Topical verapamil HCl, topical trifluoperazine, and topical magnesium sulfate for the treatment of Peyronie's disease--a placebo-controlled pilot study.
BACKGROUND
Transdermal and intralesional verapamil has been reported to be useful in the treatment of Peyronie's Disease. This study evaluates a topically applied calcium channel blocker (verapamil hydrochloride 15% gel), a topically applied calmodulin blocker (trifluoperazine), and a topically applied weak calcium channel blocker (magnesium sulfate), each incorporated in a transdermal vehicle.


OBJECTIVE
This pilot study was conducted to assess the efficacy of a 15% verapamil gel applied topically to the penile shaft twice daily for the treatment of Peyronie's Disease.


METHODS
To assess improvement in curvature, plaque size, resolution of painful erections, and improvement in erection quality.


METHODS
Two simultaneous, three armed, double blinded, placebo-controlled studies were conducted. After randomization into one of four groups, patients were treated for 3 months. At the end of 3 months' treatment using blinded drug, each patient was treated with open label topical verapamil for 6 months. The studies were completed after each patient had been treated and evaluated for 9 months after randomization.


RESULTS
Fifty-seven patients were randomized. In total, 94.4% of patients treated for 9 months with topical verapamil experienced improvement in curvature with an average percent curvature change of 61.1% compared with 43.6% curvature improvement at 3 months. At 9 months the average percent plaque change was 84.7% compared with 55% at 3 months. Pain resolution at 9 months was 100% compared with 87.5% at 3 months. Patient perception of erection quality also increased at 9 months to 81.8% compared with 72.7% at 3 months.


CONCLUSIONS
Topical verapamil gel proved effective in eliminating pain on erection, decreasing the size of plaque, decreasing curvature, and improving erection quality in patients with Peyronie's Disease. Treatment results improved significantly after 9 months' treatment as compared with 3 months' treatment.
Fitch
William P
WP
Urology Consultants, P.A., San Antonio, TX, USA. janice@urologyconsults.com
Easterling
W Jerry
WJ
Talbert
Robert L
RL
Bordovsky
Michael J
MJ
Mosier
Michael
M
D000287:Administration, Topical; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008278:Magnesium Sulfate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D010411:Penile Induration / Q000188:drug therapy*; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome; D014268:Trifluoperazine / Q000008:administration & dosage*; D014700:Verapamil / Q000008:administration & dosage*
D014268:Trifluoperazine; D008278:Magnesium Sulfate; D014700:Verapamil