Back to resultsClinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Primary Purpose
Vaginal Prolapse
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Polypropylene Mesh
Sponsored by
About this trial
This is an interventional prevention trial for Vaginal Prolapse
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Secondary Outcome Measures
Intraoperative complication
Patient tolerance of the synthetic mesh placed
Postoperative complications
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00196495
Brief Title
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Official Title
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ethicon, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Polypropylene Mesh
Primary Outcome Measure Information:
Title
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Secondary Outcome Measure Information:
Title
Intraoperative complication
Title
Patient tolerance of the synthetic mesh placed
Title
Postoperative complications
Title
Quality of life
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Weisberg, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
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