Multicenter Study on the Efficacy and Safety of Intracavernous 'TM' (Standro(R)) for the Treatment of Erectile Dysfunction in Korean / 대한비뇨기과학회지

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of an intracavernous injection of lyophilized papaverine/phentolamine/alprostadil (Standro(R)) for the treatment of erectile dysfunction (ED) in Koreans. MATERIALS AND METHODS: 249 men (>20 years old), with ED (>6 month duration), were enrolled from 14 clinical centers. The intracavernous 'TMs' were titrated in a stepwise fashion at the clinic, from 0.05-0.25ml (17.64mg papaverine, 0.6mg phentolamine, and 6mug alprostadil per ml), with increment of 0.02-0.05ml, according to the etiology and severity of the ED and the patients' ages. RESULTS: Of the 249 men, 238 completed the dose titration, and progressed to home treatment of 3 months duration. Of these 238, 193 (psychogenic 13.0%, organic 75.5%, mixed 11.5%) completed the home treatment (4 or more self-injections), with the other 45 dropping out (lost to follow-up in 24, patient refusal in 9, no chance to have intercourse in 7 and omitted recording of patient diary in 2). The success rate per trial (a total number of sufficient erection for vaginal intromission/a total number of injections) and per patient (number of patients who had one or more sufficient erections for vaginal intromission/the enrolled patients at beginning or 193 patients), and the satisfaction rate per patient (number of patients who had both patient and partner satisfaction with erection/193 patients) were 74.1, or 91.2 and 75.1%, respectively. The adverse reactions were prolonged erections in 3, urethral pain in 1 and penile skin edema in 2. Three patients complained of penile pain during an erection, but there was no dropout due to the pain. No significant changes in laboratory tests were found after the home treatment. CONCLUSIONS: A 'TM' seems to be effective and safe for an intracavernous injection for the treatment of men with erectile dysfunction.