Treating erectile dysfunction with a combination of Low-intensity shock waves and Vacuum erectile device

Antonio Ruffo1, Francesco Trama2, Enrico Maisto2, Antonio Russo2, Leo Romis3, Giovanni Di Lauro1, Giuseppe Romeo2, Fabrizio Iacono2
  • 1 Ospedale Santa Maria delle Grazie (Pozzuoli)
  • 2 Università di Napoli Federico II (Napoli)
  • 3 Ospedale Santa Maria delle Grazie (Napoli)


Erectile dysfunction (ED) is the main complaint in male sexual medicine and it can affect patients (pts) physically and psychologically [1]. The primary goal in the management of ED would be to cure it when possible, and not just to treat the symptom alone [2]. One of the new promising treatments is Low intensity shock waves (LISW). In this study, we combine LISW [3]and a vacuum Device[4] for the treatment of ED.

Materials and Methods

This is a single-blind, two-arm randomized study. Sixty-five pts with mild to severe ED were enrolled. Group A (30 pts) underwent four weekly treatment sessions of LISW. During each session, 3600 shocks at 0.09 mJ/mm2 were given, 900 shocks at each anatomical area in right and left corpus cavernous, and right and left crus. Group B (30pts) underwent LISW plus vacuum device rehabilitation for 6 months.
he principle of Vaccum erection device therapy is so mechanically create negative pressure surrounding the penis to engorge it with blood and then restrain blood egress from the organ to maintain the erection like effect.
It is placed directly over the flaccid penis and operated, and after the penis is erected an elastic constriction ring or band is positioned at the base of the penis; then the vacuum is released and the device is removed.
They were investigated using the International Index of Erectile Function (IIEF-5) and the Sexual Encounter Profile (SEP) diaries (SEP- Questions 2 and 3).


At 6 months’ follow-up, in Group A was reported a mean improvement of IIEF-5 scores from 11.05 ± 5.35 at baseline to 20.06 ± 5.28, SEP-Q2 from 48% to 72%, SEP-Q3 from 28% to 55%. In Group B was reported a mean improvement of IIEF-5 scores improved from 10.54 ± 6.87 at baseline to 22.06 ± 5.28, SEP-Q2 from 52% to 85%, SEP-Q3 from 30% to 62%.


The finding of this study demonstrate that LISW plus Vacuum device therapy gives better results than LISW alone in the treatment of ED. LISW induces neovascularization and it can improve cavernously arterial flow which can result in an improvement of erectile function by releasing tissue factors (NO, VEGF). The vacuum device using the negative pressure generated by the apparatus, enables a greater influx of arterial blood within the cavernous bodies with an increase in oxygen saturation at microvascular level[5].


This combination therapy is proved to be effective and without side effects.
It can be a safe and valid tool in the management of erectile dysfunction or in men that can not undergo treatment with PDE5-i.


1. 1. Hatzimouratidis K, Amar E, Eardley I, Giuliano F, Wespes E; European Association of Urology.
Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2010
2. Lewis RW, Fugl-Meyer KS, Corona G, et. Al. Defnitions/Epidemiology/risk factor for sexual dysfuntion. J Sex Med 2010; 7:1598-607.
3. Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, Di Lauro G, Iacono F. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz. Urology 2015