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


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

In This Article

Abstract and Introduction


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.


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