Recruiting

Crede Manoeuver & Prolapse Reduction

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT04087642

Conditions

Pelvic Organ Prolapse

de Novo Stress Urinary Incontinence

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative Crede manoeuver

Preoperative prolapse reduction cough stress test

Study Details

Brief summary:

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.

Conditions

Pelvic Organ Prolapse

de Novo Stress Urinary Incontinence

Stress Urinary Incontinence

Study ID

NCT04087642

Start date

Sep 1, 2019

Status verified date

Feb, 2024

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction

Exclusion Criteria:

  • Stress urinary incontinence (SUI) on history
  • Previous anti-incontinence surgery
  • Pregnancy
  • Prior urethral repair surgery (diverticulum, fistula)
  • Women who do not speak or read English or French
  • Isolated posterior compartment prolapse
  • Geographic location preventing women to come to 6 week and 6 month appointments

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intraoperative Crede manoeuver

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.

active comparator: Preoperative prolapse reduction cough stress test

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.

Interventions

Intraoperative Crede manoeuver

In this group, both tests will be performed but the intraoperative Crede manoeuver will determine if an anti-incontinence procedure should be performed concomitantly. If the test is positive, it will be performed. If the test is negative, it will not be performed.

Preoperative prolapse reduction cough stress test

In this group, both tests will be performed but the preoperative prolapse reduction cough stress test will determine if an anti-incontinence procedure should be performed concomitantly. If the test is positive, it will be performed. If the test is negative, it will not be performed.

Primary outcome measure

  • Subjective postoperative de novo stress urinary incontinence (PONSUI) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Maryse Larouche, MD, MPH

1-514-934-1934ml.larouche@mcgill.ca

Locations

St. Mary's Hospital

Recruiting

Montreal, Quebec, Canada, H3T1M5

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A3J1

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-02-28.