Low-intensity shock wave therapy shows efficacy over 6 weeks in men with moderate vasculogenic erectile dysfunction (ED), according to new trial findings.
In the trial, investigators randomly assigned 70 patients at a single center to 12 total sessions of low-intensity shock wave therapy or sham therapy twice weekly for 6 weeks. Each group had 35 patients. Using the ARIES 2TM device, they applied 5000 impulses at 0.096 mJ/mm2 energy flux density and 5 Hz frequency to the intervention group. All participants had previously shown good or partial response to phosphodiesterase-5 (PDE5) inhibitors.
At 3 months, a minimal clinically important difference in the International Index of Erectile Function (IIEF-EF) scores was achieved by 79% of the shock wave group compared with 0% of the sham group, Nikolaos Pyrgidis, MD, MSc, of the Institute for the Study of Urological Diseases in Thessaloniki, Greece, and colleagues reported in The Journal of Urology. Dr Pyrgidis’s team observed a minimal clinically important difference with shock wave therapy at 1 month in 59% of the treated group compared with 2.9% of the sham group, respectively.
Mean IIEF-EF scores improved a significant 3.9 and 4.4 points more from baseline to 1 and 3 months, respectively, with treatment vs sham therapy. Low-intensity shock wave therapy also significantly improved the proportion of patients who responded “yes” to question 3 of Sexual Encounter Profile diaries at 1 month (19%) and at 3 months (23%).
“Our findings suggest that low-intensity shock wave therapy is highly effective and safe in patients with moderate vasculogenic erectile dysfunction,” the authors wrote.
The investigators acknowledged study limitations, including the small number of patients and a relatively short follow-up period that did not permit them to evaluate the long-term efficacy of the shock wave therapy.
“Importantly, since we applied a specific low-intensity shock wave therapy protocol, our results may not be extrapolated to other low-intensity shock wave therapy generator systems or protocols.”
Disclosure: This research was supported by Dornier MedTech GmbH. Please see the original reference for a full list of disclosures.
Kalyvianakis D, Mykoniatis I, Pyrgidis N, et al. The effect of low-intensity shock wave therapy on moderate erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial. J Urol. 2022 Aug;208(2):388-395. doi:10.1097/JU.0000000000002684