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Physical Therapy vs Medication for Overactive Bladder in Older Women

Phase < 1

Recruiting

Led By Steve Fisher

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment

Women aged 60 year or older

Must not have

Severe uncontrolled hypertension

Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare physical therapy to drug treatment to see if it can reduce OAB symptoms and risk of falls in older women.

Who is the study for?

This trial is for women aged 60 or older who can walk, have overactive bladder (OAB) or urinary incontinence, and are at high risk of falling. They must be able to consent, have tried lifestyle changes for their bladder condition, and have Medicare or private insurance. It excludes those with certain medical conditions like glaucoma, severe psychiatric issues, chronic liver/kidney diseases, or on conflicting medications.

What is being tested?

The study compares pelvic floor muscle training by physical therapists against two drug treatments—Mirabegron and Trospium Chloride—for managing OAB in older women prone to falls. Each participant will receive one treatment randomly for 12 weeks to assess the feasibility of a larger trial and impact on OAB symptoms.

What are the potential side effects?

Pelvic floor training may cause muscle soreness. Mirabegron could lead to increased blood pressure, headaches, or common cold symptoms. Trospium Chloride might result in dry mouth, constipation, blurred vision or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a bladder control problem confirmed by a score or doctor's advice.

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I am a woman aged 60 or older.

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I can walk across a room with or without help.

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I have been diagnosed with a type of urinary incontinence by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have very high blood pressure that isn't controlled with medication.

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I have a neurological condition like MS, Parkinson's, brain injury, dementia, or stroke that affects my bladder control.

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I have myasthenia gravis.

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I have a long-term liver or kidney disease.

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I live in a nursing home.

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I am currently taking medications for muscle control or heart issues.

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I have been diagnosed with glaucoma.

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I have had surgery for a nerve stimulator or bladder injections for urinary issues.

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I am currently receiving chemotherapy or radiation for genitourinary cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up. for reporting.