Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00196495
First received: September 12, 2005
Last updated: December 15, 2006
Last verified: December 2006

September 12, 2005
December 15, 2006
June 2004
Not Provided
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by the twelve-month recurrence rate. Recurrence is defined Stage II or higher prolapse (POPQ)
Complete list of historical versions of study NCT00196495 on ClinicalTrials.gov Archive Site
  • Intraoperative complication
  • Patient tolerance of the synthetic mesh placed
  • Postoperative complications
  • Quality of life
Same as current
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Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Vaginal Prolapse
Device: Polypropylene Mesh
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2005
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Inclusion Criteria:

  • Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
  • Patient who is at leat 21 years of age.
  • Patient whose family is complete.
  • Patient may not have uncontrolled diabetes.

Exclusion Criteria:

  • Patients may not have coagulation disorders.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196495
2003-016
Not Provided
Not Provided
Ethicon, Inc.
Not Provided
Study Director: Martin Weisberg, MD Ethicon, Inc.
Ethicon, Inc.
December 2006

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