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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress Urinary Incontinence; Female Stress Incontinence
• Intervention / Treatment: Biological: UVT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Hôtel-Dieu, CHU de Nantes
  • Paris, France, 75013
    • Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
  • Pierre-Bénite, France, 69310
    • Hôpital Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UVT; Biological sling used as a replacement of the synthetic sling.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No major signs of incontinence	Use of less than 2 pads a day	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Progressive recuperation of continence	Continence evaluated by uroflow test and 3-day voiding diary	15 days, 6 weeks, 3 months, 6 months, 12 months
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
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
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

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: UVT-TBF1; 2020-A02983-36 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No