National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift

Phase 4

• Conditions: Genital Prolapse
• Interventions: Procedure: fascial repair; Procedure: mesh repair

• Registration Number: NCT00771225
• Lead Sponsor: University of Sao Paulo

Brief Summary

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

Detailed Description

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

Study Timeline

• Status Verified: 2008-10
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2008-11
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03
• Primary Completion: 2012-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Between 50 and 80 yrs

Exclusion Criteria

• Less than 50 and more than 80 yrs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prolapse surgery with fascial repair	fascial repair	-
prolapse surgery with fascial repair	mesh repair	-
prolapse surgery with mesh repair	fascial repair	-
prolapse surgery with mesh repair	mesh repair	-

Primary Outcome Measures

Name	Time	Method
Correction of genital prolapse	8 years

Trial Locations

Locations (1)

Simone Brandao; 🇧🇷 Sao Paulo, Brazil