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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
Must not have
Stress urinary incontinence (SUI) on history
Isolated posterior compartment prolapse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.
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.
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 below
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I need surgery for a significant pelvic organ prolapse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience urine leakage when I cough, sneeze, or exercise.
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My condition is a prolapse affecting only the back wall of my vagina.
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I have had surgery to repair my urethra.
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I have had surgery before to treat urinary incontinence.
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I am a woman who cannot speak or read English or French.
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I cannot attend appointments due to my location.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Trial 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
461 Previous Clinical Trials
164,253 Total Patients Enrolled
Maryse Larouche, MD, MPHPrincipal InvestigatorSt. Mary's Research Centre and RI-MUHC

Media Library

Intraoperative Crede Manoeuver Clinical Trial Eligibility Overview. Trial Name: NCT04087642 — N/A
Stress Urinary Incontinence Research Study Groups: Preoperative prolapse reduction cough stress test, Intraoperative Crede manoeuver
Stress Urinary Incontinence Clinical Trial 2023: Intraoperative Crede Manoeuver Highlights & Side Effects. Trial Name: NCT04087642 — N/A
Intraoperative Crede Manoeuver 2023 Treatment Timeline for Medical Study. Trial Name: NCT04087642 — N/A
~19 spots leftby Dec 2025
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