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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.
Sponsor:
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00774215
First received: October 16, 2008
Last updated: January 25, 2010
Last verified: October 2008
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774215

Locations
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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Patrick Culligan, MD, Director, Division of Urogynecology & Reconstructive Pelvic Surgery, Atlantic Health System
ClinicalTrials.gov Identifier: NCT00774215     History of Changes
Other Study ID Numbers: R07-09-016
Study First Received: October 16, 2008
Last Updated: January 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
Pelvic Organ Prolapse
Cystocele
Rectocele
Enterocele
 Synthetic Mesh
Vaginal Mesh
Transobturator

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013