Treated Umbilical Vein Graft vs Autologous Sling for Women’s Stress Urinary Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 interventional study, participants are randomly assigned to receive either a treated umbilical vein allograft or an autologous fascial pubovaginal sling for stress urinary incontinence. All patients undergo surgery on day 0 and attend follow-up visits at 3 weeks, 3 months, 6 months, and 12 months to monitor outcomes and bladder function. The study aims to determine if the vein graft can match the effectiveness of the standard sling while potentially avoiding donor-site complications. Safety and durability of the implanted material are also monitored throughout follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Estaing, CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Hôpital Michalon, CHU de Grenoble Alpes
  La Tronche, France Recruiting
• Hôtel-Dieu, CHU de Nantes
  Nantes, France Recruiting
• Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
  Paris, France Recruiting
• Hôpital Lyon Sud, Hospices Civils de Lyon
  Pierre-Bénite, France Recruiting
• Hôpital Charles-Nicolle, CHU de Rouen
  Rouen, France Recruiting

Study contacts

• Study coordinator: Laurence BARNOUIN, MD
• Email: laurence.barnouin@tbf-lab.com
• Phone: +33472686909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.