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OpenTrials
Completed

NCT Number: NCT05060211

Incontinence and MRI Results in Children with Cerebral Palsy

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. .

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancouver symptom score for dysfunctional elimination syndroms

Other

Validated questionnaire concerning bladder and bowel symptoms

Other names: VSSDES

Magnetic Resonance Imaging

Other

Known MRI results of the patient file

Other names: MRI

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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