Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Laparoscopic Obturator Urethropexy
* Procedure: Burch Urethropexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Obturator Urethropexy<br>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<br>* Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.<br>|
| Active Comparator: Burch Urethropexy<br>Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment | Procedure: Burch Urethropexy<br>* Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment<br>|

What is the study measuring?
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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 |