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Predictive Tests for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery
N/A
Recruiting
Led By Maryse Larouche, MD, MPH
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will compare two methods for predicting and preventing a specific kind of urinary incontinence after childbirth.
Who is the study for?
This trial is for women with a prolapse condition (anterior, uterine or apical) that's at least moderate in severity and needs surgery. It's not for those who are pregnant, don't speak English or French, have only posterior prolapse, can't attend follow-up visits, already have stress urinary incontinence, or had previous surgeries for incontinence or urethral repair.Check my eligibility
What is being tested?
The CREDE study is testing two methods to predict and prevent new-onset stress urinary incontinence after pelvic organ prolapse surgery: the intraoperative Crede manoeuver versus a preoperative cough test. The impact on patient outcomes and quality of life will also be assessed.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, traditional side effects like you might see with drugs aren’t expected. However, there may be discomfort associated with the tests themselves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a significant pelvic organ prolapse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Stress Incontinence
Secondary outcome measures
Complications
Impact on quality of life
Objective PONSUI
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intraoperative Crede manoeuverExperimental Treatment1 Intervention
Method 1 (M1) consists in intraoperative Crede maneuver: After POP surgical reduction, the bladder will be retrograde filled with 300 ml of sterile water through a catheter that will then be removed. Brief and forceful suprapubic pressure will be applied. The test is positive if the surgeon visualizes a urinary leak.
In this group, the intraoperative Crede manoeuver will determine if an anti-incontinence procedure should be performed concomitantly.
Group II: Preoperative prolapse reduction cough stress testActive Control1 Intervention
An examiner will perform the test preoperatively in the office, at the same visit as the recruitment. With a volume of 250-350 mL of urine in the bladder (confirmed by bladder scanner), a prolapse reduction cough stress test will be performed (posterior speculum blade for reduction). The test is positive if the examiner visualizes a urinary leak.
In this group, the preoperative prolapse reduction cough stress test will determine if an anti-incontinence procedure should be performed concomitantly.
Find a Location
Who is running the clinical trial?
St. Mary's Research Centre, MontrealUNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,626 Total Patients Enrolled
Maryse Larouche, MD, MPHPrincipal InvestigatorSt. Mary's Research Centre and RI-MUHC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience urine leakage when I cough, sneeze, or exercise.My condition is a prolapse affecting only the back wall of my vagina.I have had surgery to repair my urethra.I need surgery for a significant pelvic organ prolapse.I have had surgery before to treat urinary incontinence.I am a woman who cannot speak or read English or French.I cannot attend appointments due to my location.
Research Study Groups:
This trial has the following groups:- Group 1: Preoperative prolapse reduction cough stress test
- Group 2: Intraoperative Crede manoeuver
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.
Does this research study have the capacity to recruit new participants?
"Yes, the clinicaltrials.gov data confirms that this experiment is actively recruiting participants. Initially posted on September 1st 2019 and last modified on December 21st 2021, 100 individuals are needed from 2 different medical centres."
Answered by AI
What is the maximum capacity for participants in this experiment?
"Affirmative. The clinical trial is actively looking for volunteers, as per the information found on clinicaltrials.gov. It was first announced on September 1st 2019 and has been updated recently on December 21st 2021. This study requires 100 individuals to be recruited from 2 different sites."
Answered by AI
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