Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

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.

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> 50gm and < 400gm

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.