Lower Urinary Tract SymptomsNCT06012903
Lower Urinary Tract Symptoms and School Functioning in Children
An observational study of Lower Urinary Tract Symptoms and Neurodevelopmental Disorders, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Neurodevelopmental Disorders, Incontinence, Urinary
- What is being tested?
- Questionnaire Welbevinden, Questionnaire Vancouver symptom score for dysfunctional elimination syndrome and Developmental Coordination Disorder Questionnaire
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Oct 2022to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children following education in recruited primary, regular education schools and their respective parents/guardians and teachers
Who may be able to join
- 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
Who cannot join
- High school students
- home-schooled children
- children who attend special needs education
- Language barrier to understanding Dutch
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital/Ghent University
Ghent, East Flanders, 9000
Bieke Samijn, Dr., +32 9 332 19 38, Bieke.Samijn@UGent.be
About this study
Official title: 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.
- Conditions
- Lower Urinary Tract Symptoms, Neurodevelopmental Disorders, Incontinence, Urinary, ADHD, ASD, Developmental Coordination Disorder
- Being tested
- Questionnaire Welbevinden, Questionnaire Vancouver symptom score for dysfunctional elimination syndrome, Developmental Coordination Disorder Questionnaire, Questionnaire concerning LUTS, NDDs and treatment perceptions, Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom
- Keywords
- lower urinary tract symptoms, Quality of life, Pediatrics, neurodevelopmental disorders, VSSDES, DCD-Q
- Medical subject headings
- Lower Urinary Tract Symptoms, Neurodevelopmental Disorders, Urinary Incontinence, Attention Deficit Disorder with Hyperactivity, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire WelbevindenOther
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 syndromeOther
Also called VSSDES
Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.
Developmental Coordination Disorder QuestionnaireOther
Also called DCD-Q
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
Questionnaire concerning LUTS, NDDs and treatment perceptionsOther
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 classroomOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Not described Receives: Other: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning LUTS, NDDs and treatment perceptions | |
| Children | Not described Receives: Other: Questionnaire Welbevinden | |
| Teachers | Not described Receives: Other: Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder and bowel dysfunction
Prevalence of lower urinary tract symptoms and/or bowel symptoms measured with the vancouver symptom score for dysfunctional elimination syndrome.
Measured: through study completion from the parent-group, 25 minutes
School functioning
Quality of life in school environment, measured as the child's well-being about school functioning with the questionnaire Welbevinden.
Measured: through study completion from the children-group, 30 minutes
Secondary outcomes (2)
Influencing factors on school functioning
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.
Measured: through study completion from the parent-, children- and teacher-group, 30 minutes
Perception of treatment characteristics
Perception of parents about treatment characteristics for lower urinary tract symptoms are evaluated by means of a questionnaire including questions about treatment perceptions .
Measured: through study completion of the parent-group, 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start6 Oct 2022
- Primary completion6 Jun 2025 (estimated)
- Study completion6 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Ellen Vandamme, MD, Principal investigator, University Hospital, GhentBieke Samijn, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012903
- Sponsor's protocol ID
- BC-11326
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Lower Urinary Tract Symptoms and School Functioning in Children in Regular Elementary School
- ClinicalTrials.gov ID
- NCT06012903
- Acronym / sponsor ID
- BC-11326
- Conditions
- Lower Urinary Tract Symptoms, Neurodevelopmental Disorders, Incontinence, Urinary, ADHD, ASD, Developmental Coordination Disorder
- Keywords
- lower urinary tract symptoms, Quality of life, Pediatrics, neurodevelopmental disorders, VSSDES, DCD-Q
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 6 Jun 2025 (estimated)
- Study completion
- 6 Jun 2025 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Questionnaire Vancouver symptom score for dysfunctional elimination syndrome, Other: Developmental Coordination Disorder Questionnaire, Other: Questionnaire concerning LUTS, NDDs and treatment perceptions |
| Children | – | Other: Questionnaire Welbevinden |
| Teachers | – | Other: Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroom |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children following education in recruited primary, regular education schools and their respective parents/guardians and teachers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- High school students
- home-schooled children
- children who attend special needs education
- Language barrier to understanding Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire WelbevindenA validated questionnaire recommended by the Flemish inspection of education to measure well-being in primary school children of the 4th, 5th and 6th grade. | Other | Children |
| Questionnaire Vancouver symptom score for dysfunctional elimination syndromeAlso: VSSDESVancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016. | Other | Parents |
| Developmental Coordination Disorder QuestionnaireAlso: DCD-QValidated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning. | Other | Parents |
| Questionnaire concerning LUTS, NDDs and treatment perceptionsUnvalidated, complementary questions including the presence of LUTS, earlier diagnosis of bladder and/or boweldysfunction and neurodevelopmental disorders and perception concerning treatment characteristics. | Other | Parents |
| Questionnaire about policies and practices regarding children's toilet use and drinking habits in the classroomThese 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. | Other | Teachers |
Primary outcome
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.
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.
2 secondary outcomes
Influencing factors on school functioning
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Vandamme, MD principal investigator
University Hospital, Ghent
Bieke Samijn, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Neurodevelopmental Disorders, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bieke Samijn, PhD (+32 9 332 19 38, bieke.samijn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder and bowel dysfunction (time frame: through study completion from the parent-group, 25 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.