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

This study has been completed.
Information provided by:
Atlantic Health System Identifier:
First received: October 16, 2008
Last updated: January 25, 2010
Last verified: October 2008
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 Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Atlantic Health System:

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

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

Estimated Enrollment: 103
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

Inclusion Criteria:

  • All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

Exclusion Criteria:

  • Unable to give informed consent to participate
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Please refer to this study by its identifier: NCT00774215

United States, New Jersey
Atlantic Health System - Division of Urogynecology
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patrick Culligan, MD, Director, Division of Urogynecology & Reconstructive Pelvic Surgery, Atlantic Health System Identifier: NCT00774215     History of Changes
Other Study ID Numbers: R07-09-016
Study First Received: October 16, 2008
Last Updated: January 25, 2010

Keywords provided by Atlantic Health System:
Pelvic Organ Prolapse
Synthetic Mesh
Vaginal Mesh

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical processed this record on April 26, 2017