Actively Recruiting

Phase Not Applicable
Age: 50Years +
FEMALE
NCT03875989

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Led by University Hospital, Limoges · Updated on 2023-08-29

214

Participants Needed

9

Research Sites

443 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

CONDITIONS

Official Title

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient at 50 years of age or older
  • Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points 50 according to the POP-Q system
  • A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
  • Able to give informed consent
  • Performance Status score  2
Not Eligible

You will not qualify if you...

  • Need for surgical treatment for myorraphy of levator ani muscles
  • Previous surgical cystocele repair
  • Evolving gynecologic cancer
  • Pregnancy, desire for future pregnancy, or lactating woman
  • Inability to participate in study follow-up or to provide informed consent
  • Lack of social insurance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 9 locations

1

CHU de Bordeaux

Bordeaux, France, 33000

Actively Recruiting

2

CH de Brive

Brive-la-Gaillarde, France, 19100

Actively Recruiting

3

CHU de Clermont Ferrand

Clermont-Ferrand, France, 63100

Actively Recruiting

4

CH de Gueret

Guéret, France, 23000

Actively Recruiting

5

CHU de Limoges

Limoges, France, 87000

Actively Recruiting

6

CHU de Saint-Etienne

Saint-Etienne, France, 42000

Actively Recruiting

7

CHU de Toulouse - Paule de Viguier

Toulouse, France, 31059

Actively Recruiting

8

CHU de Toulouse - Rangueil

Toulouse, France, 31400

Actively Recruiting

9

CH de Tulle

Tulle, France, 19000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Vaginal Native Tissues Repair for Pelvic Organ Prolapse | DecenTrialz