Skip to main content
Clinical Trials/NCT04133935
NCT04133935
Withdrawn
Not Applicable

Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial

Mount Sinai Hospital, Canada0 sitesJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Mount Sinai Hospital, Canada
Primary Endpoint
Subjective Continence Rates
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
October 1, 2033
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Nucelio Luiz de Barros Moreira Lemos MD, PhD

Principal Investigator

Mount Sinai Hospital, Canada

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

Outcomes

Primary Outcomes

Subjective Continence Rates

Time Frame: 1 year

Patient reported symptoms of incontinence

Secondary Outcomes

  • Perioperative and postoperative complications(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Objective continence rates(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Recurrent/persistent/de novo urgency(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Recurrent SUI(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Sexual function(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Urinary retention(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Recurrent urinary tract infection(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
  • Overall quality of life(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)

Similar Trials