A National, Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift-by Gynecare)

This study is ongoing, but not recruiting participants.

First Received: October 10, 2008 Last Updated: January 5, 2009 History of Changes

Sponsors and Collaborators:	University of Sao Paulo University of Sao Paulo General Hospital Hospital Mater Dei Irmandade da Santa Casa de Misericordia de Sao Paul Hospital do Servidor Publico Estadual Hospital Odilon Berthens
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00771225

Purpose

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.

Condition	Intervention	Phase
Genital Prolapse	Procedure: surgery	Phase IV

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Caregiver), Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Correction of genital prolapse [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Intervention Details:

genital prolapse surgery

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 75 years old.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 50 and 80 yrs

Exclusion Criteria:

Less than 50 and more than 80 yrs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771225

Locations

Brazil
Simone Brandao
Sao Paulo, Brazil, 05508-000

Sponsors and Collaborators

University of Sao Paulo

University of Sao Paulo General Hospital

Hospital Mater Dei

Irmandade da Santa Casa de Misericordia de Sao Paul

Hospital do Servidor Publico Estadual

Hospital Odilon Berthens

Investigators

Principal Investigator:

Simone Brandao

University of Sao Paulo

More Information

No publications provided

Responsible Party:	Hospital Universitario da Universidade de Sao Paulo ( Johnson&Johnson )
Study ID Numbers:	300-07-002
Study First Received:	October 10, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00771225 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

genital prolapse
surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Genital Diseases, Female
Prolapse

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Genital Diseases, Female
Prolapse

ClinicalTrials.gov processed this record on May 06, 2009