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/NCT05962086</url>
    </required_header>
    <id_info>
      <org_study_id>2210-092-1369</org_study_id>
      <nct_id>NCT05962086</nct_id>
    </id_info>
    <brief_title>Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism</brief_title>
    <official_title>Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism: A Multicenter, Retrospective Cohort</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Asan Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Severance Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Keimyung University Dongsan Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pusan National University Yangsan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University 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>
        To identify developmental and clinical biomarkers that affect urinary incontinence at the&#xD;
        ages of 5, 7, and 10 according to different neuro-urological clinical factors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This retrospective observational cohort study aims to identify developmental and clinical&#xD;
        biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to the&#xD;
        types of spinal dysraphism, conus medullaris location, and urodynamics test results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 22, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Achieving full continence at age 5</measure>
      <time_frame>Age 5</time_frame>
      <description>Achieving full urinary and fecal continence at age 5</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Achieving full continence at age 7</measure>
      <time_frame>Age 7</time_frame>
      <description>Achieving full urinary and fecal continence at age 7.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Achieving full continence at age 10</measure>
      <time_frame>Age 10</time_frame>
      <description>Achieving full urinary and fecal continence at age 10</description>
    </primary_outcome>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Spinal Dysraphism</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Spinal dysraphism (SD) is a congenital abnormality that results in an abnormal structure in&#xD;
          the spine, including the bony structure, the spinal cord, and the nerve roots. Patients&#xD;
          with SD often suffer from multiple complications such as neurological problems, urological&#xD;
          problems, orthopedic problems, and pain. A numerous studies have demonstrated that at least&#xD;
          70-90% of the patients experience neurogenic bladder or neurogenic detrusor overactivity,&#xD;
          which affects both physical and psychosocial aspects of quality of life.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been&#xD;
          following up and receiving treatments due to neurogenic bladder.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - As the study is a retrospective study, there is no exclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kwanjin Park, MD/PHD</last_name>
      <role>Study Chair</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sang Woon Kim, MD/PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Severance Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sang Hoon Song, MD/PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Asan Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Minki Baek, MD/PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Samsung Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jae Min Chung, MD/PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pusan National University Yangsan Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ji Yong Ha, MD/PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Keimyung University Dongsan Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kwanjin Park, MD/PHD</last_name>
      <phone>+82-2-2072-0695</phone>
      <email>urodori9@snu.ac.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Louis Kim, BS</last_name>
      <phone>+82-10-4201-0636</phone>
      <email>kim.hyunkyu11@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pusan National University Yangsan Hospital</name>
        <address>
          <city>Yangsan</city>
          <state>Gyeongsangnam-do</state>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jae Min Chung, MD/PHD</last_name>
        <email>busanuro@hanmail.net</email>
      </contact>
      <investigator>
        <last_name>Jae Min Chung, MD/PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Keimyung University Dongsan Medical Center</name>
        <address>
          <city>Daegu</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ji Yong Ha, MD/PHD</last_name>
        <email>urovision1978@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ji Yong Ha, MD/PH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Asan Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sang Hoon Song, MD/PHD</last_name>
        <email>mdexodus@amc.seoul.kr</email>
      </contact>
      <investigator>
        <last_name>Sang Hoon Song, MD/PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Minki Baek, MD/PHD</last_name>
        <email>drminkibaek@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Minki Baek, MD/PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kwanjin Park, MD/PHD</last_name>
        <email>urodori9@snu.ac.kr</email>
      </contact>
      <investigator>
        <last_name>Kwanjin Park, MD/PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yonsei University Severance Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sang Woon Kim, MD/PHD</last_name>
        <email>khisin@yuhs.ac</email>
      </contact>
      <investigator>
        <last_name>Sang Woon Kim, MD/PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Kwanjin Park</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Spina Bifida</keyword>
    <keyword>Neurogenic Bladder</keyword>
    <keyword>Neurogenic Detrusor Overactivity</keyword>
    <keyword>Detrusor Overactivity</keyword>
    <keyword>Incontinence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Dysraphism</mesh_term>
      <mesh_term>Neural Tube Defects</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Not willing to share individual participant data (IPD) for this particular study.</ipd_description>
    </patient_data>
    <!-- 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/NCT05962086
  org study id: 2210-092-1369
  nct id: NCT05962086
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To identify developmental and clinical biomarkers that affect urinary incontinence at the
        ages of 5, 7, and 10 according to different neuro-urological clinical factors.
  This retrospective observational cohort study aims to identify developmental and clinical
        biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to the
        types of spinal dysraphism, conus medullaris location, and urodynamics test results.
  observational model: Cohort
  time perspective: Retrospective
  measure: Achieving full continence at age 5
  time frame: Age 5
  description: Achieving full urinary and fecal continence at age 5
  measure: Achieving full continence at age 7
  time frame: Age 7
  description: Achieving full urinary and fecal continence at age 7.
  measure: Achieving full continence at age 10
  time frame: Age 10
  description: Achieving full urinary and fecal continence at age 10
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 10 Years
  healthy volunteers: No
  last name: Kwanjin Park, MD/PHD
  role: Study Chair
  affiliation: Seoul National University Hospital
  last name: Sang Woon Kim, MD/PHD
  role: Principal Investigator
  affiliation: Severance Hospital
  last name: Sang Hoon Song, MD/PHD
  role: Principal Investigator
  affiliation: Asan Medical Center
  last name: Minki Baek, MD/PHD
  role: Principal Investigator
  affiliation: Samsung Medical Center
  last name: Jae Min Chung, MD/PHD
  role: Principal Investigator
  affiliation: Pusan National University Yangsan Hospital
  last name: Ji Yong Ha, MD/PHD
  role: Principal Investigator
  affiliation: Keimyung University Dongsan Medical Center
  last name: Kwanjin Park, MD/PHD
  phone: +82-2-2072-0695
  email: urodori9@snu.ac.kr
  last name: Louis Kim, BS
  phone: +82-10-4201-0636
  email: kim.hyunkyu11@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Kwanjin Park
  investigator title: Professor
  mesh term: Spinal Dysraphism
  mesh term: Neural Tube Defects
  sharing ipd: No
  ipd description: Not willing to share individual participant data (IPD) for this particular study.