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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)

Interventions

  • Device: Polypropylene Mesh

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Intraoperative complication
  • Patient tolerance of the synthetic mesh placed
  • Postoperative complications
  • Quality of life

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ethicon, Inc.
  • Overall Official(s)
    • Martin Weisberg, MD, Study Director, Ethicon, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.