(249) LOW INTENSITY SHOCKWAVE THERAPY FOR ERECTILE DYSFUNCTION: A SHAM-CONTROLLED TRIAL CONCOMITANTLY EXAMINING LOWER URINARY TRACT SYMPTOMS AND PROSTATE SPECIFIC ANTIGEN

Abstract Introduction There is a high association between ED and LUTS/BPH, with a well-established cross talk between the two conditions, however, there are no reports, to the best of our knowledge, examining the changes in lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) symptoms after LiSWT treatment for ED. Perineal LiSWT to treat LUTS/BPH symptoms in men poorly responsive to medical therapy resulted in statistically significant improvements in International Prostate Symptom Score (IPPS) and Quality of Life Due to Urinary Symptoms (QOL) sustained at 3 months (Zhang et al). In addition, there are no reports, to the best of our knowledge, examining changes in PSA blood test values after LiSWT treatment for ED; however in a population of men with chronic pelvic pain syndrome treated with perineal LiSWT, there were no statistically significant differences in prostate specific antigen (PSA) between the LiSWT and placebo group at the 4 week follow-up. (Kim et al). Objective To review the secondary outcome measures of urinary function and PSA in a randomized sham-controlled trial of LiSWT of men with ED. Methods A single-blind, sham-controlled, randomized, prospective study in men with ED naïve to shockwave and radial ballistic pressure wave therapy was performed. Participants meeting inclusion/exclusion criteria were randomized to one of two treatment arms and assigned to active or sham, 2:1, within each arm. The primary outcome measures addressed changes from baseline in various objective ED parameters. Secondary outcome measures included IPPS and QOL for urinary function, and PSA. Data from each treatment arm were analyzed by two-way repeated measures ANOVA with Geisser–Greenhouse correction. Follow-up pairwise comparisons to baseline were performed using Dunnett’s multiple comparison test. In participants with one on-treatment assessment, missing data due to early discontinuation from the study were imputed by the “last observation carried forward” method. Results In this study population of men with ED, the baseline IPSS score was high, consistent with symptoms of LUTS/BPH. For both Sham Treatment Arms, there was no improvement in IPSS score. There was, however, a consistent decrease in IPSS scores when sham treatment patients were converted to active treatment in Arms 1 and 2 but these did not reach statistical significance. For participants initially randomized to Active Treatment, IPSS scores consistently decreased after LiSWT with reductions of 1.75 and 2.0 points, respectively, in Arms 1 and 2 at Assessment 2 (Fig. 1). Concerning QOL scores related to urinary function, a majority of participants experienced a high value at baseline (Fig. 1). This either stayed the same or improved at Assessment 1. PSA levels remained stable throughout the study with no significant increases in any treatment arm (Fig. 2). Conclusions There are limited data on LiSWT trials for ED concomitantly investigating LUTS/BPH. In our study, improved IPSS and QOL measures occurred, possibly related to LiSWT-induced prostate smooth muscle relaxation, without any change in PSA. Clinical trials using LiSWT for ED should consider utilizing LUTS/BPH outcome measures to better understand mechanisms of improved erectile/urinary function. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Softwave/TRT.