¹Department of Physiology and CESEX, Faculty of Medicine, Campus CC Salud, University of La Laguna, Tenerife, Spain

Correspondence: M Mas, MD, PhD, Department of Physiology and CESEX, Faculty of Medicine, Campus CC Salud, University of La Laguna, Tenerife 38071, Spain. E-mail: mmas@ull.es

Received 9 August 2004; Revised 28 September 2004; Accepted 8 October 2004; Published online 10 February 2005.

Abstract

In a prospective, placebo-controlled, one group crossover design study, we tested whether adding programmed intracavernous PGE1 injections (IC-PGE1) can improve the effectiveness of sildenafil in erectile dysfunction (ED) patients unresponsive to monotherapy with this drug. In all, 40 ED patients who had experienced unsatisfactory erections with both the 50 and 100 mg sildenafil doses were treated with four bi-weekly 20 g IC-PGE1 injections given in the clinic and provided with either placebo or 50 mg sildenafil capsules for the next 4 weeks. Thereafter, they were crossed over to the other oral treatment for an additional 4-week period. The IIEF-Erectile Function domain score (IIEF-EFS), the main outcome measure, was found considerably higher (P<0.001) with the combined IC-PGE1–50 mg sildenafil treatment than with IC-PGE1–placebo or sildenafil alone (50 or 100 mg) in a subset of 26 subjects (65%). They thus shifted from the 'severe' or 'moderate' to the 'mild' grading of ED classification.