This study included men ≥ 50 years old who presented with an IPSS of ≥ 13, a flow rate between 5-15 mL/s, and a prostate volume 30-80 mL. This was a randomized study 2:1 between WaVE vs. sham which includes cystoscopies. There was a blinded comparison done at 3 months and the treatment arm was followed for 12 months. Pain, IPSS, voiding outcomes, and quality of life were assessed.
Of the 197 patients, 136 were placed in the treatment group and 61 in the control group. 42 subjects had middle lobe and 30 subjects received treatment of middle lobe. 70% of the treatment group had a ≥8 point improvement in IPSS at 3 months and through the end of the study compared to the control group. Peak flow rate in the treatment group increased by 6.2mL/s at 3 months and sustained though 12 months (p<0.0001). Obese patients had similar improvements in IPSS compared to non-obese patients. This was true for both storage and voiding domains of IPSS. It is also noted that there was no deterioration in sexual function including ejaculatory effect and erectile function. In WaVE patients, ejaculatory effect improved 31%. Both IIEF-15 and MSGQ-EjF scores did not differ between both groups at 3 months and also did no differ in WaVE patients from baseline at the end of the 12 month mark. At 3 months, 32% of WaVE patients achieved at 3 months and in 1 year, 27% was achieved in all ED categories. Obese patients had similar results of MCID and improvement in ejaculatory effect as non obese patients but they were more likely to have severe ED. 6 men presented with decreased ejaculatory volume and 4 men reported anejaculation.
In conclusion, WaVE was seen to significantly improve symptoms that were caused by BPH in patients who complained of moderate to sever lower urinary tract symptoms. (LUTS). Erectile function was not affected by this treatment and obese patients were seen to experience similar improvements as non obese patients. Overall, according to the authors, quality of life was improved due to treatment.
Presented By: Nikhil Gupta
Author(s): Nikhil Gupta*, Tobias Kohler, Kevin McVary
Affiliation: Springfield, Illinois
Written By: Kheira Bettir, University of Irvine, California for UroToday.com
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA