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Behavioral Intervention
Tele-rehabilitation for Urinary Incontinence
N/A
Waitlist Available
Led By Chantale Dumoulin, PhD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report no important cognitive deficit (determined with a Mini-Mental State Evaluation (MMSE) score of 24/30 or more)
Have at least three urinary leakage per week, persisting for 3 months or more
Must not have
Had an active urinary or vaginal infection in the past 3 months
Received pelvic floor physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through intervention completion, for 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare a usual care group to a tele-rehabilitation group to see if the treatment is effective when done remotely.
Who is the study for?
This trial is for women aged 65 or older with stress/mixed urinary incontinence, experiencing at least three leakages per week for over three months. Participants must be able to walk independently, understand French or English, have no significant cognitive deficits, and have internet access. Women with certain medical conditions like severe prolapse, chronic constipation, obesity (BMI over 35), or those on UI medication are excluded.
What is being tested?
The study tests a group pelvic floor muscle training program delivered via tele-rehabilitation to treat urinary incontinence in older women. It aims to see if this online method is feasible and effective compared to traditional face-to-face sessions especially during times when gatherings are restricted.
What are the potential side effects?
Since the intervention involves exercise-based therapy without medications, side effects may include temporary muscle soreness or fatigue from the pelvic floor exercises. No drug-related side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mental function test score shows no significant cognitive issues.
Select...
I have been experiencing urinary leakage three times a week for at least 3 months.
Select...
I can walk and move around on my own without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a urinary or vaginal infection in the last 3 months.
Select...
I have had treatment for urinary issues or pelvic organ prolapse in the last year.
Select...
I am on medication for urinary incontinence or drugs that affect my muscles.
Select...
I have changed my hormonal replacement therapy in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through intervention completion, for 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through intervention completion, for 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
number of UI episodes
percentage reduction (%) in the number of UI episodes
Secondary study objectives
Changes in UI-related quality of life
Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
+14 moreOther study objectives
Cognitive function
Pelvic floor muscle function
Signs and severity of pelvic prolapse
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Group pelvic floor tele-rehabilitationExperimental Treatment1 Intervention
12 weekly treatment online sessions + daily home exercise program
Find a Location
Who is running the clinical trial?
Réseau québécois de recherche sur le vieillissement (RQRV)UNKNOWN
1 Previous Clinical Trials
24 Total Patients Enrolled
Université de MontréalLead Sponsor
221 Previous Clinical Trials
104,260 Total Patients Enrolled
Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealOTHER
23 Previous Clinical Trials
8,888 Total Patients Enrolled
3 Trials studying Urinary Incontinence
1,531 Patients Enrolled for Urinary Incontinence
Chantale Dumoulin, PhDPrincipal InvestigatorUniversité de Montréal
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand instructions in either French or English.You are very overweight, with a body mass index (BMI) over 35.My mental function test score shows no significant cognitive issues.I have had a urinary or vaginal infection in the last 3 months.I have had treatment for urinary issues or pelvic organ prolapse in the last year.I have been experiencing urinary leakage three times a week for at least 3 months.You have a confirmed pattern of stress or mixed urinary incontinence as shown by the Questionnaire for Incontinence Diagnosis (QUID).I am on medication for urinary incontinence or drugs that affect my muscles.I do not have conditions like severe constipation, major organ prolapse, or serious health issues that could affect pelvic floor muscle training.I can walk and move around on my own without help.I have changed my hormonal replacement therapy in the last 6 months.I am 65 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group pelvic floor tele-rehabilitation
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.