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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Sao Paulo General Hospital
Irmandade da Santa Casa de Misericordia de Sao Paulo
Federal University of São Paulo
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00771225
First received: October 10, 2008
Last updated: February 2, 2010
Last verified: October 2008
History of Changes
  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: fascial repair
Procedure: mesh repair
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
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)
Arms Assigned Interventions
prolapse surgery with fascial repair Procedure: fascial repair
surgery to treat genital prolapse with fascia repair
Other Names:
  • prolapse repair withouth mesh
  • prolapse repair with mesh
  • prolift
Procedure: mesh repair
surgery to genital prolapse with mesh
Other Names:
  • prolapse repair withouth mesh
  • prolapse repair with mesh
  • prolift
prolapse surgery with mesh repair Procedure: fascial repair
surgery to treat genital prolapse with fascia repair
Other Names:
  • prolapse repair withouth mesh
  • prolapse repair with mesh
  • prolift
Procedure: mesh repair
surgery to genital prolapse with mesh
Other Names:
  • prolapse repair withouth mesh
  • prolapse repair with mesh
  • 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.

  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
Irmandade da Santa Casa de Misericordia de Sao Paulo
Federal University of São Paulo
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Investigators
Principal Investigator: Simone Brandao University of Sao Paulo
  More Information

No publications provided

Responsible Party: Johnson&Johnson, Hospital Universitario da Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT00771225     History of Changes
Other Study ID Numbers: 300-07-002
Study First Received: October 10, 2008
Last Updated: February 2, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
genital prolapse
surgery
fascial repair
mesh
prolift

Additional relevant MeSH terms:
Prolapse
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013