Responder Analysis from a Multicentered Survey of Men’s Perception who underwent Low Intensity Extracorpeal Shock Wave Therapy (LIESWT), as a Novel and Experimental Intervention for the Treatment of Erectile Dysfunction (ED)

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Introduction

Low-intensity extracorporeal shock wave therapy (LI-ESWT) is an experimental, non-FDA approved yet novel treatment modality that has recently been developed for treating erectile dysfunction (ED). The basic science hypothesis concerning the mechanism of action is that LI-ESWT causes microtrauma at the cellular level which may stimulate the release of angiogenic factors, and cause neovascularization of the treated tissue. Completed research report improvement in erectile functioning, decreased reliance on phosphodiesterase inhibitor medication as well as the regained ability to attain and maintain natural or spontaneous erections. We report here a preliminary responder analysis of men who had LIESWT as part of their erectile dysfunction treatment paradigm.

Objective
We report here the preliminary responder analysis results of an internet based, random retrospective survey on past users of this novel technology for the treatment of ED.

Methods
A random survey was sent to a convenience sample from 10 national centers (Hawaii, Washington (2), Portland, Utah, Oklahoma (2), Arizona, California, Oregon) to men who had completed 6 sessions of LIESWT for the treatment of ED. The internet-based survey examined patient perception and experience of this intervention. We present the responders analysis ( n=47) . All procedures were performed by sexual medicine health care professionals after a detailed and comprehensive history, physical examination, and laboratory/hormonal assessment.

Results
Surveys were completed anonymously over the course of a 2-week period by men who had undergone 6 sessions of LIESWT. 28% of participants were aged 50-59; whereas 63 percent were over the age of 60. Other adjunctive treatments included erectile dysfunction (ED) medication, testosterone replacement therapy (TRT), previous plasma rich protein injections and Intracavernosal injections. 83% of those who got the procedure noticed an improvement within the first 5 weeks. 89% of responders noticed an improvement in erection firmness whereas 81% noticed an improvement in quality of erections. 77% of responders noticed an improvement in their level of sexual satisfaction and 72% noticed an improvement in sexual pleasure. 60% noticed an improvement in the overall quality of the orgasm. Overall, the procedure was well tolerated with <0.5% (3/670 procedures) adverse events reported (1 pain in penis, 1 “knot in penis” and 1 pain in the head) reported. Overall, 65% of LIESWT users would recommend this procedure to a friend.

Conclusions: LIESWT is a novel and experimental intervention for the treatment of ED. While it shows excellent promise, most data contain some shortcomings, including: small numbers, limited follow-p ,and various non-standardized protocols. Results from a double-blind, randomized, control trial confirm that LI-ESWT may result in significant clinical improvement of erectile function and a shift towards improvement in penile hemodynamics without any adverse effects. Our participant responder analysis demonstrates that LIESWT improves erectile function and other sexuality parameters. Further larger, randomized sham-controlled, and comparative clinical trials are warranted before LI-ESWT may be considered new standard of care for men with vasculogenic ED.

LeeAnn Prochaska (1). Josephine Schultz (1),Michael L Krychman MD (2)

1-Revibe Men’s Health 2Southern California Center for Sexual Health and Survivorship Medicine Inc , Vigor Services