 (0.5) 

G2: 4 (1.0) 

Hypertonia, 

mild,** %:† 

G1: 0 

G2: 0 

Hypertonia, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Anxiety, mild,** 

%:† 

G1: 0.5 

G2: 0 

Anxiety, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Nervousness, 

mild,** %:† 

G1: 0 

G2: 0 

Nervousness, 

moderate,** %:† 

G1: 0.3 

G2: 0 

Tremor, mild,** 

%:† 

G1: 0.3 

G2: 0.3 

Tremor, 

moderate,** %:† 

G1: 0 

G2: 0 
C-496 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Diokno et al., 

2003* 

Chu et al., 2005† 

(continued) 

 Confusion, 

mild,** %:† 

G1: 0.3 

G2: 0.3 

Confusion, 

moderate,** %:† 

G1: 0 

G2: 0 
C-497 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Giannitsas et al., 

2004 

Country and 

setting: 

Greece, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized for 

which drug to 

receive first 

two-way 

crossover, table of 

random numbers 

Intervention: 

Oxybutynin 15 mg 

t.i.d. vs. 

Tolterodine 4mg 

bid; 6 weeks 

treatment with 3-4 

weeks washout 

Groups: 

G1: Oxybutynin 15 

mg t.id. 

G2: Tolterodine 

4mg bid 

Stratified by UDS 

findings: 

a: high volume (> 

250mL); low 

pressure (< 

25cmH2O)

b: high volume 

(≥ 250mL); 

high pressure 

(> 25cmH2O) 

C: low volume 

(< 250mL); low 

pressure (< 

25cmH2O) 

d: low volume 

(< 250mL); 

high pressure 

(> 25cmH2O) 

N at enrollment: 

Total: 128 

N at follow-up: 

Total: 107 

Ga: 6 

Gb: 25 

Gc: 36 

Gd: 40 

Women, %: 

100 

Inclusion criteria: 

• Age ≥ 18 

• DO on 

urodynamics 

Exclusion 

criteria: 

• Symptomatic or 

recurrent UTI 

• BOO 

• Neurologic 

disease 

• History of 

previous pelvic 

surgery 

• Narrow angle 

glaucoma 

• SUI 

• History of 

anticholinergic 

side effects 

• Interstitial 

cystitis 

• Child-bearing 

age without BC 

Voids/day, mean 

± SD: 

Total: 8.5 ± 2.63 

Ga: 7.2 ± NR 

Gb: 8.0 ± 2.40 

Gc: 8.3 ± 2.31 

Gd: 9.3 ± 2.91 

Volume (mL)/day, 

mean ± SD: 

Total: 1568.5 ± 

398.64 

Ga: 1756 ± NR 

Gb: 1594.6 ± 

326.12 

Gc: 1678.8 ± 

402.15 

Gd: 1420.5 ± 

384.96 

Voided volume 

(mL), mean ± SD:

Total: 196.1 ± 

60.19 

Ga: 253 ± NR 

Gb: 213.5 ± 53.57

Gc: 209.8 ± 57.43

Gd: 163.4 ± 51.97

Bladder volume 

(mL), first desire 

void, mean ± SD:

Total: 105.6 ± 

39.38 

Ga: 109 ± NR 

Gb: 128.0 ± 41.78

Gc: 94.3± 35.40 

Gd: 101.1 ± 38.14

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

Total: 172 ± 98.4 

Ga: 258 ± NR 

Gb: 303.3 ± 60.51

Gc: 111.9 ± 48.11

Gd: 124.4 ± 56.66

Voids/day, mean 

± SD: 

G1: 7.7 ± 1.87 

G2: 7.6 ± 2.18 

G1a: 6.1 ± NR 

G2a: 6.3 ± NR 

G1b: 7.3 ± 1.69 

G2b: 7.0 ± 1.87 

G1c: 7.5 ± 1.41 

G2c: 7.2 ± 1.58 

G1d: 8.3 ± 2.23 

G2d: 8.4 ± 2.53

Volume (mL)/day, 

mean ± SD: 

G1: 1764.4 ± 

333.03 

G2: 1670.7 ± 

338.6

G1a: 1862 ± NR 

G2a: 1720 ± NR

G1b: 1715.6 ± 

292.54 

G2b: 1665.8 ± 

251.19

G1c: 1847.9 ± 

333.81 

G2c: 1808.1 ± 

317.59

G1d: 1694.7 ± 

331.33 

G2d: 1550.3 ± 

373.65 

Voided volume 

(mL), mean ± SD: 

G1: 239.9 ± 64.98 

G2: 236.7 ± 63.03

G1a: 321 ± NR 

G2a: 286 ± NR 

G1b: 243.3 ± 

59.56 

G2b: 248.3 ± 

53.91

G1c: 252.9 ± 

55.75 

G2c: 258.6 ± 

60.63

G1d: 217.6 ± 

67.07 

G2d: 203.1 ± 

55.43 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-498 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Age, mean ± SD: 

Total: 56 ±16.3 

Ga: 53 ± 17.2 

Gb: 57 ± 16.2 

Gc: 57 ± 16.3 

Gd: 54 ± 16.6 

Weight (kg), 

mean ± SD: 

Total: 63 ± 5.6 

Ga: 63 ± 5.6 

Gb: 70 ± 9.1 

Gc: 67 ± 8.8 

Gd: 69 ± 7.5

 Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

Total: 34.8 ± 21.97

Ga: 17.4 ± NR 

Gb: 37.7 ± 14.03 

Gc: 18.5 ± 4.60 

Gd: 50.3 ± 25.14 

Overactivity 

index, mean ± 

SD: 

Total: 36.8 ± 31.36

Ga: 15.3 ± NR 

Gb: 24.8 ± 19.66 

Gc: 26.3 ± 16.14 

Gd: 57.0 ± 38.85 

Cystometric 

capacity (mL), 

mean ± SD: 

Total: 362.8 ± 

119.10

Ga: 403 ± NR 

Gb: 410.0 ± 97.78

Gc: 357.6 ± 

127.52 

Gd: 331.4 ± 

114.17 

Bladder volume 

(mL), first desire 

void, mean ± SD: 

G1: 129.0 ± 30.14 

G2: 117.9 ± 27.62

G1a: 144 ± NR 

G2a: 140 ± NR

G1b: 153.5 ± 

25.72 

G2b: 132.0 ± 

31.01

G1c: 120.8 ± 

25.07 

G2c: 113.2 ± 

23.16

G1d: 119.4 ± 

29.43 

G2d: 110.1 ± 

26.15 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

G1: 212.9 ± 

106.10 

G2: 206.9 ± 

103.56

G1a: 382 ± NR 

G2a: 364 ± NR

G1b: 355.28 ± 

74.79

G1c: 142.4 ± 

43.51 

G2c: 144.6 ± 

48.43

G1d: 173.3 ± 

57.37 

G2d: 162.7 ± 

53.87 

G1d/BL: P < 0.01 

G2d/BL: P < 0.01 
C-499 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

 Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

G1: 30.9 ± 22.63 

G2: 30.9 ± 19.01

G1a: 14.0 ± NR 

G2a: 17.4 ± NR

G1b: 35.6 ± 12.86 

G2b: 29.6 ± 13.56

G1c: 17.2 ± 6.80 

G2c: 17.9 ± 6.69

G1d: 42.9 ± 28.91 

G2d: 44.1 ± 20.75 

Overactivity 

index, mean ± 

SD: 

G1: 24.4 ± 22.61 

G2: 24.7 ± 23.46

G1a: 7.0 ± NR 

G2a: 9.5 ± NR

G1b: 14.1 ± 12.09 

G2b: 14.1 ± 12.71

G1c: 18.3 ± 15.89 

G2c: 16.9 ± 16.84

G1d: 38.9 ± 26.50 

G2d: 40.7 ± 26.58 

Cystometric 

capacity (mL), 

mean ± SD: 

G1: 419.3 ± 

120.86 

G2: 415.63 ± 

114.06

G1a: 465 ± NR 

G2a: 453 ± NR

G1b: 449.6 ± 

106.23 

G2b: 459.4 ± 

101.17

G1c: 409.9 ± 

130.22 

G2c: 411.05 ± 

132.49

G1d: 401.8 ± 

118.34 

G2d: 386.7 ± 

96.53 

Dry mouth, n (%): 

G1: 52 (40.6) 

G2: 20 (15.6) 
C-500 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued)

 Constipation, n 

(%): 

G1: 11 (10.3) 

G2: 3 (2.8) 

Discontinued 

due to AEs, n: 

Dry mouth: 12 

Palpitations: 1 
C-501 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Goode et al., 2002 

Country and 

setting: 

US; academic 

health center 

outpatient geriatric 

medicine clinic 

Enrollment 

period: 

July 1989 to 

August 1995 

Funding: 

National Institutes 

on Aging 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT, placebo 

controlled 

Computergenerated random 

numbers using a 

block size of 6, w/ 

prior stratification 

by type and 

severity of 

incontinence 

Intervention: 

Biofeedbackassisted 

behavioral vs. 

drug treatment 

(oxybutynin 

chloride; possible 

range of doses 2.5 

mg/d-5.0 mg t.i.d.) 

vs. placebo 

All patients had 4 

visits over an 8-

week period. 

Patients in G1 had 

biofeedback 

added to 

behavioral training 

in absence of 50% 

improvement by 

session 3. 

Groups: 

G1: Behavioral ± 

biofeedback 

G2:

Pharmacologic 

G3: Placebo 

N at enrollment: 

468 screened 

271 not eligible 

197 randomized 

105 had pre and 

post treatment 

urodynamics 

G1: 33 

G2: 35 

G3: 37 

Inclusion criteria: 

• Communitydwelling women 

at least age 55 

• Ambulatory 

• At least 2 urge 

accidents per 

week by 

baseline 

bladder diary 

• Urge 

incontinence as 

predominant 

pattern 

• Urodynamic 

evidence of 

bladder 

dysfunction 

Exclusion 

criteria: 

• Continual 

leakage 

• Postvoid 

residual urine 

volume >200mL

• Uterine 

prolapse past 

the introitus 

• Narrow-angle 

glaucoma 

• Unstable angina

• Decompensated 

congestive 

heart failure 

• Hx of malignant 

arrhythmias 

• MMSE <20 

(Dementia) 

Voids per day, 

mean n ± SD: 

G1: 10.0 

G2: 10.9

G3: 10.0 

Cystometry at 

baseline, mL

First desire to void

G1: 97.1 ± 50.7 

G2: 101.1 ± 62.1 

G3: 124.6 ± 73.7 

Strong desire to 

void 

G1: 188.5 ± 93.1 

G2: 212.1 ± 86.7 

G3: 222.3 ± 87.0 

Bladder capacity 

G1: 288.3 ± 117.0

G2: 308.7 ± 93.7 

G3: 328.9 ± 107.6

Voids per day, 

mean n ± SD: 

G1: 8.2 

G2: 8.8

G3: 9.7 

DI on UDS, n (%) 

+Baseline DI/+DI 

post-treatment 

G1: 7 (21.2) 

G2: 1 (2.9) 

G3: 5 (13.5) 

DI on UDS, n (%) 

+Baseline DI/-DI 

post-treatment 

G1: 1 (3.0) 

G2: 7 (20.0) 

G3: 7 (18.9) 

DI on UDS, n (%) 

-Baseline DI/+DI 

post-treatment 

G1: 3 (9.1) 

G2: 3 (8.6) 

G3: 3 (8.1) 

DI on UDS, n (%) 

-Baseline DI/-DI 

post-treatment 

G1: 22 (66.7) 

G2: 24 (68.6) 

G3: 22 (59.5) 

Cystometry posttreatment, mL 

First desire to void 

G1: 115.9 ± 64.9 

G2: 145.6 ± 74.0 

G3: 133.5 ± 59.6 

Strong desire to 

void 

G1: 228.9 ± 106.4 

G2: 282.0 ± 93.2 

G3: 230.1 ± 78.8 

Bladder capacity 

G1: 305.6 ± 117.9 

G2: 377.6 ± 92.1 

G3: 323.0 ± 109.0 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: +

Baseline OAB 

status: +

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-502 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Goode et al., 2002 

(continued) 

Age, yrs ± SD: 

G1: 65.3 ± 4.5 

G2: 67.9 ± 7.9 

G3: 67.6 ± 7.7 

Race/ethnicity, 

%: 

Black: 2 

White: 98 

Women: 

100% 

Parity mean ± 

SD: 

G1: 3.1 ± 1.7 

G2: 2.1 ± 1.3 

G3: 2.3 ± 1.5 

 Cystometry, 

change in mean 

volume by group 

First desire to void 

G1: 18.8 

G2: 44.4 

G3: 8.9 

P= 0.149 

Strong desire to 

void 

G1: 40.5 

G2: 69.9 

G3: 7.8 

P= 0.018 

Bladder capacity 

G1: 17.3 

G2: 68.9 

G3: -6.0 

P= 0.000 

Standardized 

Estimates of 

Direct and 

Mediated Effects 

of Treatment

G1 v G3 

Total effect: 0.28* 

Direct effect: 0.23 

Mediated Effect: 

0.05 

G2vG3 

Total Effect: 0.34* 

Direct Effect: 0.30* 

Mediated Effect: 

0.04 

*P<0.01 
C-503 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Halaska et al., 

2003 

Country and 

setting: 

Europe and Asia, 

Academic medical 

center 

Enrollment 

period: 

May 1996 to May 

1999 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized 

controlled 

double blind 

crossover 

Intervention: 

Trospium vs. 

Oxybutynin

Groups: 

G1: Trospium 20 

mg bid 

G2: Oxybutynin 

5mg bid 

N at enrollment: 

G1: 268 

G2: 90 

N at follow-up: 

G1: 200 

G2: 66 

Women, n (%): 

G1: 228 (85) 

G2: 78 (87) 

Age, mean 

(range): 

G1: 54.2 (19, 89) 

G2: 52.2 (19, 85) 

Weight (kg), 

mean (range): 

G1: 72.3 (50-120) 

G2: 70.4 (50-90) 

Height (cm), 

mean (range): 

G1: 164.8 (144-

185) 

G2: 165.5 (145-

183) 

Smokers, n (%): 

G1: 38 (14) 

G2: 10 (11) 

Previous illness, 

n (%): 

G1: 184 (69) 

G2: 66 (73) 

Previous 

medication, n 

(%): 

G1: 101 (38) 

G2: 46 (51) 

Inclusion criteria: 

• Age ≥ 18 yrs 

• Urge syndrome 

• Urge 

incontinence 

• UUI as one 

component of 

MUI 

• UUI due to 

neurologic 

condition 

(detrusor 

hyperreflexia) 

Exclusion 

criteria: 

• Absolute 

tachycardia 

• Closed angle 

glaucoma 

• Myasthenia 

gravis 

• Arteriosclerosis 

of cerebral 

vessels 

• SUI 

• Heart or renal 

failure 

• Frequency from 

diuretics 

• BOO 

• Acute UTI 

• Hiatus hernia 

with reflux 

esophagitis 

• Stenosis of GI 

tract 

• Megacolon 

• Colonic 

ulceration 

• Allergy to study 

medications 

• Anticholinergics, 

TCAs, alpha 

blockers, beta 

sympathomimetics ≤ 7 

days 

• Urological or 

gynecologic 

surgery ≤ 3 mos

• Pregnant or 

lactating 

• In another study

Urgency 

episodes/day, 

mean: 

G1: 10.2 

G2: 11.0 

Incontinence 

episodes/ day, 

mean: 

G1: 1.5 

G2: 2.1 

Voids/day, mean:

G1: 11.4 

G2: 12.5 

Max cystometric 

capacity (mL), 

mean: 

G1: 205 

G2: 205 

Urgency 

episodes/day, 

mean: 

G1: 6.7 

G2: 7.4 

Incontinence 

episodes/ day, 

mean: 

G1: 0.5 

G2: 1.1 

Voids/day, mean: 

G1: 7.9 

G2: 8.3 

Max cystometric 

capacity (mL), 26 

wks, mean 

change: 

G1: 92.0 

G2: 117.0 

G1/BL: P ≤ 0.001 

G2/BL: P ≤ 0.001 

Max cystometric 

capacity (mL), 52 

wks, mean 

change: 

G1: 115.0 

G2: 119.4 

G1/BL: P ≤ 0.001 

G2/BL: P ≤ 0.001 

Bladder volume 

(mL), first 

contraction, 26 

wks, mean 

change: 

G1: 63.5 

G2: 61.2 

Bladder volume 

(mL), first 

contraction, 52 

wks, mean 

change: 

G1: 46.1 

G2: 36.7 

Bladder volume 

(mL), first 

sensation, 26 

wks, mean 

change: 

G1: 73.6 

G2: 76.93 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: +
C-504 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Halaska et al., 

2003 

(continued) 

 Bladder volume 

(mL), first 

sensation, 26 

wks, mean 

change: 

G1: 78.6 

G2: 70.2 

Abnormal EKG, n 

(%): 

G1: 4 (0.1) 

G2: 2 (0.2) 

Any adverse 

event, n (%): 

G1: 10 (3.7) 

G2: 6 (6.7) 

Poor efficacy, n 

(%): 

G1: 8 (3) 

G2: 2 (2.2) 

Poor compliance, 

n (%): 

G1: 15 (15.6) 

G2: 6 (6.7) 

Abdominal pain, 

n (%): 

G1: 5 (2) 

G2: 0 (0) 

Constipation, n 

(%): 

G1: 18 (7) 

G2: 4 (4) 

Diarrhea, n (%): 

G1: 2 (1) 

G2: 2 (2) 

Dyspepsia, n (%): 

G1: 13 (5) 

G2: 3 (3) 

Dysphagia, n 

(%): 

G1: 9 (3) 

G2: 3 (3) 

Dry mouth, n (%): 

G1: 87 (33) 

G2: 45 (50) 

P < 0.001 

Nausea, n (%): 

G1: 6 (2) 

G2: 2 (2) 
C-505 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Halaska et al., 

2003 

(continued) 

 UTI, n (%): 

G1: 33 (12) 

G2: 10 (11)

Headache, n (%): 

G1: 11 (4) 

G2: 8 (9) 

Visual 

disturbances, n 

(%): 

G1: 9 (3) 

G2: 5 (6) 

Virus infection, n 

(%): 

G1: 9 (3) 

G2: 4 (4) 

Abnormal EKG, n 

(%): 

G1: 4 (0.1) 

G2: 2 (0.2) 

Sleeplessness, n 

(%): 

G1: 10 (4) 

G2: 2 (2) 
C-506 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Herschorn et al., 

2004 

Country and 

setting: 

Canada; Family 

medicine and 

urology clinics 

Enrollment 

period: 

June 2000 to 

December 2001 

Funding: 

Pharmacia Pfizer 

Canada 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Health education 

with tolterodine vs. 

tolterodine alone

Groups: 

G1: Health 

education with 

tolterodine 

G2: tolterodine 

alone 

N at enrollment: 

G1: 39 

G2: 45 

N at follow-up, 5 

weeks: 

G1: 37 

G2: 40 

N at follow-up, 10 

weeks: 

G1: 35 

G2: 32 

N at follow-up, 16 

weeks: 

G1: 34 

G2: 31 

Age, yrs ± SD: 

G1: 65.7 ± 14.5 

G2: 63.1 ± 15.7 

Race/ethnicity: 

NR 

Women, %: 

G1: 92.3 

G2: 84.4 

Parity: 

NR 

Inclusion criteria: 

• Age ≥ 50 

• Symptoms of 

OAB^ 

• Attend 

investigators’ 

practice 

• Normal 

cognitive 

function 

• Able to read 

English 

Exclusion 

criteria: 

• Enrollment in 

another clinical 

trial 

• Interstitial 

cystitis 

• UTI 

• Already taking 

tolterodine 

Duration of OAB, 

yrs ± SD: 

G1: 8.7 ± 11.0

G2: 8.7 ± 10.8 

Mild bladder 

problems, n (%): 

G1: 13 (33.3) 

G2: 13 (28.9) 

Moderate bladder 

problems, n (%): 

G1: 19 (48.7) 

G2: 28 (62.2) 

Severe bladder 

problems, n (%): 

G1: 7 (18.0) 

G2: 4 (8.9) 

Obtained 

prescription, n 

(%): 

G1: 38 (97.4) 

G2: 37 (82.2) 

P < 0.05 

Intends to fill 

prescription, (%):

G1: 0 (0) 

G2: 6 (7.5) 

Change in 

incontinence 

episodes/wk, 

mean ± SD: 

G1: -7.72 ± 21.16 

G2: -10.24 ± 

19.56† 

Change in 

voids/d, mean ± 

SD: 

G1: -1.82 ± 3.41 

G2: -2.18 ± 4.89 

P = NR 

Change in 

nocturnal voids, 

mean ± SD: 

G1: -0.44 ± 1.13† 

G2: -0.07 ± 0.91 

No change in 

bladder problem 

severity, n (%): 

G1: 14 (42.4) 

G2: 20 (66.7) 

Improved 

bladder problem 

severity, n (%): 

G1: 15 (45.4)† 

G2: 6 (20) 

Worsened 

bladder problem 

severity, n (%): 

G1: 4 (12.1) 

G2: 4 (13.3) 

Compliance, 10 

weeks, %: 

G1: 41 

G2: 38 

P > 0.05 

Compliance, 16 

weeks, %: 

G1: 39 

G2: 31 

P > 0.05 

Continued or 

started non-drug 

OAB treatment, 

16 weeks, %: 

G1: 82 

G2: 53 

P > 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 
C-507 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Herschorn et al., 

2004 

(continued) 

 Stopped nondrug OAB 

treatments, %: 

G1: 12.8 

G2: 28.9 
C-508 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jarvis et al., 1981

Country and 

setting: 

UK, Academic 

medical center

Enrollment 

period: 

NR

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Inpatient bladder 

drill vs. outpatient 

drug therapy 

Groups: 

G1: inpatient 

bladder drill 

G2: flavoxate 

hydrochloride 200 

mg tds and 

imipramine 25 mg 

tds x 4 wks 

N at enrollment: 

G1: 25 

G2: 25 

N at follow-up: 

G1: 25 

G2: 25 

Women, %: 

100 

Age, mean ± SD 

(range): 

G1: 47 ± 15.4 (17-

78) 

G2: 46 ± 12.8 (17-

65) 

Inclusion criteria: 

• Women 

• UDS-diagnosed 

detrusor 

instability 

Exclusion 

criteria: 

• DM 

• Neurological 

abnormalities 

• UTIs 

• Taking a drug 

suspected of 

affecting lower 

urinary tract 

function 

• Genuine stress 

incontinence 

UUI, n: 

G1: 25 

G2: 25 

SUI, n: 

G1: 19 

G2: 17 

Urgency, n: 

G1: 25 

G2: 25 

Frequency, n: 

G1: 25 

G2: 25 

Nocturia, n: 

G1: 21 

G2: 19 

Duration of 

symptoms 

(years), mean ± 

SD (range): 

G1: 4.3 ± 2.7 (1-

15) 

G2: 5.4 ± 3.2 (1-

20) 

Bladder volume 

(mL), first 

sensation, mean:

G1: 87 

G2: 79 

Max cystometric 

capacity (mL), 

mean: 

G1: 381 

G2: 353 

UUI, n: 

G1: 4 

G2: 11 

SUI, n: 

G1: 1 

G2: 9 

Urgency, n: 

G1: 4 

G2: 11 

Frequency, n: 

G1: 6 

G2: 12 

Nocturia, n: 

G1: 4 

G2: 13 

Continent, n (%): 

G1: 21 (84) 

G2: 14 (56) 

P < 0.05 

Symptom-free, n 

(%): 

G1: 19 (76) 

G2: 12 (48) 

P < 0.05 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 152 

G2: 140 

Max cystometric 

capacity (mL), 

mean: 

G1: 470 

G2: 446 

Adverse events, 

drug therapy, n:* 

Dizziness: 8 

Headache: 6 

Dry mouth: 6 

Nausea: 4 

Drowsiness: 2 

Vomiting: 1 

Discontinued 

due to AEs, n: 

Dizziness: 1 

Headache: 1 

Vomiting: 1 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to follow up: 

++ 

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of follow 

up: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-509 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lauti et al., 2008 

Country and 

setting: 

New Zealand, 

Academic 

Enrollment 

period: 

February 2003 to 

July 2003 

Funding: 

University of 

Otago 

Author industry 

relationship 

disclosures: 

None 

Design: 

RCT pilot study, 

unmasked 

Intervention: 

Oxybutynin vs. 

bladder retraining 

vs. combination 

therapy

Groups: 

G1: Oxybutynin 

2.5 mg/day (daily 

dose could be 

increased by 2.5 

mg every 5 days

to a maximum of 

15 mg/day) 

G2: Bladder 

retraining 

G3: Combination 

therapy 

N screened: 

120 

N at enrollment: 

G1: 21 

G2: 16 

G3: 19 

N at 3 month 

follow-up: 

G1: 18 

G2: 16 

G3: 12 

N at 12 month 

follow-up: 

G1: 16 

G2: 14 

G3: 12 

Age, mean ± SD: 

G1: 53.8 ± 14.8 

G2: 63.9 ± 17.2 

G3: 47.6 ± 16.3 

Race/ethnicity: 

NR 

Women, %: 

Total: 100 

Parous, %: 

G1: 81 

G2: 62.5 

G3: 73.7 

Inclusion criteria: 

• Age > 18 

• Predominant 

UUI 

Exclusion 

criteria: 

• Predominant 

SUI 

• Contraindication

s to 

anticholinergic 

drugs 

• Current UTI 

• Neurological 

disease 

• Psychiatric 

disorder 

• Untreated coexisting pelvic 

organ prolapse 

below the 

hymenal ring 

• Obstructed 

voiding 

• Functionalreversible cause 

of incontinence 

• Inability to toilet 

independently 

• Limited fluency 

of written/spoken 

English 

• Current or recent 

use of any of the 

trial interventions

Urgency 

episodes/day, 

mean ± SD: 

G1: 3.8 ± 2.7 

G2: 3.1 ± 2.2 

G3: 3.5 ± 2.0 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 2.2 ± 1.5 

G2: 1.0 ± 1.1 

G3: 1.8 ± 1.6 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.1 ± 1.0 

G2: 1.4 ± 1.0 

G3: 0.8 ± 0.7 

Voids per day, 

mean ± SD: 

G1: 7.8 ± 2.8 

G2: 8.0 ± 1.7 

G3: 8.4 ± 2.5 

OAB-q total 

HRQL, mean ± 

SD: 

G1: 73.1 ± 17.4 

G2: 69.5 ± 24.6 

G3: 71.6 ± 21.5 

OAB-q severity, 

mean ± SD: 

G1: 47.0 ± 16.2 

G2: 42.3 ± 17.7 

G3: 45.9 ± 18.7 

OAB-q coping, 

mean ± SD: 

G1: 72.0 ± 21.6 

G2: 66.2 ± 31.7 

G3: 73.8 ± 26.2 

OAB-q concern, 

mean ± SD: 

G1: 68.2 ± 19.0 

G2: 68.8 ± 27.6 

G3: 63.8 ± 29.2 

OAB-q sleep, 

mean ± SD: 

G1: 63.1 ± 28.7 

G2: 59.8 ± 29.9 

G3: 55.1 ± 27.6 

Urgency 

episodes/day, 3 

mos, mean ± SD: 

G1: 2.2 ± 1.8 

G2: 1.5 ± 2.1 

G3: 1.7 ± 1.8 

Urgency 

episodes/day, 12 

mos, mean ± SD: 

G1: 2.3 ± 2.5 

G2: 1.9 ± 2.1 

G3: 2.0 ± 1.1 

Incontinence 

episodes/day, 3 

mos, mean ± SD: 

G1: 0.8 ± 0.8 

G2: 0.1 ± 0.3 

G3: 0.6 ± 0.8 

Incontinence 

episodes/day, 12 

mos, mean ± SD: 

G1: 0.9 ± 0.0 

G2: 0.9 ± 1.0 

G3: 0.8 ± 0.7 

Nocturia 

episodes/day, 3 

mos, mean ± SD: 

G1: 1.0 ± 0.5 

G2: 0.8 ± 0.7 

G3: 0.6 ± 0.5 

Nocturia 

episodes/day, 12 

mos, mean ± SD: 

G1: 1.0 ± 0.9 

G2: 1.2 ± 0.6 

G3: 0.7 ± 0.7 

Voids/day, 3 

mos, mean ± SD: 

G1: 6.7 ± 1.8 

G2: 6.3 ± 1.6 

G3: 6.7 ± 2.2 

Voids/day, 12 

mos, mean ± SD: 

G1: 7.2 ± 1.1 

G2: 6.8 ± 1.4 

G3: 7.6 ± 1.5 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: +

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-510 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

 OAB-q social, 

mean ± SD: 

G1: 92.5 ± 14.6 

G2: 85.4 ± 19.9 

G3: 92.8 ± 18.6 

SF-12 quality of 

life, physical, 

mean ± SD: 

G1: 49.0 ± 9.6 

G2: 41.7 ± 11.5 

G3: 46.2 ± 10.6 

SF-12 quality of 

life, mental, 

mean ± SD: 

G1: 49.1 ± 9.3 

G2: 53.1 ± 8.8 

G3: 46.3 ± 8.3 

OAB-q total 

HRQL, 3 mos, 

mean ± SD: 

G1: 82.3 ± 16.1 

G2: 89.6 ± 9.4 

G3: 91.8 ± 7.4 

OAB-q total 

HRQL, 12 mos, 

mean ± SD: 

G1: 87.9 ± 11.6 

G2: 81.6 ± 19.3 

G3: 88.9 ± 9.9 

OAB-q severity, 3 

mos, mean ± SD: 

G1: 37.2 ± 22.0 

G2: 16.8 ± 12.0 

G3: 21.6 ± 10.9 

OAB-q severity, 

12 mos, mean ± 

SD: 

G1: 24.6 ± 10.6 

G2: 33.1 ± 16.6 

G3: 21.9 ± 14.8 

OAB-q coping, 3 

mos, mean ± SD: 

G1: 79.2 ± 22.1 

G2: 91.6 ± 9.5 

G3: 92.7 ± 9.4 

OAB-q coping, 

12 mos, mean ± 

SD: 

G1: 89.2 ± 13.7 

G2: 81.5 ± 23.7 

G3: 90.5 ± 10.0 

OAB-q concern, 

3 mos, mean ± 

SD: 

G1: 78.6 ± 18.0 

G2: 87.7 ± 14.5 

G3: 90.2 ± 12.4 

OAB-q concern, 

12 mos, mean ± 

SD: 

G1: 85.3 ± 15.5 

G2: 81.7 ± 19.7 

G3: 85.2 ± 13.4 

OAB-q sleep, 3 

mos mean ± SD: 

G1: 77.7 ± 24.9 

G2: 81.3 ± 14.6 

G3: 85.0 ± 19.6 
C-511 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

 OAB-q sleep, 12 

mos, mean ± SD: 

G1: 79.9 ± 18.3 

G2: 72.0 ± 24.5 

G3: 83.2 ± 18.4 

OAB-q social, 3 

mos, mean ± SD: 

G1: 96.4 ± 9.7 

G2: 95.6 ± 7.0 

G3: 98.9 ± 1.9 

OAB-q social, 12 

mos, mean ± SD: 

G1: 97.3 ± 7.1 

G2: 91.9 ± 14.2 

G3: 97.3 ± 6.9 

SF-12 quality of 

life, physical 

G1: 50.6 ± 8.0 

G2: 42.1 ± 12.7 

G3: 48.4 ± 10.8 

SF-12 quality of 

life, physical, 12 

mos, mean ± SD: 

G1: 50.0 ± 7.3 

G2: 45.1 ± 13.9 

G3: 45.3 ± 13.4 

SF-12 quality of 

life, mental, 3 

mos, mean ± SD: 

G1: 50.4 ± 9.6 

G2: 51.2 ± 9.5 

G3: 46.7 ± 7.6 

SF-12 quality of 

life, mental, 12 

mos, mean ± SD: 

G1: 49.6 ± 7.5 

G2: 50.1 ± 10.7 

G3: 50.6 ± 8.4 

Dry mouth, n (%): 

G1: 3 (21) 

G2: 5 (46) 

G3: 5 (42) 

Headaches, n 

(%): 

G1: 6 (43) 

G2: 1 (11) 

G3: 7 (58) 

Dizziness, n (%): 

G1: 4 (29) 

G2: 2 (20) 

G3: 3 (25) 
C-512 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lauti et al., 2008 

(continued) 

 Constipation, n 

(%): 

G1: 3 (21) 

G2: 3 (27) 

G3: 3 (27) 

Fatigue, n (%): 

G1: 9 (64) 

G2: 5 (46) 

G3: 7 (64) 
C-513 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lee et al., 2002 

Country and 

setting: 

South Korea, 

University 

Enrollment 

period: 

NR 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine 2mg 

bid vs. Oxybutynin 

5mg bid 

Groups: 

G1: Tolterodine 

2mg bid 

G2: Oxybutynin 

5mg bid 

N at enrollment: 

G1: 112 

G2: 116 

N at follow-up: 

G1: 97 

G2: 90 

Women, n (%): 

G1: 84 (74) 

G2: 92 (79) 

Age, mean 

(range): 

G1: 52 (27, 82) 

G2: 52 (20, 86) 

Race/ethnicity 

(%): 

Asian: 

G1: 100 

G2: 100 

BMI, kg/m2

(range): 

G1: 23 (17, 32.5) 

G2: 23.5 (16, 38) 

Previous drug 

therapy: N (%) 

G1: 36 (32) 

G2: 26 (22) 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

> 6 mos 

• ≥ 8 voids/day, 

with or without 

incontinence 

(measured by 

diary) 

Exclusion 

criteria: 

• SUI 

• Women not 

using reliable 

contraception 

• Pregnant or 

nursing 

• Prior treatment 

with 

anticholinergic < 

2 wks 

• Renal or hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary 

retention 

• Gastric 

retention 

• Hypersensitivity 

to drugs 

• UTI 

• IC 

• Hematuria 

• BOO 

• Concomitant 

bladder training, 

e-stim treatment

• Indwelling 

catheter 

• Intermittent 

catherization 

• Concomitant 

treatment for 

OAB ≤ 2 mos 

Incontinence 

episodes/day, 

mean (range): 

G1: 2.6 (0.3, 9.3) 

G2: 2.4 (3.0, 14.7)

Patients with 

incontinence 

episodes, n (%): 

G1: 46 (41) 

G2: 42 (36) 

Voids/day, mean 

(range): 

G1: 12.2 (8.0, 

23.7) 

G2: 12.4 (7.7, 

29.7) 

Incontinence 

episodes/day, 

mean change ± 

SD (% change): 

G1: -2.2 ± 2.3 (-

85) 

G2: -1.4 ± 1.8 (-

58) 

G1/BL: P = 

0.0001 

G1/BL: P = 

0.0001 

G1/G2: P = 0.10 

Voids/ day, mean 

change ± SD (% 

change): 

G1: -2.6 ± 2.9 (-

21) 

G2: -1.8 ± 4.2 (-

15) 

G1/BL: P = 

0.0001 

G1/BL: P = 

0.0001 

G1/G2: P = 0.14 

Benefit of Tx, %: 

G1: 45 

G2: 46 

G1/G2: P = NS 

Patients 

reporting 

adverse events, 

n (%): 

G1: 62 (55) 

G2: 94 (82) 

Discontinued 

due to AEs, n 

(%): 

G1: 11 

G2: 18 

Dry mouth, n (%): 

G1: 39 (35) 

G2: 72 (63) 

G1/G2: P = 0.001 

Dry mouth, mild, 

n (%): 

G1: 29 (26) 

G2: 40 (35) 

Dry mouth, 

moderate, n (%): 

G1: 9 (8) 

G2: 26 (23) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-514 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lee et al., 2002 

(continued)

 Dry mouth, 

severe, n (%): 

G1: 1 (1) 

G2: 6 (5) 

Voiding disorder, 

n (%): 

G1: 10 (9) 

G2: 16 (14)

Dyspepsia, n (%): 

G1: 8 (7) 

G2: 6 (5) 

Abdominal pain, 

n (%): 

G1: 6 (5) 

G2: 6 (5) 

Headache, n (%): 

G1: 4 (4) 

G2: 6 (5) 
C-515 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Macaulay et al., 

1987 

Country and 

setting: 

UK, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

Wellcome Trust, 

trustees of St. 

George’s Hospital 

Author industry 

relationship 

disclosures: 

NR

Design: 

RCT 

(randomization not 

specified) 

Intervention: 

Brief eclectic 

psychotherapy, 

bladder training or 

medication 

Groups: 

G1: psychotherapy 

G2: bladder drill 

G3: propantheline 

N at enrollment: 

G1: 19 

G2: 16 

G3: 15 

N at follow-up: 

G1: 18 

G2: 15 

G3: 14 

Women, %: 

100 

Age: 

NR 

Race/ethnicity: 

NR 

Follow-up: 

3 months 

Inclusion criteria:

• Previous 

completion of 

survey on psych 

conditions w/ 

OAB 

• Detrusor 

instability on 

UDS or sensory 

urgency 

Exclusion 

criteria: 

NR 

Detrusor 

instability, n: 

G1: 10 

G2: 8 

G3: 8 

Sensory 

urgency, n: 

G1: 9 

G2: 8 

G3: 7 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 10.8 

Bladder capacity 

(mL), mean: 

G1: 393 

G2: NR 

G3: 323 

Bladder volume 

(mL), first 

sensation, mean:

G1: 107 

G2: 110 

G3: 70 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 45.5 

G3: NR 

Voids/day, mean: 

G1: NR 

G2: NR 

G3: 8.3 

G3/BL: P < 0.005 

Bladder capacity 

(mL), mean:

G1: 414 

G2: NR 

G3: 368 

G1/BL: P = NS 

G3/BL: P = NS 

Bladder volume 

(mL), first 

sensation, mean: 

G1: 142 

G2: 150 

G3: 137 

G1/BL: P = NS 

G2/BL: P < 0.05 

G3/BL: P = 0.06 

Detrusor 

pressure rise (cm 

H2O), mean: 

G1: NR 

G2: 29.5 

G3: NR 

G2/BL: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: - 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-516 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Mattiasson et al., 

2003 

Country and 

setting: 

Sweden, 

Denmark, Norway 

(Tolterodine 

Scandinavian 

Study Group) 

Enrollment 

period: 

October 1999 to 

December 2000 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR

Design: 

RCT, singleblinded (balanced 

blocks of 4, 

computerized 

randomization list) 

Intervention: 

Pharmacologic ± 

behavioral 

therapy; 

Tolterodine 2mg 

b.i.d. ± BT; 

Tolterodine 

dosage could be 

decreased to 1mg 

P.O. b.i.d. during 

the first 2 wks if 

intolerable SE; 

BT taught with a 

written handout 

Groups: 

G1: Tolterodine + 

BT x 24 wks 

G2: Tolterodine x 

24 wks 

N at enrollment: 

Total: 505 

N at follow-up: 

G1: 244 

G2: 257 

N Completed 

treatment: 

G1: 77% 

G2: 79% 

Total: 74% 

Women, n (%) 

G1: 177 (73) 

G2: 201 (78) 

Age, median 

(range): 

G1: 62 (19, 86) 

G2: 63 (22, 86) 

Race/ethnicity: 

NR 

Follow-up: 

24 weeks 

Inclusion criteria:

• Age ≥ 18 

• ≥ 8 voids/day 

and urinary 

urgency (± UUI) 

as determined 

by 1 wk bladder 

diary 

• With or without 

UUI 

• Women of 

reproductive age 

had to be using 

reliable birth 

control 

Exclusion 

criteria: 

• Contraindication 

to antimuscarinic 

therapy 

• Use of 

electrostimulatio

n therapy or BT 

within prior 3 mo

• Indwelling 

catheter or 

intermittent 

catheterization 

• Pregnancy or 

lactation 

• Use of 

anticholinergic 

agents or 

concomitant 

treatment for 

OAB (estrogen 

permitted) 

Urgency 

episodes/day, 

mean (range): 

G1: 6.0 (0, 23.0) 

G2: 6.6 (0, 34.3) 

Incontinence 

episodes/day, 

mean (range): 

G1: 2 (0.3, 20.3) 

G2: 2.3 (0.3, 16.3)

Voids/day, mean 

(range):

G1: 10.3 (7.3, 

27.6) 

G2: 10.6 (7.7, 

24.6) 

Duration of 

symptoms > 5 

years, n (%): 

G1: 120 (49) 

G2: 124 (48) 

Previous drug 

therapy for OAB, 

n (%): 

G1: 40 (160 

G2: 35 (14) 

Previous surgery 

affecting lower 

urinary tract, n 

(%): 

G1: 28 (11.5) 

G2: 30 (12) 

Symptoms

caused at least 

moderate 

problems, %: 

G1: 92 

G2: 93 

 

Urgency 

episodes/day, 

median % 

change (IQR): 

G1: -38 (-76.7, 

-14.1) 

G2: -38 (-68.7, 

-8.0) 

G1/G2: P = 0.75 

Incontinence 

episodes/day, 

median IQR% 

change; n=301: 

G1: -87 (-100, -20) 

G2: -81 (-100, 

-41.8) 

G1/G2: P = 0.28 

Voids/day, 

median % 

change (IQR):

G1: -33 (-42.3, 

21.3) 

G2: -25 (-38.8, 

-13.0) 

G1/G2: P < 0.001 

Voided volume 

(mL), median % 

change (IQR): 

G1: 31.5 (13.3, 

56.2) 

G2: 20 (3.1, 45.4) 

G1/G2: P <0.001 

Symptoms are 

“minor or less”, 

%: 

G1: 66.5 

G2: 61.5 

Overall improvement in 

symptoms, %: 

G1: 76 

G2: 71 

Worsening of 

symptoms, %: 

G1: 3 

G2: 5 

Dry mouth, n (%):

G1: 76 (31) 

G2: 90 (35) 

Headache, n (%): 

G1: 15 (6) 

G2: 21 (8) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-517 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Mattiasson et al., 

2003 

(continued) 

 Constipation, n 

(%): 

G1: 7 (3) 

G2: 14 (5) 

≥ 1 SE, n (%): 

G1: 158 (65) 

G2: 177 (69) 

G1/G2: P = NS 

Withdrawal due 

to, %: 

AE: 15 

Withdrawal due 

to lack of 

efficacy: 

3 

Withdrawal of 

consent : 

2 

Protocol 

violations: 

1 

Completed 

treatment: 

G1: 77% 

G2: 79% 
C-518 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Millard, 2004 

Country and 

setting: 

International, 

Multicenter study, 

54 sites

Enrollment 

period: 

NR

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

Tolterodine ± 

simplified pelvicfloor exercise 

regimen for 24 

weeks 

Groups: 

G1: tolterodine 2 

mg b.i.d. and 

simple PFME 

program 

G2: tolterodine 2 

mg b.i.d. daily 

N at enrollment: 

G1: 227 

G2: 253 

N at follow-up, 12 

weeks, n (%): 

G1: 181 (79.7) 

G2: 205 (81.0) 

N at follow-up, 24 

weeks, n (%): 

G1: 164 (72.2) 

G2: 190 (75.1) 

Women, n (%): 

G1: 169 (75.4%) 

G2: 190 (75.4%) 

Age, mean ± SD: 

G1: 53.6 ± 16.9 

G2: 53.2 ± 17.4 

Race/ethnicity: 

Asian: 

G1: 176 (78.6%) 

G2: 203 (80.6% 

White/mixed: 

G1: 48 (21.4%) 

G2: 49 (19.4%) 

Inclusion criteria: 

• Age 18-90 

• ≥ 8 voids/day 

• Urgency 

• ≥ 1 UI episode/d

• Sx for ≥ 6 

months 

Exclusion 

criteria: 

• Symptomatic SI 

• Significant PVR 

volume 

• Neuropathy 

• Glaucoma 

• UTI 

• + urine cytology 

• Use of 

concomitant 

anticholinergic 

therapy w/in 14 

days of 

randomization 

Urgency 

episodes/day, 

mean ± SD: 

G1: 4.2 ± 3.6 

G2: 4.1 ± 4.0 

Urgency 

episodes/day, 

median (IQR): 

G1: 3.6 (1.3, 6.0) 

G2: 3.0 (1.3, 6.0) 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 3.44 ± (3.4) 

G2: 3.21 ± (3.4) 

Incontinence 

episodes/day, 

median (IQR): 

G1: 2.3 (1.3, 4.0) 

G2: 2.9 (1.3, 3.7) 

Voids/day, mean 

± SD: 

G1: 11.87 ± 4.3 

G2: 12.78 ± 5.6 

Voids/day, 

median (IQR): 

G1: 10.7 (9.0, 

13.7) 

G2: 11.3 (9.0, 

15.0) 

Voided volume 

(mL), mean ± SD:

G1: 146.1 ± 67.7 

G2: 146.0 ± 83.3 

Voided volume 

(mL), median 

(IQR): 

G1: 137 (98, 186) 

G2: 132 (99, 189) 

Duration of 

symptoms, n (%):

≤ 5 years: 

G1: 166 (74.1) 

G2: 173 (68.7) 

> 5 years: 

G1: 56 (25) 

G2: 78 (31) 

Urgency 

episodes/day, 

wk 12, mean 

change ± SD (% 

change): 

G1: -1.9 ± 4.0 

(-64.5) 

G2: -2.2 ± 3.6 

(-69.8) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Urgency 

episodes/day, 

wk 12, median 

change: 

G1: -1.6 

G2: -1.3 

G1/G2: P = 

0.7658 

Urgency

episodes/day, 

wk 24, mean 

change ± SD (% 

change): 

G1: -2.2 ± 3.6 

(-78.7) 

G2: -2.7 ± 3.5 

(-83) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Urgency 

episodes/day, 

wk 24, median 

change: 

G1: -1.9 

G2: -2.0 

G1/G2: P = 

0.3029 

Incontinence 

episodes/day, 

wk 12, mean 

change ± SD: 

G1: -2.15 ± 3.0 

G2: -2.15 ± 2.7 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 

0.2215 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-519 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

 Previous UT 

surgery, n (%): 

G1: 44 (19.6) 

G2: 43 (17.1) 

Prev anticholinergics, n (%): 

G1: 19 (8.5) 

G2: 14 (5.6) 

Prev UUI drug, n 

(%): 

G1: 101 (45.1) 

G2: 91 (36.1) 

Patient subjective rating of 

UI symptoms as 

“severe” or 

“many severe”, 

%: 

G1: 54.0 

G2: 56.8 

Incontinence 

episodes/day, 

wk 12, median 

change: 

G1: -1.6 

G2: -1.6 

G1/G2: P = 

0.8251 

Incontinence 

episodes/day, 

wk 24, mean 

change ± SD (% 

change): 

G1: -2.23 ± 3.0 

(-64) 

G2: -2.26 ± 3.0 

(-70) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = NS 

Incontinence 

episodes/day,

wk 24, median 

change: 

G1: -1.6 

G2: -1.6 

G1/G2: P = 

0.8341 

Voids/day, wk 12, 

mean change ± 

SD (% change): 

G1: -2.68 ± 3.8 

(-22) 

G2: -3.42 ± 4.6 

(-26) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 

0.9478 

Voids/day, wk 24, 

mean change ± 

SD (% change): 

G1: -2.58 ± 5.0 

(-22) 

G2: -3.58 ± 5.2 

(-26) 

G1/BL: P = 0.001 

G1/BL: P = 0.001 

G1/G2: P = 

0.3549 
C-520 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

 Voided volume 

(mL), wk 12, 

median change 

(% change): 

G1: 20.4 (17.2) 

G2: 17.5 (15.8) 

Voided volume 

(mL), wk 12, 

median change 

(% change): 

G1: 21.1 (18.1) 

G2: 19.1 (15.4) 

Patient 

subjective report 

of improvement 

in bladder 

condition, wk 12, 

%: 

G1: 82.6 

G2: 83.9 

Patient 

subjective report 

of improvement 

in bladder 

condition, wk 24, 

%: 

G1: 81.7 

G2: 85.9 

Adverse events, 

n (%): 

G1: 22 (9.7) 

G2: 23 (9.1) 

Mild dry mouth, 

%: 

G1: 18.1

G2: 21.3

Moderate dry 

mouth, %: 

G1: 7.5

G2: 5.1

Severe dry 

mouth, %: 

G1: 4.0

G2: 3.2 

Headache, %: 

6 

Constipation, %: 

4.8

Nausea, %: 

2.7 
C-521 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Millard, 2004 

(continued) 

 Dry eyes, %: 

2.5 

Dizziness, %: 

2.4 
C-522 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 2004 

Country and 

setting: 

US, Specialty 

clinic 

Enrollment 

period: 

Subanalysis of 

OBJECT trial, 

women only 

Funding: 

ALZA Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

10mg ER 

Oxybutynin daily 

vs. 4mg 

Tolterodine (2mg 

bid)

Groups: 

G1: 10mg ER 

Oxybutynin daily x 

12 wks 

G2: 4mg 

Tolterodine (2mg 

bid) x 12 wks 

Stratified by age: 

a: Age ≤ 64 

b: Age 65-74 

c: Age ≥ 75 

N at enrollment: 

G1: 152 

G2: 163 

N at follow-up: 

G1: 132 

G2: 146 

Women, %: 

100 

Age, yrs ± SD: 

G1: 58.4 

G2: 58.8 

Race/ethnicity: 

NR

Inclusion criteria: 

• ≥ 7 and ≤ 50 

UUI 

episodes/week 

• ≥ 10 voids/day 

• MUI included if 

predominant 

UUI 

Exclusion 

criteria: 

• UTI 

• IC 

• Urethral 

diverticulum 

• Bladder tumor 

• Bladder stone 

• Delivery within 6 

mos 

• Pelvic, bladder, 

vaginal surgery 

in ≤ 6 mos 

• PVR ≥ 150 mL 

• Cardiovascular, 

renal, 

pulmonary, 

gastrointestinal, 

endocrine, 

neurologic, 

autoimmune, 

hematological, 

urological, 

psychiatric, or 

hepatic disease 

• Hematuria 

• Positive urine 

culture 

• Narrow angle 

glaucoma 

• Obstructive 

uropathy 

• Myasthenia 

gravis 

• POP to hymenal 

ring 

• GI obstruction 

• Decreased GI 

motility 

• GI narrowing 

• GI retention 

• Investigational 

drugs within 1 

month of 

screening 

• Hypersensitivity 

to drugs 

UUI episodes/ 

week, mean: 

G1: 25.2 

G2: 25.1 

Incontinence 

episodes/week, 

mean: 

G1: 28.1 

G2: 28.9 

Voids/week, 

mean: 

G1: 91.7 

G2: 91.6 

Naïve to anticholinergics, %: 

G1: 60.5 

G2: 60.7 

UUI episodes/ 

week, %: 

G1: 6.2 

G2: 8.5 

G1a: 5.0 

G2a: 8.4 

G1b: 5.5 

G2b: 7.5 

G1c: 8.5

G2c: 11.1 

G1/G2: P = 0.038 

G1a/G2a: P = 

0.005 

G1b/G2b: P =

0.337 

G1c/G2c: P = 

0.568 

Incontinence 

episodes/week, 

mean: 

G1: 7.3

G2: 10.1 

G1a: 5.8 

G2a: 10.0 

G1b: 6.1 

G2b: 9.2 

G1c: 10.5

G2c: 12.5 

G1/G2: P = 0.030 

G1a/G2a: P = 

0.005 

G1b/G2b: P = 

0.164 

G1c/G2c: P = 

0.714 

Voids/week, 

mean: 

G1: 68.0 

G2: 71.2 

G1a: 63.7 

G2a: 71.2 

G1b: 73.8 

G2b: 71.9 

G1c: 66.8

G2c: 65.5 

G1/G2: P = 0.272 

G1a/G2a: P = 

0.024 

G1b/G2b: P = 

0.706 

G1c/G2c: P = 

0.838 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-523 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2004 

(continued) 

• Current drug/ 

EtOH abuse 

• Pregnant 

• Breastfeeding 

• Inability to 

follow protocol 

Dry mouth, %: 

G1: 28.3 

G2: 33.7 

Constipation, %: 

G1: 8.6 

G2: 6.7 

Retention, %: 

G1: 4.0 

G2: 1.2 

Blurred vision, 

%: 

G1: 2.6 

G2: 0.6 

Dizziness, %: 

G1: 3.9 

G2: 4.3 

Insomnia, %: 

G1: 0.7 

G2: 1.8 

Somnolence, %: 

G1: 3.3 

G2: 1.8 

Nervousness, %: 

G1: 0 

G2: 1.2 

Headache, %: 

G1: 9.2 

G2: 10.4 

Dyspepsia, %: 

G1: 5.3 

G2: 6.1 

Nausea, %: 

G1: 3.3 

G2: 1.8 

Vomiting, %: 

G1: 2.0 

G2: 1.8 
C-524 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Schmidt et al., 

1999 

Country and 

setting: 16 

centers in US, 

Canada, and 

Europe 

Enrollment 

period: 

1993- April 1997 

Funding:

Medtronics Inc. 

Author conflict of 

interest: Schmidt, 

Jonas, Oleson, 

Janknegt, Siegel: 

financial interest 

and/or other 

relationship with 

Medtronic Inc. 

Design: 

randomized 

controlled trial 

Intervention:

implantable 

Interstim system 

stimulating the 

nerve ramus in 

preoperatively 

tested sacral 

nerve foramen 

Groups: 

G1: implantation 

with immediate 

stimulation (n=34 

for efficacy 

analysis) 

G2: control group 

receiving standard 

medical therapy 

for 6 months; 

allowed to cross 

over at 6 months if 

remained eligible 

for implantation 

(n=42 for efficacy 

analysis) 

N at enrollment: 

155 

N randomized: 

98 (the remaining 

57 did not respond 

to test stimulation 

so were not 

randomized) 

N at follow-up: 

76 at 6 months 

Age: mean 46.6 

±13.0 (range 20.2 

– 78.9) 

Gender: 125 F 

(80.6%), 30 M 

(19.4%) 

Race/ethnicity:

NR

Inclusion criteria:

• age > 16 years 

• refractory to 

standard 

medical therapy

• ≥ 100 mL 

bladder capacity 

with normal 

upper urinary 

tract 

• good surgical 

candidate 

• able to 

complete study 

documentation 

and return for 

follow-up 

evaluation 

Exclusion 

criteria: 

• Neurological 

conditions 

• Stress urinary 

incontinence 

• Primary pelvic 

pain 

Duration of urinary 

symptoms before 

enrollment: mean 

9.0±7.4 (range 

0.6-35.4) 

Mean number of 

daily incontinence 

episodes: 8.9± 5.9

G1: 9.7 ± 6.3 

G2: 9.3 ± 4.8 

Mean leak severity 

rating: 1.9± 0.6 

G1: 2.0 ± 0.7 

G2: 1.8 ± 0.6 

Mean absorbent 

pads/diapers 

replaced daily 

4.8± 4.8 

G1: 6.2 ± 5.0 

G2: 5.0 ± 3.7 

Mean heavy 

incontinence 

episodes per day: 

G1: 3.4 ±3.8 

G2: 2.6 ±3.5 

3-day diary data: 

90.3% of patients 

had at least 1 

moderate/heavy 

and 74.8% had at 

least 1 heavy 

incontinence 

episode 

Previous 

treatment for 

urinary 

problems: 153 

(89.7%), including 

pharmacological in 

144 (92.5%, 

nonsurgical in 55 

(35.5%), and 

surgical in 88 

(56.8%) 

At 6 months: 

Mean number of 

daily incontinence 

episodes: 

G1: 2.6± 5.1 

(p<0.0001) 

G2: 11.3 ± 5.9 

(p=0.002) 

Mean leak severity 

rating: 

G1: 0.8 ± 0.9 

(p<0.0001) 

G2: 2.0± 0.6 

(p=0.006) 

Mean absorbent 

pads/diapers 

replaced daily 

G1: 1.1 ± 2.0 

(p<0.0001) 

G2: 6.3 ± 3.6 

(p=0.003) 

Mean heavy 

incontinence 

episodes per day: 

G1: 0.3 ±0.9 

(P<0.0001) 

G2: 3.9 ±3.8 

G1: 47% 

completely dry at 

6 months; 3 

patients had no 

reduction in 

incontinence after 

6 months (one 

underwent device 

explantation and 2 

had increased 

frequency of 

urination and 

incontinence) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

 
C-525 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Schmidt et al., 

1999 

(continued) 

 Safety data 

(pooled for 157 

patients): adverse 

events requiring 

surgical 

repositioning or 

replacement of 

implant devices 

document in 51 

(32.5%) 

168 post-implant 

events reported by 

83 patients, 

including pain at 

the 

neurostimulator 

site in 15.9%, pain 

at implant site in 

19.1, and lead 

migration in 7.0% 

Infection or skin 

irritation led to 

device 

explantation in 2 

patients and 

temporary explant 

in 2 patients 

No permanent 

injuries or nerve 

damage reported. 
C-526 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Song, et al., 2006

Country and 

setting: 

Korea, Medical 

Center 

Enrollment 

period: 

May 2001 to April 

2002

Funding: 

NR

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT

Intervention: 

bladder training 

(BT) vs. 

Tolterodine vs. BT 

+ Tolterodine 

Groups: 

G1: BT x 12 wks 

G2: Tolterodine 2 

mg bid x 12 wks 

G3:Tolterodine 2 

mg bid + BT x 12 

wks 

N at enrollment: 

G1: 46 

G2: 47 

G3: 46 

N at follow-up: 

G1: 26 

G2: 32 

G3: 31 

Women, %: 

100

Age, mean ± SD: 

G1: 45.73 ± 12.68 

G2: 48.41 ± 9.38 

G3: 45.42 ± 9.54 

Race/ethnicity, 

%: 

Korean: 100 

Inclusion criteria:

• Age ≥ 18

• ≥ 8 voids/day 

• Urge with or 

without 

incontinence 

• Symptom 

duration ≥ 3 

months 

• No prior history 

of treatment for 

OAB 

Exclusion 

criteria: 

• Active urinary 

tract infection 

• Clinically 

significant SUI 

• Bladder outlet 

obstruction 

• Interstitial cystitis

• Glaucoma 

• Megacolon 

• Maximal urine 

flow rate of < 10 

mL/sec 

• Postvoid 

residual volume 

> 30% of the 

total amount 

voided on 

uroflowmetry 

Voids/day, mean 

± SD: 

G1: 10.93 ± 2.14 

G2: 11.63 ± 2.57 

G3: 11.90 ± 1.51 

Nocturia 

episodes/day, 

mean ± SD: 

G1: 1.45 ± 1.14 

G2: 1.72 ± 1.04 

G3: 1.96 ± 1.49 

Urgency, mean 

score ± SD: 

G1: 2.58 ± 1.30 

G2: 2.81 ± 0.74 

G3: 3.00 ± 1.10 

Maximum flow 

rate (mL/s), mean 

± SD: 

G1: 20.35 ± 8.44 

G2: 22.56 ± 4.94 

G3: 21.19 ± 4.96 

Residual urine 

(mL), mean ± SD:

G1: 9.08 ± 22.56 

G2: 7.59 ± 12.39 

G3: 6.42 ± 10.16 

Symptom 

duration (years), 

mean ± SD: 

G1: 6.44 ± 6.84 

G2: 4.54 ± 5.15 

G3: 4.10 ± 3.99 

Voids/day, mean 

(% decrease) 

G1: 8.1 (25.9%)* 

G2: 8.1 (30.2%)* 

G3: 7.9 (33.5%)* 

G3/G1: P < 0.05 

Nocturia 

episodes/day, 

mean (% 

reduction): 

G1: 0.6 (56.1%)* 

G2: 0.6 (65.4%)* 

G3: 0.6 (66.3%)* 

Urgency, mean 

score (% 

reduction): 

G1: 1.4 (44.8%)* 

G2: 1.1 (62.2%)* 

G3: 1.2 (60.2%)* 

G3/G1: P = 0.021 

G2/G1: P = 0.017 

G2/G3: P = NS 

Satisfaction,

mean score (% 

improved): 

G1: 1.5 (53.9) 

G2: 1.4 (63.0) 

G3: 1.3 (71.0) 

Dry mouth, n (%): 

G1: 0 (0.0) 

G2: 7 (21.9) 

G3: 9 (28.9) 

Hesitancy, n (%) 

G1: 0 (0.0) 

G2: 3 (9.4) 

G3: 2 (6.5) 

Decreased 

appetite/constipation, n (%): 

G1: 0 (0.0) 

G2: 2 (6.3) 

G3: 2 (6.5) 

Headache, n (%): 

G1: 0 (0.0) 

G2: 1 (3.1) 

G3: 0 (0.0) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-527 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Swift et al., 2003 

Country and 

setting: 

Europe (167 

centers), North 

America (74 

centers), Australia 

and New Zealand 

(4 centers), 

University 

Enrollment 

period: 

February 1999 to 

October 1999 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

double blind 

placebo-controlled 

double dummy, 

random permuted 

blocks of 6 

Intervention: 

Tolterodine ER vs. 

