Water Vapor Ablation Eases BPH/LUTS, Preserves Sexual Function
Significant improvements in lower urinary tract symptoms are durable to 24 months, data show.
SAN DIEGO—Transurethral convective water vapor energy (WAVE) ablation of prostate tissue offers an effective minimally invasive alternative for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia, according to the findings of separate studies presented at the American Urological Association 2016 annual meeting.
The studies showed that treatment with the Rezum System (NxThera, Inc.), which uses the thermal energy of steam to ablate prostate tissue, provides durable symptom improvement while preserving sexual function.
In a study of 197 men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), Kevin McVary, MD, of the Southern Illinois University School of Medicine in Springfield, and colleagues randomly assigned patients to undergo WAVE ablation (136 men) and 61 to receive a control procedure consisting of rigid cystoscopy with mimicked active treatment sounds. At 3 months, lower urinary tract symptoms (LUTS) improved 11 points in the WAVE group compared with 4.3 points in the control arm. In patients with severe LUTS (International Prostate Symptom Score [IPSS] greater than 19), 85% achieved a 30% or greater reduction in symptoms. At 3 months, peak flow rate increased 68% (6.2 mL/sec) in the WAVE group compared with no change in the control group. These improvements were sustained in 96% of treated subjects who completed their 1 year follow-up.
At study entry, 52% of treatment subjects had a history of erectile dysfunction (ED) and 26% had decreased-stoppage ejaculation. Dr. McVary's group included only sexual active men (91 of the 136 WAVE patients) in sexual function analyses. In these men, the International Index of Erectile Function baseline mean score was 17.2 and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction mean score was 7.8. The researchers reported no clinically meaningful negative changes in scores over 12 months. Modest decreases in ejaculatory volume occurred in 6 men (4.4%), anejaculation in 4 men (2.9%). No new ED was reported.
In another study, Christopher Dixon, MD, of Bronx-Lebanon Medical Center in Bronx, NY, and colleagues found that WAVE ablation provides effective and sustained relief of BPH/LUTS for 2 years with no deterioration in sexual function. The study included 65 men with moderate-to-severe LUTS who underwent WAVE treatment. The researchers observed significant clinical improvements at 1, 3, 6, 12, and 24 months in IPSS, which decreased at those time points by 7.2, 13.4, 13.1, 12.5, and 12.1 points, respectively. At 24 months, these results were equivalent to a significant 55% improvement in IPSS and a 58% improvement in peak flow rate. Additionally, patients reported an improved quality of life, which was sustained at 24 months with a 58% improvement. Sexual function was preserved. One patient had prolonged urinary retention that required transurethral resection of the prostate.