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

NCT06678984 | Not Yet Recruiting Phase 3

• 2 other identifiers: UVT-TBF22024-A00352-45
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Stress Urinary Incontinence in Women

Outcome Measures

Primary Outcomes (1)

• Difference between treatment groups in change from baseline to final 12-month postoperative visits in the amount of urinary leakage.

  The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital. One-hour pad test will be performed in the following way: * Subject puts on one standardized, pre-weighed pad without voiding. * 0-15 Minutes: Subject drinks 500 mL of sodium-free liquid in \< 15 min while sitting or resting. * 15 - 45 Minutes: Subject walks for 30 minutes, including climbing one flight of stairs (up and down). * 45 - 60 Minutes: Subject performs the following activities: Standing up from sitting (10 times), Coughing vigorously (10 times), Running on the spot (1 min), Bending to pick up an object from the floor (5 times), Wash hands in running water (1 min). * The weight of the pad is measured to determine the amount of leakage.

  12 months

Secondary Outcomes (8)

• Difference between treatment groups in change from baseline to 3- and 6-month postoperative visits in the amount of urinary leakage.

  3 months, 6 months

• Difference between treatment groups in the proportion of subjects who achieved a reduction of more than 50% in the amount of urinary leakage between baseline and the 12-month visit.

  12 months

• Difference between treatment groups in change from baseline to final 12-month postoperative visits in the number of incontinence episodes and pads used daily.

  12 months

• Difference between treatment groups in changes between initial and postoperative visits in frequency, severity and impact on quality of life of patients' urinary incontinence, as measured by the ICIQ-UI-SF.

  3 months, 6 months, 12 months

• Difference between treatment groups in changes between initial and postoperative visits in the distress caused by urinary incontinence symptoms, as measured by the UDI-6.

  3 months, 6 months, 12 months

Study Arms (2)

Treated umbilical vein allograft

EXPERIMENTAL

Procedure: with treated umbilical vein allograft

Autologous Fascial Pubovaginal Sling

ACTIVE COMPARATOR

Procedure: with autologous fascial pubovaginal sling

Interventions

with treated umbilical vein allograft PROCEDURE

Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling

Treated umbilical vein allograft

with autologous fascial pubovaginal sling PROCEDURE

Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling

Autologous Fascial Pubovaginal Sling

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (8)

Hôpital Estaing, CHU de Clermont-Ferrand

Clermont-Ferrand, 63100, France

Location

Hôpital Michalon, CHU de Grenoble Alpes

La Tronche, 38700, France

Location

Hôtel-Dieu, CHU de Nantes

Nantes, 44000, France

Location

Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris

Paris, 75013, France

Location

Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Hôpital Charles-Nicolle, CHU de Rouen

Rouen, 76000, France

Location

Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Hôpital Rangueil, CHU de Toulouse

Toulouse, 31400, France

Location

Central Study Contacts

Laurence BARNOUIN, MD

CONTACT

+33472686909; laurence.barnouin@tbf-lab.com

Justine BOSC, MSc

CONTACT

+33472686911; justine.bosc@tbf-lab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)