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

NorthShore University HealthSystem

Status: Active, not recruiting

Conditions: Stress Urinary Incontinence

Treatments: Procedure: Urethropexy

Study type: Observational

Funder types: Other

Identifiers

NCT04881721

EH21-062

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)