In an article by Gruenwald et al published in Ther Adv Urol (2013) the authors report a novel treatment for patients with erectile dysfunction.
In an initial study of 15 patients, one month after LI-ESWT, the erectile function in all the men improved. An increase by more than five points in the International Index of Erectile Function – Erectile Function (IIEF-EF) domain score was noted in 14 men, and by more than 10 points in 7 men. Five men did not respond to LI-ESWT. Overall, the average increase in the IIEF-EF domain scores was 7.4 points (13.5–20.9, p = 0.001). Furthermore, erectile function and penile blood flow were measured using nocturnal penile tumescence (NPT) and venous occlusion plethysmography of the penis, respectively. LI-ESWT improved all NPT parameters, especially in the 15 men who responded to LI-ESWT, where significant increases in the duration of the erections and penile rigidity were recorded. Penile blood flow also improved significantly and a strong correlation was found between the increase in the IIEF-EF domain scores and the improvement in penile blood flow at the 1-month follow-up examination. At the 6-month follow-up visit, 10 men reported that they still had spontaneous erections that were sufficient for penetration and did not require PDE5i support.
In view of these very successful preliminary results, the effect of LI-ESWT was further investigated in a group of men whose ED was more severe than that of the first group of study patients [Gruenwald et al (2012)]. The average initial IIEF-EF domain score of the 29 men who were recruited for this second study was 8.8 ± 1. All 29 men had not responded to oral PDE5i therapy, and had multiple cardiovascular risk factors (23), cardiovascular disease (11), and diabetes mellitus (14). The specific aim of this second study was to investigate the ability of LI-ESWT to convert nonresponders to PDE5i therapy to PDE5i responders, so that they were able to achieve vaginal penetration with oral PDE5i therapy. The results were comparable to the first study. Three months after the completion of the LI-ESWT protocol, the IIEF-EF domain scores improved by at least five points in 22 men (76%) and the mean IIEF-EF domain score increased by 10 points (to 18.8 ± 1, p < 0.0001). At the end of the study, eight men (28%) achieved normal erections (IIEF-EF domain score greater than 25) and 21 of the 29 men were able to achieve vaginal penetration with oral PDE5i therapy. Overall, 21 men (72%) were converted to PDE5i responders. Cavernosal blood flow and penile endothelial function, as measured again by venous occlusion plethysmography of the penis (flow-mediated dilatation techniques [FMDs]), were both found to be significantly improved (p = 0.0001) in the men who responded to LI-ESWT.
These preliminary results are very interesting, but require confirmation in larger studies.