Clinical Trial: Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up

Brief Summary:

The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.

The secondary objectives of this study are the following:

  1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
  2. to overall quality of life assessment and expectations of patients.
  3. to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
  4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).

Detailed Summary:
Sponsor: University Hospital, Lille

Current Primary Outcome: PFDI-20 score [ Time Frame: 4 years ]

The patient-reported outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. It is a self-administered questionnaire on symptoms of prolapse


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Lille

Dates:
Date Received: October 20, 2014
Date Started: October 2014
Date Completion: December 2019
Last Updated: October 13, 2016
Last Verified: October 2016