Treatment of Vasculogenic Erectile Dysfunction with Piezowave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED^®) Technique. A Prospective, Multicentric, Placebo-Controlled Study

Low intensity shockwave (LiSW) treatment is known to improve revascularization. The method has been evaluated and is used to treat vasculogenic erectile dysfunction (ED). The present study aimed to demonstrate the efficacy of a linear focused piezoelectric shockwave device (Richard Wolf/ELvationPiezowave²) to treat patients with vasculogenic ED using a novel linear shockwave tissue coverage LSTC-ED^® technique. A total of 75 patients were treated using the Piezowave² device and the LSTC-ED^® technique. Patients’ erectile function was evaluated using the modified IIEF-5 (International Index of Erectile Function) scale at the beginning of treatment and at 1 month post treatment; patients were additionally questioned using our own Treatment Satisfaction Questionnaire (TSQ). The study also included a group of 50 patients treated by placebo; the outcomes of both groups were compared. The average IIEF-5 score of patients in the treatment group increased from 14.4 at baseline to 18.6 at 1 month post treatment. According to the IIEF-5 scale, treatment was successful in 81.33% of patients (61/75). According to the Treatment Satisfaction Questionnaire (answers 1 to 3 of the TSQ), treatment was successful in 77.3% of patients (58/75). In the placebo group of 50 patients only 5 patients showed an improvement based on IIEF score, and 8 reported an improvement based on their answers to the TSQ. No significant adverse effects were observed during treatment or in the follow-up period. The