Lower Urinary Tract Symptoms and School Functioning in Children

Quality of Life Clinical Trial

Official title:

Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012903
• Other study ID #: BC-11326
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• ADHD
• ASD
• Child Development
• Developmental Coordination Disorder
• Enuresis
• Incontinence, Urinary
• Lower Urinary Tract Symptoms
• Motor Skills Disorders
• Neurodevelopmental Disorders
• Quality of Life
• Urinary Incontinence

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