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

May 3, 2023 updated by: Kwanjin Park, Seoul National University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CBBDQs Score
Time Frame: 1 day
Measured score of the Childhood Bladder and Bowel Dysfunction Questionnaire for 5-12 years old.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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