Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

Inclusion criteria

• Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec
• Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS
• Able to complete the study protocol in the opinion of the investigator

Exclusion criteria

• Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
• Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure
• Presence of an artificial urinary sphincter 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
• Active urinary tract infection (UTI) confirmed by culture
• History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
• Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
• History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
• Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
• Significant obstruction from median lobe in the opinion of the investigator
• Disease or other health condition that is not suitable for this study