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

NCT05207189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-06-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • TBF Genie Tissulaire

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-03-28
Completion
2024-03-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207189 on ClinicalTrials.gov