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

NCT ID: NCT05207189

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2024-03-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVT

Biological sling used as a replacement of the synthetic sling.

Group Type: EXPERIMENTAL

UVT

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Women over 40 years of age and under 75 years of age.
• Failure of primary surgical technique with synthetic sling requiring its removal due to complications such as vaginal exposure or urinal tract erosion.
• Inclusion more than 3 months after primary surgery.
• Any fistula or abnormality of the urinary tract, any erosion or complication due to the synthetic sling placement must be repaired during surgery. In case of persistence of complication or limited possibility to insert the UVT due to major vesical or urethral lesion, the patient will not be included.
• Patients with controlled urinal tract infections.
• Patients who received the study information and provided consent.
• Patients who are members or the beneficiary of a national health insurance plan.

Exclusion Criteria

• Breast feeding women or women without effective contraception. In absence of effective contraception, a pregnancy test followed by an effective contraception are mandatories for non-menopausal women.
• Patients with mild cases treated by physiotherapy and pelvic floor exercises for urinary incontinence or without surgical complications.
• Patients with current urinary infection, severe anemia or other pathologies that counter-indicate surgery.
• Cystocele and rectocele not treated during the surgery.
• Persons under guardianship or confined by a judicial or administrative decision.
• Patients unable to have discernment for rehabilitation, unable to perform follow-up or unable to provide their consent.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôtel-Dieu, CHU de Nantes

Nantes, , France

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

Paris, , France

Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Countries

France

Other Identifiers

2020-A02983-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

UVT-TBF1

Identifier Type: -

Identifier Source: org_study_id