Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
June 5, 2024
June 1, 2024
1.4 years
January 24, 2022
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Activated brain regions demonstrating brain activity
fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).
through study completion, an average of 6 weeks
Study Arms (1)
Complete evaluation UDO and fMRI
EXPERIMENTALEvaluation including both urodynamic evaluation and functional MRI testing
Interventions
Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.
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)
Eligibility Criteria
You may qualify if:
- Healthy adults
You may not qualify if:
- lower or upper urinary tract dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
- University of Zurichcollaborator
Study Sites (1)
Ghent University Hospital
Ghent, Flanders, 9000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bieke Samijn, PhD
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2022
First Posted
February 24, 2022
Study Start
May 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
June 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share