NCT04881721

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Urethropexy	Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence

Timeline

• Start date: 2021-08-25
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-05-11
• Last updated: 2023-03-13

Locations

1 site across 1 country: United States