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

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00196495
Collaborator
(none)
90
Enrollment
17
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Polypropylene Mesh
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Study Start Date :
Jun 1, 2004
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate. []

Secondary Outcome Measures

  1. Intraoperative complication []

  2. Patient tolerance of the synthetic mesh placed []

  3. Postoperative complications []

  4. Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ethicon, Inc.

Investigators

  • Study Director: Martin Weisberg, MD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00196495
Other Study ID Numbers:
  • 2003-016
First Posted:
Sep 20, 2005
Last Update Posted:
Dec 18, 2006
Last Verified:
Dec 1, 2006
Additional relevant MeSH terms:
Uterine Prolapse
Prolapse

Study Results

No Results Posted as of Dec 18, 2006