Quality of life in patients with spinal cord injury receiving VIAGRA (R) (sildenafil citrate) for the treatment of erectile dysfunction

Study design: A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997. Objectives: To evaluate the effect of sildenafil citrate (VIAGRA(R)) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spin al cord injury (SCI). Setting: Study centers in Australia, Belgium, France, Germany, Norway, Swed en and the United Kingdom. Methods: Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men wit h SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Severa l commonly used psychometric instruments, including the Medical Outcomes Su rvey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS F amily Survey, assessed general QoL issues. Results: Significant improvements were seen for overall satisfaction with s ex life (ITEF Q13), sexual relationship with partner (IIEF Q14), and concer ns about erectile problems (P < 0.0001). Improvements were reported in scor es for the generic QoL parameters of mental health, well-being, depression, and anxiety (P < 0.05 sildenafil versus placebo). Conclusion: Treatment with sildenafil can significantly improve key QoL par ameters in men with ED caused by SCI. Sponsorship: This study was funded by Pfizer Inc.