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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at recruitment, 13 weeks after recruitment and 12 months after recruitment
Awards & highlights
GROUP Trial 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.Check my eligibility
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.See study design
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.
GROUP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk without help from any device.
Select...
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.
Select...
I am 60 years old or older.
GROUP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at recruitment, 13 weeks after recruitment and 12 months after recruitment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at recruitment, 13 weeks after recruitment and 12 months after recruitment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent reduction in the number of UI episodes
Secondary outcome measures
Adherence to intervention and home exercises
Change in PFM function
Change in PFM morphology
+6 moreGROUP 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
22 Previous Clinical Trials
8,527 Total Patients Enrolled
Chantal Dumoulin, Ph.D.Principal InvestigatorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had physiotherapy or surgery in the past year.I can walk without help from any device.My hormone therapy has been the same for the last 6 months.Your pelvic organ prolapse is more severe than 2 degrees.I have symptoms of stress or mixed urinary incontinence.I have conditions that could affect pelvic floor muscle training.I have had 3 or more episodes of urinary incontinence weekly for over 3 months.I have chronic constipation.You have a very high body mass index, which means you are very overweight.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group physiotherapy
- Group 2: Individual one-on-one physiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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