Rivermark | RAPID-III | NCT06849258

About

Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland affecting nearly half of men over 50 and over 80% of men over 80. As the prostate grows, it squeezes the urethra, causing urinary symptoms such as frequent urination, weak urine flow, difficulty starting, and incomplete bladder emptying. These symptoms significantly impact sleep, daily activities, and quality of life. Current treatments include medications, minimally invasive procedures, and surgery, but all carry trade-offs in side effects, recovery time, and durability

Purpose

This randomized, double-blind study evaluates the FloStent™—a small nitinol implant placed in the prostatic urethra during a brief flexible cystoscopy—compared to a sham procedure. The FloStent is designed to mechanically hold open the urethra and relieve BPH-related urinary symptoms. The primary endpoint is improvement in International Prostate Symptom Score (IPSS) at 12 months. Enrolling 215 patients across 19 US and Australian sites, the trial aims to confirm the device’s safety and effectiveness.

Eligibility

• Men with symptomatic BPH and an International Prostate Symptom Score (IPSS) greater than 13
• Peak urinary flow rate between 5 and 13 mL/sec, and a minimum voided volume greater than 125 mL
• Prostate volume between 25 and 80 mL, and prostatic urethral length between 20 and 50 mm
• Post-void residual urine volume less than 250 mL
• No known prostate or bladder cancer

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.