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

NCT06678984 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

PROCEDURE

with treated umbilical vein allograft

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

PROCEDURE

with autologous fascial pubovaginal sling

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

Sponsors & Collaborators

  • TBF Genie Tissulaire

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-05-01
Completion
2028-05-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678984 on ClinicalTrials.gov