Clinical trial NCT03991429: Brain Imaging in Men With Lower Urinary Tract Symptoms
Official title: Higher Neural Contribution Underlying Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia Undergoing Bladder Outlet Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voiding Disorders
Keywords: Voiding dysfunction
Benign Prostatic Hyperplasia (BPH)
Lower urinary tract symptoms (LUTS)
Functional Magnetic Resonance Imaging
Urodynamic studies
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 11
Sex: MALE
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) signals
timeFrame: 1 year
Secondary outcomes:
measure: Fractional Anisotropy (FA)
timeFrame: 1 year
measure: Mean Diffusivity (MD)
timeFrame: 1 year
measure: Uroflow measure
timeFrame: 1 year
measure: Postvoid Residual
timeFrame: 1 year
measure: Urinary symptoms scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Rose Khavari, MD
role: PRINCIPAL_INVESTIGATOR
References: