Clinical Trial: Prosthetic Pelvic Organ Prolapse Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

Brief Summary:

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.

It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.


Detailed Summary: This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.
Sponsor: University Hospital, Lille

Current Primary Outcome: Morbidity (Dindo Classification) [ Time Frame: 12 months ]

Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.


Original Primary Outcome: Morbidity (Dindo Classification) [ Time Frame: 12 months ]

Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacroprexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.


Current Secondary Outcome:

  • Specific complications [ Time Frame: 12 months ]

    Comparison for the specific complications of sub-vesical mesh according to the route :

    • Symptomatic erosions, shrinkages, infections,
    • Serious Adverse event
  • Medium-term tolerance [ Time Frame: 12 months ]

    Comparison of both techniques for the medium-term tolerance:

    • Sexual: sexual quality of life, de novo dyspareunia;
    • Urinary: urinary quality of life, urinary functional signs, urgenturia, leakage
    • Post-operative chronic pelvic pains
  • Clinical Efficiency [ Time Frame: 12 months ]

    Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency:

    • rate of anatomical recurrences at one year,
    • functional Symptoms of prolapse, general quality of life


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: July 6, 2012
Date Started: September 2012
Date Completion:
Last Updated: November 3, 2015
Last Verified: November 2015