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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 belowSelect...
I can walk without help from any device.
Select...
I have symptoms of stress or mixed urinary incontinence.
Select...
I have had 3 or more episodes of urinary incontinence weekly for over 3 months.
Select...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had physiotherapy or surgery in the past year.
Select...
I have chronic constipation.
Timeline
Screening ~ 3 weeks3 visits
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
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
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 moreAwards & 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
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.
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