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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:
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

Tracking Information
First Submitted Date  ICMJE October 10, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date February 3, 2010
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Correction of genital prolapse [ Time Frame: 8 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00771225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift
Official Title  ICMJE A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Genital Prolapse
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • prolapse surgery with fascial repair
    Interventions:
    • Procedure: fascial repair
    • Procedure: mesh repair
  • prolapse surgery with mesh repair
    Interventions:
    • Procedure: fascial repair
    • Procedure: mesh repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 50 and 80 yrs

Exclusion Criteria:

  • Less than 50 and more than 80 yrs
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771225
Other Study ID Numbers  ICMJE 300-07-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson&Johnson, Hospital Universitario da Universidade de Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Simone Brandao University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP