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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
A prospective, randomized study using transdermal electromotive administration of verapamil and dexamethasone for Peyronie's disease.
Journal of Urology 2004 April
PURPOSE: Uncontrolled studies with intraplaque electromotive administration of verapamil and dexamethasone have demonstrated objective improvements in Peyronie's disease. We performed a prospective controlled study to assess the efficacy of intraplaque electromotive verapamil/dexamethasone vs electromotive lidocaine.
MATERIALS AND METHODS: Patients with Peyronie's disease were randomized into a study group (47 patients) and a control group (49 patients). For each treatment session an electrode receptacle was sited over the plaque and filled with either 5 mg verapamil and 8 mg dexamethasone (study group) or 2% lidocaine (control group), and a 2.4 mA electric current was applied for 20 minutes. All patients were scheduled for 4 sessions per week for 6 weeks. Assessment before and after treatment included measurements of plaque volume and penile curvature, and pain on erection (from questionnaire).
RESULTS: A total of 37 patients in the study group and 36 in the control group completed treatment courses. In the study group there were significant decreases in median plaque volume from 824 to 348 mm, and in penile curvature from 43 to 21 degrees. In the control group median volume and curvature were unchanged. The difference in results after treatment between the 2 groups was also significant. Significant pain relief occurred in both groups, transient in the control group and permanent in the study group. All patients experienced temporary erythema at the electrode site. There were no other side effects.
CONCLUSIONS: Intraplaque electromotive verapamil and dexamethasone induce substantial objective improvement in Peyronie's disease compared to electromotive lidocaine administration.
MATERIALS AND METHODS: Patients with Peyronie's disease were randomized into a study group (47 patients) and a control group (49 patients). For each treatment session an electrode receptacle was sited over the plaque and filled with either 5 mg verapamil and 8 mg dexamethasone (study group) or 2% lidocaine (control group), and a 2.4 mA electric current was applied for 20 minutes. All patients were scheduled for 4 sessions per week for 6 weeks. Assessment before and after treatment included measurements of plaque volume and penile curvature, and pain on erection (from questionnaire).
RESULTS: A total of 37 patients in the study group and 36 in the control group completed treatment courses. In the study group there were significant decreases in median plaque volume from 824 to 348 mm, and in penile curvature from 43 to 21 degrees. In the control group median volume and curvature were unchanged. The difference in results after treatment between the 2 groups was also significant. Significant pain relief occurred in both groups, transient in the control group and permanent in the study group. All patients experienced temporary erythema at the electrode site. There were no other side effects.
CONCLUSIONS: Intraplaque electromotive verapamil and dexamethasone induce substantial objective improvement in Peyronie's disease compared to electromotive lidocaine administration.
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