Predictive Tests for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Maryse Larouche, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Stress urinary incontinence, Pregnancy, others

No Placebo Group

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. ^{1 2 3 4 5}

Is the predictive test for stress urinary incontinence after pelvic organ prolapse surgery safe?

The research articles do not provide specific safety data for the predictive tests or procedures like the Crede Manoeuver or stress tests. However, surgeries for stress urinary incontinence are generally considered low-risk, similar to common procedures like hernia repairs. ^{3 4 6 7 8}

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. ^{3 8 9 10 11}

Research Team

Maryse Larouche, MD, MPH

Principal Investigator

St. Mary's Research Centre and RI-MUHC

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

I need surgery for a significant pelvic organ prolapse.

Exclusion Criteria

I experience urine leakage when I cough, sneeze, or exercise.

My condition is a prolapse affecting only the back wall of my vagina.

I have had surgery to repair my urethra.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative prolapse reduction cough stress test to determine eligibility for anti-incontinence procedure

1 visit

1 visit (in-person)

Surgical Intervention

Participants undergo POP surgical repair and intraoperative Crede maneuver to assess PONSUI risk and determine need for anti-incontinence procedure

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety, effectiveness, and complications after surgery, including assessments at 6 weeks and 6 months

6 months

2 visits (in-person)

Treatment Details

Interventions

• Intraoperative Crede Manoeuver (Procedure)
• Preoperative Prolapse Reduction Cough Stress Test (Diagnostic Test)

Trial Overview The CREDE study is testing two methods to predict and prevent new-onset stress urinary incontinence after pelvic organ prolapse surgery: the intraoperative Crede manoeuver versus a preoperative cough test. The impact on patient outcomes and quality of life will also be assessed.

Participant Groups

Group I: Intraoperative Crede manoeuver Experimental Treatment 1 Intervention

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.

Group II: Preoperative prolapse reduction cough stress test Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Mary's Hospital Montreal, Canada

McGill University Health Centre Montréal, Canada

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Patients Recruited

170,000+

St. Mary's Research Centre, Montreal

Collaborator

Trials

1

Patients Recruited

100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of motor urge incontinence after surgical repair of pelvic organ prolapse. Nguyen, JK., Bhatia, NN.[2004]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of postoperative urodynamic assessment for long-term urinary function results after treatment of genital prolapse. 103 examinations after treatment of genital prolapse]. Therby, D., Viala, F., Cosson, M., et al.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of a model predicting de novo stress urinary incontinence after pelvic organ prolapse surgery. Yasa, C., Gungor Ugurlucan, F., Dural, O., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic prediction of occult stress urinary incontinence before vaginal surgery for advanced pelvic organ prolapse: evaluation of postoperative outcomes. Duecy, EE., Pulvino, JQ., McNanley, AR., et al.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative detrusor contractility temporarily decreases in patients undergoing pelvic organ prolapse surgery. Kitta, T., Mitsui, T., Kanno, Y., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of Perioperative Tasks for Women Undergoing Anti-incontinence Surgery: Developed by the AUGS Quality Improvement and Outcomes Research Network. Erekson, E., Whitcomb, EL., Kamdar, N., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing professional equipoise and views about a future clinical trial of invasive urodynamics prior to surgery for stress urinary incontinence in women: a survey within a mixed methods feasibility study. Hilton, P., Bryant, A., Howel, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress urinary incontinence after vaginal prolapse repair: development and internal validation of a prediction model with and without the stress test. van der Ploeg, JM., Steyerberg, EW., Zwolsman, SE., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of the preoperative 1-h pad test with pessary insertion for predicting the need for a mid-urethral sling following pelvic prolapse surgery: a cohort study. Song, X., Zhu, L., Ding, J.[2018]

The study involved 137 women and found a significant association between occult incontinence and the risk of developing postoperative stress urinary incontinence (POSUI) after pelvic organ prolapse surgery.

Despite the association, the tests used to identify women at risk for POSUI showed poor predictive performance at the individual level, indicating that occult incontinence alone is not a reliable indicator for recommending prophylactic anti-incontinence procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occult incontinence as predictor for postoperative stress urinary incontinence following pelvic organ prolapse surgery. Svenningsen, R., Borstad, E., Spydslaug, AE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pessary test in women with urinary incontinence. Bhatia, NN., Bergman, A.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Resolution of motor urge incontinence after surgical repair of pelvic organ prolapse. [2004]

2. France pubmed.ncbi.nlm.nih.gov

[Value of postoperative urodynamic assessment for long-term urinary function results after treatment of genital prolapse. 103 examinations after treatment of genital prolapse]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

External validation of a model predicting de novo stress urinary incontinence after pelvic organ prolapse surgery. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Urodynamic prediction of occult stress urinary incontinence before vaginal surgery for advanced pelvic organ prolapse: evaluation of postoperative outcomes. [2012]

5. Australia pubmed.ncbi.nlm.nih.gov

Postoperative detrusor contractility temporarily decreases in patients undergoing pelvic organ prolapse surgery. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Performance of Perioperative Tasks for Women Undergoing Anti-incontinence Surgery: Developed by the AUGS Quality Improvement and Outcomes Research Network. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing professional equipoise and views about a future clinical trial of invasive urodynamics prior to surgery for stress urinary incontinence in women: a survey within a mixed methods feasibility study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Stress urinary incontinence after vaginal prolapse repair: development and internal validation of a prediction model with and without the stress test. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

The value of the preoperative 1-h pad test with pessary insertion for predicting the need for a mid-urethral sling following pelvic prolapse surgery: a cohort study. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Occult incontinence as predictor for postoperative stress urinary incontinence following pelvic organ prolapse surgery. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Pessary test in women with urinary incontinence. [2009]