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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Withdrawn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
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 30, 2019
    Last Updated
    November 13, 2021
    Sponsor
    Mount Sinai Hospital, Canada
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    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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