Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction.

PURPOSE: We assessed the efficacy and safety of sildenafil citrate as treatment for erectile dysfunction. MATERIALS AND METHODS: A total of 433 completely evaluated men with chronic erectile dysfunction were treated with sildenafil citrate. Response was assessed prospectively by baseline and followup physician interviews, and by a patient self-administered 15-item questionnaire on the domains of patient treatment response and satisfaction, partner treatment satisfaction, comparative previous treatment satisfaction, adverse effects, and patient and partner quality of life. RESULTS: Of the 304 men (70.2%) who completed the questionnaire 278 received sildenafil, including 186 who previously had undergone treatment for erectile dysfunction, principally involving intracavernous injection therapy. A response was elicited by a median dose of 100 mg. in 188 patients (67.6%) who achieved erection suitable for sexual intercourse. Those with psychogenic erectile dysfunction responded significantly better than those with organic dysfunction (p <0.001). Erection suitable for intercourse was attained by 30.8% of patients with erectile dysfunction after radical prostatectomy and 80% with cavernous veno-occlusive dysfunction. Of previous intracavernous injection responders 29.9% were refractory to sildenafil, while 33. 3% of previous intracavernous injection nonresponders responded to sildenafil. The sildenafil response was considered inferior to the intracavernous injection response by 43.6% of the men who previously responded to intracavernous injection, of whom 51.5% continued to receive intracavernous injection as the only treatment (19.5%) or as an alternative to sildenafil (32%). Adverse effects in 53.6% of cases were assessed as mild in 56.4%, moderate in 38.3% and severe in 5.3%. Multiple adverse effects were reported by 62.4% of patients, while 17 (6.1%) discontinued sildenafil as a direct result of intolerable adverse effects. The most common adverse effects were facial flushing in 33.5% of cases, headaches in 23.4%, nasal congestion in 12.6%, dyspepsia in 10.1% and dizziness in 10.8%. Baseline patient and partner quality of life scores significantly improved after sildenafil treatment (p <0.001), while significantly improved quality of life was noticed by 51.5% and 43.1%, respectively. CONCLUSIONS: Sildenafil citrate is effective oral first line treatment for erectile dysfunction. Although more than 50% of men reported adverse effects, most were considered mild and rarely resulted in treatment cessation. There was a trend in those on intracavernous injection who responded to sildenafil to continue intracavernous injection as the only therapy or as an alternative to sildenafil. Also, we noted that some cases refractory to sildenafil responded to intracavernous injection. These findings imply that intracavernous injection remains an effective erectile dysfunction treatment option.

Treatment of intracorporeal injection nonresponse with sildenafil alone or in combination with triple agent intracorporeal injection therapy.

PURPOSE: We assess the efficacy of sildenafil as salvage therapy for intracorporeal injection therapy nonresponse. MATERIALS AND METHODS: The study group comprised 93 patients with a mean age of 53.6 years (range 24 to 77) with chronic erectile dysfunction. In all cases a home trial of intracavernosal injection of high dose alprostadil and triple agent intracavernosal injection therapy had failed. Patients were treated with sildenafil citrate alone or in combination with intracavernosal injection therapy. RESULTS: The etiology of erectile dysfunction was arteriogenic in 29 cases, cavernosal venous leakage in 36, mixed vasculogenic in 24, psychogenic in 3 and post-priapism intracavernous fibrosis in 1. Of the 32 sildenafil responders (34% of the study group) 30 required 100 and 2 required 50 mg. The 29 sildenafil intracavernosal injection (combined therapy) responders (31% of the study group) required 100 mg. sildenafil. There were 32 nonresponders (34% of the study group). Mean International Index of Erectile Function questions 3 and 4 scores were 1.7 and 1.5 at baseline, 2.3 and 1.9 with intracavernosal injection, 4.6 and 42.2 with sildenafil, and 4.1 and 4.10 with combined therapy, respectively. Of the 93 patients 29 (31%) treated with intracavernosal injection reported adverse effects, including penile pain in 27, dizziness in 5 and headache in 2. Of the patients treated with sildenafil 34 (37%) reported side effects, including headache in 30, facial flushing in 25, dyspepsia in 12, nasal congestion in 9, dizziness in 5 and visual disturbances in 1. Of the 41 patients given combined therapy 20 (49%) reported adverse effects, including penile pain in 15, headache in 15, facial flushing in 12, dyspepsia in 7, nasal congestion in 3, dizziness in 12 and syncope in 1. CONCLUSIONS: Sildenafil alone or sildenafil plus intracavernosal injection is effective salvage therapy for intracavernosal injection nonresponse. Sildenafil in combination with intracavernosal injection is associated with a 33% incidence of adverse effects, including a 20% incidence of dizziness.

Pharmacological treatment of premature ejaculation.

Ejaculatory dysfunction is the most common male sexual disorder and premature ejaculation the most common presentation of ejaculatory dysfunction. Convincing data are lacking from controlled clinical studies to support sustainable long term efficacy of psychosexual counselling in the management of premature ejaculation. The pharmacological treatment of premature ejaculation is now receiving increased attention from both physicians with an interest in sexual medicine and from the pharmaceutical industry.