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
  Purpose

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 Intervention Phase
Vaginal Prolapse
Device: Polypropylene Mesh
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Further study details as provided by Ethicon, Inc.:

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

Estimated Enrollment: 90
Study Start Date: June 2004
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196495

Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Martin Weisberg, MD Ethicon, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196495     History of Changes
Other Study ID Numbers: 2003-016
Study First Received: September 12, 2005
Last Updated: December 15, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014