Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate

Inclusion Criteria:

1. Patient is age 50 or older.

2. Patient has signed informed consent and agrees to attend all follow-up study visits.

3. Patient has had LUTS secondary to BPH or any complications secondary to BPH andqualifying for active intervention.

4. Patient has a baseline IPSS Score > 13 at baseline.

5. Patient has a prostate size of at least 80 grams and not more than 250 grams,measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).

6. Patient has BPH symptoms refractory to medical treatment or for whom medication iscontraindicated, not tolerated, or refused.

7. Patient must be a candidate for HoLEP or PAE.

Exclusion Criteria:

1. Subject has untreated active infection (e.g., active urinary tract infection orprostatitis)

2. Subject has a diagnosis or received treatment for chronic prostatitis or chronicpelvic pain syndrome (e.g., nonbacterial chronic prostatitis).

3. Patients with indwelling urinary catheters or those performing self-catheterization.

4. Biopsy proven prostate or bladder cancer.

• Patient with elevated PSA will be counselled by urologist and a shared decisionwill be made with the patient after discussion about pros and cons of prostatebiopsy.

5. Patients with neurogenic bladder disorder.

6. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinaryobstruction due to causes other than BPH, or other potentially confounding bladderor urethral disease or condition.

7. Patients with prior history transurethral resection of the prostate (TURP), GreenLight laser treatment, or other prostate surgical treatments within past year(12months).

8. Any known condition that limits catheter-based intervention or is a contraindicationto embolization, such as intolerance to a vessel occlusion procedure or severeatherosclerosis.

9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolleddiabetes mellitus, significant respiratory disease or known immunosuppression whichrequired hospitalization within the previous 6 months.

10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 daysprior to the date of informed consent.

11. Patient is interested in future fertility and wish to preserve ejaculation will beexcluded from HoLEP arm

12. History of coagulation cascade disorders (which are not normalized by medicaltreatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperativeor postoperative bleeding.

13. History of major allergic reaction to iodinated contrast agents will be excludedfrom PAE arm.

14. History of hypersensitivity to gelatin products will be excluded from PAE arm.

15. Subject has a life expectancy of less than 2 yrs.

16. Post void residual more than 500 ml at baseline.

17. Participation in any other BPH trials during the time of study.