Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087642
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
St. Mary's Research Centre, Montreal
Information provided by (Responsible Party):
Maryse Larouche, McGill University Health Centre/Research Institute of the McGill University Health Centre

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 sling placed. This information will help inform larger studies on the topic.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse de Novo Stress Urinary Incontinence Stress Urinary Incontinence Diagnostic Test: Intraoperative Crede manoeuver Diagnostic Test: Preoperative prolapse reduction cough stress test Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intraoperative Crede manoeuver

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 a mid-urethral sling should be placed concomitantly.

Diagnostic Test: Intraoperative Crede manoeuver
In this group, both tests will be performed but the intraoperative Crede manoeuver will determine if a mid-urethral sling is placed concomitantly. If the test is positive, a sling will be placed. If the test is negative, no sling will be placed.

Active Comparator: Preoperative prolapse reduction cough stress test

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 a mid-urethral sling should be placed concomitantly.

Diagnostic Test: Preoperative prolapse reduction cough stress test
In this group, both tests will be performed but the preoperative prolapse reduction cough stress test will determine if a mid-urethral sling is placed concomitantly. If the test is positive, a sling will be placed. If the test is negative, no sling will be placed.




Primary Outcome Measures :
  1. Subjective postoperative de novo stress urinary incontinence (PONSUI) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Objective PONSUI [ Time Frame: 6 months ]
    Positive cough stress test

  2. Urinary symptoms [ Time Frame: 6 months ]
    Scores on Urinary Distress Inventory (UDI-6)

  3. Complications [ Time Frame: 6 months ]
    Perioperative and postoperative complications including: bladder perforation, voiding dysfunction, urinary tract infection and mesh exposure

  4. Prevalence and correlation of each test result [ Time Frame: At baseline ]
    Percentage of positive tests and correlation between both tests

  5. Impact on quality of life [ Time Frame: 6 months ]
    Urinary Impact Questionnaire (UIQ-7)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 declining the use of any mesh product or a mid-urethral sling procedure
  • Absolute contraindication to MUS (pelvic kidney, vascular graft, low ventral hernias)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087642


Contacts
Layout table for location contacts
Contact: Maryse Larouche, MD, MPH 1-514-934-1934 ext 32931 ml.larouche@mcgill.ca

Locations
Layout table for location information
Canada, Quebec
St. Mary's Hospital Recruiting
Montreal, Quebec, Canada, H3T1M5
Contact: Maryse Larouche, Md, MPH         
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A3J1
Contact: Maryse Larouche, MD, MPH         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
St. Mary's Research Centre, Montreal
Investigators
Layout table for investigator information
Principal Investigator: Maryse Larouche, MD, MPH St. Mary's Research Centre and RI-MUHC

Layout table for additonal information
Responsible Party: Maryse Larouche, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04087642     History of Changes
Other Study ID Numbers: MP-37-2019-4845
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical