CHICAGO—Low-intensity shock wave therapy (LI-ESWT) to the penis can effectively treat vasculogenic erectile dysfunction (ED), according to a new study.
The treatment was associated with significant improvements in erectile function as measured using the International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) questionnaire and significant improvements in penile hemodynamic parameters, investigator Yoram Vardi, MD, of Rambam Medical Center in Israel, reported at the World Meeting on Sexual Medicine.
The study included 60 men with vasculogenic ED who had responded to phosphodiesterase-5 (PDE-5) inhibitors. Subjects had a mean age of 56.5 years and at screening had an IIEF-ED score of 19 or higher with PDE-5 inhibitor use. After a one-month washout, the men underwent a baseline assessment of erectile function using the IIEF-ED questionnaire and objective local endothelial function testing using penile flow mediated dilatation (FMD). In a blinded fashion, researchers randomly assigned men to receive either LI-ESWT or a sham treatment.
The average IIEF-ED score at baseline was 12.3 (without PDE-5), with no statistically significant difference between the treatment and sham groups.
The treatment protocol included 12 sessions of LI-ESWT twice weekly for three weeks, repeated after a three-week no-treatment interval. No PDE-5 inhibitor was permitted during the study. Erectile function was re-evaluated one month after treatment. For subjects who did not respond sufficiently to the treatment (defined as an increase in IIEF-ED score of less than five points), an additional 12 session shock wave treatment was offered.
The average increase in IIEF-ED score between baseline and one month post treatment follow up was 6.7 for the treatment group compared with 2.9 for the sham group. In addition, 65% of the treated group had a five-point increase or greater in IIEF-ED score compared with only 25% of the sham group. The differences between the groups were statistically significant.
FMD tests showed that all penile hemodynamic parameters increased significantly only in the treatment group. No adverse events were reported. All other evaluated parameters showed similar results. Of 23 subjects who underwent a second shock wave treatment, 16 (80%) were from the sham group. One month after the end of the second treatment session, the IIEF-ED score of these 16 patients increased significantly from an average of 11.8 to 16.6.
The meeting is cosponsored by the International Society for Sexual Medicine and Sexual Medicine Society of North America.