NCT05207189

Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications

Phase II Study Evaluating the Treatment of Women Urinary Incontinence by Suburethral Slings; UVT Allograft; in Patients Presenting With Complication of the Synthetic Sling Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open, multi center trial is to evaluate a new biological replacement for synthetic slings in the treatment of female stress urinary incontinence.

Detailed description

It was estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. Indeed, if medical treatment or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique to treat stress urinary incontinence as it allows for a reduction in surgery time and morbidity and can be placed under local anesthesia. However, the risk of complications associated with the use of synthetic products is high and contributes to the recent decline of popularity of synthetic slings. As the demand for incontinence treatment remains high, fascia autograft surgeries are being proposed, even though they require an additional surgical procedure and expose the patient to complications at the donor site of the graft. The study product aims to address the growing need for a safer but equally effective implant to avoid autografting while keeping the standard surgical technique. The aim of this exploratory study is to evaluate a biological sling replacement to failed synthetic slings in the treatment of female stress urinary incontinence.

Conditions

• Female Stress Incontinence
• Stress Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	UVT	Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical vein allograft placed in replacement of a failed synthetic sling during a surgical act performed by the investigator.

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2022-01-26
• Last updated: 2024-06-05

Locations

3 sites across 1 country: France