Lower Urinary Tract Symptoms and School Functioning in Children

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT06012903
Collaborator
University Ghent (Other)
250
1
19.8
12.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire Welbevinden
  • Other: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome
  • Other: Developmental Coordination Disorder Questionnaire
  • Other: Questionnaire concerning LUTS, NDDs and treatment perceptions
  • Other: Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School
Actual Study Start Date :
Oct 6, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Parents

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.
Other Names:
  • VSSDES
  • Other: Developmental Coordination Disorder Questionnaire
    Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
    Other Names:
  • DCD-Q
  • 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.

    Children

    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.

    Teachers

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Bladder and bowel dysfunction [through study completion from the parent-group, 25 minutes]

      Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome.

    2. School functioning [through study completion from the children-group, 30 minutes]

      Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden.

    Secondary Outcome Measures

    1. Influencing factors on school functioning [through study completion from the parent-, children- and teacher-group, 30 minutes]

      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.

    2. Perception of treatment characteristics [through study completion of the parent-group, 25 minutes]

      Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital/Ghent University Ghent East Flanders Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent
    • University Ghent

    Investigators

    • Principal Investigator: Ellen Vandamme, MD, University Hospital, Ghent
    • Principal Investigator: Bieke Samijn, PhD, University Ghent

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT06012903
    Other Study ID Numbers:
    • BC-11326
    First Posted:
    Aug 28, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Ghent
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2023