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

NCT00771225 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2010-02-03

No results posted yet for this study

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.

Conditions

  • Genital Prolapse

Interventions

PROCEDURE

fascial repair

surgery to treat genital prolapse with fascia repair

PROCEDURE

mesh repair

surgery to genital prolapse with mesh

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    collaborator OTHER

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • Federal University of São Paulo

    collaborator OTHER

  • Feculdade de Medicina da Universidade de Sao Paulo - Brasil

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Simone Brandao · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-11-30
Completion
2013-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771225 on ClinicalTrials.gov