Predictive Tests for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery

Recruiting at 2 trial locations

Overseen By Maryse Larouche, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

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

Disqualifiers: Stress urinary incontinence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to predict and prevent stress urinary incontinence (urine leakage during activities like coughing) that may occur after pelvic organ prolapse surgery. It compares two methods: a preoperative test where a doctor checks for leaks when a patient coughs (Preoperative Prolapse Reduction Cough Stress Test) and an intraoperative maneuver that checks for leaks during surgery (Intraoperative Crede Manoeuver). The trial aims to determine which method better predicts and prevents urinary issues, thereby improving patients' quality of life. Women with significant pelvic organ prolapse requiring surgery, but without a history of stress urinary incontinence, might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance surgical outcomes and quality of life for future patients.

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 prior data suggests that these methods are safe for predicting stress urinary incontinence?

Research has shown that the intraoperative Crede maneuver is generally safe. This technique involves gently pressing on the bladder during surgery to check for urine leaks. Studies have found it to be a simple and safe method.

The preoperative prolapse reduction cough stress test is another safe and straightforward procedure performed before surgery. In this test, a healthcare provider checks for urine leaks by having the patient cough while gently pushing back any bulging pelvic organs.

Both methods help predict and prevent urinary incontinence (loss of bladder control) after surgery. Reports of significant problems with either technique are absent, making them well-tolerated options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to improve the decision-making process during pelvic organ prolapse surgery, particularly in determining the need for additional anti-incontinence procedures. Traditionally, stress urinary incontinence is managed with surgeries like sling procedures, but identifying patients who will benefit from these interventions can be challenging. The trial evaluates methods like the preoperative prolapse reduction cough stress test and the intraoperative Crede maneuver, which aim to predict incontinence risk more accurately. By enhancing predictive accuracy, these techniques could lead to more tailored and effective surgical plans, potentially reducing unnecessary procedures and improving patient outcomes.

What evidence suggests that these methods are effective for predicting stress urinary incontinence after pelvic organ prolapse surgery?

In this trial, participants will undergo one of two predictive tests for stress urinary incontinence (SUI) following pelvic organ prolapse surgery. Research has shown that the intraoperative Crede maneuver, one of the tests in this trial, can predict SUI. Specifically, one study indicated it predicted SUI in about 32.5% of women after surgery, suggesting its usefulness in deciding whether to perform additional procedures during surgery to prevent incontinence. The other test, the preoperative prolapse reduction cough stress test, is used before surgery to check for signs of SUI. These tests assist doctors in determining if preventive steps are needed before surgery. Both methods aim to reduce the risk of developing urinary incontinence post-surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Maryse Larouche, MD, MPH

Principal Investigator

St. Mary's Research Centre and RI-MUHC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Crede Manoeuver
• Preoperative Prolapse Reduction Cough Stress 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

St. Mary's Research Centre, Montreal

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

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]

Surgeons certified in female pelvic medicine and reconstructive surgery (FPMRS) performed more anti-incontinence procedures and were more likely to complete essential perioperative tasks compared to non-FPMRS surgeons, indicating a higher standard of care.

Patients operated on by FPMRS-certified surgeons experienced fewer readmissions within 30 days post-surgery, suggesting that these specialists may provide safer and more effective surgical outcomes for stress urinary incontinence.

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]

In a study of 103 patients who underwent surgery for genitourinary prolapse, 86% of those who experienced incontinence shortly after surgery continued to be incontinent long-term, regardless of their urodynamic assessment results.

The study found that postoperative urodynamic assessments did not reliably predict bladder function or correlate with patient-reported symptoms, suggesting that postoperative symptoms are a better indicator of surgical success than urodynamic parameters.

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]

The pessary test, conducted on 30 women with urinary incontinence, effectively mimicked the outcomes of corrective incontinence surgery, demonstrating significant urodynamic changes (P < .01).

This test reliably distinguished between bladder instability and stress urinary incontinence due to anatomical defects, making it a simple and cost-effective diagnostic tool that does not compress the urethra.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 24 women aged 49 to 84 undergoing pelvic organ prolapse surgery, there was a significant temporary decrease in bladder contractility and urinary flow rates immediately after the operation, indicating a short-term impairment in lower urinary tract function.

By 3 months post-surgery, bladder contractility showed significant improvement, suggesting that while patients experience initial urinary function issues, these tend to resolve over time.

