Prospective Analysis of Prostatic Arterial Embolization

The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Patients with moderate to severe lower urinary tract symptoms resulting from BPH are eligible for this study. Specifically, patients that have been on conservative medical therapy for at least 6 months with no relief of symptoms are being asked to participate in this trial. Patients meeting this criterion would traditionally be considered for more invasive treatment options such as surgery. We believe that PAE is an acceptable alternative to the more invasive treatment options currently the standard of care (available) and therefore we are asking you to participate in this study. We would like to demonstrate that PAE utilizing Embosphere Microsphere will improve their symptoms.

The gold standard of treatment for BPH is transurethral resection of the prostate (TURP). It is very effective but is also an invasive open surgical procedure that carries a high risk of sexual dysfunction and incontinence as side effects of the procedure. It is the goal of this study to demonstrate that these complications are not associated with PAE and that PAE will improve symptoms associated with BPH.

Embosphere Microspheres are small biocompatible plastic spheres that are released inside a vessel under x-ray control. Once inside the vessel, the spheres will block the vessel and decrease blood flow to the tissue supplied by that vessel. Embosphere Microspheres have been cleared by the Food and Drug Administration (FDA) for use in the embolization of blood vessels supplying uterine fibroids and vascular tumors. Additionally, they are approved in the European Union for treatment of BPH. This study has been approved by the FDA to use Embosphere Microspheres for research purposes in the treatment of BPH.