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

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00774215
Collaborator
(none)
103
Enrollment
1
Location
18
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    103 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse
    Study Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2009
    Actual Study Completion Date :
    Apr 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Atlantic Health System - Division of Urogynecology Morristown New Jersey United States 07960

    Sponsors and Collaborators

    • Atlantic Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00774215
    Other Study ID Numbers:
    • R07-09-016
    First Posted:
    Oct 17, 2008
    Last Update Posted:
    Jan 26, 2010
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    Pelvic Organ Prolapse
    Cystocele
    Rectocele
    Enterocele
    Synthetic Mesh
    Vaginal Mesh
    Transobturator
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Jan 26, 2010