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Vaginal Native Tissues Repair for Pelvic Organ Prolapse

NCT03875989 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-08-29

No results posted yet for this study

Summary

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

  • Prolapse, Vaginal

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2025-09-27
Completion
2028-03-27

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 NCT03875989 on ClinicalTrials.gov