NCT04490642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

July 26, 2020

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CBBDQs Score

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

    1 day

Study Arms (2)

Concomitant bladder and bowel Dysfunction

25 patients with concomitant bladder and bowel dysfunction.

Other: Questionnaire

Those without concomitant bladder and bowel dysfunction

25 patients without concomitant bladder and bowel dysfunction.

Other: Questionnaire

Interventions

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).

Concomitant bladder and bowel DysfunctionThose without concomitant bladder and bowel dysfunction

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Those with or without bladder and bowel dysfunction.
  • Between the ages of 5 to 12 years old.

You may not qualify if:

  • \- Younger than 5 years and older than 12 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Seoul National University Children's Hospital

Seoul, 03258, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kwanjin Park, M.D. Ph.D

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 26, 2020

First Posted

July 29, 2020

Study Start

July 27, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations