Topical prostaglandin-E1 for the treatment of erectile dysfunction.

This study was undertaken as a phase I, placebo controlled, nonblinded investigation of the safety and efficacy of topical prostaglandin-E1 for the treatment of erectile dysfunction. Nine men with erectile dysfunction secondary to spinal cord injury and 1 man with mild arterial insufficiency were enrolled in the trial and underwent color flow Doppler ultrasound of the penis after application of topical prostaglandin-E1 to the penis, scrotum and perineum. Eight men completed all phases of the study. Mean cavernous artery diameter increased from 0.09 to 0.11 cm. (p < 0.05) and mean peak systolic flow velocity increased from 15.4 to 22.8 cm. per second (p < 0.05) using color flow Doppler ultrasound. Peak systolic flow velocity increased in both cavernous arteries in 7 of 10 patients. Clinical erections were observed in 2 patients but they were not present with placebo application. Diastolic blood pressure and heart rate varied after application of prostaglandin-E1 to the genitalia. No patient was symptomatic and no adverse skin effects were observed in the 8 patients completing all phases of the study. In conclusion, topical prostaglandin-E1 appears to be safe and well tolerated after application to the genitalia, and significantly increases blood flow to the penis. Further investigation is being pursued.

RCT Entities:   Population Interventions Outcomes