TOPICAL TREATMENT OF ERECTILE DYSFUNCTION - RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF CREAM CONTAINING AMINOPHYLLINE, ISOSORBIDE DINITRATE, AND CO-DERGOCRINE MESYLATE

Objective-To examine the effectiveness in treating impotence of topica lly applied cream containing three vasodilators-aminophylline, isosorb ide dinitrate, and co-dergocrine mesylate-which act by different mecha nisms. Design-Randomised double blinded placebo controlled crossover t rial over two weeks. Subjects-36 men with erectile dysfunction randoml y allocated to two equal groups. Interventions-Active cream containing aminophylline 3%, isosorbide dinitrate 0.25%, and co-dergocrine mesyl ate 0.05% for one week and placebo for another. Main outcome measures- Patients' reported experience of penile responses and side effects of treatment in questionnaires. Penile tumescence and arterial Row in the laboratory. Results-21 patients reported full erection and satisfacto ry intercourse with the active cream. Three men reported full erection and satisfactory intercourse with either cream. The active cream was more effective in psychogenic than organic impotence (eight out of nin e men with psychogenic impotence achieved a full erection zi four out of eight with neurogenic impotence and two out of seven with arterial insufficiency). No major side effects were reported. In the laboratory the active cream increased penile arterial flow (0.19 (SD 0.08) m/s v 0.02 (0.15) m/s with placebo) and induced tumescence in 24 patients. Conclusions-Topical treatment with a cream containing three different vasodilators might be considered before intracavernous injection of va soactive agents, particularly in psychogenic impotence.