UnknownNot Applicable

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

Canada100 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Subjective postoperative de novo stress urinary incontinence (PONSUI)

Timeframe: 6 months

Trial details

NCT IDNCT04087642

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Maryse Larouche, MD, MPH

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

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials