Transdermal electromotive administration of verapamil and dexamethasone for Peyronie's disease

Abstract

OBJECTIVETo evaluate the effects of the transdermal electromotive administration of verapamil and dexamethasone on plaque size, penile deviation, pain, erectile function and capacity for vaginal penetration in patients with Peyronie's disease. PATIENTS AND METHODSForty-nine patients were treated four times weekly for six consecutive weeks. During each session the drug mixture was administered from a receptacle fixed to the skin overlying the plaques, using 2.4 mA pulsed current for 20 min. Plaque size and penile deviation were evaluated by dynamic penile duplex ultrasonography, X-ray and photographs; pain, erectile function and capacity for vaginal penetration were assessed using a questionnaire. Vital signs and side-effects were recorded. Differences before and after treatment were assessed. RESULTSThe plaque disappeared in 8% of patients, with a measurable reduction in volume in 74% and no change in 18% ( P < 0.001). Penile deviation resolved in 10% of the men, decreased in 74% and remained unchanged in 16% ( P < 0.001). The plaque volume was halved in two-thirds of the men, to a mean ( SD ) of 515 (301) mm 3 , and the penile deviation halved in 45% of patients, to 24 (5) ∞ ; pain was completely eliminated in 88% ( P < 0.001). Erectile function was completely restored in 42% of patients with initial erectile dysfunction and improved in 17% ( P < 0.001); vaginal penetration improved in 73%. No toxicity was noted, except for a transient skin erythema at the site of the penile and dispersive electrodes.

Comparison of transdermal electromotive administration of verapamil and dexamethasone versus intra‐lesional injection for Peyronie's disease

“…88% of the patients had notable improvements in penile deformity, and 80% reported improvements in penile rigidity. In another uncontrolled study (Di Stasi et al, 2003), the plaque disappeared altogether or decreased in volume in 82% of the patients. Penile curvature had resolved or else decreased in 84% of the patients, and 88% of the patients reported no penile pain after the treatment.…”

“…Transdermal electromotive administration (TEA), which effectively delivers up to 70% of the drug to the target site seems to be an intriguing option. The efficacy of TEA of verapamil and dexamethasone has been evaluated in a few uncontrolled studies and has proved to be a safe drug delivery system in the penis (Montorsi et al, 2000;Di Stasi et al, 2003Greenfield et al, 2007;Tuygun et al, 2009). However, no randomized, controlled surveys have been carried out so far to compare the efficacy of transdermal electromotive administration as against the intra-lesional injection of a combination of verapamil and dexamethasone.…”

740 Prospective, randomized study using transdermal electromotive administration of verapamil and dexamethasone for Peyronie's disease

“…The reliability of objective measurements of plaque size, penile deviation and subjective score scales of a questionnaire provided to patients were determined by a test-retest multicenter pilot study. 8 Clinical assessment and objective measurements were performed before and 4 weeks after the conclusion of treatment. Duplex ultrasound examinations using a 7.5 MHz transducer were performed in the state of maximum pharmacologically induced erection using an intracavernosal injection of 20 g prostaglandin E1.…”

Androtherm Application for the Peyronie's Disease

“…Others had also used EMDA with Dexamethasone + Verapamil combination [21], also compared to the Lidocain effect alone [22].…”