Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Impaired Toilet Training, Lower Urinary Tract Symptoms and Bowel Dysfunction in Children With Developmental Coordination Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06311110
• Other study ID #: #BC-11326 AM04
• Status: Active, not recruiting
• Start date: October 30, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: June 30, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bowel Dysfunction
• Developmental Coordination Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Lower Urinary Tract Symptoms
• Motor Skills Disorders

Intervention

Other:
• Vancouver symptom score for dysfunctional elimination symptoms Questionnaire
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.
• Developmental Coordination Disorder Questionnaire
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning. The questionnaire is filled in by the parents of the child.
• Questionnaire concerning impaired toilettraining and comorbities
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital/Ghent University	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impaired toilet training	Prevalence of impaired toilet training in children with DCD compared to TDC	through study completion, 25 minutes
Primary	Daytime incontinence	Prevalence of daytime incontinence at 5 years old in children with DCD compared to TDC	through study completion, 25 minutes
Primary	Enuresis	Prevalence of enuresis at 5 years old in children with DCD compared to TDC	through study completion, 25 minutes
Primary	Fecal incontinence	Prevalence of fecal incontinence at 4 years old in children with DCD compared to TDC	through study completion, 25 minutes
Secondary	Toilet training difficulties	Prevalence and amount of toilet training difficulties in children with DCD compared to TDC	through study completion, 25 minutes
Secondary	General bladder and bowel dysfunction	Prevalence of LUTS, bowel problems or combined bladder and bowel dysfunction in children with DCD compared to TDC	through study completion, 25 minutes