DOES LOW-INTENSITY EXTRACORPOREAL SHOCK WAVE THERAPY HAVE A PHYSIOLOGIC EFFECT ON ERECTILE FUNCTION? SHORT-TERM RESULTS OF A RANDOMIZED, DOUBLE-BLIND, SHAM-CONTROLLED STUDY

The Journal of Urology Volume 187, Issue 4, Supplement , Page e606, April 2012
DOES LOW-INTENSITY EXTRACORPOREAL SHOCK WAVE THERAPY HAVE A PHYSIOLOGIC EFFECT ON ERECTILE FUNCTION? SHORT-TERM RESULTS OF A RANDOMIZED, DOUBLE-BLIND, SHAM-CONTROLLED STUDY
Vardi, Appel, Kilchevsky, Gruenwald
 

Affiliations

  • ·Haifa, Israel
INTRODUCTION AND OBJECTIVES
Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs. Our aim is to study the clinical and physiologic effect of LI-ESWT on the erectile function of men with erectile dysfunction (ED) and cardiovascular risk factors who are phosphodiesterase-5 inhibitor (PDE5i) responders.
METHODS
After a 1-month PDE5i washout period, 67 men were randomized in a 2:1 ratio to receive either 12 sessions of LI-ESWT (treated) or sham therapy (sham-treated). Erectile function and penile hemodynamics were assessed prior to the first treatment (V1) and one month after the final treatment (FU1) using validated sexual function questionnaires and veno-occlusive strain gauge plethysmography.
RESULTS
Clinically, we found a significantly greater increase in the International Index of Erectile Function-ED (IIEF-ED) domain score from V1 to FU1 in the treated group versus the sham-treated group (6.7±0.9 vs. 3.0±1.4 [mean ± SEM], P=0.0322). Nineteen men in the treated group who were unable to achieve erections hard enough for penetration initially (Erection Hardness Score (EHS) ≤ 2) were subsequently able to achieve erections firm enough for penetration (EHS ≥ 3) following treatment, compared to none in the sham-treated group. Physiologically, penile blood flow significantly improved in the treated group versus the sham-treated group (maximal post-ischemic penile blood flow: 8.2 ml/min/dL vs 0.1 ml/min/dl, p<0.0001). None of the men experienced discomfort or reported any adverse effects due to the treatment.
CONCLUSIONS
This is the first randomized, double-blind, sham-controlled study showing that LI-ESWT has a positive short-term clinical and physiologic effect on the erectile function of men who respond to oral PDE5i therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with ED.
Source of Funding: Medispec Ltd, Israel provided a partial unrestricted grant that included the use of the focused shockwave probe, Omnispec ED1000.
PII: S0022-5347(12)02381-6