PURPOSE: We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months. MATERIALS AND METHODS: Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical trial. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general quality of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation. RESULTS: The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p < 0.001, Student's paired t-tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p < 0.001). Overall mental health as measured by the Duke Health Profile also improved (p < 0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain. CONCLUSIONS: Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.
PURPOSE: We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months. MATERIALS AND METHODS: Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical trial. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general quality of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation. RESULTS: The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p < 0.001, Student's paired t-tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p < 0.001). Overall mental health as measured by the Duke Health Profile also improved (p < 0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain. CONCLUSIONS: Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.