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

Phase 4CompletedNCT00196495

Ethicon, Inc.90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Vaginal Prolapse

Interventions

Polypropylene MeshDEVICE

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Intraoperative complication

Patient tolerance of the synthetic mesh placed

Postoperative complications

Quality of life

Data from ClinicalTrials.gov

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