This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

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 non-comparative treatment 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.

1 year

Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death

There as poor compliance by patients to the follow-up protocol beyond 1 week post procedure. Only 10 of 15 patients participated in follow-up at three months. By 12 months, only 3 patients provided some elements of follow-up.