Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Laparoscopic Obturator Urethropexy; Procedure: Burch Urethropexy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic Obturator Urethropexy; Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment	Procedure: Laparoscopic Obturator Urethropexy; Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
ACTIVE_COMPARATOR: Burch Urethropexy; Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment	Procedure: Burch Urethropexy; Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Continence Rates	Patient reported symptoms of incontinence	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective continence rates	Objective continence rates will be assessed with a cough test and a one-hour pad test.	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Perioperative and postoperative complications	Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification.	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Urinary retention	Urinary retention will be assessed by an elevated post-void residual urine	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent urinary tract infection	Recurrent urinary tract infection will be assessed through a urine culture	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent/persistent/de novo urgency	Recurrent/persistent/de novo urgency will be based on patient symptoms	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent SUI	Recurrent SUI will be assessed through a cough test/a one-hour pad test	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Sexual function	Using the Female Sexual Function Index-6 (FSFI-6).	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Overall quality of life	Using the Pelvic Floor Distress Inventory-20 (PFDI-20).	6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): January 1, 2032
• Study Completion (ANTICIPATED): October 1, 2033

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 19-0210-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No