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

Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05255692

Enrollment

Registered

2022-02-24

Start date

2025-05-01

Completion date

2026-09-30

Last updated

2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fMRI Research

Keywords

Bladder control, functional magnetic resonance imaging

Brief 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.

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_TESTinvasive 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_TESTfunctional 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults

Exclusion criteria

* lower or upper urinary tract dysfunction

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Belgium

Contacts

Primary ContactBieke Samijn, PhD

bieke.samijn@ugent.be+3293321938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026