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

NCT05207189 | Completed Phase 2

• 2 other identifiers: UVT-TBF12020-A02983-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Female Stress Incontinence; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Decrease of the signs of complications of the first surgery

  15 days, 6 weeks, 3 months, 6 months, 12 months

• Decrease of pain and analgesic consumption

  15 days, 6 weeks, 3 months, 6 months, 12 months

• Progressive recuperation of continence

  15 days, 6 weeks, 3 months, 6 months, 12 months

• Decrease of Urinary Incontinence (UI) severity

  6 weeks, 3 months, 6 months, 12 months

• Decrease of distress caused by UI symptoms

  6 weeks, 3 months, 6 months, 12 months

Study Arms (1)

UVT

EXPERIMENTAL

Biological sling used as a replacement of the synthetic sling.

Biological: UVT

Interventions

UVT 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.

UVT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (3)

Hôtel-Dieu, CHU de Nantes

Nantes, 44000, France

Location

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

Paris, 75013, France

Location

Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 26, 2022
• Study Start: November 8, 2021
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)