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

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ClinicalTrials.gov Identifier: NCT00771225
Recruitment Status : Unknown
Verified October 2008 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2008
Last Update Posted : February 3, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Genital Prolapse Procedure: fascial repair Procedure: mesh repair Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)
Study Start Date : November 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Correction of genital prolapse [ Time Frame: 8 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: October 2008

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