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/NCT06012903</url>
    </required_header>
    <id_info>
      <org_study_id>BC-11326</org_study_id>
      <nct_id>NCT06012903</nct_id>
    </id_info>
    <brief_title>Lower Urinary Tract Symptoms and School Functioning in Children</brief_title>
    <official_title>Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Ghent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Ghent</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Ghent</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>
        Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may&#xD;
        negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs)&#xD;
        can adversely affect children as well and can cause restrictions in their daily life,&#xD;
        especially in their school-environment.&#xD;
  &#xD;
        The goal of this observational study is to identify the prevalence of LUTS in Flemish primary&#xD;
        school children.The main questions it aims to answer are:&#xD;
  &#xD;
          -  How prevalent are LUTS in regular primary education?&#xD;
  &#xD;
          -  Is there a relation with well-being in school environment?&#xD;
  &#xD;
          -  Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked&#xD;
             to fill in questionnaires related to this research question.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 6, 2022</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Bladder and bowel dysfunction</measure>
      <time_frame>through study completion from the parent-group, 25 minutes</time_frame>
      <description>Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>School functioning</measure>
      <time_frame>through study completion from the children-group, 30 minutes</time_frame>
      <description>Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Influencing factors on school functioning</measure>
      <time_frame>through study completion from the parent-, children- and teacher-group, 30 minutes</time_frame>
      <description>Prevalence and influence of neurodevelopmental disorders, school-related factors and LUTS. Results from the vancouver symptom score for dysfunctional elimination syndrome, Developmental Coordination Disorder Questionnaire, questions concerning neurodevelopmental disorders and a questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom will be correlated with results from the questionnaire Welbevinden.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perception of treatment characteristics</measure>
      <time_frame>through study completion of the parent-group, 25 minutes</time_frame>
      <description>Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions .</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Lower Urinary Tract Symptoms</condition>
    <condition>Neurodevelopmental Disorders</condition>
    <condition>Incontinence, Urinary</condition>
    <condition>ADHD</condition>
    <condition>ASD</condition>
    <condition>Developmental Coordination Disorder</condition>
    <condition>Child Development</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Parents</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Children</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Teachers</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Welbevinden</intervention_name>
      <description>A validated questionnaire recommended by the Flemish inspection of education to measure well-being in primary school children of the 4th, 5th and 6th grade.</description>
      <arm_group_label>Children</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Vancouver symptom score for dysfunctional elimination syndrome</intervention_name>
      <description>Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.</description>
      <arm_group_label>Parents</arm_group_label>
      <other_name>VSSDES</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Developmental Coordination Disorder Questionnaire</intervention_name>
      <description>Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.</description>
      <arm_group_label>Parents</arm_group_label>
      <other_name>DCD-Q</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire concerning LUTS, NDDs and treatment perceptions</intervention_name>
      <description>Unvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics.</description>
      <arm_group_label>Parents</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom</intervention_name>
      <description>These unvalidated questionnaire was based on the questionnaire developed by Ko et al. (2016) about the school's policies and practices regarding children's toilet use and drinking habits in the classroom, covering students in grades one through six. Epidemiological questions related to LUTS were added to complement the questionnaire.</description>
      <arm_group_label>Teachers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children following education in recruited primary, regular education schools and their&#xD;
          respective parents/guardians and teachers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children in 4th-6th grade&#xD;
  &#xD;
            -  Parents whose children are in grades 1-6&#xD;
  &#xD;
            -  Teachers responsible for teaching children in grades 1-6&#xD;
  &#xD;
            -  Children who attend regular primary education&#xD;
  &#xD;
            -  Capable of speaking &amp; comprehending Dutch&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  High school students&#xD;
  &#xD;
            -  home-schooled children&#xD;
  &#xD;
            -  children who attend special needs education&#xD;
  &#xD;
            -  Language barrier to understanding Dutch&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ellen Vandamme, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Ghent</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bieke Samijn, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Ghent</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bieke Samijn, PhD</last_name>
      <phone>+32 9 332 19 38</phone>
      <email>bieke.samijn@ugent.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ghent University Hospital/Ghent University</name>
        <address>
          <city>Ghent</city>
          <state>East Flanders</state>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bieke Samijn, Dr.</last_name>
        <phone>+32 9 332 19 38</phone>
        <email>Bieke.Samijn@UGent.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lower urinary tract symptoms</keyword>
    <keyword>Quality of life</keyword>
    <keyword>Pediatrics</keyword>
    <keyword>neurodevelopmental disorders</keyword>
    <keyword>VSSDES</keyword>
    <keyword>DCD-Q</keyword>
    <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>Lower Urinary Tract Symptoms</mesh_term>
      <mesh_term>Neurodevelopmental Disorders</mesh_term>
      <mesh_term>Motor Skills Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06012903
  org study id: BC-11326
  nct id: NCT06012903
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may
        negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs)
        can adversely affect children as well and can cause restrictions in their daily life,
        especially in their school-environment.
  
        The goal of this observational study is to identify the prevalence of LUTS in Flemish primary
        school children.The main questions it aims to answer are:
  
          -  How prevalent are LUTS in regular primary education?
  
          -  Is there a relation with well-being in school environment?
  
          -  Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked
             to fill in questionnaires related to this research question.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Bladder and bowel dysfunction
  time frame: through study completion from the parent-group, 25 minutes
  description: Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome.
  measure: School functioning
  time frame: through study completion from the children-group, 30 minutes
  description: Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden.
  measure: Influencing factors on school functioning
  time frame: through study completion from the parent-, children- and teacher-group, 30 minutes
  description: Prevalence and influence of neurodevelopmental disorders, school-related factors and LUTS. Results from the vancouver symptom score for dysfunctional elimination syndrome, Developmental Coordination Disorder Questionnaire, questions concerning neurodevelopmental disorders and a questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom will be correlated with results from the questionnaire Welbevinden.
  measure: Perception of treatment characteristics
  time frame: through study completion of the parent-group, 25 minutes
  description: Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions .
  arm group label: Parents
  arm group label: Children
  arm group label: Teachers
  intervention type: Other
  intervention name: Questionnaire Welbevinden
  description: A validated questionnaire recommended by the Flemish inspection of education to measure well-being in primary school children of the 4th, 5th and 6th grade.
  arm group label: Children
  intervention type: Other
  intervention name: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome
  description: Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.
  arm group label: Parents
  other name: VSSDES
  intervention type: Other
  intervention name: Developmental Coordination Disorder Questionnaire
  description: Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
  arm group label: Parents
  other name: DCD-Q
  intervention type: Other
  intervention name: Questionnaire concerning LUTS, NDDs and treatment perceptions
  description: Unvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics.
  arm group label: Parents
  intervention type: Other
  intervention name: Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom
  description: These unvalidated questionnaire was based on the questionnaire developed by Ko et al. (2016) about the school's policies and practices regarding children's toilet use and drinking habits in the classroom, covering students in grades one through six. Epidemiological questions related to LUTS were added to complement the questionnaire.
  arm group label: Teachers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ellen Vandamme, MD
  role: Principal Investigator
  affiliation: University Hospital, Ghent
  last name: Bieke Samijn, PhD
  role: Principal Investigator
  affiliation: University Ghent
  last name: Bieke Samijn, PhD
  phone: +32 9 332 19 38
  email: bieke.samijn@ugent.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Urinary Incontinence
  mesh term: Enuresis
  mesh term: Lower Urinary Tract Symptoms
  mesh term: Neurodevelopmental Disorders
  mesh term: Motor Skills Disorders
  sharing ipd: No