Clinical trial NCT03946124
Conditions: Overactive Bladder
Sponsor: University of Pennsylvania
Start date: 2015-07-25; Completion date: 2017-07-19
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Though OAB treatment may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Aim is to validate instruments to measure physical activity and preference for medication, and to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. It's plan a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication.

Detailed description:
Older adults with overactive bladder (OAB) have reduced physical activity and are at increased risk for falls. Though recent studies suggest that treatment of OAB may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. Furthermore, physical activity outcomes in older adults with OAB are affected by treatment preference and potential neurocognitive dysfunction caused by anti-cholinergic medication. The aims of the present proposal are 1) to validate an instrument to measure physical activity 2) to validate an instrument to measure preference for medication and 3) to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. Plan: a prospective cohort study of adults aged 65 or older with OAB undergoing treatment with anti-cholinergic medication. The primary outcome will be physical activity measured using a self-reported instrument and accelerometer at baseline and 8 weeks after treatment. Secondary outcomes will be fall risk defined by changes in neurocognitive testing, urinary symptoms, and medication adherence at 8 weeks after treatment. The findings of this study could provide a paradigm shift in the management of older adults with OAB and at increased risk for falls.

Arms: arm 1: Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.
Interventions: intervention 1: Fesoterodine
Intervention descriptions: intervention 1: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
 
 
 
 
 
 
 
Official Title: Prevention of Fall in Older Adults with Overactive Bladder 
NCT: NCT03946124 
Document date: 03/29/2018 


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Protocol
Abstract
Older adults with overactive bladder (OAB) have reduced physical activity and are at increased risk for 
falls. Though recent studies suggest that treatment of OAB may improve physical activity, there is a 
lack of easily administered instruments for measuring physical activity in older adults. Furthermore, 
physical activity outcomes in older adults with OAB are affected by treatment preference and potential 
neurocognitive dysfunction caused by anti-cholinergic medication. The aims of the present proposal are 
1) to validate an instrument to measure physical activity 2) to validate an instrument to measure 
preference for medication and 3) to determine the effect of preference for anti-cholinergic medication 
on adherence, physical activity, and falls risk. We plan a prospective cohort study of adults aged 65 or 
older with OAB undergoing treatment with anti-cholinergic medication. The primary outcome will be 
physical activity measured using a self-reported instrument and accelerometer at baseline and 8 weeks 
after treatment. Secondary outcomes will be fall risk deﬁned by changes in neurocognitive testing, 
urinary symptoms, and medication adherence at 8 weeks after treatment. The ﬁndings of this study 
could provide a paradigm shift in the management of older adults with OAB and at increased risk for 
falls.
Objectives
Overall objectives
Our primary objective is to show that treatment preference and physical activity can be measured using 
patient-reported instruments. We also hypothesize that preference for anti-cholinergic medications is 
associated with higher adherence and improvement in domains relevant to falls in adults with OAB, 
including urgency, physical activity, and balance. Finally, we plan to show that treatment of urgency 
urinary incontinence with anti-cholinergic medication does not worsen neurocognitive function relevant 
to falls. Speciﬁcally, the overriding goal of this proposal is to validate patient-reported instruments that 
measure physical activity and preference for medication in elderly adults with overactive bladder, and 
examine the effect of treatment on physical activity and risk for falls (fall efﬁcacy) in adults who prefer 
medication for the treatment of overactive bladder. Speciﬁc Aim 1: To determine the construct validity 
and responsiveness of physical activity instruments in older adults undergoing treatment for overactive 
bladder.  We hypothesize that physical activity levels as measured by questionnaires will correlate with 
physical activity as measured by accelerometer. We will measure responsiveness of the instruments by 
comparing change in physical activity levels before and after treatment of OAB. The results will be 
informative as to which, if any, instrument is useful for measuring physical activity in adults with OAB. 
Speciﬁc Aim 2: To determine the construct validity of an instrument to measure preference for 
medication in older adults undergoing treatment for overactive bladder.  We hypothesize that adults with 
preference for medication will have higher adherence to treatment at 8 weeks than adults who do not 
prefer medication. The results will enlighten us to which, if any, instrument, is useful for measuring 
preference for treatment with anti-cholinergic medication in adults with OAB. Speciﬁc Aim 3: To use 
the newly validated instruments to measure the impact of preference for medication on domains related 
to falls (physical activity, urinary symptoms, neurocognitive testing) in older adults undergoing 
treatment with anti-cholinergic medications for overactive bladder.  We hypothesize that adults with 
preference for medications will have greater improvement in physical activity and urinary symptoms, 
and no difference in neurocognitive testing, than women who do not have preference for medications. 
This aim will establish if the new instruments are useful in measuring outcomes of preference and 
physical activity in the clinical setting and also provide preliminary data on the impact of treatment 
preference and anti-cholinergic medications on physical activity and falls risk in older adults with 
overactive bladder.
Primary outcome variable(s)
The primary outcome will be physical activity measured using a self-reported instrument and 
accelerometer at baseline and 8 weeks after treatment.
Secondary outcome variable(s)
Secondary outcomes will be fall risk deﬁned by changes in neurocognitive testing, urinary symptoms, 
and medication adherence at 8 weeks after treatment.
Background
An estimated 29.8 million adults aged 40 and older in the United States suffer from overactive bladder 


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(OAB), a condition characterized by urgency to urinate.1 Overactive bladder is commonly associated 
with urgency urinary incontinence (UUI), and older adults with UUI are at twofold higher risk for falls. 
UUI is increasingly being recognized as a marker for musculoskeletal weakness.2, 3 According to the 
bio-psycho-ecological paradigm,4, 5 falls associated with overactive bladder are a combined result of 
the interaction between three elements: bladder urgency; mental abilities including anxiety and 
embarrassment related to bladder urgency; and physical difﬁculty in reaching the toilet in a timely 
fashion. Anti-muscarinic medications are the most common class of medication used for the treatment 
of UUI. Six main anti-muscarinic medications are available in the United States, with similar efﬁcacy 
(Qaseem 2014, AUA/SUFU OAB guidelines), and are generally prescribed based on insurance coverage 
as well as tolerance of side effect proﬁle. These medications are known to improve at least two of these 
domains: bladder urgency,6 and mental anxiety related to urinary incontinence.7 Prior studies also 
suggest that reduction of bladder urgency with medications may improve ability to reach the toilet by 
improving physical ability, which is the third domain associated with falls. In an abstract presented at 
AUGS 2014, we have shown that treatment of overactive bladder in adults (mean age 61.0 ± 13.8) with 
fesoterodine was associated with improved physical activity as measured by the two physical activity 
questions of the SF-12.8 Several studies have reported that treatment of overactive bladder is associated 
with improvement in physical activity related to travel, transportation, and planning to locate 
restrooms.9, 10, 11 While these activities do not necessarily correlate with physical activities known to 
reduce the risk of falls e.g. walking, climbing stairs, or participating in sports these studies provide 
promising evidence that treatment of OAB with anti-cholinergic medications could potentially reduce 
falls. However, though several physical activity questionnaires exist, none have been validated in older 
adults with urgency urinary incontinence. Finally, anti-cholinergic medications have been implicated in 
neurocognitive changes that could potentially increase the risk of falls.12 Therefore, there remains a key 
gap in knowledge regarding the effect of anti-cholinergic medications on physical activity and 
neurocognitive testing in older adults with urgency urinary incontinence. The efﬁcacy of medications is 
closely related to adherence. Despite multiple beneﬁts from anti-cholinergic treatment, the estimated 
adherence to anti-cholinergic medication is less than 10% at one year.13 Poor adherence carries the 
potential for wasted health care resources and continued suffering for patients. There is a lack of 
knowledge on how to best identify patients who will be adherent to anti-cholinergic treatment, and 
therefore derive the most beneﬁt from medication. Recent studies in other conditions such as depression 
suggest that a key indicator for adherence is patient-expressed preference for treatment. We have 
previously shown that the health belief model is valid in women with OAB; women who believe in the 
intrinsic harm of medications have signiﬁcantly worse adherence than those who believe in the beneﬁt 
of medications.14 Urgency urinary incontinence is associated with increased risk of falls in older 
adults: Falls in the elderly have severe life-threatening consequences including injuries, immobility, and 
mortality.15 Several systematic reviews have conﬁrmed that urgency urinary incontinence is an 
independent risk factor for falls.16, 17, 18 Gosch et al found that amongst patients admitted for fragility 
fractures, those with urinary incontinence displayed increased rates of cognitive dysfunction and 
depression compared to those without incontinence. Patients with incontinence were more likely to 
have musculoskeletal complaints that inhibit mobility, including lower back pain, weaker grip strength, 
and slower walking velocity.2 Despite the close relationship between UUI and falls, studies that 
determine if treatment of UUI can reduce fall risk are lacking. Improvement in physical activity can 
reduce the risk of falls in older adults: Women with UUI exhibit avoidance of physical exercise.20, 21, 
22 One of the major risk factors for falls is decline in physical functioning, which is accelerated by lack 
of physical activity. In a meta-analysis of 30 studies, decline in lower extremity strength was associated 
with falls (odds ratio 1.76, 95% CI 1.3-2.4).23 On the other hand, improvement in physical activity by 
strength and balance training or simply by increased physical activity is effective in reducing fear of 
falling as well as actual falls.24, 25 The Nurses Health Study prospectively showed that older women 
who remained physically active longer were less likely to report the development of new onset UUI.26 
However, it is not known if treatment of UUI can improve physical activity in older adults. Anti-
cholinergic medications may improve physical activity in older adults with urgency urinary 
incontinence: Prior studies suggest that treatment of overactive bladder with anti-cholinergic 
medications is associated with improvement in physical activity associated with quality of life.9, 10, 27, 
28 In these studies, activity was measured using the Physical Limitations domain of the Kings Health 
Questionnaire (KHQ) or the Coping score of the Overactive Bladder Questionnaire (OAB-q). However, 
these domains examine social-related activities such as planning for travel/transportation and locating 
of convenient restrooms, and are therefore quality-of-life rather than physical activity measures. This 
may not reﬂect change in actual physical activity such as walking, climbing stairs, or participating in 
sports. Data from our preliminary study at Penn presented at AUGS/IUGA 2014 suggest that treatment 
with fesoterodine, in combination with behavior modiﬁcation and Kegel exercises, improves womens 


