xml: <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/NCT05964803</url>
    </required_header>
    <id_info>
      <org_study_id>KocUrol5</org_study_id>
      <nct_id>NCT05964803</nct_id>
    </id_info>
    <brief_title>Lower Urinary Tract Symptoms in Males Living With HIV</brief_title>
    <official_title>Males Living With HIV and LUTS: A Case-control Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koç University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Koç University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary aim of this study is to learn whether the frequency of lower urinary tract&#xD;
        symptoms differ between the males with seronegativity for HIV and males living with HIV.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>International Consultation on Incontinence Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>ICIQ-Short Form (ICIQ-SF)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>International Prostate Symptom Score (IPSS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>King's Healthcare Questionnaire (KHQ)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>8-item Overactive Bladder Questionnaire (OAB-V8)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>Once</time_frame>
      <description>Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>HIV Seropositivity</condition>
    <condition>Lower Urinary Tract Symptoms</condition>
    <arm_group>
      <arm_group_label>Males living with HIV</arm_group_label>
      <description>Males living with HIV and followed by infectious diseases clinic will be directed to Urology department.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HIV-negative controls</arm_group_label>
      <description>Males admitted to Infectious Diseases clinic and documented to be HIV-negative.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>MLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).</description>
      <arm_group_label>HIV-negative controls</arm_group_label>
      <arm_group_label>Males living with HIV</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted to Infectious Diseases Clinic (100 living with HIV, 100 HIV-negative&#xD;
          males) will be directed to Urology clinic. The same questionnaires will be given and scores&#xD;
          will be compared.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients above 18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-Turkish speakers&#xD;
  &#xD;
            -  Previous surgeries or medications for lower urinary tract symptoms&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Males above 18 years old</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tufan Tarcan, Prof</last_name>
      <phone>905434948365</phone>
      <email>bilgi@tufantarcan.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ersin Köseoğlu</last_name>
      <phone>905306930442</phone>
      <email>ersinkoseoglu@ku.edu.tr</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Koç University</investigator_affiliation>
      <investigator_full_name>Ersin Köseoglu</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Seropositivity</mesh_term>
      <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964803
  org study id: KocUrol5
  nct id: NCT05964803
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary aim of this study is to learn whether the frequency of lower urinary tract
        symptoms differ between the males with seronegativity for HIV and males living with HIV.
  observational model: Case-Control
  time perspective: Prospective
  measure: Questionnaires
  time frame: Once
  description: International Consultation on Incontinence Questionnaire
  measure: Questionnaires
  time frame: Once
  description: Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
  measure: Questionnaires
  time frame: Once
  description: ICIQ-Short Form (ICIQ-SF)
  measure: Questionnaires
  time frame: Once
  description: International Prostate Symptom Score (IPSS)
  measure: Questionnaires
  time frame: Once
  description: King's Healthcare Questionnaire (KHQ)
  measure: Questionnaires
  time frame: Once
  description: 8-item Overactive Bladder Questionnaire (OAB-V8)
  measure: Questionnaires
  time frame: Once
  description: Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
  arm group label: Males living with HIV
  description: Males living with HIV and followed by infectious diseases clinic will be directed to Urology department.
  arm group label: HIV-negative controls
  description: Males admitted to Infectious Diseases clinic and documented to be HIV-negative.
  intervention type: Diagnostic Test
  intervention name: Questionnaires
  description: MLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
  arm group label: HIV-negative controls
  arm group label: Males living with HIV
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Males above 18 years old
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tufan Tarcan, Prof
  phone: 905434948365
  email: bilgi@tufantarcan.com
  last name: Ersin Köseoğlu
  phone: 905306930442
  email: ersinkoseoglu@ku.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Koç University
  investigator full name: Ersin Köseoglu
  investigator title: MD
  mesh term: HIV Seropositivity
  mesh term: Lower Urinary Tract Symptoms
  sharing ipd: No