Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Mirabegron; Trospium chloride

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 on the International Consultation on Incontinence Modular Questionnaire

• Overactive Bladder (ICIQ-OAB) instrument.

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