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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorTBF Genie Tissulaire

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators