Efficacy, safety and predictive factors of therapeutic success with sildenafil for erectile dysfunction in patients with different spinal cord injuries.

STUDY DESIGN: Multicenter, open, prospective, before-after study. OBJECTIVE: To assess the efficacy and safety of sildenafil therapy for erectile dysfunction in patients with spinal cord injury, and the association between the response to sildenafil and factors such as causes and levels of spinal cord injury, grade of ASIA deficit, time since injury, orgasmic perception, and degree of baseline erection. SETTING: Homes of outpatients of 16 spinal cord injury units in Spain. METHOD: One hundred and seventy patients with erectile dysfunction secondary to spinal cord injury, from whom baseline data were collected on their sexual function, and who started treatment with sildenafil 50 mg. An efficacy assessment was made by the patient and his partner, and the score of the International Index of Erectile Function (IIEF) was recorded. RESULTS: It was reported by 88.2% of the patients and 85.3% of their partners that treatment with sildenafil had improved their erections, regardless of the baseline characteristics of the spinal cord injury and erectile function. In responders, this improvement was confirmed by an increase from 12.5 to 24.8 points (P<0.001) of the Erectile Function Domain of IIEF. A significant improvement was also seen in patients' satisfaction with sexual activity and general satisfaction derived from sexual life. Preservation of orgasmic perception and a baseline degree of erection of 3 or 4 (P=0.006) were predictors of therapeutic success. No serious adverse events occurred. CONCLUSION: Sildenafil is an effective, well-tolerated treatment for erectile dysfunction caused by spinal cord injury, regardless of the cause, neurological level, ASIA grade, and time since injury. SPONSORSHIP: Spanish Society of Paraplegia.