PD45-10 THE SAFETY AND EFFICACY OF LI-ESWT IN 604 PATIENTS FOR ERECTILE DYSFUNCTION: SUMMARY OF CURRENT AND EVOLVING EVIDENCE (2015)

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy II1 Apr 2015PD45-10 THE SAFETY AND EFFICACY OF LI-ESWT IN 604 PATIENTS FOR ERECTILE DYSFUNCTION: SUMMARY OF CURRENT AND EVOLVING EVIDENCE Robert Feldman, Bela Denes, Boaz Appel, Satya Srini Vasan, Tamar Shultz, and Arthur Burnett Robert FeldmanRobert Feldman More articles by this author , Bela DenesBela Denes More articles by this author , Boaz AppelBoaz Appel More articles by this author , Satya Srini VasanSatya Srini Vasan More articles by this author , Tamar ShultzTamar Shultz More articles by this author , and Arthur BurnettArthur Burnett More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2582AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Low intensity shock wave therapy (Li-ESWT) is currently approved in over 20 countries and available at over 200 clinics worldwide. A US multicenter study has been completed and the data are currently under FDA review. Herein we provide an overview of the clinical experience to date on the safety and efficacy of Li-ESWT for the treatment of erectile dysfunction. Studies were conducted in men with ED considered responders and in men considered poor responders to PDE5i. We report pooled data from 5 randomized, placebo-controlled studies (USA, Israel, Greece and India) and 3 single-arm open label studies (Israel, Japan). Li-ESWT for ED has been recently included in the European Association of Urology guideline 2013 for male sexual dysfunction METHODS The database included men (N=604) using the same treatment protocol with Li-ESWT ( ED1000 Medispec applicator; Active Rx N=440; Sham Rx N=164).; Li-ESWT was applied to the corpora 2X weekly for 3 weeks and repeated after a 3 week rest period for a total of 12 Rx sessions. Changes in IIEF-EF domain were assessed at baseline and at mid-treatment; 1 month (FU1), 3 months (3M), 6 months (FU2) 12 (FU3) and 24 months (FU4) post treatment. Objective measurements of efficacy were assessed by various measures including penile US Doppler (Greece, penile triplex), Flow Mediated Dilation (FMD, Israel) and nocturnal penile tumescence (NPT, USA). Incidence and severity of adverse events were recorded. RESULTS Results of pooled data revealed that 55%, 61%, 65% and 71% of the subjects achieved a minimally clinical important difference (MCID) in their –IIEF-EF score from baseline at midterm, FU1, FU2 and FU3 and FU4 respectively. The mean change in IIEF-EF from baseline was 5, 6.8, 6.2 and 7 points at midterm, FU1, FU2 and FU3 and FU4 respectively. Li-ESWT applied via the ED-1000 was well tolerated; reported AEs were mild and resolved spontaneously. Results from selected studies in which objective measures were assessed are presented in table 1. CONCLUSIONS In these pooled data analyses, Li-ESWT was demonstrated to be safe and effective for the treatment of ED in men considered responders as well as non-responders to PDE5i therapy. Li-ESWT was well tolerated, adverse events were mild, self-limited and resolved spontaneously. These results support the role of Li-ESWT in the management of men with ED. Table 1. Results from selected studies in which objective measures were assessed Country USA Greece Israel Israel Israel RCT RCT RCT1 †Group D ††RCT2 Response to PDE5i prior to Li-ESWT Responders Responders Responders Responders Poor responders ‡MCID II-EF EF domain 62% vs. 37.5% in treatment vs. placebo group, p=0.025 58.6% vs.12.5% in treatment vs. placebo group, p=0.003 49.3% vs. 9.1% in treatment vs. placebo group, p<0.01 45.8% vs. 12.5% in treatment vs. placebo group, p=0.021 40.5% vs. 0% in treatment vs. placebo group, p=0.001 IIEF-EF mean change from baseline 6.1 vs.2.5 points in treatment vs. placebo group, p=0.02 4.6 vs.1.4 points in treatment vs. placebo group, p<0.001 5.3 vs. 0.2 in treatment vs. placebo group, p<0.001 5.5 vs. -0.1 points in treatment vs. placebo group, p<0.001 5.4 vs. 0.1 points in treatment vs. placebo group, p<0.001 US Doppler NA PSV increased by 4.5 vs. 0.6 cm/sec in treatment vs. placebo, p<0.001 NA NA NA FMD NA NA Mean AUC difference, treatment vs. placebo, 361.3 p=0.002 Mean AUC difference, treatment vs. placebo, 316.9 p=0.002 Mean AUC difference, treatment vs. placebo, 276.2 p=0.001 NPT Mean difference treatment vs. placebo, 0.52 p=0.016 NA NA NA NA Population 103 pt. (treatment-84, placebo-40) 46 pt. (treatment-31, placebo-15) 89 pt. (treatment-59, placebo-30) 24 pt. 55 pt. (treatment- 37, placebo-18) †Group D-Subjects from the placebo group of the RCT study, who did not demonstrated significant improvement in their IIEF-EF domain score, received an additional treatment course with an active shockwave applicator. The treatment protocol those subjects received was identical to the original study protocol.††RCT-Subjects that were poor responders to PDE5i prior to Li-ESWT, were allowed PDE5i use at baseline and following last treatment until FU1 assessment (all pt. achieved erection hardness score ≤2 at baseline, and EHS≥3 in 62% at FU1 . Population pilot study included).‡MCID (Rosen)-Success define as: an increase in the IIEF-EF Domain score ≥2 points from baseline for mild ED, ≥5 points for moderate ED, and ≥7 points for severe ED. ED Severity define as : Mild ED: IIEF-EF score 17-22 ,Moderate ED: IIEF-EF score 11-16, Severe ED: IIEF-EF score 0-10. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e905-e906 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.Metrics Author Information Robert Feldman More articles by this author Bela Denes More articles by this author Boaz Appel More articles by this author Satya Srini Vasan More articles by this author Tamar Shultz More articles by this author Arthur Burnett More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...