Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women
Phase: NA
Conditions: Urinary Incontinence
Sponsor: University of California, San Francisco

 
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Lessening Incontinence through Low-impact Activity 
(LILA) 
(a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women) 
 
 
Principal investigator: 
 
Alison Huang, MD, MAS 
Associate Professor of Medicine 
University of California San Francisco 
 
 
Supported by: 
 
The National Center for Complementary and Integrative Health 
Grant #1R34AT008028-01A1 
 

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Protocol Revision History 
 
Version Number: 1.0  
Version Date: 12/16/2014 
Summary of Revisions Made: Initial protocol approved by NCCAM (NCCIH) 
 
Version Number: 2.1 
Version Date: 01/20/2015 
Summary of Revisions Made: Change stretching/strengthening to physical conditioning; 
physical mobility assessment moved to baseline, medication inventory added to Week 8, 
Credibility and Expectations of Treatment moved to randomization, NCCAM changed to NCCIH 
 
Version Number: 2.2 
Version Date: 07/15/2016 
Summary of Revisions Made: Increased sample size to 60 participants and updated staff 
contact address. 
 
Version Number: 2.3 
Version Date: 09/28/2016 
Summary of Revisions Made: Increased sample size to 90 participants and updated staffing. 
 
TABLE OF CONTENTS 
PRÉCIS ......................................................................................................................................... 6 
1. 
STUDY OBJECTIVES ........................................................................................................... 7 
2.  BACKGROUND AND RATIONALE ....................................................................................... 7 
2.1 Background on Condition ............................................................................................. 7 
2.2 Study Rationale ............................................................................................................ 8 
3.  STUDY DESIGN .................................................................................................................... 9 
4.  SELECTION AND ENROLLMENT OF PARTICIPANTS ....................................................... 9 
4.1 Inclusion Criteria ........................................................................................................... 9 
4.2 Exclusion Criteria ........................................................................................................ 10 
4.3 Study Enrollment Procedures ..................................................................................... 11 
5.  STUDY INTERVENTIONS .................................................................................................. 12 
5.1 Yoga Therapy Program .............................................................................................. 12 
5.2 Physical Conditioning Control Program ...................................................................... 14 
5.3 Concomitant Interventions .......................................................................................... 15 
5.3.1 
Required Interventions .................................................................................. 15 
5.3.2 
Prohibited Interventions ................................................................................. 16 
5.4 Adherence Assessment .............................................................................................. 16 
6.  STUDY PROCEDURES ...................................................................................................... 17 
6.1 Study Measures .......................................................................................................... 17 
6.1.1  Urinary Incontinence ......................................................................................... 17 
6.1.2  Condition-Specific Quality of Life ...................................................................... 17 
6.1.3  Anxiety and Perceived Stress ........................................................................... 18 
6.1.4  Yoga/Physical Conditioning Self-efficacy and Competency ............................. 18 
6.1.5  Additional Screening and Covariate Measures ................................................. 19 
6.2 Evaluations ................................................................................................................. 19 
6.2.1 
Screening Evaluations ................................................................................... 19 
6.2.2   Consenting Procedure ..................................................................................... 20 
6.2.3   Screening Procedures ..................................................................................... 20 

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6.2.4 
Randomization and Blinding .......................................................................... 21 
6.2.5 
Follow-up/Final Evaluations ........................................................................... 23 
6.2.6 
Early Termination (also see section 8 below) ................................................ 24 
6.2.7  Table of Measures and Procedures .................................................................. 26 
7. SAFETY ASSESSMENTS ...................................................................................................... 27 
7.1 Potential Risks and Protective Measures ................................................................... 27 
7.2 Methods and Timing of Safety Assessments .............................................................. 28 
7.3     Adverse Events and Serious Adverse Events ........................................................... 28 
7.3.1  AE/SAE Definitions ........................................................................................... 28 
7.3.2  AE/SAE Documentation .................................................................................... 29 
7.4 Reporting Procedures ................................................................................................. 29 
7.4.1   SAE Reporting ................................................................................................. 29 
7.4.2   Non-Serious AE Reporting .............................................................................. 30 
7.5 Follow-up for AEs/SAEs ............................................................................................. 30 
7.6 Independent Safety Monitoring ................................................................................... 30 
8.   INTERVENTION DISCONTINUATION ................................................................................. 31 
9. STATISTICAL CONSIDERATIONS ........................................................................................ 31 
9.1 General Design Issues ............................................................................................... 31 
9.2 Sample Size and Randomization ................................................................................ 32 
9.4     Assessment of Feasibility of Recruitment and Retention .......................................... 32 
9.5    Assessment of Adherence to Interventions ................................................................ 33 
9.6 Interim Analyses and Stopping Guidelines ................................................................. 34 
9.7 Outcomes ................................................................................................................... 34 
9.7.1 
Feasibility Outcomes ..................................................................................... 34 
9.7.2 
Primary Efficacy Outcome ............................................................................. 34 
9.7.3 
Secondary Efficacy Outcomes ...................................................................... 35 
9.8 Data Analyses ............................................................................................................. 35 
10. DATA COLLECTION AND QUALITY ASSURANCE ............................................................ 36 
10.1 Data Collection Forms ................................................................................................ 36 
10.2 Data Management ...................................................................................................... 36 
10.3 Quality Assurance ....................................................................................................... 37 
10.3.1 Staff Training ................................................................................................. 37 
10.3.2 Data Quality Assessment .............................................................................. 37 
10.3.3 Protocol Deviations ........................................................................................ 37 
10.3.4 Monitoring ...................................................................................................... 38 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY .............................................................. 38 
11.1 Institutional Review Board (IRB) Review .................................................................... 38 
11.2 Informed Consent Forms ............................................................................................ 38 
11.3 Participant Confidentiality ........................................................................................... 38 
11.4 Study Discontinuation ................................................................................................. 39 
12.  PUBLICATION OF RESEARCH FINDINGS ........................................................................ 39 
13. REFERENCES ..................................................................................................................... 39 
APPENDIX A:  INFORMED CONSENT FORM .......................................................................... 44 
 

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STUDY TEAM ROSTER  
Investigators 
 
Alison Huang, MD, MAS 
1545 Divisadero Street, Suite 322 
San Francisco, CA 94115 
E-mail: ahuang@medicine.ucsf.edu 
Tel: 415-514-8697   F: 415-514-8666 
Leslee Subak, MD 
550 16th Street, 6th Floor 
San Francisco, CA 94158 
E-mail: leslee.subak@ucsf.edu  
Tel: 415-353-9758   F: 415-476-5367 
Margaret Chesney, PhD 
1545 Divisadero Street, Suite 508 
San Francisco, CA 94115 
Email: chesneym@ocim.ucsf.edu 
Tel: 415-353-7719   F: 415-353-7711 
Eric Vittinghoff, PhD 
550 16th Street, 3rd Floor 
San Francisco, CA 94158 
Email: Eric.Vittinghoff@ucsf.edu 
Tel: 415-514-8025 
Project Directors 
 
Ann Chang 
550 16th Street, 6th Floor 
San Francisco, CA 94158 
Email: Ann.Chang@ucsf.edu  
Tel: 415-353-9782   F: 415-476-5367 
Lisa Abinanti 
550 16th Street, 6th Floor 
San Francisco, CA 94158 
Email: Lisa.Abinanti@ucsf.edu  
Tel: 415-353-9978   F: 415-476-5367 
Clinical Coordinators 
 
Traci Coggins-Plaut 
2320 Sutter Street, Suite 201 
San Francisco, CA 94115 
Email: Traci.Plaut@ucsf.edu  
Tel: 415-885-3856 
Consultants 
 
Sarah Pawlowsky, DPT 
1500 Owens Street, Room 400 
San Francisco, CA 94158 
Email: sarah.pawlowsky@ucsf.edu  
Fax: 415-353-9554 
Leslie Howard 
Email: lesliehowardyoga@gmail.com 
Tel: 415-823-1699 
Judith Lasater, PhD 
156 Madrone Avenue 
San Francisco, CA 94127 
Email: judithyoga@mac.com 
Tel: 415-515-1527 
Data and Safety Monitor 
 
Andrew Avins, MD, MPH 
The Permanente Medical Group, Inc. 

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2000 Broadway, 3rd Floor 
Oakland, CA   94612 
E-mail: andrew.avins@ucsf.edu  
tel: 510/891-3557   fax: 510/891-3606 

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PRÉCIS  
 
Study Title  
Lessening Incontinence through Low-impact Activity (LILA), a.k.a. Yoga to Enhance 
Behavioral Self-Management of Urinary Incontinence in Women 
 
Objectives  
To develop and test procedures for a future full-scale efficacy trial of a group-based 
yoga therapy intervention in middle-aged and older women with urinary incontinence.  
Design   
Pilot, randomized, parallel-group trial of a group-based yoga therapy program versus 
physical conditioning control program for treatment of urinary incontinence in 
ambulatory middle-aged and older women. 
Sample Size and Population  
Up to ninety women aged 50 years and older who document stress-, urgency-, or 
mixed-type incontinence occurring an average of once per day on a voiding diary, 
are not participating in other organized yoga activities, are not using other clinical 
treatments for incontinence, and meet minimum mobility and other eligibility criteria 
will be recruited from the general San Francisco Bay Area.   
Interventions and Duration 
Eligible women will be randomized in a 1:1 ratio to participate in either a 12-week 
yoga therapy program (N~45) or a time-equivalent physical conditioning exercise 
control program (N~45).  Women randomized in the yoga therapy program will take 
part in twice weekly group yoga classes focusing on selected Iyengar-based yoga 
techniques as well as practice study-specific yoga techniques at home for at least 
one hour per week for a total of 12 weeks.  Women randomized to the physical 
conditioning control group will take part in twice weekly group physical conditioning 
classes and practice physical conditioning exercises at least one hour per week at 
home for 12 weeks.   
Outcomes and Measurements 
To assess feasibility, rates of enrollment and retention will be carefully monitored, 
and adherence yoga or stretching practice will be assessed during the 12-week 
intervention as well as 12 weeks after the end of the intervention programs.  To 
collect preliminary data on treatment efficacy for urinary incontinence, validated 3-
day voiding diaries will be used to document changes in the frequency of 
incontinence over 12 weeks of treatment, as well as persistence of changes 12 
weeks after the end of the intervention programs.  To collect preliminary data on 
treatment efficacy for other symptom and quality-of-life outcomes, validated self-
administered questionnaires will also be used to examine changes in other urinary 
tract symptoms, condition-specific quality of life, and anxiety and perceived stress 
over 12 weeks of treatment, as well as persistence of changes12 weeks after the 
end of the intervention programs.  
 
 

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1. STUDY OBJECTIVES 
 
Aim 1:  To examine the feasibility of recruiting and retaining ambulatory women aged 
50 years and older into a randomized trial of a yoga therapy versus physical 
conditioning program for treatment of incontinence, and explore potential differences 
in retention and adherence by duration of treatment and follow-up.   
Expected outcome 1: We expect to recruit and randomize 15 to 30 women in each 3-month 
enrollment wave to confirm our ability to assemble a class size of 8 to 15 women per group 
per wave in a future full-scale trial. 
Expected outcome 2:  We expect drop-out rates in both treatment groups to increase over 
time, but remain <20% after 12 weeks of treatment and <30% at 12 weeks of post-treatment 
follow-up. 
Expected outcome 3: We expect adherence to decrease over time, but remain >75% at 12 
weeks of treatment (for group classes and home practice) and >50% at 12 weeks post-
treatment (for home practice only). 
Aim 2:  Explore whether a clinically meaningful reduction in incontinence frequency 
could be detected in a full-scale trial of yoga versus physical conditioning, and 
examine potential differences in treatment efficacy by duration of treatment and 
follow-up.   
Expected outcome 1: We will collect data on the standard deviation, intra-class correlation, 
and between-group difference in change in incontinence frequency to guide sample size 
projections for a future full-scale trial powered to detect a 25% greater reduction in 
incontinence frequency associated with yoga therapy. 
Expected outcome 2: We will examine time-related trends in treatment effects on 
incontinence frequency to guide expectations of treatment efficacy over 8 versus 12 weeks 
of treatment as well as persistence of treatment benefits after 12 weeks of post-treatment 
follow-up in a future full-scale trial. 
Aim 3:  Explore potential effects of yoga versus physical conditioning on other 
symptom and quality-of-life outcomes associated with incontinence and examine 
potential differences in treatment efficacy by duration of treatment and follow-up.   
Expected outcome 1: We will collect data on standard deviations, intra-class correlations, 
and between-group differences for changes in anxiety, depression, and quality-of-life 
questionnaire scores to guide estimates of minimum detectable effects for these secondary 
outcomes in a future full-scale trial. 
Expected outcome 2: We will examine time-related trends in treatment effects on these 
secondary outcomes to guide expectations of treatment efficacy over 8 versus 12 weeks as 
well as persistence of benefits after 12 weeks of post-treatment follow-up in a future full-
scale trial. 
2.  BACKGROUND AND RATIONALE 
2.1 Background on Condition 
Approximately one in four middle-aged and older women suffer from urinary 
incontinence, a condition associated with depression, social isolation, functional 
decline, falls and fractures, and admission to long-term care facilities.1-8  In economic 
analyses, the annual estimated direct costs of incontinence among U.S. women 
exceed $20 billion, greater than that of breast, ovarian, cervical, and uterine cancers 
combined.9 

