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
Parallel
FloStent
DeviceFlexible cystoscopy to deploy medical device used to treat BPH
Sham (Control)
DeviceFlexible Cystoscopy without deployment of medical device used to treat BPH
Change in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL). The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
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