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Sub Urethral Sling With or With Out Anterior Repair

Sponsor
Tabriz University (Other)
Overall Status
Completed
CT.gov ID
NCT01246271
Collaborator
(none)
98
Enrollment
1
Location
22
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    98 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair
    Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Sub urethral sling
    sus with anterior vainal wall repair

    Outcome Measures

    Primary Outcome Measures

    1. Urinary incontinence cure rate according ICIQ-UIsf [3 month after surgery]

    Secondary Outcome Measures

    1. morbidity and complication [3 month after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    27 Years to 78 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients must be female

    2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire

    3. Stress incontinence on urodynamics

    4. Patients must be capable of filling in the symptom diary

    5. Prolapse beyond the introitus

    Exclusion Criteria:

    1. Patients who are medically unfit to undergo surgical intervention.

    2. Patients who have undergone previous continence surgery

    3. Patients with voiding dysfunction

    4. Patients with recurrent urinary tract infection

    5. Patients who are not sure that their family is complete

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology department Imam Reza Hospital Tabriz Iran, Islamic Republic of

    Sponsors and Collaborators

    • Tabriz University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01246271
    Other Study ID Numbers:
    • 89-234
    • 8948
    First Posted:
    Nov 23, 2010
    Last Update Posted:
    Nov 23, 2010
    Last Verified:
    Jan 1, 2008
    Additional relevant MeSH terms:
    Urinary Incontinence

    Study Results

    No Results Posted as of Nov 23, 2010