In the largest study of its kind, a series of 9-second shots with barely boiling water into enlarged prostates appears to be a safe and effective approach to treating benign prostatic hyperplasia (BPH), a Canadian-American team reported in the journal Urology.
Dr Dean Elterman
The technology, called Rezūm, proved effective even in a patient with a prostate gland roughly the size of a grapefruit, said Dean Elterman, MD, a urologist at University Health Network, University of Toronto, Canada, who led the research.
“What’s unique about my study is it’s real-world. We didn’t have criteria to include men. So, uniquely, our prostate size on average was about 77 g, whereas, in the clinical trials, it was around 40 g,” Elterman told Medscape Medical News. “The other really interesting thing is in the United States, the upper limit that you can treat with Rezūm is 80 g. We actually had 83 patients out of our 220 odd patients who have prostates bigger than 80 g.”
Treatment for BPH varies from medication to surgical procedures such as transurethral resection of the prostate (TURP). Approved by the US Food and Drug Administration in 2015, Rezūm involves a single-use scope with a 1-cm retractable needle pocked by an array of steam-emitting holes. Clinicians thread the scope up the urethra and release the 103° C vapor.
For the prostate, “it’s just like having a cup of hot tea,” Elterman said. “Over 9 seconds, the heat of that steam will transmit into the enlarged prostate tissue that’s causing the blockage, and the heat will cause the cells of the prostate to actually die ― immediately.”
In the study, a total of 229 patients (mean age, 67.3 years) with a mean prostate volume of 71.5 g (range, 20 – 160 g) underwent treatment with Rezūm. The mean time of the procedure was 4.8 min (range, 1.5 – 14 min), and the mean number of injections was 11 (range, 4 – 28). The mean duration of post-procedure catheterization was roughly 10 days.
Peak urinary flow (Qmax) had improved by 60% at 3 months and by 74% at 12 months; post-void residual volume (PVR) had improved by 51% and 61% at 3 and 12 months, respectively, according to the researchers. Erectile and ejaculatory function were preserved for all patients.
Success in the Largest Prostates
Guidelines from the American Urological Association now include water vapor thermal therapy as a surgical option for BPH patients whose prostate volumes are less than 80 g. The new study included 83 men with prostates larger than that cutoff.
In this subgroup, the average prostate volume was 104.6 g (range, 80 – 160 g), and 65% had a median lobe. Procedures and recovery times tended to be a bit longer than for the other men in the study. However, improvements in Qmax were similar (55% at 3 months), the researchers report.
The mean duration of the procedure was roughly 6 min (range, 2.5 – 14 min). The mean duration of post-procedure catheterization was 11.8 days. Men reported significant improvements in the International Prostate Symptom Score across all time points in the study, and Qmax improved from a baseline of 9.2 mL/s up to 14.3 mL/s (55%) by 3 months after the procedure.
“What this really shows is that not only is [the procedure] safe, not only is it fast, but it really treats an extremely wide range of prostate sizes,” Elterman told Mescape Medical News. “The biggest I did was 160 g. I mean, that’s a monster. That’s a Florida grapefruit. This paper really shows that we’ve been able to push the limits of the technology and still get really good outcomes.”
Elterman said two patients with prostates of 140 – 160 g requested a second Rezūm treatment 1.5 years after their first procedure. “It’s no wonder that some of these really enormous prostates may need a second go at it, but that was only two patients out of 229. I can say anecdotally, because these results were from 2019 – 2020, it looks like it’s still holding up. We have very low retreatment rates,” he said.
Brian Helfand, MD, PhD, chief of urology at NorthShore University HealthSystem, in Glenview, Illinois, noted that although the new findings looked encouraging, the study lacked a comparison group.
“With any BPH therapy, it is important to compare outcomes to a known and proven therapy, such as TURP. In addition, while Rezūm can provide some relief in the short term, data would support that we need to look at retreatment rates at longer time periods.”
Several of the authors report consulting for Boston Scientific Company Inc, which markets Rezūm. Christopher Vannabouathong, MSc, received payment for medical writing. Helfand is a consultant for PROCEPT BioRobotics.
Urology. Published online February 16, 2022. Abstract
Howard Wolinsky is a medical writer in Chicago.
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