Abstract

The Rezum System (Rezum) represents a novel, minimally invasive surgical therapy used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). We evaluated the safety and efficacy of Rezum in patients with mild, moderate, or severe LUTS. A single office, retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017 and 2019. Patients were categorized into three cohorts based on baseline International Prostate Symptom Score (IPSS) LUTS severity: mild LUTS (IPSS ≤ 7), moderate LUTS (IPSS 8-19), or severe LUTS (IPSS ≥ 20) cohorts. Outcome measures, including IPSS, quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), BPH medication usage, and adverse events (AEs) were collected and analyzed at baseline, 1-, 3-, 6-, and/or 12-months postoperatively. A total of 238 patients were included: 33 with mild LUTS, 109 with moderate LUTS, and 96 with severe LUTS. At 1-month follow-up, the moderate and severe LUTS cohorts saw significant improvements in IPSS (moderate LUTS: -3.0 [-6.0, 1.5], p < 0.001; severe LUTS: -10.0 [-16.0, -5.0], p < 0.001) and QoL (moderate LUTS: -1.0 [-3.0, 0.0], p < 0.001; severe LUTS: -1.0 [-3.0, 0.0], p < 0.001) and improvements remained durable up to 12-months (p < 0.001). The mild LUTS cohort saw significant worsening in IPSS by 2.0 (0.0, 12.0) at 1-month (p = 0.002) but returned to baseline at 3-months (p = 0.114). However, the mild LUTS cohort experienced significant improvements in QoL by -0.5 (-3.0, 0.0) at 3-months (p = 0.035) and nocturia by 0.0 (-1.0, 0.0) at 6-months (p = 0.002), both of which remained durable to 12-months (p < 0.05). Most AEs were transient and nonserious, with gross hematuria (66.5%) being most common. There were no significant differences in QoL point reduction, Qmax improvement, PVR reduction, and AE occurrence between the cohorts at 12-months (p > 0.05). At 12-months, 80.0%, 87.5%, and 66.0% of the patients in the mild, moderate, and severe LUTS cohorts discontinued their BPH medications, respectively. Rezum provides rapid and durable relief in LUTS in patients with moderate or severe LUTS and can be offered to patients with mild LUTS who have bothersome nocturia and wish to discontinue their BPH medications.

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