Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Inclusion Criteria

• Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
• LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
• Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
• Post-void residual (PVR) ≤ 250 ml
• Prostate volume 20 - 80 gm as determined by TRUS
• Prostatic urethra length is 35 - 55 mm as determined by TRUS
• Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria

• Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
• Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
• Presence of a penile implant or stent(s) in the urethra or prostate
• Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
• 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
• Confirmed or suspected malignancy of prostate or bladder
• Active or history of epididymitis within the past 3 months
• Previous pelvic irradiation or radical pelvic surgery
• 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)
• Visible hematuria with subject urine sample without known contributing factor
• Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
• Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
• 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)
• Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
• Use of 5-alpha reductase inhibitor within 6 months prior to treatment
• Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
• Post-void residual volume > 250 ml or catheter dependent bladder drainage
• Overactive bladder (OAB) or urge incontinence
• Known poor detrusor muscle function (e.g. Qmax 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
• 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
• Expected life expectancy 1 cm
• Current uncontrolled diabetes (hemoglobin A1c > 7%)
• Unable or unwilling to provide all the protocol-required semen samples
• Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel