Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: invasive urodynamic evaluation, functional magnetic resonance imaging during bladder filling.
- Who it may be relevant to
- Registry conditions: fMRI Research. Basic parameters: 20 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
Overview
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.
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
Interventions
- Diagnostic test invasive urodynamic evaluation
Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured. - Diagnostic test functional magnetic resonance imaging during bladder filling
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)
Primary outcome measures
- Activated brain regions demonstrating brain activity [Time frame: through study completion, an average of 6 weeks]
Eligibility criteria
Inclusion criteria
- Healthy adults
Exclusion criteria
- lower or upper urinary tract dysfunction
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Belgium · 1 center
- Ghent University Hospital — Ghent
Identifiers
NCT: NCT05255692 · BC-10572