Incontinence and MRI Results in Children With Cerebral Palsy

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05060211
Collaborator
University Ghent (Other)
250
1
23.2
10.8

Study Details

Study Description

Brief 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. .

Condition or Disease Intervention/Treatment Phase
  • Other: Vancouver symptom score for dysfunctional elimination syndroms
  • Other: Magnetic resonance imaging

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Correlation Between Brain Lesion and Continence in Children With Cerebral Palsy: an Anatomical MRI Study
Actual Study Start Date :
Oct 25, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Incontinence ratio [During cross-sectional testing]

    Amount of patients with incontinence in the different MRICS-groups (MRI classification system for children with CP).

Secondary Outcome Measures

  1. Amount of Lower urinary tract symptoms in different MRICS-groups [During cross-sectional testing]

    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).

  2. Amount of bladder symptoms in different MRICS-groups [During cross-sectional testing]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghent University Hospital Ghent Flanders Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent
  • University Ghent

Investigators

  • Principal Investigator: Bieke Samijn, dr., Ghent University Hospital/Ghent University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05060211
Other Study ID Numbers:
  • BC-10484
First Posted:
Sep 29, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Ghent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021