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]

In a study of 206 patients with pelvic organ prolapse who did not report urinary incontinence, the preoperative 1-hour pad test effectively identified occult stress urinary incontinence (SUI), with a cutoff value of 1.9 g indicating a higher likelihood of needing a mid-urethral sling after surgery.

Patients with occult SUI had a significantly higher rate of developing new urinary incontinence post-surgery (53.3% vs. 23.6%), highlighting the importance of screening for occult SUI to inform surgical decisions.

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]

In a study of 41 women undergoing vaginal surgery for advanced pelvic organ prolapse, urodynamic testing revealed that 41.5% had occult stress urinary incontinence (SUI), highlighting its importance in identifying at-risk patients.

Post-surgery, only 7.3% of women reported urinary incontinence, and notably, none of the women without occult SUI experienced postoperative SUI, suggesting that urodynamics can help tailor surgical interventions to improve outcomes.

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]

In a study of 38 women with uterine and/or vaginal vault prolapse and motor urge incontinence, 63% experienced resolution of their urge incontinence after surgical repair, indicating that this surgery can be effective for this condition.

Two key predictors of successful resolution were identified: uninhibited detrusor contractions less than 25 cm water and the presence of bladder trabeculation, suggesting that these factors may help in assessing which patients are likely to benefit from the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 356 women undergoing vaginal prolapse repair, 17% experienced postoperative stress urinary incontinence (POSUI), highlighting a significant risk associated with this surgery.

The inclusion of a preoperative stress test improved the prediction model for POSUI, particularly for women with a 10% to 30% risk, but was not beneficial for those at low risk, suggesting targeted use of the test may enhance patient outcomes.

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]

A survey of 176 surgeons revealed that 89% consider invasive urodynamic testing (IUT) essential before surgery for stress urinary incontinence (SUI) or mixed urinary incontinence (MUI), indicating a strong consensus on its importance in clinical practice.

Despite the high regard for IUT, 70% of respondents acknowledged the need for further research on its necessity, with 60% expressing a willingness to participate in multicenter trials to explore this issue.

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]

In a study of 225 continent women undergoing surgery for pelvic organ prolapse, the rate of developing de novo stress urinary incontinence (SUI) after surgery was found to be 5.3%.

The previously described prediction model for de novo SUI showed poor predictive accuracy with an area under the ROC curve of only 0.56, indicating that it is not a reliable diagnostic tool and highlighting the need for further research to improve prediction methods.

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04087642/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?page=2&country=Canada&city=Montreal

CREDE Study: Intraoperative Crede Manoeuver Compared ... The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress ...

2. jogc.com jogc.com/article/S1701-2163(22)00157-8/pdf

The Intra-Operative Crede Maneuver to Detect Latent ... Crede was negative in 52 (67.5%) women, and positive in 25 (32.5%) (MUS placed in 21 women). Rate of postoperative de novo SUI (symptoms or retreatment) at 1.9 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24165452/

Intraoperative Crede maneuver for tape adjustment during ... Conclusion: Using CM for intraoperative tape adjustment does not improve continence rates compared to the traditional method of TOT sling placement. MeSH terms.

4. withpower.com withpower.com/trial/phase-enuresis-8-2019-3eef2

Predictive Tests for Stress Urinary Incontinence After Pelvic ... The Intraoperative Crede Manoeuver is unique because it involves a manual technique performed during surgery to help predict stress urinary incontinence after ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8210713/

Adjustment of tension applied in transobturator tapes ... Intraoperative adjustment of tension using Valsalva maneuver under saddle anesthesia gives better outcomes than the conventional tension-free technique.

6. researchgate.net researchgate.net/publication/360575424_The_Intra-Operative_Crede_Maneuver_to_Detect_Latent_Stress_Urinary_Incontinence-Technique_and_Outcomes

The Intra-Operative Crede Maneuver to Detect Latent ... The Intra-Operative Crede Maneuver to Detect Latent Stress Urinary Incontinence—Technique and Outcomes. May 2022; Journal of Obstetrics and ...

7. journals.lww.com journals.lww.com/urol/fulltext/2021/13020/adjustment_of_tension_applied_in_transobturator.9.aspx

Adjustment of tension applied in transobturator tapes in... Intraoperative adjustment of tension using Valsalva maneuver under saddle anesthesia gives better outcomes than the conventional tension-free technique.