Tolterodine IR 

Groups: 

G1: Tolterodine 

ER 4mg daily 

G2: Tolterodine IR 

2 mg BID 

G3: placebo 

N at enrollment: 

G1: 417 

G2: 408 

G3: 410 

N at follow-up: 

Total: 1092 

Women, %: 

100 

Age, yrs ± SD: 

G1: 59 ± 14 

G2: 59 ± 14 

G3: 60 ± 14 

Race/ethnicity, n 

(%): 

White: 

G1: 396 (95) 

G2: 389 (95) 

G3: 383 (93) 

Black: 

G1: 15 (4) 

G2: 12 (3) 

G3: 20 (5) 

Asian/Pacific: 

G1: 5 (1) 

G2: 4 (1) 

G3: 2 (1) 

Mixed: 

G1: 0 

G2: 3 (1) 

G3: 5 (1) 

Unknown: 

G1: 1 (<1) 

G2: 0 

G3: 0 

Inclusion criteria: 

• Women 

• Age ≥ 18 

• ≥ 8 voids/day 

• > 5 UUI/ week 

• Symptoms x ≥ 6 

months (per 

voiding diary) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 liters

• Hepatic/ renal 

disease 

• UTI 

• IC 

• Hematuria 

• BOO 

• Current e-stim 

• Current bladder 

training 

• Indwelling 

catheter 

• Intermittent 

catherization 

• Pregnant/ 

nursing 

• Childbearing 

age without BC 

• Anticholinergic 

meds 

• Meds inhibit 

cytochrome 

P450 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 22.1 ± 22.5 

G2: 22.9 ± 21.9 

G3: 23.9 ± 21.2 

Pads/day, mean 

± SD: 

G1: 1.6 ± 2.1 

G2: 1.5 ± 2.0 

G3: 1.7 ± 2.4 

Voids/day, mean 

± SD: 

G1: 10.8 ± 4.2 

G2: 11.1 ± 3.7 

G3: 11.2 ± 3.9 

Voided volume 

(mL), mean ± SD:

G1: 141.2 ± 43.1

G2: 137.2 ± 41.2

G3: 135.7 ± 43.2 

Previous drug 

therapy: n (%): 

G1: 235 (56) 

G2: 222 (54) 

G3: 225 (55) 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 10.3 ± 17.2 

G2: 12.8 ± 19.8 

G3: 16.7 ± 19.7 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Pads/day, mean 

± SD: 

G1: 1.0 ± 1.8 

G2: 1.0 ± 1.5 

G3: 1.5 ± 2.2 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Voids/day, mean 

± SD: 

G1: 9.0 ± 3.2 

G2: 9.3 ± 4.0 

G3: 9.9 ± 3.8 

G1/G3: P = 0.001

G2/G3: P = 0.005 

Voided volume 

(mL), mean ± SD: 

G1: 179.1 ± 66.6

G2: 169.7 ± 65.6

G3: 149.0 ± 56.3 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Clinical effecttiveness*, dry 

mouth: 

G1: 0.53 

G2: 0.39 

G3: 0.30 

Dry mouth, n (%): 

G1: 105 (25.3) 

G2: 127 (31.2) 

G3: 33 (8.0) 

G1/G3: P < 0.01 

G2/G3: P < 0.01 

Abdominal pain, 

n (%): 

G1: 18 (4.3) 

G2: 12 (2.9) 

G3: 7 (1.7) 

G1/G3: P = 0.03 

Flatulence, n (%): 

G1: 8 (1.9) 

G2: 11 (2.7) 

G3: 6 (1.5) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-528 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

BMI, kg/m2

 ± SD: 

G1: 28.8 ± 13.8 

G2: 29.0 ± 11.0 

G3: 28.8 ± 6.7 

 Constipation, n 

(%): 

G1: 27 (6.5) 

G2: 27 (6.6) 

G3: 14 (3.4) 

Dyspepsia, n (%): 

G1: 11 (2.7) 

G2: 14 (3.4) 

G3: 6 (1.5) 

Nausea, n (%): 

G1: 7 (1.7) 

G2: 9 (2.2) 

G3: 9 (2.2) 

Diarrhea, n (%): 

G1: 10 (2.4) 

G2: 14 (3.4) 

G3: 9 (2.2) 

Xerophthalmia, n 

(%): 

G1: 16 (3.9) 

G2: 8 (2.0) 

G3: 8 (2.0) 

Abnormal vision, 

n (%): 

G1: 5 (1.2) 

G2: 4 (1.0) 

G3: 2 (0.5) 

Headache, n (%): 

G1: 29 (7.0) 

G2: 14 (3.4) 

G3: 19 (4.6) 

UTI, n (%): 

G1: 15 (3.6) 

G2: 11 (2.7) 

G3: 19 (4.6) 

Insomnia, n (%): 

G1: 7 (1.7) 

G2: 2 (0.5) 

G3: 9 (2.2) 

Somnolence, n 

(%): 

G1: 12 (2.9) 

G2: 11 (2.7) 

G3: 8 (2.0) 

Dizziness, n (%): 

G1: 7 (1.7) 

G2: 7 (1.7) 

G3: 4 (1.0) 
C-529 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

 Hypertension, n 

(%): 

G1: 6 (1.4) 

G2: 4 (1.0) 

G3: 4 (1.0) 

Sinusitis, n (%): 

G1: 8 (1.9) 

G2: 2 (0.5) 

G3: 3 (0.7) 

Arthritis, n (%): 

G1: 1 (0.2) 

G2: 5 (1.2) 

G3: 1 (0.2) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 5 (1.2) 

G3: 1 (0.2) 
C-530 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Szonyi et al., 1995 

Country and 

setting: 

UK 

Enrollment 

period: 

NR 

Funding: 

Smith & Nephew 

Pharmaceuticals 

Ltd 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Oxybutynin plus 

bladder training 

vs. placebo plus 

bladder training 

Groups: 

G1: Oxybutynin 

2.5 mg bid with 

dose titration on 

days 29 and 43 

plus bladder 

training 

G2: placebo + 

bladder training 

N at enrollment: 

G1: 30 

G2: 30 

N at follow-up: 

G1:16 

G2: 23 

Women, n (%): 

56 (93) 

Age, mean ± SD: 

82.2 ± 6.06 

Race/ethnicity: 

NR 

Weight (kg),

mean ± SD:

67.4 ± 14.92

Inclusion criteria:

• Age > 70 

• Frequency, 

urgency and UUI

• Mobile 

• Able to keep 

diary 

Exclusion 

criteria: 

• UTI 

• Hepatic or renal 

disease 

• Glaucoma 

• Uncontrolled 

diabetes 

• Taking 

imipramine or 

propantheline 

Voids/2 weeks, 

median change 

(95% CI): 

G1/G2: 577 (-

27.0, 6.0) 

P = 0.0025 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -6 (-5, 7.0) 

Daytime 

incontinence 

episodes/2 

weeks, median 

change (95% CI): 

G1 vs. G2: -9.5 (-

11.0, 3.0) 

Nocturia 

episodes/2 

weeks, median 

change (95% CI): 

G1/G2: -1.0 (-3.0, 

2.0) 

Patient assessment of benefit, 

%: 

29 days: 

G1: 86

G2: 55

P = 0.02 

43 days: 

G1: 71

G2: 59

P = 0.41 

57 days: 

G1: 79

G2: 55

P = 0.09 

Patient response, 

29 days, n: 

Cure: 

G1: 1

G2: 0 

Significant 

improvement: 

G1: 15

G2: 8

Marginal 

improvement: 

G1: 7

G2: 8 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-531 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Szonyi et al., 1995 

(continued)

 No change: 

G1: 5

G2: 13

Patient response, 

57 days, n: 

Cure: 

G1: 4

G2: 3

Significant 

improvement: 

G1: 14

G2: 8

Marginal 

improvement: 

G1: 3 

G2: 4

No change: 

G1: 7

G2: 14

Dry mouth, %: 

G1: 93

G2: 86

Blurred vision, 

%: 

G1: 50

G2: 59 

Heartburn, %: 

G1: 57

G2: 45

Constipation, %: 

G1: 50

G2: 45

Dry skin, %: 

G1: 50

G2: 59

Poor compliance 

(< 75% of 

tablets), %: 

G1: 20

G2: 20 
C-532 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Tseng et al., 2009 

Country and 

setting: 

Taiwan, University 

Enrollment 

period: 

January 2005 to 

November 2005 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective cohort 

randomized 

Intervention: 

Tolterodine 2 mg 

b.i.d. vs. 

tolterodine 2 mg 

b.i.d. + conjugated 

equine estrogen 

0.625 mg twice 

per week

Groups: 

G1: tolterodine 2 

mg b.i.d. 

G2: tolterodine 2 

mg b.i.d. + 

conjugated equine 

estrogen 0.625 mg 

twice per week 

N at enrollment: 

G1: 40 

G2: 40 

N at follow-up: 

G1: 40 

G2: 40 

Age, mean ± SD: 

G1: 64.5 ± 7.4 

G2: 66.2 ± 6.8 

Race/ethnicity:

NR 

Women, N (%): 

G1: 40 (100) 

G2: 40 (100) 

BMI, kg/m2

 ± SD: 

G1: 24.5 ± 3.9 

G2: 25.3 ± 3.8 

Previous 

antimuscarinic 

Rx, n (%): 

G1: 5 (12.5) 

G2: 6 (15) 

Prior 

hysterectomy, n 

(%): 

G1: 12 (30) 

G2: 14 (35) 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

• Amenorrheic 

Exclusion 

criteria: 

• Advanced POP 

> Stage 2 

• Women with 

storage and 

voiding 

dysfunction 

undiagnosed 

• Severe 

constipation 

• Elevated PVR 

• Neurological 

deficit 

• Renal/ hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary retention

• Gastric retention

• Hypersensitivity 

to drugs 

• BOO 

• Cardiac 

conduction 

disorders 

• Myasthenia 

gravis 

• History of CVA 

• History of VTE 

• Gallbladder 

disease 

• Known or 

suspected 

breast 

carcinoma 

• Undiagnosed 

genital bleeding 

• HRT within 3 

months of study 

enrollment 

UUI episodes/ 

day, mean ± SD: 

G1: 1.8 ± 0.7 

G2: 2.1 ± 1.1 

Urgency 

episodes/ day, 

mean ± SD: 

G1: 4.5 ± 0.8 

G2: 4.3 ± 0.7 

Nocturia 

episodes/ day, 

mean ± SD: 

G1: 3.5 ± 0.8 

G2: 3.3 ± 0.8 

Voids/day, mean 

± SD: 

G1: 14.1 ± 1.3 

G2: 14.8 ± 1.5 

UDI-6 score, 

mean ± SD: 

G1: 9.5 ± 3.9 

G2: 8.6 ± 3.8 

IIQ-7 score, mean 

± SD: 

G1: 10.2 ± 4.5 

G2: 9.4 ± 3.6 

Voided volume 

(mL), mean ± SD:

G1: 108.5 ± 14.0 

G2: 115.8 ± 15.1 

UUI 

episodes/day, 

mean ± SD: 

G1: 1.5 ± 0.5 

G2: 1.5 ± 0.5 

P = NS 

Urgency 

episodes/ day, 

mean ± SD: 

G1: 3.5 ± 0.5 

G2: 3.3 ± 0.6 

Nocturia 

episodes/ day, 

mean ± SD: 

G1: 2.9 ± 0.6 

G2: 2.6 ± 0.7 

Voids/day, mean 

± SD: 

G1: 6.4 ± 1.9 

G2: 5.8 ± 0.9 

P = 0.001 

UDI-6 score, 

mean ± SD: 

G1: 7.2 ± 2.9 

G2: 6.9 ± 2.7

P < 0.001 

IIQ-7 score, mean 

± SD: 

G1: 6.5 ± 2.7 

G2: 6.1 ± 2.5 

P < 0.001 

Voided volume 

(mL), mean ± SD: 

G1: 134.5 ± 15.8 

G2: 141.9 ± 16.1 

P = 0.007 

Adverse events: 

None 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Method and 

blinding: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: 

++ 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-533 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

Country and 

setting: 

North America (74 

centers), 

Australasia (4 

centers), Europe 

(89 centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine ER vs. 

Tolterodine IR vs. 

placebo

Groups: 

G1: tolterodine ER 

4 mg t.i.d. 

G2: tolterodine IR 

2 mg b.i.d. 

G3: placebo 

N at enrollment: 

G1: 507 

G2: 514 

G3: 508 

N at follow-up: 

Total: 1442 

G1: 398 

G3: 374 

Women, n (%): 

G1: 417 (82) 

G2: 408 (79) 

G3: 410 (81) 

Age, mean 

(range): 

G1: 60 (20, 89) 

G2: 60 (22, 92) 

G3: 61 (22, 93) 

Race/ethnicity, 

%:* 

White: 

G1: 95.7 

G3: 94.7 

Black: 

G1: 3.0 

G3: 3.5 

Asian/Pacific 

Islander: 

G1: 1.0 

G3: 0.8 

Other: 

G1: 0.3 

G3: 1.1 

Inclusion criteria: 

• Age ≥ 18 

• Urinary 

frequency (≥ 8 

voids/day) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 L 

• Contraindications to 

antimuscarinic 

treatment 

• Hepatic or renal 

disease 

• UTIs 

• Interstitial 

cystitis 

• Hematuria 

• BOO 

• Current 

electrostimulation or bladder 

training therapy 

• Indwelling 

catheter or 

intermittent selfcatheterization 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Being treated 

for OAB with 

other 

anticholinergic 

drugs or drugs 

that inhibit 

cytochrome 

P450 3A4 

isoenzymes 

• Estrogen 

therapy < 2 

months 

• Treatment w/ 

investigational 

drug < 2 months

Incontinence 

episodes/week, 

mean (range): 

G1: 22.1 (0, 

168.0) 

G2: 23.2 (0, 

168.0) 

G3: 23.3 (0, 

168.0) 

≥ 5 incontinence 

episodes/week, n 

(%): 

G1: 492 (97) 

G2: 498 (97) 

G3: 494 (97) 

Pads/day, mean 

(range): 

G1: 1.4 (0-18) 

G2: 1.4 (0-25) 

G3: 1.5 (0-22) 

Voids/day, mean 

(range): 

G1: 10.9 (2.3, 

51.3) 

G2: 11.1 (2.0, 

48.6) 

G3: 11.3 (2.0, 

37.4) 

≥ 8 voids/day, n 

(%): 

G1: 458 (90) 

G2: 469 (91) 

G3: 467 (92) 

Previous drug 

therapy, n (%): 

G1: 270 (53) 

G2: 276 (54) 

G3: 263 (52) 

Poor efficacy, %:

G1: 43 

G2: 38.4 

G3: 40.7 

Able to finish 

tasks before 

visiting a toilet, 

%:* 

G1: 5 

G3: 6 

Urinary Urgency, 

subjective 

assessment, 12 

wks, n (%):* 

Improvement:

G1: 173 (44) 

G3: 118 (32) 

G1/G3: P < 0.001 

No change: 

G1: 201 (51) 

G3: 212 (57) 

Deterioration: 

G1: 22 (6) 

G3: 44 (12) 

G1/G3: P < 0.002 

Urinary urgency, 

improvement, 12 

wks, women 

only, %:* 

G1: 46.6 

G3: 26.6 

G1/G3: P = 0.001 

OR 1.81 (95% CI: 

1.31, 2.49) 

Not able to hold 

urine, 12 wks, 

%:* 

G1: 58 

G3: 32 

G1/G3: P < 0.001 

Incontinence 

episodes/week, 

mean change ± 

SD (%) 

G1: -11.8 ± 17.8 

G2: -10.6 ± 16.9 

G3: -6.9 ± 15.4 

G1/G3: P = 

0.00001 

G2/G3: P = 

0.0005 

G1/G2: P < 0.05 

Incontinence 

episodes/week, 

median % 

change: 

G1: -71 

G2: -60 

G3: -30 

G1/G2: P < 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-534 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

 Voided volume 

(mL), mean 

(range): 

G1: 141 (36, 338) 

G2: 137 (38, 283) 

G3: 136 (31, 374) 

Pads/day, mean 

± SD: 

G1: -0.5 ± 1.4 

G2: -0.5 ± 18 

G3: -0.2 ± 1.4 

G1/G3: P = 

0.0145 

G2/G3: P = 

0.0035 

Voids/day, mean 

± SD: 

G1: -3.5 ± 4.9 

G2: -3.3 ± 4.4 

G3: -2.2 ± 4.0 

G1/G3: P = 

0.00001 

G2/G3: P = 

0.0002 

Voluntary voids/ 

day, mean ± SD: 

G1: -1.8 ± 3.4 

G2: -1.7 ± 3.3 

G3: -1.2 ± 2.9 

G1 vs. G3 

G1/G3: P = 

0.00047 

G2/G3: P = 

0.0079 

Bladder 

symptoms, 

improvement, 12 

wks, women 

only, %:* 

G1: 62.8 

G3: 48.4 

G1/G3: P = 0.001 

OR 1.78 (95% CI: 

0.34, 2.37) 

Treatment 

benefit, 12 wks, n 

(%):* 

Much benefit: 

G1: 172 (43.2) 

G3: 88 (23.5) 

G1/G3: P < 0.001 

Little benefit 

G1: 138 (34.7) 

G3: 118 (31.6) 

No benefit 

G1: 88 (22.1) 

G3: 168 (44.9) 
C-535 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

 Able to finish 

tasks before 

visiting a toilet, 

12 wks, %:* 

G1: 33 

G3: 18 

G1/G3: P < 0.001

Voided volume 

(mL), mean 

change ± SD: 

G1: +34 ± 51 

G2: +29 ± 47 

G3: +14 ± 41 

G1/G3: P = 

0.00001 

G2/G3: P = 

0.0001 

Discontinued 

due to AEs, n 

(%): 

G1: 27 (5) 

G2: 28 (5) 

G3: 33 (6) 

Reported serious 

adverse events, 

n: 

G1: 7 

G2: 12 

G3: 18 

Parasympathetic 

Dry mouth, n (%): 

G1: 118 (23) 

G2: 156 (30) 

G3: 39 (8) 

Xerophthalmia, n 

(%): 

G1: 17 (3) 

G2: 12 (2) 

G3: 10 (2) 

Abnormal vision, 

n (%): 

G1: 6 (1) 

G2: 4 (1) 

G3: 2 (0.5) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 6 (1) 

G3: 1 (0.5) 
C-536 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

 Gastrointestinal 

Constipation, n 

(%): 

G1: 30 (6) 

G2: 35 (7) 

G3: 22 (4) 

Dyspepsia, n (%): 

G1: 15 (3) 

G2: 16 (3) 

G3: 7 (1) 

Abdominal pain, 

n (%): 

G1: 19 (4) 

G2: 13 (3) 

G3: 8 (2) 

Diarrhea, n (%): 

G1: 10 (2) 

G2: 16 (3) 

G3: 11 (2) 

Flatulence, n (%): 

G1: 10 (2) 

G2: 14 (3) 

G3: 9 (2) 

Nausea, n (%): 

G1: 7 (1) 

G2: 10 (2) 

G3: 10 (2) 

Headache, n (%): 

G1: 32 (6) 

G2: 19 (4) 

G3: 23 (5) 

Somnolence, n 

(%): 

G1: 14 (3) 

G2: 13 (3) 

G3: 9 (2) 

Dizziness, n (%): 

G1: 11 (2) 

G2: 9 (2) 

G3: 5 (1) 

Fatigue, n (%): 

G1: 11 (2) 

G2: 6 (1) 

G3: 4 (1) 

Insomnia, n (%): 

G1: 7 (1) 

G2: 2 (0.5) 

G3: 9 (2) 
C-537 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2001 

Freeman et al., 

2003* 

(continued) 

 Urinary tract 

infection, n (%): 

G1: 16 (3) 

G2: 13 (3) 

G3: 20 (4) 

Dysuria, n (%): 

G1: 5 (1) 

G2: 8 (2) 

G3: 1 (0.5) 

Peripheral 

edema, n (%): 

G1: 7 (1) 

G2: 7 (1) 

G3: 4 (1) 
C-538 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Wang et al., 2006 

Country and 

setting: 

Taiwan; Academic 

medical center 

Enrollment 

period: 

July 2004 to 

November 2005 

Funding: 

National Science 

Council, Taiwan 

Author industry 

relationship 

disclosures: 

NR 

Design: 

12-wk RCT 

Intervention: 

Electric 

Stimulation (ES) 

vs. Oxybutynin vs. 

Placebo for 12 

weeks

Groups: 

G1: ES: 

intravaginal 

electrode; biphasic 

symmetric pulsed 

current w/ a 10-Hz 

frequency, 400-

millisecond pulse 

width, 10/5 duty 

cycle, and varying 

intensity, 20 

min/session, twice 

weekly 

G2: Oxybutynin, 

2.5 mg 3 times 

daily 

G3: Placebo pill 3 

times daily 

N at enrollment: 

G1: 25 

G2: 26 

G3: 23 

N at follow-up: 

G1: 24 

G2: 23 

G3: 21 

Age: 

NR 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Female 

• OAB for ≥ 6 

mos 

• Age 16-80 

• Urgency ≥ 4 

times per day 

Exclusion 

criteria: 

• Use of 

anticholinergics 

or TCAs 

• Previous 

treatment with 

pelvic-floor 

muscle training, 

bladder training 

• Pelvic prolapse 

repair 

• Pregnancy 

• Neurologic 

disorders 

• DM 

• Demand cardiac 

pacemaker 

• IUD use 

• Genital prolapse 

greater than 

ICS Stage II 

• PVR>100 mL 

• Overt SI 

• Antiincontinence 

surgery 

• UTI 

Warning time, s 

(range) 

G1: 41.5 (8-105) 

G2: 44 (2-215) 

G3: 65 (26-265 

MVV, mL/void 

(range): 

G1: 340 (120-450)

G2: 310 (130-800)

G3: 350 (120-600)

Daily voided 

volume, mL 

(range) 

G1: 2160 (1010-

2950) 

G2: 2106 (1560-

3153) 

G3: 2305 (1305-

3300) 

Pads per day 

(range): 

G1: 1 (0-4.1) 

G2: 0 (0-3) 

G3: 1 (0-4) 

Urgency (subj): 

G1: 11.4 (4.0-

16.0) 

G2: 12.1 (5-18) 

G3: 9.8 (4.2-15.5) 

Frequency 

(subj): 

G1: 12.8 (8.8-

16.0) 

G2: 11.5 (4.3-

19.5) 

G3: 11.5 (6.5-

22.8) 

Nocturia (subj): 

G1: 1.75 (0-6.5) 

G2: 0 (0-2.5) 

G3: 0.65 (0-3.1) 

UI (subj): 

G1: 1 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

Warning time, s 

(range) 

G1: 72 (32-633) 

G2: 54.5 (138-

850) 

G3: 66.5 (26-219) 

p-value (among 3 

groups): <0.001 

MVV, 

mL/micturition 

(range): 

G1: 355 (150-550) 

G2: 336.5 (138-

850) 

G3: 340 (160-600) 

p-value (among 3 

groups): 0.035 

Voided volume/d, 

mL (range) 

G1: 2270 (1210-

3106) 

G2: 2100 (1619-

3200) 

G3: 2305 (1351-

3221) 

p-value (among 3 

groups): 0.050 

Pad count, pad/d 

(range): 

G1: 0 (0-2) 

G2: 0 (0-2.5) 

G3: 1 (0-3) 

p-value (among 3 

groups): 0.012 

Urgency (subj) 

G1: 1.0 (0.0-12.3) 

G2: 6 (0.5-13) 

G3: 7.4 (3.9-13.4) 

p-value (among 3 

groups): <0.001 

Frequency (subj) 

G1: 7.8 (1.8-13.0) 

G2: 7.4 (2-14) 

G3: 10 (3.9-13.4) 

p-value (among 3 

groups): 0.002 

Nocturia (subj) 

G1: 0 (0-3.0) 

G2: 0 (0-2.5) 

G3: 1 (0-3.6) 

p-value (among 3 

groups): 0.002 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-539 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Wang et al., 2006 

(continued) UI (subj) 

G1: 0.5 (0-2) 

G2: 0 (0-2) 

G3: 1 (0-2) 

p-value (among 3 

groups): 0.413 

P values before 

vs. after 

treatment 

Warning time, s 

(range): 

G1: 0.002 

G2: 0.001 

G3: 0.532 

MVV, mL/void 

(range): 

G1: 0.018 

G2: 0.004 

G3: 0.979 

Daily voided 

volume, mL 

(range): 

G1: 0.024 

G2: 0.728 

G3: 0.627 

Pad per day 

(range): 

G1: 0.010 

G2: 0.662 

G3: 0.501 

Urgency (subj): 

G1: <0.001 

G2: <0.001 

G3: 0.003 

Frequency 

(subj): 

G1: <0.001 

G2: <0.001 

G3: 0.070 

Nocturia (subj): 

G1: 0.001 

G2: 0.394 

G3: 0.176 

UI (subj): 

G1: 0.814 

G2: 0 083 

G3: 0.854 
C-540 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2005 

Country and 

setting: 

US, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Novartis Pharma 

Thomson 

ACUMED 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized 

double- blind 

placebocontrolled 

four way 

crossover 

Intervention: 

Darifenacin 15 mg 

qd vs. darifenacin 

30 mg qd vs. 

Oxybutynin vs. 

placebo

Groups:* 

G1: Darifenacin 

15mg daily 

G2: Darifenacin 

30mg daily 

G3: Oxybutynin 5 

mg t.i.d. 

G4: placebo 

N at enrollment: 

G1-G4: 76

N included, 

tolerability: 

G1-G4: 61

N included, 

efficacy: 

G1-G4: 58

Women, n (%): 

G1-G4: 71 (93.4) 

Age, mean 

(range): 

G1-G4: 59.9 (33-

84) 

Race/ethnicity: 

NR 

Weight (kg), 

mean (range): 

G1-G4: 75.7 (42-

157) 

Inclusion criteria: 

• Age 18-85 

• ≥ 4 UUI 

episodes/week 

• ≥ 8 voids/day 

(from 14 day 

run in placebo 

voiding diary) 

Exclusion 

criteria: 

• Neurogenic 

bladder 

• SUI 

• Contraindication 

to 

antimuscarinic 

treatment 

• UTI 

• Bladder 

symptoms 

• Bladder stones 

• BOO 

• Concomitant 

disease 

• Concurrent 

bladder training 

• Concurrent 

thyroid or HRT 

• Other bladder 

meds 

• Pregnant or 

breastfeeding 

Urgency 

episodes/day, 

mean ± SD: 

G1-G 4: 9.3 ± 3.4 

Urgency severity, 

mean ± SD: 

G1-G4: 2.0 ± 0.4 

Incontinence 

episodes/week, 

mean ± SD: 

G1-G4: 20.4 ± 

17.7 

Voids/ day, mean 

± SD: 

G1-G4: 10.4 ± 3.0

Urgency 

episodes/day, 

mean: 

G1: 7.95 

G2: 7.59 

G3: 8.12 

G4: 8.71 

G1-G3/G4: P < 

0.05 

Urgency severity, 

mean: 

G1: 1.93 

G2: 1.84 

G3: 1.89 

G4: 2.03 

G1-G3/G4: P < 

0.05 

Incontinence 

episodes/week, 

mean: 

G1: 10.93 

G2: 8.82 

G3: 9.45 

G4: 14.64 

G1-G3/G4: P < 

0.05 

Voids/day, mean 

± SD: 

G1: 9.33 

G2: 8.85 

G3: 9.24 

G4: 9.62 

G2/G4: P < 0.05 

Dry mouth, (%): 

G1: 13.1 

G2: 34.4 

G3: 36.1 

G4: 4.9 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

G2/G4: P < 0.05 

G3/G4: P < 0.05 

Constipation, 

(%): 

G1: 9.8 

G2: 21.3 

G3: 8.2 

G4: 3.3 

G2/G3: P < 0.05 

G2/G4: P < 0.05 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: -, NR 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 
C-541 

Evidence Table 6. KQ 3 Comparison of Treatments (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2005 

(continued) 

 Blurred vision, 

(%): 

G1: 0 

G2: 0 

G3: 3.3 

G4: 0 

Dizziness, (%): 

G1: 0 

G2: 0 

G3: 1.6 

G4: 0 
Evidence Table 7. KQ4 Modifiers of outcomes 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Anderson et al., 

2006 

[See evidence 

table for Diokno et 

al. 2003] 

Country and 

setting: 

US, Multicenter 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

1 of 6 

ALZA Corp (1) 

Design: 

RCT 

Intervention: 

different extended 

release 

anticholinergic 

medications in 

women with or 

without prior 

anticholinergic 

treatment for OAB 

Groups: 

G1: Prior 

anticholinergic 

treatment 

G1a: ER 

oxybutynin 10 mg 

po daily 

G1b: ER 

tolterodine, 4mg 

po daily 

G2: No prior 

anticholinergic 

treatment 

G2a: ER 

oxybutynin 10 mg 

po daily 

G2b: ER 

tolterodine, 4mg 

po daily 

Ga: ER 

oxybutynin 10 mg 

po daily 

Gb: ER 

tolterodine, 4mg 

po daily 

N at enrollment: 

Total: 790 

G1: 373 

G1a: 180 

G1b: 193 

G2: 417 

G2a: 211 

G2b: 206 

N at follow-up, 12 

weeks: 

G1: 341 

G1a: 165 

G1b: 176 

G2: 355 

G2a: 174 

G2b: 181 

Inclusion criteria:

• Women 

• Age ≥ 18 

• Mean of 21-60 

UUI episodes 

per week and 

mean of ≥ 10 

voids per 24 hr 

Exclusion 

criteria: 

NR 

UUI episodes/ 

wk, mean ± SD: 

G1a: 36.8 ± 16.4 

G1b: 37.4 ± 14.0 

G2a: 37.5 ± 14.0 

G2b: 36.2 ± 13.9 

Incontinence 

episodes/wk, 

mean ± SD: 

G1a: 41.5 ±19.0 

G1b: 43.0 ± 18.0 

G2a: 45.0 ±19.4 

G2b: 41.9 ± 17.9 

Voids/week, 

mean ± SD: 

G1a: 92.8 ± 23.7 

G1b: 94.6 ± 25.2 

G2a: 96.5 ± 27.1 

G2b: 97.9 ± 24.2 

UUI episodes/wk, 

mean ± SD: 

G1a: 11.4 ± 17.9 

G1b: 13.3 ± 15.1 

G2a: 10.2 ± 13.7 

G2b: 9.3 ± 13.3 

G1a/G1b: P = 0.3 

UUI episodes/wk, 

completed wk 12, 

mean ± SD: 

G1a: 9.9 ± 14.1 

G1b: 12.9 ± 14.9 

P = 0.049 

No UUI, 12 wk, 

%: 

G1a: 25.2 

G1b: 16.4 

G2a: 29.4 

G2b: 26.4 

G1a/G1b: P = 

0.046 

G2a/G2b: P = 

0.495 

Incontinence 

episodes/wk, 

mean ± SD: 

G1a: 12.7 ± 18.7 

G1b: 16.5 ± 19.8 

G2a: 11.9 ± 15.1 

G2b: 11.3 ± 16.0 

G1a/G1b: P = 

0.09 (P = 0.012 if 

completed wk 12)

G2a/G2b: P = 

0.886 

Voids/week, 

mean ± SD: 

G1a: 68.4 ± 17.2 

G1b: 72.8 ± 25.4 

G2a: 64.8 ± 22.0 

G2b: 69.4 ± 21.3 

G1a/G1b: P = 

0.05 (P = 0.026 

iwk 12) G2a/G2b: 

P = 0.035 (P = 

0.026 wk 12) 

Dry mouth, % 

G1a: 32 

G1b: 19 

G2a: 27.5 

G2b: 25.2 

G1a/G1b: P = 

0.004 

G2a/G2b: P = 0.6 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-542 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Anderson et al., 

2006 

(continued) 

Women, %: 

100 

Age, mean ± SD: 

G1a: 62.6 ± 12.9 

G1b: 62 ± 12.6 

G2a: 57.5 ± 13.4 

G2b: 58.8 ± 12.4 

Race/ethnicity, 

%: 

White: 

G1a: 87 

G1b: 88 

G2a: 82 

G2b: 84 

Black: 

G1a: 7 

G1b: 9 

G2a: 9 

G2b: 8.7 

Asian: 

G1a: 0.6 

G1b: 0 

G2a: 0 

G2b: 1 

Hispanic: 

G1a: 5.6 

G1b: 3.1 

G2a: 8.1 

G2b: 6.3 

Other 

G1a: 0 

G1b: 0.5 

G2a: 0.9 

G2b: 0 

Constipation, %: 

G1a: 7.8 

G1b: 5.2 

G2a: 5.2 

G2b: 10.2 

Diarrhea, %: 

G1a: 7.8 

G1b: 5.7 

G2a: 8.1 

G2b: 6.8 

Headache, %: 

G1a: 4.4 

G1b: 5.2 

G2a: 6.6 

G2b: 6.8 

Discontinued d/t 

AE, n (%): 

G1a: 7 (3.9) 

G1b: 6 (3.1) 

G2a: 13 (6.2) 

G2b: 13 (6.3) 

Withdrew, %: 

G1: 3.5 

G2: 6.2

C-543 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Appell, Abrams et 

al., 2001 

Country and 

setting: 

Multinational, 

Multicenter 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Open-label 

extension study 

(after 12-wk RCT 

and 1 wk washout) 

Intervention: 

Tolterodine 2 mg 

BID with option for 

patients to selflower their dosage 

to 1mg bid 

Groups: 

NA 

N at enrollment: 

854 

N at follow-up, n 

(%): 

594 (70) 

Age, yrs, mean 

(range): 

59.5 (19-89) 

Race/ethnicity: 

NR 

Women, %: 

76 

Parity mean ± 

SD: 

NR 

Previous drug 

therapy for OAB, n 

(%) 

472 (55) 

Previous lower 

urinary tract 

surgery, n (%) 

291 (34)

Inclusion criteria: 

