| Eligibility |
Inclusion Criteria:
1. Male subject 50-80 years of age who has symptomatic BPH
2. International Prostate Symptom Score (IPSS) = 13
3. Peak urinary flow rate (Qmax) = 5 ml/sec and = 12 ml/sec (with minimum voided volume
of = 150 ml)
4. Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
5. Prostatic urethral length = 32 mm and = 55 mm as determined by TRUS
6. History of inadequate response, contraindication, or refusal of BPH medical therapy
7. Able to complete the study protocol in the opinion of the investigator
Exclusion Criteria:
1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the
follow-up requirements
2. Unwilling to abstain or use protected sex for the first 30 days post treatment
3. Unwilling to abstain from sexual intercourse or use a highly effective contraceptive
for at least 6 months post-procedure
4. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
5. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezum,
UroLift) or surgical intervention of the prostate
6. Prostate specific antigen (PSA) = 10 ng/ml unless prostate cancer is ruled out by
biopsy
7. Confirmed or suspected malignancy of prostate or bladder
8. Active or history of epididymitis within the past 3 months
9. Previous pelvic irradiation or pelvic trauma surgery
10. Active urinary tract infection (UTI) confirmed by culture
11. Bacterial prostatitis within the last 12 months
12. Non-bacterial prostatitis within the last 5 years
13. Visible or invisible hematuria (> 4 Red Blood Cells (RBCs) per high power field) on 2
separate urine specimens within the last 3 months without a know contributing factor
14. Neurogenic bladder or sphincter abnormalities or neurological disorders that might
affect bladder or sphincter function
15. History of urinary incontinence
16. Previous or current diagnosis of urethral strictures, bladder neck contracture or
detrusor muscle spasms
17. Previous rectal surgery, other than hemorrhoidectomy
18. Use of antihistamines, anticonvulsants or antispasmodics within 1 week prior to
baseline assessment unless there is documented evidence of stable dosing for at least
6 months
19. Use of antidepressants with adrenergic effects (i.e. duloxetine, imipramine and
amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary
disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there
is documented evidence of stable dosing for at least 3 months prior to baseline
assessment
20. Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to
baseline assessment
21. Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)]
within 3 months of baseline assessment
22. Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of
baseline assessment
23. Use of estrogen or drugs producing androgen suppression unless there is documented
evidence of stable dosing for at least 3 months prior to baseline assessment
24. Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of
baseline assessment
25. Use of warfarin or novel oral anti-coagulants [e.g., apixaban (Eliquis), fondaparinux
(Arixtra), rivaroxaban (Xarelto) or edoxaban (Savaysa)], unless the medication is
safely discontinued prior to the procedure and is not planned to be restarted for at
least 5 days post-procedure
26. Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to
the procedure or planned use within 5 days post-procedure
27. History of hypersensitivity reactions to paclitaxel, on medication that may have
negative interaction with paclitaxel, presence of solid tumor with a baseline
neutrophil count of <1500 cells/mm3 or AIDS-related Kaposi's sarcoma with baseline
neutrophil count of <1000 cells/mm3
28. Incidence of spontaneous urinary retention within 6 months prior to baseline
assessment
29. Current post-void residual volume > 300 ml or catheter dependent bladder drainage
30. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
31. Current bladder or prostatic urethral stones
32. Biopsy of prostate within 40 days prior to procedure
33. History of cancer in non-genitourinary system which is not considered in complete
remission (except basal cell or squamous cell carcinoma of the skin). A potential
participant is considered in complete remission if there has been no evidence of
cancer within five years
34. Current uncontrolled diabetes (i.e. hemoglobin A1c = 8%)
35. History of clinically significant comorbidities or presence of unstable conditions
[e.g. cardiovascular, lung, renal (serum creatinine > 2.0 mg/dl), hepatic, bleeding
disorders or metabolic impairment] that may confound the results of the study or have
a risk to subject per investigator's opinion
36. Any cognitive disorder that interferes with or precludes direct and accurate
communication with the study investigator regarding the study or affects the ability
to complete the study quality of life questionnaires
37. Life expectancy < 10 years
38. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for
treatment in this study
39. Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1
cm]
40. Device that corresponds with the subject's prostate size is not available
41. Currently enrolled in or plan to enroll in another investigational clinical study for
any disease except for observational only study
42. In the opinion of the investigator, it is not in the subject's best interest to
participate in the study
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