NEW YORK (Reuters Health) - Rezum water vapor thermal therapy was safe and effective in patients with benign prostatic hyperplasia (BPH), in a registry study.
"This prospectively collected registry of real-world cases shows Rezum to be a fast, effective treatment for BPH even in men with small-to-large prostates, median lobes, and retention with catheters, with a very low complication and retreatment rate at one year," Dr. Dean Elterman of University Health Network, University of Toronto told Reuters Health by email.
The American Urological Association guideline currently includes the therapy for BPH when prostate volumes are less than 80cc, whereas the European Association of Urology labels the procedure investigational, due to the lack of long-term safety and efficacy data.
The registry included "83 men with prostates >80cc, with a mean in this larger group of 105cc (range 80cc-160cc)," Dr. Elterman said. "These very large prostates would normally require invasive surgery (with an) operative time (of) 1-2 hours at least. These cases were performed in six minutes under local anesthesia or light intravenous sedation."
As reported in Urology, Dr. Elterman and colleagues analyzed data on 229 BPH patients (mean age, 67.3) in two Canadian registries. All patients had baseline medical and BPH history documented, along with uroflowmetry and validated questionnaires up to 12 months post-surgery.
The mean prostate volume was 71.5 mL (range 20 mL-160 mL), and 83 patients had prostate volumes of 80 mL or more; 55% had a median lobe.
The mean number of injections was 11 and mean procedural length was 4.8 minutes. The mean duration of post-procedure catheterization was 9.8 days.
International Prostate Symptom Score (IPSS) scores improved from baseline by 29%, 53%, and 59% at 1, 3, and 12 months, respectively, and IPSS QoL improved during the same period by 30%, 50%, and 67% at the same time points.
Peak urinary flow improved by 60% at 3 months and 74% at 12 months, whereas post-void residual volume improved by 51% and 61%.
No statistically significant changes were seen in scores for the International Index of Erectile Dysfunction or Male Sexual Health Questionnaire for Ejaculatory Dysfunction.
No grade III or greater Clavien-Dindo events occurred.
Dr. Ram Anil Pathak, a urologist at Atrium Health Wake Forest Baptist in Winston-Salem, commented on the study in an email to Reuters Health. "There is a paucity of data regarding the clinical efficacy and durability of Rezum, with only one randomized control trial showing symptomatic improvements for small to moderate size. "
"Moreover, he said, "there are no studies that compare Rezum to other BPH treatment modalities. In fact, the European Association of Urology labels the procedure investigational secondary to the lack of long-term safety and efficacy data (most studies mature at about 4-5 years)."
"Minimally-invasive alternatives to BPH surgery are vast and include prostatic artery embolization, prostatic urethral lift, temporary implantable nitinol device, aquablation, laser vaporization/enucleation, and even robotic approaches," he noted. "In what seems like an arms race of management strategies, comparative data pitting these modalities against each other is sorely needed. In the interim, Rezum appears to be a safe option for many patients desiring treatment for symptomatic BPH."
Dr. Elterman and three coauthors are consultants for Boston Scientific, which produces the Rezum water vapor system.
SOURCE: https://bit.ly/3Cca7cQ Urology, online February 16, 2022.
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