• 18+ years old 

• Cystometric 

evidence of 

detrusor 

overactivity 

(phasic detrusor 

contraction with 

amplitude 10+ 

cm H2O 

• ≥ 8 voids/day 

• ≥ 1+ urinary 

incontinence 

episode/day 

Exclusion 

criteria: 

• SUI 

• Hepatic or renal 

disease 

• UTI 

• IC 

• Hematuria 

• Contraindication 

to 

antimuscarinic 

therapy 

• Previous 

serious AE on 

oxybutynin 

• Voiding difficulty 

w/ treatment of 

urinary retention

• Treatment w/in 

14 days prior to 

baseline visit 

• Initiation of 

antimuscarinic 

or any drug for 

UI during study 

• Electrostimulation or 

bladder training 

• Indwelling or 

intermittent 

catheter 

• Total voided 

volume >3L/day

Detrusor 

instability, %: 

93.7 

Urge 

incontinence 

episodes, n (%): 

724 (85) 

Symptom 

duration > 5 yrs, 

n (%): 

412 (48) 

Urgency, n (%): 

841 (98) 

Severe/very 

severe problems, 

n (%): 

384 (45) 

voids/day, mean 

(range): 

11.4 (5.3-37.0) 

Urge 

incontinence 

episodes/day, 

mean (range): 

3.5 (0.1-24.0) 

Volume voided 

mean mL 

(range): 

159 (25-423) 

Adverse events 

at end of 12-wk 

RCT, n (%): 

Any: 358 (76) 

ANS: 203 (43) 

CNS: 59 (12) 

GI: 125 (26) 

Respiratory: 68 

(14) 

Urinary: 50 (11) 

Dry mouth: 187 

(39) 

UTI: 26 (5) 

Headache: 49 (10)

Constipation: 31 

(7) 

Abdominal pain: 

36 (8) 

URI: 28 (6) 

Voids/day, 3 

mos, mean 

(range) 

8.8 (2.0-23.4) 

Voids/day, 3 

months, mean 

change (95% CI): 

-2.6 (-2.8 to -2.3) 

P = 0.0001 

Voids/day, 9 

mos, mean 

(range): 

8.9 (1.9-31.6) 

Voids/day, 9 

months, mean 

change (95% CI): 

-2.5 (-2.9 to -2.4) 

P = 0.0001 

Void frequency, 9 

mos, median 

change: 

-22% 

Urge 

incontinence 

episodes/day, 3 

mos, mean 

(range): 

1.3 (0.0-24.0) 

Urge 

incontinence 

episodes/day, 

mean change 

(95% CI): 

-2.1 (-2.4 to -1.9) 

P = 0.0001 

Urge 

incontinence 

episodes/day, 3 

mos, mean 

(range): 

1.5 (0.0-24.0) 

Urge 

incontinence 

episodes/day, 

mean change 

(95% CI): 

-2.0 (-2.2 to -1.7) 

P = 0.0001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-544 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Appell, Abrams et 

al., 2001 

(continued) 

Urge 

Incontinence 

episodes/day, 

median change, 

%: 

-76% 

Volume voided, 

3 mos, mean mL 

(range): 

201 (33-444) 

Volume voided, 3 

mos, mean 

change mL (95% 

CI): +41 (36-45) 

P = 0.0001 

Volume voided, 9 

mos, mean 

change mL 

(range): 

199 (34-514) 

Volume voided 

mean change mL 

(95% CI): 

+40 (35-45) 

P = 0.0001 

Volume voided, 9 

mos, median 

change, %: 

+22% 

Improvement, 9 

mos, %: 

65 

Any adverse 

event, n (%): 

652 (76) 

ANS, n (%): 

268 (31) 

General, n (%): 

219 (26) 

CNS/PNS, n (%): 

82 (10) 

GI, n (%) 

201 (24) 

Respiratory, n 

(%): 

139 (16) 

Urinary, n (%): 

165 (19) 

C-545 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Appell, Abrams et 

al., 2001 

(continued) 

Dry mouth, n (%): 

236 (28) 

Mild dry mouth, 

%: 

19% 

Moderate dry 

mouth, %: 

7% 

Severe dry 

mouth, %: 

 2% 

UTI, n (%): 

106 (12) 

Headache, n (%): 

57 (7) 

Constipation, n 

(%): 

57 (7) 

Abdominal pain, 

n (%): 

50 (6) 

Upper 

respiratory tract 

infection, n (%): 

45 (5) 

Serious adverse 

events, n: 

72 

Discontinued 

due to AE, n (%): 

73 (9) 

Reduced dosage 

to 1 mg bid, n 

(%): 

108 (13%) 

C-546 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Capo et al. 2008 

Country and 

setting: 

US, 207 centers 

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US, Inc., and 

GlaxoSmithKline 

Author industry 

relationship 

disclosures: 

5/5 

Astellas (4) 

Boehringer 

Mannheim 

Pharmaceuticals 

(1) 

Cephalon Inc. (1) 

GlaxoSmithKline 

(3) 

Reliant 

Pharmaceuticals 

(1) 

Schering Plough 

Corporation (1) 

Abbott (1) 

Akros (1) 

AstraZenica (1) 

Johnson & 

Johnson (1) 

Lilly (1) 

Manking (1) 

Merck (1) 

Novartis (1) 

NovoNordisk (1) 

Pfizer Inc. (1) 

Solvay (1) 

Takeda & TAP (1) 

Pri Med (1) 

Lucente (1) 

Design: 

RCT 

Intervention: 

12-wk treatment 

with 5 mg 

solifenacin 

succinate. Dosage 

could be 

increased at wk 4 

and wk 8 to 10 

mg, maintained or 

decreased in 

response to pt 

perceived efficacy 

and tolerability 

Groups: 

G1: Hispanic 

subgroup of G2 

G2: full study 

population 

including G1 

N at enrollment: 

G1: 94 

G2: 2205 

N at follow-up, 

range:

G1: 47-80 

G2: 1254-2005 

Age, yrs ± SD: 

G1: 51.8 ± 12.8 

G2: 59.7 ± 14.4 

Weight in lbs, 

mean ± SD: 

G1: 171.1±36.4 

G2: 182.2±47.0 

Race/ethnicity, n 

(%) 

G1: Hispanic 94 

(100) 

G2: White 1761 

(79.9) 

Hispanic 94 (4.3) 

Black 274 (12.4) 

Asian 59 (2.7) 

Other 17 (0.8) 

Women, N (%): 

G1: 74 (78.7) 

G2: 1813 (82.2) 

Inclusion criteria: 

• ≥ 18 yrs of age 

• OAB symptoms 

≥3 mos 

• Toilet without 

difficulty 

• Washout of 

other OAB 

meds ≥ 7 days 

• Non-drug 

treatment of 

OAB if 

established ≥ 4 

wks prior to 

study and 

continued 

Exclusion 

criteria: 

• SUI 

• Stress 

predominant 

MUI 

• UTI or chronic 

inflammation 

clinically 

significant 

outflow 

• Obstruction due 

to BPH 

• Narrow-angle 

glaucoma 

• Urinary or 

gastric retention

• Severe renal or 

hepatic 

impairment 

• Chronic severe 

constipation or 

gastrointestinal 

obstructive 

disease 

• Bladder cancer 

• Women not 

using a reliable 

contraceptive 

• Hypersensitivity 

to the study 

medication, any 

of its 

components, or 

to 

anticholinergic 

medication 

Urge 

incontinence, n 

(%): 

G1: 63 (67.0) 

G2: 1586 (71.9) 

Urinary urgency, 

n %: 

G1: 88 (93.6) 

G2: 2007 (91.0) 

Frequency, n, 

(%): 

G1: 86 (91.5) 

G2: 1969 (89.3) 

Nocturia, n (%): 

G1: 79 (84.0) 

G2: 1792 (81.3) 

Patient 

perception of 

bladder 

condition, mean 

score: 

G1: 4.0

G2: 4.0

Most bothersome 

OAB symptomfrequency, n %:

G1: 38 (40.4) 

G2: 619 (28.1) 

Most bothersome 

OAB symptomurinary urgency, 

n %: 

G1: 22 (23.4) 

G2: 508 (23.0) 

Most bothersome 

OAB symptomurge 

incontinence, n 

%: 

G1: 17 (18.1) 

G2: 602 (27.3) 

Increased 

dosage 5 

mg/day, n (%)-Wk 

4: 

G1: 46 (48.9)

Increased 

dosage 10 

mg/day, n (%)-Wk 

4: 

G1: 37 (39.4) 

Discontinued, n 

Wk 4: 

G1: 1 

Increased 

dosage 5 

mg/day, n (%)-Wk 

8: 

G1: 31 (33.0)

Increased 

dosage 10 

mg/day, n (%)-Wk 

8: 

G1: 39 (41.5) 

Discontinued-Wk 

8, n: 

1 

Returned to 5 

mg/day-Wk 8, n: 

5 

Increased 

dosage to 10 

mg/day-Wk 8, n: 

12 

Patient 

Perception of 

Bladder, mean 

Wk 4: 

G1: 3.3* 

G2: 3.3* 

Patient 

Perception of 

Bladder, mean 

Wk 8: 

G1: 2.8* 

G2: 2.8* 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-547 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al. 2008 

(continued) 

Parity : 

NR 

Most bothersome 

OAB symptomnocturia, n %: 

G1: 12 (12.8 

G2: 337 (15.3) 

Most bothersome 

OAB symptomnone specified, n 

%: 

G1: 5 (5.3) 

G2: 139 (6.3)

Patient 

Perception of 

Bladder, mean 

Wk 12: 

G1: 3.0* 

G2: 2.9* 

*P<0.001 vs BL 

Symptom bother 

from VAS, 

change from 

Baseline, mean 

scores (mm), pvalue, CI: 

Urinary urgency: 

G1: -39.2 

P<0.001, -45.9, -

32.5 

G2: -39.5 

P<0.001, -41.0, -

38.1 

Urge 

Incontinence: 

G1: -37.7 

P<0.001, -46.0, -

29.4 

G2: -40.1, 

P<0.001, -41.8, -

38.4 

Frequency: 

G1: -40.0 

P<0.001, -46.9, -

33.2 

G2: -41.8 

P<0.0001, -43.3, -

40.3 

Nocturia: 

G1: -43.2 

P<0.001, -50.4, -

36.1 

G2: -36.9, -38.4, -

35.4 

OAB-q subscales 

at end-point, 

change from 

baseline, mean, 

p-value, CI: 

Symptom bother: 

G1: -29.1 

P<0.001, -34.8, -

23.4 

G2: -29.6 

P<0.001, -30.7, -

28.6 

C-548 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al. 2008 

(continued) 

Coping: 

G1: 24.0 

P<0.001, 18.0, 

30.1 

G2: 27.4 

P< 0.001 26.2, 

28.5 

Concern: 

G1: 25.8 

P<0.001, 19.5, 

32.2 

G2: 29.6 

P< 0.001, 28.4, 

30.8 

Sleep: 

G1: 25.7 

P<0.001, 19.4, 

32.0 

G2: 27.3 

P< 0.001, 26.1, 

28.5 

Social Interaction 

G1: 15.9 

P<0.001, 11.5, 

20.3 

G2: 14.7 

P< 0.001, 13.7, 

15.6 

Overall Healthrelated QoL: 

G1: 23.2 

P<0.001, 18.0, 

28.5 

G2: 25.4 

P< 0.001, 24.4, 

26.4 

Any Adverse 

Event, n (%): 

G1: 48 (51.4) 

G2: 1321 (59.4) 

Dry mouth, n (%): 

G1: 17 (18.1) 

G2: 477 (21.4) 

Constipation, n 

(%): 

G1: 12 (12.8) 

G2: 295 (13.3) 

Headache, n (%): 

G1: 3 (3.2) 

G2: 76 (3.4) 

C-549 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Capo et al. 2008 

(continued) 

Dizziness, n (%): 

G1: 2 (2.1) 

G2: 27 (1.2) 

Blurred vision, n 

(%): 

G1: 4 (4.3) 

G2: 57 (2.6) 

Palpitations, n 

(%): 

G1: 2 (2.1) 

G2: 6 (0.3) 

Upper 

respiratory tract 

infection, n (%): 

G1: 3 (3.2) 

G2: 68 (3.1) 

UTI, n (%): 

G1: 3 (3.2) 

G2: 76 (3.4) 

Bronchitis, n (%): 

G1: 3 (3.2) 

G2: 31 (1.4) 

Nasopharyngitis, 

n (%): 

G1: 2 (2.1) 

G2: 50 (2.3) 

Influenza, n (%): 

G1: 2 (2.1) 

G2: 11 (0.5) 

Insomnia, n (%): 

G1: 2 (2.1) 

G2: 17 (0.8) 

Depression, n 

(%): 

G1: 2 (2.1) 

G2: 19 (0.9) 

Hypertension, n 

(%): 

G1: 2 (2.1) 

G2: 16 (0.7) 

C-550 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et 

al., 2002 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

2 week washout 

12 week treatment 

period 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

7 of 7 

Abbot (1) 

Alza (3) 

Amgen (1) 

AstraZeneca (1) 

Bayer (1) 

Bioform (1) 

Genyx (1) 

Glaxo (1) 

Interneuron (2) 

Lilly (2) 

Merck (1) 

Otsulta (1) 

Pharmacia (3) 

Pfizer (1) 

Praecis (2) 

Roche (1) 

Seprecor (1) 

Surx (1) 

Synthelabo (1) 

Vivus (1) 

Watson (7) 

Yamanouchi (1) 

Design: 

RCT 

Followed by: 

12 week open 

label dose titration 

Intervention: 

Oxybutynin TDS 

vs placebo

Groups: 

G1: OXY TDS 1.3 

mg 

G2: OXY TDS 2.6 

mg 

G3: OXY TDS 3.9 

mg 

G4: placebo 

N at enrollment: 

G1: 130 

G2: 133 

G3: 125 

G4: 132 

N at follow-up: 

G1: 128 

G2: 131 

G3: 123 

G4: 130 

Women, N (%): 

G1: 120 (92.3) 

G2: 123 (92.5) 

G3: 114 (91.2) 

G4: 121 (91.7)

Age, mean ± SD: 

G1: 61.5 ± 11.8 

G2: 61.9 ± 13.5 

G3: 59.4 ± 14.5 

G4: 62.7 ± 13.1 

Race/ethnicity, n 

(%): 

White: 

G1: 119 (91.5) 

G2: 118 (88.7) 

G3: 118 (94.4)

G4: 118 (89.4) 

Black: 

G1: 7 (5.4) 

G2: 10 (7.5) 

G3: 3 (2.4)

G4: 11 (8.3) 

Inclusion criteria: 

• Age ≥ 18 

• History of OAB 

• ≥ 10 episodes 

UUI either pure 

urge or 

predominant 

urge on 7 day 

voiding diary 

• ≥ 56 voids/ 7 

day diary 

• Average 

recorded urinary 

volume of ≤ 350 

mL 

Exclusion 

criteria: 

• Incontinence 

related to 

chronic illness 

• Concomitant 

medications 

• History of lower 

urinary tract 

surgery in ≤ 6 

mos 

• IC 

• Urethral 

syndrome 

• Painful bladder 

syndrome 

• Overflow urinary 

incontinence 

• Alcohol/drug 

abuse 

• Known 

hypersensitivity 

to oxybutynin, 

similar 

compounds or 

transdermal 

systems 

• Active skin 

disorder 

• Narrow angle 

glaucoma 

• Excessive 

caffeine intake > 

5 cups/day 

Incontinence 

episodes/week, 

median: 

G1: 31.0 

G2: 30.0 

G3: 31.0 

G4: 30.0 

Voids/day, mean 

± SD: 

G1: 12.4 ± 2.9 

G2: 12.1 ± 3.3 

G3: 12.3 ± 3.3 

Voided volume 

(mL), mean: 

G1: 175 

G2: 165 

G3: 156 

G4: 170

Open Label: 

Incontinence 

episodes/week, 

open label, 

median: 

G1: 30.0 

G2: 29.0 

G3: 37.0 

G4: NA

Prior years 

incontinent, 

years, mean ±

SD: 

G1: 9.1 ± 10.3

G2: 8.9 ± 8.8

G3: 9.9 ± 9.8

G4: 9.1 ± 9.1 

IIQ (QoL), total 

score, mean: 

G1: 167 

G2: 161 

G3: 144 

G4: 160 

Prior 

anticholinergic 

treatment, n, (%):

G1: 30 (23.1) 

G2: 28 (21.1) 

G3: 28 (22.4) 

G4: 27 (20.5 

Incontinence 

episodes/ week, 

median change: 

G1: -16.0 

G2: -14.0 

G3: -19.0 

G4: -14.5

G3/G4: P < 

0.0165 

Voids/day, mean 

change ± SD: 

G1: -1.8 ± 2.6 

G2: -1.8 ± 2.4 

G3: -2.3 ± 2.5 

G4: -1.7 ± 3.0 

G3/G4: P = 

0.0457 

Voided volume, 

mL, mean 

increase ± SD: 

G1: -2 

G2: 19 

G3: 24 

G4: 6 

G3/G4: P = 

0.0063 

G2/G4: P = 

0.0157 

Open Label: 

Incontinence 

episodes/week, 

median change: 

G1: -18.0 

G2: -17.0 

G3: -19.0 

G4: NA

IIQ (QoL), total 

score, mean 

change: 

G1: 119 

G2: 104 

G3: 89 

G4: 113 

G3/G4: P = 

0.0327 

UDI (QoL), total 

score, mean ± 

SD: 

G1: NR 

G2: NR 

G3: 78.8 ± 51.9 

G4: 94.7 ± 50.0 

G3/G4: P = 

0.0266 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-551 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2002 

(continued) 

Other: 

G1: 4 (3.1) 

G2: 5 (3.8) 

G3: 4 (3.2) 

G4: 3 (2.3) 

Dry mouth, n (%): 

G1: 6 (4.6) 

G2: 9 (6.8) 

G3: 12 (9.6) 

G4: 11 (8.3)

Dizziness, n (%): 

G1: 2 (1.5) 

G2: 4 (3.0) 

G3: 5 (4.0) 

G4: 5 (3.8) 

Dysuria, n (%): 

G1: 1 (0.8) 

G2: 3 (2.3) 

G3: 3 (2.4) 

G4: 0 (0) 

Somnolence, n 

(%): 

G1: 1 (0.8) 

G2: 0 (0) 

G3: 2 (1.6) 

G4: 1 (0.8) 

Nausea, n (%): 

G1: 6 (4.6) 

G2: 5 (3.8) 

G3: 2 (1.6) 

G4: 7 (5.3) 

Constipation, 

(%): 

G1: 7 (5.4) 

G2: 3 (2.3) 

G3: 1 (0.8) 

G4: 4 (3.0) 

Palpitations, n 

(%): 

G1: 1 (0.8) 

G2: 0 (0) 

G3: 1 (0.8) 

G4: 0 (0) 

Vision abnormal, 

n (%): 

G1: 3 (2.3) 

G2: 2 (1.5) 

G3: 0 (0) 

G4: 2 (1.5) 

Localized 

application site 

reactions, n (%): 

G1: 32 (26.4) 

G2: 7 (5.7) 

G3: 8 (6.9) 

C-552 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et 

al., 2002 

(continued) 

Application site 

erythema, n (%): 

G1: 23 (19) 

G2: 29 (23.6) 

G3: 14 (12.0) 

Application site 

erythema, mild, 

double blind 

period, n (%): 

G1: 79 (31.5) 

G2: 29 (36.2) 

G3: NA 

Application site 

erythema, 

moderate, double 

blind period, n 

(%): 

G1: 46 (18.3) 

G2: 46 (18.1) 

G3: NA 

Application site 

erythema, 

severe, double 

blind period, n 

(%): 

G1: 6 (2.4) 

G2: 8 (3.1) 

G3: NA 

Application site 

erythema, mild, 

open label, n (%): 

G1: 18 (34.6) 

G2: 58 (38.4) 

G3: 87 (43.9) 

Application site 

erythema, 

moderate, open 

label, n (%): 

G1: 7(13.5) 

G2: 23 (15.2) 

G3: 24 (12.1) 

Application site 

erythema, 

severe, open 

label, n (%): 

G1: 0 (0) 

G2: 2 (1.3) 

G3: 0 (0) 

C-553 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Dmochowski et al. 

2003 

Country and 

setting: 

US; Community 

Enrollment 

period: 

NR 

2 week washout 

12 week treatment 

period 

Funding: 

Watson Pharma 

Author industry 

relationship 

disclosures: 

6 of 6 

Watson Pharma 

Design: 

RCT 

Intervention: 

Oxybutynin TDS 

vs Tolterodine ER 

vs placebo, 2 

week washout 

plus 12 weeks 

treatment period; 

drug/placebo 

applied 

transdermally 

twice weekly to 

the abdomen and 

oral capsule 

ingested once 

daily

Groups: 

G1: OXY TDS 3.9 

mg/day 

G2: Tolterodine 

ER 4 mg daily 

G3: placebo 

N at enrollment: 

G1: 121 

G2: 123 

G3: 117 

Total: 361 

N at follow-up: 

G1: NR 

G2: NR 

G3: NR 

Total: 320 (89%) 

Age, mean yrs ± 

SD: 

G1: 63.1 ± 12.0 

G2: 62.9 ± 13.5 

G3: 64.5 ± 12.3 

Race/ethnicity, 

mean (%): White: 

G1: 111 (91.7) 

G2: 120 (97.6) 

G3: 110 (94.0) 

Race/ethnicity, 

mean (%): 

Black: 

G1: 8 (6.6) 

G2: 1(0.8) 

G3: 4 (3.4) 

Inclusion criteria: 

• ≥ 18yo men and 

women 

• Current 

pharmacological 

treatment for 

OAB with 

beneficial 

response 

• ≥4 episodes 

UUI episodes 

either pure urge 

or predominant 

urge on 3 day 

voiding diary 

• ≥ 24 voids/ 3 

day diary 

• Average 

recorded urinary 

volume of ≤350 

ml 

Exclusion 

criteria: 

• History of lower 

urinary tract 

surgery in 

previous 6 

months 

• IC 

• Urethral 

syndrome 

• Painful bladder 

syndrome 

• Overflow urinary 

incontinence 

Incontinence 

episodes/ day, 

mean ± SD: 

G1: 4.7 ± 2.9 

G2: 5.0 ± 2.9 

G3: 5.0± 3.2 

Incontinence 

episodes/day, 

median: 

G1: 4 

G2: 4 

G3: 4 

Void frequency/ 

day, mean ± SD: 

G1: 12.4 ± 2.9 

G2: 12.1 ± 3.3 

G3: 12.3 ± 3.3 

Void 

frequency/day, 

median: 

G1: 12 

G2: 12 

G3: 12 

Voided volume, 

mL, mean ± SD: 

G1: 165 ± 62 

G2: 165 ± 61 

G3: 175 ± 68 

Voided volume, 

mL, median: 

G1: 160 

G2: 150 

G3: 171 

Global 

assessment of 

disease, QOL, 

baseline, (SD): 

G1: 65 (19) 

G2: 63 (20)

G3: 65 (20) 

IIQ (QOL)- travel 

domain, 

baseline, (SD): 

G1: 49 (28) 

G2: 47 (29) 

G3: 43 (29) 

Incontinence 

episodes/ day, 

mean ± SD: 

G1: 1.9 ± 2.7 

G2: 1.9 ± 3.0 

G3: 2.9 ± 3.8 

P=0.0137 G1 v G3 

P=0.0011 G2 v G3 

P=0.5878 G1 v G2 

Incontinence 

episodes/day, 

mean change±SD 

G1: 2.9±3.0 

G2: 3.2±2.8 

G3: 2.1±3.0 

Incontinence 

episodes/day, 

median 

G1: 1 

G2: 1 

G3: 2 

Incontinence 

episodes/day, 

median change 

G1: 3 

G2: 3 

G3: 2 

Void frequency/ 

day, mean ± SD: 

G1: 10.4 ± 3.2 

G2: 9.9 ± 3.1 

G3: 10.9 ± 3.8 

P=0.101 G1 v G3 

P= 0.0025 G2 v 

G3 

P=0.276 G1 v G2 

Void 

frequency/day, 

mean 

change±SD: 

G1: -1.9±2.7 

G2: -2.2±2.6 

G3: -1±1.4 

Void 

frequency/day, 

median: 

G1: 10 

G2: 10 

G3: 10 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-554 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et al. 

2003 

(continued) 

Race/ethnicity, 

mean (%): Other: 

G1: 2 (1.6) 

G2: 2 (1.6) 

G3: 3 (2.6) 

Women, N (%): 

G1: 109 (90.1) 

G2: 117 (95.1) 

G3: 109 (93.2) 

Parity : 

NR 

Prior 

antimuscarinic 

treatment, 

Tolterodine, n, 

(%): 

G1: 57 (47)

G2: 60 (49) 

G3: 54 (46) 

Prior 

antimuscarinic 

treatment, 

Oxybutynin, n, 

(%): 

G1:61 (51)

G2: 59 (48) 

G3: 59 (50)

Prior 

antimuscarinic 

treatment, Other, 

n, (%): 

G1: 7 (6)

G2: 6 (5)

G3: 6 (5)

UDI (QOL), 

irritative 

symptoms, 

baseline, (SD): 

G1: 62 (20) 

G2: 66 (18) 

G3: 63 (20)

Void 

frequency/day, 

median change: 

G1: 2 

G2: 2 

G3: 1 

Voided volume, 

mL, mean ± SD: 

G1: 198 ± 84 

G2: 193 ± 75 

G3: 182 ± 84 

P=0.0010 G1 v G3 

P=0.0017 G2 v G3 

P=0.7690 G1 v G2 

Voided volume, 

mL, mean 

change±SD: 

G1: 32±55 

G2: 29±57 

G3: 9±63 

Voided volume, 

mL, median: 

G1: 188 

G2: 189 

G3: 165 

Voided volume, 

mL, median 

change: 

G1: 24 

G2: 29 

G3: 5.5 

Global 

assessment of 

disease, QOL, 

change, (SD): 

G1: 30 (30)

G2: 33 (28)

G3: 21 (31)

P=0.0106 G1 v G3 

P=0.001 G2 v G3 

P=0.1861 G1 v G3 

IIQ (QOL)- travel 

domain, change, 

(%): 

G1: 23 (25) 

G2: 22 (29) 

G3: 11 (30) 

P=0.0018 G1 v G3 

P=0.0045 G2 v G3 

C-555 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et al. 

2003 

(continued) 

UDI (QOL), 

irritative 

symptoms, 

change, (SD): 

G1: 25 (26) 

G2: 28 (26) 

G3: 18 (24) 

P=0.0156 G1 v G3 

P= 0.0010 G2 v 

G3 

Treatment 

compliance with 

assigned dosage 

regimen: 92%: 

Frequency 

decreased to a 

greater extent for 

patients with > 14 

micturations per 

day at baseline 

G1: -2.9/day, 

p=0.0036 (data 

for other groups 

not reported) 

Adverse effects: 

Dry mouth, %: 

G1: 4.1 

G2: 7.3 

G3: 1.7 

P=0.2678 G1 v G3 

P=0.0379 G2 v G3 

Constipation, 

(%): 

G1: 3.3 

G2: 5.7 

G3: NR 

Mild systemic 

adverse effects, 

n (%): 

G1: 15 (12.4) 

G2: 13 (10.6) 

G3: 6 (5.1) 

Moderate 

systemic adverse 

effects, n (%) 

G1: 7 (5.8) 

G2: 13 (10.6) 

G3: 7 (6.0) 

C-556 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Dmochowski et al. 

2003 

(continued) 

Severe systemic 

adverse effects, 

n (%) 

G1: 1 (0.8) 

G2: 3 (2.4) 

G3: 1 (0.9)

Mild localized 

application site 

reactions, n (%): 

G1: 9 (7.4) 

G2: 2 (1.6) 

G3: 5 (4.3) 

Moderate 

localized 

application site 

reactions, n (%): 

G1: 17 (14.0) 

G2: 4 (3.3) 

G3: 2 (1.7) 

Severe localized 

application site 

reactions, n (%): 

G1: 6 (5.0) 

G2: 1 (0.8) 

G3: 1 (0.9) 

Treatment 

discontinuation 

due to adverse 

effects, n (%): 

G1: 13 (10.7) (12 

due to application 

site reactions, 1 

due to hot flushes) 

G2: 2 (1.6) (1 due 

to fatigue and 1 

due to dizziness) 

G3: NR 

Postvoid 

residual>150 mL 

at end of 

treatment: 

G1: 4 

G2: 4 

G3: 3 

No reports of 

symptomatic 

urinary retention 

Withdraw due to 

AEs:

 23 

C-557 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Elinoff et al. 2006 

Roberts et al. 

2006 

Country and 

setting: 

US; 82 Primary 

care & Ob-Gyn 

offices 

Enrollment 

period: 

NR 

Funding: 

Pfizer 

Author industry 

relationship 

disclosures: 

6 of 6 

Pfizer (6) 

Astellas (1) 

Novartis (1) 

Design: 

Open-label, 

single-arm cohort 

Intervention: 

Tolterodine ER 4 

mg qd for 12 wks

Groups: 

NA 

N at enrollment: 

896 

N at follow-up: 

758 

Age, yrs ± SD: 

56 ± 15 

Race/ethnicity, N 

(%): 

White: 691 (80) 

Black: 94 (11) 

Asian: 22 (3) 

Other: 53 (6) 

Women, N (%): 

708 (82) 

Parity: 

NR 

Inclusion criteria: 

• 18+ years old 

• OAB symptoms 

for ≥3 mos 

• ≥ 8 voids/day 

• 2+ episodes of 

urgency or UUI 

in a 3-d period 

• 3+ on the OAB 

Bother Rating 

Scale 

Exclusion 

criteria: 

• Stress, 

functional, or 

overflow 

incontinence 

• Acute UTI 

• Clinically 

significant LUT 

pathology 

• Indwelling 

catheter 

• Intermittent selfcath 

• Use of 

anticholinergics, 

antimuscarinics 

for OAB, drugs 

to trt UUI, potent 

cytochrome 

P450 3A4 

inhibitors, or 

investigational 

drugs 

Duration of OAB, 

yrs ± SD: 

 6 (8) 

Trt duration w/ 

study drug, days 

(SD): 

 80 (19) 

Daytime 

frequency 

episodes, #/d, 

mean ± SD: 

 9.3 ± 2.8 

Nocturnal 

frequency 

episodes, #/d, 

mean ± SD: 

 3.0 ± 1.7 

UUI episodes, 

#/d, mean ± SD: 

 2.7 ± 3.2 

Urgency 

episodes, #/d, 

mean ± SD: 

 5.0 ± 3.8 

OAB-q scores 

Symptom bother: 

60.0 

Coping: 50.0 

Concern: 51.4 

Sleep: 44.4 

Social Interaction: 

84.0 

Total HRQL: 55.2 

AUA-SI 

Total: 18 

Irritative: 10 

Obstructive: 8 

Most bothersome 

symptom, n (%) 

Daytime 

frequency: 256 

(30) 

Nocturnal 

frequency: 241 

(28) 

UUI: 206 (24) 

Urgency: 154 (18)

Urgency, mean 

change% (95% 

CI). wk 12:^ 

-81.3 (-85.7, -73.3) 

UUI episodes, 

mean change % 

(95% CI), wk 12:^ 

-80.0 (-85.7, -69.7) 

Nighttime 

frequency, mean 

change % (95% 

CI), wk 12:^ 

 -40.0 (-44.4, -

33.3) 

Daytime 

frequency, mean 

change % (95% 

CI), wk 12:^ 

 -31.6 (-34.6, -

28.1) 

OAB-q scores, 

Median change 

from baseline to 

12 wks (95% CI): 

Symptom bother: -

37.5 (-37.5 , -35.0) 

Coping: 32.5 

(30.0, 35.0) 

Concern: 34.3 

(31.4, 37.1) 

Sleep: 28.0 (28.0, 

32.0) 

Social Interaction: 

12.0 (12.0 to 16.0) 

Total HRQL: 28.9 

(27.2 to 31.2) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

+ 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-558 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Elinoff et al. 2006 

Roberts et al. 