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Current first-line treatment for both stress- and urgency-type incontinence includes 
behavioral management strategies such as bladder re-training and pelvic floor 
exercises to increase bladder capacity, strengthen the muscles supporting the bladder 
neck, and suppress involuntary bladder contractions. Unfortunately, many patients 
who attempt to practice these techniques after routine teaching by general 
practitioners are not able to do so effectively.10-13  Although the efficacy of these 
techniques can be improved by in-depth, one-on-one training and biofeedback with 
pelvic physical therapists or other specialized medical practitioners, this type of 
intensive pelvic floor rehabilitation therapy is costly, and access to trained pelvic 
physical therapists in the community is limited.14,15   
Second-line treatment for urgency-type incontinence (i.e., leakage caused by a sudden 
urge to void) consists primarily of anticholinergic drugs that are modestly effective in 
reducing incontinence, but have multiple side effects such as dry mouth, stomach 
upset, constipation, and cognitive impairment.  As a result, over half of patients who 
initiate anticholinergic therapy discontinue it within a year.16-18  For stress-type 
incontinence (i.e., leakage with activities that increase abdominal pressure), surgery 
and other invasive procedures can be effective, but are inappropriate or poorly 
tolerated by many patients, especially older women who are at greatest risk of 
incontinence.19  There is a need for alternate therapies that that are not only effective, 
but also more accessible and better tolerated. 
2.2 Study Rationale 
Yoga is a complementary behavioral intervention with the potential to improve 
incontinence through multiple mechanisms, while avoiding the shortcomings of existing 
therapies. When taught in a way that emphasizes mindful awareness of specific bodily 
structures, yoga can be used to help women control and strengthen their pelvic floor 
muscles through group instruction and home practice. As a result, a group-based yoga 
program that incorporates practice of specific yoga postures to promote awareness 
and engagement of the pelvic floor may provide a more accessible alternative to 
traditional, one-on-one pelvic floor rehabilitation therapy, provided that it can be taught 
in a standardized way that is appropriate for patients’ clinical and safety needs.   
Yoga can also alleviate anxiety, stress, and associated autonomic imbalance, as 
factors that contribute to incontinence and magnify its impact on quality of life. Clinical 
studies indicate that women with high self-reported levels anxiety or stress are at 
increased risk of developing incontinence, and that women with chronic incontinence 
experience worsening of their incontinence after exposure to stress-inciting events.20-27  
Although cognitive behavioral therapy, hypnotherapy, and other types of 
psychotherapy have been explored as potential treatments for incontinence,28-31 these 
strategies are again limited by the need for intensive, one-on-one sessions with mental 
health specialists.  In contrast, a group-based yoga program that promotes relaxation 
through deep breathing and other restorative techniques may provide a more 
generalizable, community-based strategy for women to decrease anxiety and stress32-
36 in order to improve both bladder control and quality of life. 
To examine the feasibility of using yoga to treat incontinence in middle-aged and older 
women, our research team previously developed a group-based, Iyengar-style yoga 
therapy program consisting of twice weekly classes and once weekly home practice 
sessions. In a pilot trial involving 19 ambulatory middle-aged and older women with at 
least 7 episodes of urgency, stress, or mixed-type incontinence per week, women 

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randomized to this therapeutic yoga program experienced a 70% decrease in 
incontinence frequency over 6 weeks, versus 16% for the waitlist control (P=.05), 
without any increase in adverse events.37   
We now plan to conduct an R34-scale pilot study to develop, test, and refine 
procedures for a more rigorous, full-scale efficacy trial of yoga for treatment of 
incontinence in middle-aged and older women. Information collected during this pilot 
trial will allow the research team to evaluate and strengthen procedures for recruiting, 
randomizing, and retaining participants for a future efficacy trial, as well as collect 
more preliminary data on the potential efficacy of the study interventions on clinical 
and quality-of-life outcomes. 
3.  STUDY DESIGN 
The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy 
program versus physical conditioning control program for treatment of urinary incontinence 
in ambulatory middle-aged and older women. Women aged 50 years and older who 
document at least 3 episodes of stress-, urgency-, or mixed-type incontinence on a 
screening 3-day voiding diary, are not using other clinical treatments for incontinence, and 
meet minimum physical mobility requirements and other eligibility criteria will be recruited 
from the general San Francisco Bay Area by research coordinators based at the University 
of California San Francisco. Eligible women will be randomized in a 1:1 ratio to participate in 
either a 12-week yoga therapy program (N~45) focusing on selected Iyengar-based yoga 
techniques, or a time-equivalent physical conditioning exercise control program (N~45).  
Women randomized in the yoga therapy program will take part in twice weekly group yoga 
classes involving 8 to 15 other women as well as practice study-specific yoga techniques at 
home for at least one hour per week for a total of 12 weeks.  Women randomized to the 
physical conditioning control group will take part in twice weekly group physical conditioning 
classes and practice physical conditioning exercises at least one hour per week at home for 
12 weeks.  During a 12-week post-treatment follow-up period, participants will also be 
encouraged to continue practicing yoga or stretching exercises for at least an hour per 
week. 
To address aim 1, the study team will carefully track the progress of recruitment and 
randomization and monitor participants’ adherence to group classes and home practice over 
12 weeks of yoga or stretching training as well as 12 weeks after the end of the training 
programs. To address aim 2, validated voiding diaries will be used to document changes in 
the frequency of urinary incontinence over 12 weeks of yoga or stretching training as well as 
persistence of changes 12 weeks after the end of the training programs. To address aim 3, 
validated questionnaires will be used to examine changes in anxiety and perceived stress 
symptoms and condition-specific quality of life over 12 weeks of yoga or stretching training 
as well as persistence of changes 12 weeks after the end of the training programs.   
4.  SELECTION AND ENROLLMENT OF PARTICIPANTS  
Eligibility criteria have designed to identify a population that is generalizable to most 
ambulatory middle-aged and older women with incontinence in the community who do not 
have a major contraindication to practicing yoga.   
4.1 
Inclusion Criteria 
Candidates must meet all of the following criteria to participate in the study: 

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 
Women aged 50 years or older who report urinary incontinence starting at least 3 
months prior to screening 
 
Self-report at least 3 urinary incontinence episodes on a screening 3-day voiding 
diary (i.e., an average of at least one episode per day) 
 
Self-report urgency-predominant (i.e., at least half of incontinence episodes 
being urgency-type), stress-predominant (i.e., at least half of episodes being 
stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type 
episodes) incontinence on the screening voiding diary 
 
Willing to refrain from initiating medical treatments that may affect their 
incontinence or voiding pattern during the study intervention period 
4.2 
Exclusion Criteria 
Candidates meeting any of the following criteria at baseline will be excluded from 
participation: 
 
Participation in formal or organized yoga classes or instruction within the past 3 
months; or any prior yoga therapy directed specifically at improving urinary 
incontinence or pelvic floor dysfunction 
 
Participation in at least weekly organized physical conditioning classes or 
instruction in the past 3 months involving muscle stretching and strengthening 
exercises (not including aerobic classes that do not emphasize stretching or 
strengthening). 
 
Currently pregnant (by self-report or screening urine pregnancy test), gave birth 
within the past 6 months, or planning pregnancy during the study period 
(approximately 2 to 6 months) 
 
Current urinary tract infection (screening dipstick urinalysis with leukocyte 
estrace, nitrites or blood) or a history or 3 or more urinary tract infections in the 
preceding year 
 
Report history of neurologic conditions such as stroke, multiple sclerosis, spinal 
cord injury, or Parkinson’s disease, or a lumbosacral spine condition associated 
with neurological symptoms 
 
Unable to walk up a flight of stairs or at least 2 blocks on level ground without 
assistance (i.e., functional capacity < 4 METs) 
 
Unable to get up from a supine to a standing position in 10 seconds or less and 
without assistance 
 
Morbid obesity defined by a measured body mass index of >40 kg/m2 at the 
screening evaluation. 
 
Report any history of prior anti-incontinence or urethral surgery (not including 
urethral dilation), pelvic cancer, or pelvic irradiation for any reason 
 
Report use of bladder botox, electrostimulation, bladder training, or pelvic floor 
exercise training (with certified practitioners) in the past 3 months 
 
Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, 
bladder surgery, colon surgery) within the past 3 months 
 
Report use of medications with the potential to affect incontinence (anticholinergic 
bladder medications, tricyclic antidepressants, selective norepinephrine reuptake 
inhibitors, mirabegron, loop diuretics) within the past month 
 
Report starting stopping, or changing the dose of a medication with the potential 
to affect anxiety or stress symptoms (i.e., selective serotonin reuptake inhibitors, 
anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, 
stop, or change to dose of such a medication during the study period 

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 
Report use of medical devices (i.e. pessary) for incontinence within the previous 
month (participants may stop use of device and re-present for study) 
 
Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth 
defect leading to urine leakage 
 
Report symptomatic pelvic organ prolapse (assessed using a standardized 
question, ““Have your pelvic organs (uterus, bladder, or rectum) been dropping 
out of your vagina causing a feeling of bulging, pressure, or protrusion or a 
sensation like your “insides are coming out”?”) 
 
Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic 
floor exercises  
 
Report conditions that, in the judgment of the investigators, render potential 
participants unlikely to follow the protocol, including plans to move, substance 
abuse, significant psychiatric problems, or dementia 
 
Participation in another research study that involves investigational drugs or 
devices that could potentially confound the results of this study  
 
Unable to understand study procedures, complete study interviews, or and 
provide informed consent in English 
4.3 
Study Enrollment Procedures  
Recruitment:  Participants will be recruited from the greater San Francisco Bay area 
using a multi-component approach that has been employed successfully in past 
clinical trials led by the investigators. This includes community-based media efforts 
(newspaper and radio advertisements, notices posted in community and senior 
centers, mass community mailings), recruitment from a database of women who 
have given permission to be contacted for women’s health research studies based at 
the University of California San Francisco, and posting of recruitment fliers in 
clinician offices (such as general internal medicine, geriatrics, gynecology, or 
alternative medicine).   
Recruitment will be organized in waves to assemble successive cohorts of women 
who are confirmed to meet all eligibility criteria and who are available to attend 
upcoming group yoga or physical conditioning classes. Based on past experience, 
the investigators assume that three waves will be needed to recruit and randomize at 
60 eligible participants, with up to three months of recruitment required per wave, 
and 15 to 20 eligible women randomized in each wave. This will allow for a minimum 
of ~8 women taking part in each class series in each intervention group. 
Screening: Preliminary eligibility will be determined by research coordinators through 
a Screening Telephone Interview followed by an in-person Screening Clinic Visit.  
During the Screening Telephone Interview, coordinators will follow a standardized 
screening interview script to assess preliminary eligibility related to age, gender, 
incontinence history, and exclusionary conditions and medications and document 
reasons for ineligibility on the screening interview form (see section 6.2.3, Screening 
Procedures, for more detail). Candidates who appear preliminarily eligible at the end 
of the screening telephone interview will be scheduled to attend an in-person 
Screening Clinic Visit. After providing written informed consent at this visit, women 
will undergo more detailed assessment of incontinence symptoms, use of clinical 
incontinence therapies, exclusionary medical conditions, exclusionary medications, 
urine dipstick and pregnancy testing (for women of childbearing potential), and brief 
physical function assessment (see description of study procedures below), with 
reasons for eligibility or ineligibility documented on the screening clinic intake form.   

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At the end of the Screening Clinic Visit, women who appear eligible will be given a 
blank voiding diary and instructions for completing it at home over a 3-day period and 
returning it to study staff at a Baseline Clinic Visit. Those who are confirmed to have 
stress-predominant, urgency-predominant, or mixed urgency-stress incontinence 
occurring at least 3 times over the 3-day diary period and meet all other 
inclusion/exclusion criteria at the Baseline Clinic Visit will be considered eligible for 
randomization to one of the two intervention groups. 
Randomization: During each recruitment/randomization wave, eligible women will be 
randomized in a 1:1 ratio to one of the two intervention groups. Randomization will 
be stratified by clinical type of incontinence (i.e., stress, urgency, or mixed), to 
ensure adequacy of randomization within these three types. Randomization will be 
implemented by computer algorithm using randomly permuted blocks of sizes 2 and 
4, with proof of eligibility required before assignment. To avoid manipulation, 
standard allocation concealment procedures will be followed (see section 6.2.4. on 
Randomization for more detail).   
To avoid excessive lag time between randomization and the start of the yoga therapy 
or physical conditioning programs, randomization will take place within two weeks of 
the yoga or physical conditioning program orientation session. For candidates whose 
Baseline Clinic Visit falls within this two-week window, randomization will take place 
directly at the Baseline Clinic Visit. For candidates who complete their Baseline Clinic 
Visit more than two weeks before the start of the yoga or physical conditioning 
intervention programs, a Randomization Telephone Call will be scheduled to 
complete randomization within the two-week window. 
5.  STUDY INTERVENTIONS  
5.1 
Yoga Therapy Program  
Overview and rationale: The 12-week yoga therapy program will provide instruction 
and practice in a variety of yoga postures and techniques that have been selected by 
the study yoga expert consultants for their potential to improve bladder control and 
safety and feasibility for the target population. The study will feature a therapeutic 
program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its 
potential therapeutic applications, has been employed successfully in other studies 
of yoga for different indications,32,34,38-44 and differs from other Hatha yoga styles 
(power yoga, bikram yoga) in multiple ways that are likely to maximize both efficacy 
and safety for this study. These include: 1) emphasis on precise anatomical and 
postural alignment during practice of yoga postures; 2) incorporation of props to 
minimize risk of injury and accommodate those with lower strength or flexibility; 3) 
emphasis on mindful awareness during practice of postures rather than rapid cycling 
through postures. The resulting yoga program, which was pre-tested and refined in 
the investigators’ pilot LILY trial,37 is designed to maximize women’s awareness of 
and control over the pelvic floor and improve underlying stress and anxiety, while still 
being feasible for ambulatory women across a wide range of ages, as well as 
grounded in techniques common to Iyengar yoga at large.  
Content and postures: The study yoga program will focus on a core set of 14 
postures that are widely used in yoga practice, have been pre-tested in the 
investigators’ earlier pilot study, and can be safely adapted for ambulatory women of 
all ages, including those with moderately decreased flexibility or mobility. These 

