Clinical trial NCT04133935: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized controlled trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subjective Continence Rates
timeFrame: 1 year
Secondary outcomes:
measure: Objective continence rates
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Perioperative and postoperative complications
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Urinary retention
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Recurrent urinary tract infection
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Recurrent/persistent/de novo urgency
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Recurrent SUI
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Sexual function
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
measure: Overall quality of life
timeFrame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Other outcomes:
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