Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls (NCT05880862) | Clinical Trial Compass
CompletedEarly Phase 1
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
United States48 participantsStarted 2023-09-28
Plain-language summary
The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling.
The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population.
The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population?
Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the outpatient physical therapy clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.
Who can participate
Age range
60 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women aged 60 year or older.
. Ambulatory (able to walk across a small room with or without an assistive device).
. Urgency UI, OAB, or Mixed UI (both urgency and stress UI) as identified by study physicians.
. Answered "yes" to one of the items on the 3-Key Questions, questionnaire.
. A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment.
. Able to provide one's own informed consent.
. Has tried basic lifestyle modifications for her bladder condition.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluability
Timeframe: Assessed at the end of the 12-week intervention period
2
Clinical-Based Adherence
Timeframe: Assessed at the end of the 12-week intervention period
3
Home-Based Adherence
Timeframe: Assessed at the end of the 12-week intervention period
4
Medication Adherence
Timeframe: Assessed at the end of the 12-week intervention period
Trial details
NCT IDNCT05880862
SponsorThe University of Texas Medical Branch, Galveston
. Male (their causes of urinary incontinence are often different from women)
. Unstable psychiatric conditions (e.g., psychosis, suicidal) based on history and medical records.
. Nursing home resident
. Genitourinary cancer undergoing active treatment with chemotherapy or radiation.
. Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility)
. New OAB treatments planned during the 6-month study duration - includes medications and/or surgery.
. History of surgically implanted sacral nerve stimulator or botulinum toxin bladder injections for UI.