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include both active postures engaging the pelvic floor and more passive postures 
promoting relaxation: Baddha Konasana (bounded angle pose), Bharadvajasana 
(seated twist pose), Malasana (squat pose), Parsvokonasana (side angle pose), 
Parsvottasana (intense side stretch pose), Salabhasana (locust pose), Savasana 
(corpse pose), Salamba Set Bandhasana (supported bridge pose), Supta Baddha 
Konasana (reclined cobbler’s pose), Utkatasana (chair pose), Supta 
Padagushthasana (reclined big toe pose), Tadasana (mountain pose), Trikonasana 
(triangle pose), Viparita Karani Variation (legs up the wall pose), and Virabhadrasana 
2 (warrior 2 pose). 
Staff qualifications and training: Each yoga therapy class series will be led by a 
primary instructor who will: 1) have at least 2 years of experience teaching yoga in 
the community; 2) review a detailed, study-specific written instructor manual 
describing all of the postures and yoga techniques to be used in the study program; 
3) complete at least 2 hours of in-person training in study-specific techniques with 
one of the study yoga expert consultants (Leslie Howard or Judith Lasater); 4) 
complete study-specific training in documentation of participant attendance, review of 
home practice logs, and recording of yoga postures practiced during group classes 
on appropriate study forms; 5) carry and submit proof of personal liability insurance 
(minimum of $2 million coverage); and 6) confirm his or her willingness to adhere to 
the study intervention procedures. To maximize the generalizability of the study 
results and minimize observed effects due to specific providers, different primary 
instructors will be sought for each yoga class series. For each class series, a back-
up instructor will also be identified who can teach a class in the event that the 
primary instructor is ill or is unable to teach due to an emergency. 
Orientation and classes:  Prior to group instruction, participants in each class series 
will attend a 90-minute group orientation led by an appointed class instructor. This 
will include an overview of the general principles of Iyengar yoga, an orientation to 
the structures of the pelvis, spine, and lower extremity, and an introduction to the 
yoga postures and the props to be used in the study. After the orientation, women 
will attend 90-minute group classes twice weekly for 12 weeks, led by the same 
instructor as well as an assistant to provide personalized attention to students. 
During group classes with an expected size of 8 to 15 participants, the instructor will 
guide women in practicing yoga postures, calling attention to ways in which postures 
can improve pelvic floor function and adapt postures to accommodate physical 
limitations. Women will also be taught to avoid habits that may worsen incontinence 
during practice, such as squeezing of abdominal rather than pelvic muscles. 
Following a study-specific guide, instructors will gradually introduce postures as 
classes progress, with the goal of making participants comfortable with all core 
postures by the end of 8 weeks and fully confident in performing postures by 12 
weeks. 
Home practice: In addition to attending group classes, participants will be asked to 
practice yoga at home at least one additional time per week and will be given a diary 
to keep track of the dates and times of practice.  Women will also be given a written 
manual, pre-tested in the pilot LILY study,37 that includes pictures and descriptions of 
each yoga posture to guide them in home practice. Each participant will be given a 
limited set of yoga props (a mat, belt, and 2 blocks) for home practice.  Women will 
be encouraged to practice with other members of their classes, but will be 
discouraged from practicing with individuals who are not in their class and from 
taking part in non-study yoga activities that might dilute study techniques. After the 

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end of the main 12-week study period, participants will be encouraged to continue 
practice yoga at least one hour per week at home, although they will not continue to 
attend study-specific group classes. 
Quality and safety: The study program will incorporate multiple modifications to help 
women across the age range to perform postures in ways that minimize risk of 
muscle strain or injury. Participant manuals will include specific instructions on 
adapting each posture and/or using props to accommodate problems with mobility, 
flexibility, or balance. To promote quality and safety, the instructors leading classes 
will be required to have at least 2 years of experience teaching yoga and have 
completed dedicated, study-specific training with the study’s expert consultants. 
Following procedures established in the pilot study, a consultant will visit at least one 
class in each series to ensure that postures are being taught according to protocol, 
evaluate students’ success in learning yoga, and ensure fidelity across instructors.  
Monthly conference calls will be conducted to help instructors trouble-shoot issues 
that arise in instruction. 
5.2 
Physical Conditioning Control Program  
Overview and rationale: This trial will include a 12-week physical conditioning 
program that will provide a rigorous time-and-attention control for the yoga program, 
but has been designed to avoid engaging the pelvic floor or promoting mindful 
relaxation. To minimize differential expectations of treatment success, women will be 
told that they are enrolling in a study of two different types of low-impact physical 
activity-based interventions (yoga versus physical conditioning) to enhance 
management of incontinence. Physical conditioning exercises have been adapted 
from exercises used in prior studies conducted by the investigators, such as the 
PRYSMS trial of restorative yoga vs. stretching for metabolic syndrome (designed by 
Sarah Pawlowsky, DPT, consultant on this proposal), in which participants 
maintained good adherence to the stretching program despite a long study period.  
Similar to postures in the yoga therapy program, the exercises in the physical 
conditioning program have been selected for their potential to be performed safely by 
women across a range of ages and flexibility levels. 
Content and exercises:  After a brief education about sitting and standing posture, 
the physical conditioning program will focus on a core set of stretching/strengthening 
exercises that will be performed sitting in a chair: levator scapulae, upper trapezius, 
scalenes, shoulder horizontal adduction, triceps, pectoral stretch with hands behind 
head, wrist flexors and extensors, trunk flexion, trunk extension, trunk side-bend, 
trunk rotation, and hamstring stretches.  Additional chair exercises will incorporate a 
stretching strap: pectoral stretch with strap, gastrocnemius stretch with strap, and 
hand behind back with strap.  A few stretches will be performed on an exercise mat 
on the floor: supine single knee to chest, supine hamstrings stretch with strap, 
quadriceps stretch with strap, supine shoulder flexion with stretch strap, and seated 
adductor stretch. Three exercises will be performed in the standing position: 
gastrocnemius, soleus, shoulder flexion, and shoulder abduction stretches. 
Staff qualifications and training: Each physical conditioning class series will be led by 
a primary instructor who: 1) is either certified as a personal trainer through the 
National Academy of Sports Medicine or the American College of Sports Medicine, 
or licensed as a physical therapist by the Physical Therapy Board of California; 2) 
has at least 2 years of experience working as a physical therapist or physical trainer 
in either individual or group settings; 3) will have reviewed a detailed, study-specific 

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training manual describing all of the stretching/strengthening exercises to be used in 
the study program; 4) will have completed at least 2 hours of in-person training in 
study-specific techniques with study expert consultant Sarah Pawlowsky, DPT; 5) will 
have completed study-specific training in documentation of participant attendance, 
review of home practice logs (for adherence), and recording of exercises performed 
during group classes on appropriate study forms; 6) carries and submits proof of 
personal liability insurance (minimum of $2 million coverage); 7) confirms his or her 
willingness to adhere to the study intervention procedures. To maximize the 
generalizability of the study results and minimize observed effects due to specific 
providers, different primary instructors will be sought for each class series. For each 
class series, a back-up instructor will also be identified who can teach a class in the 
event that the primary instructor is ill or is unable to teach due to an emergency. 
Group orientation and classes: Similar to the yoga therapy program, the physical 
conditioning program will begin with a group orientation led by a physical therapist or 
trainer and an assistant, who will provide an overview of the stretching/strengthening 
exercises to be covered in the program. This will be followed by 90-minute twice 
weekly group classes, each with 8 to 15 participants, led by the same therapist and 
assistant, who will have received in-person study-specific training from consultant 
Sarah Pawlowsky, DPT. Classes will be designed to make women comfortable with 
all stretching/strengthening exercises by 8 weeks and fully confident in performing 
exercises by 12 weeks. 
Home practice: In addition to attending group classes, women will be asked to 
perform stretching/strengthening exercises at home at least one additional time per 
week and record the dates and times of practice in a log. Women will receive a 
detailed manual with pictures and descriptions of each stretching/strengthening 
exercise to guide them in home practice, as well as a stretch strap and exercise mat 
to use at home. After the end of the main 12-week study period, participants will be 
encouraged to continue practice stretching/strengthening exercises at least one hour 
per week at home, although they will not continue to attend study-specific group 
classes. 
Quality and safety:  Instructors leading physical conditioning classes will be physical 
therapists or trainers who have at least 2 years of experience working with adults of 
a range of ages and have completed dedicated in-person training with Sarah 
Pawlowsky, DPT.  Dr. Pawlowsky will provide quality monitoring and assess 
women’s success in learning stretching/strengthening exercises by making an in-
person visit to at least one class in each series. She will also lead monthly 
conference calls with instructors, similar to quality monitoring for the yoga program.  
5.3 
Concomitant Interventions  
5.3.1 Required Interventions 
Participants in both intervention groups will also receive a pamphlet at the 
Baseline Clinic Visit that provides basic patient-directed information about 
first-line behavioral self-management of incontinence, including pelvic muscle 
exercises, timed urination, and urge suppression. This pamphlet is consistent 
with usual care of incontinence in the general community, and has been used 
in previous studies of experimental treatments for incontinence conducted by 
the investigators.45 Since information about behavioral self-management of 
incontinence is available from multiple websites and public resources, 

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systematic provision of this information will help avoid differential use of self-
management techniques between treatment groups, and will also reflect 
expected concomitant use of these techniques with yoga in clinical practice.  
Participants will be queried about use of these techniques at baseline, at the 
8-week and 12-week clinic visits, and as part of the 24-week assessment, so 
that information about co-interventions can be incorporated into data 
analyses if appropriate. 
5.3.2 Prohibited Interventions 
Participants will be asked to refrain from using other clinical treatments for 
incontinence during the 12-week intervention period as well as the 12-week 
post-treatment follow-up period. These include medications with the potential 
to affect incontinence symptoms (anticholinergic bladder medications, 
selective norepipherine reuptake inhibitors, tricyclic antidepressants, 
mirabegron), invasive or surgical bladder treatments, medical devices used to 
improve bladder symptoms (e.g., pessary), and behavioral treatment 
programs administered by certified practitioners (e.g., pelvic floor 
rehabilitation therapy, biofeedback programs). Additionally, participants will 
be asked to refrain from starting or changing the dosage of medications that 
could affect anxiety and perceived stress symptoms (e.g., antidepressants, 
sedatives/hypnotics, or antipsychotic agents), although maintenance of stable 
dosages of these medications will be acceptable. 
Participants will be queried about use of these prohibited interventions at 
baseline, at the 8-week and 12-week clinic visits, and as part of the 24-week 
assessment. If participants are found to be using prohibited interventions, 
they will not be required to terminate the study early, but study staff will also 
re-urge participants to avoid using prohibited interventions if at all possible 
(although this may not be possible for some types of interventions), and 
information about use of prohibited interventions can be taken into account in 
data analyses. 
5.4 
Adherence Assessment  
Adherence to group yoga and physical conditioning classes will be documented by 
the study class instructors using standardized attendance logs. Attendance logs will 
be returned to clinical coordinators on at least a weekly basis throughout the yoga 
therapy and physical conditioning programs. Clinical coordinators will immediately 
contact any participant who misses a scheduled class to ask about reasons for 
missing the class, reinforce the importance of class attendance, and troubleshoot 
any barriers to attendance. 
Adherence to home practice of yoga or stretching/strengthening exercises will be 
tracked using home practice logs. Participants will be instructed to record the date, 
time, and duration of each home practice session in their logs, as well as the specific 
yoga poses or stretching/strengthening exercises practiced during each session.  
Home practice logs will be collected by class instructions and returned to the clinical 
coordinators on a weekly basis during the 12-week treatment program. Clinical 
coordinators will contact any participant whose log indicates that she is not practicing 
yoga or stretching exercises at least one hour a week at home. Additionally, home 
practice logs will be returned by mail 12 weeks after the end of the intervention 
program to assess home practice during the post-treatment follow-up period. 

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Every effort will be made to encourage participants to complete all intervention 
classes and practice sessions. Prior to randomization, study coordinators will stress 
the importance of adherence to group classes and home practice, and only those 
women who indicate that they are available on scheduled class dates and willing to 
practice yoga or stretching exercises at home as recommended will be eligible for 
randomization. The importance of adherence will again be stressed at the orientation 
session for each yoga or physical conditioning series, as well as during follow-up 
telephone calls 2 weeks and follow-up visits at 8 weeks. Additionally, attendance 
sheets from yoga and stretching classes will be carefully monitored, and home 
practice logs will be reviewed weekly, so that study staff can immediately call any 
women who miss classes or fail to document home practice in order to reinforce the 
importance of attendance/practice and troubleshoot barriers to adherence. 
6.  STUDY PROCEDURES  
6.1 
Study Measures 
6.1.1  Urinary Incontinence 
The primary efficacy outcome, frequency of any urinary incontinence, will be 
assessed using a 3-day voiding diary that has been shown to be a valid and 
reliable method for documenting change in incontinence symptoms and is 
widely used in clinical trials of incontinence treatments.46,47  At 
screening/baseline, 8 weeks, 12 weeks, and 12 weeks after the end of the 
yoga and physical conditioning programs (24 weeks), each participant will 
receive written instructions and a blank diary to take home, and will use the 
diary to record all voiding and incontinence episodes over a 3-day period and 
classify incontinence episodes by clinical type (urgency, stress, other). Upon 
return of the diary, an analyst will abstract data to determine the number of 
total as well as urgency and stress incontinence episodes per day. For diaries 
that are completed after randomization, data will be abstracted by an analyst 
who is blinded to treatment assignment. 
6.1.2  Condition-Specific Quality of Life  
To address incontinence-related quality of life, participants will complete the 
following validated questionnaire measures at baseline, 8 weeks, and 12 
weeks, as well as 12 after the end of the yoga and physical conditioning 
programs (24 weeks): 
A. Incontinence Impact Questionnaire (IIQ)-- a validated, 28-item measure of 
the impact of incontinence on 4 domains of functioning and quality of life 
(physical activity, emotional health, relationships, and travel).48,49 Scores 
range from 0 to 100; higher scores indicate worse impact.  
B.  Urogenital Distress Inventory-6 (UDI-6)-- a validated, 6-item measure that 
assesses subjective distress from frequent urination, urgency 
incontinence, stress incontinence, small-volume leakage, difficulty 
emptying the bladder, and genital pain.49 Scores are scaled from 0 to 100. 
C. Patient Perception of Bladder Condition (PPBC)-- a validated single-item 
measure assessing the degree to which respondents consider their 
condition to be a problem on a 6-point scale.50,51 

