Abstract
OBJECTIVE: This report evaluates clinical experience with the Rezūm system after US Food and Drug Administration clearance in consecutive cases accrued by multiple community urologists for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Treatment techniques for transurethral convective radiofrequency water-vapor thermal therapy and outcomes with up to 12 months' follow-up are presented. MATERIALS AND METHODS: A total of 131 patients with moderate-severe LUTS were included in a retrospective analysis of BPH procedures with the Rezūm system. Pre- and postprocedure assessments included International Prostate Symptom Score (IPSS), quality of life, peak urinary flow rate, voided volume, and postvoid residual urine volume. Urologists used their own discretion for patient selection, with variable prostate sizes, LUTS severity, urinary retention, or presence of an obstructing median lobe. Safety signals and surgical retreatment rates were monitored prospectively. RESULTS: Men aged 47-96 years with prostates 13-183 cm(3) showed significant improvement in IPSS, quality of life, and postvoid residual volume durable through 12 months after thermal therapy. Patients with either moderate (IPSS 8-19) or severe (IPSS 20-35) symptoms achieved significantly improved scores. Postprocedure adverse events normally anticipated and related to endoscopic instrumentation were transient and mild-moderate in nature. No de novo erectile or ejaculatory dysfunction was reported. CONCLUSION: This study corroborates prior published pilot and randomized controlled trial results indicating significant relief of urinary symptoms and reproducibility of responses to thermal therapy. Convective radiofrequency thermal therapy with the Rezūm system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.