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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
Subjective Continence Rates
Patient reported symptoms of incontinence
Time frame: 1 year
Objective continence rates
Objective continence rates will be assessed with a cough test and a one-hour pad test.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
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