Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Phase 4
Completed
- Conditions
- Vaginal Prolapse
- Registration Number
- NCT00196495
- Lead Sponsor
- Ethicon, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
- Secondary Outcome Measures
Name Time Method Intraoperative complication Patient tolerance of the synthetic mesh placed Postoperative complications Quality of life