NCT02272361

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cystocele

Interventions

Type	Name	Description
OTHER	laparoscopic sacrocolpopexy
OTHER	vaginal mesh surgery

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-06-20
• Completion: 2018-06-20
• First posted: 2014-10-22
• Last updated: 2019-07-11

Locations

12 sites across 1 country: France