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6.1.3  Anxiety and Perceived Stress  
To evaluate anxiety and perceived stress symptoms that may be associated 
with incontinence, participants will complete the following validated 
questionnaire measures at screening/baseline, 8 weeks, and 12 weeks, as 
well as 12 weeks after the end of the yoga and physical conditioning programs 
(24 weeks): 
A. Spielberger State Trait Anxiety Inventory (STAI): Somatic anxiety (i.e., the 
affective component of anxiety believed to be related to autonomic 
physiological arousal response) will be measured using the trait 
component of the STAI, a 20-item self-administered measure validated in 
clinical populations, including patients with bladder symptoms, with scores 
ranging form 20 to 80.52,53 
B. Hospital Anxiety and Depression Scale (HADS): Cognitive anxiety (i.e., the 
mental component of anxiety associated with fear of failure) will be 
measured by the HADS, a validated self-administered questionnaire that 
includes a 7-item Anxiety Subscale54 shown to be sensitive to change in 
incontinence trials.55 Scores range from 0 to 21, with higher scores 
indicating greater anxiety. 
C. Perceived Stress Scale (PSS): Perceived stress will be assessed by the 
PSS, a 10-item measure of thoughts and feelings related to perceived 
stress in the past month, validated in a probability sample of the United 
States.56 Scores range from 0 to 40; higher scores indicated greater 
stress. 
D. Center for Epidemiologic Studies Depression Scale (CES-D): Depressive 
symptoms will be assessed by the CES-D, a 20-item measure that has 
been widely used in clinical trials, including bladder interventions, and is 
sensitive to change.57 Total scores range from 0 to 60. 
6.1.4  Yoga/Physical Conditioning Self-efficacy and Competency 
A. Yoga Posture Self-Efficacy: At 8 weeks and 12 weeks, as well 12 weeks 
after the end of the yoga therapy program (24 weeks), women in the yoga 
group will complete a structured questionnaire (modeled after an existing 
self-efficacy measure 58 and pre-tested in the investigators’ previous pilot 
study) to indicate how confident they are that they can perform each of the 
postures featured in the program (from ‘not at all’ to ‘extremely confident’). 
Total scores will range from 0 to 56, with higher scores indicating greater 
confidence. A corresponding questionnaire will be administered to the 
physical conditioning group participants. 
B. Independent Yoga Competency Assessment: To provide a more objective 
assessment of women’s success in learning yoga, a yoga expert 
consultant will attend one class at the end of each series and observe 
women as they practice yoga. The consultant will rate each woman’s 
success in performing each yoga posture on a 5-point scale, ranging from 
“not at all” to “extremely” successful. Total scores will range from 0 to 56.  
In the physical conditioning control group, Sarah Pawlowsky, DPT, will 
provide similar assessments. 
C. Yoga Practice Adherence Self-Efficacy: At 8 weeks and 12 weeks, as well 
12 weeks after the end of treatment (24 weeks), women will complete a 
measure of confidence in adhering to yoga or stretching practice, modeled 
after existing physical activity adherence self-efficacy scales 59 and tested 

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in the pilot study. Women will indicate on a 5-point scale how confident 
they are that they can practice yoga or stretching when they: 1) are tired, 
2) are in a bad mood, 3) have limited time, 4) are away from home, and 5) 
are not regularly attending yoga classes. Scores will range from 0 to 20. 
D. Credibility and Expectations of Treatment: To assess whether women 
perceive the yoga and physical conditioning interventions as equally 
credible and have similar expectations for improvement in incontinence, 
we will administer a modified version of an expectancy/credibility measure 
used in other women’s health studies at baseline.60 
6.1.5  Additional Screening and Covariate Measures  
The following data will be collected to assess eligibility, assess whether 
treatment groups are comparable at baseline, and guide statistical adjustments 
in the event groups are not balanced: 
A. Demographic history including date of birth, gender/sex, race/ethnicity, 
education history, employment history, marital status (screening/baseline) 
B. Urologic/urogynecologic history including age of onset of incontinence, past 
and current treatment of incontinence, history of pelvic surgery, history of 
pregnancy and delivery, menstrual/menopausal status (screening/baseline) 
C. General medical history including general health assessed by the CDC 
Healthy Days module,61 selected medical conditions associated with 
incontinence such as diabetes, and current medication use 
(screening/baseline and 12 weeks) 
D. Health-related habits such as tobacco/alcohol use, prior yoga experience, 
prior group-based physical activity instruction, physical activity level by the 
International Physical Activity Questionnaire62,63 (screening/baseline) 
E. Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI),39,40 a 
validated questionnaire evaluating sleep quality, latency, efficiency, and 
problems (screening/baseline, 8 weeks, 12 weeks, 24 weeks) 
F. Physical exam measures including measured height, weight, heart rate, and 
blood pressure (screening/baseline, 8 weeks, and 12 weeks) 
G. Physical function including self-reported function using the PROMIS Adult 
Physical Function Profile short-form.64 Participants will also undergo direct 
physical mobility evaluation using the Short Physical Performance Battery65 
(screening/baseline, 8 weeks, and 12 weeks). 
6.2 
Evaluations  
6.2.1 Screening Evaluations 
Screening evaluations will be conducted by study coordinators based at 
outpatient facilities at 2330 Post Street on the Mt. Zion campus of UCSF, 
which contain all equipment needed for screening assessments.  Screening 
procedures will include a brief preliminary Screening Telephone Interview, 
followed by an in-person Screening Clinic Visit, completion of a 3-day voiding 
diary at home, and review of the diary at an in-person Baseline Clinic Visit. All 
screening procedures must be completed within a 90-day period in order for 
participants to be eligible for randomization.  If screening procedures cannot 
be completed within 90 days, initial screening procedures must be repeated 
to ensure that participant eligibility has not changed prior to randomization. 

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6.2.2   Consenting Procedure 
Prior to administration of any data collection instruments, signed consent will 
be obtained by a research coordinator at the beginning of the Screening 
Clinic Visit. A single informed consent process will be used that will cover 
both the screening and post-randomization procedures. All participants must 
be able to read and understand the consent form in English and must provide 
written informed consent before enrolling in the study. Following the UCSF 
IRB-approved template (see Appendix A), the consent form will describe the 
purpose of the study, the procedures involved in recruiting, randomized, and 
monitoring participants, and the potential risks and benefits associated with 
participation. A study coordinator will first explain the study procedures to the 
potential participant, referring as necessary to the detailed IRB-approved 
consent form. The coordinator will then give a paper copy of the consent form 
to the potential participant to read. After the potential participant has read the 
consent form, she will be asked if she has any questions or concerns about 
the study. Once these questions/concerns have been addressed, the 
participant will be asked to sign the consent form, and will be given a copy of 
the consent form to take home for future reference. Coordinators will also 
have each participant read and sign a HIPAA authorization form granting 
study staff permission to access protected health information if needed. 
Pursuant to California Health & Safety Code 24172, each participant will also 
receive a copy of the Experimental Subject's Bill of Rights. A copy of the 
signed consent form and HIPAA authorization form will be stored in the 
participants’ chart in locked research offices.  
6.2.3   Screening Procedures 
Telephone Screening Interview 
 Women who call in response to recruitment advertisements or who have 
previously given permission to be contacted about opportunities to 
participate in women’s health research at UCSF will be provided with a 
brief overview of the study goals and procedures by a clinical coordinator 
over the telephone. 
 If interested, candidates will complete a brief telephone survey to assess 
preliminary eligibility (including age, gender, duration/frequency/type of 
incontinence, current and past incontinence treatment, prior yoga practice, 
physical mobility, exclusionary conditions and medications, availability for 
upcoming yoga therapy or physical conditioning classes). 
 
Screening Clinic Visit 
 At this visit, a clinical coordinator will explain the requirements of the study 
while referring to the detailed informed consent form, and candidates will 
provide written informed consent if they are still interested in proceeding 
with the study. 
 Candidates will complete questionnaires about their demographic, 
urologic/urogynecologic, and medical history to determine if they meet 
criteria related to age, gender, duration/frequency/type of incontinence, 
current and past incontinence treatment, prior yoga practice, exclusionary 
conditions and medications 

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 Over-the-counter and prescription medications will be reviewed to 
determine if candidates are taking any exclusionary medications. 
 Height, weight, and resting blood pressure and pulse measurements will 
be obtained. 
 Physical function will be assessed by questionnaire. 
 A clean-catch urine sample will be collected to assess for possible urinary 
tract infection and rule out pregnancy (for the minority of candidates who 
are still of child-bearing potential).   
 Potentially eligible women will be instructed on completing a 3-day voiding 
diary to document all incontinence and voiding episodes at home. 
 A Baseline Clinic Visit will be scheduled at least 3 days later for review of 
the completed voiding diary and determination of final eligibility. 
 
Baseline Clinic Visit 
 Candidates will return with the completed 3-day voiding diary, and results 
will be reviewed by a clinical coordinator. Candidates whose diaries 
indicate predominantly urgency, stress, or mixed-type incontinence, 
document at least 3 incontinence episodes per 3-day diary, and meet all 
other eligibility criteria will be eligible to continue.   
 Women will complete structured questionnaires about anxiety and 
perceived stress, incontinence-specific quality of life, and sleep quality.   
 Physical function will be assessed by direct physical mobility evaluation. 
 Participants will be given a brief written pamphlet about usual first-line 
behavioral management of incontinence (see description in interventions 
section above).  
 If the Baseline Clinic Visit takes place within 2 weeks of the start of the 
yoga or physical conditioning program orientation session, eligible 
participants will be randomized to one of the two interventions at this visit. 
 If the Baseline Clinic Visit takes place more than 2 weeks before the start 
of the yoga or physical conditioning program, eligible participants will be 
scheduled for a Randomization Telephone Call within two weeks of the 
start of the program to determine their intervention assignment. 
6.2.4 Randomization and Blinding 
Randomization 
Women who are confirmed to be eligible and available to take part in 
upcoming yoga or physical conditioning group class series will be randomized 
in a 1:1 ratio to one of the two intervention groups. Randomization will ideally 
take place within 1 month of completion of screening procedures, and in no 
cases will be able to take place more than 2 months after completion of 
screening procedures. Randomization must also take place within 2 weeks of 
the start of yoga or physical conditioning class series. If the Baseline Clinic 
Visit occurs within 2 weeks of the start of the yoga therapy or physical 
conditioning program, eligible participants will be randomized to one of the 
two interventions directly at this visit. If the Baseline Clinic Visit occurs more 
than 2 weeks before the start of the intervention program, eligible participants 
will be scheduled for a Randomization Telephone Call within two weeks of 
the start of the program to determine their intervention assignment. 
During the Baseline Clinic visit or during the Randomization Telephone Call 

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(whichever is appropriate), randomization will be performed according to a 
pre-established computer-algorithm using randomly permuted blocks of sizes 
2 and 4 (limited block size to ensure that the number of randomized 
participants within each strata always exceeds the block size).  
Randomization will be stratified by clinical type of incontinence (i.e., stress, 
urgency, or mixed) to ensure adequacy of randomization among women with 
each major incontinence type. Randomization will be implemented. Prior to 
randomization, the research coordinator will complete a randomization 
checklist confirming that the participant meets all eligibility criteria. 
Additionally, participants’ availability and willingness to attend upcoming yoga 
or physical conditioning group classes will be re-confirmed before 
randomization assignment is obtained. 
Standard allocation concealment procedures will be followed to avoid 
manipulation of randomization.66 Prior to the start of recruitment, the 
randomization scheme will be developed by a statistical programmer who will 
have no contact with participants or role in data entry, cleaning, or analysis.  
To execute the randomization scheme, a research assistant who will also 
have no contact with participants or access to study data will then prepare a 
series of sealed, opaque envelopes containing group assignment, numbered 
consecutively with the randomization sequence numbers. When the 
participant is ready for randomization, study coordinators will enter the date, 
participant name, and study ID in the randomization log and select the next 
numbered envelope corresponding to the participants’ type of incontinence 
(stress-, urgency-, or mixed-type) to determine group assignment. Once a 
participant has been randomized, she cannot be re-assigned to a different 
intervention group. All randomization envelopes will be retained for review; 
randomization dates and times should follow the order of the sequence 
numbers, providing a check on validity.   
Blinding 
Although participants cannot be blinded to treatment assignment (due to the 
behavioral nature of the intervention), study procedures have been carefully 
designed to avoid bias associated with knowledge of group assignment.  
First, to minimize differential expectations of treatment success, participants 
will be told that they are participating in a study of two different types of low-
impact group activity-based interventions to enhance self-management of 
incontinence, and that we do not know which is more effective (which is true). 
The primary outcome will be assessed by voiding diaries, a measure that is 
resistant to reporting bias, and data from returned diaries will be abstracted 
by blinded analysts. Similarly, data from participant follow-up questionnaires 
assessing other symptom and quality-of-life outcomes associated with 
incontinence will be abstracted by blinded analysts.   
Only study personnel who are involved in delivering the therapeutic 
interventions, assessing and promoting adherence to these interventions, 
and/or monitoring adverse events related to these interventions will be aware 
of group assignment. All investigators, study analysts involved in abstracting 
efficacy outcomes data, and statistical programmers involved in ongoing data 
cleaning will be blinded to treatment allocation. Unless stipulated by the Data 
and Safety Monitor or required to assist with the clinical management of a 
participant experiencing a serious adverse event, these investigators and 

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staff will remain blinded until after all participants have completed their final 
visit, trial data are edited and cleaned, and the trial dataset is locked.  A 
statistical programmer who is not involved in data collection or cleaning will 
be appointed to create the unblinded group-specific data tables for closed 
session Data and Safety Monitor reviews.   
6.2.5 Follow-up/Final Evaluations 
Follow-up evaluations will consist of a 2-week telephone call, 8-week clinic 
visit, 12-week clinic visit, and 24-week mail-in assessment: 
2-Week Telephone Call  
 
Two weeks after the start of the yoga therapy or physical conditioning 
program, coordinators will call women to assess adverse events, address 
any concerns, and reinforce adherence to group classes and home 
practice of yoga therapy or stretching/strengthening exercises.   
 
Adherence to and challenges in performing usual behavioral self-
management strategies for incontinence will also be assessed.   
 
Women will be reminded to continue recording home yoga or physical 
conditioning practice in their practice logs and return their logs each week 
to the yoga class instructors. They will also be reminded to start filling out 
a second voiding diary 3 days before the 8-Week Clinic Visit. 
 
8-Week Clinic Visit 
 
Eight weeks after the start of the yoga or physical conditioning program, 
women will return for a follow-up visit, bringing their second completed 
voiding diary.  
 
Voiding diaries will be retrieved by the research coordinator and delivered 
to a blinded analyst for data abstraction.  
 
Adverse events will be recorded using standardized forms (see safety 
monitoring section).  Adherence to yoga or stretching practice and 
incontinence self-management strategies will be re-assessed.   
 
Yoga/physical conditioning posture and practice self-efficacy 
questionnaire measures will be administered.     
 
Women will re-self-administer questionnaires about anxiety/stress 
symptoms, incontinence-specific quality of life, and sleep quality.  
 
Current use of prescription and over-the-counter medications will be re-
reviewed. 
 
Physical function will be re-assessed by questionnaire as well as by 
physical mobility testing. 
 
Women will be given a third voiding diary to complete before the 12-week 
visit, and the 12-week visit will be scheduled. 
 
12-Week Clinic Visit 
 
Twelve weeks after the start of the yoga or physical conditioning program, 
women will return for another clinic visit, bringing their third completed 
voiding diary.  
 
Voiding diaries will be retrieved by the research coordinator and delivered 
to a blinded analyst for data abstraction. 
 
Adverse events will be recorded using standardized forms (see safety 
monitoring section). 

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 
Yoga/physical conditioning posture and practice self-efficacy 
questionnaire measures will be re-administered.     
 
Women will re-self-administer questionnaires about anxiety/stress 
symptoms, incontinence-specific quality of life, and sleep quality.   
 
Current use of prescription and over-the-counter medications will be re-
reviewed. 
 
Physical function will be re-assessed by questionnaire as well as by 
physical mobility testing. 
 
A satisfaction questionnaire will be administered to assess overall 
satisfaction with study procedures and change in incontinence symptoms. 
 
Women will be encouraged continue practicing yoga or 
stretching/strengthening exercises for at least an hour per week for the 
next 12 weeks and record this practice in their home practice logs. 
 
24-Week Assessment 
 
Approximately twelve weeks after completion of the yoga or physical 
conditioning program, coordinators will call participants to them to 
complete their fourth and final voiding diary at home (the blank diary will 
be mailed in advance to participants at home). 
 
Adverse events will be assessed by telephone and recorded using 
standardized forms (see safety monitoring section). 
 
Women will also be asked to complete questionnaires addressing 
symptom, quality-of life, and sleep outcomes as well as yoga/physical 
conditioning practice adherence and self-efficacy at home (questionnaires 
will be mailed in advance to participants at home). 
 
Women will also be asked to complete a close-out satisfaction 
questionnaire addressing their overall satisfaction with study procedures 
and change in incontinence symptoms. 
 
Women will return with their final completed voiding diary and 
questionnaires using a pre-stamped and addressed envelope. 
 
Recommended time windows for completion each of the post-randomization 
follow-up evaluations will be as follows: 
Follow-Up Assessment 
Time Window 
2-week telephone call 
11 to 17 days after the start of the yoga therapy 
or physical conditioning program 
8-week clinic visit 
50 to 62 days (i.e., 8 weeks +/- 6 days) after the 
start of the yoga therapy or physical 
conditioning program 
12-week clinic visit 
78 to 90 days  (i.e., 12 weeks +/- 6 days) after 
the start of the yoga therapy or physical 
conditioning program 
24-week telephone and 
mail-in assessment 
Within 189 days (27 weeks) of the start of the 
yoga therapy or physical conditioning program 
(allowing time for return of mail-in packet) 
6.2.6 Early Termination (also see section 8 below) 
If a randomized participant opts to terminate the study before the 12-Week 
Clinic Visit, or if the principal investigator in consultation with the Data and 
Safety Monitor determines that early termination is necessary to protect the 

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safety of a participant, the study coordinator will encourage the participant to 
complete an early termination visit. This visit will include as many of the 
procedures originally scheduled to take place at the 12-Week Clinic Visit as 
possible, including: assessment of adverse events; re-administration of 
questionnaires about condition-specific quality of life, anxiety/stress 
symptoms, yoga or physical conditioning self-efficacy; review of current 
medications; re-assessment of weight, blood pressure, and heart rate; re-
assessment of physical function; and administration of a satisfaction 
questionnaire. The participant’s reasons for terminating the study early will be 
explored and documented in her study file. 

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6.2.7  Table of Measures and Procedures 
Summary of Measures and Procedures at Study Visits 
 
Screening 
Phone Call 
Screening 
Clinic Visit 
Baseline 
Clinic Visit 
Randomization 
Phone Call 
2-Week 
Phone Call
8-Week 
Clinic Visit 
12-Week 
Clinic Visit
12 week post-
treatment 
Brief telephone screening interview 
X 
 
 
 
 
 
 
 
Informed consent and HIPAA authorization 
 
X 
 
 
 
 
 
 
Demographic/urogynecologic history questionnaires 
 
X 
 
 
 
 
 
 
Health-related habits questionnaire 
 
X 
 
 
 
 
 
 
Review of current medications 
 
X 
 
 
 
X 
X 
 
Physical function assessment 
 
X 
 
 
 
X 
X 
 
Mobility assessment 
 
 
X 
 
 
X 
X 
 
Height, weight, blood pressure, and pulse measures 
 
X 
 
 
 
 
X 
 
Urine dipstick testing 
 
X 
 
 
 
 
 
 
Urine pregnancy testing (if appropriate) 
 
X 
 
 
 
 
 
 
3-day voiding diary return 
 
 
X 
 
 
X 
X 
X 
Review of eligibility and randomization  
 
 
X* 
X* 
 
 
 
 
Incontinence self-management pamphlet 
 
 
X 
 
 
 
 
 
Assessment of credibility/expectations of treatment 
 
 
 
X 
 
 
 
 
Incontinence Impact Questionnaire 
 
 
X 
 
 
X 
X 
X 
Urogenital Distress Inventory-6 
 
 
X 
 
 
X 
X 
X 
Patient Perception of Bladder Condition 
 
 
X 
 
 
X 
X 
X 
Spielberg State-Trait Anxiety Inventory  
 
 
X 
 
 
X 
X 
X 
Hospital Anxiety and Depression Scale  
 
 
X 
 
 
X 
X 
X 
Perceived Stress Scale  
 
 
X 
 
 
X 
X 
X 
Center for Epidemiologic Studies Depression Scale 
 
 
X 
 
 
X 
X 
X 
Pittsburg Sleep Quality Index 
 
 
X 
 
 
X 
X 
X 
Adverse events assessment 
 
 
 
 
X 
X 
X 
X 
Yoga/physical conditioning self-efficacy 
questionnaires 
 
 
 
 
 
X 
X 
X 
Assessment of co-interventions 
 
 
 
 
 
X 
X 
X 
Satisfaction/close-out questionnaire 
 
 
 
 
 
 
X 
X 
 
*Randomization will take place at either the Baseline Clinic Visit or the Randomization Phone Call

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7. SAFETY ASSESSMENTS  
7.1 
Potential Risks and Protective Measures 
Although participation in this study is not expected to place participants at substantial 
risk of harm, study procedures may be associated with the following risks: 
 
Yoga Therapy Intervention:  Possible risks associated with group yoga instruction 
and home yoga practice include muscle soreness and muscle/ligament strain, or 
other musculoskeletal injury if participants fall or lose their balance while trying to 
practice the yoga poses. 
 
Physical Conditioning Control Intervention:  Similar to the yoga therapy 
intervention, possible risks associated with physical conditioning control 
intervention include muscle soreness and muscle/ligament strain, or 
musculoskeletal injury if participants fall or lose their balance while trying to learn 
or practice the exercises. 
 
Questionnaires and Diaries: Although the information participants provide on 
data collection forms and diaries is confidential, some participants may feel 
embarrassed at having to answer questions, especially those related to 
incontinence symptoms or anxiety/stress symptoms.  However, loss of 
confidentiality is unlikely to pose any significant legal or financial risk to 
participants. 
 
Physical Examination/Performance Measurements:  There are no direct risks 
associated with undergoing measurement of height, weight, blood pressure, or 
heart rate, or evaluation of physical mobility, although participants may 
experience this as inconvenient or unpleasant. 
 
Behavioral Incontinence Self-Management Pamphlet:  Provision of standard 
written information on usual first-line behavioral self-management strategies for 
incontinence such as pelvic floor muscle exercises and timed urination should 
pose no risks to participants, although participants may find it inconvenient or 
unpleasant to read the pamphlet. 
 
Urine Dipstick and Pregnancy Testing: There are no direct risks associated with 
collection of the screening urine sample, although some participants may 
experience this as inconvenient or unpleasant. 
To minimize potential risks to participants associated with study interventions and 
procedures, the following steps will be taken: 
 
Yoga Therapy Intervention.  The instructors leading the group yoga classes will 
be trained yoga teachers who will have experience in guiding adults from a wide 
range of ages to learn and practice yoga safely and will undergo specific, in-
person training by the study’s yoga expert consultants.  The study protocol 
incorporates props such as blocks and straps to help participants perform yoga 
postures in such a way that will minimize the chance of muscle strain or other 
injury.  The yoga instruction manuals have been designed to include explicit tips 
on modifying or adapting postures to accommodate problems with mobility, 
flexibility, or balance. 
 
Physical Conditioning Control Intervention:  Instruction for the physical 
conditioning control classes will be provided trained physical therapists or 

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personal trainers who are experienced in teaching patients of all ages to perform 
stretching and strengthening exercises safely, and who will have completed in-
person training with co-investigator Sarah Pawlowsky, PT.  
Stretching/strengthening exercises have been selected to be appropriate for 
middle-aged and older women who may have flexibility or mobility limitations in 
addition to incontinence. 
 
Questionnaires and Diaries. All study questionnaires and diaries will be stored in 
a locked file cabinet in a locked room in our research clinic, or on password-
secured servers. All study staff are fully trained in good clinical practice, HIPAA 
procedures, and the importance of participant confidentiality is emphasized. 
 
Physical Examination/Performance Measures.  Study personnel responsibility for 
performing physical exam measures and evaluating physical mobility will have 
prior clinical experience with performing physical exam measurements in middle-
aged and older women and will receiving study-specific training to ensure that 
they perform measurements in a manner that is sensitive and minimizes 
discomfort to participants. 
 
Urine Dipstick and Pregnancy Testing.  Study coordinators will receive training 
on obtaining screening urine samples in a manner that is sensitive and minimizes 
discomfort to participants. 
 
Behavioral Incontinence Self-Management Pamphlet:  Study coordinators will be 
available to answer participants’ questions about the pamphlet if they arise. 
7.2 
Methods and Timing of Safety Assessments 
To monitor participant safety, a clinical coordinator will assess for adverse events at 
each follow-up telephone and in-person contact following randomization, starting with 
the 2-Week Telephone Call. Negative changes in health will be recorded as adverse 
events or serious adverse events on standardized forms as appropriate (see 
sections 7.3 and 7.4 below for definitions and documentation). Additionally, if 
participants contact clinical coordinators in between scheduled study visits and calls 
and report negative changes in their health, these will also be recorded as adverse 
events or serious adverse events. 
Coordinators will not prompt participants to provide information about specific types 
of adverse events at follow-up visits, but instead encourage participants to volunteer 
information by asking the standardized, open-ended question, “Have there been any 
changes in your health since your last visit?”  Any negative changes in health 
reported by participants will then be recorded on standardized AE or SAE forms, as 
appropriate (see section 7.3 below).   
7.3     Adverse Events and Serious Adverse Events    
7.3.1  AE/SAE Definitions  
An Adverse Event (AE) is any untoward medical occurrence in participant that 
occurs during the study or with use of the study interventions. An adverse 
finding can include a sign, symptom, abnormal assessment, or any 
combination of these. Medical conditions or diseases present before starting 
study interventions will only be considered adverse events if they worsen 
after starting the intervention. 
A Serious Adverse Event (SAE) is any AE that results in death, a life-

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threatening event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant disability/incapacity, a congenital 
anomaly or birth defect, or any other important medical event that jeopardizes 
the safety of participants based upon appropriate medical judgment. 
7.3.2  AE/SAE Documentation 
All negative changes in health reported by participants will be recorded on 
standardized AE or SAE forms, as appropriate. Each adverse event will be 
assigned an AE number and will be recorded on a separate AE form to avoid 
duplication in reporting. For each AE, clinical coordinators will record the date 
of onset and resolution of the AE and record the nature or type of AE.  Based 
on information provided by the participant, coordinators will also classify the 
severity of the AE as “mild” if it does not have a noticeable impact on the 
patient, “moderate” if it causes the patient some inconvenience, or “severe” if 
it results in substantial disruption to the patient’s functioning or well-being. In 
consultation with the principal investigator, coordinators will also indicate 
whether any indicate whether any specific action such as discontinuation of 
the study intervention was taken in response to the AE.   
Each serious adverse event will be assigned an SAE number and recorded 
on an SAE form.  Similar to regular AEs, clinical coordinators will record the 
date of onset and resolution of each SAE and record the nature or type of 
SAE. Coordinators will also document any treatment provided for the SAE, 
indicate any laboratory or other clinical data obtained about the SAE, indicate 
the participant’s condition at the time of reporting of the SAE, and indicate 
whether any specific action such as study discontinuation was taken in 
response to the SAE. Each SAE form will be reviewed and signed by the 
principal investigator, who will use a standard attribution scale to indicate the 
potential relationship between any SAEs and study interventions (not, 
unlikely, possible, probably, or definitely related to study intervention). 
7.4 
Reporting Procedures 
 
 
7.4.1   SAE Reporting 
 
Clinical coordinators will notify the principal investigator immediately when 
a SAE is discovered, in addition to filling out a standardized SAE form 
that will be reviewed and signed by the principal investigator (see section 
7.3.3 above regarding SAE documentation). 
 
The principal investigator will then report any deaths to the institutional 
review board at the University of California San Francisco, the 
independent Data and Safety Monitor (DSM), and the NCCIH program 
officer within 24 hours of awareness of the event.   
 
Other unexpected serious adverse events that are potentially 
intervention-related will be reported by the principal investigator to the 
UCSF IRB, the DSM, and the NCCIH Program Officer within 48 hours of 
learning of the event.  
 
Anticipated or unrelated SAEs will be handled in a less urgent manner but 
will also be reported to the UCSF IRB and the DSM within 1 week of 
awareness of the event, and at least quarterly to the NCCIH Program 
Officer.  Of note, no SAEs that are directly related to the study procedures 
are currently anticipated. 

