A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms
Rivermark Medical
Summary
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.
Eligibility
- Age range
- 45+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DeviceFloStent
Flexible cystoscopy to deploy medical device used to treat BPH
- DeviceSham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Locations (20)
- Michael G Oefelein Clinical TrialsBakersfield, California
- Comprehensive Urology Medical GroupBeverly Hills, California
- Atlas Men's HealthLa Mesa, California
- Urology Group of Southern CaliforniaLos Angeles, California
- Prestige Medical GroupTustin, California
- Urology DenverLittleton, Colorado