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

Background 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. Methods 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. Results 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). Conclusions 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.

Emerging outcomes of water vapor thermal therapy (Rezum) in a broad range of patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia: A systematic review

“…Significant percent improvements from baseline to 3 months in IPSS, QoL, and Qmax ranged between 36% and 80% (median 51%), 32% to 86% (median 51%), and 32% to 130% (median 66%), respectively. Out of the seven studies 11‐19,21,25,26,33 that evaluated PVR from baseline to 3, 6 to 7.2, and 12 months, only two studies 21,26 found it to be significantly improved at all three follow‐ups (median percent improvements 54%, 56%, and 57%, respectively) (Table 4).…”

“…However, only the results from the cohort who underwent Rezum were included in this review. Bole et al 28 Garden et al, 29 and Ines et al 33 included subanalyses of patients with large baseline prostate volumes in which 26%, 18%, and 7% of patients, respectively, had baseline prostate volumes of >80 g. Additionally, Ines et al 33 also included a subanalysis of patients with small baseline prostate volumes (<30 g). McVary et al 27 Baboudjian et al 34 Bassily et al 35 Besides the pilot study by Dixon et al 18,19 all the studies were conducted in the United States before 2020.…”

“…Mean procedure time ranged from 4.4 to 13.0 minutes (median 7.0 minutes). Out of the 19 studies, 11-35 14 [11][12][13][14][15][16][18][19][20][21][22][24][25][26][27][28][29][30][31][32][33][34][35] reported postoperative urinary catheter rates which ranged from 65% to 100%, with 13 studies 21,22,[25][26][27][28][29][30][31][32][33][34][35] having a rate of 100%. The mean number of days patients were catheterized postoperatively ranged from 3.0 to 32.2 days, with the upper limit reserved for those who had urinary retention at baseline (Table 3).…”

“…When compared to baseline, IPSS, QoL, and Qmax significantly improved as early as 1 month posttreatment (median percent improvements 31%, 24%, and 34%, respectively) and remained (median 51%), 32% to 86% (median 51%), and 32% to 130% (median 66%), respectively. Out of the seven studies [11][12][13][14][15][16][17][18][19]21,25,26,33 that evaluated PVR from baseline to 3, 6 to 7.2, and 12 months, only two studies 21,26 found it to be significantly improved at all three follow-ups (median percent improvements 54%, 56%, and 57%, respectively) (Table 4).…”

“…Eleven studies [11][12][13][14][15][16][17][18][19]23,24,26,27,[31][32][33]35 treated patients with an obstructing median lobe. Patients who had treatments to the median lobe experienced similar or greater improvements in LUTS when compared to patients who did not have treatments to the median lobe.…”