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7.4.2   Non-Serious AE Reporting 
 
 
If a clinical coordinator discovers an AE that does not meet the definition 
of a SAE but may still pose a substantial risk of harm to a participant and 
is potentially associated with study interventions or procedures, he/she 
will report the AE to the principal investigator within 1 working day, in 
addition to filling out a standardized AE form. 
 
Cumulative trends in all non-serious adverse events will be reviewed by 
the principal investigator and the DSM at scheduled DSM meetings (see 
below for DSM meeting schedule). More frequent review of non-serious 
adverse events may be performed if recommended by the DSM or 
desired by the principal investigator.  
 
Although the UCSF IRB does not require reporting of non-serious AEs to 
the UCSF IRB, the principal investigator may consult the UCSF IRB for 
input on handling of non-serious AEs if they may still pose a substantial 
risk of harm to a participant or are potentially associated with study 
interventions or procedures.   
7.5 
Follow-up for AEs/SAEs 
From the time that they are first reported by participants until the end of the study, 
AEs and SAEs will be followed until resolved or considered stable. At each 
scheduled follow-up contact after initial discovery of an AE or SAE, a clinical 
coordinator will assess whether the AE or SAE is continuing or has resolved, and will 
update information about event status on the AE or SAE form, as appropriate. For 
SAEs, the clinical coordinator or principal investigator will also make more active 
attempts to communicate with participants in between scheduled study visits (with 
their permission) in order to monitor resolution of SAEs.   
7.6 
Independent Safety Monitoring  
The conduct of the study and safety of participants will be evaluated by an 
independent Data and Safety Monitor (DSM), Dr. Andrew Avins, MD, MPH, Senior 
Research Scientist at Kaiser Permanente Northern California, who is a clinical 
researcher experienced with designing, implementing, and monitoring safety in 
therapeutic interventions studies as well as a practicing clinician. The DSM is 
independent of the investigators and staff participating in the study, and has no 
financial ties to the outcome of the study. The DSM will periodically review the 
conduct and outcomes of the study and provide feedback to the investigators, with 
particular attention to protecting the safety of the participants. 
Prior to initiation of the trial, the DSM will review and approve the study design and 
plans for recruitment, adherence, interventions, data quality, and safety monitoring.  
At periodic intervals during the course of the trial, the DSM will evaluate the 
adequacy and timeliness of participant recruitment, adherence to the protocol, and 
the potential of the study to meet the stated goals; evaluate the quality and integrity 
of the data, including adequacy of data management and data security procedures; 
evaluate participant safety including trends in adverse events and relationship to the 
study procedures; consider factors external to the study when relevant information, 
such as scientific developments, may have an impact on the safety of the 
participants or the ethical conduct of the study; and make recommendations, if 

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necessary, to the investigators, the UCSF IRB, and the NCCIH on continuation, 
termination, or other modifications of the study protocol. 
The DSM will periodically review aggregate and unblinded trial data according to the 
Data and Safety Monitoring Plan (DSMP).  An emergency meeting may also be 
called by the principal investigator at any time should questions of participant safety 
arise.  Each review will include an assessment of the adequacy and timeliness of 
participant recruitment, adherence to the visit and intervention protocols, data quality 
and timeliness, adverse effects, and participant safety.  Interim reports for the DSM 
will be prepared by an unblinded biostatistician at the Women’s Health Clinical 
Research Center, and sent to the DSM at least 5 days prior to a pre-scheduled 
meeting or conference call.  
After each interim review, the DSM will provide a signed statement that indicates 
whether the study should continue, terminate, or be altered based on ability to meet 
study recruitment and data quality goals and participant safety. He will include any 
recommendations for changes to the protocol if necessary to enhance participant 
safety or potentiate the ability of the trial to answer the research hypotheses.  This 
statement will be provided to the principal investigator and will be sent to the UCSF 
IRB and to the NCCIH program officer.  All materials, discussions, and proceedings 
of the DSM process will be completely confidential.   
8.   INTERVENTION DISCONTINUATION  
Participation in the yoga therapy and/or physical conditioning interventions may be 
discontinued if determined to be necessary to protect the safety of a participant.  The 
decision to discontinue the therapeutic intervention will be made on a case-by-case by the 
principal investigator, with input from the DSM if needed. Possible reasons for 
discontinuation of the therapeutic intervention may include: 1) development of a clinically 
significant adverse event limiting a participant’s ability to safety take part in yoga or physical 
conditioning practice; 2) disruptive behavior exhibited by a participant during group yoga or 
physical conditioning classes or study visits that endangers the safety or comfort of other 
study participants, class instructors, or study staff; or 3) decision to terminate the study by 
the IRB, NCCIH, or other regulatory bodies. 
In the event that the yoga therapy or physical conditioning control intervention is 
discontinued, participants will continue to be followed through the 24-week mail-in 
assessment (or early termination visit) to collect outcomes data, provided that the participant 
is willing and the principal investigator (with input from the DSM, if appropriate) judges that it 
is safe and feasible to do so. If follow-up assessments are continued, no modifications to the 
schedule of follow-up assessments will be made unless necessary to protect the safety of 
participants or to accommodate limitations in function resulting from an adverse event. 
Follow-up assessments in participants who have discontinued the therapeutic interventions 
will not include continue evaluation of adherence to group classes or home practice, 
assessment of yoga posture or practice adherence self-efficacy, or independent evaluation 
of participants’ success in performing yoga postures. 
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
A parallel-group, superiority trial design has been selected as the being the most 
appropriate for the overall scientific goals of this research.  Although this pilot trial will 

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not be powered to prove or disprove any scientific hypotheses, it will provide a 
means of testing and refining procedures for a future full-scale parallel-group 
superiority trial to determine the efficacy of the therapeutic yoga intervention for 
improving urinary incontinence in middle-aged and older women.   
To control for the time and attention that participants will spend on group classes and 
home practice, a physical conditioning exercise program has been selected as an 
active behavioral control intervention for this trial. Although this control program may 
offer non-specific benefits for participants’ overall health, the investigators believe 
that it is unlikely to substantially improve women’s incontinence. Inclusion of the 
physical conditioning program will also minimize differential expectations of treatment 
benefit between the two groups, in an effort to promote equal adherence to study 
interventions and visits in both groups. 
9.2 
Sample Size and Randomization 
The investigative team plans to randomize and monitor up to 90 participants, with 
approximately 45 randomized to the yoga therapy group and 45 to the physical 
conditioning control group.  No formal sample size estimates or power analyses have 
been performed for this pilot study, as one of the goals of this pilot is to collect 
preliminary data that may be used to guide sample size estimates for a larger clinical 
trial, if indicated. Study data on the standard deviation, intra-class correlation, and 
between-group difference in change in incontinence frequency and other efficacy 
outcomes will be used to guide sample size projections for a future full-scale trial 
powered to detect a 25% greater reduction in incontinence frequency associated with 
yoga therapy. 
 
9.3       Intervention Assignment Procedures 
Randomization to the yoga therapy or physical conditioning control group will be 
performed by computer algorithm, with proof of eligibility required before assignment.  
Randomization will be implemented using randomly permuted blocks of sizes 2 and 
4, and will also be stratified by clinical type of incontinence (i.e., stress, urgency, or 
mixed), to ensure adequacy of randomization within types. To avoid manipulation, 
standard allocation concealment procedures will be followed.66  A study analyst will 
prepare sealed, opaque envelopes containing group assignment, numbered 
consecutively with the randomization sequence numbers.  At the baseline visit, when 
eligibility and incontinence type have been confirmed, coordinators will enter the 
date, participant name, and study ID in the randomization log and select the next 
numbered envelope to determine group assignment. All envelopes will be retained 
for review; randomization dates and times should follow the order of the sequence 
numbers, providing a check on validity.  Although participants cannot be blinded to 
treatment assignment (due to the behavioral nature of the intervention), diary and 
questionnaire data used to evaluate the primary and secondary efficacy outcomes 
will be abstracted by blinded analysts.  
9.4     Assessment of Feasibility of Recruitment and Retention 
The feasibility of recruiting and randomizing ambulatory middle-aged and older 
women with incontinence into a randomized controlled trial of a yoga therapy versus 
physical conditioning program will be examined by monitoring the average number of 
participants recruited and randomized per month and per recruitment wave.  The 
study team will also track the success rate of various recruitment approaches (fliers, 

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print notices, newspaper ads, etc.) and monitor the costs of recruitment per 
participant in order to guide future recruitment efforts.  The investigators plan to 
recruit and randomize 15 to 30 women in each 3-month enrollment wave to confirm 
the feasibility of assembling a class size of 8 to 15 women per group per wave in a 
future full-scale trial. 
The study team will also monitor participant retention rates during both the 12-week 
treatment period and the 12-week post-treatment follow-up period of the trial.  Drop-
out rates in both treatment groups are expected to increase over time (i.e., to be 
greater at 12 weeks than at 8 weeks or 4 weeks), but remain within acceptable 
parameters at 12 weeks of treatment and 12 weeks of post-treatment follow-up.  If 
drop-out is substantial, the study team will conduct exploratory pooled logistic 
regression analyses to identify participant characteristics associated with drop-out.   
The following parameters will be used to measure the adequacy of retention: 
 
During the 12-week intervention 
12 weeks post-intervention 
Optimal 
< 10% 
< 20% 
Expected 
< 15% 
< 25% 
Acceptable 
< 20% 
< 30% 
 
9.5    Assessment of Adherence to Interventions  
The study team will assess the feasibility of maintaining participant adherence to 
group classes and home practice by tracking the number and percentage of 
participants in each intervention group who complete at least 75%, 80%, and 90% of 
the recommended group classes as well as 75%, 80%, and 90% of the 
recommended home practice hours during the 12-week treatment period.  During the 
12-week post-treatment follow-up period, the study team will also track the number 
and percentage of participants who complete 25%, 50%, and 75% of recommended 
home practice hours; however, it should be noted that the study intervention is 
designed to be a self-contained 12-week intervention, in which sustained practice of 
yoga therapy or stretching/ strengthening exercises after the end of classes is 
encouraged but not considered mandatory.  If appropriate, exploratory regression 
analyses will be used to identify participant characteristics associated with 
adherence to group classes and home practice. 
The following parameters will be used to measure the adequacy of adherence: 
 
Attendance at group 
sessions during the 
12-week intervention 
Completion of home 
practice hours during 
the 12-week intervention 
Completion of home 
practice hours post-
intervention* 
Optimal 
≥ 90% 
≥ 90% 
≥ 75% 
Expected 
≥ 80% 
≥ 80% 
≥ 50% 
Acceptable 
≥ 75% 
≥ 75% 
any 
*Practice of yoga or stretching/strengthening exercises at home after 12 weeks, 
while desirable and encouraged, will not be considered mandatory to study success. 

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9.6 
Interim Analyses and Stopping Guidelines 
Interim analyses and/or stopping for unexpected efficacy: As this is a pilot study that 
is not powered to prove or disprove any hypotheses regarding efficacy, no formal 
interim analyses to evaluate efficacy will be performed. Given the short duration of 
treatment and small size of the study, the investigators believe that there is no 
scientific or ethical reason to stop the trial early or alter the trial design if treatment 
appears to be more effective than expected. Thus, as long as no safety issues arise, 
the trial will not be stopped or altered if the therapeutic intervention appears 
unexpectedly effective.  
Interim analyses and/or stopping for harm: Although this study involves a low-impact 
behavioral intervention that is not expected to pose a significant risk to participant 
safety, consideration may be given to stopping the trial early if unexpected and 
clinically significant adverse effects occur in either treatment group that may 
endanger the safety of participants. These may take the form of SAEs or non-serious 
AEs posing a substantial safety risk and warranting early termination of the trial. If 
evidence of adverse effects emerges, the investigators in consultation with the DSM 
may determine that these side effects are minor and the study can continue as 
planned, or may decide to alter or stop the study to prevent these side effects. 
Because the sample is small, and preservation of the nominal type-I error rate is less 
important for safety than for efficacy, no formal interim analysis procedures are 
proposed. 
Interim analyses and stopping for futility: Consideration may be given to stopping the 
trial if recruitment and retention are so poor that the ability to meet recruitment goals 
or meet retention thresholds is severely compromised. For example, consideration 
will be given to stopping this study prior to its scheduled completion if recruitment 
falls more than 30% below planned rates and/or timely follow-up (i.e., completion of 
study visits within recommended windows) falls below 70%. 
9.7 
Outcomes  
9.7.1 Feasibility Outcomes   
The feasibility of recruiting and randomizing middle-aged and older women 
with urinary incontinence into a randomized trial of yoga therapy versus 
physical conditioning will be examined by calculating the average number of 
participants recruited and randomized per month and per recruitment wave.  
It is assumed that the study team will need to recruit and randomize 15 to 30 
women in each 3-month enrollment wave to confirm ability to assemble a 
class size of 8 to 15 women per group per wave in a future full-scale trial.   
 
The feasibility of retaining participants in this trial design will be assessed by 
monitoring rates of drop-out or loss-to-follow-up over 8 and 12 weeks of 
treatment as well as during the 12-week post-treatment follow-up period.  
Drop-out rates in both treatment groups are expected to increase over time 
(i.e., to be greater at 12 weeks than at 8 weeks), but remain  less than 20% 
after 12 weeks of treatment and less than 30% at 12 weeks of post-treatment 
follow-up.   
9.7.2 Primary Efficacy Outcome   
Although this pilot study will not be powered to prove or disprove any 

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hypotheses regarding efficacy, preliminary data will be gathered to guide 
planning on a future full-scale trial in which the primary efficacy outcome will 
be change in the average frequency of urinary incontinence based on a 
validated 3-day symptom diary.  To that end, frequency of incontinence will 
be assessed based on voiding diaries completed at screening/baseline, 8 
weeks, and 12 weeks, as well as 12 weeks after the completion of the yoga 
therapy or physical conditioning programs.  The total number of any, stress-
type, and urgency-type incontinence episodes will be calculated for each 
diary and then divided by the total number of days of recording to calculate 
the average number of incontinence episodes per day of each type. 
9.7.3 Secondary Efficacy Outcomes   
Preliminary data will also be gathered to guide planning for a future full-scale 
trial evaluating secondary efficacy outcomes such as change in other 
symptom and quality-of-life outcomes associated with incontinence.  To that 
end, changes in anxiety and perceived stress symptoms and incontinence-
related quality of life will be assessed using validated questionnaires 
completed at screening/baseline, 8 weeks, and 12 weeks, as well as 12 
weeks after the completion of yoga therapy or physical conditioning 
programs.  
9.8 
Data Analyses  
To address aim 1 (feasibility), descriptive statistical techniques will be used to 
describe rates of recruitment, randomization, retention, and adherence for each 
recruitment wave.  If drop-out is substantial, we will conduct exploratory pooled 
logistic regression analyses to try to identify participant characteristics associated 
with drop-out. Similarly, if adherence is less than expected, we will use linear, 
logistic, and/or proportional odds models, depending on the distribution of the 
outcome, to explore associations of participant characteristics with levels of 
adherence both to classes and home practice. 
 
