- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06311110
Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD
August 1, 2024 updated by: University Hospital, Ghent
Impaired Toilet Training, Lower Urinary Tract Symptoms and Bowel Dysfunction in Children With Developmental Coordination Disorder
This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC).
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
84
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
- Name: Bieke Samijn, PhD
- Phone Number: +32 9 332 19 38
- Email: bieke.samijn@ugent.be
Study Locations
-
-
-
Ghent, Belgium
- Recruiting
- University Hospital Ghent
-
Contact:
- Bieke Samijn
- Phone Number: +32 9 332 19 38
- Email: bieke.samijn@uzgent.be
-
-
East Flanders
-
Ghent, East Flanders, Belgium, 9000
- Recruiting
- Ghent University Hospital/Ghent University
-
Contact:
- Bieke Samijn, Dr.
- Phone Number: +32 9 332 19 38
- Email: Bieke.Samijn@UGent.be
-
-
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 with developmental coordination disorder and grade- and gender matched typically developing children.
Description
Inclusion Criteria:
- Diagnosed with DCD by a multidisciplinary team (DCD case group)
- Children with a typical development, grade and gender matched with the DCD case group (TDC control group).
Exclusion Criteria:
- A DCD-Q score indicative for DCD (TDC control group)
- Presence of other developmental disorders, such as ASS, ADHD or intellectual disability (TDC control group)
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 |
|---|---|
|
DCD case group
The case group consists of children with developmental coordination disorder.
|
Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.
The questionnaire is filled in by the parents of the child.
Other Names:
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
The questionnaire is filled in by the parents of the child.
Other Names:
Unvalidated, complementary questions concerning impaired toilettraining and comorbidities.
Questions were based on ICCS standardisation guidelines (Austin et al., 2015).
The questionnaire is filled in by the parents of the child.
|
|
TDC control group
The control group consists of typically developing children, grade and gender matched with the DCD case group.
|
Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016.
The questionnaire is filled in by the parents of the child.
Other Names:
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning.
The questionnaire is filled in by the parents of the child.
Other Names:
Unvalidated, complementary questions concerning impaired toilettraining and comorbidities.
Questions were based on ICCS standardisation guidelines (Austin et al., 2015).
The questionnaire is filled in by the parents of the child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impaired toilet training
Time Frame: through study completion, 25 minutes
|
Prevalence of impaired toilet training in children with DCD compared to TDC
|
through study completion, 25 minutes
|
|
Daytime incontinence
Time Frame: through study completion, 25 minutes
|
Prevalence of daytime incontinence at 5 years old in children with DCD compared to TDC
|
through study completion, 25 minutes
|
|
Enuresis
Time Frame: through study completion, 25 minutes
|
Prevalence of enuresis at 5 years old in children with DCD compared to TDC
|
through study completion, 25 minutes
|
|
Fecal incontinence
Time Frame: through study completion, 25 minutes
|
Prevalence of fecal incontinence at 4 years old in children with DCD compared to TDC
|
through study completion, 25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toilet training difficulties
Time Frame: through study completion, 25 minutes
|
Prevalence and amount of toilet training difficulties in children with DCD compared to TDC
|
through study completion, 25 minutes
|
|
General bladder and bowel dysfunction
Time Frame: through study completion, 25 minutes
|
Prevalence of LUTS, bowel problems or combined bladder and bowel dysfunction in children with DCD compared to TDC
|
through study completion, 25 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 14, 2023
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
March 7, 2024
First Submitted That Met QC Criteria
March 7, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
August 2, 2024
Last Update Submitted That Met QC Criteria
August 1, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #BC-11326 AM04
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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