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Group vs Individual Physiotherapy for Urinary Incontinence (GROUP Trial)

N/A
Waitlist Available
Led By Chantal Dumoulin, Ph.D.
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory without the need of an assisted device
Suffering from stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) symptoms
Must not have
Have received physiotherapy or surgical treatment within the last year
Chronic constipation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at recruitment, 13 weeks after recruitment and 12 months after recruitment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether group-based pelvic floor muscle training is as effective as one-on-one training for treating urinary incontinence in women 65 and over, and if it is more cost-effective.

Who is the study for?
This trial is for women aged 60 or older who have stress urinary incontinence (SUI) or mixed symptoms, with at least three episodes of incontinence weekly for over three months. Participants should be able to walk unaided and understand French or English. Those overweight, with certain medical conditions, or recent treatments are excluded.
What is being tested?
The study compares group-based pelvic floor muscle (PFM) training to individualized PFM training for treating urinary incontinence in aging women. It aims to see if the group approach is as effective and more cost-efficient than one-on-one sessions.
What are the potential side effects?
While physiotherapy is generally safe, potential side effects may include temporary soreness or discomfort in the pelvic area due to exercises. There's also a small risk of increased urinary symptoms if exercises aren't performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk without help from any device.
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I have symptoms of stress or mixed urinary incontinence.
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I have had 3 or more episodes of urinary incontinence weekly for over 3 months.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had physiotherapy or surgery in the past year.
Select...
I have chronic constipation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after recruitment (once/week during 12 weeks), 13 weeks after after recruitment, 6 months after recruitment, at 9 months after recruitment, 12 months after recruitment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after recruitment (once/week during 12 weeks), 13 weeks after after recruitment, 6 months after recruitment, at 9 months after recruitment, 12 months after recruitment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent reduction in the number of UI episodes
Secondary study objectives
Adherence to intervention and home exercises
Change in PFM function
Change in PFM morphology
+6 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group physiotherapyExperimental Treatment1 Intervention
12 weekly treatment visit + daily home exercise program
Group II: Individual one-on-one physiotherapyActive Control1 Intervention
12 weekly treatment visit + daily home exercise program

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealLead Sponsor
23 Previous Clinical Trials
8,558 Total Patients Enrolled
Chantal Dumoulin, Ph.D.Principal InvestigatorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Media Library

Group physiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT02039830 — N/A
Stress Incontinence Research Study Groups: Group physiotherapy, Individual one-on-one physiotherapy
Stress Incontinence Clinical Trial 2023: Group physiotherapy Highlights & Side Effects. Trial Name: NCT02039830 — N/A
Group physiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02039830 — N/A
~27 spots leftby Nov 2025