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

UVT-TBF1

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.

2021-11-08

2024-04-01

2024-04-01

Active (not recruiting)

Early phase I

16

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2023-04-25