Brain Imaging in Men With Lower Urinary Tract Symptoms

NCT03991429 | Completed

• 1 other identifier: Pro00020695
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Voiding Disorders

Keywords

Voiding dysfunction; Benign Prostatic Hyperplasia (BPH); Lower urinary tract symptoms (LUTS); Functional Magnetic Resonance Imaging; Urodynamic studies

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Level Dependent (BOLD) signals

  BOLD signal intensity in the Regions of Interest at the point of "full urge" at baseline and following Bladder Outlet Obstruction (BOO) procedures in groups 1, 2, and controls.

  1 year

Secondary Outcomes (5)

• Fractional Anisotropy (FA)

  1 year

• Mean Diffusivity (MD)

  1 year

• Uroflow measure

  1 year

• Postvoid Residual

  1 year

• Urinary symptoms scores

  1 year

Study Arms (3)

Group 1

Patients with BPH and significant improvement in storage symptoms after BOO procedures

Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis

Group 2

Patients with BPH who have persistent storage symptoms after BOO procedures

Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis

Group 3 (Control group)

Men without LUTS who are planning to undergo radical prostatectomy

Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis

Interventions

Simultaneous functional MRI and urodynamic studies DIAGNOSTIC_TEST

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.

Group 1; Group 2; Group 3 (Control group)

Questionnaires BEHAVIORAL

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.

Group 1; Group 2; Group 3 (Control group)

Post Void Residual (PVR), Uroflow and Bladder Diary OTHER

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

Group 1; Group 2; Group 3 (Control group)

Urinalysis DIAGNOSTIC_TEST

Urine sample

Group 1; Group 2; Group 3 (Control group)

Eligibility Criteria

• Age: 45 Years - 90 Years
• Gender Eligibility Details: Male patients with benign prostatic hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Men with
• Neurogenic bladder
• Urethral stricture
• Prior BOO procedures
• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Urodynamics; Surveys and Questionnaires; Urinalysis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological

Study Officials

• Rose Khavari, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Houston Methodist Hospital Urologist & Research Director

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: June 19, 2019
• Study Start: June 4, 2019
• Primary Completion: July 30, 2022
• Study Completion: July 31, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

US (1)