New Therapeutical Procedures of Peyronie’s Disease: Transfer Capacitive Resistive Energy in Association with Hydroelectrophoresis with Verapamil
Introduction: Efficacy evaluation of a new treatment, improving the symptoms of Peyronie’s disease (PD) in patients with a curvature deformity < 30° and with an onset of symptoms of at least 6 months before the treatment. We investigated the effects of Transfer Capacitive Resistive Energy (TCARE) therapy accompanied by hydroelectrophoresis (HEP), a new electromotive system, for the transcutaneous delivery of Verapamil in men with PD. Materials and Methods: Sixty-one patients affected by PD were enrolled. They were randomly divided into two groups: Group 1 (n. 30 patients, median age 56, range 49-62 yrs) was assigned to receive only TCARE; Group 2 (n. 31 patients; median age 58, range 51-60 yrs) received both TCARE and HEP. Every patient underwent 16 treatment sessions, 2 sessions a week for each group. TCARE was performed with resistive energy and each treatment lasted 15 minutes. In Group 2 TCARE was also followed by HEP (with Hydro4and apparatus, Swiss4Med SA, Morbio Inferiore, Switzerland). HEP delivered 10 mg/4ml of Verapamil per session (2 ampoules of Verapamil 5mg/2ml each; Isoptin, BGP products, Rome, Italy) for a 20-minute lasting. The endpoints were: a pain increase in erection, the International Index of Erectile Function questionnaire (IIEF-15) scale score, and penile curvature (in degrees). They were evaluated at the beginning of the study, at the end and three months after the discontinuation of the treatment. The pain was measured by using the Numeric Rating Scale (NRS) for pain 1-10 and the erectile function by IIEF15. The penile curvature was measured instead by using photography, a personal paper protractor after injection of PGE1 10 mcg. Some side effects during or immediately after the treatment were recorded. Statistical analysis was performed using ANOVA for repeated measurements, corrected with Bonferroni. The side effects were compared between the two groups using the Chi-square Test (test χ2). Results: The pain, the erectile function, and the penile curvature were all significantly improved with both treatments (p<0.001). In Group 2 (TCARE + HEP) the improvement was greater than Group 1 (p<0.001 for IIEF and curvature; p <0.05 for pain). The amelioration was maintained until three months after the end of treatment. No relevant side effects were observed or indicated by the patients. Conclusions: TCARE followed by Verapamil administration by HEP is an effective and safe treatment for PD.