2006 

(continued) 

AUA-SI, Median 

change from 

baseline to 12 wks 

(95% CI)

*Total: -9 (-9 to -8) 

*Irritative: -5 (-5 to 

-5) 

*Obstructive: -4 (-

4 to -3) 

*: p<0.001 

Urgency, mean 

change, wk 12 % 

(95% CI): 

-75.0 (-80.0, -71.4) 

Change from 

baseline to wk 

12, UUI episodes, 

mean % (95% CI): 

-86.1(-80.0, -71.4) 

Nighttime 

frequency, mean 

change % (95% 

CI): 

-37.5 (-40.0, -33.3) 

Daytime 

frequency, mean 

change, wk 12 % 

(95% CI): 

-29.0 (-31.0, -27.3)

All-cause AE: 

 51% 

Discontinued 

treatment, n %: 

15 ( 7) 

Trt-related AE: 

23% 

Dry mouth, %: 

10.0 

Constipation, %: 

 3.7% 

Headache, %: 

3.0% 

UTI, %: 

2.7% 

C-559 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

Country and 

setting: 

US, multicenter

(207 sites)

Enrollment 

period: 

NR 

Funding: 

Astellas Pharma 

US 

Glaxo-SmithKline 

Author industry 

relationship 

disclosures: 

4 of 4* 

Astellas (4) 

Pfizer (1) 

Novartis (1) 

4 of 4^ 

Astellas (3) 

GlaxoSmthKline 

(2) 

Novartis (1) 

Watson (1) 

Yamanouchi (1) 

Design: 

Prospective case 

series 

Intervention: 

Solifenacin qd 

(started on 5 

mg/d; option of 

increasing to 10 

mg/d at week 4; 

option to maintain 

10 mg dose or 

decrease to 5 mg 

at wk 8); for 12 

weeks of 

treatment 

10 mg dose, n 

(%): 

4 wks: 

G1: 55% 

8 wks: 

G1: 59% (8% 

went back to 5mg; 

19% increased to 

10 mg) 

Groups:

G1: Urge 

incontinence as 

most bothersome 

symptom 

G2: Black 

participants 

G3: Full study 

population 

N at enrollment: 

G1:582 

G2: 274 

G3: 2205 

Age, mean yrs ± 

SD: 

G1: 60.9 ± 13.1 

G2: 54.7 ± 13.6 

G3: 59.7 ± 14.4 

Race/ethnicity, n 

(%): 

White: 

G1: 493 (84.7) 

G3: 1761 (79.9) 

African 

American: 

G1: 62 (10.7%) 

G3: 274 (12.4%) 

Inclusion criteria:

• -Age ≥ 18 

• Symptoms of 

OAB for ≥ 3 mos

• Ambulatory 

• Able to use the 

toilet without 

difficulty 

• Urgency, UUI, 

frequency or 

nocturia ≥ 3 mos

Exclusion 

criteria: 

• Previous use of 

solifenacin 

UUI, n (%): 

G1: 582 (100%) 

G2: NR 

G3: 1596 (71.9%) 

Urgency, n (%): 

G1: 534 (91.8) 

G2: NR 

G3: 2007 (91.0) 

Frequency, n 

(%): 

G1: 488 (83.8) 

G2: NR 

G3: 1969 (89.3) 

Nocturia, n (%): 

G1: 438 (75.3) 

G2: NR 

G3: 1792 (81.3) 

Most bothersome 

OAB symptom

Urgency, n (%): 

G2: 48 (17.5) 

G3: 508 (23.0) 

UUI, n (%): 

G1: 582 (100) 

G2: 63 (23.0) 

G3: 602 (27.3) 

Frequency, n 

(%): 

G2: 106 (38.7) 

G3: 619 (28.1) 

Nocturia, n (%): 

G2: 34 (12.4) 

G3: 337 (15.3) 

None specified, n 

(%): 

G2: 23 (8.4) 

G3: 139 (6.3) 

OAB for 3 mos -1 

yr, n (%):

G1: 57 (9.8) 

G3: 349 (15.8%) 

OAB for 1-5 yrs, 

n (%):

G1: 294 (50.5) 

G3: 1124 (51.0) 

OAB for >5 yrs: 

G1: 231 (39.7) 

G3: 732 (33.2) 

Patient 

perception of 

bladder 

condition scale, 

4 wks, mean:

G1: 3.3* 

G2: 3.1* 

G3: 3.3* 

Patient 

Perception of 

Bladder 

Condition Scale, 

8 wks, mean:

G1: 3.0* 

G2: 2.7* 

G3: 2.9* 

Patient 

Perception of 

Bladder 

Condition Scale, 

12 wks or early 

termination, 

mean:

G1: 2.9* 

G2: 2.6* 

G3: 2.9* 

Symptom 

severity, mean 

VAS, wk 4: 

Urinary urgency: 

G1: 40.9 

G2: 39.7 

G3: 40.6 

UUI: 

G1: 36.9 

G2: 29.9 

G3: 32.8 

Frequency: 

G1: 34.5 

G2: 39.3 

G3: 39.9 

Nocturia: 

G1: 30.4 

G2: 35.4 

G3: 38.2

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: - 

Loss to followup: 

NR 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-560 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

Other: 

G1: 27 (4.6%) 

G3: 170 (7.7%) 

Women, n (%): 

G1: 536 (92.1) 

G2: 213 (77.7) 

G3: 1813 (82.2) 

Weight (lbs), 

mean ± SD 

(range): 

G2: 198 ± 51.6 

(100-400) 

G3: 182.2 ± 47.0 

(80-413) 

Perception of 

bladder 

condition scale 

(mean): 

G1: 4.6 

G2: 4.2 

G3: 4.4 

Symptom 

severity, mean 

VAS: 

Urinary urgency: 

G1: 72.3 

G2: 70.8 

G3: 68.7 

UUI: 

G1: 78.5 

G2: 70.8 

G3: 64.1 

Frequency: 

G1: 65.7 

G2: 70.8 

G3: 70.6 

Nocturia: 

G1: 57.9 

G2: 66.5 

G3: 65.2 

OAB-q, symptom 

severity, mean ± 

SE:

G1: 63.1 ± 0.84 

G2: 59.4 (NR) 

G3: 56.9 (NR) 

OAB-q, coping, 

mean ± SE: 

G1: 48.9 ± 1.18

G2: 46.5 (NR) 

G3: 53.1 (NR) 

OAB-q, concern, 

mean ±SE : 

G1: 43.1 ± 1.12 

G2: 46.6 (NR) 

G3: 50.8 (NR) 

OAB-q, sleep, 

mean ± SE: 

G1: 55.2 ± 1.22 

G2: 43.8 (NR) 

G3: 49.2 (NR) 

OAB-q, social, 

mean ± SE: 

G1: 73.6 ± 1.14 

G2: 68.9 (NR) 

G3: 76.0 (NR) 

Symptom 

severity, mean 

VAS, wk 8: 

Urinary urgency: 

G1: 31.1 

G2: 29.4 

G3: 30.0 

UUI: 

G1: 28.9 

G2: 22.1 

G3: 24.5 

Frequency: 

G1: 24.9 

G2: 27.0 

G3: 28.6 

Nocturia: 

G1: 25.4 

G2: 36.4 

G3: 29.0 

Symptom 

severity, mean 

VAS, wk 12 (or 

early 

termination): 

Urinary urgency: 

G1: 27.5 

G2: 25.3 

G3: 28.0 

UUI: 

G1: 24.3 

G2: 20.0 

G3: 22.7 

Frequency: 

G1: 21.6 

G2: 24.5 

G3: 27.4 

Nocturia: 

G1: 22.0 

G2: 21.4 

G3: 27.2 

Symptom 

severity, VAS, 

mean change 

from baseline 

(95% CI): 

Urinary urgency*: 

G1: -43.1 (-45.8, -

40.4) 

G2: -43.0 (-47.6, 

-38.5) 

G3: -39.5 (-41.0, 

-38.1) 

C-561 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

OAB-q, HRQoL, 

mean ± SE: 

G1: 53.4 ± 1.01 

G2: 50.5 (NR) 

G3: 56.3 (NR) 

UUI*: 

G1: -51.7 (-54.5, -

49.0) 

G2: -42.3 (-47.8, 

-36.8) 

G3: -40.1 (-41.8, 

-38.4) 

Frequency*: 

G1: -42.0 (-45.0, -

39.0) 

G2: -44.2 (-48.8, 

-39.6) 

G3: -41.8 (-43.3, 

-40.3) 

Nocturia*: 

G1: -34.4 (-37.3, -

31.5) 

G2: -42.6 (-47.5, 

-37.8) 

G3: -36.9 (-38.4, 

-35.4) 

OAB-q, symptom 

severity, mean 

change (+ SE or 

95% CI)*: 

G1: -35.9 ± 1.08 

G2: -33.6 (-37.0, 

-30.3) 

G3: -29.6 (-30.7, 

-28.6) 

OAB-q, coping, 

mean change (+

SE or 95% CI)*: 

G1: 32.5 ± 1.16 

G2: 32.9 (29.3, 

36.6) 

G3: 27.4 (26.2, 

28.5) 

OAB-q, concern, 

mean change (+

SE or 95% CI)*: 

G1: 37.0 ± 1.21 

G2: 34.0 (30.4, 

37.6) 

G3: 29.6 (28.4, 

30.8) 

OAB-q, sleep, 

mean change (+

SE or 95% CI)*:

G1: 26.0 ± 1.19

G2: 33.8 (29.7, 

37.9) 

G3: 27.3 (26.1, 

28.5)

C-562 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

OAB-q, social, 

mean change +

SE (95% CI)*:

G1: 17.7 ± 1.03

G2: 20.1 (16.7, 

23.5) 

G3: 14.7 (13.7, 

15.6) 

OAB-q, HRQoL, 

mean change (+

SE or 95% CI)*:

G1: 29.6 ± 1.02

G2: 30.8 (27.5, 

34.1) 

G3: 25.4 (24.4, 

26.4) 

Side effects, n 

(%): 

G1: 357 (61.3) 

G2: 128 (46.4) 

G3: 1321 (59.4) 

Dry mouth, n (%): 

G1: 104 (17.9) 

G2: 36 (13.0) 

G3: 477 (21.4) 

Constipation, n 

(%): 

G1: 85 (14.6) 

G2: 19 (6.9) 

G3: 295 (13.3) 

Nausea, n (%): 

G1: NR 

G2: 7 (2.5) 

G3: 39 (1.8) 

Headache, n (%): 

G1: 21 (3.6) 

G2: 9 (3.3) 

G3: 76 (3.4) 

Blurred vision, n 

(%): 

G1: 20 (3.4) 

G2: 7 (2.5) 

G3: 57 (2.6) 

C-563 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Garely et al., 

2007* 

Mallett et al., 

2007^ 

(continued) 

Upper 

respiratory tract 

infection, n (%): 

G1: 27 (4.6) 

G2: 7 (2.5) 

G3: 69 (3.10) 

UTI, n (%) 

G1: 21 (3.6%) 

G2: NR 

G3: NR 

Rash, n (%): 

G1: NR 

G2: 6 (2.2) 

G3: 22 (0.99) 

Nasopharyngitis, 

n (%) 

G1: 13 (2.2%) 

G2: NR 

G3: NR 

Cough, n (%) 

G1: 12 (2.1%) 

G2: NR 

G3: NR 

Withdrew, n (%): 

G1: NR 

G2: 21 (7.6) 

G3: 216 (9.7) 

C-564 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Giannitsas et al., 

2004 

Country and 

setting: 

Greece, Specialty 

treatment center 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Randomized for 

which drug to 

receive first 

two-way 

crossover, table of 

random numbers 

Intervention: 

Oxybutynin 15 mg 

tid vs Tolterodine 

4mg bid; 6 weeks 

treatment with 3-4 

weeks washout 

Groups: 

G1: Oxybutynin 

15 mg tid 

G2: Tolterodine 

4mg bid 

Stratified by UDS 

findings: 

a: high volume (> 

250mL); low 

pressure (< 

25cmH2O)

b: high volume 

(≥ 250mL); 

high pressure 

(> 25cmH2O) 

C: low volume 

(< 250mL); low 

pressure (< 

25cmH2O) 

d: low volume 

(< 250mL); 

high pressure 

(> 25cmH2O) 

N at enrollment: 

Total: 128 

N at follow-up: 

Total: 107 

Ga: 6 

Gb: 25 

Gc: 36 

Gd: 40 

Women, %: 

100 

Inclusion criteria: 

• Age ≥ 18 

• DO on 

urodynamics 

Exclusion 

criteria: 

• Symptomatic or 

recurrent UTI 

• BOO 

• Neurologic 

disease 

• History of 

previous pelvic 

surgery 

• Narrow angle 

glaucoma 

• SUI 

• History of 

anticholinergic 

side effects 

• Interstitial 

cystitis 

• Child-bearing 

age without BC 

Voids/day, mean 

± SD: 

Total: 8.5 ± 2.63 

Ga: 7.2 ± NR 

Gb: 8.0 ± 2.40 

Gc: 8.3 ± 2.31 

Gd: 9.3 ± 2.91 

Volume (mL)/day, 

mean ± SD: 

Total: 1568.5 ± 

398.64 

Ga: 1756 ± NR 

Gb: 1594.6 ± 

326.12 

Gc: 1678.8 ± 

402.15 

Gd: 1420.5 ± 

384.96 

Voided volume 

(mL), mean ± SD:

Total: 196.1 ± 

60.19 

Ga: 253 ± NR 

Gb: 213.5 ± 53.57

Gc: 209.8 ± 57.43

Gd: 163.4 ± 51.97

Bladder volume 

(mL), first desire 

void, mean ± SD:

Total: 105.6 ± 

39.38 

Ga: 109 ± NR 

Gb: 128.0 ± 41.78

Gc: 94.3± 35.40 

Gd: 101.1 ± 38.14

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

Total: 172 ± 98.4 

Ga: 258 ± NR 

Gb: 303.3 ± 60.51

Gc: 111.9 ± 48.11

Gd: 124.4 ± 56.66

Voids/day, mean 

± SD: 

G1: 7.7 ± 1.87 

G2: 7.6 ± 2.18 

G1a: 6.1 ± NR 

G2a: 6.3 ± NR 

G1b: 7.3 ± 1.69 

G2b: 7.0 ± 1.87 

G1c: 7.5 ± 1.41 

G2c: 7.2 ± 1.58 

G1d: 8.3 ± 2.23 

G2d: 8.4 ± 2.53

Volume (mL)/day, 

mean ± SD: 

G1: 1764.4 ± 

333.03 

G2: 1670.7 ± 

338.6

G1a: 1862 ± NR 

G2a: 1720 ± NR

G1b: 1715.6 ± 

292.54 

G2b: 1665.8 ± 

251.19

G1c: 1847.9 ± 

333.81 

G2c: 1808.1 ± 

317.59

G1d: 1694.7 ± 

331.33 

G2d: 1550.3 ± 

373.65 

Voided volume 

(mL), mean ± SD: 

G1: 239.9 ± 64.98 

G2: 236.7 ± 63.03

G1a: 321 ± NR 

G2a: 286 ± NR 

G1b: 243.3 ± 

59.56 

G2b: 248.3 ± 

53.91

G1c: 252.9 ± 

55.75 

G2c: 258.6 ± 

60.63

G1d: 217.6 ± 

67.07 

G2d: 203.1 ± 

55.43 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-565 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Age, mean ± SD: 

Total: 56 ±16.3 

Ga: 53 ± 17.2 

Gb: 57 ± 16.2 

Gc: 57 ± 16.3 

Gd: 54 ± 16.6 

Weight (kg), 

mean ± SD: 

Total: 63 ± 5.6 

Ga: 63 ± 5.6 

Gb: 70 ± 9.1 

Gc: 67 ± 8.8 

Gd: 69 ± 7.5 

Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

Total: 34.8 ± 21.97

Ga: 17.4 ± NR 

Gb: 37.7 ± 14.03 

Gc: 18.5 ± 4.60 

Gd: 50.3 ± 25.14 

Overactivity 

index, mean ± 

SD: 

Total: 36.8 ± 31.36

Ga: 15.3 ± NR 

Gb: 24.8 ± 19.66 

Gc: 26.3 ± 16.14 

Gd: 57.0 ± 38.85 

Cystometric 

capacity (mL), 

mean ± SD: 

Total: 362.8 ± 

119.10

Ga: 403 ± NR 

Gb: 410.0 ± 97.78

Gc: 357.6 ± 

127.52 

Gd: 331.4 ± 

114.17 

Bladder volume 

(mL), first desire 

void, mean ± SD: 

G1: 129.0 ± 30.14 

G2: 117.9 ± 27.62

G1a: 144 ± NR 

G2a: 140 ± NR

G1b: 153.5 ± 

25.72 

G2b: 132.0 ± 

31.01

G1c: 120.8 ± 

25.07 

G2c: 113.2 ± 

23.16

G1d: 119.4 ± 

29.43 

G2d: 110.1 ± 

26.15 

G1/BL: P < 0.05 

G2/BL: P < 0.05 

Bladder volume 

(mL), first 

contraction, 

mean ± SD: 

G1: 212.9 ± 

106.10 

G2: 206.9 ± 

103.56

G1a: 382 ± NR 

G2a: 364 ± NR

G1b: 355.28 ± 

74.79

G1c: 142.4 ± 

43.51 

G2c: 144.6 ± 

48.43

G1d: 173.3 ± 

57.37 

G2d: 162.7 ± 

53.87 

G1d/BL: P < 0.01 

G2d/BL: P < 0.01 

Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

G1: 30.9 ± 22.63 

G2: 30.9 ± 19.01

G1a: 14.0 ± NR 

G2a: 17.4 ± NR

G1b: 35.6 ± 12.86 

G2b: 29.6 ± 13.56

C-566 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Giannitsas et al., 

2004 

(continued) 

Pressure 

(cmH20), first 

contraction, 

mean ± SD: 

G1c: 17.2 ± 6.80 

G2c: 17.9 ± 6.69

G1d: 42.9 ± 28.91 

G2d: 44.1 ± 20.75 

Overactivity 

index, mean ± 

SD: 

G1: 24.4 ± 22.61 

G2: 24.7 ± 23.46

G1a: 7.0 ± NR 

G2a: 9.5 ± NR

G1b: 14.1 ± 12.09 

G2b: 14.1 ± 12.71

G1c: 18.3 ± 15.89 

G2c: 16.9 ± 16.84

G1d: 38.9 ± 26.50 

G2d: 40.7 ± 26.58 

Cystometric 

capacity (mL), 

mean ± SD: 

G1: 419.3 ± 

120.86 

G2: 415.63 ± 

114.06

G1a: 465 ± NR 

G2a: 453 ± NR

G1b: 449.6 ± 

106.23 

G2b: 459.4 ± 

101.17

G1c: 409.9 ± 

130.22 

G2c: 411.05 ± 

132.49

G1d: 401.8 ± 

118.34 

G2d: 386.7 ± 

96.53 

Dry mouth, n (%): 

G1: 52 (40.6) 

G2: 20 (15.6) 

Constipation, n 

(%): 

G1: 11 (10.3) 

G2: 3 (2.8) 

Discontinued 

due to AEs, n: 

Dry mouth: 12 

Palpitations: 1

C-567 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Gleason et al. 

1999 

Country and 

setting: 

US, Community 

Enrollment 

period: 

NR 

12 week follow up 

Funding: 

Alza Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Multicenter 

Open label 

Single treatment 

Intervention: 

Oxybutynin ER 

Groups: 

G1: Oxybutynin 

ER 5- 30 mg/ day 

(dose adjustment 

period) 

N at enrollment: 

G1: 256 

N at follow-up: 

G1: 219 

37 missing data 

20 from AEs 

4 dc’d lack of 

effectiveness, 

included in 

analysis 

Age, yrs ± SD: 

NR 

38.8% were 65+ 

Race/ethnicity, 

mean (%): white: 

G1: 235 (91.8) 

Women, N (%): 

G1: 234 (91.4) 

Inclusion criteria: 

• ≥ adult men and 

women 

• Idiopathic urge 

incontinence 

• Mixed 

incontinence 

with clinically 

significant urge 

component 

Exclusion criteria: 

• Uncontrolled 

medical 

condition 

• PVR > 100 ml 

• Significant 

bacteriuria 

• Significant 

pyuria 

UUI episodes/ 

week, mean ± 

SD: 

G1: 18.8 ± 1.2 

Total incontinent 

episodes/ week, 

mean ± SD: 

G1: 22.2 ± 1.3 

Voids/ week, 

mean ± SD: 

G1: 81.1 ± 1.8 

PVR, ml, mean ± 

SD: 

G1: 17.4 ± 1.3 

Voided volume, 

ml, ± SD: 

G1: 121 ± 79.1 

UUI episodes/ 

week, mean ± 

SD: 

G1: 2.8 ± 0.6 

P<0.001 

Total incontinent 

episodes/ week, 

mean ± SD: 

G1: 4.0 ± 0.7 

P<0.001 

Voids/ week, 

mean ± SD: 

G1: 66.8 ± 1.4 

Reduction 

Voids/week, 

mean ± SD: 

G1: 14.3 ± 1.3 

95%CI: 11.7-16.8

PVR, ml, mean ± 

SD: 

G1: 21.0 ± 2.2

P = NR

Voided volume, 

ml, ± SD: 

G1: 113.4 ± 84.6

P = NR

Participants free 

UUI episodes, %: 

55.7 

Dry Mouth, n (%): 

G1: 128 (58.6) 

Discontinuation 

d/t AE, n (%): 

20 (7.8) 

Nausea (%): 

2.3 

Dry Mouth (%): 

1.6 

Somnolence (%): 

1.2 

Urinary retention, 

n (%): 

2 (0.8) 

Increased PVR, 

n, (%): 

1 (0.4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-568 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Hill et al., 2007 

[See evidence 

table for Haab et 

al., 2006] 

Country and 

setting: 

France, Denmark, 

Sweden, Australia, 

Canada, US, 

Multicenter 

Enrollment 

period: 

NR 

Funding: 

Novartis Pharma 

AG (educational 

grant) 

Author industry 

relationship 

disclosures: 

NR 

Design: 

2-yr, noncomparative, 

open-label 

extension study 

Intervention: 

Darifenacin 

following 2 feeder 

studies of 

darifenacin 

3.75/7.5/15 mg qd 

or placebo x 12 

wks

Groups: 

NA 

N at enrollment: 

214 

N at follow-up 

(%): 

137 (64.0) 

Patient years of 

exposure: 

308 

Women, n (%): 

172 (80.4) 

Age, n (%): 

65-74 years: 166 

(77.6) 

75-89 years: 48 

(22.4) 

Race/ethnicity: 

NR 

Menopausal, n 

(%): 

13 (6.1) 

Inclusion criteria: 

• Age ≥ 65 

• Successful 

completion of 

one of 2 

previous, 12-wk 

feeder studies 

with no major 

protocol 

violation 

Exclusion 

criteria: 

NR

Urgency 

episodes/day, 

median: 

8.1 

Urgency severity, 

median VAS 

score: 

51.8 

Incontinence 

episodes/week, 

median: 

18.7 

Voids/day, 

median: 

10.1 

Voided volume 

(mL), median: 

156 

Concomitant drug 

treatment, n (%): 

210 (98.1) 

Urgency 

episodes/day, 

median change 

(median % 

change): 

-3.7 (-52.0) 

P < 0.05 

Urgency severity, 

VAS score, 

median change 

(median % 

change): 

-12.6 (-23.3) 

P < 0.05 

Incontinence 

episodes/week, 

median change 

(median % 

change): 

-11.0 (-83.7) 

P < 0.05 

Significant leaks/ 

week, median 

change (median 

% change): 

-4.9 (-100.0) 

P < 0.05 

Incontinence 

episodes, 

responders, % 

reduction, %: 

≥ 50%: 74.1 

≥ 70%: 60.0 

≥ 90%: 44.4 

Voids/day, 

median change 

(median % 

change): 

-1.2 (-12.4) 

P < 0.05 

Normalization of 

voiding 

frequency (< 8 

voids/day) after 

darifenacin 

treatment, %: 

3 months: 34 

2 years: 33.8 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-569 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Hill et al., 2007 

(continued) 

Nocturia

episodes/week, 

median change 

(median % 

change): 

-1.4 (-10.9) 

G1/BL: P < 0.05 

Increased dose 

to 15 mg at 2 wks 

and maintained, 

n (%): 

110 (51.4) 

Remained on 7.5 

mg dose, n (%): 

55 (25.7) 

Had dose 

adjusted at other 

times, n (%): 

49 (22.9) 

Compliance, ≥

80% of doses, n 

(%): 

214 (84) 

Voided volume 

(mL), median 

change (median 

% change): 

11.1 (6.3) 

Dry mouth, n (%):

50 (23.4) 

Constipation, n 

(%): 

48 (22.4) 

CVD, %: 

1.4 

Peripheral/CNS, 

%: 

3.3 

C-570 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Jacquetin and 

Wyndaele, 2001 

Country and 

setting: 

France (22 

centers) and 

Belgium (10 

centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Double-blind, 

placebocontrolled, 

parallel-group, 

multicenter phase 

III study w/ 2-wk 

washout period 

Intervention: 

Tolterodine vs 

placebo for 4 

weeks

Groups: 

G1: Tolterodine 

2mg bid 

G2: Tolterodine 1 

mg bid 

G3: placebo 

(frequency NR) 

N at enrollment: 

NR 

N at follow-up: 

G1: 103 

G2: 97 

G3: 51 

Women, n (%): 

G1: 84 (82) 

G2: 74 (76) 

G3: 41 (80) 

Age, mean 

(range): 

G1: 58 (21-88) 

G2: 53 (18-85) 

G3: 56 (19-89) 

Race/ethnicity:

NR 

BMI, kg/m2

(range): 

G1: 26.4 (17.7-

39.7) 

G2: 25.5 (16.7-

46.3) 

G3: 24.8 (17.6-

36.9) 

Inclusion criteria: 

• Age ≥ 18 

• UDS-verified 

detrusor 

overactivity 

• ≥ 1 UUI 

episode/ day 

• ≥ 8 voids/day 

Exclusion 

criteria: 

• SI 

• Hepatic or renal 

dz 

• +UTI or 

recurrent UTIs 

• Interstitial 

cystitis 

• Hematuria 

• Clinically 

significant 

voiding difficulty

• Pts receiving 

bladder training, 

electrostimulation therapy 

• Indwelling 

catheter 

• Intermittent cath

• Pregnant or 

nursing 

• Women of 

childbearing age 

w/o reliable 

contraception 

UUI, n (%) 

G1: 75 (73)

G2: 75 (77)

G3: 39 (76)

UUI episodes/ 

day, mean 

(range): 

G1: 3.2 (0.1-24.0) 

G2: 2.7 (0.1-24.0) 

G3: 2.4 (0.1-8.4) 

Voids/day, mean 

(range): 

G1: 10.8 (6.2-

34.7) 

G2: 10.7 (4.9-

26.4) 

G3: 11.7 (6.3-

26.3) 

≥ 8 voids/day, n 

(%): 

G1: 96 (93) 

G2: 89 (92) 

G3: 49 (96) 

Urinary 

symptoms > 5 

years, n (%): 

G1: 46 (45) 

G2: 42 (43) 

G3: 17 (33) 

Previous lower 

urinary tract 

surgery, n (%): 

G1: 36 (35)

G2: 29 (30)

G3: 16 (31)

Previous drug 

therapy for OAB, 

n (%): 

G1: 66 (64) 

G2: 59 (61) 

G3: 36 (71) 

Previous poor 

efficacy 

response, n (%): 

G1: 50 (76) 

G2: 45 (76) 

G3: 26 (72) 

UUI episodes/ 

day, mean 

change ± SD: 

G1: -1.3 ± 1.8

G2: -1.1 ± 2.2

G3: -0.4 ± 1.9

G1/G3: P = 

0.0089

G2/G3: P = 0.045

Voids/day, mean 

change ± SD: 

G1: -1.4 ± 4.3

G2: -1.4 ± 2.8

G3: -1.2 ± 2.7 

G1/G3: P = NS

G2/G3: P = NS 

Good efficacy 

response in 

current study, 

previous poor 

efficacy 

response, n/N 

(%)

G1: 20/39 (51) 

G2: 18/37 (49) 

G3: 7/19 (37) 

G1/G3: P = NS 

G2/G3: P = NS 

Voided volume 

(mL), mean 

change ± SD: 

G1: 19 ± 46

G2: 20 ± 42

G3: 7 ± 40

G1/G3: P = 0.056

G2/G3: P = 0.055 

Dry mouth, n (%): 

G1: 35 (34) 

G2: 20 (21) 

G3: 3 (6) 

G1/G2: P < 0.05 

G1/G3: P < 0.05 

G2/G3: P < 0.05 

Abdominal pain, 

n (%): 

G1: 4 (4) 

G2: 6 (6) 

G3: 2 (4) 

Constipation, n 

(%): 

G1: 2 (2) 

G2: 4 (4) 

G3: 2 (4) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: - 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

NR 

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-571 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Jacquetin and 

Wyndaele, 2001 

(continued) 

Voided volume 

(mL), mean 

(range): 

G1: 158 (43-382) 

G2: 150 (46-320) 

G3: 148 (23-284)

Headache, n (%): 

G1: 3 (3) 

G2: 3 (3) 

G3: 2 (4) 

Total AEs 

reported, n: 

G1: 84 

G2: 78 

G3: 26 

Any AE, n (%): 

G1: 55 (53) 

G2: 39 (40) 

G3: 16 (31) 

G1/G3: P < 0.05 

Discontinued 

due to AEs, n 

(%):* 

G1: 2 (2) 

G2: 3 (3) 

G3: 1 (2) 

C-572 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Koonings et al., 

1991 

Country and 

setting: 

US 

Enrollment 

period: 

January 1986 to 

October 1987 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohort 

Intervention: 

Oxybutynin 

chloride 5 mg tid x 

4 wks

Groups: 

NA 

N at enrollment: 

126 

N at follow-up: 

114 

Women, %: 

100 

Age, mean 

(range): 

39 (21-74) 

Race/ethnicity: 

NR 

Menopausal, n: 

44 

Parity, mean 

(range): 

2 (0-12) 

Inclusion criteria: 

• Confirmed 

diagnosis of 

detrusor 

instability 

• Uninhibited 

detrusor 

contraction > 15 

cm H2O on 

standing 

provocative 

urethra 

cystometry 

Exclusion 

criteria: 

• Urethritis (on 

urethroscopy) 

• Cystitis (on 

cystoscopy) 

• Neurologic 

findings on 

screening test of 

S2-S4 lower 

voiding center 

• MUI 

• Glaucoma

Uninhibited 

detrusor 

contraction 

starting prior to 

urethral pressure 

change, n (%): 

73 (64%) 

Urethral pressure 

drop (≥ 20 

cmH2O) prior to 

detrusor 

contraction, n 

(%): 

41 (6) 

Good response, 

n (%): 

66 (58) 

Poor response, n 

(%): 

48 (42) 

Response, 

women with 

uninhibited 

detrusor 

contraction 

starting prior to 

urethral 

pressure, n (%): 

Good: 61 (81) 

Poor: 5 (12) 

P < 0.01 

Response, 

women with 

urethral pressure 

drop (≥ 20 

cmH2O) prior to 

detrusor 

contraction, n 

(%): 

Good: 12 (16) 

Poor: 36 (88) 

P < 0.01 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-573 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Kreder et al., 2003 

