Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezūm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia

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 cm³ 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.

Keywords: convective RF thermal therapy; lower urinary tract symptoms; minimally invasive procedure; prostate; prostatic hyperplasia.

Figure 1

Rezūm delivery device and vapor needle. Note: The vapor needle resides within the insulated lumen of the delivery device until it is deployed into the prostate tissue.

Figure 2

IPSS improvements shown for all treated patients throughout 12 months after convective RF thermal therapy in this postmarket study. Notes: These outcomes are compared with IPSS changes from the previously published pilot study and RCT showing similarity and durability of improvements in the three Rezūm system studies. Values are means, and error bars represent 95% CIs. IPSS improvements relative to baseline significant at all time points (P<0.001/P<0.0001). Abbreviations: IPSS, International Prostate Symptom Score; RF, radiofrequency; RCT, randomized controlled trial.

Figure 3

Patients with meaningful clinical improvements in IPSS ≥3-point decrease relative to pretreatment. Abbreviation: IPSS, International Prostate Symptom Score.

Figure 4

Observed IPSS changes for subset of patients with meaningful clinical improvement in urinary symptoms, defined as ≥3-point decrease in IPSS. Notes: Values are means, and error bars represent 95% CIs. *Improvements relative to baseline significant at all time points (P<0.02/P<0.0001). Abbreviation: IPSS, International Prostate Symptom Score.