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ability to perform physical activities pertaining to leisure and moderate exercise. These studies suggest 
anti-cholinergic medications improve older adults physical activity and potentially reduce their risk for 
falls.  Neurocognitive measures, anti-cholinergic medications and falls: Worsening functional and 
cognitive abilities are signiﬁcantly associated with both falls and urinary incontinence. Anti-cholinergic 
medications may also cause neurocognitive dysfunction and potentially increase fall risk.12 Useful 
measures of neurocognitive function include: 1) the Mini-Cog Evaluation, the most studied screening 
instrument for cognitive impairment, with a 88.3% sensitivity and 86.2% speciﬁcity.29 2) Multiple 
studies show that the greatest factor predicting future falls is a history of a prior fall,30, 31, 32 3) Short 
Physical Performance Battery testing: the SPPB measures standing balance, walking speed, and ability 
to rise from a chair. Scores for each measure range from 0 to 4, with 4 indicating the highest level of 
performance and 0 the inability to complete the test. A summary score (range 0-12) is subsequently 
calculated by adding the three scores. The SPPB can be used to predict higher fall rates and recurrent 
fallers. Physical activity can be measured using self-reported questionnaires: Accurate and efﬁcient 
measurement of activity in elderly subjects is complex. Accelerometers are considered reliable 
instruments for objective measurement of physical activity behavior.37 However, use is limited by 
expense, discomfort, shortcomings in measuring aquatic and static exercise activities, and non-
compliance.38 Self-administered physical activity questionnaires are inexpensive, useful alternatives for 
measuring energy expenditure. Many physical questionnaires exist, but most are not validated in older 
adults and none have been validated in adults with UUI. The most widely used questionnaire, the 
International Physical Activity Questionnaire (IPAQ), has been validated only in subjects aged 15 to 
69.39 Other potentially useful questionnaires are the Community Healthy Activities Model Program for 
Seniors (CHAMPS) questionnaire,40 and the Birmingham Bowel questionnaire. Both are validated in 
older adults but not in the OAB population. The ideal questionnaire to measure physical activity in 
older adults with OAB is not known. Adherence to anti-cholinergic medication is low: As mentioned 
above, despite the beneﬁcial effects of anti-cholinergic medications, adherence is low. In two studies 
conducted at the University of Pennsylvania, adherence was associated with increased doubts in the 
efﬁcacy and beneﬁt of medicine as measured by the Belief Screen of the Brief Medication 
Questionnaire.14, 42  In this study, we choose to use a well-tolerated anticholinergic with fewer side 
effects: fesoterodine. Often, patients who had prior unsatisfactory symptom control and/or unacceptable 
adverse events with tolterodine or oxybutynin reported better efﬁcacy and/or more acceptable adverse 
event proﬁles with fesoterodine. (AUA SUFU guidelines). Preferred treatments are associated with 
improved adherence: While adherence is the result of a complex interaction between psychological, 
socioeconomic, and clinical factors, there is a known connection between satisfaction with treatment 
and adherence.43 Patients beliefs of the necessity of is also important; indifference towards medications 
beneﬁt as well as a greater ratio of concerns about medications versus necessity were associated with 
non-adherence in patients with rheumatoid arthritis.44  Additionally, patient participation in decisions 
regarding treatment are important for adherence. The shared decision-making framework, in which 
patient and physician discuss, share, and build consensus for a preferred treatment, may improve 
adherence.45 In patients with depression, self-reported adherence was signiﬁcantly higher when there 
was concordance between preference for decision making and actual participation in decision 
making.46 A systematic review by Joosten et al found that in the limited literature that examined 
adherence as an outcome in shared decision-making models, patients who participated in decision 
making were more likely to adhere to medications at follow-up.47 There is a key gap in knowledge on 
how to measure preference for treatment for overactive bladder and the impact of these preferences on 
adherence. SUPPORTING DATA The studies below provide preliminary data for the proposed study 
and demonstrate the mentors expertise in mentoring fellows and in questionnaire validation. 
Preliminary Studies: 1. Physical Activity in Women Undergoing Treatment for Overactive Bladder. 
Mentored fellow: Chu. Funded: Pﬁzer-AUA. Presented at IUGA/AUGS Joint Conference, Washington 
DC, July 2014. The aim of this study is to determine if treatment of overactive bladder with 
anticholinergic medications has an impact on self-reported physical activity. Methods: 137 women with 
OAB symptoms treated with ﬂexible-dose fesoterodine therapy, evaluated at baseline and 8 weeks post-
treatment. Urinary symptoms and health beliefs were measured using validated questionnaires. Physical 
activity scores were calculated using the Short Form 12 (SF-12) Does your health now limit you in a) 
Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf? and b) 
Limit you in climbing several ﬂights of stairs? Results: At 8 weeks, the proportion of women with no 
restriction in physical activity was higher in responders than non-responders (52% vs. 33%) while the 
proportion of women with severe restriction was lower in responders than non-responders (13% vs. 
17%).  Conclusion: Treatment of OAB in combination with behavior modiﬁcation, Kegel exercises, and 
anti-cholinergic medication improves womens performance of physical activities pertaining to leisure 
and moderate exercise. 2. Exercise for the Prevention of Falls in Older Women with Urge Incontinence. 


