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