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Nicardipine vs. saline injection as treatment for Peyronie's disease: a prospective, randomized, single-blind trial.

Author(s): Soh J, Kawauchi A, Kanemitsu N, Naya Y, Ochiai A, Naitoh Y, Fujiwara T, Kamoi K, Miki T

Affiliation(s): Department of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan Urology, Fujiwara Urological Clinic, Kyoto, Japan. soh@koto.kpu-m.ac.jp

Publication date & source: 2010-11, J Sex Med., 7(11):3743-9.

Publication type: Randomized Controlled Trial

INTRODUCTION: Various conservative treatments for Peyronie's disease (PD) have been attempted over the years. Intralesional verapamil injection has been tested in prospective randomized studies, but the effect of this treatment seems insufficient. Nicardipine is a calcium antagonist alternative to verapamil and is reportedly more effective in vitro. AIM: The objective of our study was to evaluate the usefulness of intralesional nicardipine injection as a conservative treatment for PD in the transition period of acute and chronic phase. METHODS: Eighty-six patients (age: 38-72 years, mean: 52) were enrolled in this study. A total of 74 patients were assigned randomly to nicardipine group (10 mg diluted in 10 mL of distilled water daily, N=37) and control group (10 mL of saline water, N=37). A total of six injections were administrated biweekly. Mean OUTCOME MEASURE: The subjects were assessed by International Index of Erectile Function (IIEF)-5 and international pain scale. The plaque size was measured by ultrasonography after 20 microg intracavernosal injection of alprostadil (prostaglandin E1). The penile curvature was also measured by taking a photograph at maximum rigidity. RESULTS: A reduction of pain score was seen throughout the course of treatment in both groups with a significant difference between the nicardipine and control groups (multiple analysis of variance test, P=0.019). A significant improvement of IIEF-5 score occurred only in the nicardipine group at 48 weeks after the initiation of treatment (P<0.01). The plaque size was significantly reduced at 48 weeks only in the nicardipine group (12 points, P=0.0004 by paired t-test). The penile curvature was significantly improved in both groups (P<0.01) without significant difference between them (P=0.14). There were no severe side effects, such as hypotension or other cardiovascular events. CONCLUSION: Our findings indicate that intralesional nicardipine injection is clinically effective as a conservative treatment for PD in the transition period of acute and chronic phase. (c) 2010 International Society for Sexual Medicine.

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