What real-world data on BPH therapies reveal about retreatment rates

Over time, there have been many advancements in the treatment of BPH, although these various therapies don’t come without complications or need for retreatment.

In a recent study presented at the 2021 American Urological Association annual meeting,¹ Steven A. Kaplan, MD, and Daniel Rukstalis, MD, assessed the retreatment rates and postoperative complications associated with various BPH therapies, including transurethral resection of the prostate (TURP), GreenLight laser, Rezum, and the prostatic urethral lift (UroLift). In this interview, Kaplan discusses notable findings from the study as well as his own patient selection process for treatments. Kaplan is a professor of urology at the Icahn School of Medicine and director of the Men’s Wellness Program at Mount Sinai, New York, New York

Could you discuss the background for this study?

One of the things we're always interested in is the retreatment rates for patients who have either minimally invasive therapies and/or surgical therapies for lower urinary tract symptoms secondary to BPH. We base the retreatment rate and the discussion on clinical trials, and that's the best of the best. But, is that really what goes on in the real world? This question was the basis for why we did the study. We looked at a large database that encompassed patients from 2015 to 2019 and looked at the surgical retreatment rates for common procedures, such as transurethral resection of the prostate, GreenLight laser, and 2 minimally invasive therapies, UroLift and Rezum. What we found was that the retreatment rates were pretty high at 1 year. We were trained to expect 1% per year, and we found that it was variable anywhere from about 5% to 6.5%, even for TURP and GreenLight, which are surgical procedures.

What were some of the notable findings? Were any of them surprising to you and your co-authors?

The most notable finding was the fact that the retreatment rates were higher than we thought. Essentially, we looked at the real-world rates and calculated hazards following retreatment with either minimally invasive therapies or traditional surgery. More specifically, we analyzed over 19,000 men who had a TURP, over 10,000 men who had a GreenLight laser, about 5200 men who had a prostatic urethral lift, and about 935 men who had Rezum. We also looked at return procedures and retreatments. We defined return procedures as a postoperative procedure performed during a return visit to an outpatient setting. That could be a re-catheterization, irrigation for blood clots, and more importantly, surgical retreatments, where a second BPH procedure occurred after the initial index procedure. What we found was that when we looked at the rates of return procedures at 365 days, it was lowest for prostatic urethral lift—17%. It was 23% for Rezum, which was statistically higher than UroLift, and it was 22% for GreenLight and 21% for TURP. And if you look at the hazard ratios for return procedures, it was 24% higher for TURP vs prostatic urethral lift, 35% higher for GreenLight vs prostatic urethral lift and 41% higher for a Rezum than prostatic urethral lift. The surgical retreatment rate was higher than we thought and highest for Rezum. For UroLift it was 5.4%, for TURP, 5.3%; for GreenLight, 5.2%; and for Rezum, 7.2%. So, if you look at the retreatment rate, it's much higher for Rezum. This is the most important part, that the retreatment rates for all the procedures was higher than we thought and highest for Rezum.

With so many available treatment options, what is your patient selection process for each modality?

It's a little bit of a lot of things, and it's no one thing. For a lot of patients, it depends on their expectations. For some patients, I must help manage their expectations. In general, there are some patients who want a sequential therapy. They say, "I don't want to go to the operating room. You can do something in your office.” Those are the patients who usually wind up having a minimally invasive therapy, like Rezum or UroLift. There are some patients who say, "I want 1 procedure. Done." Those are the patients who tend to have a surgery, like a GreenLight or a TURP. In our case, we're doing a lot of Aquablation, which is a newer procedure. There are also other factors. For example, when the patient can't urinate at all, I tend to do a surgical procedure because although there’s been some reports about using minimally invasive therapies, I want to make sure that the patient urinates, so I'm going to do a surgical procedure. There's also prostate size. Some patients have too big of prostates to do a minimally invasive procedure. For some people, they may have different goalposts, if you will. But that, to me, is the criteria that I look at.

What is the take-home message for the practicing urologist?

Retreatment rates are higher than we thought. That, to me, was the most important thing. Yes, Rezum had the highest retreatment rate, much higher than we saw in their clinical trials, but retreatment rates for everything were much higher than we've seen in clinical trials. We're going to be analyzing more and more data over a longer period of time, but if these data sets hold out, we have to let our patients know that this is going to happen here. This is not 1% per year, like we've been taught. It could be 5% per year. Is it cumulative? Is it going to be 10% next year or is it going to stay level? We don't know. So, those are the things we need to find out. Those are things we need to share with our patients. And you know who's looking? The payers. We have to be aware that those people who are paying for this stuff are going to be looking at this as well. This is the beginning of an exploration and an identification. What we need to do is to see whether or not this is a blip at 1 year and will stay that way, or whether it keeps on going up because that's going to change how we do business in terms of speaking to our patients.

Reference

1. Kaplan S, Rukstalis D. UroLift PUL compared to Rezum, TURP and GreenLight pvp: US medicare and commercial claims analysis reveals lowest complications for PUL and highest retreatment for Rezum. Paper presented during the 2021 American Urological Association annual meeting. September 10-13; virtual. Abstract LBA01-01