Age

45–any

Sex

MALE

Healthy volunteers

Not accepted

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
Prostate volume 25 to 80 mL
Prostatic urethral length 20-50 mm
Able to complete the study protocol and visits

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
Active urinary tract infection (UTI)
Uncontrolled diabetes
Part of a vulnerable population (cognitively challenged or are incarcerated)

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms