Cystocele Clinical Trial
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
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).
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