The Safety and Efficacy of Li-ESWT in 604 patients for Erectile Dysfunction: Summary of Current and Evolving Evidence
Robert A. Feldman, Bela S. Denes, Boaz Appel, Satya S. Vasan, Tamar Shultz and Arthur L. Burnett
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
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 of pooled data revealed that 56.4%, 66.5%, 63.2% and 62.1% of the subjects achieved a minimally clinical important difference (MCID) in their –IIEF-EF score from baseline at midterm, FU1, FU2 and FU3 respectively. The mean change in IIEF-EF from baseline was 5.4, 7.4, 6.4 and 5.9 points at midterm, FU1, FU2 and FU3 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.
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.
Source of Funding: Medispec Ltd.