<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/NCT02241902</url>
  </required_header>
  <id_info>
    <org_study_id>MCho1</org_study_id>
    <nct_id>NCT02241902</nct_id>
  </id_info>
  <brief_title>Impact of Postoperative Pyuria on Treatment Outcomes After PVP</brief_title>
  <official_title>Does Postoperative Pyuria Influence Treatment Outcomes After Photoselective Vaporization of the Prostate (PVP)?: A Short-term Serial Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DongGuk University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to identify serial changes in the incidence of postoperative pyuria&#xD;
      after the Photoselective Vaporization of the Prostate (PVP), to determine whether the&#xD;
      presence of postoperative pyuria could be correlated with surgical outcomes after surgery and&#xD;
      to identify predicting factors that influence on persistent pyuria after the PVP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">March 2015</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>Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS)</measure>
    <time_frame>1-week, and 1-, 3- and 6-months after the surgery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <condition>Pyuria</condition>
  <arm_group>
    <arm_group_label>No pyuria</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Persistent pyuria</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        men who underwent photoselective vaporization (PVP) using 80 watt&#xD;
        potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for&#xD;
        benign prostatic hyperplasia refractory to medical treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men who underwent photoselective vaporization (PVP) using 80 watt&#xD;
             potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for&#xD;
             benign prostatic hyperplasia refractory to medical treatment&#xD;
&#xD;
          -  sterile urine on urinalysis and urine culture before surgery&#xD;
&#xD;
          -  absence of indwelling urethral catheter before surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous diagnosis of prostate carcinoma or bladder cancer&#xD;
&#xD;
          -  co-existence of urinary stone&#xD;
&#xD;
          -  any antibiotic treatment within 2-weeks before surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Chul Cho, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>DongGuk University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Chul Cho, M.D., Ph.D.</last_name>
    <phone>82-31-961-7456</phone>
    <phone_ext>7456</phone_ext>
    <email>cmc1206@empal.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dongguk University ilsan Hospital</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-do</state>
        <zip>410-773</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Chul Cho, M.D., Ph.D.</last_name>
      <phone>82-31-961-7456</phone>
      <phone_ext>7456</phone_ext>
      <email>cmc1206@empal.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>DongGuk University</investigator_affiliation>
    <investigator_full_name>Min Chul Cho</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyuria</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</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/NCT02241902
org study id: MCho1
nct id: NCT02241902
lead sponsor: 
has dmc: No
The aim of this study was to identify serial changes in the incidence of postoperative pyuria
      after the Photoselective Vaporization of the Prostate (PVP), to determine whether the
      presence of postoperative pyuria could be correlated with surgical outcomes after surgery and
      to identify predicting factors that influence on persistent pyuria after the PVP.
observational model: Cohort
time perspective: Prospective
measure: Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS)
time frame: 1-week, and 1-, 3- and 6-months after the surgery
arm group label: No pyuria
arm group label: Persistent pyuria
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Min Chul Cho, M.D., Ph.D.
role: Principal Investigator
affiliation: DongGuk University
last name: Min Chul Cho, M.D., Ph.D.
phone: 82-31-961-7456
phone ext: 7456
email: cmc1206@empal.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: DongGuk University
investigator full name: Min Chul Cho
investigator title: Assistant professor
mesh term: Pyuria
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia