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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary Stress Incontinence

Secondary study objectives

Complications

Impact on quality of life

Objective PONSUI

+2 more

Awards & 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: 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.

0 / 7Eligibility criteria met