Rivermark Medical
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.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 n…
Flexible cystoscopy to deploy medical device used to treat BPH
Flexible Cystoscopy without deployment of medical device used to treat BPH