Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean

Sponsor
Seoul National University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04490642
Collaborator
(none)
50
3
29.1
16.7
0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean
Actual Study Start Date :
Jul 27, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Concomitant bladder and bowel Dysfunction

25 patients with concomitant bladder and bowel dysfunction.

Other: Questionnaire
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).

Those without concomitant bladder and bowel dysfunction

25 patients without concomitant bladder and bowel dysfunction.

Other: Questionnaire
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).

Outcome Measures

Primary Outcome Measures

  1. CBBDQs Score [1 day]

    Measured score of the Childhood Bladder and Bowel Dysfunction Questionnaire for 5-12 years old.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Those with or without bladder and bowel dysfunction.

  • Between the ages of 5 to 12 years old.

Exclusion Criteria:
  • Younger than 5 years and older than 12 years of age.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080
2 Seoul National University Children's Hospital Seoul Korea, Republic of 03258
3 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Study Chair: Kwanjin Park, M.D. Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kwanjin Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04490642
Other Study ID Numbers:
  • 2006-203-1137
First Posted:
Jul 29, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022