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Funded: CTSA, Perelman School of Medicine of the University of Pennsylvania. We have an ongoing 
study to examine the efﬁcacy of exercise for the prevention of falls in older women with urgency 
urinary incontinence. For this study we have recruited 36 community dwelling older women with UUI. 
Falls risk (using questionnaires and neurocognitive tests) and urinary symptoms were measured before 
and after the exercise intervention. This study shows 1) our ability to recruit older adults with urgency 
urinary incontinence and 2) feasibility of performing neurocognitive tests in older adults with urgency 
urinary incontinence. Related studies on Preference and Adherence: 3. Primary Adherence and Health 
Beliefs Regarding Anti-cholinergic Medications for Urge Incontinence.14 Mentored fellow: Saks. 
Funded: T32 HD007440, 10/1/00 - 4/30/11. Published. The aim of this prospective cohort study was to 
examine the role of health care beliefs in primary adherence to anti-cholinergic medications. Methods: 
150 women with OAB prescribed anti-cholinergic medication were recruited from the Penn 
urogynecology clinic. Urinary symptoms and health beliefs were measured using validated 
questionnaires. Primary adherence (initial ﬁlling of a prescription) to medication was measured through 
pharmacy records. Results: The incidence of primary adherence was 73%. Patients beliefs in the general 
overuse/harm of medications were signiﬁcant negative predictors of primary adherence (OR=0.35, 95% 
CI 0.16,0.79). Conclusion: Health care beliefs are strongly associated with primary adherence. 4. 
Validation of a Self-administered Instrument to Measure Adherence to Anti-cholinergic Drugs in 
Women with Overactive Bladder.42 Mentored fellow: Andy. Funded: Pﬁzer-AUA. Published. The aim 
of this study was to evaluate the validity of the MASRI for measuring adherence in women starting 
anti-cholinergic medications. Methods: Prospective study in 131 women with OAB treated with 
fesoterodine. Adherence was measured at 8 and 12 weeks using an interviewer administered Brief 
Medication Questionnaire (BMQ) that assesses barriers to adherence (criterion standard), the MASRI, 
and pill count. Results: Women diagnosed as non-adherent by the MASRI were more likely to report a 
belief barrier to taking medication as compared to adherent women at 8 weeks (80% vs. 38%, P0.001) 
and at 12 weeks (70% vs. 40%, P=0.003). The MASRI correctly identiﬁed 93% and 96% of non-
adherent women at 8 and 12 weeks, respectively. Sensitivity, speciﬁcity, and positive likelihood ratio of 
the MASRI for predicting non-adherence was 91%, 82%, and 5.1% at 8 weeks and 90%, 85% and 6.1% 
at 12 weeks. Conclusion: The MASRI is a valid self-administered tool for measuring adherence to anti-
cholinergic medication in women with OAB. Expertise in Questionnaire Validation:  5. Construct 
Validity of Utility Preference Score Instruments in Women with Urinary Incontinence.48 Mentored 
fellow: Harvie. Funded: International Urogynecology Association (IUGA). Published. The aim of this 
study was to evaluate the construct validity of three instruments for measuring utility preference scores 
in women with urinary incontinence. Methods: We recruited 260 consecutive women presenting to Penn 
urogynecology clinic with pelvic organ prolapse, stress, or urgency urinary incontinence. Utility scores 
were measured using the HUI-3, EQ-5D, SF-6D and a VAS. Results: The pattern of increasing (better) 
utility scores from UUISUIno incontinence persisted for all the health-status classiﬁcation system 
instruments but not the VAS. Only the HUI-3 and SF-6D were able to discriminate between UUI and 
SUI. Utility scores from all four instruments were signiﬁcantly negatively correlated with the UDI-6 
and UIQ-7. Correlations were lowest for the VAS. Conclusion: Utility preference scores are valid 
quantitative measures of the negative impact of urinary incontinence on general health-related quality-
of-life. The VAS and Euro-QOL provide poor discrimination for women with incontinence.
Study Design
Phase*
Not applicable
Design
Overall Study Design: All three aims are derived from the same prospective cohort design examining 
effects in adults aged 65 and older with OAB undergoing treatment with medication in a clinical setting. 
A follow up period of 8 weeks has been selected because this is the period of maximal drop in 
adherence.13, 49  Six anti-muscarinic medications are currently available for overactive bladder in the 
United States: darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium. There is no 
evidence to support that one anti-cholinergic medication is better than another. Literature indicates that 
no one treatment is clearly superior to another, (Qaseem 2014) and that selection of anti-muscarinic 
medication should be based on the physicians discretion based on tolerability of side effects and 
insurance costs. (AUA/SUFU OAB guidelines) In this study, patients will be provided medication free 
of costs, so insurance would not play a role in deciding medication type. Additionally, fesoterodine is an 
appropriate ﬁrst choice for medication as it has comparable side effects to other anti-cholinergic 
medication typically used in overactive bladder, including dry mouth, constipation, and CNS effects.


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(Tzefos 2009, AHRP reference guide) Additionally, fesoterodine has been compared to tolterodine, and 
may show greater efﬁcacy. (Tzefos 2009) In fact, fesoterodine tends to have low incidence of dry 
mouth, and moderate incidence of constipation compared to other anti-muscarinics, making it a well-
tolerated and appropriate ﬁrst choice for most patients.(Ellsworth 2014) Low CNS penetration may also 
potentiate fewer CNS side effects.(Ellsworth2014) Additionally, our previously presented data on the 
potential positive effects of anticholinergic medication on physical activity was collected using 
fesoterodine, so there is a precedent for using this anticholinergic in a study examining changes in 
activity and sedentary behavior. Therefore, fesoterodine, the drug used in this study, is an appropriate 
medication for routine and standard care of overactive bladder. Fesoterodine is being supplied by Pﬁzer 
for the use of this study.  As part of routine clinical care at the urogynecology clinics of the University 
of Pennsylvania Health System, all patients receive a pelvic exam, measurement of post-void residual 
by bladder ultrasound, and administration of four urinary questionnaires as part of evaluation of urinary 
symptoms. The OABq-SF and the UDI-6 will be used to screen patients. Inclusion Criteria: adults aged 
65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-
Short Form (OABq-SF),50 who are eligible for pharmacologic therapy for overactive bladder  
Exclusion Criteria: predominant stress incontinence (on UDI-6), current/recent use (6 m) or 
contraindication to anti-cholinergic medication, severe voiding difﬁculties, men on 5-alpha reductase 
inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract 
conditions such as calculus or recurrent UTI. Recruitment/Retention Experience: The urogynecology/
urology clinics of the Hospital of University of Pennsylvania are high volume referral clinics staffed by 
four urogynecologists and one urologist. We see 125 female and 50 male patients with OAB per month 
with eligibility:participation ratio of 1.5:1 in clinical trials.42, 48, 51 In recent trials, 50% of recruited 
adults were Caucasian and 45% African-American. We anticipate that the female:male ratio will be 2:1. 
Recruitment : Pre-screening will occur at a patients routine visit, or via chart review following clinical 
care. If a patient appears to be eligible, they will be referred to the study coordinator to schedule a 
baseline visit. Patients of urogynecology or other referring geriatrics/urology/primary care practices 
may also self-refer for participation, as long as their medical records are available for eligibility 
determination.  Baseline visit: At this visit, the trained coordinator will obtain informed consent, 
administer physical activity and other questionnaires (see Instrument and Testing Schedule below). 
Routine pre-treatment counseling on medical treatment, as well as counseling on additional non-
medical (biofeedback, behavioral strategies, pelvic ﬂoor muscle training) and interventional treatments 
(neuromodulation), will also be provided. Then the coordinator will administer the Preference 
instrument on a bidirectional scale with 0 being undecided, and either extreme (5 or -5) being a strong 
preference for that particular treatment. The Short Physical Performance Battery (SPPB) test will also 
be performed with the oversight of trained personnel for safety. Accelerometers and instructions for 
wearing the accelerometer will be provided at that time. The monitor will be retrieved from the patient 
by a study coordinator or investigator 1 week later. Intervention: All subjects (irrespective of 
preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. They will start 
medication 1 week after the baseline visit. After 4 weeks of treatment, dose may be increased to 8 mg 
over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. 
Change of prescription to another anti-cholinergic may occur during the study period, if determined 
necessary by the physician. Criteria that would warrant stopping fesoterodine include: - inability to 
tolerate common side effects, including dry mouth, dry eyes, and constipation - lack of satisfactory 
urinary symptom control on the highest dose of fesoterodine - immediate withdrawal in case of life-
threatening side effects (uncommon, including angina, angioedema, diverticulitis, gastroenteritis, heat 
prostration, hypersensitivity reactions, irritable bowel syndrome, QT prolongation)  Once withdrawn 
from fesoterodine, managing physicians would use their clinical judgment to switch the patient to 
another anti-cholinergic medication or switch to another class of medication (beta 3 agonist, or 
mirabegron). These patients would continue to be followed until after the 8 week follow-up visit, as the 
statistical plan will involve intention-to-treat analysis. The patients will continue to participate in the 8 
week follow-up visit (including questionnaires and SPPB), regardless of whether or not they were 
switched to another medication. All adults will receive printed educational material on ﬂuid 
modiﬁcation, behavioral strategies, and Kegel exercises. 8 week follow up visit: One week prior, the 
study coordinator will once again provide subjects with accelerometers and instructions for wearing the 
accelerometer. At the 8 week visit, the patient will again complete self-administered physical activity, 
urinary symptoms, adherence, pill count, and neurocognitive instruments and tests with the oversight of 
a trained investigator (see Instrument and Testing Schedule below). The monitor will be retrieved from 
the patient by a study coordinator or investigator at the 8 week follow up visit.  Instrument and Testing 
Schedule BASELINE VISIT:  Urinary questionnaires (OABq-SF, UDI-6) Preference: Belief in 
Medication Questionnaire (BMQ), Bidirectional Visual Analogue Preference scale Physical activity: 


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Accelerometer (gold standard), Self-reported questionnaires (IPAQ, CHAMPS) Neurocognitive 
measures: Questionnaires (Mini Cog, Falls risk), Short Physical Performance Battery Quality of Life: 
SF-12 Bowels: Birmingham 8 WEEK FOLLOW-UP VISIT: Physical activity: Accelerometer (gold 
standard), Self-reported questionnaires (IPAQ, CHAMPS) Neurocognitive measures: Questionnaires 
(Mini Cog, Falls risk follow up), Short Physical Performance Battery Quality of Life: SF-12 Urinary: 
Questionnaires (OABq-SF, UDI-6) Adherence: Questionnaires (Belief in Medication follow up 
questionnaire, MASRI), pill count Patient Global Index of Improvement (PGI-I) form Bowels: 
Birmingham Qaseem A, Dallas P, Forciea MA, Starkey M, Denberg TD, Shekelle P; Clinical 
Guidelines Committee of the American College of Physicians. Nonsurgical management of urinary 
incontinence in women: a clinical practice guideline from the American College of Physicians. Ann 
Intern Med. 2014 Sep 16;161(6):429-40. Ellsworth PI. The pharmacologic management of idiopathic 
overactive bladder in primary care. J Fam Pract. 2014 Feb;63(2 Suppl):S38-45. Review. Association of 
Reproductive Health Professionals. A Quick Reference Guide for Clinicians: Diagnosis and 
Management of Overactive Bladder. https://www.arhp.org/uploadDocs/OABQRG.pdf. Assessed 
6.5.2015
Study duration
Penn Urogynecology has an established track record of successfully recruiting adults with OAB into 
cohort studies and randomized control trials. We plan to recruit 13 to 14 patients per month to reach 
target enrollment of 80 patients by 6 months. As in most clinical trials of OAB, we anticipate that two-
thirds of recruited subjects will be female. Patients will be followed for a total of 8 weeks (see Design). 
Ideally, we would start subject recruitment in March 2016, and subject recruitment and data collection 
would be ﬁnished in September of 2016.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
INSTITUTIONAL PLANS Facilities Available at the Sponsoring Institution The University of 
Pennsylvania has a long history of multidisciplinary clinical and translational research in womens 
health. The proposed clinical study is a multi-disciplinary collaboration between the Divisions of 
Urogynecology (OB/GYN), Urology (Surgery), Geriatrics and the Exercise Physiology Unit. Dr. Arya 
will recruit patients from three sites, including:  the Divisions of Urogynecology (OB/GYN)  the 
Division of Urology (Surgery)  the Division of Geriatrics (Internal Medicine)  There is a long track 
record of collaboration between Urogynecology, Urology and Geriatrics for recruiting patients for 
clinical trials through the Pelvic Floor Disorder Network (U-10, NIH) under Dr. Arya (PI) and Dr. 
Smith (co-PI), and Dr. Johnson (co-investigator).The University of Pennsylvania Health System 
(UPHS) is an academic tertiary care referral center that draws patients from a wide geographic area. 
Patients represent a diverse racial and socioeconomic distribution, including inner city and suburban 
populations. The Division of Urogynecology cares for the full spectrum of urinary incontinence and 
related disorders and has four clinics at Hospital of University of Pennsylvania, Pennsylvania Hosptial, 
Chestnut Hill Hospital and Radnor. The Continence Center of the Division of Urology (Director: Ariana 
Smith, MD) has female urology clinics at both the Hospital of the University of Pennsylvania and 
Pennsylvania Hospital. The clinical and research infrastructure of these two hospitals are completely 
integrated with electronic inpatient and outpatient medical records, shared clinical responsibilities, on-
call schedule, and research nurses and study coordinators. The Division of Geriatrics (Internal 
Medicine) has over 20 academic and research faculty who offer consultative services to departments 
conducting clinical trials and/or translation research, including extensive expertise in research in older 
adults. The Womens Health Clinical Research Center (WHCRC) of the Department of OB/GYN 
provides infrastructure to assist experienced as well as new investigators in the implementation and 
conduct of clinical research including assistance in IRB, continuing renewals, amendments and adverse 
event reporting and assistance in setting up a study binder and study monitoring. Exercise Medicine 
Unit, The Center for Clinical and Translational Research Center (CTRC), Director Katie Schmitz, Ph.D. 
(co-mentor, letter of support): The Exercise Medicine Unit (5,884 square feet) offers exercise training 
and testing services for clinical research studies. The exercise training room contains treadmills, arc 
trainer, recumbent bike, functional trainer, adjustable bench, and a power block area. It is staffed by a 
full-time, certiﬁed exercise trainer who can help design exercise training protocols and administer them 
to clinical research study participants. Dr. Schmitz will provide mentorship in biostatistics and with 


Page 13 of 21
implementing the physical activity monitors and analysis of the accelerometer data. The Clinical Center 
for Epidemiology and Biostatistics (CCEB) provides a Clinical Research Certiﬁcate Program for 
clinicians associated with the university and provides a foundation in biostatistics, research 
methodology, epidemiology and grant writing to allow those completing to coursework to have the tools 
to pursue a career as an independent researcher. The CCEB will provide biostatistics support for this 
project. The CCEB has been actively involved in clinically- and pharmacologically-oriented research 
since 1978. As a Type II Center, it is the primary home for epidemiology and biostatistics at the 
University of Pennsylvania. It is an interdisciplinary and interdepartmental program of more than 275 
individuals and includes clinical and non-clinical faculty, fellows, research staff, biostatisticians, and 
clerical staff. Many studies in the CCEB have focused exclusively on women's health issues.  Fellow 
research facilities of the Division of Urogynecology are located in close proximity to all patient activity. 
Fellows have their own dedicated desk stations and a state-of-the-art computer and printer. The PC has 
word-processing, spreadsheet, and statistical database analysis programs (STATA). The fellows have 
full access to secretarial support, information services, slide preparation and poster presentations 
assistance, and videotaping/editing services. Each fellows computer is connected to the main hospital 
network, which allows for easy and rapid retrieval of inpatient data, biomedical library access, and free 
access to the Internet. Literature searches may be conducted from the fellows ofﬁce through these 
means. Additionally, the Biomedical Library is in close proximity and has extensive facilities for 
literature searches, journals, and inter-library loan. The library periodically holds courses on updated 
methods of database searches, and experienced medical librarians are always on staff.  Funding and 
Technical Assistance: Funding support will be provided by the Pﬁzer/Urology Care Foundation 
Urologic Research Training Award Program for medications and support staff (project coordinator). 
Penn will support the infrastructure needed for recruiting patients for the study (from Urogynecology, 
Urology, Geriatrics), technical assistance with physical activity monitoring and analysis of 
accelerometer data (Exercise Physiology Unit, Dr. Schmitz), and creation of database in REDCap and 
statistical support (CCEB, Dr. Schmitz). The WHCRC of the Department of OB/GYN will provide 
assistance with IRB, adverse event reporting, storage and dispensing of drug, setting up study binder 
and study monitoring.
Characteristics of the Study Population
Target population
Adult subjects aged 65 or older with overactive bladder undergoing treatment with medication
Subjects enrolled by Penn Researchers
80
Subjects enrolled by Collaborating Researchers
0
Accrual
Recruitment/Retention Experience: The urogynecology/urology clinics of the Hospital of University of 
Pennsylvania are high volume referral clinics staffed by four urogynecologists and one urologist. We 
see 125 female and 50 male patients with OAB per month with eligibility:participation ratio of 1.5:1 in 
clinical trials. In recent trials, 50% of recruited adults were Caucasian and 45% African-American. We 
anticipate that the female:male ratio will be 2:1. Sample Size: Speciﬁc Aim 1: A sample size of 68 
evaluable subjects will provide 90% power to detect a correlation coefﬁcient of 0.72 or greater, 
assuming a correlation coefﬁcient of 0.5 or less between the physical activity questionnaires and the 
criterion standard (accelerometer) is undesirable (null hypothesis). Assuming a 15% loss to follow-up, 
we plan to enroll 80 patients to ensure an adequate sample of at least 68 subjects with complete 
datasets.  Speciﬁc Aim 2: We have conservatively assumed that 50% subjects will express preference 
for medication. Prior Penn studies show 56% adherence at 8 weeks in unselected subjects. Assuming 
that adherence will be 80% in subjects expressing preference for medication, a sample size of 80 
subjects will provide 90% power to demonstrate a 30% difference in adherence rates in subjects who do 
or do not have preference for medication.  Speciﬁc Aim 3: Assuming two-tailed alpha of 0.05, a sample 
size of 80 subjects will provide 90% power to show a 30% difference in physical activity in the 
proportion of subjects expressing preference for medication versus those without preference.


