Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year
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.
Pelvic Organ Prolapse
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse|
- Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ]
- Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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