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

Phase 4

• Conditions: Genital Prolapse

• 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

Primary Outcome Measures

Name	Time	Method
Correction of genital prolapse	8 years

Trial Locations

Locations (1)

Simone Brandao; 🇧🇷 Sao Paulo, Brazil