Verapamil Versus Saline In Electromotive Drug Administration For Peyronie's Disease: A Double-Blind, Placebo Controlled Trial
Main Category: Urology / NephrologyArticle Date: 20 Mar 2007 - 11:00 PDT
'Verapamil Versus Saline In Electromotive Drug Administration For Peyronie's Disease: A Double-Blind, Placebo Controlled Trial'
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UroToday.com- The search for less invasive treatments for Peyronie's disease continues. Transdermal drug delivery was proposed to be superior to oral and injection therapy because it bypasses hepatic metabolism and minimizes the pain and trauma of injection. Verapamil has been widely investigated and used as drug therapy for Peyronie's disease in recent years due to its proposed effect on wound healing due to an inhibitory effect on fibroblasts. It is also thought to inhibit the cytokine formation and release that are known to stimulate scar formation.
Several mechanisms for verapamil delivery have been investigated, including topical therapy, injection therapy and through inotophoresis or electromotive drug administration (EMDA). Iontophoresis enhances transdermal drug transport via direct electrophoresis, electro-osmosis and enhanced diffusion. It has been shown that studies of tunica albugineal tissue have appreciable levels of verapamil after EMDA.
A recent study by J. M. Greenfield, Larry Levine and colleagues from Rush University in Chicago examined the efficacy of verapamil delivered via EMDA for the treatment of Peyronie's disease. The study is published in the March 2007 issue of the Journal of Urology.
A double-blind, placebo controlled trial of verapamil versus saline delivered via EMDA was performed to better assess the efficacy of this treatment modality. A total of 23 patients were randomized to the verapamil group (group 1) and 19 were randomized to the saline group (group 2). Group 1 received 10 mg of verapamil in 4 cc of saline delivered via a Mini-Physionizer device at a power of 2.4 mA for 20 minutes. Treatments were done twice weekly for a total of 3 months. Physical exam and duplex ultrasonography were performed prior to and at the conclusion of the study to assess results.
Analysis of the results showed that 15 patients from group 1 (65%) had measured improvement in curvature (mean 9.1 degrees), 5 (22%) showed no change and in 3 (13%) the condition worsened. In group 2, 11 patients (58%) had measured improvement (mean 7.6 degrees), 7 (35%) had no change, and 1 (5%) the condition worsened. When examining patients that showed significant improvement (20 degreed or greater), seven patients (30%) in group 1 and 4 (21%) in group 2 met this criterion.
Although a greater percent of patients treated with verapamil in the EMDA protocol had a measured decrease in curvature, the results were not statistically different. This treatment option may still be a choice for patients that wish to avoid injection therapy or surgical correction and has the added advantage of being able to be performed at home.
Greenfield JM, Shah SJ, Levine LA
J Urol. 2007 Mar; 177(3):972-5
Reviewed by UroToday.com Contributing Editor Michael J. Metro, MD
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