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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:
ClinicalTrials.gov Identifier:
NCT00774215
First Posted: October 17, 2008
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Atlantic Health System
  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:


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

  Eligibility

Information from the National Library of Medicine

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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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 16, 2008
First Posted: October 17, 2008
Last Update Posted: January 26, 2010
Last Verified: October 2008

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