Country and 

setting: 

US and Canada, 

Community 

Enrollment 

period: 

NR 

16 week follow up 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Subgroup analysis 

of multicenter, 

single blind cohort 

Intervention: 

Tolterodine 1-2 

mg bid

Groups: 

G1: MUI with 

primary urge 

G2: UUI 

N at enrollment: 

G1: 171 

G2: 552 

N at follow-up: 

G1: 170 

G2: 551 

Women, n (%): 

G1: 165 (96.5) 

G2: 464 (84) 

Age, median 

(range): 

G1: 62 (21, 88) 

G2: 65 (20, 88) 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 65 

• History, PE, 

UDS consistent 

with urge 

incontinence 

• ≥ 4 episodes UI 

on 5 day voiding 

diary 

• ≥ 8 voids/day 

• Either urgency 

or ≥ 1 UI 

episodes / day 

Exclusion 

criteria: 

• MUI with 

predominate 

stress 

component 

• Contraindication

s to 

antimuscarinic 

therapy 

• Hepatic/renal 

disease 

• Symptomatic or 

recurrent UTI 

• Hematuria 

• IC 

• Voiding difficulty 

with risk of 

retention 

• Concurrent 

bladder training 

• Electrostimulatio

n therapy 

• Indwelling 

catheter 

• CIC 

• Women with 

reproduction 

potential 

• Pregnant/ 

nursing 

• Concomitant 

anticholinergic 

meds/ treatment

Incontinence 

episodes/day, 

median (range): 

G1: 3 (1, 19) 

G2: 3 (1, 15) 

≥ 2 nocturia 

episodes/day, n 

(%): 

G1: 100 (58.5) 

G2: 334 (60.5) 

Using pads, n 

(%): 

G1: 122 (71) 

G2: 342 (62) 

Voided volume 

(mL), median 

(range): 

G1: 169 (62, 506) 

G2: 164 (31, 524) 

Duration of 

symptoms > 5 

years, n (%): 

G1: 91 (53) 

G2: 259 (47) 

Previous drug 

therapy for OAB, 

n (%): 

G1: 85 (50) 

G2: 275 (50) 

Incontinence 

episodes/day, 

median % 

change: 

G1: -67 

G2: -75 

P = NS 

Cure rate, 

dryness, n (%): 

G1: 66 (39) 

G2: 243 (44) 

P = NS 

Voids/day, 

median % 

change: 

G1: -15 

G2: -17 

P = NS 

≤ 8 voids/day 

dryness, n (%): 

G1: 40 (23.5) 

G2: 130 (24) 

P = NS 

Nocturia 

episodes/day, 

median % 

change: 

G1: -50 

G2: -33 

P = NS 

≤ 2 nocturnal 

voiding 

episodes/day, n 

(%): 

G1: 83 (83) 

G2: 254 (76) 

P = NS 

Achieved no pad 

usage, n (%): 

G1: 26 (21) 

G2: 93 (27) 

P = NS 

Voided volume 

(mL), median 

change (range): 

G1: 26.5 (-261, 

195) 

G2: 27 (-345, 389) 

G1/BL: P < 0.001 

G2/BL: P < 0.001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-574 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Landis et al., 2004 

[See evidence 

table for van 

Kerrebroeck et al., 

2001] 

Country and 

setting: 

Multinational, 

Community 

Enrollment 

period: 

NR 

12 weeks 

Funding: 

Pharmacia 

Author industry 

relationship 

disclosures: 

2 of 4 

ALZA (1) 

Bristol-Myers 

Squibb (1) 

Pharmacia (2) 

Design: 

RCT 

Intervention: 

Tolterodine ER vs 

placebo 

1 week run-in 

period with 12 

weeks treatment 

Groups: 

G1: Tolterodine 

ER 4 mg daily 

G2: placebo 

Stratified: 

a: 5-20 UUI 

episodes/week 

b: ≥ 21 UUI 

episodes/week 

N at enrollment: 

G1: 492 

G1a: 321 

G1b: 171 

G2: 494 

G2a: 284 

G2b: 210 

N at follow-up: 

G1a: 321 

G1b: 171 

G2a: 284 

G2b: 210 

Women, N (%): 

G1a: 262 (81.6) 

G1b: 143 (83.6) 

G2a: 223 (78.5) 

G2b: 178 (84.8) 

Age, mean ± SD: 

G1a: 60.86 ± 

14.45 

G1b: 60.04 ± 

14.10 

G2a: 60.61 ± 

13.59 

G2b: 61.84 ± 

13.85 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• ≥ 5 UUI 

episodes/ week 

• ≥ 8 voids/day 

• Symptoms of 

OAB x 5 months

Exclusion 

criteria: 

NR 

UUI episodes/ 

week, median 

(range): 

G1a: 11 (5-20)

G1b: 34 (21-168) 

G2a: 11 (5-20)

G2b: 31.5 (21-

168) 

Voids/day, 

median (range): 

G1a: 9.57 (2.57- 

34.85) 

G1b: 10.71 (2.28- 

51.28) 

G2a: 10.28 (2.28-

28.42) 

G2b: 11.14 (2-

37.42) 

Voided volume 

(mL), median 

(range): 

G1a: 142.72 

(36.19-338) 

G1b: 135.12 

(51.45-270.52) 

G2a: 136.25 

(32.51-237.5) 

G2b: 126.94 

(21.16-373.46) 

Number prior Tx 

for OAB, n (%): 

G1a: 162 (50.6) 

G1b: 100 (58.5) 

G2a: 139 (49.1) 

G2b: 117 (55.7) 

Number prior Tx 

for OAB w/ good 

efficacy, n (%): 

G1a: 85 (52.8) 

G1b: 63 (63.0) 

G2a: 84 (60.4) 

G2b: 68 (58.6) 

UUI episodes/ 

week, median % 

change: 

G1a: -71.42 

G1b: -67.56 

G2a: -38.46 

G2b: -29.81 

G1a/G2a: P = 

0.0264 

G1b/G2b: P = 

0.0221 

Voids/day, 

median change: 

G1a: -1.22 

G1b: -1.9 

G2a: -0.85

G2b: -0.4 

G1a/G2a: P < 

0.04 

G1b/G2b: P < 

0.02 

Voided volume 

(mL), median 

change: 

G1a: 24.0 

G1b: 27.0 

G2a: 4.0 

G2b: 2.9 

G1a/G2a: P < 

0.0001 

G1a/G2a: P < 

0.0001 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-575 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Layton et al. 2001 

Country and 

setting: 

England; 

Community 

Enrollment 

period: 

November 1998 to 

May 1999 

Funding: 

Pharmacia 

Upjohn 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective 

observational 

cohort 

Intervention: 

Tolterodine 

prescription event 

monitoring in UK

Groups: 

NA 

N at enrollment: 

35,295 had 

commenced 

treatment 

26,991 green 

forms mailed out 

14,526 returned 

forms 

Response rate: 

53.8% 

Age, yrs ± SD: 

62.7 ± 16.4 

Women, N (%): 

9965 (68.6) 

Parity: 

NR 

Inclusion criteria: 

• Patients 

prescribed 

tolterodine in 

general practice 

in UK 

Exclusion 

criteria: 

• None 

Dry mouth, n: 

250 

Unspecified 

adverse effects, 

n: 

168 

Headache, n: 

123 

Constipation, n: 

78 

General malaise, 

n: 

78 

Hallucinations, n: 

23 

Palpitations/tach

ycardia, n: 

42 

Other cardiac 

arrhythmias, n: 

29 

Chest pains, n: 

87 

Quality: 

Overall quality 

score: good 

INTERNAL 

VALIDITY: good 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

NA 

Drop-out rates: NA

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: + 

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: - 

C-576 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Lee et al., 2002 

Country and 

setting: 

South Korea, 

University 

Enrollment 

period: 

NR 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine 2mg 

bid vs Oxybutynin 

5mg bid 

Groups: 

G1: Tolterodine 

2mg bid 

G2: Oxybutynin 

5mg bid 

N at enrollment: 

G1: 112 

G2: 116 

N at follow-up: 

G1: 97 

G2: 90 

Women, n (%): 

G1: 84 (74) 

G2: 92 (79) 

Age, mean 

(range): 

G1: 52 (27, 82) 

G2: 52 (20, 86) 

Race/ethnicity 

(%): 

Asian: 

G1: 100 

G2: 100 

BMI, kg/m2

(range): 

G1: 23 (17, 32.5) 

G2: 23.5 (16, 38) 

Previous drug 

therapy: N (%) 

G1: 36 (32) 

G2: 26 (22) 

Inclusion criteria: 

• Age ≥ 18 

• OAB symptoms 

> 6 mos 

• ≥ 8 voids/day, 

with or without 

incontinence 

(measured by 

diary) 

Exclusion 

criteria: 

• SUI 

• Women not 

using reliable 

contraception 

• Pregnant or 

nursing 

• Prior treatment 

with 

anticholinergic < 

2 wks 

• Renal or hepatic 

disease 

• Narrow angle 

glaucoma 

• Urinary 

retention 

• Gastric retention

• Hypersensitivity 

to drugs 

• UTI 

• IC 

• Hematuria 

• BOO 

• Concomitant 

bladder training, 

e-stim treatment

• Indwelling 

catheter 

• CIC 

• Concomitant 

treatment for 

OAB ≤ 2 mos 

Incontinence 

episodes/day, 

mean (range): 

G1: 2.6 (0.3, 9.3) 

G2: 2.4 (3.0, 14.7)

Patients with 

incontinence 

episodes, n (%): 

G1: 46 (41) 

G2: 42 (36) 

Voids/day, mean 

(range): 

G1: 12.2 (8.0, 

23.7) 

G2: 12.4 (7.7, 

29.7) 

Incontinence 

episodes/day, 

mean change ± 

SD (% change): 

G1: -2.2 ± 2.3 (-

85) 

G2: -1.4 ± 1.8 (-

58) 

G1/BL: P = 

0.0001 

G1/BL: P = 

0.0001 

G1/G2: P = 0.10 

Voids/ day, mean 

change ± SD (% 

change): 

G1: -2.6 ± 2.9 (-

21) 

G2: -1.8 ± 4.2 (-

15) 

G1/BL: P = 

0.0001 

G1/BL: P = 

0.0001 

G1/G2: P = 0.14 

Benefit of Tx, %: 

G1: 45 

G2: 46 

G1/G2: P = NS 

Patients 

reporting 

adverse events, 

n (%): 

G1: 62 (55) 

G2: 94 (82) 

Discontinued 

due to AEs, n 

(%): 

G1: 11 

G2: 18 

Dry mouth, n (%): 

G1: 39 (35) 

G2: 72 (63) 

G1/G2: P = 0.001 

Dry mouth, mild, 

n (%): 

G1: 29 (26) 

G2: 40 (35) 

Dry mouth, 

moderate, n (%): 

G1: 9 (8) 

G2: 26 (23) 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-577 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Lee et al., 2002 

(continued) 

Dry mouth, 

severe, n (%): 

G1: 1 (1) 

G2: 6 (5) 

Voiding disorder, 

n (%): 

G1: 10 (9) 

G2: 16 (14) 

C-578 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Malone-Lee et al., 

2003

Country and 

setting: 

UK, Hospital 

Enrollment 

period: 

1993-1999

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Prospective 

observational 

Intervention: 

Oxybutynin 2.5mg 

bid and bladder 

retraining 

Groups: 

G1: urinary 

frequency and 

urgency w/ 

detrusor instability 

G2: urinary 

frequency and 

urgency w/o 

detrusor instability 

N at enrollment: 

G1: 266 

G2: 86 

N at follow-up: 

Total: 347 

G1: NR 

G2: NR 

Age, mean 

(range): 

G1: 54.8 (20, 90) 

G2: 51.8 (21, 88) 

Race/ethnicity:

NR 

Inclusion criteria:

• Women 

• Age ≥ 18 

• ≥ 8 voids/day 

Exclusion 

criteria: 

• Neurological 

disease 

• Significant stress 

incontinence 

• Symptomatic 

UTI 

• Interstitial cystitis 

Incontinence 

episodes/day, 

median (95% CI):

G1: 2 (0, 7) 

G2: 2 (0, 6.3) 

Voids/day 

median (95% CI):

G1: 14 (8, 24) 

G2: 12 (8, 22) 

Incontinence 

episodes/day, 

median change 

(95% CI): 

G1: 0 (2, 6) 

G2: 0 (2, 6) 

G1/G2: P = 0.73 

Voids/day, 

median change 

(95% CI): 

G1: -5 (1.9-14) 

G2: -5 (1-12.3) 

G1/G2: P = 0.61 

Dry mouth, n (%): 

G1: 219 (84) 

G2: 69 (70) 

Constipation, n 

(%): 

G1: 84 (32) 

G2: 19 (22) 

Heartburn, n (%): 

G1: 71 (27) 

G2: 20 (23) 

Dry skin, n (%): 

G1: 46 (18) 

G2: 4 (5) 

G1/G2: P = 0.01 

Headache, n (%): 

G1: 25 (10) 

G2: 3 (3.5) 

Dry eyes, n (%): 

G1: 12 (5) 

G2: 1 (1) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-579 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Michel et al., 2002 

Country and 

setting: 

Germany, 

Community 

Enrollment 

period: 

NR 

12 week follow up 

Funding: 

Pharmacia GmbH 

Author industry 

relationship 

disclosures: 

1 of 4 

Pharmacia(1) 

SanofiSynthelabo(1) 

Design: 

Open-label 

observational 

post-marketing 

surveillance 

Intervention: 

Tolterodine 

Groups: 

Tolterodine 

Median dose: 2 

mg daily 

Dose (mg), mean 

± SD: 

3.81 ± 1.16 

N at enrollment: 

2,250 

N at follow-up: 

1,979 

Women, n (%): 

1,730 (76.9) 

Age, mean ± SD: 

61.1 ± 13.8 

Race/ethnicity: 

NR 

BMI, kg/m2

 ± SD: 

73.2 ± 11.3 

Inclusion criteria: 

• Physician 

medical 

judgement 

Exclusion 

criteria: 

NR 

Urgency 

episodes/day, 

mean ± SD: 

8.4 ± 5.1 

Incontinence 

episodes/day, 

mean ± SD: 

3.4 ± 4.2 

Voids/day, mean 

± SD: 

12.4 ± 4.3 

Urgency 

episodes/day, 

mean ± SD: 

2.0 ± 3.0 

P = NR 

Incontinence 

episodes/day, 

mean ± SD: 

 0.8 ± 2.0 

P = NR 

Voids/day, mean 

± SD: 

 7.7 ± 2.7 

P = NR 

Urgency, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

0.764 

(0.583, 1.001) 

P = 0.0508 

Age, years: 0.981 

(0.973, 0.990) 

P < 0.001 

Frequency, BL 

episodes/day: 

1.038 

(0.997- 1.080) 

P = 0.0724 

Urgency, BL 

episodes/day: 

0.851 

(0.823, 0.880) 

P < 0.001 

Incontinence, BL 

episodes/day: 

0.979 

(0.950, 1.000) 

P = 0.1735 

Tolterodine dose, 

mg/day: 0.913 

(0.830, 1.005) 

P = 0.0623 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: - 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-580 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 2002 

(continued) 

Incontinence, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

1.453 (1.062, 

1.990) 

P = 0.0196 

Age, years: 0.978 

(0.968, 0.987) 

P < 0.001 

Frequency, BL 

episodes/day: 

1.034 

(0.993, 1.076) 

P = 0.1036 

Urgency, BL 

episodes/day: 

1.053 

(1.018, 1.088) 

P = 0.0027 

Incontinence, BL 

baseline 

episodes/day: 

0.744 

(0.716, 0.774) 

P < 0.001 

Tolterodine dose, 

mg/day: 0.866 

(0.784, 0.956) 

P = 0.0043 

Frequency, 

successful 

treatment, OR 

(95% CI): 

Gender, M/F: 

0.745 

(0.552, 1.004) 

P = 0.0532 

Age, years: 0.981 

(0.971, 0.991) 

P = 0.001 

Frequency, BL 

episodes/day: 

0.735 

(0.701, 0.771) 

P < 0.001 

Urgency, BL 

episodes/day: 

1.008 

(0.975, 1.041) 

P = 0.6526 

C-581 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 2002 

(continued) 

Incontinence, BL 

episodes/day: 

0.969 

(0.937, 1.002) 

P = 0.0644 

Tolterodine dose, 

mg/day: 1.070 

(0.957, 1.196) 

P = 0.2335 

Effect on Global 

efficacy, OR 

(95% CI): 

Gender, M/F: 

0.656 (0.526, 

0.818) 

P = 0.0002 

Age, years: 0.986 

(0.980, 0.993) 

P < 0.001 

Frequency, BL 

epsidoes/day: 

1.002 

(0.972, 1.033) 

P = 0.8896 

Urgency, BL 

episodes/day: 

1.009 

(0.984, 1.033) 

P = 0.4906 

Incontinence, BL 

episodes/day: 

0.963 

(0.939, 0.987) 

P < 0.0026 

Tolterodine dose, 

mg/day: 1.000 

(0.926, 1.080) 

P = 0.9971 

Effect on global 

tolerability of 

Tolterodine, OR 

(95% CI): 

Gender, M/F: 

0.993 (0.790, 

1.249) 

P = 0.9519 

Age, years: 0.995 

(0.988, 1.002) 

P = 0.1915 

Frequency, BL 

episodes/day: 

1.002 

(0.971, 1.034) 

P = 0.8995 

C-582 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 2002 

(continued) 

Urgency, BL 

episodes/day: 

1.022 

(0.997, 1.048) 

P = 0.0889 

Incontinence, BL 

episodes/day: 

0.990 

(0.965, 1.016) 

P < 0.459 

Tolterodine dose, 

mg/day: 1.114 

(1.028, 1.206) 

P = 0.0085 

C-583 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Michel et al., 

2007* 

Michel et al., 2005 

Country and 

setting: 

Germany, NR 

Enrollment 

period: 

November 2001 to 

June 2003 

Funding: 

Pharmacia 

(became Pfizer 

before publication) 

Author industry 

relationship 

disclosures: 

5/5* 

4SC (1) 

Astellas (1) 

Boehringer 

Ingelheim (2) 

Eli Lilly (2) 

Pfizer (4) 

Theravance (1) 

Anformed (1) 

Design: 

Retrospective 

cohort, open label 

Intervention: 

Tolterodine ER 

Groups: 

G1: Incontinent 

G2: Continent 

N at enrollment: 

Total: 3,824 

G1: 2,571 

G2: 1,253 

N at follow-up: 

Total: 3,416 

Women, %: 

Total: 75.8

G1: 81.7 

G2: 62.6 

P < 0.001 

Age, mean ± SD: 

Total: 64.8 ± 13.3 

G1: 66.3 ± 12.6 

G2: 61.4 ± 14.1 

P < 0.001 

Race/ethnicity: 

NR 

Follow-up: 

9 months 

Inclusion criteria:

NR 

Exclusion 

criteria: 

NR 

Urgency 

episodes/day, 

mean ± SD: 

Total: 7.9 ± 5.2 

G1: 8.0 ± 5.2 

G2: 7.7 ± 5.2 

P = 0.1937 

Incontinence 

episodes/day, 

mean ± SD: 

G1: 4.8 ± 3.7 

G2: NA 

Voids/day, mean 

± SD: 

Total: 14.0 ± 4.6 

G1: 14.1 ± 4.6 

G2: 13.5 ± 4.4 

P < 0.001 

Daytime voids/ 

day, mean ± SD: 

Total: 10.7 ± 3.7 

G1: 10.8 ± 3.7 

G2: 10.4 ± 3.4 

P = 0.0128 

Frequency ≥ 8 

voids/day, %: 

G1: 95.7 

G2: 95.2 

Nocturia 

episodes/day, 

mean ± SD: 

Total: 3.4 ± 1.7 

G1: 3.5 ± 1.8 

G2: 3.2 ± 1.6 

P < 0.001 

Pad use/day, 

mean ± SD: 

G1: 3.4 ± 2.8 

G2: 0.1 ± 0.6 

P < 0.001 

Duration of 

symptoms (mo), 

mean ± SD: 

G1: 50 ± 53 

G2: 40 ± 46 

P < 0.001 

Previous 

treatment, %: 

G1: 50.8 

G2: 44.8 

P = 0.0007 

Incontinence 

episodes/day, 

mean change ± 

SD: 

G1: -3.8 ± 3.5 

G2: NA 

Urgency 

episodes/day, 

mean ± SD: 

Total: 1.6 ± 2.8 

No urgency, %: 

G1: 53.4 

G2: 63.2 

Voids/day, mean 

± SD: 

Total: 7.5 ± 3.0 

Daytime voids/ 

day, mean ± SD: 

Total: 6.2 ± 2.3 

Frequency ≥ 8 

voids/day, %: 

G1: 43.7 

G2: 39.1 

Nocturia 

episodes/day, 

mean ± SD: 

Total: 1.4 ± 1.1 

Pad use/day, 

mean change ± 

SD: 

G1: -2.4 ± 2.5 

Limitation of 

daily activities, 

score change ± 

SD: 

G1: 4.49 ± 2.65 

G2: 4.10 ± 2.51 

Limitations in 

daily life caused 

by bladder problems, score ± SD: 

G1: 7.59 ± 1.65

G2: 6.66 ± 1.69

P < 0.001 

Total adverse 

events, n (%): 

Total: 496 (13.0) 

Dry mouth, n (%): 

299 (7.8) 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: NA

Masking: NA 

Pt selection 

criteria: - 

Loss to followup: 

NR 

Drop-out rates: NA

Power calculation: 

- 

Statistical issues: +

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of followup: 

++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-584 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Michel et al., 

2007* 

Michel et al., 2005 

(continued) 

Withdrew: 11% 

Unable to 

tolerate 

medication: 2.8% 

Administrative 

reasons: 2.6% 

Lack of efficacy :

2.4% 

Patient request:

1.2% 

C-585 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Moore et al., 1990 

Moore and 

Sutherst 1990 

Country and 

setting: UK, 

academic health 

center

Enrollment 

period: 

NR

Funding: 

Tillots 

Laboratories

Author industry 

relationship 

disclosures: 

NR 

Design: RCT with 

crossover

Intervention: 

oxybutynin 

hydrochloride vs 

placebo 

Groups: 

G1:oxybutynin 

hydrochloride 3 

mg tid 

G2:placebo 

N at enrollment: 

53

N at follow-up: 

G1: 27 

G2: 22 

Age, mean ± SD: 

G1: 46.0 ± 11.7 

G2: 46.4 ± 12.4 

Race/ethnicity: 

NR 

Parity, mean: 

G1: 2.3 

G2: 2.2 

Inclusion criteria: 

• UDS-defined 

idiopathic detrusor 

instability 

• Involuntary 

detrusor 

contractions > 30 

cm H2O during 

filling phase of 

cystometry 

Exclusion 

criteria: 

• Neurological 

disorder 

• Urologic 

disorder 

• Age > 75 years 

• Genuine SI 

• Low-compliance 

bladder 

• Bacterial or 

interstitial 

cystitis 

• Previous 

treatment with 

oxybutynin 

Voids/day, mean 

± SD: 

G1: 11.1 ± 7.9 

G2: 12.1 ± 5.7 

Volume at first 

desire to void 

mean mL ± SD: 

G1: 94.2 ± 66 

G2: 107.4 ± 101 

Max detrusor 

filling pressure 

mean cm H2O, 

±SD: 

G1: 55.3 ± 23 

G2: 59.2 ± 26 

Max cystometric 

capacity (mL) 

G1: 275 ± 164 

G2: 290 ± 168 

Residual urine 

volume mean mL 

± SD: 

G1: 23.1 ± 34.2 

G2: 22.7 ± 34.0 

Duration of OAB, 

mean yrs ± SD): 

G1: 7.5 ± 7.9 

G2: 8.9 ± 9.0 

Change in 

volume at first 

desire to void, 

period 1, mean 

mL ± SD (95% CI) 

G1: 70.0 ± 103 

G2: 7.7 ± 76 

G1/G2: P = 0.02 

95% CI: (10, 113) 

Change in 

maximum 

detrusor filling 

pressure, mean ± 

SD: 

G1:-16.9 ± 19.5 

G2:1.0 ± 28.7 

G1/G2: P = 0.02 

95% CI: (-32.5, -

3.2) 

Change in 

maximum 

cystometric 

capacity, mean ± 

SD: 

G1:104.0 ± 131 

G2:7.0 ± 103 

G1/G2:p=0.006 

95% CI: (29, 165) 

Change in 

residual urine 

Volume, period 

1: 

G1: 22.4 (79.3) 

G2: 7.7 (45.7) 

P=0.42 

Change in 

residual urine 

Volume, period 

2: 

G1: 10.0 ± 27.1 

G2: 25.7 ± 55.6 

P = 0.33 

Dry mouth on 

oxybutynin, %: 

88 

Dry mouth on 

placebo, %: 

33 

Mouth ulcers on 

oxybutynin, %: 

16 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: ++ 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-586 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Moore et al., 1990 

Moore and 

Sutherst 1990 

(continued)

Mouth ulcers on 

placebo, %: 

0 

Constipation on 

oxybutynin, % 

12.5 

Constipation on 

placebo, % 

0 

Drowsiness on 

oxybutynin, %: 

12.5 

Drowsiness on 

placebo, %: 

7 

Nausea on 

oxybutynin, %: 

8.3 

Nausea on 

placebo, %: 

2.3 

Initial hesitancy 

on oxybutynin, 

%: 

4.2 

Initial hesitancy 

on placebo, %: 

2.3 

Dizziness on 

oxybutynin, %: 

4.2 

Dizziness on 

placebo, %: 

7.0 

Metallic taste on 

oxybutynin, %: 

2.4 

Metallic taste on 

placebo, %: 

2.3 

Crown Crisp 

Experimental 

Index, >50% 

improvement:*

Free floating 

anxiety: 

6.4 

C-587 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Moore et al., 1990 

Moore and 

Sutherst 1990 

(continued)

Phobic anxiety: 

5.3 

Obsessionalism: 

6.2 

Somatic 

complaints: 

6.2 

Depression: 

4.0 

Hysteria: 

2.6 

Total: 

30.7 

Crown Crisp 

Experimental 

Index, <49% 

improvement:* 

Free floating 

anxiety: 

8.8 

Phobic anxiety: 

6.8 

Obsessionalism: 

8.1 

Somatic 

complaints: 

8.9 

C-588 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Rudy, et al. 2006 

Rudy, et al. 2006 

Staskin and 

Harnett, 2004 

Country and 

setting: 

US; 52 sites 

Enrollment 

period: 

NR 

Funding: 

Indevus 

Author industry 

relationship 

disclosures: 

5 of 5 

Indevus (5) 

Design: 

RCT 

Intervention: 

Trospium chloride 

vs placebo x 12 

wks

Groups: 

G1: trospium 

chloride 20 mg 

BID 

G2: matching 

placebo 

N at enrollment: 

G1: 329 

G2: 329 

N at follow-up: 

G1: 323 

G2: 325 

Age, mean yrs ± 

SE: 

G1: 61.1 ± 0.69 

G2: 61.0 ± 0.70 

Women, N (%): 

G1: 269 (81.8) 

G2: 267 (81.2) 

Race/ethnicity, n 

(%): 

Black: 

G1: 26 (7.9)

G2: 21 (6.4) 

White: 

G1: 284 (86.3) 

G2: 300 (91.2) 

Hispanic: 

G1: 13 (4.0) 

G2: 5 (1.5) 

Asian: 

G1: 5 (1.5) 

G2: 3 (0.9) 

Parity: 

NR 

Inclusion criteria: 

• 18+ years old 

• 6+ mos of OAB 

sx 

• 10+ voids/d 

• Sx of urgency 

• 7+ urge UIE/wk 

Exclusion 

criteria: 

• Predominantly 

SUI, insensate 

UI, or overflow 

UI 

• Neurogenic 

bladder d/o’s 

• Significant renal 

dz 

• Uninvestigated 

hematuria 

• UTI at washout 

or more than 2x 

during the prior 

12 mos 

• PVR>100mL 

• Use of any 

anticholinergic 

drug or other 

drug therapy for 

OAB w/in 21 

days before 

randomization 

• Bladder surgery 

w/in 6 mos 

before 

randomization 

• Cancer 

• Interstitial 

cystitis 

• PSA>10ng/mL 

• Diuretic use 

• Estrogen 

therapy 

• Nonmedical 

bladder therapy 

not part of a 

stable, longterm program 

• Pregnancy 

• Contraindication 

to 

antimuscarinic 

therapy 

Daily voids, 

mean n: 

G1: 12.94 

G2: 13.17 

P=0.3169 

Urgency severity 

score associated 

with toilet voids, 

median: 

G1: 1.79 

G2: 1.75 

P=0.4100 

Volume voided in 

mL per void/24h, 

mean: 

G1: 154.80 ± NR 

G2: 154.64 ± NR 

P=0.9667 

Median daily 

urge 

incontinence 

episodes: 

G1: 2.86 

G2: 2.86 

P=0.9849 

Nocturnal 

voids/24 hr, 

median: 

G1: 2.00 

G2: 2.00 

P=0.9048 

Nocturnal 

urgency severity 

score associated 

with toilet voids, 

mean: 

G1: 2.03 

G2: 2.01 

P=0.6863 

OAB-SCS, 

median: 

G1: 36.56 

G2: 36.88 

P=0.7176 

Stanford 

Sleepiness 

Scale, mean 

G1: 1.98 

G2: 1.94 

Change from 

baseline to day 

1: 

Daily voids, 

mean: 

G1: -0.66 

G2: -0.35 

P=0.14 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: 0.00 

G2: 0.02 

P=0.47 

Median daily 

urge 

incontinence 

episodes: 

G1: -1.00 

G2: -0.57 

P=0.042 

OAB-SCS, 

median: 

G1: -2.50 

G2: -0.14 

P=0.014 

Change from 

baseline to day 

2: 

Daily voids, 

mean: 

G1: -1.11 

G2: -0.75 

P=0.09 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.08 

G2: -0.03 

P=0.13 

Median daily UI 

episodes: 

G1: -1.29 

G2: -0.86 

P=0.0022 

OAB-SCS, 

median: 

G1: -3.86 

G2: -2.14 

P=0.015 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: + 

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-589 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Stanford 

Sleepiness 

Scale, age group 

<65 years: 

G1: 1.99 

G2: 2.09 

Stanford 

Sleepiness 

Scale, age group 

>65 years: 

G1: 1.96 

G2: 1.71 

Stanford 

Sleepiness 

Scale, age group 

<75 years: 

G1: 2 

G2: 1.97 

Stanford 

Sleepiness 

Scale, age group 

>75 years: 

G1: 1.86 

G2: 1.79 

Prior OAB 

medications, n 

(%): 

G1: 162 (49.2) 

G2: 169 (51.4) 

Prior hx of 

pelvic-floor 

training, n (%): 

G1: 62 (18.8) 

G2: 76 (23.1) 

Currently 

practice 

undergarment 

change d/t 

incontinence, n 

(%): 

G1: 227 (69.0) 

G2: 239 (72.6)

Change from 

baseline to day 

3: 

Daily voids, 

mean: 

G1: -1.30 

G2: -0.77 

P=0.012 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.11 

G2: -0.04 

P=0.015 

Median daily UI 

episodes: 

G1: -1.57 

G2: -0.86 

P<0.0001 

OAB-SCS, 

median: 

G1: -4.71 

G2: -2.71 

P=0.0019 

Change from 

baseline to day 

4: 

Daily voids, 

mean: 

G1: -1.33 

G2: -0.95 

P=0.086 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.12 

G2: -0.05 

P=0.031 

Median daily UI 

episodes: 

G1: -1.57 

G2: -1.00 

P<0.0001 

OAB-SCS, 

median: 

