Clinical Trial: Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse

Brief Summary: This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.

Detailed Summary:

This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh "kit" from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms.

This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well

Sponsor: Atlantic Health System

Current Primary Outcome: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit [ Time Frame: 1 year post operatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Atlantic Health System

Dates:
Date Received: October 16, 2008
Date Started: October 2007
Date Completion:
Last Updated: January 25, 2010
Last Verified: October 2008