Prostate Embolization for Benign Prostatic Hyperplasia

Objectives of the investigation

This study has a primary goal of determining the safety of prostatic artery embolization
(PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse
events, particularly bladder and rectal complications, which may occur as a result of this
procedure. Secondarily, the study will allow us to begin to determine its effectiveness in
diminishing obstructive symptoms associated with BPH.

Duration of investigation

The investigation will enroll 30 patients, with a target enrollment period of less than 12
months. Each patient will be consented for follow-up up to 5 years, but each patient will
reach the first important safety endpoint 1 week after treatment and the first clinical
efficacy assessment 3 months after treatment.

Objectives

To determine the safety and effectiveness of prostate artery embolization for the treatment
of BPH.

Description of study type

This is a prospective observational non-comparative study of an initial cohort of 30
patients.

Study Population

The patients will be recruited from the urology practice at Georgetown University and from
other urologists in the area and by patient self-referral. The study also will be announced
on a study website, the content of which will be approved by the IRB at Georgetown University
Medical Center.

The primary outcome is the absence of complications to the bladder, rectum or other pelvic
structures detected in the first week after therapy. Each patient will be judged free of
these adverse events or not. For those with an adverse event, the complication will be scored
using the Society of Interventional Radiology (SIR) definitions. Descriptive statistics will
be used to summarize these events, along with patient demographics and initial clinical
status.

Appropriate parametric and non-parametric tests will be used to assess change in laboratory
measures, urine flowmetry parameters, and scores from the IPSS and IIEF. Changes in prostate
volumes and the estimated volume of devascularized tissue will be calculated for each patient
and outcomes from the different embolics will be compared. Appropriate paired parametric and
non-parametric tests will be used to determine statistical significance. A p value of 0.05
will be considered statistically significant.

Inclusion Criteria:

1. You must have symptoms from BPH for at least 6 months

2. Your symptoms must meet the entrance criteria, as determined by a short questionnaire
you will be asked to complete.

3. You must have urinary flow rates that meet entrance criteria, as measured by a simple
urination test.

4. Enlargement of the prostate, as measured by the urologist, with a volume of between 50
and 100 cc.

5. You must be at least 50 years of age, but not more than 90.

Exclusion Criteria:

- 1. Prostate Cancer 2. Blockage of major arteries in your pelvis or other arterial
abnormalities that prevent embolization or that might increase risks of injury. You
will be screened for these conditions if you consent to participate.

3. Significantly decreased kidney function 4. Prior prostate surgery, whether it has
been performed via a scope through the penis or with conventional surgery.

5. Bladder or urinary conditions other than BPH requiring therapy. You will be
screened for these conditions if you consent to participate.

6. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled
diabetes, significant respiratory disease, or known immunosuppression.

7. History of clotting disorders. 8. Current medications (use of alpha-blockers within
two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within
two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics
within one week of treatment unless you have been on the same drug with a stable
urination pattern.

9. Active urinary tract infection 10. Allergy to iodinated contrast agents, collagen
or gelatin products 11. Acute urinary retention that has NOT been treated by a urinary
catheter. 12. Significant retained urine after voiding as measured by ultrasound. In
this case, significant means more than 250 ml (about 1 cup).

13. Bladder stones or blood in urine within three months 14. Previous rectal surgery,
excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease 15.
Prior pelvic irradiation or radical pelvic surgery 16. If you are interested in future
fertility 17. Unable to speak and read English.