Page 14 of 21
Key inclusion criteria
Inclusion Criteria: adults aged 65 or older, urinary urgency of quite a bit severity or more on the 
Overactive Bladder Questionnaire-Short Form (OABq-SF),50 who are eligible for pharmacologic 
therapy for overactive bladder
Key exclusion criteria
Exclusion Criteria: predominant stress incontinence (on UDI-6), current/recent use (6 m) or 
contraindication to anti-cholinergic medication, severe voiding difﬁculties, men on 5-alpha reductase 
inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract 
conditions such as calculus or recurrent UTI.
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
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Populations vulnerable to undue inﬂuence or coercion
All patients will be advised that participation in the study is completely voluntary. Financial 
reimbursement is minimal ($50), and is only for covering transpotation/parking costs, which will 
minimize the risk of coercion for the economically disadvantaged. Patients will also be assured that 
their participation will not affect their care or treatment. Also, each person will be provided the 
opportunity to decline or participate in the study through the process of thorough informed consent. 
Penn employees and students who may be approached during their evaluation in the urogynecology 
clinics will be told that their decision to participate will not impact their standing with the University.
Subject recruitment
Dr. Chu and other study investigators will recruit patients from physician ofﬁces/clinics from three 
clinical divisions, including:  the Divisions of Urogynecology (OB/GYN)  the Division of Urology 
(Surgery)  the Division of Geriatrics (Internal Medicine)  There is a long track record of collaboration 
between Urogynecology, Urology and Geriatrics for recruiting patients for clinical trials through the 
Pelvic Floor Disorder Network (U-10, NIH) under Dr. Arya (PI) and Dr. Smith (co-PI), and Dr. Johnson 
(co-investigator).The University of Pennsylvania Health System (UPHS) is an academic tertiary care 
referral center that draws patients from a wide geographic area. Patients represent a diverse racial and 
socioeconomic distribution, including inner city and suburban populations. The Division of 
Urogynecology cares for the full spectrum of urinary incontinence and related disorders and has four 
clinics at Hospital of University of Pennsylvania, Pennsylvania Hosptial, Chestnut Hill Hospital and 
Radnor. The Continence Center of the Division of Urology (Director: Ariana Smith, MD) has female 
urology clinics at both the Hospital of the University of Pennsylvania and Pennsylvania Hospital. The 
clinical and research infrastructure of these two hospitals are completely integrated with electronic 
inpatient and outpatient medical records, shared clinical responsibilities, on-call schedule, and research 
nurses and study coordinators. The Division of Geriatrics (Internal Medicine) has over 20 academic and 
research faculty who offer consultative services to departments conducting clinical trials and/or 
translation research, including extensive expertise in research in older adults. Potential subjects will be 
identiﬁed either by clinical providers during routine visits to the recruitment ofﬁces, or by the research 
staff using Epic. Potentially eligible subjects may be identiﬁed by reviewing the EMR of patients 
scheduled for visits. The study staff will then either send a message to the provider reminding them to 
discuss the study with the subject when they come for their visit, OR will contact the subject via phone 
in advance to introduce the study. Potential subjects may also be identiﬁed via Epic after they have 
completed their clinical visit. Patients who have had clinical appointments in recent years may be 
identiﬁed as potential subjects via review of Epic or request from the PennData Store. If they were not 


Page 15 of 21
offered study participation in the ofﬁce, they will be contacted by phone or mail regarding their interest 
in participation. Potential subjects also have the option of self-referring, if they see study recruitment 
materials and are interested in participation, and their medical records are available for review and 
conﬁrmation of eligibility.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
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Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
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If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Patients will be reimbursed a total of $50 for their time. This will be provided in $25 increments: once 
at the baseline visit, and once at the follow-up 8 week visit. Subjects will be paid using ClinCards.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
Study visits will typically occur in the subjects home, unless they prefer to come to the ofﬁce. 1. 
Recruitment and Enrollment:  Following a routine ofﬁce visit, or upon self-referral and review of 
records, the patient will be scheduled for a baseline visit with the coordinator, if eligible. Additional 
pre-screening may occur with the subject via phone. 2. Baseline visit:  The study coordinator will ﬁnish 
conﬁrming eligibility via pre-screening questions (if not already completed prior to the visit). Once 
eligibility is conﬁrmed, subjects will provide consent. Additionally, the subjects will ﬁll out the 
following questionnaires:  Preference: Belief in Medication Questionnaire (BMQ, gold standard), 
Bidirectional Visual Analogue Preference scale Physical activity: Accelerometer (gold standard), Self-
reported questionnaires (IPAQ, CHAMPS) Neurocognitive measures: Questionnaires (Minicog, Falls 
risk) Urinary: Questionnaires (OABq-SF, UDI-6) Quality of Life: SF-12 Bowels: Questionnaires 
(Birmingham) Short Physical Performance Testing will be performed with oversight from trained 
personnel.  The study coordinator will provide subjects with accelerometers and instructions for 
wearing the accelerometer. The monitor will be retrieved from the patient by a study coordinator or 
investigator a week later. 3. Intervention:  All subjects will receive a 90-day supply of open label 
fesoterodine 4 mg per day, which they will start 1 week after the baseline visit. After 2 weeks, dose may 
be increased to 8 mg over the telephone based on symptom report. Change of prescription to another 
anti-cholinergic may occur during the study period, if determined necessary by the physician. See full 
criteria in previous intervention section above. 4. 8 week follow up visit:  At this visit, the patient will 
complete the following self-administered physical activity, urinary symptoms, adherence, pill count, 
and neurocognitive instruments and tests: Physical activity: Accelerometer (gold standard), Self-
reported questionnaires (IPAQ, CHAMPS) Neurocognitive measures: Questionnaires (Minicog, Falls 


Page 16 of 21
risk), Short Physical Performance Battery Urinary: Questionnaires (OABq-SF, UDI-6) Bowels: 
Questionnaires (Birmingham) Quality of Life: SF-12 Adherence: Questionnaires (BMQ follow up, 
MASRI), pill count Patient Global Index of Improvement (PGI-I) form The study coordinator will again 
provide subjects with accelerometers and instructions for wearing the accelerometer, one week prior to 
the 8 week visit. The monitor will be retrieved from the patient by a study coordinator or investigator at 
the 8 week visit. Instrument and Testing Schedule BASELINE VISIT:  Preference: Belief in Medication 
Questionnaire (BMQ, gold standard), Bidirectional Visual Analogue Preference scale Physical activity: 
Accelerometer (gold standard), Self-reported questionnaires (IPAQ, CHAMPS) Neurocognitive 
measures: Questionnaires (Mini cog, Falls risk), Short Physical Performance Testing Urinary: 
Questionnaires (OABq-SF, UDI-6) Quality of Life: SF-12 Bowels: Questionnaires (Birmingham) 8 
WEEK FOLLOW-UP VISIT: Physical activity: Accelerometer (gold standard), Self-reported 
questionnaires (IPAQ, CHAMPS) Neurocognitive measures: Questionnaires (Mini Cog, Falls risk), 
Short Physical Performance Testing Urinary: Questionnaires (OABq-SF, UDI-6) Bowels: 
Questionnaires (Birmingham) Quality of Life: SF-12 Adherence: Questionnaires (BMQ follow up, 
MASRI), pill count Patient Global Index of Improvement (PGI-I) form
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Deception
Does your project use deception?
No
International Research
Are you conducting research outside of the United States?
No
Analysis Plan
Analysis Plan Speciﬁc Aim 1 and 2: We will evaluate physical activity, adherence, and neurocognitive 
function before and after treatment to examine changes from baseline to 8 weeks in subjects with and 
without preference for medication. Concurrent validity, the relationship of the instrument to other 
similar evaluations, will be measured by comparing IPAQ, and CHAMPS scores to accelerometer data 
at baseline using the Spearman correlation coefﬁcient and the intraclass correlation coefﬁcient. 
Speciﬁcally, we will compare energy expenditure in MET*min/week (IPAQ) or MET*hour/week 
(CHAMPS) to that measured by the Actigraph accelerometer over the course of a week. For preference, 
we will compare subjects scores as indicated on the bidirectional scale to their necessity-harm 
differential as calculated by the Belief Screen of the BMQ using Spearman correlation coefﬁcient. 
Contingency analyses tables will be used to determine the sensitivity and speciﬁcity of the bidirectional 
preference scale and the necessity-harm differential (as calculated on the Belief Screen) that best 
discriminates between those with preference for medication and those without. Discriminant validity, 
the ability to distinguish between populations, will be determined by comparing mean differences in 
energy expenditure for each physical activity instrument between responders and non-responders to 
anticholinergic medication as deﬁned by the PGI-I. We will compare total MET*min/week (IPAQ) or 
MET*hour/week (CHAMPS), as well as energy spent in sedentary and moderate-to-vigorous physical 
activities (CHAMPS) between responders and non-responders using Wilcoxon rank sum test. For 
preference, we will compare the BMQ Belief necessity-harm differential and bidirectional preference 
scale score using Wilcoxon rank sum test. Responsiveness, the ability of the instruments to detect 
clinically meaningful change, will be assessed. First, pretreatment energy expenditure and preference 
will be compared with post-treatment activity and preference scores, respectively, using the t-test. Next, 
effect size (change in mean score/SD of baseline) and standardized response mean (change in mean 
score/SD of the change) will be assessed. For both, values of 0.50.7 will be considered moderate 
responsiveness; 0.81, good; and 1, excellent. We will measure minimum clinically important difference 
(MCID); speciﬁcally, the smallest change in physical activity associated with clinically meaningful 
change in global rating scale (mean change in energy expenditure in subjects indicating a little better or 
greater in the global rating scale). Speciﬁc Aim 3: We will compare within subject change in physical 
activity from baseline to 8 weeks using the paired t-test. Improvement in physical activity will be 
deﬁned as 15% increase in energy expenditure as compared to baseline. The effect of age, co-
morbidities, baseline activity, severity of cognitive impairment, BMI on physical activity will be 
examined using regression analysis. We will also compare change in activity, proportion of subjects 


