Incontinence and MRI Results in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Correlation Between Brain Lesion and Continence in Children With Cerebral Palsy: an Anatomical MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060211
• Other study ID #: BC-10484
• Status: Completed
• Start date: October 25, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

More than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (LUTS). This can negatively influence quality of life of the child and the total social environment.

Previous research demonstrated that the brain lesion, characteristic for cerebral palsy (CP), is a prognostic factor for the functional abilities of a child with CP. Previous research within our department demonstrated functional impairment as a risk factor for incontinence. This demonstrates an indirect connection between the brain lesion and incontinence of a child with CP. However, this connection isn't alway correct as some children with high functionality also demonstrate incontinence.

As bladder control is also regulated by higher brain centers, the present study wants to investigate a direct connection between the brain lesion of the child, visible by means of MRI, and the incontinence status of the child. .

Description:

The current study is a cross-sectional observational study in which a correlation is investigated between known anatomical MRI results and the continence status of a child with CP.

Although neuroimaging isn't seen as a requirement for the definition and diagnosis of CP2, MRI imaging is often part of diagnostic evaluation. The Surveillance of Cerebral Palsy in Europe (SCPE) working group composed the MRI classification system or MRICS classifying neuroimaging results in maldevelopments, predominant white matter injury, predominant grey matter injury, miscellaneous and normal. These results will be correlated with results of the validated Vancouver symptoms score for dysfunctional elimination syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cerebral palsy

• MRI investigation in history

• Dutch or French speaking child and parent

Exclusion Criteria:

• No MRI investigation in history

• Child or parent not speaking Dutch or French

Related Conditions & MeSH terms

• Cerebral Palsy
• Lower Urinary Tract Symptoms
• Paralysis

Intervention

Other:
• Vancouver symptom score for dysfunctional elimination syndroms
Validated questionnaire concerning bladder and bowel symptoms
• Magnetic resonance imaging
Known MRI results of the patient file

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence ratio	Amount of patients with incontinence in the different MRICS-groups (MRI classification system for children with CP).	During cross-sectional testing
Secondary	Amount of Lower urinary tract symptoms in different MRICS-groups	Score of 'Vancouver symptom score for dysfunctional elimination syndrome'-questionnaire and individual questions in the different MRICS- groups (MRI classification system for children with CP).	During cross-sectional testing
Secondary	Amount of bladder symptoms in different MRICS-groups	Score of individual questions from the 'Vancouver symptom score for dysfunctional elimination syndrome' questionnaire in the different MRICS- groups (MRI classification system for children with CP).	During cross-sectional testing