RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: TBF Genie Tissulaire • ClinicalTrials.gov ID: NCT06678984

Registry updated: 2026-10-06

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Description

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.

Interventions

with treated umbilical vein allograft (Procedure)
Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
with autologous fascial pubovaginal sling (Procedure)
Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling

Eligibility criteria

Inclusion Criteria: * Women aged 18 to 85 years. * Patients with stress urinary incontinence or mixed urinary incontinence with a predominant stress component. * Patients with stress urinary incontinence due to cervico-urethral hypermobility or urethral hypermobility. * Patients with urethral hypermobility confirmed by Ulmsten suburethral support maneuver. * Urinary incontinence demonstrated by one-hour pad test. * Patients with significant and persistent discomfort despite perineal rehabilitation. * Patients able to understand the information concerning the study and having voluntarily dated and signed the informed consent form. * Patients able and willing to comply with the requirements and instructions of the study. * Patients who are members or the beneficiary of a national health insurance plan. Exclusion Criteria: * Pregnant or breastfeeding women or those not using effective contraception. * Patients with a body mass index (BMI) ≥ 35 kg/m2. * Patients with moderate stress urinary incontinence treated with physiotherapy and pelvic support exercises. * Patients with voiding disorders or at risk of performing self-catheterization. * Patients who have already undergone surgical treatment for urinary incontinence. * Patients unable to perform the pad test or unwilling to perform it at each follow-up visit. * Patients considered by the principal investigator to be poor candidates for surgical procedures and/or anesthesia due to their physical or mental state. * Patients with current urinary tract infection, severe anemia, uncontrolled diabetes or other conditions contraindicating surgery. * Patients with neurogenic bladder. * Patients with a history of conditions, illnesses or surgical procedures that may confound the results of the urinary incontinence assessment, including but not limited to: pelvic organ prolapse (e.g., cystocele, rectocele), neurological disorders (e.g., multiple sclerosis, Parkinson's disease), recurrent urinary tract infections, recurrent bladder stones, interstitial cystitis, history of pelvic irradiation (external beam therapy or brachytherapy), current diagnosis of genitourinary malignancy. * Patients deprived of liberty by a judicial or administrative decision. * Patients incapable of discernment for rehabilitation, unable to follow up or give consent.

Conditions

Stress Urinary Incontinence in Women

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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