Quality of life effects of alprostadil therapy for erectile dysfunction: Results of a trial in Europe and South Africa

Objectives: Quality of life (QOL) data were used to evaluate the effects of self-administered intracavernosal injection of alprostadil for erectile dy sfunction, when used for up to 18 months during a 13 country Phase III clin ical trial. Methods: The Duke Health Profile was used to measure patients' physical and psychosocial QOL at baseline, 3, 6, 12 and 18 months. Changes from baselin e were measured using paired t-tests, with additional analyses by cause of dysfunction, starting dosage, and prior treatment. Results: Patients displayed significant improvements in mental and social h ealth and self-esteem at six months (P < 0.01, n = 570), with greater impro vements at 12 and 18 months. Anxiety and depression measures also improved significantly at 12 and 18 months, as did the summary general health score. Worse pain scores were observed in the first year but not at 18 months. Th ose with a starting dosage of 10-20 mu g, those with psychogenic causes of dysfunction, and those with no prior treatment for erectile dysfunction gen erally showed the greatest improvements. Conclusion: In this study, the clinical improvements in erectile function d ue to intracavernosal alprostadil therapy were complemented by QOL improvem ents, particularly in the mental health, of many patients.