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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction
Locations
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
St. Mary's Hospital
RECRUITING
Montreal
Contact Information
Primary
Maryse Larouche, MD, MPH
ml.larouche@mcgill.ca
1-514-934-1934
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: St. Mary's Research Centre, Montreal
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre