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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05207189
Other study ID # UVT-TBF1
Secondary ID 2020-A02983-36
Status Completed
Phase Phase 2
First received
Last updated
Start date November 8, 2021
Est. completion date March 28, 2024

Study information

Verified date June 2024
Source TBF Genie Tissulaire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 28, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 75 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary No major signs of incontinence Use of less than 2 pads a day 6 months
Primary No complication related to investigational product Evaluation of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms 6 months
Secondary Decrease of the signs of complications of the first surgery Monitoring of urinary retention, dysuria, local inflammation, irritation of suture and suspension areas, and other indirect symptoms 15 days, 6 weeks, 3 months, 6 months, 12 months
Secondary Decrease of pain and analgesic consumption Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) 15 days, 6 weeks, 3 months, 6 months, 12 months
Secondary Progressive recuperation of continence Continence evaluated by uroflow test and 3-day voiding diary 15 days, 6 weeks, 3 months, 6 months, 12 months
Secondary Decrease of Urinary Incontinence (UI) severity Decrease in the score of the International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) (0 = no UI, 21 = very severe UI) 6 weeks, 3 months, 6 months, 12 months
Secondary Decrease of distress caused by UI symptoms Decrease of the Urogenital Distress Inventory (UDI-6) score (0 = no distress caused by UI symptoms, 100 = highest possible distress cause by UI symptoms) 6 weeks, 3 months, 6 months, 12 months
Secondary Improvement of health-related quality of life Decrease of the Incontinence Impact Questionnaire (IIQ-7) score (0 = no impact of UI on health-related quality of life, 100 = highest possible impact of UI on health-related quality of life) 6 weeks, 3 months, 6 months, 12 months
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