Clinical Trial

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

Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-05; most recent amendment 2025-09-24.
Trial Details
NCT Number NCT06678984
Lead Sponsor TBF Genie Tissulaire
Conditions Stress Urinary Incontinence in Women
Enrollment 96 participants
Start Date 2025-10
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-30