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:
- to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
- to overall quality of life assessment and expectations of patients.
- 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.
- 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 ]
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