Comparing treatments for overactive bladder in older women at risk of falls
Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study
This study is testing whether pelvic floor muscle training or two different medications can help older women with urgency urinary incontinence while also looking at their risk of falling.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 60 Years to 99 Years |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT05880862 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of pelvic floor muscle training (PFMT) and two medications, Mirabegron and Trospium Chloride, for treating urgency urinary incontinence (UUI) in women aged 60 and older who are at high risk of falling. The study will involve a randomized pilot multi-arm design, assessing the feasibility of these treatment options and their impact on both urinary incontinence and fall-related outcomes. Participants will receive either PFMT administered by physical therapists or one of the two medications over a 12-week period. The trial seeks to address the lack of direct evidence comparing these treatment approaches in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 and older with urgency urinary incontinence or overactive bladder who are ambulatory and at high risk of falling.
Not a fit: Patients who are male, nursing home residents, or have unstable psychiatric conditions or active genitourinary cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for older women suffering from urinary incontinence while minimizing the risk of falls.
How similar studies have performed: While there is limited direct evidence comparing these specific treatment approaches, the study addresses a critical gap in existing research, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 60 year or older. 2. Ambulatory (able to walk across a small room with or without an assistive device). 3. Urgency UI, OAB, or Mixed UI (both urgency and stress UI) as identified by study physicians. 4. Answered "yes" to one of the items on the 3-Key Questions, questionnaire. 5. A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment. 6. Able to provide one's own informed consent. 7. Has tried basic lifestyle modifications for her bladder condition. 8. Has Medicare or private insurance Exclusion Criteria: 1. Male (their causes of urinary incontinence are often different from women) 2. Unstable psychiatric conditions (e.g., psychosis, suicidal) based on history and medical records. 3. Nursing home resident 4. Genitourinary cancer undergoing active treatment with chemotherapy or radiation. 5. Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility) 6. New OAB treatments planned during the 6-month study duration - includes medications and/or surgery. 7. History of surgically implanted sacral nerve stimulator or botulinum toxin bladder injections for UI. 8. Taking other antimuscarinic drugs or Digoxin 9. Severe uncontrolled hypertension 10. Diagnosed Glaucoma 11. Myasthenia gravis 12. Chronic liver or kidney diseases
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch at Galveston — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Steve Fisher — University of Texas Medical Branch at Galveston
- Study coordinator: Steve Fisher, PT, PhD
- Email: stfisher@utmb.edu
- Phone: 4097723068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.