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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 15, 2006

Start Date ^ICMJE

June 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by the twelve-month recurrence rate. Recurrence is defined Stage II or higher prolapse (POPQ)

Change History

Complete list of historical versions of study NCT00196495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Intraoperative complication
Patient tolerance of the synthetic mesh placed
Postoperative complications
Quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Vaginal Prolapse

Intervention ^ICMJE

Device: Polypropylene Mesh

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00196495

Other Study ID Numbers ^ICMJE

2003-016

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Ethicon, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Martin Weisberg, MD

Ethicon, Inc.

Information Provided By

Ethicon, Inc.

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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