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OpenTrials
Completed

NCT Number: NCT00196495

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.

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Key information

Conditions

Vaginal Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polypropylene mesh

Device

Primary outcomes

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

Secondary outcomes

  1. Intraoperative complication

  2. Patient tolerance of the synthetic mesh placed

  3. Postoperative complications

  4. Quality of life

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Dec 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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