Study assesses Rezum therapy in large prostates

In this video, Kevin T. McVary, MD, discusses the background of the study, “Water vapor thermal therapy in men with prostate volume ≥80 cm3: A systematic review and meta-analysis,” for which he served as the lead author. McVary is a professor of urology and the director of the center for male health at Loyola University Medical Center in Chicago, Illinois.

Video Transcript:

As many of the viewers may be aware, when the pivotal studies for Rezum were done, convective water vapor thermal therapy were done, based on the submission of the protocol to the FDA, the size limits were 30 to 80 grams. Now, there's really nothing magical about 30 to 80 grams; 30 to 80 grams has become the place where new technologies wade into the world of BPH. It's where they start, in part, because well, the other guy did it, and the other guy did it, and before him, another guy did it. It's a reasonable mechanism to try and get into the field if you're a new technology. The predicate was always 30 to 80. So, when the Rezum therapy was approved, the FDA put those limits on volume, between 30 and 80 grams. Now, less than 30 grams, you have to be cautious because the needle for the scope has a predictable length. And when you start to drop below 30 grams in prostate, that needle may be actually outside the prostate. So, maybe that's a hard stop. But on the upside, given that there really isn't magic about stopping at 80 grams, clinicians, and let me tell you, plenty of patients are asking, "can I have Rezum? I like the quick recovery, preservation sexual function, the fact that it's office space, these types of issues. I'd like to like to try that."

And many clinicians, and I think appropriately, many clinicians say, "No, it says 30 to 80, and I'm sticking to that in my practice." So, that's the lay of the land. There's certainly need to understand how well they work above 80 grams. I was also one of those cautious urologists; I was the PI of the pivotal trial. I was also cautious when it was released, and I began to treat patients outside of a research setting. But I did break the 80-gram barrier some time ago, and I became very comfortable using it for bigger and bigger glands. But, that's my practice. When we talk to colleagues, it's always nice to have data. There's a bit of an unmet need about the impact of Rezum in these bigger prostates. And many clinicians have followed suit, where they're also doing bigger and bigger prostates. My own guess is probably incremental as well. The reason this particular meta-analysis is attractive is because there are a limited number–15 or less, depending on how you do the math–limited trial numbers or limited reports where patients prostates were bigger than 80 grams. We thought we have a need, trying to understand how well it works. Does it work? Is that very favorable safety profile carried into the bigger glands? Is the good profile for preservation of sexual function also carried in when you go higher than 80 grams? Those are the background about why this particular project has relevance to clinicians, and actually supports maybe a more formal assessment using glands in excess of 80 grams. So long-winded version, but there was a need.

This transcription has been edited for clarity.