Vaginal Native Tissues Repair for Pelvic Organ Prolapse (TAPP)

August 28, 2023 updated by: University Hospital, Limoges
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pelvic organ prolapse is usually the result of loss of pelvic support. It is widely accepted that 50% of women after 50 years old will develop prolapse, evaluated through the POPQ Classification . Pelvic organ prolapse cause significant psychological distress and negatively affect quality of life. Among the surgery for prolapse, the cystocele cureis is the most frequent (67.7%). Native tissue cystocele repairs is the cornerstone of prolapse surgery especially since the learned societies (Food and Drug Administration, Haute Autorité de Santé, Collège National des Gynécologues-Obstétriciens Français) warned clinicians and patients about serious mesh related complications. In France, 41.5% of vaginal cystocele repair are with native tissue. The main surgeries are anterior colporraphy and vaginal patch plastron, used in routine in our center with re-intervention rates less than 4% at one year. Rate of success of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. A prospective study find a success rate at 35% of the anterior colporraphy based on a combined definition, anatomic and functional as recommended recently. However the definition of anatomic was strict (POPQ<2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say aAa and Ba points <0.

We think that the vaginal patch plastron will have a better anatomic and functional success comparatively to the anterior colporraphy as it corrects median cystoceles by a vaginal strip as well as lateral cystoceles by the bilateral paravaginal suspension.

The description of the two surgeries will be standardized between all the surgeons. We will compare the anterior colporraphy consisting in bladder median support by retensioning Halban fascia with colpectomy to the vaginal patch plastron consisting in making a vaginal strip attached to the bladder combined with suspension by fixation of the vaginal strip to the tendinous arch of the pelvic fascia.

Patients will be blind of their surgery. They will have a follow-up visit 45 days after the surgery to evaluate the post- operative complications according to the Clavien-Dindo classification. They will have phone call at 4 and 8 months after the surgery to make sure they've not suffered for complications. At last, they will have a follow-up visit 1 year after the surgery by an independent assessor blind of the surgery to evaluate the primary outcome (anatomic and functional success).

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux
        • Contact:
        • Principal Investigator:
          • Claude HOCKE, MD
        • Sub-Investigator:
          • Mathilde CORET, MD
        • Sub-Investigator:
          • Jean-Luc BRUN, MD
        • Sub-Investigator:
          • Géraldine CHAUVIN, MD
      • Brive-la-Gaillarde, France, 19100
        • Recruiting
        • CH de Brive
        • Contact:
        • Principal Investigator:
          • Christelle MESNARD, MD
        • Sub-Investigator:
          • Tristan GAUTHIER, MD
        • Sub-Investigator:
          • Dimitrios HARISIS, MD
      • Clermont-Ferrand, France, 63100
      • Guéret, France, 23000
        • Recruiting
        • CH de Gueret
        • Contact:
        • Principal Investigator:
          • Yves AUBARD, MD
        • Sub-Investigator:
          • Aymeline LACORRE, MD
      • Limoges, France, 87000
        • Recruiting
        • CHU de Limoges
        • Sub-Investigator:
          • Tristan GAUTHIER, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aymeline LACORRE, MD
        • Sub-Investigator:
          • Hugues CALY, MD
        • Sub-Investigator:
          • Maxime LEGROS, MD
        • Sub-Investigator:
          • François MARGUERITTE, MD
        • Sub-Investigator:
          • Yves AUBARD, MD
      • Saint-Étienne, France, 42000
      • Toulouse, France, 31059
        • Recruiting
        • CHU de Toulouse - Paule de Viguier
        • Contact:
        • Principal Investigator:
          • Fabien VIDAL, MD
        • Sub-Investigator:
          • Yann TANGUY LE GAC, MD
        • Sub-Investigator:
          • Géraldine CARTRON, MD
        • Sub-Investigator:
          • Martin BAUJAT, MD
      • Toulouse, France, 31400
        • Recruiting
        • CHU de Toulouse - Rangueil
        • Contact:
        • Principal Investigator:
          • Elodie CHANTALAT, MD
        • Sub-Investigator:
          • Jacques RIMAILHO, MD
        • Sub-Investigator:
          • Stéphanie MOTTON, MD
        • Sub-Investigator:
          • Marc SOULE-THOLY, MD
      • Tulle, France, 19000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient at 50 years of age or older
  • Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 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
  • Performans Status score ≤ 2

Exclusion Criteria:

  • Patient with need for surgical treatment for myorraphy of levator ani muscles
  • Patient with previous surgical cystocele repair.
  • Patient with evolving gynaecologic cancer.
  • Pregnancy or wish for future pregnancy, lactating woman.
  • Inability to participate in study follow-up or to provide informed consent.
  • Lack of social insurance .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Procedure: Anterior colporraphy
It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.
Experimental: Arm B
Procedure: vaginal patch plastron
It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of the prolapse surgery
Time Frame: 1 year

The success rate of the prolapse surgery defined by a composite of objective and subjective measures:

  • Anatomic success defined by Aa and Ba values <0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND

  • Subjective success through reliable condition-specific quality-of-life questionnaires:

    • A negative 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 Pelvic Floor Distress Inventory (PFDI-20)) AND
    • Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND
  • No need for other treatment for prolapse (surgical nor medical)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of the prolapse surgery
Time Frame: 1 year

The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:

  • Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR

  • Subjective failure through reliable condition-specific quality-of-life questionnaires:

    • 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) OR
    • A PGI-I score > 2 OR
  • Need of a new treatment for prolapse (surgical or medical)
1 year
Rate of post-operative complications
Time Frame: 45 Days
Rate of post-operative complications according to the Clavien-Dindo classification 45 days after the surgery by the patient's surgeon (not blinded)
45 Days
Sexual function
Time Frame: 1 year
The sexual function improvement will be evaluated by the difference in PISQ 12 score (condition-specific quality-of-life questionnaire) between the inclusion and one year after the surgery for sexually active women
1 year
Rate of the prolapse surgery
Time Frame: 2 years

The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:

  • Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR

  • Subjective failure through reliable condition-specific quality-of-life questionnaires:

    • 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) OR
    • A PGI-I score > 2 OR
  • Need of a new treatment for prolapse (surgical or medical)
2 years
Rate of the prolapse surgery
Time Frame: 3 years

The failure rate of the prolapse surgery defined by a composite of objective and subjective measures:

  • Recurrent prolapse defined by Aa and/or Ba values > or= 0 in POP-Q OR

  • Subjective failure through reliable condition-specific quality-of-life questionnaires:

    • 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) OR
    • A PGI-I score > 2 OR
  • Need of a new treatment for prolapse (surgical or medical)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Estimated)

September 27, 2025

Study Completion (Estimated)

March 27, 2028

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI18_0013 (TAPP)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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