SIS Graft and Traditional Repair in Vaginal Wall Prolapse
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT00827528
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.
- Detailed Description
The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
- anterior vaginal wall prolapse with poin Ba at least at +1;
- pre and postmenopausal patients
- patients without surgical indication;
- infection;
- coagulopathy;
- gynecologic cancer;
- liver or kidney active diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method surgical anatomic results one year
- Secondary Outcome Measures
Name Time Method impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications one year
Trial Locations
- Locations (1)
Federal University of São Paulo
🇧🇷São Paulo, São Paulo/SP, Brazil
Federal University of São Paulo🇧🇷São Paulo, São Paulo/SP, Brazil