LC Bead LUMI for Prostatic Artery Embolization

This will be an open label pilot study with a small population undergoing an intervention to
determine initial safety and potential for efficacy as measured by improvement of LUTS and
decrease in prostate size

Inclusion Criteria

1. Male

2. Age > 40

3. Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)

4. Have previously taken BPH medication for 6 months without desired improvement of LUTS
or has started medication and stopped due to unwanted side effects

5. Moderate to severe LUTS as defined by IPSS score >18

6. Peak urine flow rate (Qmax) <12 mL/sec

7. Capable of giving informed consent

8. Life expectancy greater than 1 year

Exclusion Criteria

1. Severe vascular disease

2. Uncontrolled diabetes mellitus

3. Immunosuppression

4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease,
multiple sclerosis, cerebral vascular accident, diabetes, etc.

5. Complete urinary retention

6. Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular
filtration rate < 60 as approximated using serum creatinine levels) unless anuric and
on dialysis.

7. Confirmed or suspected bladder cancer

8. Urethral strictures, bladder neck contracture, or other potentially confounding
bladder pathology

9. Ongoing urogenital infection

10. Previous pelvic radiation or radical pelvic surgery

11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE),
transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (> 10 ng/mL or >
4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy).

12. Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or
platelets < 50,000

13. Contrast hypersensitivity refractory to standard medications (antihistamines,
steroids)