Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
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 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|
- Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
- Intraoperative complication
- Patient tolerance of the synthetic mesh placed
- Postoperative complications
- Quality of life
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196495
|Study Director:||Martin Weisberg, MD||Ethicon, Inc.|