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Four-year real-world clinical and decisional regret outcomes of The Rezum System: A single office, retrospective study in a diverse, multiethnic population
Jaskirat Singh, BS1, Mustufa Babar, B.S.2, Max Abramson, BS2, Rahman Sayed, BS2, Kevin Labagnara, BS2, Justin Loloi, MD3, Michael Zhu, BS2, Kevin Tang, BS2, Azizou Salami, BS2, Matthew Ines, BS1, Sandeep Singh, BS1, Nazifa Iqbal, BA1, Michael Ciatto, MD1.
1DSS Urology, Queens Village, NY, USA, 2Albert Einstein College of Medicine, Bronx, NY, USA, 3Montefiore Medical Center, Department of Urology, Bronx, NY, USA.

BACKGROUND: The Rezum System (Rezum) is an attractive minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). We evaluated four-year clinical and decisional regret outcomes of Rezum in a real-world, diverse patient population.
METHODS: A single office, retrospective study was conducted on patients treated with Rezum between 2017 and 2019. Patients were included if they had a recorded baseline International Prostate Symptom Score (IPSS) and at least one follow-up within four years. Clinical outcomes, including IPSS, quality of life (QoL), maximum flow rate (Qmax), adverse events (AEs), and BPH medication usage were collected at baseline, 1-, 3-, 6-, 12-, and/or 48-month follow-up. Regret was assessed at 48-month using the validated 5-item Decisional Regret Scale (DRS). High regret was defined as a DRS score >50%.
RESULTS: A total of 267 patients were included, with a mean age of 63.6 8.7 years and median prostate volume and IPSS of 43cc (35, 60) and 18 (11, 24), respectively. The patient population had diverse representation including the largest cohort being Asian (33.0%), followed by Non-Hispanic Black (28.5%) and Hispanic (23.6%). Most patients (83.5%) elected for general anesthesia. Median number of injections per lateral prostatic lobe was 2 (1, 2) and per medial lobe was 1 (0, 1). Significant changes in IPSS and QoL were seen as early as 1-month (IPSS -38.9%, p<0.001; QoL -40.0%, p<0.001), as well as Qmax (66.7%, p<0.001) by 3-months. Improvements remained durable to 48-months (IPSS -72.2%, p<0.001; QoL -80.0%, p<0.001; Qmax 49.0%, p=0.005). Most AEs were transient and Clavien-Dindo I/II, with gross hematuria being the most common (66.3%), followed by penile burning (61.5%). BPH medication usage was 90.4% at baseline, 22.2% by 12-months, and 36.0% by 48-months. By 48-months, 19 patients (7.7%) underwent reoperation. At 48-months, 96 patients (88.1%) reported low regret and 13 patients (11.3%) reported high regret. Those who reported high regret did not experience significant changes in IPSS (-3.3%, p=0.2) and QoL (-20%, p=0.3) from baseline to 48-months.
CONCLUSIONS: In a diverse patient population and real-world setting, Rezum provides rapid and durable improvements in LUTS through four years, with low rates of reoperation and decisional regret.


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