Kevin T. McVary, MD, FACS, discusses the expanded label for Rezum in BPH

In a recent interview, Kevin T. McVary, MD, FACS, discussed the expanded FDA label for the Rezūm System, which now includes prostate volumes up to 150 cm³, a significant increase from the previous 30cm³-80 cm³ range. He emphasizes that although the expanded indication is beneficial, it doesn't mean every patient with a larger prostate should automatically opt for Rezūm. Instead, shared decision-making is crucial, ensuring patients are aware of all available treatment options for large prostates, not just Rezūm, despite its improved indications.

McVary addressed a meta-analysis published in Urology that showed statistically significant improvements in International Prostate Symptom Score (IPSS), IPSS-Quality of Life, Qmax, and post-void residual in men with prostate volumes of at least 80 cm³ after Rezūm treatment. Clinically, he finds it reassuring that extending Rezūm treatment to larger prostates does not compromise outcomes. Improvements in IPSS, quality of life, post-void residual, and sexual function in larger glands are comparable to those seen in the previously approved range.

Furthermore, recent findings indicate that larger prostates may experience equal, if not better, and faster improvements with no adverse impact on sexual function compared to smaller prostates. McVary noted this was an unexpected but consistent finding, suggesting that treating larger prostates with Rezūm does not sacrifice care, outcomes, or safety.

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