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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196495
First Posted: September 20, 2005
Last Update Posted: December 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ethicon, Inc.
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196495


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

ClinicalTrials.gov Identifier: NCT00196495     History of Changes
Other Study ID Numbers: 2003-016
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 18, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse