Urologist finds Rezum AE rates in larger prostates “reassuring”

In a recent interview with Urology Times^®, Kevin T. McVary, MD, FACS, discussed the short-term safety and efficacy of the Rezūm System for larger prostates, referencing a meta-analysis in Urology that reported low serious adverse event rates and a 1.2% retreatment rate at a 6-month follow-up for prostate volumes of at least 80 cm³. McVary said he finds these low adverse event rates reassuring, particularly for clinicians who might be hesitant to treat larger prostates. He also notes that patients find his confidence in tackling larger prostates very reassuring.

However, McVary provides a caveat, emphasizing that "6 months is not 6 year.” He stresses the importance of continued observation to determine if these positive short-term results are sustainable. Despite this, his expectation is that the results will be sustainable because the short-term outcomes for larger prostates appear superimposable on the longer-term outcomes for smaller, previously restricted prostate volumes, suggesting similar biological behavior.

Regarding the long-term durability of Rezūm, especially with the expanded prostate volume indication, McVary tells patients that larger prostate glands seem to behave at least as well as smaller ones. He acknowledges the need for longer-term observation but states there's no current signal to discourage the expanded indication. He differentiates between pivotal trial data and meta-analyses, noting that pivotal trials are a "special cohort.” The consistency between the outcomes, particularly the 5-year data from the pivotal trial showing significant reductions in International Prostate Symptom Score and BPH Impact Index, and improvements in quality of life and maximum flow rate, is very reassuring to him and comforting for patients.

REFERENCE

1. McVary KT, Miller LE, Bhattacharyya S, et al. Water vapor thermal therapy in men with prostate volume ≥80 cm³: A systematic review and meta-analysis. Urology. 2024:184:244-250. doi:10.1016/j.urology.2023.10.036