To address aim 2 (preliminary efficacy for change in incontinence frequency), we will 
use linear mixed models with unstructured residual covariance matrix to conduct a 
preliminary analysis of the 8, 12, and 24 week changes from baseline in incontinence 
frequency, adjusting for the baseline values, and treating week as categorical. This 
will provide estimates of the residual standard deviation, intra-class correlation, and 
fitted between-group differences at each follow-up time point. To assess trends and 
persistence, we will compare estimated between-group differences across weeks.  
All estimates will be presented with 95% confidence intervals. 
 
The methods specified for aim 2 will also be used for aim 3 (preliminary efficacy for 
secondary symptom and quality-of-life outcomes).  Outcomes will be normalized as 
necessary before analysis, and checked for equal variance across group and 
visit.  In previous studies, changes in incontinence frequency and in other symptom 
and quality-of-life scores have been approximately normally distributed. 

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 
Data Collection Forms  
Study data will be obtained from participant-completed symptom diaries and logs, 
participant- or interviewer-administered questionnaires, physical examination and 
performance measures, and urine sampling/testing. Forms for recording or 
abstracting data will be developed specifically for this study, including: 
- 
Voiding diary abstraction form: After participants complete their 3-day voiding 
diary at home, they will return the completed diary to the study clinic, and diary 
data will be abstracted using a Voiding Diary Abstraction Form. At the Baseline 
Visit, a clinical coordinator will abstract diary data for eligibility assessment 
purposes; at all post-randomization follow-up assessments, an analyst who is 
blinded to intervention assignment will abstract diary data. 
- 
Questionnaires assessing anxiety and perceived stress, condition-specific quality 
of life, and participant satisfaction:  These questionnaire forms will be completed 
by the participant during clinic visits and returned in person to a clinical 
coordinator, or completed by the participant at home and then mailed back to the 
study clinic (in the case of the 12 week post-treatment assessment). 
Questionnaire data collected after randomization will be entered into the 
electronic database by an analyst who is blinded to intervention assignment. 
- 
Questionnaires assessing demographic history, general medical and 
urologic/urogynecologic history, medication use, tobacco and alcohol use, and 
physical activity and function: These questionnaires will be administered by a 
clinical coordinator during in-person study visits, and data from questionnaires 
will subsequently be entered by the coordinator into the electronic database. 
Because these data will not be used to assess efficacy outcomes, the 
coordinators who administer and entering data from these forms will not 
necessarily be blinded to intervention assignment. 
- 
Physical examination, physical performance testing, and urine testing data forms: 
Clinical coordinators will record the results of height and weight measurements, 
blood pressure and heart rate measurements, physical performance testing, and 
urine dipstick and pregnancy testing on study-specific forms, and data from these 
forms will then be entered by coordinators into the electronic database. Because 
these data will not be used to assess any efficacy outcomes, the coordinators 
who are responsible for collecting, recording, and entering these data will not 
necessarily be blinded to intervention assignment. 
10.2 
Data Management  
Data will be entered, managed, and edited using Research Electronic Data Capture 
(REDCap), a secure, web-based application developed by a multi-institutional 
consortium initiated at Vanderbilt University to support data capture for research 
studies. Data can be entered from any location with secure web authentication, data 
logging, and Secure Sockets Layer (SSL) encryption.  REDCap offers advanced 
features including auto-validation, branching logic, stop actions, data import 
functions, and data comparison functions. The REDCap system complies with 
HIPAA regulations, data will be stored on HIPAA compliant serves, protected by 
firewalls. 

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10.3 
Quality Assurance  
10.3.1 Staff Training 
All investigators, project directors, and clinical coordinators involved in the 
study will complete training in Human Subjects Research offered by the 
Collaborative Institutional Training Initiative (CITI), which includes specific 
training modules on assessing risk to subjects, avoiding group harms, 
conflicts of interest, cultural competence, FDA-regulated research, HIPAA-
regulated research, informed consent, IRB member responsibilities, IRB chair 
responsibilities, records-based research, research with vulnerable subjects, 
and unanticipated problems and reporting.  All investigators, project directors, 
and coordinators will maintain active CITI certification for the duration of the 
study. 
Coordinators and analysts involved in data collection will also attend a study-
specific training meeting led by the principal investigator and the project 
directors prior to the start of participant recruitment.  At a minimum, the 
training meeting will include: (1) an introduction to the goals, design, and 
procedures of the LILA study; (2) an overview of goals, structure, and 
procedures for administering and abstracting data from the voiding diary and 
other study-specific data collection measures; (3) a review of definitions and 
procedures for assessing, documenting, and reporting adverse events.   
Coordinators and analysts will also receive training and undergo supervised 
practice in reviewing and abstracting data from the voiding diary as the 
primary efficacy measure in the trial. They will also receive training and 
undergo supervised practice performing measurements of blood pressure 
and heart rate and assessing physical function/performance measures.  
Following the training, clinical staff will be certified for performing these 
functions. 
10.3.2 Data Quality Assessment 
Data collection forms will be reviewed on an ongoing basis for data 
completeness and accuracy as well as protocol compliance. All forms used to 
collect data on primary and secondary efficacy outcomes (i.e., voiding diary 
abstraction forms, questionnaires addressing anxiety and perceived stress 
and condition-specific quality of life) will be verified against paper-based 
source forms by a staff member who was not involved in entering the data. 
 
Quality of data entry will be periodically assessed using measures such as 
number of missing forms, number of missing queries, and proportion of all 
study variables queried. The results of assessment of data quality will be 
incorporated into study progress reports for scheduled DSM meetings. 
10.3.3 Protocol Deviations 
Exceptions to the protocol are expected to occur rarely or not at all and, 
where possible, will be approved in advance by the principal investigator. 
Protocol exceptions may occur for the following reasons: 
• 
exceptions necessary to protect the safety or well-being of a participant 
(in this case, the protocol exception should apply to that participant only) 

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• 
exceptions due to oversight or error on the part of study staff, which are 
subsequently detected by the investigators, project managers, clinical 
coordinators, or data analysts. 
 
For each protocol exception, study staff will document the exception on a 
Protocol Exceptions Log (located in the Regulatory Binder). Entries in the 
Protocol Exceptions Log should include the participant ID, date of the 
exception, date exception is being recorded, description of exception, and 
action taken in response to the exception, if any. The principal investigator 
will document approval for each exception determined in advance, or 
acknowledgement for each exception detected after the fact.  
 
For this study, missed yoga therapy or physical conditioning classes will not 
be considered a protocol deviation, and neither will failure to complete 
recommended home practice sessions, although study staff will make every 
effort to promote adherence to classes and home practice (see section 5.4). 
10.3.4 Monitoring 
If desired by NCCIH, the study team will undergo on-site monitoring by an 
independent quality monitor who is independent of both the sponsor and 
UCSF (e.g., Westat). Site monitoring visits may include review of participant 
records, informed consent forms, source data collection forms, and the 
electronic study database. The schedule of site monitoring will be agreed 
upon in advance by NCCIH, the principal investigator, and the independent 
monitoring organization. The principal investigator, project manager, and 
study coordinators will be available to meet in person with the independent 
monitor and provide access to all study-specific forms, materials, and 
databases. 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 
Institutional Review Board (IRB) Review  
The study protocol, informed consent document, data and safety monitoring plan, 
and data collection forms will be reviewed and approved by the UCSF IRB prior to 
implementation of study procedures. Any subsequent modifications to these 
documents will also be reviewed and approved by the UCSF IRB prior to 
administration in the study. 
11.2 
Informed Consent Forms 
A signed consent form will be obtained from each participant at the Screening Visit 
before in-person data collection procedures are initiated (see section 6.2.2. for 
description of informed consent procedures). A copy of the consent form will be 
given to each participant, and documentation of signed consent will be filed in the 
participant’s study file.  The template for the form is attached as Appendix A. 
11.3 
Participant Confidentiality  
Study data will be protected to preserve participant confidentiality both during and 
after the study. Each participant will be assigned a unique numerical study identifier 
which will be used on study forms instead of names or other identifying information. 

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The document linking study ID to participant identifiers (name, address, contact 
names and addresses) will be maintained in a password-protected file stored on a 
secure server protected by firewalls. Only the clinical coordinators or study 
investigators who need to get access to participant identifiers to contact participants 
will have access to the password to this file.   
Paper source forms will be stored in a locked cabinet in a locked office at the UCSF 
Women’s Health Clinical Research Center, and only research staff who need to 
access these forms for data collection, data editing, or quality monitoring purposes 
will have the key to this cabinet. Information that could identify individual participants 
will not be released without written permission of the participant, except as 
necessary for monitoring by the IRB, NCCIH, the OHRP, or other government 
agencies responsible for protecting participant safety. Paper-based source forms will 
be securely destroyed 3 years after the end of the study. 
11.4 
Study Discontinuation  
The study may be discontinued at any time at the recommendation of the UCSF IRB, 
NCCIH, the OHRP, or other government agencies if necessary to protect the safety 
or confidentiality of research participants.  
12.  PUBLICATION OF RESEARCH FINDINGS  
Any publications resulting from this research will be made available to the public consistent 
with the NIH public access policy. At the request of the NCCIH program officer, the 
principal investigator will also provide a copy of any abstracts or manuscripts resulting from 
this work to the program officer prior to submission. 
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APPENDIX A:  INFORMED CONSENT FORM 
 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (UCSF) 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
Study Title: Lessening Incontinence through Low-impact Activity (LILA) 
 
This is a research study about two types of low-impact physical activity-based programs to 
improve urinary incontinence in women. The study researchers, Alison Huang, MD, MAS and 
Leslee Subak, MD, and their associates from the UCSF Department of Medicine, UCSF 
Department of Obstetrics, Gynecology, and Reproductive Sciences, and the UCSF Women’s 
Health Clinical Research Center, will explain this study to you. 
 
Medical research studies include only people who choose to take part.  Take your time to make 
your decision about participating.  You may discuss your decision with your family and friends 
and with your health care team.  If you have any questions, you may ask the study staff.  
 
You are being asked to take part in this study because you are a woman with urinary 
incontinence.  
 
Why is this study being done? 
 
The purpose of this study is to gather information about the effects of a group-based yoga or 
low-impact physical conditioning program on urinary incontinence in women. The National 
Center for Complementary and Integrative Health (NCCIH) is providing funding for this study.   
 
How many people will take part in this study? 
 
About 60 women aged 50 years or older will participate in this study at UCSF.  
 
What will happen if I take part in this research study? 
 
The study will require up to 4 in-person clinic visits (screening visit, baseline visit, 8-week visit, 
and final 12-week visit), 24 yoga or physical conditioning group training sessions (an initial 
orientation, followed by twice weekly group classes for weeks 1-12), up to 3 telephone visits 
(Randomization, Week 2, and Week 24), and 1 mail-in visit packet (Week 24).  
 
Before you begin the main part of the study, you will undergo the following procedures 
to make sure you understand the requirements of the study and that you are eligible: 
 
Screening Visit (located at the UCSF Women’s Health Research Office at 2330 Post Street) 
 
If you decide you want to be in the study, you will have the following procedures to find out if 
you qualify to be in this study: 
 
The study will be discussed with you, and you will be asked to review and sign the 
consent form. 
 
Your medical and gynecologic history will be reviewed, including all medications you are 
currently taking. 
 
Your height, weight, blood pressure, and heart rate will be measured. 

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 
You will be asked to give a urine sample to check for signs of urinary tract infection and 
pregnancy. 
 
We will give you questionnaires to fill out, which will include information on your 
race/ethnicity, relationship status, educational history, and health-related behaviors such 
as drinking alcohol, smoking, and exercise.   
 
If you qualify so far, you will receive a 3-day voiding diary (a diary in which you will 
record when you urinate or have accidental urine leakage) and detailed instructions on 
how to complete it. You will be asked to complete the diary at home bring it with you to 
your next visit. 
 
You be given a follow-up appointment for the Baseline Visit. 
 
This screening visit will take about one hour.  
 
Baseline Visit (located at the UCSF Women’s Health Research Office at 2330 Post Street) 
 
One to two weeks after the Screening Visit, you will return for the Baseline Visit.  You will have 
the following additional procedures done at this visit:   
 
You will be asked if you have had any changes in your health or in your medications.  
 
Your completed 3-day voiding diary will be collected and reviewed by study staff. 
 
You will be asked to complete questionnaires about your urinary symptoms, stress, 
mood, and quality of life. 
 
You will undergo a brief assessment of physical mobility, including walking speed, 
balance, and ability to rise from the ground and from a chair. 
 
If the screening procedures show that you are eligible to be in the study, and you still 
want to take part, then the study coordinator will schedule a Randomization Phone Call, 
about 1-2 weeks before the start of the yoga or physical conditioning intervention 
Programs.   
 
If you complete your screening procedures within 2 weeks of the start of the intervention 
programs, you may skip the Randomization Phone Call, and the randomization 
procedures described below will instead take place at the end of the baseline visit. 
 
The complete Baseline Visit will take about one hour.  
 
Randomization Phone Call 
If you still want to take part, then you will go on to the main part of the study at this 
phone call.  During the main part of the study: 
 
You will be randomly assigned to either the Yoga Therapy program or Physical Conditioning 
program for 12 weeks.  This means that you will have a 50/50 chance (like flipping a coin) of 
being placed in one of two groups.  Neither you nor the study doctors can choose the group 
you will be in.  You will have an equal chance of being placed in one of the two possible 
groups:  
 
If you are assigned to the Yoga Therapy Program, you will be given an informational 
pamphlet about urinary incontinence and behavioral strategies for controlling it. You will 
receive the schedule for the Yoga Therapy Program (described below) and instructions on 
preparing for that program.  The research coordinator will schedule your final visit, to take 
place about 12 weeks after you start the program.  You will be reminded to avoid using any 
standard medical treatments for incontinence before your final visit. 
 
If you are assigned to the Physical Conditioning Program, you will be given an informational 
pamphlet about urinary incontinence and behavioral strategies for controlling it. You will 
receive the schedule for the Physical Conditioning Program (described below) and 

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instructions on preparing for that program.  The research coordinator will schedule your final 
visit, to take place about 12 weeks after you start the program.  You will be reminded to 
avoid using any standard medical treatments for incontinence before your final visit. 
 
Yoga Therapy Program (located at TBD) 
 
If you are assigned to the Yoga Therapy Program, you will take part in the following: 
 
Yoga Orientation Session 
You will be asked to attend a 90 minute introductory yoga workshop during which a trained 
yoga teacher will explain the philosophy of yoga and demonstrate some of the postures and 
breathing techniques that you will be learning during the yoga training visits. You will also be 
given a yoga guide pamphlet and yoga props (mat, strap, and block) to help you practice at 
home. You will receive information about urinary incontinence and behavioral strategies. 
 
Yoga Training Sessions 
After the Orientation, we will schedule you to attend group yoga training sessions twice a 
week for 12 weeks (weeks 1-12).  The sessions will be offered at regular times throughout 
the study. The number of individuals in the group will not be more than 15, all of whom will 
be women with incontinence.  Each session will be led by a certified yoga instructor.  In 
these sessions, you will practice a series of yoga postures. You will also practice different 
yogic breathing techniques, such as breathing slowly through the nose or controlling the rate 
of your breathing.  Part of each session may also be spent doing guided meditation or 
relaxation. Each of these classes will take about 90 minutes.  
 
Home Yoga Practice 
Between the classes, we will ask that you also practice yoga for about one hour one time 
per week at home. You will be asked to keep a daily log of your home practice of yoga. You 
will be given instructional materials that describe the yoga poses (participant yoga manual) 
to help you practice at home.  
 
Physical Conditioning Program (located at TBD) 
 
If you are assigned to the Physical Conditioning Program, you will take part in the 
following: 
 
Physical Conditioning Orientation Session 
You will be asked to attend a 90 minute introductory workshop during which a trained 
physical therapist will explain the philosophy of the physical conditioning program and 
demonstrate some of the stretching and strengthening techniques that you will be learning 
during the training visits. You will also be given a pamphlet to help you practice at home. 
You will receive information about urinary incontinence and behavioral strategies. 
 
Physical Conditioning Group Training Sessions 
After the Orientation, we will schedule you to attend group training sessions twice a week for 
12 weeks (weeks 1-12).  The sessions will be offered at regular times throughout the study. 
The number of individuals in the group will not be more than 15, all of whom will be women 
with incontinence.  For each training session, you should wear loose-fitting comfortable 
clothes. Each session will be led by a certified instructor.  In these sessions, you will practice 
a series of stretching and strengthening exercises. 
 

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Home Physical Conditioning Exercises 
Between the classes, we will ask that you also practice stretching /strengthening exercises 
for about one hour one time per week at home. You will be asked to keep a daily log of your 
home practice of these exercises. You will be given instructional materials that describe the 
exercises (participant physical conditioning manual) to help you practice at home.  
 
This phone call will take between 5 and 15 minutes.  
 
 
Week 2 Phone Visit: 
 
During this follow-up telephone call: 
 
You will be asked if you have had any changes in your health or your medications.  
 
You will be reminded of your next Clinic Visit appointment (the Week 8 Visit). 
 
You will discuss your progress with yoga/stretching practice with the coordinator, who 
will answer questions and provide further instruction if needed. 
 
This phone call will take between 5 and 15 minutes.  
 
Week 8 Clinic Visit: 
 
The following procedures will be done at this visit:  
 
You will be asked if you have had any changes in your health or in medications. 
 
Your completed 3-day voiding diary will be collected and reviewed by study staff. 
 
Your weight, blood pressure, and heart rate will be re-measured.  
 
You will complete the same questionnaires about your urinary symptoms, stress, mood, 
and quality of life that you completed at the Baseline Visit. 
 
You will complete questionnaires about your confidence in performing the yoga or 
stretching/strengthening exercises. 
 
You will undergo repeat assessment of assessment of physical mobility, including 
walking speed, balance, and ability to rise from the ground and from a chair. 
 
You will discuss your progress with yoga or physical conditioning practice with the 
coordinator, who will answer questions and provide further instruction if needed. 
 
The Week 8 Visit will take about 1 hour.  
 
Week 12 Clinic Visit (Final Clinic Visit): 
 
The following procedures will be done at this visit:  
 
You will be asked if you have had any changes in your health or in medications. 
 
Your completed 3-day voiding diary will be collected and reviewed by study staff. 
 
Your weight, blood pressure, and heart rate will be re-measured.  
 
You will complete the same questionnaires about your urinary symptoms, stress, mood, 
and quality of life that you completed at the Baseline Visit. 
 
You will complete questionnaires about your confidence in performing the yoga or 
stretching/strengthening exercises 
 
You will undergo repeat assessment of assessment of physical mobility, including 
walking speed, balance, and ability to rise from the ground and from a chair. 
 
You will be asked some questions about how you felt about the study and the usefulness 
of yoga or physical conditioning exercises to help your incontinence. 

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The final visit will take about 1 hour.  
 
 
Week 24 Phone and Mail-in Packet: 
 
Twelve weeks after completing the yoga or physical conditioning program, a study coordinator 
will call you. During this follow-up telephone call: 
 
You will be asked if you have had any changes in your health or your medications.  
 
You will be reminded to complete and mail a final 3-day voiding diary and set of 
questionnaires. 
 
You will complete the following procedures while at home: 
 
You will complete a final 3-day voiding diary. 
 
You will complete questionnaires about your urinary symptoms, mood, sleep, health, and 
quality of life.  
 
You will mail it all of the above completed documents to study staff, using a pre-
addressed and stamped envelope. 
 
This will take about 30 minutes to complete. 
 
How long will I be in the study? 
Participation in the study will take a total of about 54 hours over a period of about 24 weeks.  
This includes 4 hours of clinic visit time and about thirty minutes of telephone time. You will be 
asked to participate in twice weekly yoga or physical conditioning group training sessions for a 
total of 36 hours (the orientation will require 90 minutes, as well as each of the 23 subsequent 
group classes). You will be asked to practice the yoga poses or physical conditioning exercises 
at home for about an hour at least one day per week for 12 weeks, or for a total of 12 hours. 
Recording in the voiding diary at 4 time points will take approximately 15 minutes each (1 hour 
total). The final Mail-in Visit packet of questionnaires will take about 30 minutes to complete. 
 
Can I stop being in the study? 
Yes.  You can decide to stop at any time.  Tell the study staff if you are thinking about stopping 
or decide to stop.  They will tell you how to stop your participation.  
The study researchers may also stop you from taking part in this study at any time if they 
believe it is in your best interest, if you do not follow the study rules, or if the study is stopped. 
 
What side effects or risks can I expect from being in the study? 
 
 
Data Collection and Confidentiality: All information provided by study participants is 
confidential. You will be asked some questions about your health history and given some 
questionnaires about your urinary incontinence, quality of life, stress, and mood. While the 
information you provide is confidential, some people feel embarrassed at having to answer 
these types of questions. There will be slight inconvenience in time and effort to complete 
the questionnaires. 
 
 
Yoga Program: There is minimal risk associated with participating in the yoga intervention.  
Risks are rare but may include muscle soreness and muscle or ligament strain, or other 
musculoskeletal injury if you were to fall or lose balance. The instructors providing 
instruction for these classes are certified yoga instructors with years of experience 

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instructing people of a wide range of ages and with chronic health conditions. We will be 
using props such as blocks and straps to help you to perform the yoga postures, and the 
instructors will help you modify poses that are uncomfortable. 
 
 
Physical conditioning program: There is minimal risk associated with participation in the 
physical conditioning  intervention. Rare risks include muscle soreness and muscle or 
ligament strain, or other musculoskeletal injury if you were to fall or lose balance. The 
trained instructors will have physical therapy or other qualified backgrounds and will provide 
instruction on low-impact stretching and strengthening exercises that have been approved 
for use by our expert Physical Therapist consultant.  
 
 
Physical Examination Measurements: There are no risks associated with having your 
height, weight, blood pressure, or heart rate, although you may find this to be inconvenient 
or unpleasant.  
 
 
Assessment of Physical Mobility:  There are no significant risks associated with 
evaluation of your walking speed, balance, and ability to rise from the ground and from a 
chair, but you may find this to be inconvenient or unpleasant. 
 
 
Urine Dipstick and Pregnancy Testing: There are no direct risks associated with 
collection of the screening urine sample, although some participants may experience this as 
inconvenient or unpleasant. 
 
Behavioral Incontinence Self-Management Pamphlet:  Provision of standard written 
information on usual first-line behavioral self-management strategies for incontinence such 
as pelvic floor muscle exercises and timed urination should pose no risks to participants, 
although participants may find it inconvenient or unpleasant to read the pamphlet. 
 
Unknown Risks: The experimental treatments may have side effects that no one knows 
about yet.  The researchers will let you know if they learn anything that might make you 
change your mind about participating in the study. 
 
 
For more information about risks and side effects, ask your study doctor. 
 
Are there benefits to taking part in the study? 
 
Taking part in this study may or may not make your urinary incontinence better.  While doctors 
hope that yoga practice or physical conditioning exercises will be effective in improving urinary 
incontinence, there is no proof of this yet. Low impact physical activity techniques, such as yoga 
and stretching, have been reported to reduce stress and anxiety and improve sleep as well as 
improve overall fitness. Information gained from this study may help develop new treatments for 
individuals with urinary incontinence   
 
What other choices do I have if I do not take part in this study? 
Your other choices include: 
 
Getting no treatment 
 
Getting standard treatment for your urinary incontinence without being in a study. 
o 
Regular primary care and gynecologic care is available at UCSF for women with 
incontinence who choose not to enroll in this study. There are FDA-approved 
medications for some types of incontinence which are available by prescription. 

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o 
Yoga and physical conditioning classes are available at gyms and studios in the 
community.  These have not yet been proven to be effective for the treatment of 
incontinence and are not considered to be standard care.  
 
Getting a different experimental treatment/taking part in another study. 
Please talk to your doctor about your choices before deciding if you will take part in this study. 
 
Will information about me be kept private? 
 
We will do our best to make sure that the personal information gathered for this study is kept 
private.  However, we cannot guarantee total privacy.  Your personal information may be given 
out if required by law.  If information from this study is published or presented at scientific 
meetings, your name and other personal information will not be used. 
 
Organizations that may look at and/or copy your research records for research, quality 
assurance, and data analysis include: 
 
 
University of California  
 
The National Institute of Health, and other government agencies involved in keeping 
research safe for people.  
 
What are the costs of taking part in this study? 
You will not be charged for any of the study activities. 
 
Will I be paid for taking part in this study? 
You will be reimbursed up to $100 total for your time and effort in this study.  You will receive 
$25 at your baseline visit, Week 8 Visit, and Week 12 Visit upon completion of voiding diaries; 
and you will receive $25 upon returning your diary and questionnaires at Week 24 ($100 total).   
 
What happens if I am injured because I took part in this study? 
It is important that you tell your study doctors, Alison Huang, MD, MAS or Leslee Subak, MD, if 
you feel that you have been injured because of taking part in this study.  You can tell the doctor 
in person or call Alison Huang, MD, MAS at (415) 514-8697 or Leslee Subak, MD at (415) 353-
9758. 
 
Treatment and Compensation for Injury:   
If you are injured as a result of being in this study, the University of California will provide 
necessary medical treatment. The costs of the treatment may be billed to you or your insurer 
just like any other medical costs, or covered by the University of California or the study sponsor, 
the National Institutes of Health, depending on a number of factors. The University and the 
study sponsor do not normally provide any other form of compensation for injury. For further 
information about this, you may call the office of the Committee on Human Research at (415) 
476-1814.  
 
What are my rights if I take part in this study? 
Taking part in this study is your choice.  You may choose either to take part or not to take part in 
the study.  If you decide to take part in this study, you may leave the study at any time.  No 
matter what decision you make, there will be no penalty to you and you will not lose any of your 
regular benefits.  Leaving the study will not affect your medical care.  You can still get your 
medical care from our institution.  
 

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We will tell you about new information or changes in the study that may affect your health or 
your willingness to continue in the study. 
 
In the case of injury resulting from this study, you do not lose any of your legal rights to seek 
payment by signing this form. 
 
Who can answer my questions about the study? 
You can talk to the study doctor about any questions, concerns, or complaints you have about 
this study.  Contact the study doctors, Alison Huang, MD, MAS at (415) 514-8697 or Leslee 
Subak, MD at (415) 353-9758. 
 
If you wish to ask questions about the study or your rights as a research participant to someone 
other than the researchers or if you wish to voice any problems or concerns you may have 
about the study, please call the Office of the Committee on Human Research at 415-476-1814.   
 
CONSENT 
 
Please read the sentence below and think about your choice. After reading the sentence, put 
your initials in the "Yes" or "No" box.  If you have any questions about this study, please talk to 
the study doctor or coordinator.  
 
No matter what you decide to do, it will not affect your care. 
 
Someone may contact me in the future to ask me if I am interested in participating in future 
research studies. 
 
 
YES            NO 
 
 
 
You have been given copies of this consent form and the Experimental Subject's Bill of Rights 
to keep. 
 
You will be asked to sign a separate form authorizing access, use, creation, or disclosure of 
health information about you 
 
PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to participate 
or to withdraw at any point in this study without penalty or loss of benefits to which you are 
otherwise entitled. 
 
If you wish to participate in this study, you should sign below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
Participant's Signature for Consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
Person Obtaining Consent 

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