Status:
RECRUITING
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
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
St. Mary's Research Centre, Montreal
Conditions:
Pelvic Organ Prolapse
de Novo Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 r...
Detailed Description
Primary objective * To assess feasibility of a pilot study to test this hypothesis with the goal to conduct a full trial (sample size calculation, validation of instruments used, randomization proces...
Eligibility Criteria
Inclusion
- Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04087642
Start Date
September 1 2019
End Date
March 1 2026
Last Update
February 28 2024
Active Locations (2)
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1
St. Mary's Hospital
Montreal, Quebec, Canada, H3T1M5
2
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1