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NCT Number: NCT05255692

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

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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Key information

Conditions

fMRI Research

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults

Exclusion criteria

  • lower or upper urinary tract dysfunction

Treatment and study plan

invasive urodynamic evaluation

Diagnostic Test

Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.

Other names: UDO

functional magnetic resonance imaging during bladder filling

Diagnostic Test

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)

Other names: fMRI

Primary outcomes

  1. Activated brain regions demonstrating brain activity

    Time frame: through study completion, an average of 6 weeks

    fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).

Study contacts

Contact information is provided by the study sponsor or research team.

Bieke Samijn, PhD

CONTACT

[email protected]

+3293321938

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent
  • University of Zurich

Registry information

Official study title

Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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