Shockwave therapy is used as an adjunct to pharmacological treatment in erectile dysfunction; however, no standardized application protocol has yet been established.
To evaluate the effectiveness of adding 5 monthly maintenance shockwave therapy sessions to a 6-weekly-session protocol for the treatment of erectile dysfunction.
A total of 186 men with organic erectile dysfunction, not receiving pharmacological treatment, participated in a multicenter open-label randomized clinical trial. Participants were allocated to receive either 6 weekly sessions of shockwave therapy or the same protocol plus 5 additional monthly maintenance shockwave therapy sessions.
International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, minimal clinically important difference (MCID), Erection Hardness Score, Self-esteem assessed using the Self-Esteem and Relationship Questionnaire, and the incidence of adverse events, assessed at the end of treatment and at 12 and 24 weeks of follow-up.
Ninety-three men were allocated to each study group. Median IIEF-EF score at the end of treatment was 21.5 (interquartile range [IQR] 11), at 12 weeks of follow-up was 23 (IQR 12), and at 24 weeks of follow-up was 22 (IQR 10) in the maintenance protocol group, and 20 (IQR 11) at the end of treatment, 20 (IQR 10) at 12 weeks of follow-up, and 18 (IQR 13) at 24 weeks of follow-up in the weekly protocol. No statistically significant differences were found in these comparisons between the groups. In total, 35.8% of patients in the weekly protocol group and 62.8% in the maintenance protocol group achieved the MCID at 24 weeks of follow-up (P-value adjusted = .02). No significant differences were observed between groups in erection hardness or self-esteem outcomes. No serious adverse events were reported in either group.
A protocol of 6 weekly shockwave sessions plus 5 monthly maintenance sessions may be useful in men with erectile dysfunction, increasing the likelihood of achieving clinical improvement.
Strengths include the sample size, inclusion of men with varying degrees of erectile dysfunction severity, and the randomized clinical trial design. Limitations include the lack of vascular assessment using penile Doppler ultrasound.
The application of a protocol of 6 weekly shockwave therapy sessions plus 5 monthly maintenance sessions, for the treatment of organic erectile dysfunction, does not generate statistically significant changes in the IIEF score up to 6 months of treatment compared to the same protocol without maintenance sessions, but may increase the probability of achieving clinical improvement, without serious adverse events.
The journal of sexual medicine. 2026 Mar 07 [Epub]
Carolina Sandoval-Salinas, Juan M Martinez, Hector A Corredor, Jorge Barba, Francisco Patrón
Boston Medical Research Center, Boston Medical, Bogotá 110221, Colombia., Boston Medical Research Center, Boston Medical, Ciudad de México 11700, México.