Brain Imaging in Men With Lower Urinary Tract Symptoms
Condition: Voiding Disorders
MeSH terms: Prostatic Hyperplasia; Lower Urinary Tract Symptoms
Study type: Observational

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.
    

Detailed description: 
      The investigators propose a unique, multimodal prospective study that will allow
      investigators to identify for the first time the structural and functional brain
      contributions to LUTS in men with BPH and BOO at baseline and post procedure. For this, The
      investigators will recruit three different groups of patients:

      Group 1: Patients with BPH and significant improvement in the storage symptoms following BOO
      procedures.

      Group 2: Patients with BPH who have persistent storage symptoms following BOO procedures.

      Group 3 (CONTROL GROUP): Men without LUTS who are planning to undergo radical prostatectomy.

      Each participant will provide a detailed history, undergo a complete physical examination and
      will have the following assessments: IPSS, IPSS Quality of life, Incontinence Severity Index
      (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I)19, 20,
      International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire. A post
      void residual volume will be measured and a urine sample will be obtained for urinalysis
      (patients and controls). A two-day bladder diary will also be obtained from the participants.
      Participants in group 1 and 2 will undergo a clinical urodynamic study within a year prior to
      the neuroimaging scan. All participants will be followed up at one, three and six months
      after the BOO procedures (Transurethral resection/ablation of prostate and simple
      prostatectomy) and radical prostatectomy in the control group. On each visit, the
      investigators will gather the following data: Uroflow and PVR assessment, bladder diary, and
      all questionnaires will be repeated in all patients at one, three, and six months.
      Participants with persistent storage LUTS at six months will have a repeat UDS to ensure BOO
      is resolved. Group 1 and 2 will undergo simultaneous fMRI/UDS scanning twice during this
      study: First before BOO procedures and at the second one at six months. The control group
      will undergo baseline fMRI/UDS.

      Investigators' established platform for simultaneous urodynamic study and functional MRI
      scanning will allow investigators to detect structural changes during the micturition cycle.
      Providing 3D structural images and functional images to have a better understanding of the
      brain effect on LUTS. By correlating the bold signal changes, structural markers and
      participant's clinical data, investigators will provide scientific rationale for subsequent
      studies in the field of neurourology.
    

Intervention name(s): Simultaneous functional MRI and urodynamic studies; Questionnaires; Post Void Residual (PVR), Uroflow and Bladder Diary; Urinalysis
Intervention type(s): Diagnostic Test; Behavioral; Other; Diagnostic Test
Intervention description(s): 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.; 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.; Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.; Urine sample
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Houston Methodist Hospital has four fulltime fellowship-trained Urologists in the field of
        functional Urology and voiding dysfunction who perform over 300 Bladder Outlet Obstruction
        procedures per year. Patients for our study will be recruited from our clinics
      
Keywords: Voiding dysfunction; Benign Prostatic Hyperplasia (BPH); Lower urinary tract symptoms (LUTS); Functional Magnetic Resonance Imaging; Urodynamic studies