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

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196495
• Other study ID #: 2003-016
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 15, 2006
• Start date: June 2004
• Est. completion date: November 2005

Study information

• Verified date: December 2006
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Prolapse
• Vaginal Prolapse

Intervention

Device:
• Polypropylene Mesh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Secondary	Intraoperative complication
Secondary	Patient tolerance of the synthetic mesh placed
Secondary	Postoperative complications
Secondary	Quality of life