New therapeutical approach to erectile dysfunction : Using Low intensity shock-wave (LISW) therapy. A single group experience on 84 patients using two different devices.

Fabrizio Iacono1, Antonio Ruffo1, Domenico Prezioso1, Giuseppe Romeo1, Ester Illiano1, Leo Romis2, Giovanni Di Lauro2
  • 1 Università Federico II (Napoli)
  • 2 Ospedale Santa Maria delle Grazie (Napoli)

Objective

The aim of this paper is to prove the effectiveness and safety of low intensity shock waves (LISW) therapy in the management of erectile dysfunction (ED) comparing two different devices : Storz Duolith® sd1 and Direx Renova®. Shock waves have been recently used to treat ED with good results [1]. Several devices have been used [2], giving different outcomes. Renova® uses linear focused shock waves suggesting a better organ coverage while Storz Duolith® uses defocused shock waves. Our goal is to prove if LISW can be a valid therapeutical option to treat men suffering from mild to severe ED and to see which device is more appropriate.

Methods and results

For this study we enrolled 84 men with mild to severe ED. The patients (pts) were randomly divided in two groups : Grouop A underwent 4 weekly treatment using a Storz Duolith® sd1 and Group B underwent ten weekly treatments using a Direx Renova® device. At each session, in both groups, we treated four anatomical area : left/right crus penis, left/right corpus cavernosum. In group A were applied 900 shocks, 0.09 mJ/mm2 intensity at 240 shocks/min at each anatomical site for a total of 3600 shocks while in group B were given 1000 shocks, 0.33 mJ/mm2 frequency at 6 Hz at each anatomical site for a total of 4000 shocks. Patients' erectile function was assessed by IIEF-EF at two months post treatment. Four patients dropt out of treatment.
In group A mean IIEF-EF improved from 13.7 at baseline to 21.5 at two months follow-up. In group B mean IIEF-EF increased from 12.2 at baseline to 20.8 at two months follow-up.

Discussion

We observed that LISW gives a significant improvement of erectile function in both groups. Shock waves improves penile hemodynamics inducing neovascularization in the treated tissues, releasing angiogenesis-releted growth factors such as eNOS, VEGF, PCNA. In both groups we did not report any side effects. Furthermore the results of this study did not show a statistically significant difference between the two groups treated with two different devices. So we strongly believe that LISW, no matter the device used, is a safe and valid tool in the management of ED [3]. This treatment is repeatable, easy to administer and free of contraindications.

References

1. Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction.
Ther Adv Urol. Apr 2013; 5(2): 95–99.
2. Iacono F, Ruffo A, Prezioso D, Romeo G, Illiano E, Romis L, Di Lauro G. Low intensity shock wave (LISW) treatment (Renova) in order to improve male sexual function: A preliminary data on 42 patients. J Sex Med 2014;11(suppl 1):1-29
3. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med 2012 Jan;9(1):259-64

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