G1: -4.86 

G2: -3.36 

P=0.011 

C-590 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Change from 

baseline to day 

5: 

Daily voids, 

mean: 

G1: -1.73 

G2: -1.12 

P=0.0037 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.13 

G2: -0.05 

P=0.021 

Median daily UI 

episodes: 

G1: -1.57 

G2: -1.00 

P<0.0001 

OAB-SCS, 

median: 

G1: -6.43 

G2: -3.36 

P<0.0001 

Change from 

baseline to day 

6: 

Daily voids, 

mean: 

G1: -1.80 

G2: -1.28 

P=0.017 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.08 

G2: 0.04 

P<0.0001 

Median daily UI 

episodes: 

G1: -1.71 

G2: -1.00 

P<0.0001 

OAB-SCS, 

median: 

G1: -5.43 

G2: -2.93 

P<0.0001 

C-591 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Change from 

baseline to week 

1: 

Daily voids, 

mean: 

G1: -1.42 

G2: -0.96 

P=0.0039 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.09 

G2: -0.01 

P=0.0023 

Volume voided in 

mL per void/24h: 

G1: 29.23 

G2: 6.05 

P<0.0001 

Median daily 

urge 

incontinence 

episodes: 

G1: -1.43 

G2: -0.86 

P<0.0001 

Nocturnal 

voids/24 hr, 

median: 

G1: -0.29 

G2: -0.29 

P=0.8454 

Nocturnal 

urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.05 

G2: 0.03 

P=0.0442 

OAB-SCS, 

median: 

G1: -4.71 

G2: -2.29 

P<0.0001 

C-592 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Change from 

baseline to 4 

weeks:

Daily voids, 

mean: 

G1: -2.34 

G2: -1.55 

P<0.0001 

Urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.19 

G2: -0.04 

P<0.0001 

Volume voided in 

mL per void/24h: 

G1: 39.50 

G2: 9.45 

P<0.0001 

Median daily 

urge 

incontinence 

episodes: 

G1: -1.71 

G2: -1.14 

P<0.0001 

Nocturnal 

voids/24 hr, 

median: 

G1: -0.43 

G2: -0.29 

P=0.0299 

Nocturnal 

urgency severity 

score associated 

with toilet voids, 

mean: 

G1: -0.13 

G2: =0.01 

P=0.0062 

OAB-SCS, 

median: 

G1: -8.14 

G2: -3.86 

P<0.0001 

C-593 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Change from 

baseline to 12 

weeks:

Daily voids. 

mean: 

G1: -2.67 

G2: -1.76 

P<0.0001 

Urgency severity 

score associated 

with toilet voids: 

G1: -0.21 

G2: -0.02 

P<0.0001 

Volume voided in 

mL per void/24h: 

G1: 35.59 

G2: 9.44 

P<0.0001 

Daily UI 

episodes, 

median: 

G1: -1.86 

G2: -1.29 

P<0.0001 

Nocturnal 

voids/d, median: 

G1: -0.57 

G2: -0.29 

P=0.0026 

Nocturnal 

urgency severity 

score, mean: 

G1: -0.17 

G2: 0.01 

P=0.0005 

OAB-SCS, 

median: 

G1: -8.43 

G2: -4.62 

P<0.0001 

Adverse events 

Any, n (%) 

G1: 196 (59.6) 

G2:153 (46.5) 

Dry mouth: 

G1: 65 (19.8) 

G2: 17 (5.2) 

Constipation: 

G1: 36 (10.9) 

G2: 19 (5.8) 

C-594 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Headache:

G1: 18 (5.5) 

G2: 15 (4.6) 

UTI not 

otherwise 

specified: 

G1: 16 (4.9) 

G2: 8 (2.4) 

Nasopharyngitis: 

G1: 13 (4.0) 

G2: 12 (3.6) 

Cough: 

G1: 8 (2.4) 

G2: 1 (0.3) 

Diarrhea: 

G1: 7 (2.1) 

G2: 13 (4.0) 

AEs leading to 

treatment 

discontinuation, 

%: 

G1: 7.3 

G2: 4.6 

Most common 

AEs leading to 

discontinuation: 

Constipation: 

G1: 1.8% 

G2: 0.6% 

Dry mouth: 

G1: 1.5% 

G2: 0.0% 

Stanford 

Sleepiness 

Scale, change, 

wk 1: 

G1: -0.2 

G2: -0.12 

Stanford 

Sleepiness 

Scale, change wk 

4: 

G1: -0.17 

G2: -0.14 

Stanford 

Sleepiness 

Scale, change, 

wk 12: 

G1: -0.16 

G2: -0.11

C-595 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Stanford 

Sleepiness Scale 

including T-max 

time point values 

only (G1=93, 

G2=97), change 

BL to week 1: 

G1: -0.42 

G2: -0.2 

Stanford 

Sleepiness Scale 

including T-max 

time point values 

only (G1=144, 

G2=148), change 

BL to week 4: 

G1: -0.2 

G2: -0.19 

Stanford 

Sleepiness Scale 

including T-max 

time point values 

only (G1=182, 

G2=179), change 

BL to week 12: 

G1: -0.17 

G2: -0.18 

Mean Stanford 

Sleepiness 

Scale, age group 

<65 years, 

change BL to 

week 1: 

G1: -0.27 

G2: -0.19 

Mean Stanford 

Sleepiness 

Scale, age group 

>65 years, 

change BL to 

week 1: 

G1: -0.04 

G2: -0.03 

Mean Stanford 

Sleepiness 

Scale, age group 

<65 years, 

change BL to 

week 4: 

G1: -0.14 

G2: -0.27 

C-596 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Mean Stanford 

Sleepiness 

Scale, age group 

>65 years, 

change from 

baseline to week 

4: 

G1: -0.23 

G2: 0.03 

Mean Stanford 

Sleepiness 

Scale, age group 

<65 years, 

change from 

baseline to week 

12: 

G1: -0.14 

G2: -0.22 

Mean Stanford 

Sleepiness 

Scale, age group 

>65 years, 

change from 

baseline to week 

12: 

G1: -0.22 

G2: 0.03 

Mean Stanford 

Sleepiness 

Scale, age group 

< 75 years, 

change from 

baseline to week 

1: 

G1: -0.21 

G2: -0.14 

Mean Stanford 

Sleepiness 

Scale, age group 

> 75 years, 

change from 

baseline to week 

1:

G1: -0.02 

G2: 0 

Mean Stanford 

Sleepiness 

Scale, age group 

< 75 years, 

change from 

baseline to week 

4: 

G1: 0.14 

G2: -0.16

C-597 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Rudy et al., 2006 

Rudy et al., 2006 

Staskin and 

Harnett, 2004 

(continued) 

Mean Stanford 

Sleepiness 

Scale, age group 

> 75 years, 

change from 

baseline to week 

4:

G1: -0.49 

G2: -0.09 

Mean Stanford 

Sleepiness 

Scale, age group 

< 75 years, 

change from 

baseline to week 

12: 

G1: 0.15 

G2: -0.14 

Mean Stanford 

Sleepiness 

Scale, age group 

> 75 years, 

change from 

baseline to week 

12:

G1: -0.33 

G2: 0.02 

At least one CNS 

event: 

G1: 5.8% 

G2: 5.2% 

Somnolence 

G1: 0.3% 

G2: 0.6% 

Sedation: 

G1: 0 

G2: 0.3% 

Clinically 

significant 

increase (> 3 

points) from 

baseline to week 

12 in SSS score, 

n (%): 

G1: 5 (1.5) 

G2: 8 (2.5) 

C-598 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Salvatore et al., 

2007

Country and 

setting: 

Italy, 

Urogynecology 

outpatient clinic

Enrollment 

period: 

January 2004 to 

October 2005

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Cohort

Intervention: 

Tolterodine SR 4 

mg qd 

Groups: 

G1: vaginal 

profile stage 0a or 

Ia 

G2: anterior 

prolapse ≥ stage 

IIa 

N at enrollment: 

G1: 184 

G2: 51 

N at follow-up: 

NR 

Women, %: 

100 

Age, median 

(range): 

G1: 59 (20, 85) 

G2: 59 (35, 82) 

Race/ethnicity: 

NR 

Parity, mean 

(range): 

G1: 2 (0-6) 

G2: 2 (0-6) 

Menopausal, n 

(%): 

G1: 132 (72) 

G2: 7 (18) 

Inclusion 

criteria: 

Women 

Urodynamically 

proven OAB who 

had no prolapse 

or pure anterior 

vaginal prolapse 

Proven detrusor 

overactivity 

Exclusion 

criteria: 

 All symptoms or 

signs related to 

voiding 

difficulties 

Prolapse 

Previous 

surgery, n (%): 

G1: 52 (28) 

G2: 11 (22) 

HRT, n (%) 

G1: 35 (26) 

G2: 7 (18) 

Improvement in 

condition or 

cured, n (%): 

G1: 158 (85.9) 

G2: 31 (60.8)* 

P = 0.0002 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Masking: NA 

Pt selection 

criteria: + 

Loss to followup: 

NR 

Drop-out rates: 

NR 

Power 

calculation: - 

Statistical issues: 

- 

EXTERNAL 

VALIDITY: poor 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: - 

Length of 

followup: + 

Measurement 

methods: - 

Measurement 

reliability: - 

Intervention 

description: + 

C-599 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sand et al., 2004 

Country and 

setting: 

US, Specialty 

clinic 

Enrollment 

period: 

Subanalysis of 

OBJECT trial, 

women only 

Funding: 

ALZA Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

10mg ER 

Oxybutynin daily 

vs 4mg 

Tolterodine (2mg 

bid)

Groups: 

G1: 10mg ER 

Oxybutynin daily x 

12 wks 

G2: 4mg 

Tolterodine (2mg 

bid) x 12 wks 

Stratified by age: 

a: Age ≤ 64 

b: Age 65-74 

c: Age ≥ 75 

N at enrollment: 

G1: 152 

G2: 163 

N at follow-up: 

G1: 132 

G2: 146 

Women, %: 

100 

Age, yrs ± SD: 

G1: 58.4 

G2: 58.8 

Race/ethnicity: 

NR

Inclusion criteria: 

• ≥ 7 and ≤ 50 

UUI 

episodes/week 

• ≥ 10 voids/day 

• MUI included if 

predominant 

UUI 

Exclusion 

criteria: 

• UTI 

• IC 

• Urethral 

diverticulum 

• Bladder tumor 

• Bladder stone 

• Delivery within 6 

mos 

• Pelvic, bladder, 

vaginal surgery 

in ≤ 6 mos 

• PVR ≥ 150 mL 

• CV, renal, 

pulmonary, GI, 

endocrine, 

neurologic, 

autoimmune, 

hematological, 

urological, 

psychiatric, or 

hepatic disease 

• Hematuria 

• Positive urine 

culture 

• Narrow angle 

glaucoma 

• Obstructive 

uropathy 

• Myasthenia 

gravis 

• POP to hymenal 

ring 

• Gastrointestinal 

obstruction 

• Decreased GI 

motility 

• GI narrowing 

• GI retention 

• Investigational 

drugs within 1 

month of 

screening 

• Hypersensitivity 

to drugs 

UUI episodes/ 

week, mean: 

G1: 25.2 

G2: 25.1 

Incontinence 

episodes/week, 

mean: 

G1: 28.1 

G2: 28.9 

Voids/week, 

mean: 

G1: 91.7 

G2: 91.6 

Naïve to anticholinergics, %: 

G1: 60.5 

G2: 60.7 

UUI episodes/ 

week, %: 

G1: 6.2 

G2: 8.5 

G1a: 5.0 

G2a: 8.4 

G1b: 5.5 

G2b: 7.5 

G1c: 8.5

G2c: 11.1 

G1/G2: P = 0.038 

G1a/G2a: P = 

0.005 

G1b/G2b: P = 

0.337 

G1c/G2c: P = 

0.568 

Incontinence 

episodes/week, 

mean: 

G1: 7.3

G2: 10.1 

G1a: 5.8 

G2a: 10.0 

G1b: 6.1 

G2b: 9.2 

G1c: 10.5

G2c: 12.5 

G1/G2: P = 0.030 

G1a/G2a: P = 

0.005 

G1b/G2b: P = 

0.164 

G1c/G2c: P = 

0.714 

Voids/week, 

mean: 

G1: 68.0 

G2: 71.2 

G1a: 63.7 

G2a: 71.2 

G1b: 73.8 

G2b: 71.9 

G1c: 66.8

G2c: 65.5 

G1/G2: P = 0.272 

G1a/G2a: P = 

0.024 

G1b/G2b: P = 

0.706 

G1c/G2c: P = 

0.838 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-600 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sand et al., 2004 

(continued) 

• Current drug/ 

EtOH abuse 

• Pregnant 

• Breastfeeding 

• Inability to follow 

protocol 

Dry mouth, %: 

G1: 28.3 

G2: 33.7 

Constipation, %: 

G1: 8.6 

G2: 6.7 

Retention, %: 

G1: 4.0 

G2: 1.2 

Blurred vision, 

%: 

G1: 2.6 

G2: 0.6 

Dizziness, %: 

G1: 3.9 

G2: 4.3 

Insomnia, %: 

G1: 0.7 

G2: 1.8 

Somnolence, %: 

G1: 3.3 

G2: 1.8 

Nervousness, %: 

G1: 0 

G2: 1.2 

Headache, %: 

G1: 9.2 

G2: 10.4 

Dyspepsia, %: 

G1: 5.3 

G2: 6.1 

Nausea, %: 

G1: 3.3 

G2: 1.8 

Vomiting, %: 

G1: 2.0 

G2: 1.8 

C-601 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Serati et al, 2008 

Country and 

setting: 

NR; 

Urogynecology 

unit 

Enrollment 

period: 

January 2005 to 

December 2006 

Funding: 

NR

Author industry 

relationship 

disclosures:

None 

Design: 

Prospective case 

series 

Intervention: 

Tolterodine ER 5 

mg qd (prescribed 

to women with 

proven pure DO 

w/o SUI) 

Groups: 

G1: Coital 

incontinence at 

orgasm 

G2: Coital 

incontinence 

during penetration 

G3: DO + coital 

incontinence at 

orgasm (subgroup of G1) 

G4: DO w/o coital 

incontinence 

(controls) 

N at enrollment: 

G1: 49 

G2: 83 

G3: 34 

G4: 53 

N at follow-up: 

NR 

Age, median 

(range): 

G1-G2: 51 (22-70) 

G3: 50 (22-66) 

G4: 51 (19-68) 

BMI (kg/m2

), 

median (range): 

G1-G2: 24.1 (17-

43) 

G3: 25.3 (17-43) 

G4: 26 (19-35) 

Race/ethnicity: 

NR 

Postmenopausal, 

n (%): 

G1-G2: 59 (44.7) 

G3: 14 (41.2) 

G4: 19 (35.8) 

Inclusion criteria:

• Sexually active 

women with UI 

Exclusion 

criteria: 

• Documented UTI

• Previous antimuscarinic trt 

• POP-Q ≥ Stage 

2 

• Refusal to 

answer 

questions about 

sex life 

Type of UI, n (%):

DO: 

G1: 34 (69.4) 

G2: 13 (15.7) 

P < 0.0001 

SUI: 

G1: 5 (10.2) 

G2: 40 (48.2) 

MUI: 

G1: 0 

G2: 11 (13.2) 

Inconclusive: 

G1: 10 (20.4) 

G2: 19 (22.9) 

Non-responders 

to trt, n (%): 

G3: 14 (41.2) 

G4: 9 (17) 

P = 0.023 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: 

NA 

Method and 

blinding: NA 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: -

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: NR 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: - 

Intervention 

description: + 

C-602 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Serati et al, 2008 

(continued) 

Parity, median 

(range): 

G1-G2: 2 (0-5) 

G3: 2 (0-5) 

G4: 2 (0-4) 

Nulliparous, n 

(%): 

G1-G2: 7 (5.3) 

G3: NR 

G4: NR 

Follow-up: 

12 weeks 

C-603 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Steers et al., 2007 

Country and 

setting: Australia, 

Canada, US; 

multicenter, 30 

centers 

Enrollment 

period: July 2001 

to September 

2003 

Funding: 

Eli Lilly 

FVC - frequency 

volume chart 

DOA - detrusor 

overactivity 

SU - sensory urge 

PVR - postvoid 

residual urine 

BL - baseline 

PGI-I- Patient 

Global Impression 

of Improvement 

TEAEs= 

Treatment 

emergent adverse 

events 

Design: RCT, 

placebocontrolled, doubleblind, stratified by 

urodynamic 

observation (DOA 

Intervention: 

duloxetine vs 

placebo

Groups: 

G1: placebo x 2 

wks, duloxetine 

40 mg bid x 4 wks, 

duloxetine 60 mg 

bid x bid 8 wks 

G2: placebo bid x 

14 wks 

N at enrollment: 

G1: 153 

G2: 153 

N at follow-up, N 

(%): 

G1: 90 (59) 

G2: 120 (78) 

Age, mean ± SD: 

G1: 56.0 ± 14.8 

G2: 53.3 ± 14.1 

Women, N (%): 

306 (100) 

BMI, mean kg/m2 

± SD: 

G1: 29.2 (7.4) 

G2: 30.2 (7.8) 

Inclusion criteria:

• women 

• >18 yoa 

• predominant 

symptoms of 

OAB ≥ 3 months 

defined as 

bothersome 

urinary urgency 

and/or urge, 

abnormal 

voiding 

frequency (≤2 h 

mean daytime 

voiding interval)

• UDS 

observation of 

either detrusor 

OA or urgency 

that limited 

bladder capacity 

to <400mL 

Exclusion 

criteria: 

• -SUI 

• PVR >100 mL 

• Mean 24 h total 

volume voided 

of ≥ 3L 

• Urine culture 

• ≥4 UTIs in past 

yr 

• Regular use of 

meds for OAB 

w/in 4wks of 

enrollment 

• Previous use of 

duloxetine 

• Continence 

surgery ≤ 6 mos

• Any major 

surgery ≤ 3 mos

• Pelvic organ 

prolapse > ICS 

Stage II 

• Non-pharm 

intervention ≤ 3 

mos 

• PFM training 

that had not 

been stable for 

3 mos or would 

not remain 

stable during 

the trial 

Void per 24 hrs: 

G1: 10.76 

G2:: 10.49 

Daytime VI 

G1: 113.58 

G2: 119.63 

Urinary 

incontinence 

episodes(all 

assessable pts): 

G1: 1.70 

G2: 1.44 

Urinary 

incontinence 

episode (wet 

OAB): 

G1: 2.34 

G2: 2.07 

Continence 

pads/wk: 

G1: 7.81 

G2: 7.05 

Volume voided, 

mL: 

G1: 175.41 

G2: 183.40 

Nocturia 

episodes/d: 

G1: 1.47 

G2: 1.63 

Quality of Life 

Instrument 

score, mean ± 

SD: 

I-QOL 

G1: 56.65 ± 24.80

G2: 57.11 ± 23.3 

U-IIQ:

G1: 2.44 ± 1.18 

G2: 2.39 ± 1.15 

U-UDI: 

G1: 3.18 ± 0.58 

G2: 3.15 ± 0.71 

Bladder 

compliance 

(mL/cmH20) 

G1: 71.8 ± 85.7 

G2: 79.3 ± 91.0 

VE24 

G1: -1.81 

G2:: -0.62 

G1vG2, P<0.001 

Daytime VI 

G1: 29.46 

G2: 6.51 

G1vG2, P<0.001 

UIE (all 

assessable pts) 

G1: -0.74 

G2: -0.14 

p=0.006 

UIE (wet OAB) 

G1: -1.03 

G2: -0.24 

p=0.032 

Continence 

pads/wk: 

G1: -1.41 

G2: -0.53 

P=0.143 

Volume voided, 

mL: 

G1: 8.85 

G2: 5.07 

P=0.171 

Nocturia 

episodes/d: 

G1: 0.05 

G2: -0.18 

p=0.004 

8/12 wks (120 

mg/day) 

G1: 61.6 

G2: 42.1 

p=0.008 

Overall: 

G1: 53.4 

G2: 41.9 

G=0.052 

Headache: 

G1: 13 (8.5) 

G2: 8 (5.2) 

p=0.336 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: ++

Power calculation: 

+ 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-604 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 2007 

(continued) 

SUI: 

G1: 0 

G2: 0 

Maximum 

cystometric 

capacity mL 

G1: 318.3 ± 152.4

G2: 330.4 ± 135.4

Volume 

threshold for first 

detrusor 

contraction mL 

G1: 226.4 ± 141.8

G2: 250.6 ± 146.0

Moderate or 

severe bladder 

condition from 

PGI-I Scale (%): 

G1: 84.9 

G2: 88.8 

I-QOL total 

score, mean ± 

SD: 

G1: 56.6 (24.9) 

G2: 57.0 (23.2) 

UIE , mean ± SD: 

G1: 1.55 (2.08) 

G2: 1.41 (2.00) 

VE24 , mean ± 

SD: 

G1: 10.8 (3.3) 

G2: 10.6 (3.6) 

Symptom of 

bothersome 

urgency, %: 

G1: 99.3 

G2: 99.3 

Symptoms of 

urge UI, %: 

G1: 88.2 

G2: 88.9 

Symptoms of 

SUI: 

G1: 42.5 

G2: 50.3 

Urodynamic 

DOA 

G1: 42.5 

G2: 41.8 

Diarrhea: 

G1: 10 (6.5) 

G2: 5 (3.3) 

p=0.289 

Cough: 

G1: 7 (4.6) 

G2: 6 (3.9) 

p>0.999 

Change in QoL 

Instrument 

score, mean ± 

SD: 

I-QOL 

G1: 8.37 ± 15.89 

G2: 4.87 ± 15.27 

G1>G2 (P=.035) 

U-IIQ 

G1: -0.44 ± 0.76 

G2: -0.22 ± 0.87 

P=0.018 

U-UDI 

G1: -0.26± 0.67 

G2: -0.19 ± 0.59 

P=0.440 

Bladder 

compliance 

(mL/cmH20) 

G1: 16.5 ±131.3 

G2: 1.0 ± 120.8 

P=0.655 

Maximum 

cystometric 

capacity mL 

G1: 22.1 ± 116.4 

G2: 23.8 ± 108.5 

P=0.619 

Volume 

threshold for first 

detrusor 

contraction mL 

G1: 90.0 ± 200.6 

G2 : 13.9 ± 112.8 

P=0.254 

PGI-I score 

Better 

4 wks (80 mg/day) 

G1: 59.9 

G2: 42.9 

p=0.005 

C-605 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 2007 

(continued) 

Sensory 

urgency: 

G1: 57.5 

G2: 58.2 

Previous 

continence 

surgery, %: 

G1: 13.1 

G2: 11.8 

Current pelvicfloor muscle 

training, %: 

G1: 9.2 

G2: 11.8 

Previous 

behavioral 

therapy, %: 

G1: 3.3 

G2: 2.6 

Previous 

tolterodine 

therapy, %: 

G1: 10.5 

G2: 7.2 

Previous 

oxybutynin 

therapy, %: 

G1: 13.0 

G2: 9.2 

TEAEs reported, 

% 

G1: 79.1 

G2: 55.6 

P<0.001 

Appetite 

decreased 

G1: 6 (3.9) 

G2: 0 

G1>G2, p=0.030 

Arthralgia 

G1: 6 (3.9) 

G2: 3 (2.0) 

p=0.501 

Somnolence: 

G1: 6 (3.9) 

G2: 0 

p=0.30 

Sweating 

increased: 

G1: 6 (3.9) 

G2: 2 (1.3) 

p=0.283 

UTI: 

G1: 6 (3.9) 

G2: 6 (3.9) 

p>0.999 

Anorgasmia 

G1: 5 (3.3) 

G2: 0 

G1>G2, p=0.060 

Anxiety: 

G1: 5 (3.3) 

G2: 0 

G1>G2, p=0.060 

Tremor: 

G1: 5 (3.3) 

G2: 0 

G1>G2, p=0.060 

Upper 

respiratory 

infection: 

G1: 5 (3.3) 

G2: 4 (2.6) 

p>0.999 

Vomiting: 

G1: 5 (3.3) 

G2: 3 (2.0) 

p=0.723 

C-606 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Steers et al., 2007 

(continued) 

Abdominal pain: 

G1: 4 (2.6) 

G2: 1 (0.7) 

p=0.371 

Back pain: 

G1: 4 (2.6) 

G2: 1 (0.7) 

p=0.371 

Note: mean 

change consistent 

at 4 wks 

(duloxetine 80 

mg/d) and 8 wks 

(duloxetine 120 

mg/d) 

Change in I-QOL 

total score, mean 

± SD: 

Discontinuation 

due to TEAEs, % 

G1: 28.1 

G2: 5.2 

p<0.001 

Treatment 

emergent 

adverse events, 

n (%): 

Nausea: 

G1: 47 (30.7) 

G2: 7 (4.6) 

G1>G2, p<0.001 

Dry mouth: 

G1: 25 (16.3) 

G2: 2 (1.3) 

G1>G2, p<0.001 

Dizziness: 

G1: 22 (14.4) 

G2: 1 (0.07) 

G1>G2, p<0.001 

Constipation: 

G1: 21 (13.7) 

G2: 5 (3.3) 

G1>G2, p=0.002 

Insomnia: 

G1: 20 (13.1) 

G2: 5 (3.3) 

G1>G2, p=0.003 

Fatigue: 

G1: 16 (10.5) 

G2: 3 (2.0) 

G1>G2, p=0.003 

C-607 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Sussman and 

Garely, 2002 

Country and 

setting: 

US; 2 sites 

Enrollment 

period: 

NR 

Funding: 

NR 

Author industry 

relationship 

disclosures: 

NR 

Design: 

Multicenter RCT 

Intervention: 

Tolterodine ER vs. 

Oxybutynin ER

Groups: 

G1: Tolterodine 

ER 2 mg qd x 8 

wks 

G2: Tolterodine 

ER 4 mg qd x 8 

wks 

G3: Oxybutynin 

ER 5 mg qd x 8 

wks 

G4: Oxybutynin 

ER 10 mg qd x 8 

wks 

N at enrollment: 

G1: 333 

G2: 336 

G3: 313 

G4: 307 

N at follow-up: 

G1: 313 (86) 

G2: 316 (88) 

G3: 286 (81) 

G4: 285 (79) 

Age, yrs ± SD: 

G1: 63.8 ± 15.7 

G2: 63.4 ± 16.6 

G3: 59.8 ± 16.5 

G4: 63.2 ± 15.9 

Women, N (%): 

G1: 243 (73) 

G2: 254 (76) 

G3: 245 (78) 

G4: 222 (72) 

Race/ethnicity, n 

(%): 

White: 

G1: 278 (84) 

G2: 296 (88) 

G3: 256 (82) 

G4: 247 (81) 

Black: 

G1: 28 (8) 

G2: 23 (7) 

G3: 41 (13) 

G4: 42 (14) 

Inclusion criteria: 

• 18+ years old 

• OAB (urinary 

frequency + 

urgency) w/ or 

w/o UI 

Exclusion 

criteria: 

• Pure SUI 

• Urinary 

retention 

• Gastric retention

• Uncontrolled 

narrow-angle 

glaucoma 

• Hepatic or renal 

dysfunction 

• Symptomatic or 

recurrent UTI 

• ES 

• BT 

• Pelvic floor 

exercise w/in 1 

wk of first study 

visit or expected 

to start during 

study 

• Indwelling 

catheter 

• Intermittent selfcatherization 

• Contraindication 

to 

antimuscarinic 

trt 

• Estrogen 

therapy started 

less than 2 mos 

prior to first visit

• Any treatment 

for UI w/in 1 wk 

of first visit 

• Use of 

anticholinergic 

drug or potent 

inhibitors of 

cytochrome 

P450 3A4 

• Pregnant 

• Lactating 

• Childbearing 

potential w/o 

adequate 

contraception 

Presence of UI, n 

(%): 

G1: 195 (59) 

G2: 214 (64) 

G3: 199 (64) 

G4: 195 (64) 

Duration of sx, n 

(%):

<6 mos 

G1: 38 (11) 

G2: 48 (14) 

G3: 62 (20) 

G4: 43 (14) 

6mos-5yrs: 

G1: 226 (68) 

G2: 224 (67) 

G3: 183 (59) 

G4: 205 (67) 

>5yrs: 

G1: 68 (20) 

G2: 64 (19) 

G3: 67 (21) 

G4: 59 (19) 

Severity of 

bladder 

condition, % 

No problems: 

G1: 1.3 

G2: 0.3 

G3: 1.0 

G4: 0.7 

Some very minor 

problems: 

G1: 6 

G2: 5 

G3: 5 

G4: 5 

Some minor 

problems: 

G1: 18 

G2: 16 

G3: 21 

G4: 15 

Moderate 

problems

G1: 45 

G2: 50 

G3: 41 

G4: 47 

Bladder 

Condition 

Questionnaire 

Improvement in 

bladder 

condition at 8 

wks, %: 

Overall 

G1: 60 

G2: 70 

G3: 59 

G4: 60 

G2 vs G3 p<0.01 

G2 vs G4 p<0.01 

Pts with 

moderate or 

severe bladder 

condition: 

G2: 77 

G4: 65 

G2 vs G4 p<0.01 

Treatment naive 

G1: 60 

G2: 69 

G3: 60 

G4: 61 

p=0.11 for 

improvement rates 

p>0.05 for overall 

difference btw trt 

arms 

Treatment 

experienced 

G1: 57 

G2: 75 

G3: 59 

G4: 54 

p=0.11 for 

improvement rates 

p>0.05 for overall 

difference btw trt 

arms 

Adverse Events 

Withdrawal d/t 

AE, (%): 

G2: 6 

G4: 13 

P=0.001 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: -

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-608 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Sussman and 

Garely, 2002 

(continued) 

Hispanic: 

G1: 19 (6) 

G2: 15 (5) 

G3: 15 (5) 

G4: 16 (5) 

Other, n (%): 

G1: 8 (2) 

G2: 2 (<1) 

G3: 1 (<1) 

G4: 2 (<1) 

Parity: 

NR 

Severe 

problems: 

G1: 26 

G2: 21 

G3: 23 

G4: 25 

Many severe 

problems: 

G1: 4 

G2: 7 

G3: 8 

G4: 8 

Mean change in 

severity of dry 

mouth (visual 

analogue scale): 

G1: 2.3 

G2: 6.0 

G3: 6.3 

G4: 11.3 

G1 vs G2: p=NS 

G3 vs G4: p=0.05 

G2 vs G4: p=0.03

C-609 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Swift et al., 2003 

Country and 

setting: 

Europe (167 

centers), North 

America (74 

centers), Australia 

and New Zealand 

(4 centers), 

University 

Enrollment 

period: 

February 1999 to 

October 1999 

Funding: 

Pharmacia Corp 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

double blind 

placebo-controlled 

double dummy, 

random permuted 

blocks of 6 

Intervention: 

Tolterodine ER vs. 

