Large, Multi-Center, Prospective Registry of Rezūm Water Vapor Therapy for Benign Prostatic Hyperplasia

For the last 30 years, men have had the choice of living with their symptoms, taking oral medications to relax or shrink their prostate or having surgery. Surgery was either transurethral resection of the prostate (TURP) for prostates up to 80 cc or open simple prostatectomy for prostates >80-100cc. Over the past decade or so newer laser surgeries have become more common with a less invasive profile. More recently, minimally invasive surgical therapies (MISTs) have emerged as an office-based alternative that fits in between medications and surgery. The two main MIST options have been UroLift (prostatic urethral life) and Rezum (convective water vapor thermal therapy). A very recent 3rd option, iTIND (temporary implantable nitinol device) has just been introduced. Both UroLift and Rezum have had pivotal, prospective, randomized studies, now followed out to 5 years. It was these studies (at 1 year) that were submitted to the FDA for approval. Both UroLift and Rezum have similar improvements in symptoms scores, flows, and other outcome measures. UroLift recovers a little faster and has lower ejaculation dysfunction (0%vs 4-6% rezum), however, Rezum has much lower retreatment rates i.e. better durability) In the US, the FDA labeling for these procedures is 30-80cc prostate size.

Our study is unique in a number of ways. Firstly, it was prospectively collected data, starting on Day 1 with the first ever patient treated in Canada (April 9, 2019) and followed forward. This means the results represent the true outcomes of patients during. the surgeons learning curve (no prior experience). Second, it's one of the largest cohorts ever studied (229 patients)(larger than the pivotal study). Third and significantly, it includes an "all-comer" population of patients without any inclusion/exclusion criteria. This is a "real-world" sample of men, unlike those seen in a tightly controlled clinical trial. The average prostate size is 71.5cc which is much larger than the average size seen in clinical trial of Rezum (45.8 cc). Additionally, these cases are performed in under 5 minutes (very fast). Fourth, unlike other studies, it includes 83 men with prostates >80cc, with a mean in this larger group of 105cc (range 80-160).

These very large prostates would normally require invasive surgery whose operative time would be 1-2 hours at least. These cases were performed in 6 minutes under local anesthesia or light intravenous sedation. We also included men in retention with urinary catheters. Given all of these factors (wide variety of men and prostate sizes, no size limitations, men in retention, etc,) we see very significant improvements in validated symptoms scores, quality of life questions, flow rates, and residual urine. We see the preservation of sexual function including no change in erection and ejaculatory function. We see few complications (2%) and very few retreatments (2 patients 0.9%). Admittedly, given the mechanism of steam, we expect swelling of the prostate initially, which results in longer catheterization times (almost 10 days, though this includes large 100cc+ glands whom we leave catheters for 10-14 days and retention patients for whom we leave catheters for 30 days). Despite this, patients are willing to have a catheter longer to avoid more invasive surgery, with higher rates of complications.

These findings are significant as they show the versatility of Rezum over a very wide range of prostate sizes and shapes resulting in a fast, safe treatment with significant improvements in symptoms and flow. The limitations imposed by the FDA labeling really come down to the patient population in the original clinical trial, and not Rezum's ability to treat larger sized prostates, as evidenced in this study. Take home message: This prospectively collected registry of real-world cases of Rezum, shows Rezum to be a fast, effective treatment for BPH even in men with small-to-large prostates, median lobes, retention with catheters with a very low complication and retreatment rate at 1 year.

Written by: Dean Elterman, MD, MSc, FRCSC, Division of Urology, University Health Network, University of Toronto, Toronto, Canada

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