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

Ethicon

Status and phase

Completed

Phase 4

Conditions

Vaginal Prolapse

Treatments

Device: Polypropylene Mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196495

2003-016

Details and patient eligibility

About

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.

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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