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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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical-Based Adherence
Evaluability
Home-Based Adherence
+1 more
Secondary study objectives
Absorbent pad use
Falls Efficacy Scale International (FES-I)
International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB)
+6 more
Other study objectives
Qualitative interviews

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Pelvic Floor Muscle TrainingExperimental Treatment1 Intervention
A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)
Group II: MirabegronActive Control1 Intervention
Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.
Group III: Trospium ChlorideActive Control1 Intervention
A 12-week course of Trospium -extended release, 60mg once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelvic Floor Muscle Training
2007
N/A
~1170

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
252 Previous Clinical Trials
56,838 Total Patients Enrolled
2 Trials studying Urinary Incontinence
48 Patients Enrolled for Urinary Incontinence
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,185,914 Total Patients Enrolled
13 Trials studying Urinary Incontinence
2,592 Patients Enrolled for Urinary Incontinence
Steve FisherPrincipal InvestigatorUniversity of Texas Medical Branch at Galveston

Media Library

Mirabegron (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05880862 — Phase < 1
Urinary Incontinence Research Study Groups: Pelvic Floor Muscle Training, Mirabegron, Trospium Chloride
Urinary Incontinence Clinical Trial 2023: Mirabegron Highlights & Side Effects. Trial Name: NCT05880862 — Phase < 1
Mirabegron (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880862 — Phase < 1
~0 spots leftby Dec 2024
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