SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Phase 4

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Biologic Graft (SIS); Procedure: Traditional correction of anterior vaginal wall 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

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• anterior vaginal wall prolapse with poin Ba at least at +1;
• pre and postmenopausal patients

Exclusion Criteria

• patients without surgical indication;
• infection;
• coagulopathy;
• gynecologic cancer;
• liver or kidney active diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIS graft	Biologic Graft (SIS)	this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
2	Traditional correction of anterior vaginal wall prolapse	this group will use a traditional repair on correction of anterior vaginal wall prolapse.

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