Back to resultsNational,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift
Primary Purpose
Genital Prolapse
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
fascial repair
mesh repair
Sponsored by
About this trial
This is an interventional treatment trial for Genital Prolapse focused on measuring genital prolapse, surgery, fascial repair, mesh, prolift
Eligibility Criteria
Inclusion Criteria:
- Between 50 and 80 yrs
Exclusion Criteria:
- Less than 50 and more than 80 yrs
Sites / Locations
- Simone Brandao
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
prolapse surgery with fascial repair
prolapse surgery with mesh repair
Arm Description
Outcomes
Primary Outcome Measures
Correction of genital prolapse
Secondary Outcome Measures
Full Information
NCT ID
NCT00771225
First Posted
October 10, 2008
Last Updated
February 2, 2010
Sponsor
University of Sao Paulo
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
1. Study Identification
Unique Protocol Identification Number
NCT00771225
Brief Title
National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift
Official Title
A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
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
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Prolapse
Keywords
genital prolapse, surgery, fascial repair, mesh, prolift
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prolapse surgery with fascial repair
Arm Type
Other
Arm Title
prolapse surgery with mesh repair
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
fascial repair
Other Intervention Name(s)
prolapse repair withouth mesh, prolapse repair with mesh, prolift
Intervention Description
surgery to treat genital prolapse with fascia repair
Intervention Type
Procedure
Intervention Name(s)
mesh repair
Other Intervention Name(s)
prolapse repair withouth mesh, prolapse repair with mesh, prolift
Intervention Description
surgery to genital prolapse with mesh
Primary Outcome Measure Information:
Title
Correction of genital prolapse
Time Frame
8 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 50 and 80 yrs
Exclusion Criteria:
Less than 50 and more than 80 yrs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Brandao
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simone Brandao
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift
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