The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Male subjects > 45 years of age who have symptomatic BPH
International Prostate Symptom Score (IPSS) score >13
Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volume of >125 mL
Post-void residual (PVR) <250 mL
Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
Prior minimally invasive intervention or surgical intervention of the prostate or urethra
PSA >10 ng/mL
Bladder cancer or bladder stones