Predictive Tests for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Intraoperative Crede Manoeuver and related procedures for stress urinary incontinence after pelvic organ prolapse surgery?
The research suggests that surgical repair of pelvic organ prolapse can resolve urge incontinence, which is a different type of urinary issue, and that predicting stress urinary incontinence after such surgery is challenging. However, there is no direct evidence provided about the effectiveness of the specific treatments like the Crede Manoeuver for stress urinary incontinence.12345
Is the predictive test for stress urinary incontinence after pelvic organ prolapse surgery safe?
How does the Intraoperative Crede Manoeuver treatment differ from other treatments for stress urinary incontinence after pelvic organ prolapse surgery?
The Intraoperative Crede Manoeuver is unique because it involves a manual technique performed during surgery to help predict stress urinary incontinence after pelvic organ prolapse surgery, rather than relying on preoperative tests or additional surgical procedures. This approach is different from other treatments that may involve preoperative screening tests or the use of devices like pessaries to assess or manage incontinence risk.3891011
Eligibility Criteria
This trial is for women with a prolapse condition (anterior, uterine or apical) that's at least moderate in severity and needs surgery. It's not for those who are pregnant, don't speak English or French, have only posterior prolapse, can't attend follow-up visits, already have stress urinary incontinence, or had previous surgeries for incontinence or urethral repair.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants undergo preoperative prolapse reduction cough stress test to determine eligibility for anti-incontinence procedure
Surgical Intervention
Participants undergo POP surgical repair and intraoperative Crede maneuver to assess PONSUI risk and determine need for anti-incontinence procedure
Postoperative Follow-up
Participants are monitored for safety, effectiveness, and complications after surgery, including assessments at 6 weeks and 6 months
Treatment Details
Interventions
- Intraoperative Crede Manoeuver (Procedure)
- Preoperative Prolapse Reduction Cough Stress Test (Diagnostic Test)