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

NCT04087642 | Recruiting DMC

• 1 other identifier: MP-37-2019-4845
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pelvic Organ Prolapse; de Novo Stress Urinary Incontinence; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective PONSUI

  6 months

• Urinary symptoms

  6 months

• Complications

  6 months

• Prevalence and correlation of each test result

  At baseline

• Impact on quality of life

  6 months

Study Arms (2)

Intraoperative Crede manoeuver

EXPERIMENTAL

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.

Diagnostic Test: Intraoperative Crede manoeuver

Preoperative prolapse reduction cough stress test

ACTIVE COMPARATOR

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.

Diagnostic Test: Preoperative prolapse reduction cough stress test

Interventions

Intraoperative Crede manoeuver DIAGNOSTIC_TEST

In this group, both tests will be performed but the intraoperative Crede manoeuver will determine if an anti-incontinence procedure should be performed concomitantly. If the test is positive, it will be performed. If the test is negative, it will not be performed.

Intraoperative Crede manoeuver

Preoperative prolapse reduction cough stress test DIAGNOSTIC_TEST

In this group, both tests will be performed but the preoperative prolapse reduction cough stress test will determine if an anti-incontinence procedure should be performed concomitantly. If the test is positive, it will be performed. If the test is negative, it will not be performed.

Preoperative prolapse reduction cough stress test

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• St. Mary's Research Centre, Montreal: collaborator

Study Sites (2)

St. Mary's Hospital

Montreal, Quebec, H3T1M5, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Maryse Larouche, MD, MPH

  St. Mary's Research Centre and RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryse Larouche, MD, MPH

CONTACT

1-514-934-1934; ml.larouche@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 12, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)