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NCT03991429 · ClinicalTrials.gov registry record
Brain Imaging in Men With Lower Urinary Tract Symptoms
A clinical trial, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- 11
- Enrollment target
NCT03991429: Completed study, sponsored by The Methodist Hospital Research Institute.
NCT03991429 is a clinical trial that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03991429 has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
Benign Prostatic Hyperplasia (BPH) affects the storage and voiding phases of the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Surgical options for bladder outlet obstruction (BOO), including prostate ablation and transurethral resection, are currently offered for symptomatic improvement. However, 30% of patients report persistent LUTS after BOO procedures. Neuroplasticity induced by BPH and BOO can be contributory of persistent LUTS in these men, having different brain activation patterns during the micturition cycle. The investigators proposed unique multimodal functional Magnetic Resonance Imaging (fMRI) study that will identify for the first time, structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and following BOO procedures. The investigators hypothesize that men with symptomatic BPH who have persistent LUTS following BOO procedures have a distinct brain activation pattern in Regions of Interest (RoI) that regulate the micturition cycle.
Primary Outcome
BOLD signal intensity in the Regions of Interest at the point of "full urge" at baseline and following Bladder Outlet Obstruction (BOO) procedures in groups 1, 2, and controls.
Interventions
- BEHAVIORAL Questionnaires
- DIAGNOSTIC_TEST Urinalysis
- DIAGNOSTIC_TEST Simultaneous functional MRI and urodynamic studies
- OTHER Post Void Residual (PVR), Uroflow and Bladder Diary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2022-07-31 |
What the finished NCT03991429 record still lists
NCT03991429 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Questionnaires is the first listed.
NCT03991429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03991429 about?
NCT03991429 is a clinical study titled "Brain Imaging in Men With Lower Urinary Tract Symptoms". Benign Prostatic Hyperplasia (BPH) affects the storage and voiding phases of the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Surgical options for bladder outlet obstruction (BOO), includ...
What is the current status of trial NCT03991429?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2019-06-04. Estimated completion is 2022-07-31.
What interventions are being tested in trial NCT03991429?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Urinalysis (DIAGNOSTIC_TEST), Simultaneous functional MRI and urodynamic studies (DIAGNOSTIC_TEST), Post Void Residual (PVR), Uroflow and Bladder Diary (OTHER).
Who is sponsoring clinical trial NCT03991429?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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