Quality of life in patients with spinal cord injury receiving VIAGRA® (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 spinal cord injury (SCI). Setting: Study centers in Australia, Belgium, France, Germany, Norway, Sweden 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 with 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. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues. Results: Significant improvements were seen for overall satisfaction with sex life (ITEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P < 0.0001). Improvements were reported in scores 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 parameters in men with ED caused by SCI. Sponsorship: This study was funded by Pfizer Inc.