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

RecruitingPhase 3Ages 18 Years - 85 YearsFemaleTBF Genie Tissulaire
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • with treated umbilical vein allograft
  • with autologous fascial pubovaginal sling
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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