Randomized trial of sildenafil for the treatment of erectile dysfunction in spinal cord injury

Erectile dysfunction is a common complication of spinal cord injury. This d ouble-blind, placebo-controlled, two-way crossover study assessed the effic acy and safety of oral sildenafil in men with erectile dysfunction caused b y traumatic spinal cord injury. A total of 178 men (mean age, 38 years) rec eived placebo or sildenafil 1 hour before sexual activity for 6 weeks; afte r a 2-week washout period, the men received the alternate treatment for 6 w eeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on ef ficacy and tolerability. Efficacy was assessed by using global efficacy que stions, the International Index of Erectile Function (IIEF), and a patient log of erectile activity. Of 143 men with residual erectile function at bas eline, 111 (78%) reported improved erections and preferred sildenafil to pl acebo. For all men (including those who reported no residual erectile funct ion at baseline), 127 of 168 (76%) reported improved erections and preferre d sildenafil to placebo. For all men, 132 of 166 (80%) reported that silden afil improved sexual intercourse compared with 17 of 166 men (10%) reportin g improvement with placebo. IIEF questions assessing the ability to achieve and maintain erections and satisfaction with sexual intercourse demonstrat ed significant improvement with sildenafil. Sildenafil was well tolerated, with a low rate of discontinuation because of treatment-related adverse eve nts (2% vs 1% for placebo). Oral sildenafil is an effective and well-tolera ted treatment for erectile dysfunction caused by spinal cord injury.