Lower Urinary Tract Symptoms and School Functioning in Children

NCT06012903 | Recruiting

• 1 other identifier: BC-11326
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

lower urinary tract symptoms; Quality of life; Pediatrics; neurodevelopmental disorders; VSSDES; DCD-Q

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Influencing factors on school functioning

  through study completion from the parent-, children- and teacher-group, 30 minutes

• Perception of treatment characteristics

  through study completion of the parent-group, 25 minutes

Study Arms (3)

Parents

Other: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning LUTS, NDDs and treatment perceptions

Children

Other: Questionnaire Welbevinden

Teachers

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

Interventions

Questionnaire Welbevinden 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.

Children

Questionnaire Vancouver symptom score for dysfunctional elimination syndrome OTHER

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

Also known as: VSSDES

Parents

Developmental Coordination Disorder Questionnaire OTHER

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

Also known as: DCD-Q

Parents

Questionnaire concerning LUTS, NDDs and treatment perceptions OTHER

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

Parents

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

Teachers

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children following education in recruited primary, regular education schools and their respective parents/guardians and teachers

You may qualify if:

• 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

You may not qualify if:

• High school students
• home-schooled children
• children who attend special needs education
• Language barrier to understanding Dutch

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital/Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Neurodevelopmental Disorders; Urinary Incontinence; Attention Deficit Disorder with Hyperactivity; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Ellen Vandamme, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Bieke Samijn, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bieke Samijn, PhD

CONTACT

+32 9 332 19 38; bieke.samijn@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 28, 2023
• Study Start: October 6, 2022
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)