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TVTO Versus TVTFFM for Urinary Stress Incontinence

Sponsor
Western Galilee Hospital-Nahariya (Other)
Overall Status
Completed
CT.gov ID
NCT01392664
Collaborator
(none)
200
Enrollment
2
Locations
52.9
Duration (Months)
100
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Women who had urinary stress incontinence and underwent one of two procedures: the classic TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We will enroll women that underwent one of the two surgeries: TVTO or the modification where the needle passes somewhat to the side to prevent the post operative pain, for urinary stress incontinence. Data will be collected from the charts. Telephone interviews will be carried out. Physical examination will also be incorporated.

    Study Design

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

    Outcome Measures

    Primary Outcome Measures

    1. Resolution of urinary stress incontinence [One year after surgery]

      We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.

    Secondary Outcome Measures

    1. Side effect of surgery [six-12 months]

      We will question the women if they have symptoms such as pain in the hip joints, vaginal discharge and bleeding. Physical examination will be retrieved from the charts.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women with Urinary Stress Incontinence treated by TVT
    Exclusion Criteria:
    • Women without with Urinary Stress Incontinence or not treated by TVT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Western Galilee Hospital Nahariya Israel
    2 Clinics of Dr Neuman 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:
    menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
    ClinicalTrials.gov Identifier:
    NCT01392664
    Other Study ID Numbers:
    • 920090040
    First Posted:
    Jul 12, 2011
    Last Update Posted:
    Jun 7, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jun 7, 2016