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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

NCT04087642 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • St. Mary's Research Centre, Montreal

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Maryse Larouche, MD, MPH · St. Mary's Research Centre and RI-MUHC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-12-01
Completion
2026-03-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087642 on ClinicalTrials.gov