Lower Urinary Tract Symptoms and School Functioning in Children

NCT ID: NCT06012903

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-06

Study Completion Date

2025-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parents

Questionnaire Vancouver symptom score for dysfunctional elimination syndrome

Intervention Type OTHER

Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.

Developmental Coordination Disorder Questionnaire

Intervention Type OTHER

Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.

Questionnaire concerning LUTS, NDDs and treatment perceptions

Intervention Type OTHER

Unvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics.

Children

Questionnaire Welbevinden

Intervention Type OTHER

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.

Teachers

Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Questionnaire Vancouver symptom score for dysfunctional elimination syndrome

Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.

Intervention Type OTHER

Developmental Coordination Disorder Questionnaire

Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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VSSDES DCD-Q

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen Vandamme, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Bieke Samijn, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University Hospital/Ghent University

Ghent, East Flanders, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Bieke Samijn, PhD

Role: CONTACT

+32 9 332 19 38

Facility Contacts

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Bieke Samijn, Dr.

Role: primary

+32 9 332 19 38

Other Identifiers

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BC-11326

Identifier Type: -

Identifier Source: org_study_id

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