Hydroelectrophoresis for Transdermal Administration of Verapamil or of Hyaluronic Acid in Peyronie's Disease: A Prospective, Open Label, Multicenter Study

Abstract

Aim & Objective: To assess the efficacy of a new electromotive system for the transcutaneous delivery of verapamil or of hyaluronic acid to improve the symptoms of Peyronie' s disease (PD) in patients with a curvature deformity of < 30° at the beginning of therapy. Methods & Materials: Sixty-one PD patients were studied. Thirty were randomly assigned to receive verapamil 10 mg/session (Isoptin®, BGP Products, Rome-Italy), (Group 1, median age 56 years, range 49-62), and 31 were randomly assigned to receive hyaluronic acid 8 mg/session (Sinovial®, IBSA, Lodi-Italy) (Group 2, median age 58 years, range 51-56). There were ten sessions, 2 sessions/week for each drug. Each drug was transdermally administered using the hydroelectrophoresis technique and carried out using a Hydro4and apparatus (Swiss4Med SA, Morbio Inferiore, Switzerland). With respect to the efficacy of the drugs studied, the endpoints were: side effects, pain, erectile function, penile deviations and plaque area (cm2) before, and 3 and 6 months after drug administration. The differences were assessed using the Mann-Whitney Rank test (unmatched groups) or using the Wilcoxon Signed Rank test (matched groups). The differences between the groups in terms of side effects were assessed using the chi-square test. Results: No significant difference emerged among the baseline values of the two groups. Pain, erectile function, plaque area and penile deformity significantly improved in both groups after treatment, but a notably higher improvement occurred in the patients in whom hyaluronic acid was administered. Only a few negligible side effects occurred in the Group 1 patients treated with Verapamil, with no significant difference between the groups. Conclusion: Administration of both hyaluronic acid and verapamil using the Hydro4and apparatus is a safe and efficient method for PD therapy.