Comparing two methods to predict urinary incontinence after pelvic surgery
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
This study is testing which method better predicts urinary incontinence after pelvic surgery in women, to see how it affects their recovery and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT04087642 on ClinicalTrials.gov |
What this trial studies
The CREDE pilot study aims to compare the effectiveness of the intraoperative Crede maneuver against the preoperative prolapse reduction cough stress test in predicting postoperative de novo stress urinary incontinence (PONSUI) in women undergoing pelvic organ prolapse surgery. This randomized study will assess the rates of PONSUI and its impact on patient-reported outcomes and quality of life at 6 weeks and 6 months post-surgery. The study will also evaluate the feasibility of conducting a larger trial by validating instruments and randomization processes.
Who should consider this trial
Good fit: Ideal candidates are women with anterior, uterine, or apical prolapse requiring surgical correction, who do not have a history of stress urinary incontinence.
Not a fit: Patients with a history of stress urinary incontinence, previous anti-incontinence surgery, or isolated posterior compartment prolapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the prediction and prevention of urinary incontinence in women undergoing pelvic surgery, enhancing their quality of life.
How similar studies have performed: While this approach is novel in its specific comparison, similar studies have shown promise in predicting urinary incontinence outcomes in pelvic surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec and 1 other locations
- St. Mary's Hospital — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Maryse Larouche, MD, MPH — St. Mary's Research Centre and RI-MUHC
- Study coordinator: Maryse Larouche, MD, MPH
- Email: ml.larouche@mcgill.ca
- Phone: 1-514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.