Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

NCT04133935 | Withdrawn

• 1 other identifier: 19-0210-A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Subjective Continence Rates

  Patient reported symptoms of incontinence

  1 year

Secondary Outcomes (8)

• Objective continence rates

  6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years

• Perioperative and postoperative complications

  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

• Recurrent/persistent/de novo urgency

  6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years

Study Arms (2)

Laparoscopic Obturator Urethropexy

EXPERIMENTAL

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

Burch Urethropexy

ACTIVE COMPARATOR

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

Procedure: Burch Urethropexy

Interventions

Laparoscopic Obturator Urethropexy PROCEDURE

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

Laparoscopic Obturator Urethropexy

Burch Urethropexy PROCEDURE

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

Burch Urethropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Upon recruitment to the study, the surgeon will then open a sequentially numbered, opaque, sealed envelope that will randomize the patient to either receiving Burch colposuspension or LOU. The patient will not be made aware of the group they were allocated to. A clinical staff who was not involved with the surgery and blinded to the allocation of the patient will complete the Post-operative Follow-up Form at each visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blinded, randomized controlled trial

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 21, 2019
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): October 1, 2033
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share