Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A prospective, non-randomized study. The subjects will be enrolled and treated with the
 Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The
 post-treatment follow-up visit can be up to 5 years.

 The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH
 Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.
A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to
 be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to
 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1
 year. The subjects may choose to be followed-up annually for 5 years or until study close,
 whichever comes first.

 Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.

 Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure
 follow-up; 2). Major device or procedure related complications at 3-month post-procedure
 follow-up.
Inclusion Criteria:

 1. Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13)
 and is a candidate for interventional therapy

 2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)

 3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of
 ≥ 125 ml

 4. Post-void residual (PVR) ≤ 250 ml

 5. Prostate volume 20 - 80 gm as determined by TRUS

 6. Prostatic urethra length is 35 - 55 mm as determined by TRUS

 7. Able to complete the study protocol in the opinion of the investigator

 Exclusion Criteria:

 1. Interested in maintaining fertility and unwilling to use protected sex for the first
 30 days post treatment

 2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if
 sexual partner is of child bearing potential

 3. Presence of a penile implant or stent(s) in the urethra or prostate

 4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm,
 UroLift) or surgical intervention of the prostate

 5. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and
 ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator
 via additional tests including digital rectal exam (DRE) and/or biopsy

 6. Confirmed or suspected malignancy of prostate or bladder

 7. Active or history of epididymitis within the past 3 months

 8. Previous pelvic irradiation or radical pelvic surgery

 9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis
 within last year documented by culture (UTI is defined as >100,000 colonies per ml
 urine from midstream clean catch or catheterization specimen)

 10. Visible hematuria with subject urine sample without known contributing factor

 11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might
 affect bladder or sphincter function

 12. Previous or current diagnosis of urethral strictures, bladder neck contracture or
 detrusor muscle spasms

 13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week
 prior to treatment unless there is documented evidence of stable dosing for last 6
 months (no dose changes)

 14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil
 or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior
 to treatment

 15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment

 16. Incidence of spontaneous urinary retention within 6 months prior to baseline
 assessment

 17. Post-void residual volume > 250 ml or catheter dependent bladder drainage

 18. Overactive bladder (OAB) or urge incontinence

 19. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)

 20. Current bladder stones or prostatic calculi

 21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days
 following the procedure

 22. History of cancer in non-genitourinary system which is not considered cured (except
 basal cell or squamous cell carcinoma of the skin). A potential participant is
 considered cured if there has been no evidence of cancer within five years

 23. 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

 24. 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

 25. Expected life expectancy < one year

 26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the
 follow-up requirements

 27. Currently enrolled in or plan to enroll in another investigational clinical trial for
 any disease except for observational only study

 28. In the opinion of the investigator, it is not in the subject's best interest to
 participate in the study

 29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet
 medications other than aspirin (e.g., clopidogrel)

 30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for
 treatment in this study

 31. Device that corresponds with the subject's prostate size per the IFU is not available

 32. Intravesical prostatic protrusion (IPP) > 1 cm

 33. Current uncontrolled diabetes (hemoglobin A1c > 7%)

 34. Unable or unwilling to provide all the protocol-required semen samples

 35. Sensitivity to paclitaxel, on medication that may have negative interaction with
 paclitaxel, or contraindicated for systemic paclitaxel