<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/NCT02243540</url>
  </required_header>
  <id_info>
    <org_study_id>JSPaick1</org_study_id>
    <nct_id>NCT02243540</nct_id>
  </id_info>
  <brief_title>Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy</brief_title>
  <official_title>Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)</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>
      The aim of this study was to evaluate an impact of preoperative bladder underactivity on&#xD;
      treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser&#xD;
      enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to&#xD;
      compare it between the two types of surgery for benign prostatic hyperplasia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Anticipated">September 2014</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline bladder voiding efficiency at 12 months after surgery</measure>
    <time_frame>12-months postoperatively</time_frame>
    <description>bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)</description>
  </primary_outcome>
  <enrollment type="Anticipated">1828</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        men who underwent photoselective vaporization of the prostate (PVP) or holmium laser&#xD;
        enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients in whom 12-month follow-up data were available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a previous diagnosis of urethral stricture&#xD;
&#xD;
          -  prostate or bladder carcinoma&#xD;
&#xD;
          -  neurogenic bladder disease&#xD;
&#xD;
          -  a previous history of urological 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>Jae-Seung Paick, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jae-Seung Paick, M.D., Ph.D.</last_name>
    <phone>82-2-2072-2422</phone>
    <phone_ext>2422</phone_ext>
    <email>jspaick@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-Seung Paick, M.D., Ph.D.</last_name>
      <phone>82-2-2072-2422</phone>
      <phone_ext>2422</phone_ext>
      <email>jspaick@snu.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 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 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jae-Seung Paick</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypokinesia</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/NCT02243540
org study id: JSPaick1
nct id: NCT02243540
lead sponsor: 
has dmc: No
The aim of this study was to evaluate an impact of preoperative bladder underactivity on
      treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser
      enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to
      compare it between the two types of surgery for benign prostatic hyperplasia.
observational model: Cohort
time perspective: Retrospective
measure: Change from baseline bladder voiding efficiency at 12 months after surgery
time frame: 12-months postoperatively
description: bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jae-Seung Paick, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Jae-Seung Paick, M.D., Ph.D.
phone: 82-2-2072-2422
phone ext: 2422
email: jspaick@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jae-Seung Paick
investigator title: Professor
mesh term: Hypokinesia
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia