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

NCT06311110 | Recruiting

• 1 other identifier: #BC-11326 AM04
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Developmental Coordination Disorder; Lower Urinary Tract Symptoms; Bowel Dysfunction

Outcome Measures

Primary Outcomes (4)

• Impaired toilet training

  Prevalence of impaired toilet training in children with DCD compared to TDC

  through study completion, 25 minutes

• Daytime incontinence

  Prevalence of daytime incontinence at 5 years old in children with DCD compared to TDC

  through study completion, 25 minutes

• Enuresis

  Prevalence of enuresis at 5 years old in children with DCD compared to TDC

  through study completion, 25 minutes

• Fecal incontinence

  Prevalence of fecal incontinence at 4 years old in children with DCD compared to TDC

  through study completion, 25 minutes

Secondary Outcomes (2)

• Toilet training difficulties

  through study completion, 25 minutes

• General bladder and bowel dysfunction

  through study completion, 25 minutes

Study Arms (2)

DCD case group

The case group consists of children with developmental coordination disorder.

Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning impaired toilettraining and comorbities

TDC control group

The control group consists of typically developing children, grade and gender matched with the DCD case group.

Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning impaired toilettraining and comorbities

Interventions

Vancouver symptom score for dysfunctional elimination symptoms Questionnaire OTHER

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.

Also known as: VSSDES

DCD case group; TDC control group

Developmental Coordination Disorder Questionnaire OTHER

Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning. The questionnaire is filled in by the parents of the child.

Also known as: DCD-Q, CVO

DCD case group; TDC control group

Questionnaire concerning impaired toilettraining and comorbities OTHER

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.

DCD case group; TDC control group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with developmental coordination disorder and grade- and gender matched typically developing children.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University Hospital/Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

University Hospital Ghent

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders; Lower Urinary Tract Symptoms; Intestinal Diseases

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ellen Vandamme, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Bieke Samijn, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bieke Samijn, PhD

CONTACT

+32 9 332 19 38; bieke.samijn@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 14, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

BE (2)