“…Adverse events occurred in 20 (80%) patients, with edema, penile pain and ecchymosis as the most common. A double-blind, placebocontrolled trial by Gelbard et al 59 in 1993, composed of 49 men, showed a statistically significant improvement in vacuum-induced curvature in the treatment group when compared with placebo; however, maximal improvement ranged from 151 to 201 and was only seen in the patients with curvature of less than 301 and plaques of less than 2 cm in length. Currently, this agent is in a large scale, multicenter, multination, randomized, placebo-controlled trial, 60 which may become the first FDA-approved treatment for PD.…”