NCT05255692

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• fMRI Research

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2022-02-24
• Last updated: 2024-06-05

Locations

1 site across 1 country: Belgium