<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/NCT04490642</url>
  </required_header>
  <id_info>
    <org_study_id>2006-203-1137</org_study_id>
    <nct_id>NCT04490642</nct_id>
  </id_info>
  <brief_title>Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean</brief_title>
  <official_title>Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to conduct a linguistic and cultural validation of the Children Bladder and&#xD;
      Bowel Dysfunction (CBBDQs) for 5-12 years old from English to Korean. Once it has been&#xD;
      validated into the Korean language, it will be a valuable source that will better serve&#xD;
      patients with BBD symptoms in an outpatient setting and use in future clinical studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BBD, or Bladder and Bowel Dysfunction, is relatively a common disorder affecting&#xD;
      approximately 40% of children, it has significant and detrimental effects on patients such as&#xD;
      decreased quality of life, psychosocial distress, and recurrent vesicoureteral reflux (VUR)&#xD;
      accompanied by Urinary Tract Infection (UTI). A study has found that a large number of BBD&#xD;
      patients have comorbid neuropsychiatric disorders such as Attention Deficit Hyperactive&#xD;
      Disorders (ADHD) and Obsessive-Compulsive Disorder (OCD). Furthermore, neuropsychiatric&#xD;
      patients with concomitant dysfunctional voiding have significantly less favorable outcomes&#xD;
      both physically and psychologically than those with BBD only.&#xD;
&#xD;
      With a wide range of life-debilitating symptoms and outcomes, a combination of bladder and&#xD;
      bowel dysfunction is often missed or unrecognized by caregivers and clinicians. Some patients&#xD;
      do not outgrow as they age, and symptoms continue into adulthood. Moreover, recurrent VUR and&#xD;
      UTI due to dysfunctional voiding may lead to kidney failure and renal scarring.&#xD;
&#xD;
      In order to assist with diagnosing bladder and bowel dysfunction, valid questionnaires are&#xD;
      needed. However, to this present day, there is no gold standard questionnaire that assesses&#xD;
      concomitant dysfunctions. Some questionnaires ask the guardians to fill out on behalf of the&#xD;
      patients, which can be perplexing in evaluating symptoms as patient- and parents- reported&#xD;
      symptoms are different.&#xD;
&#xD;
      The Children Bladder and Bowel Dysfunction Questionnaire (CBBDQs) for 5-12 years old was&#xD;
      originally developed by van Engeleburg-van Lonkhuyzen M. et al., and is age-specific and&#xD;
      appropriate 18 items that both measures bladder and bowel dysfunction. It adhered COSMIN&#xD;
      (COnsensus- Based Standards for the selection of health Measurement Instruments), and has&#xD;
      been proven to be easy to fill out and suitable to be completed by either patients or&#xD;
      caregivers. Most importantly, it allows professionals to evaluate the symptoms effectively.&#xD;
      To best of our knowledge, it has not been translated into other languages than English (from&#xD;
      the original language, Dutch). As it is only available in English and Dutch, linguistic and&#xD;
      cultural validations are necessary as there is no similar questionnaire in Korean.&#xD;
&#xD;
      This study followed systematic guidelines outlined by COSMIN (COnsensus-based Standards for&#xD;
      the selection of health Measurement Instruments) and similar to the linguistic validation&#xD;
      (development) of the Korean version of the Dysfunctional Voiding Symptoms Score (DVSS) by&#xD;
      Park et al.&#xD;
&#xD;
      The study aims to conduct a linguistic and cultural validation of the Children Bladder and&#xD;
      Bowel Dysfunction (CBBDQs) for 5-12 years old from English to Korean. Once it has been&#xD;
      validated into the Korean language, it will be a valuable source that will better serve&#xD;
      patients with BBD symptoms in an outpatient setting and use in future clinical studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>CBBDQs Score</measure>
    <time_frame>1 day</time_frame>
    <description>Measured score of the Childhood Bladder and Bowel Dysfunction Questionnaire for 5-12 years old.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Dysfunctional Voiding</condition>
  <condition>Bladder Dysfunction</condition>
  <condition>Bowel Dysfunction</condition>
  <condition>Pediatric Urology</condition>
  <arm_group>
    <arm_group_label>Concomitant bladder and bowel Dysfunction</arm_group_label>
    <description>25 patients with concomitant bladder and bowel dysfunction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Those without concomitant bladder and bowel dysfunction</arm_group_label>
    <description>25 patients without concomitant bladder and bowel dysfunction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Final version Childhood Bladder and Bowel Dysfunction for 5-12 years old questionnaire in Korean language to patients who never encountered beforehand in other available languages (Dutch, English).</description>
    <arm_group_label>Concomitant bladder and bowel Dysfunction</arm_group_label>
    <arm_group_label>Those without concomitant bladder and bowel dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 50 subjects (25 subjects with bladder and bowel dysfunction and 25 without) will&#xD;
        be recruited from the outpatient unit of pediatric urology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those with or without bladder and bowel dysfunction.&#xD;
&#xD;
          -  Between the ages of 5 to 12 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Younger than 5 years and older than 12 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kwanjin Park, M.D. Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03258</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04490642
org study id: 2006-203-1137
nct id: NCT04490642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to conduct a linguistic and cultural validation of the Children Bladder and
      Bowel Dysfunction (CBBDQs) for 5-12 years old from English to Korean. Once it has been
      validated into the Korean language, it will be a valuable source that will better serve
      patients with BBD symptoms in an outpatient setting and use in future clinical studies.
BBD, or Bladder and Bowel Dysfunction, is relatively a common disorder affecting
      approximately 40% of children, it has significant and detrimental effects on patients such as
      decreased quality of life, psychosocial distress, and recurrent vesicoureteral reflux (VUR)
      accompanied by Urinary Tract Infection (UTI). A study has found that a large number of BBD
      patients have comorbid neuropsychiatric disorders such as Attention Deficit Hyperactive
      Disorders (ADHD) and Obsessive-Compulsive Disorder (OCD). Furthermore, neuropsychiatric
      patients with concomitant dysfunctional voiding have significantly less favorable outcomes
      both physically and psychologically than those with BBD only.

