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TERMINATED
NCT04087642
NA

CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery

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

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2019-09-01

Completion Date

2025-03-11

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Locations (2)

St. Mary's Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada