<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/NCT02243085</url>
  </required_header>
  <id_info>
    <org_study_id>MCho2</org_study_id>
    <nct_id>NCT02243085</nct_id>
  </id_info>
  <brief_title>Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate</brief_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 investigate the incidence of de novo urge urinary incontinence&#xD;
      after the photoselective vaporization of the prostate for benign prostatic hyperplasia using&#xD;
      the validated overactive bladder symptom score, and to determine the predictors of de novo&#xD;
      urge urinary incontinence following the photoselective vaporization of the prostate.&#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">October 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>de novo urge urinary incontinence at 6 months after surgery</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <condition>Urgency</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>photoselective vaporization</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        men who underwent photoselective vaporization of the prostate 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 in whom 6-months follow-up data were available&#xD;
&#xD;
          -  men who did not complain of urge urinary incontinence based on the OABSS (overactive&#xD;
             symptom score): OABSS question 4 score of ≤ 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous prostate or bladder surgery&#xD;
&#xD;
          -  a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or&#xD;
             neurogenic bladder disease&#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 17, 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 17, 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>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</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/NCT02243085
org study id: MCho2
nct id: NCT02243085
lead sponsor: 
has dmc: No
The aim of this study was to investigate the incidence of de novo urge urinary incontinence
      after the photoselective vaporization of the prostate for benign prostatic hyperplasia using
      the validated overactive bladder symptom score, and to determine the predictors of de novo
      urge urinary incontinence following the photoselective vaporization of the prostate.
observational model: Cohort
time perspective: Retrospective
measure: de novo urge urinary incontinence at 6 months after surgery
time frame: 6 months postoperatively
description: de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2
arm group label: photoselective vaporization
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: Urinary Incontinence
mesh term: Enuresis
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia