Benign Prostatic Hyperplasia (BPH), Genital Diseases, Male, Hyperplasia, Lower Urinary Tract Symptoms (LUTS), Male Urogenital Diseases, Prostatic Hyperplasia, Prostatic Hypertrophy, Prostatism
Conditions
Keywords
Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), BPH, PAE, LUTS, Prostatic Artery Embolization
Brief summary
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Detailed description
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.
Interventions
DEVICEEmbozene Microspheres
Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.
Sponsors
Siemens Medical Solutions
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients between ages 45-80 years * Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months * IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of \<12mL/s (milliliters per second) . * All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging
Exclusion criteria
* Patients with urinary tract infections (\> 2/year), prostatitis, or interstitial cystitis * Cases of biopsy proven prostate cancer or urethral cancer. * Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study. * Patients who are classified as New York Heart Association Class III (Moderate), or higher. * Patients with history of prior pelvic irradiation. * Hypersensitivity reactions to contrast material not manageable with prophylaxis. * Patients with serum creatinine values \>1.7mg/dl or glomerular filtration rates less than 50.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | 12 months | QMax (peak urinary flow rate) assessment |
| Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures | 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine flow rate as measured by QMax | 1 month |
| Post-void residual measured in ml/cc | 1 month |
| UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score | 1 month |
| UCLA-PCI-SF score | 24 months |
Countries
United States
Contacts
Primary ContactJoshua Feazell, BS
Backup ContactBrigitte J Kelly, BSN RN CCRC
Outcome results
None listed