Comparison of the efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand sildenafil for erectile dysfunction.

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.