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 Optilumeâ„¢ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.
Who can participate
Age range50 Years
SexMALE
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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