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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bowel Dysfunction; Bladder Dysfunction; Pediatric Urology; Dysfunctional Voiding
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03258
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

A total of 50 subjects (25 subjects with bladder and bowel dysfunction and 25 without) will be recruited from the outpatient unit of pediatric urology.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBBDQs Score	Measured score of the Childhood Bladder and Bowel Dysfunction Questionnaire for 5-12 years old.	1 day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 2006-203-1137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No