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/NCT06016595</url>
    </required_header>
    <id_info>
      <org_study_id>16.08.2023/23-43</org_study_id>
      <nct_id>NCT06016595</nct_id>
    </id_info>
    <brief_title>Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients</brief_title>
    <official_title>Retrospective Data Analysis in Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients: Evaluation of the Relationship Between Presence of Microorganism and Severity of Symptom</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hisar Intercontinental Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hisar Intercontinental Hospital</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>
        Chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common health problem among men&#xD;
        and can cause severe quality of life. The pathophysiology of CPPS is still poorly understood&#xD;
        and effective treatments are a challenging issue. This study aims to investigate the possible&#xD;
        relationship between the presence of microorganisms in the prostatic fluid and symptom&#xD;
        severity by presenting a retrospective analysis based on data from CPPS patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such&#xD;
        as demographic information of the patients, International Prostate Symptom Score (I-PSS),&#xD;
        which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline&#xD;
        scores of the International Index of Erectile Function (IIEF), which evaluates erectile&#xD;
        function, and the presence of microorganisms in the prostate fluid were analyzed&#xD;
        retrospectively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">May 10, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation between androflor pcr positive patients and uopint and nih-cpsi</measure>
      <time_frame>2 years</time_frame>
      <description>Those with positive and negative Androflor PCR test will be evaluated. testicular torsion</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">112</enrollment>
    <condition>Chronic Prostatitis With Chronic Pelvic Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>singel</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Chronic prostatitis/chronic pelvic pain syndrome</intervention_name>
      <description>Chronic prostatitis/chronic pelvic pain syndrome UPOINT</description>
      <arm_group_label>singel</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such&#xD;
          as demographic information of the patients, International Prostate Symptom Score (I-PSS),&#xD;
          which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline&#xD;
          scores of the International Index of Erectile Function (IIEF), which evaluates erectile&#xD;
          function, and the presence of microorganisms in the prostate fluid were analyzed&#xD;
          retrospectively.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who were diagnosed with chronic prostatitis/chronic pelvic pain syndrome and&#xD;
               whose prostate fluid was taken with prostate massage and androflor testis were studied&#xD;
               were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  acute and/or chronic bacterial prostatitis, active history of genitourinary cancer,&#xD;
               history of recent prostate surgery the diagnosis of neurological diseases affecting&#xD;
               the bladder was determined&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Patients with chronic prostatitis were included in the study.</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hisar Intercontinental Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34768</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hisar Intercontinental Hospital</investigator_affiliation>
      <investigator_full_name>Basri Cakiroglu</investigator_full_name>
      <investigator_title>Ass. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatitis</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Pelvic Pain</mesh_term>
      <mesh_term>Chronic Disease</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06016595
  org study id: 16.08.2023/23-43
  nct id: NCT06016595
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common health problem among men
        and can cause severe quality of life. The pathophysiology of CPPS is still poorly understood
        and effective treatments are a challenging issue. This study aims to investigate the possible
        relationship between the presence of microorganisms in the prostatic fluid and symptom
        severity by presenting a retrospective analysis based on data from CPPS patients.
  This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such
        as demographic information of the patients, International Prostate Symptom Score (I-PSS),
        which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline
        scores of the International Index of Erectile Function (IIEF), which evaluates erectile
        function, and the presence of microorganisms in the prostate fluid were analyzed
        retrospectively.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Correlation between androflor pcr positive patients and uopint and nih-cpsi
  time frame: 2 years
  description: Those with positive and negative Androflor PCR test will be evaluated. testicular torsion
  arm group label: singel
  intervention type: Diagnostic Test
  intervention name: Chronic prostatitis/chronic pelvic pain syndrome
  description: Chronic prostatitis/chronic pelvic pain syndrome UPOINT
  arm group label: singel
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Patients with chronic prostatitis were included in the study.
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hisar Intercontinental Hospital
  investigator full name: Basri Cakiroglu
  investigator title: Ass. Prof.
  mesh term: Prostatitis
  mesh term: Syndrome
  mesh term: Pelvic Pain
  mesh term: Chronic Disease
  mesh term: Somatoform Disorders