Brain Imaging in Men With Lower Urinary Tract Symptoms (NCT03991429) | Clinical Trial Compass
CompletedNot Applicable
Brain Imaging in Men With Lower Urinary Tract Symptoms
United States11 participantsStarted 2019-06-04
Plain-language 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.
Who can participate
Age range
45 Years – 90 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS
* IPSS (International prostate symptom score lower than 12)
* Nocturia equal or less than 2 on a two day bladder diary
* Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12
* Improvement in IPSS in at least 3 points for storage symptoms
* Nocturia equal or less than 2 on a two day bladder diary
* Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure
* IPSS higher than 8
* Nocturia more than 2
* Delta change in IPSS score less than negative 3 points
Exclusion Criteria:
* Men with
* Neurogenic bladder
* Urethral stricture
* Prior BOO procedures
* History of urinary retention with indwelling foley catheter or intermittent catheterization Additional exclusion criteria for Group 1 and 2 (Subjects with BPH and LUTS)
* History of bladder cancer within 5 years
* History of treatment for prostate cancer other than active surveillance
* Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.