ABSTRACT
Introduction: Efficacy evaluation of a new treatment, improving the symptoms of Peyronie’s disease (PD) inpatients 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 byhydroelectrophoresis (HEP), a new electromotive system, for the transcutaneous delivery of Verapamil in menwith PD. Materials and Methods: Sixty-one patients affected by PD were enrolled. They were randomly dividedinto 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 patientunderwent 16 treatment sessions, 2 sessions a week for each group. TCARE was performed with resistive energyand 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 ampoulesof Verapamil 5mg/2ml each; Isoptin, BGP products, Rome, Italy) for a 20-minute lasting. The endpoints were: apain increase in erection, the International Index of Erectile Function questionnaire (IIEF-15) scale score, andpenile curvature (in degrees). They were evaluated at the beginning of the study, at the end and three months afterthe discontinuation of the treatment. The pain was measured by using the Numeric Rating Scale (NRS) for pain1-10 and the erectile function by IIEF15. The penile curvature was measured instead by using photography, apersonal paper protractor after injection of PGE1 10 mcg. Some side effects during or immediately after thetreatment were recorded. Statistical analysis was performed using ANOVA for repeated measurements, correctedwith 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 bothtreatments (p<0.001). In Group 2 (TCARE + HEP) the improvement was greater than Group 1 (p<0.001 for IIEFand 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 Verapamiladministration by HEP is an effective and safe treatment for PD.