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Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol

G

Ghent University Hospital (UZ)

Status

Not yet enrolling

Conditions

fMRI Research

Treatments

Diagnostic Test: invasive urodynamic evaluation
Diagnostic Test: functional magnetic resonance imaging during bladder filling

Study type

Interventional

Funder types

Other

Identifiers

NCT05255692
BC-10572

Details and patient eligibility

About

Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).

Higher brain centers responsible for bladder function may be related to the presence of incontinence.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.

Full description

Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.

Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes

Enrollment

6 estimated patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adults

Exclusion criteria

  • lower or upper urinary tract dysfunction

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Complete evaluation UDO and fMRI
Experimental group
Description:
Evaluation including both urodynamic evaluation and functional MRI testing
Treatment:
Diagnostic Test: functional magnetic resonance imaging during bladder filling
Diagnostic Test: invasive urodynamic evaluation

Trial contacts and locations

1

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Central trial contact

Bieke Samijn, PhD

Data sourced from clinicaltrials.gov

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