<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/NCT02242422</url>
  </required_header>
  <id_info>
    <org_study_id>MCho3</org_study_id>
    <nct_id>NCT02242422</nct_id>
  </id_info>
  <brief_title>Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery</brief_title>
  <official_title>Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence</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 the serial changes in lower urinary tract symptoms&#xD;
      (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for&#xD;
      treatment of female stress urinary incontinence.&#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">November 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 in total overactive bladder symptom score (OABSS) after surgery</measure>
    <time_frame>1-week, and 1-, 3-, 6- and 12-months after surgery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>transobturator tape</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women who underwent transobturator tape surgery for treatment of female stress urinary&#xD;
        incontinence&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who underwent transobturator tape surgery for treatment of female stress urinary&#xD;
             incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any urinary tract infection&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  bladder malignancy&#xD;
&#xD;
          -  postoperative follow-up of less than 12 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 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 14, 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>Urinary Incontinence, Stress</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/NCT02242422
org study id: MCho3
nct id: NCT02242422
lead sponsor: 
has dmc: No
The aim of this study was to identify the serial changes in lower urinary tract symptoms
      (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for
      treatment of female stress urinary incontinence.
observational model: Cohort
time perspective: Retrospective
measure: Change in total overactive bladder symptom score (OABSS) after surgery
time frame: 1-week, and 1-, 3-, 6- and 12-months after surgery
arm group label: transobturator tape
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 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: Urinary Incontinence, Stress