Stress Urinary Incontinence
Conditions
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.
Interventions
PROCEDURELaparoscopic Obturator Urethropexy
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
PROCEDUREBurch Urethropexy
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Double-blinded, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Continence Rates | 1 year | Patient reported symptoms of incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative and postoperative complications | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification. |
| Urinary retention | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Urinary retention will be assessed by an elevated post-void residual urine |
| Recurrent urinary tract infection | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Recurrent urinary tract infection will be assessed through a urine culture |
| Objective continence rates | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Objective continence rates will be assessed with a cough test and a one-hour pad test. |
| Recurrent SUI | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Recurrent SUI will be assessed through a cough test/a one-hour pad test |
| Sexual function | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Using the Female Sexual Function Index-6 (FSFI-6). |
| Overall quality of life | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Using the Pelvic Floor Distress Inventory-20 (PFDI-20). |
| Recurrent/persistent/de novo urgency | 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years | Recurrent/persistent/de novo urgency will be based on patient symptoms |
Outcome results
None listed