      With a wide range of life-debilitating symptoms and outcomes, a combination of bladder and
      bowel dysfunction is often missed or unrecognized by caregivers and clinicians. Some patients
      do not outgrow as they age, and symptoms continue into adulthood. Moreover, recurrent VUR and
      UTI due to dysfunctional voiding may lead to kidney failure and renal scarring.

      In order to assist with diagnosing bladder and bowel dysfunction, valid questionnaires are
      needed. However, to this present day, there is no gold standard questionnaire that assesses
      concomitant dysfunctions. Some questionnaires ask the guardians to fill out on behalf of the
      patients, which can be perplexing in evaluating symptoms as patient- and parents- reported
      symptoms are different.

      The Children Bladder and Bowel Dysfunction Questionnaire (CBBDQs) for 5-12 years old was
      originally developed by van Engeleburg-van Lonkhuyzen M. et al., and is age-specific and
      appropriate 18 items that both measures bladder and bowel dysfunction. It adhered COSMIN
      (COnsensus- Based Standards for the selection of health Measurement Instruments), and has
      been proven to be easy to fill out and suitable to be completed by either patients or
      caregivers. Most importantly, it allows professionals to evaluate the symptoms effectively.
      To best of our knowledge, it has not been translated into other languages than English (from
      the original language, Dutch). As it is only available in English and Dutch, linguistic and
      cultural validations are necessary as there is no similar questionnaire in Korean.

      This study followed systematic guidelines outlined by COSMIN (COnsensus-based Standards for
      the selection of health Measurement Instruments) and similar to the linguistic validation
      (development) of the Korean version of the Dysfunctional Voiding Symptoms Score (DVSS) by
      Park et al.

      The study aims to conduct a linguistic and cultural validation of the Children Bladder and
      Bowel Dysfunction (CBBDQs) for 5-12 years old from English to Korean. Once it has been
      validated into the Korean language, it will be a valuable source that will better serve
      patients with BBD symptoms in an outpatient setting and use in future clinical studies.
observational model: Cohort
time perspective: Cross-Sectional
measure: CBBDQs Score
time frame: 1 day
description: Measured score of the Childhood Bladder and Bowel Dysfunction Questionnaire for 5-12 years old.
arm group label: Concomitant bladder and bowel Dysfunction
description: 25 patients with concomitant bladder and bowel dysfunction.
arm group label: Those without concomitant bladder and bowel dysfunction
description: 25 patients without concomitant bladder and bowel dysfunction.
intervention type: Other
intervention name: Questionnaire
description: Final version Childhood Bladder and Bowel Dysfunction for 5-12 years old questionnaire in Korean language to patients who never encountered beforehand in other available languages (Dutch, English).
arm group label: Concomitant bladder and bowel Dysfunction
arm group label: Those without concomitant bladder and bowel dysfunction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
last name: Kwanjin Park, M.D. Ph.D
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kwanjin Park
investigator title: Associate Professor
mesh term: Intestinal Diseases
mesh term: Gastrointestinal Diseases
sharing ipd: No