Brain Imaging in Men With Lower Urinary Tract Symptoms

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.

Conditions

• Voiding Disorders

Interventions

DIAGNOSTIC_TEST

Simultaneous functional MRI and urodynamic studies

Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.

BEHAVIORAL

Questionnaires

Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.

OTHER

Post Void Residual (PVR), Uroflow and Bladder Diary

Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.

DIAGNOSTIC_TEST

Urinalysis

Urine sample

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  lead OTHER

Principal Investigators

• Rose Khavari, MD · The Methodist Hospital Research Institute

Eligibility

Min Age

45 Years

Max Age

90 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-04

Primary Completion

2022-07-30

Completion

2022-07-31

Countries

• United States

Study Locations