LC Bead LUMI for Prostatic Artery Embolization
LC Bead LUMI for Prostatic Artery Embolization
Purpose: The purpose of this pilot study is to determine preliminary estimates of the
 parameters related to the distribution of the study endpoints including: International
 Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine
 flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and
 presence of non-target embolization.

 Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.

 Procedures (methods): This will be a multisite, open label pilot study with a small
 population undergoing an investigational intervention (prostatic artery embolization) to
 determine initial safety and potential for efficacy as measured by improvement of lower
 urinary tract symptoms (LUTS) and decrease in prostate size.
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)