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Due to COVID restrictions this study has been temporarily halted.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Burch Urethropexy | Active Comparator | Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Continence Rates | Patient reported symptoms of incontinence | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individual participant data will not be shared with other researchers.
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Double-blinded, randomized controlled trial
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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.
| Burch Urethropexy | Procedure | Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment |
|
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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |