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Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence
Sponsor: TBF Genie Tissulaire
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
Conditions
Interventions
with treated umbilical vein allograft
Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
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