A Phase 4 interventional study of Fesoterodine in Overactive Bladder, sponsored by University of Pennsylvania. Completed. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 74 is close to the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-Short Form (OABq-SF), 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.
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.
Drug: Fesoterodine
Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Measure of Physical Activity
Physical activity was measured by using accelerometer worn over the course of a week at follow up. Average daily step counts were derived from this weeklong measurement.
Time frame: 1 week
| Milestone | Fesoterodine |
|---|---|
| Started | 74 |
| Completed | 55 |
| Not completed | 19 |
| Withdrew: Withdrawal by subject | 19 |
Physical activity was measured by using accelerometer worn over the course of a week at follow up. Average daily step counts were derived from this weeklong measurement.
| steps per day | Fesoterodine |
|---|---|
| Measure of Physical Activity | 1634.19 (980.1 to 2367.3) |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fesoterodine | 0/74 (0%) | 0/74 (0%) | 7/74 (9.5%) |
| Event | Fesoterodine |
|---|---|
| Side effectsGastrointestinal disorders | 6/74 |
| Dizziness, edemaVascular disorders | 1/74 |
| Age, Continuous(years) | Fesoterodine |
|---|---|
| Mean | 76.5 ± 7.2 |
| Sex: Female, Male(Participants) | Fesoterodine |
|---|---|
| Female | 74 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Fesoterodine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 26 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Fesoterodine |
|---|---|
| United States | 74 |
| Physical Activity - Daily Steps(Steps per day) | Fesoterodine |
|---|---|
| Median | 2117.7 (988.5 to 2924.25) |
| Physical Activity - CHAMPS questionnaire caloric expenditure/week, all activities(Kcal/week) | Fesoterodine |
|---|---|
| Mean | 2552.4 ± 2560.12 |
| Physical Activity - IPAQ questionnaire total physical activity(MET-min/wk) | Fesoterodine |
|---|---|
| Mean | 785.62 ± 1609.84 |
| Short Physical Performance Battery total score(units on a scale) | Fesoterodine |
|---|---|
| Mean | 7.82 ± 2.21 |
3 further baseline measures are reported on the registry.
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
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