Open preliminary randomized prospective clinical trial of efficacy and safety of three different verapamil dilutions for intraplaque therapy of Peyronie's disease.
OBJECTIVE
To investigate the efficacy and safety of three different dilutions of verapamil used in intraplaque injections in an attempt to reduce Peyronie's disease symptoms.


METHODS
A total of 77 patients (age 48 +/- 9 years) with chronic Peyronie's disease were randomized into three groups, each receiving 12 intraplaque injections (1 injection every 2 weeks) of 10 mg verapamil in different dilutions. Group 1 (27 patients) received verapamil 10 mg/4 mL, group 2 (24 patients) received verapamil 10 mg/10 mL, and group 3 (26 patients) received verapamil 10 mg/20 mL. The variables, assessed before and 8 months after therapy, were erectile function (assessed by semistructured interview), plaque size, peak systolic velocity, end-diastolic velocity, left and right cavernosal arteries (assessed with dynamic Duplex ultrasonography), pain (assessed with a pain scale), penile curvature (measured using a photograph of a pharmacologically induced full erection), and side effects. Analysis of variance and the chi-square test were used to analyze the differences among the groups.


RESULTS
No significant differences were found in the baseline values among the groups. The peak systolic velocity of the left and right cavernosal arteries was never significantly modified. The plaque area, penile curvature, erectile function, end-diastolic velocity of the left and right cavernosal arteries, and pain improved more significantly in group 3 than in groups 1 and 2. The side effects were ecchymosis, with no significant differences among the groups.


CONCLUSIONS
The dilution of verapamil significantly improved its efficacy in improving Peyronie's disease symptoms.
Cavallini
Giorgio
G
Andrological Operative Unit, Headquarters of Società Italiana di Studi di Medicina della Riproduzione, Bologna, Italy. giorgiocavallini@libero.it
Modenini
Fabio
F
Vitali
Giovanni
G
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D010411:Penile Induration / Q000175:diagnosis / Q000188:drug therapy*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*; D014700:Verapamil / Q000008:administration & dosage*
D014665:Vasodilator Agents; D014700:Verapamil