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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
History of Changes
  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
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
Uterine Prolapse
Pathological Conditions, Anatomical
 Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on October 16, 2012