NCT05060211

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

August 16, 2021

Last Update Submit

September 5, 2024

Conditions

Keywords

cerebral palsylower urinary tract symptomsMagnetic resonance imagingbrain lesionincontinence

Outcome Measures

Primary Outcomes (1)

  • Incontinence ratio

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

    During cross-sectional testing

Secondary Outcomes (2)

  • Amount of Lower urinary tract symptoms in different MRICS-groups

    During cross-sectional testing

  • Amount of bladder symptoms in different MRICS-groups

    During cross-sectional testing

Interventions

Validated questionnaire concerning bladder and bowel symptoms

Also known as: VSSDES

Known MRI results of the patient file

Also known as: MRI

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Cerebral PalsyLower Urinary Tract Symptoms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Bieke Samijn, dr.

    Ghent University Hospital/Ghent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

September 29, 2021

Study Start

October 25, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations