Clinical trial NCT05207189: Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Stress Incontinence
Stress Urinary Incontinence
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 16
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: No major signs of incontinence
timeFrame: 6 months
measure: No complication related to investigational product
timeFrame: 6 months
Secondary outcomes:
measure: Decrease of the signs of complications of the first surgery
timeFrame: 15 days, 6 weeks, 3 months, 6 months, 12 months
measure: Decrease of pain and analgesic consumption
timeFrame: 15 days, 6 weeks, 3 months, 6 months, 12 months
measure: Progressive recuperation of continence
timeFrame: 15 days, 6 weeks, 3 months, 6 months, 12 months
measure: Decrease of Urinary Incontinence (UI) severity
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Decrease of distress caused by UI symptoms
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Improvement of health-related quality of life
timeFrame: 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hôtel-Dieu, CHU de Nantes
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud, Hospices Civils de Lyon
Study officials:
References: