Overview

This trial is active, not recruiting.

Condition genital prolapse
Treatments fascial repair, mesh repair
Phase phase 4
Sponsor University of Sao Paulo
Collaborator University of Sao Paulo General Hospital
Start date November 2008
End date November 2012
Trial size 180 participants
Trial identifier NCT00771225, 300-07-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Other)
fascial repair prolapse repair withouth mesh
surgery to treat genital prolapse with fascia repair
mesh repair prolapse repair withouth mesh
surgery to genital prolapse with mesh
(Other)
fascial repair prolapse repair withouth mesh
surgery to treat genital prolapse with fascia repair
mesh repair prolapse repair withouth mesh
surgery to genital prolapse with mesh

Primary Outcomes

Measure
Correction of genital prolapse
time frame: 8 years

Eligibility Criteria

Female participants from 50 years up to 80 years old.

Inclusion Criteria: - Between 50 and 80 yrs Exclusion Criteria: - Less than 50 and more than 80 yrs

Additional Information

Official title A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)
Principal investigator Simone Brandao
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by University of Sao Paulo.