Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

Inclusion Criteria

• Male subject ≥ 50 years old
• Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
• Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
• Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
• International Prostate Symptom Score (IPSS) ≥ 13
• Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
• Willing to provide informed consent and comply with protocol required follow-up

Exclusion Criteria

• Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
• Presence of an artificial urinary sphincter, penile prosthesis, 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
• Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA \< 25%.
• Active urinary tract infection (UTI) confirmed by culture
• Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
• History of overt urinary incontinence requiring the use of pads
• Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
• Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage
• Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec)
• Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
• Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
• Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
• Obstructive median lobe in the opinion of the investigator