Tolterodine IR 

Groups: 

G1: Tolterodine 

ER 4mg daily 

G2: Tolterodine IR 

2 mg BID 

G3: placebo 

N at enrollment: 

G1: 417 

G2: 408 

G3: 410 

N at follow-up: 

Total: 1092 

Women, %: 

100 

Age, yrs ± SD: 

G1: 59 ± 14 

G2: 59 ± 14 

G3: 60 ± 14 

Race/ethnicity, n 

(%): 

White: 

G1: 396 (95) 

G2: 389 (95) 

G3: 383 (93) 

Black: 

G1: 15 (4) 

G2: 12 (3) 

G3: 20 (5) 

Asian/Pacific: 

G1: 5 (1) 

G2: 4 (1) 

G3: 2 (1) 

Mixed: 

G1: 0 

G2: 3 (1) 

G3: 5 (1) 

Unknown: 

G1: 1 (<1) 

G2: 0 

G3: 0 

Inclusion criteria: 

• Women 

• Age ≥ 18 

• ≥ 8 voids/day 

• > 5 UUI/ week 

• Symptoms x ≥ 6 

months (per 

voiding diary) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 liters

• Hepatic/ renal 

disease 

• UTI 

• IC 

• Hematuria 

• BOO 

• Current e-stim 

• Current bladder 

training 

• Indwelling 

catheter 

• CIC 

• Pregnant/ 

nursing 

• Childbearing 

age without BC 

• Anticholinergic 

meds 

• Meds inhibit 

cytochromep45

0 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 22.1 ± 22.5 

G2: 22.9 ± 21.9 

G3: 23.9 ± 21.2 

Pads/day, mean 

± SD: 

G1: 1.6 ± 2.1 

G2: 1.5 ± 2.0 

G3: 1.7 ± 2.4 

Voids/day, mean 

± SD: 

G1: 10.8 ± 4.2 

G2: 11.1 ± 3.7 

G3: 11.2 ± 3.9 

Voided volume 

(mL), mean ± SD:

G1: 141.2 ± 43.1

G2: 137.2 ± 41.2

G3: 135.7 ± 43.2 

Previous drug 

therapy: n (%): 

G1: 235 (56) 

G2: 222 (54) 

G3: 225 (55) 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 10.3 ± 17.2 

G2: 12.8 ± 19.8 

G3: 16.7 ± 19.7 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Pads/day, mean 

± SD: 

G1: 1.0 ± 1.8 

G2: 1.0 ± 1.5 

G3: 1.5 ± 2.2 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Voids/day, mean 

± SD: 

G1: 9.0 ± 3.2 

G2: 9.3 ± 4.0 

G3: 9.9 ± 3.8 

G1/G3: P = 0.001

G2/G3: P = 0.005 

Voided volume 

(mL), mean ± SD: 

G1: 179.1 ± 66.6

G2: 169.7 ± 65.6

G3: 149.0 ± 56.3 

G1/G3: P = 0.001

G2/G3: P = 0.001 

Clinical effecttiveness*, dry 

mouth: 

G1: 0.53 

G2: 0.39 

G3: 0.30 

Dry mouth, n (%): 

G1: 105 (25.3) 

G2: 127 (31.2) 

G3: 33 (8.0) 

G1/G3: P < 0.01 

G2/G3: P < 0.01 

Abdominal pain, 

n (%): 

G1: 18 (4.3) 

G2: 12 (2.9) 

G3: 7 (1.7) 

G1/G3: P = 0.03 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: ++

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-610 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

BMI, kg/m2

 ± SD: 

G1: 28.8 ± 13.8 

G2: 29.0 ± 11.0 

G3: 28.8 ± 6.7 

Constipation, n 

(%): 

G1: 27 (6.5) 

G2: 27 (6.6) 

G3: 14 (3.4) 

Dyspepsia, n (%): 

G1: 11 (2.7) 

G2: 14 (3.4) 

G3: 6 (1.5) 

Nausea, n (%): 

G1: 7 (1.7) 

G2: 9 (2.2) 

G3: 9 (2.2) 

Diarrhea, n (%): 

G1: 10 (2.4) 

G2: 14 (3.4) 

G3: 9 (2.2) 

Flatulence, n (%): 

G1: 8 (1.9) 

G2: 11 (2.7) 

G3: 6 (1.5) 

Xerophthalmia, n 

(%): 

G1: 16 (3.9) 

G2: 8 (2.0) 

G3: 8 (2.0) 

Abnormal vision, 

n (%): 

G1: 5 (1.2) 

G2: 4 (1.0) 

G3: 2 (0.5) 

Headache, n (%): 

G1: 29 (7.0) 

G2: 14 (3.4) 

G3: 19 (4.6) 

UTI, n (%): 

G1: 15 (3.6) 

G2: 11 (2.7) 

G3: 19 (4.6) 

Insomnia, n (%): 

G1: 7 (1.7) 

G2: 2 (0.5) 

G3: 9 (2.2) 

Somnolence, n 

(%): 

G1: 12 (2.9) 

G2: 11 (2.7) 

G3: 8 (2.0) 

C-611 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Swift et al., 2003 

(continued) 

Dizziness, n (%): 

G1: 7 (1.7) 

G2: 7 (1.7) 

G3: 4 (1.0) 

Hypertension, n 

(%): 

G1: 6 (1.4) 

G2: 4 (1.0) 

G3: 4 (1.0) 

Sinusitis, n (%): 

G1: 8 (1.9) 

G2: 2 (0.5) 

G3: 3 (0.7) 

Arthritis, n (%): 

G1: 1 (0.2) 

G2: 5 (1.2) 

G3: 1 (0.2) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 5 (1.2) 

G3: 1 (0.2) 

C-612 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Van Kerrebroeck 

et al., 2002 

Freeman et al., 

2003* 

Country and 

setting: 

North America (74 

centers), 

Australasia (4 

centers), Europe 

(89 centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine ER vs 

Tolterodine IR vs 

placebo

Groups: 

G1: tolterodine ER 

4 mg sid 

G2: tolterodine IR 

2 mg bid 

G3: placebo 

N at enrollment: 

G1: 507 

G2: 514 

G3: 508 

N at follow-up: 

Total: 1442 

G1: 398 

G3: 374 

Women, n (%): 

G1: 417 (82) 

G2: 408 (79) 

G3: 410 (81) 

Age, mean 

(range): 

G1: 60 (20, 89) 

G2: 60 (22, 92) 

G3: 61 (22, 93) 

Race/ethnicity, 

%:* 

White: 

G1: 95.7 

G3: 94.7 

Black: 

G1: 3.0 

G3: 3.5 

Asian/Pacific 

Islander: 

G1: 1.0 

G3: 0.8 

Other: 

G1: 0.3 

G3: 1.1 

Inclusion criteria: 

• Age ≥ 18 

• Urinary 

frequency (≥ 8 

voids/day) 

Exclusion 

criteria: 

• SUI 

• Total daily urine 

volume > 3 L 

• Contraindications to 

antimuscarinic 

treatment 

• Hepatic or renal 

disease 

• UITs 

• Interstitial 

cystitis 

• Hematuria 

• BOO 

• Current 

electrostimulation or bladder 

training therapy 

• Indwelling 

catheter or 

intermittent selfcatheterization 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Being treated 

for OAB with 

other 

anticholinergic 

drugs or drugs 

that inhibit 

cytochrome 

P450 3A4 

isoenzymes 

• Estrogen 

therapy < 2 

months 

• Treatment w/ 

investigational 

drug < 2 months

Incontinence 

episodes/week, 

mean (range): 

G1: 22.1 (0, 

168.0) 

G2: 23.2 (0, 

168.0) 

G3: 23.3 (0, 

168.0) 

≥ 5 incontinence 

episodes/week, n 

(%): 

G1: 492 (97) 

G2: 498 (97) 

G3: 494 (97) 

Pads/day, mean 

(range): 

G1: 1.4 (0-18) 

G2: 1.4 (0-25) 

G3: 1.5 (0-22) 

Voids/day, mean 

(range): 

G1: 10.9 (2.3, 

51.3) 

G2: 11.1 (2.0, 

48.6) 

G3: 11.3 (2.0, 

37.4) 

≥ 8 voids/day, n 

(%): 

G1: 458 (90) 

G2: 469 (91) 

G3: 467 (92) 

Previous drug 

therapy, n (%): 

G1: 270 (53) 

G2: 276 (54) 

G3: 263 (52) 

Poor efficacy, %:

G1: 43 

G2: 38.4 

G3: 40.7 

Able to finish 

tasks before 

visiting a toilet, 

%:* 

G1: 5 

G3: 6 

Urinary Urgency, 

subjective 

assess-ment, 12 

wks, n (%):* 

Improvement:

G1: 173 (44) 

G3: 118 (32) 

G1/G3: P < 0.001 

No change: 

G1: 201 (51) 

G3: 212 (57) 

Deterioration: 

G1: 22 (6) 

G3: 44 (12) 

G1/G3: P < 0.002 

Urinary urgency, 

improvement, 12 

wks, women 

only, %:* 

G1: 46.6 

G3: 26.6 

G1/G3: P = 0.001 

OR 1.81 (95% CI: 

1.31, 2.49) 

Not able to hold 

urine, 12 wks, 

%:* 

G1: 58 

G3: 32 

G1/G3: P < 0.001 

Incontinence 

episodes/week, 

mean change ± 

SD (%) 

G1: -11.8 ± 17.8 

G2: -10.6 ± 16.9 

G3: -6.9 ± 15.4 

G1/G3: P = 

0.00001 

G2/G3: P = 

0.0005 

G1/G2: P < 0.05 

Incontinence 

episodes/week, 

median % 

change: 

G1: -71 

G2: -60 

G3: -30 

G1/G2: P < 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: - 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-613 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2002 

Freeman et al., 

2003* 

(continued) 

Voided volume 

(mL), mean 

(range): 

G1: 141 (36, 338) 

G2: 137 (38, 283) 

G3: 136 (31, 374) 

Pads/day, mean ± 

SD: 

G1: -0.5 ± 1.4 

G2: -0.5 ± 18 

G3: -0.2 ± 1.4 

G1/G3: P = 0.0145 

G2/G3: P = 0.0035 

Voids/day, mean 

± SD: 

G1: -3.5 ± 4.9 

G2: -3.3 ± 4.4 

G3: -2.2 ± 4.0 

G1/G3: P = 

0.00001 

G2/G3: P = 0.0002 

Voluntary voids/ 

day, mean ± SD: 

G1: -1.8 ± 3.4 

G2: -1.7 ± 3.3 

G3: -1.2 ± 2.9 

G1 vs G3 

G1/G3: P = 

0.00047 

G2/G3: P = 0.0079 

Bladder 

symptoms, 

improvement, 12 

wks, women 

only, %:* 

G1: 62.8 

G3: 48.4 

G1/G3: P = 0.001 

OR 1.78 (95% CI: 

0.34, 2.37) 

Treatment 

benefit, 12 wks, n 

(%):* 

Much benefit: 

G1: 172 (43.2) 

G3: 88 (23.5) 

G1/G3: P < 0.001 

Little benefit 

G1: 138 (34.7) 

G3: 118 (31.6) 

No benefit 

G1: 88 (22.1) 

G3: 168 (44.9) 

C-614 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2002 

Freeman et al., 

2003* 

(continued) 

Able to finish 

tasks before 

visiting a toilet, 

12 wks, %:* 

G1: 33 

G3: 18 

G1/G3: P < 0.001

Voided volume 

(mL), mean 

change ± SD: 

G1: +34 ± 51 

G2: +29 ± 47 

G3: +14 ± 41 

G1/G3: P = 

0.00001 

G2/G3: P = 0.0001 

Discontinued due 

to AEs, n (%): 

G1: 27 (5) 

G2: 28 (5) 

G3: 33 (6) 

Reported serious 

adverse events, 

n: 

G1: 7 

G2: 12 

G3: 18 

Parasympathetic 

Dry mouth, n (%): 

G1: 118 (23) 

G2: 156 (30) 

G3: 39 (8) 

Xerophthalmia, n 

(%): 

G1: 17 (3) 

G2: 12 (2) 

G3: 10 (2) 

Abnormal vision, 

n (%): 

G1: 6 (1) 

G2: 4 (1) 

G3: 2 (0.5) 

Dry skin, n (%): 

G1: 2 (0.5) 

G2: 6 (1) 

G3: 1 (0.5) 

C-615 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2002 

Freeman et al., 

2003* 

(continued) 

Gastrointestinal 

Constipation, n 

(%): 

G1: 30 (6) 

G2: 35 (7) 

G3: 22 (4) 

Dyspepsia, n (%): 

G1: 15 (3) 

G2: 16 (3) 

G3: 7 (1) 

Abdominal pain, 

n (%): 

G1: 19 (4) 

G2: 13 (3) 

G3: 8 (2) 

Diarrhea, n (%): 

G1: 10 (2) 

G2: 16 (3) 

G3: 11 (2) 

Flatulence, n (%): 

G1: 10 (2) 

G2: 14 (3) 

G3: 9 (2) 

Nausea, n (%): 

G1: 7 (1) 

G2: 10 (2) 

G3: 10 (2) 

Headache, n (%): 

G1: 32 (6) 

G2: 19 (4) 

G3: 23 (5) 

Somnolence, n 

(%): 

G1: 14 (3) 

G2: 13 (3) 

G3: 9 (2) 

Dizziness, n (%): 

G1: 11 (2) 

G2: 9 (2) 

G3: 5 (1) 

Fatigue, n (%): 

G1: 11 (2) 

G2: 6 (1) 

G3: 4 (1) 

Insomnia, n (%): 

G1: 7 (1) 

G2: 2 (0.5) 

G3: 9 (2) 

C-616 
Evidence Table 7. KQ4 Modifiers of outcomes (continued)

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Van Kerrebroeck 

et al., 2002 

Freeman et al., 

2003* 

(continued) 

Urinary tract 

infection, n (%): 

G1: 16 (3) 

G2: 13 (3) 

G3: 20 (4) 

Dysuria, n (%): 

G1: 5 (1) 

G2: 8 (2) 

G3: 1 (0.5) 

Peripheral 

edema, n (%): 

G1: 7 (1) 

G2: 7 (1) 

G3: 4 (1) 

C-617 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2002 

[See evidence 

table for Van 

Kerrebroeck et al., 

2001} 

Country and 

setting: 

North America (74 

centers), 

Australasia (4 

centers), Europe 

(89 centers) 

Enrollment 

period: 

NR 

Funding: 

Pharmacia 

Corporation 

Author industry 

relationship 

disclosures: 

NR 

Design: 

RCT 

Intervention: 

Tolterodine ER vs. 

placebo

Groups: 

G1: tolterodine ER 

4 mg qd < 65 

years of age 

G2: placebo < 65 

years of age 

G3: tolterodine ER 

4 mg qd ≥ 65 

years of age 

G4: placebo ≥ 65 

years of age 

N at enrollment: 

G1: 293 

G2: 285 

G3: 214 

G4: 223 

N at follow-up: 

G1: 257 

G2: 246 

G3: 193 

G4: 194 

Women, n (%): 

G1: 255 (87)** 

G2: 247 (87)** 

G3: 162 (76) 

G4: 163 (73) 

Age, mean ± SD: 

G1: 51 ± 10.5 

G2: 51 ± 10 

G3: 74 ± 6 

G2: 74 ± 6 

Race/ethnicity: 

NR 

Inclusion criteria: 

• Age ≥ 18 

• Urinary 

frequency (≥ 8 

voids/day) 

Exclusion 

criteria: 

• Demonstrable 

SUI 

• Total daily urine 

volume > 3 L 

• Contraindications to 

antimuscarinic 

treatment 

• Hepatic or renal 

disease 

• UTI 

• Interstitial 

cystitis 

• Hematuria 

• BOO 

• Current 

electrostimulation or bladder 

training therapy 

• Indwelling 

catheter or 

intermittent selfcatheterization 

• Pregnant or 

nursing 

• Women not 

using reliable 

contraception 

• Being treated 

for OAB with 

other 

anticholinergic 

drugs or drugs 

that inhibit 

cytochrome 

P450 3A4 

isoenzymes 

• Estrogen 

therapy < 2 

months 

• Treatment w/ 

investigational 

drug < 2 months

Not able to hold 

urine upon 

experiencing 

urgency, %: 

G1: 24.9 

G2: 29.1 

G3: 33.6 

G4: 34.5 

Able to complete 

tasks before 

toilet visit in 

response to 

urgency,%: 

G1: 6.5 

G2: 7.7 

G3: 5.1 

G4: 4.9 

Incontinence 

episodes/week, 

mean ± SD: 

G1: 21.4 ± 22.1 

G2: 23.2 ± 22.0 

G3: 23.2 ± 22.7 

G4: 23.4 ± 18.9 

Voids/day, mean 

± SD: 

G1: 11.0 ± 3.9 

G2: 11.4 ± 4.2 

G3: 10.8 ± 4.5 

G4: 11.0 ± 3.2 

Voided volume 

(mL), mean ± SD:

G1: 140 ± 41 

G2: 137 ± 45 

G3: 141 ± 45 

G4: 134 ± 39 

Previous drug 

therapy, n (%): 

G1: 148 (50.5) 

G2: 146 (51.2)

G3: 121 (56.5) 

G4: 117 (52.5) 

Percentage with 

poor efficacy, %:

G1: 74 (50.0)** 

G2: 60 (41.1)**

G3: 40 (33.1) 

G4: 46 (39.3) 

Not able to hold 

urine upon 

experiencing 

urgency, %: 

G1: 11.3 

G2: 21.1 

G3: 15.9 

G4: 25.6 

G1/G2: P = 0.003 

G3/G4: P = 0.007 

No age-related 

difference 

Able to complete 

tasks before 

toilet visit in 

response to 

urgency,%: 

G1: 32.8 

G2: 16.8 

G3: 26.2 

G4: 14.8 

G1/G2: P = 0.001 

G3/G4: P = 0.003 

No age-related 

difference 

Incontinence 

episodes/week, 

mean ± SD 

G1: -12.0 ± 17.6 

G2: -7.4 ± 15.6 

G3: -11.5± 18.2 

G4: -6.3 ± 15.0 

G1/G2: P = 0.001 

G3/G4: P < 0.001 

No age-related 

difference 

Voids/day, mean 

± SD 

G1: -2.0 ± 3.1 

G2: -1.4 ± 3.1 

G3: -1.4± 3.7 

G4: -0.9 ± 2.6 

G1/G2: P = 0.26 

G3/G4: P = 0.92 

Quality: 

Overall quality 

score: poor 

INTERNAL 

VALIDITY: poor 

Randomization: + 

Masking: + 

Pt selection 

criteria: + 

Loss to followup: +

Drop-out rates: 

NR 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: fair 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: - 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-618 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2002 

(continued) 

Perception of 

bladder 

condition, 

improved, %: 

G1: 60.1 

G2: 51.9 

G3: 54.2 

G4: 31.4 

G1/G2: P < 0.05 

G3/G4: P < 

0.0001 

Perception of 

bladder 

condition, no 

change, %: 

G1: 32.4 

G2: 38.9 

G3: 38.3 

G4: 51.1 

G4/G2: P < 

0.0001 

Perception of 

bladder 

condition, 

deterioration, %: 

G1: 7.2 

G2: 9.1 

G3: 7.5 

G4: 17.5 

Treatment 

beneficial, %: 

G1: 78.3 

G2: 58.3 

G3: 69.8 

G4: 46.9 

G1/G2: P = 0.001 

G3/G4: P = 0.001 

No age-related 

difference 

Voided volume 

(mL), mean ± SD: 

G1: 35 ± 53 

G2: 13 ± 41 

G3: 33± 47 

G4: 16 ± 41 

G1/G2: P < 0.001 

G3/G4: P < 0.001 

No age-related 

difference 

C-619 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2002 

(continued) 

Adverse events, 

%: 

G1: 50.7 

G2: 50.5 

G3: 54.2 

G4: 46.0 

Dry mouth, 

severe, % 

G1-G2: 1.7 

G3-G4: 1.9 

Dry mouth, 

moderate, % 

G1-G2: 7.6 

G3-G4: 6.5 

Dry mouth, mild, 

% 

G1-G2: 13.4 

G3-G4: 15.9 

No dry mouth, % 

G1-G2: 77.3 

G3-G4: 75.7 

C-620 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Author: 

Zinner et al., 2004 

Country and 

setting: 

US, 51 sites 

Enrollment 

period: 

NR 

Funding: 

Indevus 

Corporation 

Author industry 

relationship 

disclosures: 

4 of 5 

Alza (1) 

Indevus (4) 

Kyowa (1) 

Lilly (2) 

Merck (1) 

Ortho-McNeil (1) 

Pfizer (2) 

Pharma (1) 

Pharmacia (1) 

Schwarz (1) 

Watson (2) 

Yamanouchi (1) 

Design: 

RCT with 

2 wk washout 

period 

Intervention: 

Trospium chloride 

vs placebo

Groups: 

G1: Tropsium 

chloride 20 mg bid

G2: placebo 

N at enrollment: 

G1: 262 

G2: 261 

N at follow-up: 

G1: 256 

G2: 256 

Women, n (%): 

G1: 203 (77.5) 

G2: 186 (71.3) 

Age, mean ± SD: 

G1: 63 ± 0.8 

G2: 61.5 ± 0.8 

Race/ethnicity, n 

(%): 

White: 

G1: 222 (84.7) 

G2: 225 (86.2) 

Black: 

G1: 26 (9.9) 

G2: 20 (7.7) 

Hispanic: 

G1: 10 (3.8) 

G2: 13 (5.0) 

Other: 

G1: 4 (1.6) 

G2: 3 (1.1) 

Inclusion criteria:

• Age ≥18 years 

• OAB symptoms 

≥ 6 mos 

• Urinary urgency 

• ≥ 70 voids per 

week 

• ≥ 7 UUI 

episodes/week 

Exclusion 

criteria: 

• Stress 

predominant 

MUI 

• Insensate or 

overflow 

• Neurogenic 

bladder 

disorders 

• Significant renal 

disease 

• Hematuria 

hematuria and 

UTI at washout 

or ≥ twice in the 

prior year 

• BOO with PVR ≥

100 mL 

• Concurrent use 

of any 

anticholinergic 

drug or other 

drug therapy for 

OAB within 21 

days before 

randomization 

• Bladder surgery 

≤ 6 mos 

• Bladder cancer 

• Interstitial cystitis 

• PSA ≥ 10 ng/mL

• Diuretic use, 

estrogen therapy 

and nonmedical 

bladder therapy 

that was not part 

of a stable, longterm program. 

UUI episodes/ 

day, mean: 

G1: 3.9 

G2: 4.3 

Urgency 

episodes/day, 

mean: 

G1: 11.29 

G2: 11.72 

Urgency severity 

score, mean: 

G1: 1.8 

G2: 1.8 

Voids/day, mean:

G1: 12.7 

G2: 12.9 

Daytime voids/ 

day, mean: 

G1: 10.6 

G2: 10.9 

Nocturia 

episodes/day, 

mean: 

G1: 2.1 

G2: 2.0 

Voided volume 

(mL), mean: 

G1: 155.1 

G2: 156.1 

IIQ, mean score 

(SE): 

G1: 183.5 (5.6) 

G2: 195.4 (5.6) 

IIQ,, women only, 

mean score (SE):

G1: 191.2 (6.3)

G2: 201.9 (6.6) 

Incontinence 

Impact Questionnaire, travel 

subscale, score 

(SE): 

G1: 52.4 (1.7) 

G2: 55.6 (1.7) 

UUI episodes/ 

day, mean 

%change: 

G1: 59.0 

G2: 44.2 

G1/BL: P < 

0.0001 

Urgency 

episodes/day, 

mean change: 

G1: -0.22 

G2: -1.08 

G1/BL: P < 0.001 

Urgency severity 

score, mean: 

G1: 1.8 

G2: 1.8 

Voids/day, mean 

change: 

G1: -2.37 

G2: -1.29 

G1/BL: P < 

0.0001 

Daytime voids/ 

day, mean 

change: 

G1: -1.90 

G2: -0.98 

G1/BL: P < 

0.0001 

Nocturia 

episodes/day, 

mean change: 

G1: -0.47 

G2: -0.29 

G1/BL: P < 0.05 

Voided volume 

(mL), mean 

change: 

G1: 32.1 

G2: 7.7 

G1/BL: P < 

0.0001 

IIQ,, LS mean 

change (SE): 

G1: -54.0 (5.6) 

G2: -36.0 (5.6) 

G1/BL: P ≤ 0.05 

Quality: 

Overall quality 

score: fair 

INTERNAL 

VALIDITY: fair 

Randomization: + 

Masking: - 

Pt selection 

criteria: + 

Loss to followup: 

++ 

Drop-out rates: + 

Power calculation: 

- 

Statistical issues: 

+ 

EXTERNAL 

VALIDITY: good 

Age: + 

Baseline OAB 

status: + 

Baseline 

characteristics: ++

Length of 

followup: + 

Measurement 

methods: + 

Measurement 

reliability: + 

Intervention 

description: + 

C-621 
Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

IIQ, social 

relationships, 

score (SE): 

G1: 37.8 (1.5) 

G2: 40.3 (1.5) 

IIQ, emotional 

health, mean 

score (SE): 

G1: 47.1 (1.6) 

G2: 49.6 (1.6) 

IIQ,, physical 

activity, mean 

score (SE): 

G1: 46.1 (1.6) 

G2: 50.2 (1.6) 

Prior OAB med, n 

(%): 

G1: 135 (51.5) 

G2: 142 (54.5) 

IIQ, women only, 

LS mean change 

(SE): 

G1: -59.1 (6.6) 

G2: -35.7 (6.9) 

G1/BL: P ≤ 0.05 

IIQ, travel 

subscale, LS 

mean change 

(SE): 

G1: -14.9 (1.7) 

G2: -9.9 (1.7) 

G1/BL: P < ≤ 0.05 

IIQ, social 

relationsips, LS 

mean change 

(SE): 

G1: -10.8 (1.4) 

G2: -6.3 (1.4) 

G1/BL: P ≤ 0.05 

IIQ, emotional 

health, LS mean 

change (SE): 

G1: 14.1 (1.5) 

G2: -9.2 (1.5) 

G1/BL: P ≤ 0.05 

IIQ, physical 

activity, LS mean 

change (SE): 

G1: -13.5 (1.7) 

G2: -11.0 (1.7) 

Dry mouth, n (%): 

G1: 57 (21.8) 

G2: 17 (6.5) 

Constipation, n 

(%): 

G1: 25 (9.5) 

G2: 10 (3.8) 

Headache, n (%): 

G1: 17 (6.5) 

G2: 12 (4.6) 

C-622 
C-623 

Evidence Table 7. KQ4 Modifiers of outcomes (continued) 

Study 

Description 

Study Design, 

Interventions, 

and Population 

Inclusion/ 

Exclusion 

Criteria 

Symptom 

Characteristics Outcomes Quality Rating 

Zinner et al., 2004 

(continued) 

Diarrhea, n (%): 

G1: 8 (3.1) 

G2: 14 (5.4) 

Abdominal pain, 

n (%): 

G1: 8 (3.1) 

G2: 3 (1.1) 

Discontinuation 

due to AE, %: 

G1: 8.8 

G2: 5.7 
Appendix D. List of Excluded Studies 

Excluded Articles 

Full Text Article Exclusion Criteria Codes for Database 

X-1A: Not OAB (including post-operative/iatrogenic) 

X-1B: Stress or mixed incontinence 

X-1C: Isolated nocturia 

X-1D: Interstitial cystitis/painful bladder syndrome 

X-1E: Pelvic organ prolapse 

X-1F: Neurogenic conditions 

X-1G: Basic science or anatomy only 

X-1H: Imaging/diagnostic study only 

X-1I: Other (including questionnaire validation studies, coping strategies, etc.) 

X-2: Not original research 

X-4: Less than 75% of study population are adult females 

X-5: Non-ambulatory population 

X-6: Ineligible study type 

X-7: N <50 

X-8: Non- US cost study/general cost of incontinence (not specifically OAB) 

X-9: Treatment not currently available in the US 

X-10: Unable to obtain full text of manuscript 
List of Excluded Studies 

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older non-institutionalized women. Terodiline in the 

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Soc. 1993 Sep;41(9):915-22. X-9 

3. Biofeedback, exercise for urge incontinence. Health 

News. 1999 Jan 5;5(1):7. X-2 

4. Overactive bladder. Harv Womens Health Watch. 1999 

Oct;7(2):6. X-2 

5. Sacral nerve stimulation for the treatment of urinary 

urgency/frequency. Tecnologica MAP Suppl. 2000 Jun:12-

5. X-2 

6. Detrol LA and Diropan XL for overactive bladder. Med 

Lett Drugs Ther. 2001 Apr 2;43(1101):28. X-2 

7. Incontinence: an overview. N2N: Nurse2Nurse. 2001 

Feb;1(9):11-2, 14-5. X-2 

8. Don't let elderly patients 'put up with' incontinence. 

Senior Care Management. 2002 Jun;5(6):87-8. X-10 

9. Behavior therapy and urge incontinence. Mayo Clin 

Health Lett. 2003 May;21(5):4. X-2 

10. Skin patch approved for treatment of overactive 

bladder. Mayo Clin Womens Healthsource. 2003 

Aug;7(8):3. X-2 

11. Overactive bladder. Relief for urgency, frequency and 

incontinence. Mayo Clin Womens Healthsource. 2004 

Mar;8(3):1-2. X-2 

12. Trospium chloride (Sanctura): another anticholinergic 

for overactive bladder. Med Lett Drugs Ther. 2004 Aug 

2;46(1188):63-4. X-2 

13. Innovations in overactive bladder treatment and the 

nursing home environment. Long-Term Care Interface. 

2005;6:19-24. X-5 

14. Design of the Behavior Enhances Drug Reduction of 

Incontinence (BE-DRI) study. Contemp Clin Trials. 2007 

Jan;28(1):48-58. X-1I 

15. Appropriate pharmacotherapy for nocturia in elderly 

patients reduces urinary frequency, thereby improving 

sleep and health-related quality of life. Drugs & Therapy 

Perspectives. 2008;24(2):15-18. X-1C 

16. Blander DS, Carpiniello VL, Harryhill JF, et al. 

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Mar;69(3):436-40. X-1H 

20. Abdel-Fattah M, Ramsay I and Barrington JW. A 

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Appendix E. List of Peer Reviewers 

We extend our appreciation to the members of the Technical Expert Panel (TEP) who 

provided advice and input during our research process. We identified technical experts on the 

topic of OAB in the fields of urology, urogynecology, gynecology, primary care, nursing, and 

patient advocacy to provide assistance during the project. The TEP was both an additional 

resource and a sounding board during the project. The TEP included twelve members serving as 

technical or clinical experts, including an AUA representative. To ensure robust, scientifically 

relevant work, we called on the TEP to provide reactions to work in progress and advice on 

substantive issues or possibly overlooked areas of research. TEP members are listed below (* 

also a peer reviewer): 

Roger Dmochowski, M.D.* 

Professor 

Vanderbilt University, Urologic surgery 

Catherine DuBeau, M.D.* 

Associate Professor, University of Chicago 

Director, Geriatric Continence Center 

Heddy Hubbard, Ph.D., M.P.H., R.N., F.A.A.N.* 

Director of Guidelines 

American Urological Association 

Melissa Lavender, M.B.A. 

Founder, Executive Director, Women’s Health Foundation 

Susan Meikle, M.D., M.S.P.H. 

NICHD, Project Scientist, Pelvic Floor Disorders Network 

Diane K. Newman, R.N.C., M.S.N., C.R.N.P, F.A.A.N.* 

Co-Director, Penn Center for Continence and Pelvic Health 

University of Pennsylvania 

Richard S. Pelman, M.D.* 

American Urological Association 

Bellevue Urology Associates 

Maureen G. Phipps, M.D., M.P.H. 

Associate Professor of Obstetrics/Gynecology 

Women & Infants Hospital of Rhode Island 

Neil Resnick, M.D. 

Professor and Chief, University of Pittsburgh Medical Center, Division of Geriatric Medicine 

Director, Institute on Aging 

E‐1
E‐2

Holly Richter, M.D., Ph.D.* 

Chief, Women's Pelvic Medicine & Reconstructive Surgery 

University of Alabama-Birmingham 

Eric S. Rovner, M.D.* 

Associate Professor, Medical University of South Carolina Urology Services 

J. Christian Winters, M.D. 

Chairman and Professor, Department of Urology 

LSU Health Sciences Center 

Jennifer Wu, M.D., M.P.H.* 

Assistant Professor, Division of Urogynecology 

Duke University Medical Center ,