Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study.

Eric Chung,Ross Cartmill

doi:10.1016/j.esxm.2021.100384

Abstract

IntroductionLow intensity extracorporeal shock wave therapy (LIESWT) improves erectile function (EF) in men with vascular erectile dysfunction (ED) but longer-term outcomes remain unknown.AimTo evaluate the clinical outcomes of LIESWT at a minimum 5-year follow-up.MethodsThis is an open-label single-arm prospective study involved men with vascular ED who received LIESWT.Main Outcome MeasureChanges in patient demographics, IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, as well as overall satisfaction score (on a 5-point scale) were reviewed at 12, 24, 48, and 60 months after completion of LIESWT. A chi-square contingency analysis was used to examine the relationship between erectile function score and treatment satisfaction, with statistical significance set at 5%.ResultsThe mean follow-up period was 69.9 (63–82; median 76) months. The mean IIEF-5 scores for pretreatment and after treatment at 12, 24, 48, and 60 months were 14.8, 17.6, 16.8, 16.5, and 16.5 while the percentages of patients who reported an improvement in IIEF-5 score by 5 points were 60%, 45%, 40%, and 40%; and EDITS scores >50% were recorded in 70%, 55%, 50%, and 48% of patients at 12, 24, 48, and 60 months post-LIESWT. Ten patients required medical therapy and 2 patients opted for penile prosthesis implantation. The overall satisfaction rate appeared sustained subsequent follow-up (score 4 out of 5; 68% vs 50% vs 40% vs 40% at 12, 24, 48, and 60 months). There were minor time-limited, but no significant adverse event reported.ConclusionThis long-term study showed the observed clinical improvement in EF continues to deteriorate but appears to plateau at 40% clinical efficacy at 48–60 months after completion of LIESWT. The absence of penile pain and deformity at 5-year follow-up supports the long-term safety data of LIESWT in men with ED.Chung E, Cartmill R. Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study. Sex Med 2021;9:100384.

Highlights

Low intensity extracorporeal shock wave therapy (LIESWT) improves erectile function (EF) in men with vascular erectile dysfunction (ED) but longer-term outcomes remain unknown
The mean Index of Erectile Function (IIEF)-5 scores for pretreatment and after treatment at 12, 24, 48, and 60 months were 14.8, 17.6, 16.8, 16.5, and 16.5 while the percentages of patients who reported an improvement in IIEF-5 score by 5 points were 60%, 45%, 40%, and 40%; and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores >50% were recorded in 70%, 55%, 50%, and 48% of patients at 12, 24, 48, and 60 months post-LIESWT
Published systematic review and meta-analyses showed encouraging clinical outcomes in men with ED.[3−7] Zou et al[4] reported LIESWT was 8.31 [95% confidence interval (CI): 3.88−17.78] times more effective than sham therapy in improving erection based on erection hardness score (EHS), and 2.50 times in terms of erectile function scores

Summary

Introduction

Low intensity extracorporeal shock wave therapy (LIESWT) improves erectile function (EF) in men with vascular erectile dysfunction (ED) but longer-term outcomes remain unknown. Several sexual medicine societies have adopted LIESWT as a cautious treatment with reasonable clinical efficacy and safety to treat men with ED but should be undertaken in the setting of clinical research.[8,9] The pooled data from meta-analyses including RCTs showed an overall positive effect in terms of IIEF-EF score improvement, the estimates are small (ranging from about 2−4 points of the IIEF-EF) and the heterogeneity high.[8] Most published studies did not extend beyond 2 years follow-up[9] and the question arises whether the observed early improvement in EF can be sustained in the longer-term.[2,3−7] clinical safety data on the impact of shock waves on the penile tissue over a longer period are yet to be fully elucidated. The hypothesis of this study is to determine if observed clinical efficacy and safety of LIESWT remain similar in the long-term?

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