Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04133935
• Other study ID #: 19-0210-A
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 1, 2033

Study information

• Verified date: November 2021
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2033
• Est. primary completion date: January 1, 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Continence Rates	Patient reported symptoms of incontinence	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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