Comparison of the Efficacy and Safety of Low-Intensity Extracorporeal Shock Wave Therapy Versus On-Demand Sildenafil for Erectile Dysfunction

Qi Lei; Dong Wang; Chunhui Liu; Zhigang Ji; Su Yan

Disclosures

Transl Androl Urol. 2021;10(2):860-868. 

In This Article

Abstract and Introduction

Abstract

Background: Low-intensity extracorporeal shock wave therapy (Li-ESWT) is an effective therapy for erectile dysfunction (ED) but is not widely recognized and applied. This prospective nonrandomized study aimed to investigate the efficacy and safety of Li-ESWT.

Methods: After a 4-week washout period of past ED treatment, patients entered one of 2 active treatment groups, either 9-week Li-ESWT or 100 mg on-demand sildenafil. Patients were evaluated in the first- and third-month following initiation of treatment. The Li-ESWT protocol comprised 2 sessions per week for 3 weeks, which were repeated after a 3-week interval. Patients in the drug group took self-administered sildenafil at a dose of 100 mg before intercourse. The primary outcome was the effectiveness of Li-ESWT measured by the International Index of Erectile Function-5 (IIEF-5) scores. Other measurements included erection hardness score (EHS) and Self-Esteem And Relationship (SEAR).

Results: A total of 78 participants completed the study (46 in the Li-ESWT group and 32 in the sildenafil group). Overall, 26.9% of the participants (21/78) included were psychogenic. In the third month, the outcome measured by IIEF-5 was 21.52 in the Li-ESWT group and 21.26 in the sildenafil group (P>0.05). Proportion of improvement defined by minimal clinically important difference (MCID) criteria was 52.2% in the Li-ESWT group and 59.4% in the sildenafil group (P>0.05). The EHS and SEAR improvement was similar in the 2 groups (P>0.05 at baseline and third month). Transient and mild adverse events were observed in both groups.

Conclusions: In our study, a similar treatment efficacy and safety was shown by the application of Li-ESWT as on demand sildenafil.

Introduction

Erectile dysfunction (ED) can be conceptualized as an impairment in the sexual response's arousal phase and is defined as the consistent inability to attain and/or maintain penile erection sufficient for sexual satisfaction, including satisfactory sexual performance.[1,2] It is a major male sexual disorder affecting 52% of men aged 40–70 years, which is predicted to be a population of 322 million by 2025 worldwide. It is a multifactorial disease that influences the mental health and self-esteem of those affected and the satisfaction of sexual intercourse and quality of life for the couple.

Phosphodiesterase type 5 inhibitor (PDE5i) is considered a safe and effective therapy for ED, and works by relaxing smooth muscle cells and filling penile corpora cavernosa.[3] However, the medication needs to be taken on-demand before sexual activity, which may be burdensome and inhibit sexual activity's spontaneity. Also, the medication needs to be taken long-term to maintain sufficient erectile function. Furthermore, for various reasons, 35% of patients may not respond to PDE5i.[4]

Recently, low-intensity extracorporeal shockwave therapy (Li-ESWT), which was originally applied to ischemic heart disease, was introduced as a treatment for the penis.[5] Erectile function is altered by Li-ESWT mainly through local neovascularization with multiple potential mechanisms, reversing pathologic processes in erectile tissue such as re-innervation, and reducing inflammation and oxidative stress.[6] Several studies have shown the efficacy and safety of Li-ESWT for ED in both animal models[7,8] and clinical trials.[4,5,8–18] Systematic reviews have also revealed that Li-ESWT could improve ED measured by both patient self-reports and instrument monitored outcomes.[17,19]

The efficacy and safety of PDE5i have been validated as a treatment for ED; Li-ESWT is also effective in treating ED, but has not yet been widely recognized. To our knowledge, there has been no comparative analysis of these 2 treatments using validated instruments. Herein, we designed a prospective nonrandomized interventional study to compare the efficacy and safety of on-demand 100 mg oral sildenafil and Li-ESWT therapy for ED patients. We present the following article in accordance with the TREND reporting checklist (available at http://dx.doi.org/10.21037/tau-20-1069).

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