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Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

Sponsor
Western Galilee Hospital-Nahariya (Other)
Overall Status
Completed
CT.gov ID
NCT01392651
Collaborator
(none)
200
Enrollment
2
Locations
41
Duration (Months)
100
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Women with urinary stress incontinence

    Outcome Measures

    Primary Outcome Measures

    1. Prevention of stress incontinence [12 months]

      We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated.

    Secondary Outcome Measures

    1. Evaluation of side effects: tape erosion, pain, bleeding [12 months]

      We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.

    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 USI who underwent TVTS or TVTO procedure, more than 6 months ago
    Exclusion Criteria:
    • Women who have not undergone TVT procedure

    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 Rishon Lezion 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:
    NCT01392651
    Other Study ID Numbers:
    • 920090039
    First Posted:
    Jul 12, 2011
    Last Update Posted:
    Jul 3, 2014
    Last Verified:
    Jul 1, 2011
    Keywords provided by menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
    Urinary stress incontinence
    TVT
    Additional relevant MeSH terms:
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jul 3, 2014