Résumé
In recent years, low-intensity extracorporeal shockwave therapy (LiESWT) has been reported as a useful and non-invasive treatment for erectile dysfunction (ED). But high-evel studies were lacking. The primary objective of this study was to evaluate the modification of the IIEF-EF score in patients receiving LiESWT treatment compared to those receiving sham treatment. The change was assessed 3 months after the end of treatment.Materials and Methods: this is a prospective, randomized, multicenter, double-blind study comparing the efficiency of 4 weekly sessions of shock waves (3.600 shocks x 4 at 0.09 mJ/mm²) with a placebo treatment (3.600 shocks x 4 at 0 mJ/mm²) to improve erectile function at 3 months. We used the Renova® device (Direx, Israel) wich incorporates an electromagnetic shockwave linear transducer operable to deliver focused shockwaves in a male patient sexual organ. Inclusions took place in 5 centers, from July 2015 to March 2018. We included 153 men under the age of 80 suffering from ED for at least 6 months, in a stable relationship for more than 3 months, reporting more than 3 sexual acts per month, an IIEF-EF score between 6 and 25, and an EHS score ≥1.Results: there was a change of +2 points of IIEF-EF in the treated group compared to 0.6 points in the placebo group (p=0.052). The variation in IIEF-EF is significantly higher in young patients with a good prognosis ED. The difference between 4 and 8 weeks of TOCEFI is not significant (p=0.760). The improvement in ED is greater under iPDE5 than under TOCEFI (p<0.001). No major adverse effects were reported.Discussion: the various studies available in the literature highlight a significant heterogeneity of results through the use of very different machines and protocols. The benefit that can be expected from shockwaves seems modest and includes a significant placebo effect. Other protocols remain to be studied (change in frequency, intensity, number of sessions, etc.).Conclusion: this LiESWT protocol does not seem effective in the treatment of ED.