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NOT YET RECRUITING
NCT06678984
PHASE3

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

Sponsor: TBF Genie Tissulaire

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-10

Completion Date

2028-05-01

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

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

Locations (8)

Hôpital Estaing, CHU de Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Michalon, CHU de Grenoble Alpes

La Tronche, France

Hôtel-Dieu, CHU de Nantes

Nantes, France

Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris

Paris, France

Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, France

Hôpital Charles-Nicolle, CHU de Rouen

Rouen, France

Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Hôpital Rangueil, CHU de Toulouse

Toulouse, France