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Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

Sponsor
Western Galilee Hospital-Nahariya (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01387685
Collaborator
(none)
0
Enrollment
2
Locations
47
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Study Start Date :
    Feb 1, 2009
    Anticipated Primary Completion Date :
    Jan 1, 2013
    Anticipated Study Completion Date :
    Jan 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Satisfaction with study outcome [six to twelve months after surgery]

    Secondary Outcome Measures

    1. Side effects of the surgery: pain, vaginal erosion by tape, bleeding [Within six to twelve months after study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women who underwent surgery for pelvic floor prolapse
    Exclusion Criteria:
    • Women who did not have surgery for pelvic floor prolapse.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Western Galilee Hospital Nahariya Israel
    2 Dr Neuman clinic Tel Aviv Israel

    Sponsors and Collaborators

    • Western Galilee Hospital-Nahariya

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01387685
    Other Study ID Numbers:
    • 920090042
    First Posted:
    Jul 4, 2011
    Last Update Posted:
    Jun 20, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Prolapse

    Study Results

    No Results Posted as of Jun 20, 2014