<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/NCT02245334</url>
  </required_header>
  <id_info>
    <org_study_id>B-1403/243-004</org_study_id>
    <nct_id>NCT02245334</nct_id>
  </id_info>
  <brief_title>A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy</brief_title>
  <official_title>A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the effect of povidone-iodine on infectious complication rate caused by transrectal&#xD;
      prostate biopsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the effect of povidone-iodine on infectious complication rate caused by transrectal prostate&#xD;
      biopsy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with febrile infection</measure>
    <time_frame>1 week</time_frame>
    <description>consider fever over 38 degree celsius or admission due to fever</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>voiding questionnaire</measure>
    <time_frame>1-2 week</time_frame>
    <description>check International Prostate Symptom Score (IPSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexual function questionnaire</measure>
    <time_frame>1-2 week</time_frame>
    <description>International Index of Erectile Function-5 (IIEF-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life questionnaire</measure>
    <time_frame>1-2 week</time_frame>
    <description>European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1578</enrollment>
  <condition>Infection</condition>
  <condition>Prostatic Diseases</condition>
  <condition>Misadventure During Aspirating Needle Biopsy</condition>
  <arm_group>
    <arm_group_label>Povidone-iodine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>povidone iodine pill</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine</intervention_name>
    <description>1 pill per biopsy</description>
    <arm_group_label>Povidone-iodine</arm_group_label>
    <other_name>Gynobetadine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  who undergo transrectal prostate biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who refuse to be included, patients who have hypersensitivity to iodine,&#xD;
             patients who have abnormal thyroid function, patients who do not visit follow-up,&#xD;
             patients who have received prior radioactive-iodine therapy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangchul Lee, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sangchul Lee</last_name>
    <phone>+82-31-787-7345</phone>
    <email>uromedi@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Urology, Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyunggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Sangchul Lee, MD, PhD</last_name>
      <phone>+82-31-787-7345</phone>
      <email>uromedi@naver.com</email>
    </contact>
    <investigator>
      <last_name>Sangchul Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_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/NCT02245334
org study id: B-1403/243-004
nct id: NCT02245334
lead sponsor: 
has dmc: No
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal
      prostate biopsy
the effect of povidone-iodine on infectious complication rate caused by transrectal prostate
      biopsy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with febrile infection
time frame: 1 week
description: consider fever over 38 degree celsius or admission due to fever
measure: voiding questionnaire
time frame: 1-2 week
description: check International Prostate Symptom Score (IPSS)
measure: sexual function questionnaire
time frame: 1-2 week
description: International Index of Erectile Function-5 (IIEF-5)
measure: quality of life questionnaire
time frame: 1-2 week
description: European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
arm group label: Povidone-iodine
arm group type: Experimental
description: povidone iodine pill
arm group label: no intervention
arm group type: No Intervention
description: no intervention
intervention type: Drug
intervention name: Povidone-Iodine
description: 1 pill per biopsy
arm group label: Povidone-iodine
other name: Gynobetadine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sangchul Lee, MD.PhD.
role: Principal Investigator
affiliation: Prof
last name: Sangchul Lee
phone: +82-31-787-7345
email: uromedi@naver.com
facility: 
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Diseases
mesh term: Povidone-Iodine
mesh term: Povidone