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NCT Number: NCT06012903

Lower Urinary Tract Symptoms and School Functioning in Children

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.

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Key information

Conditions

Lower Urinary Tract Symptoms ADHD ASD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Child Development Developmental Coordination Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Urinary Male Urogenital Diseases Mental Disorders Motor Skills Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital/Ghent University

Ghent, East Flanders, 9000, Belgium

Location status: Recruiting

Location contact

Bieke Samijn, Dr.

CONTACT

[email protected]

+32 9 332 19 38

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: VSSDES

Developmental Coordination Disorder Questionnaire

Other

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

Other names: DCD-Q

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Bieke Samijn, PhD

CONTACT

[email protected]

+32 9 332 19 38

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2023
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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