Incontinence and MRI Results in Children With Cerebral Palsy

July 28, 2023 updated by: University Hospital, Ghent

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

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Flanders
      • Ghent, Flanders, Belgium, 9000
        • Ghent University Hospital

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

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with cerebral palsy attending yearly or half yearly follow-up consultation

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence ratio
Time Frame: During cross-sectional testing
Amount of patients with incontinence in the different MRICS-groups (MRI classification system for children with CP).
During cross-sectional testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Lower urinary tract symptoms in different MRICS-groups
Time Frame: 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).
During cross-sectional testing
Amount of bladder symptoms in different MRICS-groups
Time Frame: 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).
During cross-sectional testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

University Ghent

Investigators

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

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)

October 25, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-10484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Lower Urinary Tract Symptoms

Clinical Trials on Vancouver symptom score for dysfunctional elimination syndroms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe