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Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01730300
Collaborator
(none)
60
Enrollment
1
Location
11
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine bleeding. The patients were asked urogenital distress inventory (UDI) (which includes; irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact questionnaire (IIQ) (which includes; physical activity, travel, social/relationships, emotional health)questionnaires in the day of application LNR-IUD and six months later this procedure. Statistical analyse will be performed to evaluate the changes in this time period.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    May 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Urinary frequency [6 months]

      We think that the urinary frequency will be lesser after 6 months of the therapy.

    Secondary Outcome Measures

    1. social activity [6 months]

      We think that social activity will be better after reducing urinary symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology Istanbul Turkey 34250

    Sponsors and Collaborators

    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Investigators

    • Study Chair: Murat Ekin, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
    • Principal Investigator: Cihan Kaya, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
    • Principal Investigator: Mehmet E Ayag, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    murat ekin, Training Officer of Obstetrics and Gynecology Department M.D., Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT01730300
    Other Study ID Numbers:
    • LN-IUSBDSK
    First Posted:
    Nov 21, 2012
    Last Update Posted:
    May 15, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Lower Urinary Tract Symptoms

    Study Results

    No Results Posted as of May 15, 2013