NCT04133935

Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

Withdrawn NA Last updated 22 November 2021

What this trial tests

NA trial testing Laparoscopic Obturator Urethropexy in Stress Urinary Incontinence. Withdrawn.

Timeline

1 January 2023

Primary endpoint
1 January 2032

1 October 2033

Quick facts

Lead sponsor	Mount Sinai Hospital, Canada
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	1 January 2023
Primary completion	1 January 2032
Estimated completion	1 October 2033

Drugs / interventions tested

• Laparoscopic Obturator Urethropexy
• Burch Urethropexy

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Mount Sinai Hospital, Canada

Who can join

18 and older, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.