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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06012903
Other study ID # BC-11326
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 6, 2022
Est. completion date June 2024

Study information

Verified date August 2023
Source University Hospital, Ghent
Contact Bieke Samijn, PhD
Phone +32 9 332 19 38
Email bieke.samijn@ugent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs) can adversely affect children as well and can cause restrictions in their daily life, especially in their school-environment. The goal of this observational study is to identify the prevalence of LUTS in Flemish primary school children.The main questions it aims to answer are: - How prevalent are LUTS in regular primary education? - Is there a relation with well-being in school environment? - Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked to fill in questionnaires related to this research question.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: - Children in 4th-6th grade - Parents whose children are in grades 1-6 - Teachers responsible for teaching children in grades 1-6 - Children who attend regular primary education - Capable of speaking & comprehending Dutch Exclusion Criteria: - High school students - home-schooled children - children who attend special needs education - Language barrier to understanding Dutch

Study Design


Intervention

Other:
Questionnaire Welbevinden
A validated questionnaire recommended by the Flemish inspection of education to measure well-being in primary school children of the 4th, 5th and 6th grade.
Questionnaire Vancouver symptom score for dysfunctional elimination syndrome
Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.
Developmental Coordination Disorder Questionnaire
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
Questionnaire concerning LUTS, NDDs and treatment perceptions
Unvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics.
Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom
These unvalidated questionnaire was based on the questionnaire developed by Ko et al. (2016) about the school's policies and practices regarding children's toilet use and drinking habits in the classroom, covering students in grades one through six. Epidemiological questions related to LUTS were added to complement the questionnaire.

Locations

Country Name City State
Belgium Ghent University Hospital/Ghent University Ghent East Flanders

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bladder and bowel dysfunction Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome. through study completion from the parent-group, 25 minutes
Primary School functioning Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden. through study completion from the children-group, 30 minutes
Secondary Influencing factors on school functioning Prevalence and influence of neurodevelopmental disorders, school-related factors and LUTS. Results from the vancouver symptom score for dysfunctional elimination syndrome, Developmental Coordination Disorder Questionnaire, questions concerning neurodevelopmental disorders and a questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom will be correlated with results from the questionnaire Welbevinden. through study completion from the parent-, children- and teacher-group, 30 minutes
Secondary Perception of treatment characteristics Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions . through study completion of the parent-group, 25 minutes
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