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

NCT05255692 — Not applicable, Unknown, 6 participants, University Hospital, Ghent

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Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

Registry	NCT05255692
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	6 (Estimated)
Sponsor	University Hospital, Ghent (Other); collaborators: University Ghent, University of Zurich
Conditions	fMRI Research
Interventions	invasive urodynamic evaluation, functional magnetic resonance imaging during bladder filling (Diagnostic test)
Dates	start 2025-05-01 (estimated), primary completion 2026-09-30 (estimated), completion 2026-09-30 (estimated), first posted 2022-02-24, last updated 2024-06-05
Locations	1 site in Belgium

-Summary

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.

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+Detailed 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

+Arms and interventions

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

invasive urodynamic evaluation (Diagnostic test), also known as UDO: Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.
functional magnetic resonance imaging during bladder filling (Diagnostic test), also known as fMRI: Functional MRI is used to capture brain activity during tasks. The task in the current study is bladder infusion and withdrawal by means of the INFSYS-2 infusion/withdrawal pump (Leitner et al. 2017)

+Outcome measures

Primary outcomes

Activated brain regions demonstrating brain activity [through study completion, an average of 6 weeks]: fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).

+Eligibility

Sex: All, ages: 20 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* lower or upper urinary tract dysfunction

+Locations (1)

Facility	City	Country	Status
Ghent University Hospital	Ghent, Flanders	Belgium

+Investigators

Bieke Samijn, PhD, Principal investigator, University Hospital, Ghent