Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy
Primary Purpose
Stress Urinary Incontinence
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Obturator Urethropexy
Burch Urethropexy
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age and be able to read and write English
- Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal
Exclusion Criteria:
- Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
- Pregnancy
- Desired fertility
- Urethral diverticulum
- History of radical pelvic surgery or pelvic radiation therapy
- Current chemotherapy or radiation therapy for malignancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic Obturator Urethropexy
Burch Urethropexy
Arm Description
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
Outcomes
Primary Outcome Measures
Subjective Continence Rates
Patient reported symptoms of incontinence
Secondary Outcome Measures
Objective continence rates
Objective continence rates will be assessed with a cough test and a one-hour pad test.
Perioperative and postoperative complications
Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification.
Urinary retention
Urinary retention will be assessed by an elevated post-void residual urine
Recurrent urinary tract infection
Recurrent urinary tract infection will be assessed through a urine culture
Recurrent/persistent/de novo urgency
Recurrent/persistent/de novo urgency will be based on patient symptoms
Recurrent SUI
Recurrent SUI will be assessed through a cough test/a one-hour pad test
Sexual function
Using the Female Sexual Function Index-6 (FSFI-6).
Overall quality of life
Using the Pelvic Floor Distress Inventory-20 (PFDI-20).
Full Information
NCT ID
NCT04133935
First Posted
September 30, 2019
Last Updated
November 13, 2021
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04133935
Brief Title
Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy
Official Title
Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID restrictions this study has been temporarily halted.
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2032 (Anticipated)
Study Completion Date
October 1, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.
In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.
In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded, randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Upon recruitment to the study, the surgeon will then open a sequentially numbered, opaque, sealed envelope that will randomize the patient to either receiving Burch colposuspension or LOU. The patient will not be made aware of the group they were allocated to.
A clinical staff who was not involved with the surgery and blinded to the allocation of the patient will complete the Post-operative Follow-up Form at each visit.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Obturator Urethropexy
Arm Type
Experimental
Arm Description
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment
Arm Title
Burch Urethropexy
Arm Type
Active Comparator
Arm Description
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Obturator Urethropexy
Intervention Description
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
Intervention Type
Procedure
Intervention Name(s)
Burch Urethropexy
Intervention Description
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
Primary Outcome Measure Information:
Title
Subjective Continence Rates
Description
Patient reported symptoms of incontinence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective continence rates
Description
Objective continence rates will be assessed with a cough test and a one-hour pad test.
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Perioperative and postoperative complications
Description
Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification.
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Urinary retention
Description
Urinary retention will be assessed by an elevated post-void residual urine
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Recurrent urinary tract infection
Description
Recurrent urinary tract infection will be assessed through a urine culture
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Recurrent/persistent/de novo urgency
Description
Recurrent/persistent/de novo urgency will be based on patient symptoms
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Recurrent SUI
Description
Recurrent SUI will be assessed through a cough test/a one-hour pad test
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Sexual function
Description
Using the Female Sexual Function Index-6 (FSFI-6).
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Title
Overall quality of life
Description
Using the Pelvic Floor Distress Inventory-20 (PFDI-20).
Time Frame
6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age and be able to read and write English
Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal
Exclusion Criteria:
Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
Pregnancy
Desired fertility
Urethral diverticulum
History of radical pelvic surgery or pelvic radiation therapy
Current chemotherapy or radiation therapy for malignancy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers.
Learn more about this trial
Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy
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