USE OF INTRALESIONAL VERAPAMIL TO DISSOLVE PEYRONIES-DISEASE PLAQUE -A LONG-TERM SINGLE-BLIND STUDY

Objectives. Multiple conservative therapies for the treatment of Peyro nie's disease have been offered with variable and poor response rates. Calcium channel blockers have been shown in vitro and in vivo to inhi bit secretion and synthesis of extracellular matrix, including collage n, glycosaminoglycans, and fibronectin, as well as causing increased c ollagenase and anti transforming growth factor-beta activity. Calcium antagonists, including verapamil, are effective in stimulating the rem odeling and degradation of extracellular matrix in tissue by altering the metabolic pathways of fibroblasts. Recently, a pilot study (1994) showed preliminary promising results in treating plaque caused by Peyr onie's disease. This randomized single-blind placebo-based study (1994 to 1996) was undertaken to confirm the hypothesis. Methods. In this r andomized single-blind study, 14 patients completed the study and were divided into two groups: the verapamil treatment group (n = 7) or the control saline group [n = 7]. Verapamil or saline was injected direct ly into the Peyronie's plaque once a week for 6 months. Patients were evaluated before and after treatment with duplex ultrasound to confirm the extent of the lesion and to measure volume of the plaque, and by interview and mailed questionnaire 3 months after treatment. Patients being treated with oral calcium antagonists were excluded from the stu dy. Results. A decreased plaque volume was measured in 57% of the vera pamil-treated men versus 28% in the control group (P<0.04). Penile cur vature demonstrated an improvement trend of 37.71 +/- 9.3 degrees to 2 9.57 +/- 7.3 degrees in the verapamil-treated patients, but the differ ence was not significant (P<0.07). Plaque softening was noted in all p atients treated with verapamil. There was significant objective improv ement in plaque-associated penile narrowing in all patients in the ver apamil group. Subjective plaque-associated erectile dysfunction (quali ty of erection) showed improvement in 42.87% of the verapamil group ve rsus none in the control group (P<0.02). There was no local or systemi c toxicity except for an occasional ecchymosis/bruise at the injection site. After a positive clinical response, plaque size, penile angulat ion, and symptoms continued to improve. Decrease in plaque size was no ted in each of the responders in the first 3 months. Conclusions. This randomized single-blind study suggests that intralesional injection o f calcium channel blocker may be a reasonable approach in some selecte d patients for the treatment of Peyronie's disease with noncalcified p laque and penile angulation of less than 30 degrees. Patients whose pl aque failed to respond to intralesional verapamil therapy within 3 mon ths or whose angulation was greater than 30 degrees at presentation we re more likely to benefit from surgery. (C) 1998, Elsevier Science Inc . All rights resented.