Status: Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
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.
Participants needed: 215
Trial details
Age: 45+Biological sex: MaleType: InterventionalSponsor: Rivermark MedicalUpdated: Jun 11, 2026Locations: 20
Eligibility criteria
Male subjects > 45 years of age who have symptomatic BPH [+6]
Presence of an artificial urinary sphincter or stent(s) in the urethra or prosta... [+6]