Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

NCT ID: NCT04133935

Last Updated: 2021-11-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2033-10-01

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laparoscopic Obturator Urethropexy

Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment

Group Type: EXPERIMENTAL

Laparoscopic Obturator Urethropexy

Intervention Type: PROCEDURE

Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.

Burch Urethropexy

Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment

Group Type: ACTIVE_COMPARATOR

Burch Urethropexy

Intervention Type: PROCEDURE

Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment

Interventions

Laparoscopic Obturator Urethropexy

Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.

Intervention Type: PROCEDURE

Burch Urethropexy

Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nucelio Luiz de Barros Moreira Lemos MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

19-0210-A

Identifier Type: -

Identifier Source: org_study_id