Real-world evidence with The Rezūm System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes.

Abstract

To provide 12-month unbiased outcomes with The Rezūm System (Rezūm), a convective water vapor thermal therapy for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Results from this retrospective, real-world evidence (RWE) study were compared to those of previous studies with the aim to evaluate the device's safety and efficacy in a real-world patient population. Patients 45 years or older with an International Prostate Symptom Score (IPSS) score ≥8, prostate volume (PV) between 20cc and 120cc, who were 12 months posttreatment, and had at least one follow-up were included. Patients were broken into groups based on baseline PV; 30-80cc, <30cc, and >80cc. IPSS, PV, quality of life (QoL), maximum urinary flow rate (Qmax), adverse events (AE), postvoid residual, prostate-specific antigen, BPH medication usage, and International Index of Erectile Function were collected and analyzed at baseline, 1, 3, 6, and/or 12 months. A total of 179 patients were included in a retrospective study. IPSS, QoL, and Qmax significantly improved at follow-up time points (p < .05). There were no significant differences at 12 months in IPSS and QoL point reduction or Qmax improvement between the previous studies and any of the RWE groups. BPH medication reduction was seen at 3 months and remained durable up to 12 months. When compared to previous studies, the RWE study had similar rates of urinary retention, urinary tract infection, and dysuria but significantly higher rates of hematuria for the 30-80cc (71.7%), <30cc (58.8%), and >80cc (80.0%) groups (p < .001). The RWE study shows rapid and durable relief in LUTS, consistent with that observed in literature. Although Rezūm had a reasonably acceptable AEs profile, patients should be counseled preoperatively for AEs. As a first line therapy, Rezūm is an attractive option for men with BPH irrespective of their prostate size.