Pelvic Organ Prolapse Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Mary's Hospital | Montreal | Quebec |
Canada | McGill University Health Centre | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | St. Mary's Research Centre, Montreal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective postoperative de novo stress urinary incontinence (PONSUI) | SUI occurring after a surgery (usually a prolapse correction) in a patient who did not have SUI before the surgery. In this study, PONSUI is defined as answering "yes" to question #3 in the UDI-6 questionnaire: "Do you experience urine leakage related to activity, coughing or sneezing?" after the surgery, in previously continent women. | 6 months | |
Secondary | Objective PONSUI | Positive cough stress test | 6 months | |
Secondary | Urinary symptoms | Scores on Urinary Distress Inventory (UDI-6) | 6 months | |
Secondary | Complications | Perioperative and postoperative complications including: bladder perforation, voiding dysfunction, urinary tract infection and mesh exposure | 6 months | |
Secondary | Prevalence and correlation of each test result | Percentage of positive tests and correlation between both tests | At baseline | |
Secondary | Impact on quality of life | Urinary Impact Questionnaire (UIQ-7) | 6 months |
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