Page 17 of 21
showing improvement in activity, adherence (80% or greater, as measured by pill count and MASRI), 
response to medication (PGI-I), overall quality of life (SF-12), neurocognitive and balance function 
(MMSE and Berg Balance Scale scores, respectively), and urinary symptoms (OABq-SF score) in 
adults expressing preference for medication to those expressing no preference. The effect of preference 
will be measured using regression analysis, with adjustment for baseline physical activity, Charlson co-
morbitidy index, age, and BMI.
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Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
Extensive efforts will be made to ensure and maintain participant conﬁdentiality. Data from patients 
will be recorded on data collection forms, which will be associated with a Subject ID number only. The 
patient name, medical record numbers, or other identiﬁers will not be present on the data collection 
forms themselves. The Subject ID number will be composed by the sequential ordering of participants. 
A log book will be kept in for data management purposes to match Subject ID number with patient 
medical record numbers if chart review is needed for missing data. This will also be maintained in a 
secure and locked ﬁling system at all times. Any additional source documentation that may associate 
the patient and PHI to data (such as consent forms) will also be kept in a secure and locked ﬁling 
system at all times. Additionally, any data collection forms will also be kept in a separate secure and 
locked ﬁling system at all times. All data will a REDCap database using their assigned Subject ID 
number. This is protected by a secure system requiring log-in and password. The data from the 
accelerometers is downloaded using the secure software that comes with the Actigraph device, known 
as Actilife. This data is then analyzed by the software, and converted into Excel ﬁles. These Excel ﬁles 
will be password-protected.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 


Page 18 of 21
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
Study visits will typically occur in subjects' homes, allowing for complete privacy. Any telephone calls 
required to contact patients will be performed in a private manner.
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
No.
Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
x Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
No
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No


Page 19 of 21
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
No
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
No
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable
Consent
1. Consent Process
Overview
Informed consent will be obtained by the study coordinator after the patient is identiﬁed as a potential 
recruit for the study. The subjects will have as much time as needed to consider participation between 
informing the prospective participant and obtaining consent. The patient may also choose to withdraw 
from the study at any time. Investigators will emphasize that participation (or lack of participation) in 
the study: 1) not inﬂuence their evaluation, care, or treatment 2) is completely voluntary 3) does not 
involve any ﬁnancial compensation 4) may be terminated at any time. Layman terms will be used by 
those obtaining the consent. The consent will be written at a 6th grade reading level. All questions will 
be answered to the patient's satisfaction and understanding before informed consent is obtained.
Children and Adolescents
Not applicable
Adult Subjects Not Competent to Give Consent
All adult subjects must be competent to give informed consent to be eligible for inclusion into this 
study.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No
If no written statement will be provided, please provide justiﬁciation
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Page 20 of 21
Risk / Beneﬁt
Potential Study Risks
Physical Risks:  Because this is a trial involving the use of fesoterodine, there are possible physical 
risks to the patients secondary to the medication in use and the clinical outcome. However, this is 
minimal since fesoterodine is 1) a FDA-approved medication available in the United States and 
regularly used for treatment of overactive bladder, and 2) has relatively few and mild side effects.  Risks 
include: 10%: Gastrointestinal: Xerostomia (19% to 35%; dose related) 1% to 10%: - Central nervous 
system: Insomnia (1%) - Dermatological: Rash (1%) - Gastrointestinal: Constipation (4% to 6%), 
dyspepsia (2%), nausea (1% to 2%), abdominal pain (1%) - Genitourinary: Urinary tract infection (3% 
to 4%), dysuria (1% to 2%), urinary retention (1%) - Hepatic: ALT increased (1%), GGT increased 
(1%) - Neuromuscular & skeletal: Back pain (1% to 2%) - Ocular: Dry eyes (1% to 4%) - Respiratory: 
Upper respiratory tract infection (2% to 3%), cough (1% to 2%), dry throat (1% to 2%) - 
Miscellaneous: Peripheral edema (1%) - 1% (Limited to important or life-threatening): Angina, 
angioedema, diverticulitis, gastroenteritis, heat prostration, hypersensitivity reactions, irritable bowel 
syndrome, QTc prolongation Additionally, we will be starting with the lowest dose of fesoterodine 
available and monitoring all adverse effects. In a meta-analysis of randomized controlled trials with 
fesoterodine, any adverse effects were usually categorized as mild to moderate, and was most 
commonly associated with dry mouth and constipation (mild adverse effects).(Wyndaele 2014) 
Additionally, amongst elderly patients taking fesoterodine, no trials have shown changes in mean 
MMSE score, computer-based cognitive test battery (CogState), or Rey Auditory Verbal Learning Test 
scores, even in the vulnerable elderly (patients at high risk for functional decline or death within 2 
years).(Chapple 2015) There is a potential for falls during the SPPB testing, but this will be conducted 
with the oversight of trained personnel, and subjects are encouraged to vocalize concerns and stop if 
there are any potential for falling during the course of the testing. Loss of conﬁdentiality: Any study in 
which personal health information (PHI) is collected has the potential risk of loss of conﬁdentiality. 
However, extensive efforts will be made to ensure and maintain security of PHI and maintain 
participant conﬁdentiality. Patients will be identiﬁed and screened by physician investigators at each 
site involved in patient care in their ofﬁces. The patient will be brought into a private room before 
discussing the study and enrollment with the patient in the privacy of a private room. During the study, 
interactions with patients will involve questionnaires and tests which will be conducted in private rooms 
in physicians' ofﬁces. Data from patients will be recorded on data collection forms, which will be 
associated with a Subject ID number only. The patient name, medical record numbers, or other 
identiﬁers will not be present on the data collection forms themselves. The Subject ID number will be 
composed by the sequential ordering of participants. A log book will be kept in for data management 
purposes to match Subject ID number with patient medical record numbers if chart review is needed for 
missing data. This will also be maintained in a secure and locked ﬁling system at all times. Any 
additional source documentation that may associate the patient and PHI to data (such as consent forms) 
will also be kept in a secure and locked ﬁling system at all times. Additionally, any data collection 
forms will also be kept in a separate secure and locked ﬁling system at all times. One year after the 
study has been completed, any forms with patient identiﬁers (such as logs and consents) will be 
destroyed. All data will be logged into a REDCap database using their assigned Subject ID number. 
This is secure and password protected. The data from the accelerometers is downloaded using the 
secure software that comes with the Actigraph device, known as Actilife. This data is then analyzed by 
the software, and converted into Excel ﬁles. These Excel ﬁles will be password-protected.  There are no 
psychological, social, economic, monetary, or legal risks to this study. Wyndaele JJ, Schneider T, 
MacDiarmid S, Scholﬁeld D, Arumi D. Flexible dosing with fesoterodine 4 and 8 mg: a systematic 
review of data from clinical trials. Int J Clin Pract. 2014 Jul;68(7):830-40. doi: 10.1111/ijcp.12425. 
Chapple C, Oelke M, Kaplan SA, Scholﬁeld D, Arumi D, Wagg AS. Fesoterodine Clinical Efﬁcacy and 
Safety for the Treatment of Overactive Bladder in Relation to Patient Proﬁles: A Systematic Review. 
Curr Med Res Opin. 2015 Mar 23:1-78.[Epub ahead of print]
Potential Study Beneﬁts
Potential beneﬁts to the individual subject include improvement of overactive bladder symptoms from 
fesoterodine use. Additionally, by validating and measuring responsiveness in physical activity, 
neurocognitive, and balance instruments, we will be able to increase generalizability of these 
instruments and validate them for use in future clinical trials. Lastly, this will provide preliminary data 
on the impact of treatment preference and anti-cholinergic medications on physical activity and falls 
risk in older adults with overactive bladder, potentially improving quality of life and decreasing life-


