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Physical Therapy vs Medication for Overactive Bladder in Older Women

Q: Is the age limit for this clinical trial greater than twenty years?

This clinical investigation requires patients aged 60 to 99. There are 26 trials recruiting under 18s and 200 for those above the retirement age.

Q: What demographic is most likely to benefit from participating in this trial?

Patients who experience urinary incontinence and are between 60-99 years old may apply for this study, which is taking up to 48 participants.

Q: Is this research study presently enrolling participants?

The trial's listing on clinicaltrials.gov denotes that recruitment has been suspended as of May 25th, 2023. Despite this, 228 other studies remain open to participants at the moment.

Q: What are the hoped-for outcomes of this clinical experiment?

This 12-week clinical trial aims to measure Clinical-Based Adherence as its primary outcome. Secondary objectives include measuring the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB), Falls Efficacy Scale International (FES-I) and Number of Participants with Incident falls scores, which respectively gauge self perceived urinary frequency, concern about falling during daily activities and number of participants who experienced an incident fall.

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

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical-Based Adherence

Evaluability

Home-Based Adherence

+1 more

Secondary outcome measures

Absorbent pad use

Falls Efficacy Scale International (FES-I)

International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB)

+6 more

Other outcome measures

Qualitative interviews

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

243 Previous Clinical Trials

56,623 Total Patients Enrolled

2 Trials studying Urinary Incontinence

48 Patients Enrolled for Urinary Incontinence

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,837 Total Patients Enrolled

13 Trials studying Urinary Incontinence

2,652 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this clinical trial greater than twenty years?

"This clinical investigation requires patients aged 60 to 99. There are 26 trials recruiting under 18s and 200 for those above the retirement age."

Answered by AI

What demographic is most likely to benefit from participating in this trial?

"Patients who experience urinary incontinence and are between 60-99 years old may apply for this study, which is taking up to 48 participants."

Answered by AI

Is this research study presently enrolling participants?

"The trial's listing on clinicaltrials.gov denotes that recruitment has been suspended as of May 25th, 2023. Despite this, 228 other studies remain open to participants at the moment."

Answered by AI

What are the hoped-for outcomes of this clinical experiment?

"This 12-week clinical trial aims to measure Clinical-Based Adherence as its primary outcome. Secondary objectives include measuring the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB), Falls Efficacy Scale International (FES-I) and Number of Participants with Incident falls scores, which respectively gauge self perceived urinary frequency, concern about falling during daily activities and number of participants who experienced an incident fall."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880862.

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