Quality of life in patients with spinal cord injury receiving Viagra (sildenafil citrate) for the treatment of erectile dysfunction.
METHODS
A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997.


OBJECTIVE
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).


METHODS
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 (IIEF 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).


CONCLUSIONS
Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.


BACKGROUND
This study was funded by Pfizer Inc. Spinal Cord (2000) 38, 363 - 370.
Hultling
C
C
Spinalis SCI Research Unit, Karolinska sjukhuset Norrbacka, SE-171 76 Stockholm, Sweden.
Giuliano
F
F
Quirk
F
F
Peña
B
B
Mishra
A
A
Smith
M D
MD
D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D011687:Purines; D011788:Quality of Life / Q000523:psychology*; D000068677:Sildenafil Citrate; D013119:Spinal Cord Injuries / Q000150:complications*; D013450:Sulfones; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate