NCT06678984

Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. The main question the clinical trial aims to answer is: \- Is the treated umbilical vein allograft as effective as the sling made of autologous tissue for treating female stress urinary incontinence? Participants will: * Undergo surgical treatment with either the umbilical vein allograft or the sling made of autologous tissue on Day 0. * Visit the hospital for a series of tests at 3 weeks, 3 months, 6 months, and 12 months after the surgical intervention. * Record their bladder activity between each hospital visit.

Detailed description

It is estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. When medical management or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique for treating stress urinary incontinence, as it reduces surgery time and morbidity, and can be performed under local anesthesia. However, the risk of complications associated with the use of synthetic materials is significant, contributing to a recent decline in the popularity of synthetic slings. Given the high demand for incontinence treatments, autologous fascia sling surgeries are being proposed, despite requiring an additional surgical procedure and exposing patients to complications at the donor site of the graft. The study product aims to address the need for a safer, equally effective implant that eliminates the need for autografting while maintaining standard surgical techniques. The aim of this comparative study is to determine whether the efficacy of the treated umbilical vein allograft can justify its use as a substitute for the autologous fascial sling, thereby avoiding the complications associated with harvesting the autograft.

Conditions

• Stress Urinary Incontinence in Women

Interventions

Type	Name	Description
PROCEDURE	with treated umbilical vein allograft	Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
PROCEDURE	with autologous fascial pubovaginal sling	Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-11-07
• Last updated: 2025-09-30

Locations

8 sites across 1 country: France