Page 21 of 21
threatening consequences of falls in the elderly.
Alternatives to Participation (optional)
Patients are not required to participate in the study. Alternatives would include trying other medical and 
surgical treatments for overactive bladder without questionnaires, measurements of daily activity with 
an activity monitor, or other testing.
Data and Safety Monitoring
The Principal Investigator will be responsible to monitoring safety, privacy, and data integrity. This 
study contains low risks, as fesoterodine is a ﬁrst-line drug already used in daily in clinical practice for 
treatment of overactive bladder. Study progress will also be reviewed by the PI. Review of the rate of 
subject accrual, adherence to inclusion/exclusion criteria will occur to assure that participants meet the 
eligibility criteria. There will be ongoing collection of data on adverse events and compliance to the 
treatment protocol throughout the study by research staff.
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Risk / Beneﬁt Assessment
The beneﬁts of this treatment outweigh the risks. As discussed before, there is the potential for risk of 
physical harm and loss of conﬁdentiality as part of participation in this study. However, the risk of 
physical harm is minimal secondary to the minor adverse effects of fesoterodine, and minimization of 
the dose administered in this study. Additionally, these medications are already being used as ﬁrst-line 
medication in the treatment of overactive bladder in the urogynecology/urology ﬁelds. The loss of 
conﬁdentiality will be minimized by careful and secure management of all paper and electronic 
documentation of patient data. Additionally, participation in questionnaires and neurocognitive/balance 
testing could help clinicians discover patients at risk of falls and refer subjects for other medical 
evaluation as needed. Participation in this study could potentially beneﬁt the patient by decreasing 
overactive bladder symptoms and improving quality of life. If this trial is successful, beneﬁts to elderly 
patients could result in improved quality of life, decreased urinary symptoms, increased safety, and 
decreased risk of the morbidity and mortality associated with falls.
General Attachments
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ICF_000.pdf: 
 
 
 
 
 
 
 
 
 
 
Official Title: Prevention of Fall in Older Adults with Overactive Bladder 
NCT: NCT03946124 
Document date: 05/09/2017 


Version 4.1.2014
  
1 of 8 
UNIVERSITY OF PENNSYLVANIA 
RESEARCH SUBJECT 
INFORMED CONSENT AND HIPAA AUTHORIZATION FORM
Study Sponsor: Urology Care Foundation grant 
Protocol Title:  
Prevention of Falls in Older Adults with Overactive Bladder
Principal 
Investigator:
Christine Chu
1000 Courtyard Building, HUP, 3400 Spruce St, Philadelphia, 
PA 19103, 
Phone: 215 662 6910     
christine.chu@uphs.upenn.edu
Emergency 
Contact:
Christine Chu
1000 Courtyard Building, HUP, 3400 Spruce St, Philadelphia, 
PA 19103, 
Phone: 215 662 6910 (principal investigator office number)
215 662 4000 (for on call urogynecology physician)
christine.chu@uphs.upenn.edu
You are being invited to participate in a research study. Your participation is voluntary which 
means you can choose whether or not you want to participate. If you choose not to participate, 
there will be no loss of benefits to which you are otherwise entitled. Before you can make your 
decision, you will need to know what the study is about, the possible risks and benefits of being 
in this study, and what you will have to do in this study. The research team is going to talk to 
you about the research study, and they will give you this consent form to read. You may also 
decide to discuss it with your family, friends, or family doctor. You may find some of the medical 
language difficult to understand. Please ask the study doctor and/or the research team about 
this form. If you decide to participate, you will be asked to sign this form. 
Why am I being asked to volunteer?  
You are being asked to volunteer because you are interested in medical treatment of overactive 
bladder and you are 65 years of age and over. Overactive bladder is a bladder condition involving 
a sudden urge to urinate, frequent urination, and often involuntary loss of urine associated with 
the urge to urinate (urge urinary incontinence), It affects many older adults and is associated with 
increased risk of falls.  
What is the purpose of this research study? 
Overactive bladder is often an indicator of muscle weakness, increased risk of falls, and
decreased physical activity. The first-line treatment of overactive bladder is a type of medication 
called an anticholinergic agent. The purpose of this study is to evaluate the use of patient-
reported questionnaires to assess relationships between preference for treatment with an 
anticholinergic agent, adherence to treatment, and effects of treatment on physical activity level, 
risk of falls, mental function (attention, memory, language, problem solving, decision making), and 
balance. 
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Participants in this study will receive therapy with fesoterodine, which is an FDA-approved 
anticholinergic medication that has few, mild side effects. This medication has been shown to be 
effective in decreasing symptoms of overactive bladder. Participants will be evaluated for 
changes in urinary symptoms, physical activity, mental function, and balance after 8 weeks of 
treatment with fesoterodine. 
How long will I be in the study? How many other people will be in the study? 
You will be in the study for 9 weeks. 
A total of 80 subjects will be involved in this study, which will only be conducted at sites affiliated 
with Penn. 
What am I being asked to do?
You will be asked to undergo screening to determine your eligibility to participate in this study. 
During a screening visit, you will complete a short questionnaire regarding your urinary 
symptoms. You will also undergo a pelvic examination and an ultrasound examination to 
determine how much urine remains in your bladder after you urinate. 
If you choose to participate in this study, at a baseline visit one week later, you will be asked to fill 
out several questionnaires and perform simple balance tests to examine your abilities prior to the 
beginning of treatment. You will also be given an activity monitor (called an accelerometer) to 
track your daily physical activity for one week before you begin taking fesoterodine and for one 
week before you stop taking it. You will be given instructions for wearing the accelerometer at the 
time of enrollment in the study. At this visit, you will also undergo counseling on management of 
overactive bladder that you would have regardless of participation in the study. This visit should 
take approximately 1.5 hours. 
At this time, you will receive a 90-day supply of fesoterodine, 4 mg, to be taken by mouth daily. 
You will start this medication 1 week after the baseline visit (after the week of wearing the 
accelerometer). All participants in the study will receive this medication. After 4 weeks, you will be 
contacted by telephone to review your response to fesoterodine, and the dose may be increased
to 8 mg. The study doctor may also substitute a different anticholinergic medication if it seems 
necessary. 
A follow-up visit will be scheduled 8 weeks after the start of medication treatment. Prior to this 
appointment, you will receive a phone reminder to wear the activity monitor for the week before 
this visit and to bring your medication bottle to the visit. At the follow-up visit, you will repeat the 
questionnaires and balance tests conducted during the baseline visit. This visit will take 
approximately 1.5 hours. You will again be given an accelerometer to track your daily physical 
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activity for one week after this visit. After this week, you will return the accelerometer. This 
concludes your participation in the study. 
What are the possible risks or discomforts? 
The risks from fesoterodine are generally mild.  
Side Effects
Most common (>4%, or affecting more than 4 out of 
100 people)
x
dry mouth (19 to 35%)
x
constipation (4-6%)
x
dry eyes (1-4%).
Less common (<4%, or less than 4 in 100 people)
Neurologic:
x
Insomnia (1%)
Skin:
x
Rash (1%)
Stomach and intestines:
x
Dyspepsia (heartburn) (2%)
x
Nausea (1% to 2%)
x
Abdominal pain (1%)
Bladder:
x
Urinary tract infection (3% to 4%)
x
Dysuria (pain with urination) (1% 
to 2%)
x
Urinary retention (1%)
Liver: 
x
Elevated liver enzymes (1%)
Muscles, bones:
x
Back pain (1% to 2%)
Lungs:
x
Upper respiratory tract infection 
(2% to 3%)
x
Cough (1% to 2%)
x
Dry throat (1% to 2%)
Others:
x
Peripheral edema (fluid in the 
limbs) (1%)
Uncommon (<1%, or less than 1 in 100 people)
Angina (chest pain)
Angioedema (swelling under the skin)
Diverticulitis (inflammation of the 
outpouchings in the wall of the colon)
Gastroenteritis (stomach flu)
Heat prostration (overheating of the body)
Hypersensitivity reactions (allergic 
reaction)
Irritable bowel syndrome
QTc prolongation (heart rhythm disorder).
During the Berg balance scale test, which involves standing, sitting, and walking, there is a 
potential risk for falls. However, the test will be conducted with the oversight of a physician, and 
you are encouraged to speak up about concerns and stop if you feel that you might fall during the 
course of the testing. 
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Additionally, there is the potential loss of confidentiality; that is, someone could find out that you 
have participated in this study, and potentially any data on you that has been collected during the 
study. We will decrease this risk through the following: all data needed for the study will be 
stripped of any identifiers (such as name and medical record number) and associated with an 
assigned subject identification number only, so that it cannot be directly linked to you. Also, all 
files, forms, and any consent forms or any other documents that could link to you will be locked in 
a secure area at all times. Only investigators involved in this study will have access to these files 
Research may involve risks that are currently unknown. 
What if new information becomes available about the study? 
During the course of this study, we may find more information that could be important to you.  
This includes information that, once learned, might cause you to change your mind about being in 
the study.  We will notify you as soon as possible if such information becomes available. 
What are the possible benefits of the study?  
This study may benefit you by improving your urinary symptoms.
Additionally, this study may provide future benefit by allowing us to improve questionnaires and 
tests used to measure physical activity, mental function, and balance for use in future studies. We may 
also be able to better understand the connections between treatment preference and adherence to 
anticholinergic  therapy on physical activity and fall risk in older adults with overactive bladder, potentially 
providing improvement in quality of life and decreasing risks of falls for patients in the future.
What other choices do I have if I do not participate?  
If you choose not to participate, you may be offered medical treatments (including fesoterodine) 
or surgical treatments for overactive bladder without being involved in questionnaires and 
physical activity measurement. By participating in this study, you may or may not be receiving the 
medication that would be selected for you by your physician per routine clinical care. 
Will I be paid for being in this study? 
You will receive compensation for travel costs (parking, transportation). You will also receive a 
payment of $50 ($25 at the time of the baseline visit and $25 at the time of the 8-week follow-up
visit). 
Will I have to pay for anything? 
You will not have to pay for anything to participate in this study. A 90-day supply of fesoterodine 
will be provided without cost. Research visits (for questionnaires and tests) are provided without 
cost. 
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What happens if I am injured from being in the study?
Potential injuries include side effects from the medication. Although the risk of major side effects 
is minimal, if you experience harm from the side effects, you should contact the urogynecology 
on-call physician (215 662 4000) and seek care immediately from either your primary care 
physician or from the emergency room (if your situation is emergent), as advised by by the on-
call physician. If you think you have been injured as a result of taking part in this research study, 
please report these injuries to the principal investigator (the person in charge of the research 
study) as soon as possible.  The researcher’s name and phone number are listed in the consent 
form.
We will offer you the care needed to treat injuries directly resulting from taking part in this 
research.  We may bill your insurance company or other third parties, if appropriate, for the costs 
of the care you get for the injury, but you may also be responsible for some of them.
There are no plans for the University of Pennsylvania to pay you or give you other compensation 
for the injury.  You do not give up your legal rights by signing this form.   
When is the study over?  Can I leave the study before it ends?
Your participation in the study is completed with the follow-up visit. The study is expected to end 
after all participants have completed all visits, and all information has been collected. This is 
expected to be approximately 1 to 1.5 years after the study starts. This study may also be 
stopped at any time by your physician or the study Sponsor without your consent because: 
x The Principal Investigator feels it is necessary for your health or safety.  Such an 
action would not require your consent, but you will be informed if such a decision is 
made and the reason for this decision. 
x You have not followed study instructions.  
x The Sponsor or the study’s Principal Investigator has decided to stop the study. 
If you decide to participate, you are free to leave the study at any time. Withdrawal will not 
interfere with your future care.   
Who can see or use my information?  How will my personal information be protected?   
We will do our best to make sure that the personal information obtained during the course of this 
research study will be 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. 
Otherwise, only investigators and other personnel involved in the study and in routine patient care 
will be able to see or use your information. The Institutional Review Board at the University of 
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Pennsylvania will also have access to the records. Any information disclosed outside of the 
covered entity may not be protected. 
Extensive efforts will be made to ensure and maintain security of PHI and maintain participant 
confidentiality.   
During the study, any interactions with you will take place in a private room at the study doctor's 
office. Telephone calls will be conducted privately in the office setting. 
Data will be recorded on forms identified with an assigned Subject ID number only. Your name, 
medical record number, or other identifiers will not be present on the data collection forms 
themselves. Any consent forms, record logs, data collection forms, or other information will be 
stored in a secure and locked filing system at all times. Data will be entered electronically into a 
password-secured database using Subject ID. 
Electronic Medical Records and Research Results  
What is an Electronic Medical Record?  
An Electronic Medical Record (EMR) is an electronic version of the record of your care within a 
health system. An EMR is simply a computerized version of a paper medical record. 
If you are receiving care or have received care within the University of Pennsylvania Health 
System (UPHS) (outpatient or inpatient) and are participating in a University of Pennsylvania 
research study,  results of research-related procedures (i.e. laboratory tests, imaging studies and 
clinical procedures) may be placed in your existing EMR maintained by UPHS. 
  
Once placed in your EMR, these results are accessible to appropriate UPHS workforce members 
that are not part of the research team.  Information within your EMR may also be shared with 
others who are determined by UPHS to be appropriate to have access to your EMR (e.g. health 
insurance company, disability provider, etc).  
What information about me may be collected, used or shared with others?   
x Name, address, telephone number, date of birth 
x Email addresses 
x Personal and family medical history  
x Medical record number 
x Results from physical examinations, tests or procedures 
x Records of office visits and telephone calls conducted for routine care 
x Medical records related to illnesses or medical events that happen to you while you are in the 
study, if applicable 
Why is my information being used?
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Your information is used by the research team to contact you during the study. Your information 
and results of tests and procedures are used to: 
x do the research 
x oversee the research 
x to see if the research was done right.   
Who may use and share information about me?   
The following individuals may use or share your information for this research study: 
The investigator for the study and the study team  
Clinical personnel who are part of your physician’s office and part of routine care
Institutional Review Board at the University of Pennsylvania 
Who, outside of the School of Medicine, might receive my information?  
Institutional Review Board at the University of Pennsylvania 
The U.S. Food and Drug Administration 
The Principal Investigator or study staff will inform you if there are any additions to the list above 
during your active participation in the trial. Any additions will be subject to University of 
Pennsylvania procedures developed to protect your privacy. 
How long may the School of Medicine use or disclose my personal health information?   
Your authorization for use of your personal health information for this specific study does not 
expire. 
Your information may be held in a research database.  However, the School of Medicine may not 
re-use or re-disclose information collected in this study for a purpose other than this study unless: 
x 
You have given written authorization  
x
The University of Pennsylvania’s Institutional Review Board grants permission
x 
As permitted by law  
Can I change my mind about giving permission for use of my information? 
Yes. You may withdraw or take away your permission to use and disclose your health information 
at any time.  You do this by sending written notice to the investigator for the study.  If you 
withdraw your permission, you will not be able to stay in this study. 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
By signing this document you are permitting the School of Medicine to use and disclose personal 
health information collected about you for research purposes as described above. 
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Who can I call with questions, complaints or if I’m concerned about my rights as a 
research subject?
If you have questions, concerns or complaints regarding your participation in this research study 
or if you have any questions about your rights as a research subject, you should speak with the 
Principal Investigator listed on page one of this form.  If a member of the research team cannot 
be reached or you want to talk to someone other than those working on the study, you may 
contact the Office of Regulatory Affairs with any question, concerns or complaints at the 
University of Pennsylvania by calling (215) 898-2614.
When you sign this form, you are agreeing to take part in this research study. This means that 
you have read the consent form, your questions have been answered, and you have decided to 
volunteer.  Your signature also means that you are permitting the University of Pennsylvania to 
use your personal health information collected about you for research purposes within our 
institution. You are also allowing the University of Pennsylvania to disclose that personal health 
information to outside organizations or people involved with the operations of this study.
A copy of this consent and HIPAA authorization form will be given to you.  
________________________        
________________________________________ 
Name of Subject (Please Print)  
Signature of Subject  
Date 
________________________ 
________________________________________
Name of Person Obtaining 
Signature                              
 
Date 
Consent (Please Print) 
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