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).