Lower Urinary Tract Symptoms and School Functioning in Children

July 12, 2024 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • Recruiting
        • Ghent University Hospital/Ghent University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder and bowel dysfunction
Time Frame: 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.
through study completion from the parent-group, 25 minutes
School functioning
Time Frame: 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.
through study completion from the children-group, 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influencing factors on school functioning
Time Frame: 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.
through study completion from the parent-, children- and teacher-group, 30 minutes
Perception of treatment characteristics
Time Frame: 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 .
through study completion of the parent-group, 25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

University Ghent

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Estimated)

June 6, 2025

Study Completion (Estimated)

June 6, 2025

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-11326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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