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

February 2, 2010 updated by: University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-000
        • Simone Brandao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Between 50 and 80 yrs

Exclusion Criteria:

  • Less than 50 and more than 80 yrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correction of genital prolapse
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

University of Sao Paulo General Hospital
Federal University of São Paulo
Irmandade da Santa Casa de Misericordia de Sao Paulo
Feculdade de Medicina da Universidade de Sao Paulo - Brasil

Investigators

  • Principal Investigator: Simone Brandao, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300-07-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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