Brain Imaging in Men With Lower Urinary Tract Symptoms

CompletedOBSERVATIONAL
Enrollment

11

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

July 30, 2022

Study Completion Date

July 31, 2022

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

Trial Locations (1)

77030

Houston Methodist Hospital, Houston

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER

NCT03991429 - Brain Imaging in Men With Lower Urinary Tract Symptoms | Biotech Hunter | Biotech Hunter