Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

Study Overview
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Brief Summary
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In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence. Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.

Detailed Description
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This study is designed as a prospective observational study. The hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery. Specific Aims: Aim 1: Investigate the efficacy of this mesh-free suture based surgical technique for improving SUI symptoms Aim 2: Investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3D ultrasound

Official Title
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Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Urethropexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older with stress dominant urinary incontinence Stress urinary incontinence confirmed by testing (e.g. urodynamics) Able to provide informed consent and attend post-operative visits Exclusion Criteria: Detrusor overactivity (> 40cm H2O) Maximum Urethral Closure Pressure (< 40 cm H2O) Post void residual > 150 mL Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Urethropexy|Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress urinary incontinence symptoms | Severity of stress urinary incontinence symptoms by questionnaire | 2 weeks | 
| Stress urinary incontinence symptoms | Severity of stress urinary incontinence symptoms by questionnaire | 3 months | 
| Stress urinary incontinence symptoms | Severity of stress urinary incontinence symptoms by questionnaire | 12 months | 
| Voiding dysfunction | Rate of urinary retention after surgery | Within 1 year of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal Urethral Motion | Distal urethral swing angle during Valsalva measured via pelvic ultrasound | 2 months | 
| Distal Urethral Motion | Distal urethral swing angle during Valsalva measured via pelvic ultrasound | 12 months | 
| Proximal Urethral Motion | Proximal urethral swing angle during Valsalva measured via pelvic ultrasound | 2 months | 
| Proximal Urethral Motion | Proximal urethral swing angle during Valsalva measured via pelvic ultrasound | 12 months | 
| Post-operative complications | Rate of post-operative complications | Within 1 year of surgery |