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CompletedNCT05060211Updated Sep 19, 2024

Incontinence and MRI Results in Children with Cerebral Palsy

An observational study in Cerebral Palsy and Lower Urinary Tract Symptoms, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
125
Ages
5 Years to 12 Years
Sex
All
01

Study 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. .

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Lower Urinary Tract Symptoms

Keywords

  • cerebral palsy
  • lower urinary tract symptoms
  • Magnetic resonance imaging
  • brain lesion
  • incontinence
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's enrollment of 125 is above the median of 63 across 465 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of cerebral palsy
  • MRI investigation in history
  • Dutch or French speaking child and parent

Exclusion criteria

Exclusion Criteria:

  • No MRI investigation in history
  • Child or parent not speaking Dutch or French
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
125 participants (actual)
Patient registry
No

Interventions

  • OtherVancouver symptom score for dysfunctional elimination syndroms

    Validated questionnaire concerning bladder and bowel symptoms

    Also known as: VSSDES

  • OtherMagnetic resonance imaging

    Known MRI results of the patient file

    Also known as: MRI

06

What researchers measure

Primary outcomes

  1. Incontinence ratio

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

    Time frame: During cross-sectional testing

Secondary outcomes

  1. 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).

    Time frame: During cross-sectional testing

  2. 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).

    Time frame: During cross-sectional testing

07

Study locations

1 site
  • Ghent University Hospital
    Ghent, Flanders 9000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05060211
Collaborators
University Ghent
Responsible party
Sponsor
First posted
Sep 29, 2021
Start date
Oct 25, 2021
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Sep 19, 2024

Study contacts

Bieke Samijn, dr.
principal investigator · Ghent University Hospital/Ghent University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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