Mapping of the Human Brainstem During Continence and Micturition: Noninvasive 7-T fMRI Study

NCT04846387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-04-10

No results posted yet for this 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) ("L region of the pons) and PAG are expected to be activated during the storage (continence) phase and Pontine Micturition Center (PMC) ("M" region of the pons) are expected to be activated during the voiding (micturition) phase.

Conditions

  • Healthy

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

A T1-weighted Anatomical Image, Diffusion Weighted Image, and functional MRI (fMRI) of "empty bladder" image will be obtained. Additionally, fMRI image during "full bladder" state and voiding/holding tasks will be obtained.

DIAGNOSTIC_TEST

Post-Void Residual

The patient's post-void residual is determined using a portable ultrasound machine after emptying the bladder just prior to entering the MRI scanner and immediately after the MRI scan.

DIAGNOSTIC_TEST

Uroflowmetry

Patients will urinate into a funnel connected to an electric flow meter to record urine flow rates in mililters per second. This is used as part of the screening process.

BEHAVIORAL

Questionaire - AUA Symptom Score

Subjects will fill out questionnaire asking about urinary symptoms. The range is 0-35.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Rose Khavari, MD · The Methodist Hospital Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

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View NCT04846387 on ClinicalTrials.gov