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

Active, not recruiting

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04881721
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Study Start: 2021-08-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress urinary incontinence symptoms	12 months	Severity of stress urinary incontinence symptoms by questionnaire
Voiding dysfunction	Within 1 year of surgery	Rate of urinary retention after surgery

Secondary Outcome Measures

Name	Time	Method
Distal Urethral Motion	12 months	Distal urethral swing angle during Valsalva measured via pelvic ultrasound
Proximal Urethral Motion	12 months	Proximal urethral swing angle during Valsalva measured via pelvic ultrasound
Post-operative complications	Within 1 year of surgery	Rate of post-operative complications

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Skokie, Illinois, United States