Lower Urinary Tract Symptoms and School Functioning in Children (NCT06012903) | Clinical Trial Compass
RecruitingNot Applicable
Lower Urinary Tract Symptoms and School Functioning in Children
Belgium250 participantsStarted 2022-10-06
Plain-language 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.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bladder and bowel dysfunction
Timeframe: through study completion from the parent-group, 25 minutes
2
School functioning
Timeframe: through study completion from the children-group, 30 minutes