NCT00827528

SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Traditional correction of anterior vaginal wall prolapse	Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
PROCEDURE	Biologic Graft (SIS)	Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-01-22
• Last updated: 2012-03-26

Locations

1 site across 1 country: Brazil