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NCT04846387 · ClinicalTrials.gov registry record
Mapping of the Human Brainstem During Continence and Micturition: Noninvasive 7-T fMRI Study
A clinical trial, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- 20
- Enrollment target
NCT04846387: Completed study, sponsored by The Methodist Hospital Research Institute.
NCT04846387 is a clinical trial that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04846387 has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
The lower urinary tract (bladder, bladder neck, urethra and urethral sphincter) has two functions: Storage (Continence) and voiding (micturition). Lower urinary tract dysfunction (LUTD) includes symptoms in the storage phase (such as urinary frequency, urgency, incontinence) or micturition phase (such as voiding dysfunction, hesitancy and urinary retention), or both. Proper urinary tract function is controlled by a complex network of peripheral and central nervous system. A delicate and complex switch exists between storage of urine and elimination of urine and in humans, the control over this switch is located in brain stem. Although significant research efforts have been utilized to understand supraspinal neural control of LUTs in humans, our understanding of the brainstem in humans is very limited, mainly due to the small size of nuclei. The extensive involvement of the brainstem in LUTS control has urged us to look into a better way to investigate and identify the brainstem nuclei involved throughout the entire bladder cycle, especially in neurogenic patients. To our knowledge, there has been no published study using high-resolution MRI (7 Tesla) to study the role of brainstem specifically in LUT. Brainstem evaluation in regards to LUT function in a thorough and accurate manner using high-resolution techniques is of high priority for benign urology and National Institute of Health. The findings from this proposal will lay the foundation to study of brainstem control in the bladder cycle in neurogenic patients with high-resolution neuroimaging, and will be seminal research in the field. The investigators hypothesize that Grey matter (blood-oxygen-level-dependent BOLD) signals and functional connectivity (FC) evaluation of the brainstem regions involved in continence and micturition are superior in 7T when compared to 3T in humans allowing assessment of the variations between men and women. Brainstem Regions of Interest (ROIs) include Pontine Storage Center (PSC
Primary Outcome
BOLD signal intensity in the regions of interest during empty bladder, full bladder, and micturition in healthy males and females
Interventions
- DIAGNOSTIC_TEST Magnetic Resonance Imaging (MRI)
- DIAGNOSTIC_TEST Post-Void Residual
- DIAGNOSTIC_TEST Uroflowmetry
- BEHAVIORAL Questionaire - AUA Symptom Score
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2023-12-31 |
What the finished NCT04846387 record still lists
NCT04846387 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Magnetic Resonance Imaging (MRI) is the first listed.
NCT04846387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04846387 about?
NCT04846387 is a clinical study titled "Mapping of the Human Brainstem During Continence and Micturition: Noninvasive 7-T fMRI Study". The lower urinary tract (bladder, bladder neck, urethra and urethral sphincter) has two functions: Storage (Continence) and voiding (micturition). Lower urinary tract dysfunction (LUTD) includes symptoms in the storage phase (such as urinary frequency, urgency, incontinence) or micturition phase (su...
What is the current status of trial NCT04846387?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2021-01-18. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04846387?
The interventions under investigation include: Magnetic Resonance Imaging (MRI) (DIAGNOSTIC_TEST), Post-Void Residual (DIAGNOSTIC_TEST), Uroflowmetry (DIAGNOSTIC_TEST), Questionaire - AUA Symptom Score (BEHAVIORAL).
Who is sponsoring clinical trial NCT04846387?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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