<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730300</url>
  </required_header>
  <id_info>
    <org_study_id>LN-IUSBDSK</org_study_id>
    <nct_id>NCT01730300</nct_id>
  </id_info>
  <brief_title>Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems</brief_title>
  <official_title>Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing&#xD;
      Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine&#xD;
      bleeding. The patients were asked urogenital distress inventory (UDI) (which includes;&#xD;
      irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact&#xD;
      questionnaire (IIQ) (which includes; physical activity, travel, social/relationships,&#xD;
      emotional health)questionnaires in the day of application LNR-IUD and six months later this&#xD;
      procedure. Statistical analyse will be performed to evaluate the changes in this time period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary frequency</measure>
    <time_frame>6 months</time_frame>
    <description>We think that the urinary frequency will be lesser after 6 months of the therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>social activity</measure>
    <time_frame>6 months</time_frame>
    <description>We think that social activity will be better after reducing urinary symptoms</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of&#xD;
        menorrhagia or adenomyosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women using levonorgestrel releasing intrauterine device for the treatment of&#xD;
             menorrhagia or adenomyosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Ekin, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cihan Kaya, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehmet E Ayag, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Istanbul</city>
        <zip>34250</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>May 14, 2013</last_update_submitted>
  <last_update_submitted_qc>May 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>murat ekin</investigator_full_name>
    <investigator_title>Training Officer of Obstetrics and Gynecology Department M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730300
org study id: LN-IUSBDSK
nct id: NCT01730300
lead sponsor: 
has dmc: Yes
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.
observational model: Cohort
time perspective: Prospective
measure: Urinary frequency
time frame: 6 months
description: We think that the urinary frequency will be lesser after 6 months of the therapy.
measure: social activity
time frame: 6 months
description: We think that social activity will be better after reducing urinary symptoms
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: No
last name: Murat Ekin, M.D.
role: Study Chair
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
last name: Cihan Kaya, M.D.
role: Principal Investigator
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
last name: Mehmet E Ayag, M.D.
role: Principal Investigator
affiliation: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
investigator full name: murat ekin
investigator title: Training Officer of Obstetrics and Gynecology Department M.D.
mesh term: Lower Urinary Tract Symptoms