Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT00774215
- Lead Sponsor
- Atlantic Health System
- 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 Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
- All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.
- Unable to give informed consent to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit 1 year post operatively
- Secondary Outcome Measures
Name Time Method Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit 1 year
Trial Locations
- Locations (1)
Atlantic Health System - Division of Urogynecology
🇺🇸Morristown, New Jersey, United States