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Clinical Trials/NCT06012903
NCT06012903
Recruiting
Not Applicable

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

University Hospital, Ghent1 site in 1 country250 target enrollmentOctober 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
University Hospital, Ghent
Enrollment
250
Locations
1
Primary Endpoint
School functioning
Status
Recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
October 6, 2022
End Date
June 6, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Perception of treatment characteristics(through study completion of the parent-group, 25 minutes)
  • Influencing factors on school functioning(through study completion from the parent-, children- and teacher-group, 30 minutes)

Study Sites (1)

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