| To Register SMDM Homepage | |
|
|
|
||||
Purpose: Using a stringent definition of a responder, we assessed responsiveness of the Self-Esteem And Relationship (SEAR) questionnaire to changes in erectile function after treatment with Viagra.
Methods: A 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, or 100 mg), multicenter, international trial was conducted in men aged ³18y with clinically documented ED and baseline score £75 on the SEAR questionnaire Self-Esteem subscale. Patients who had taken another phosphodiesterase type 5 inhibitor, >6 doses of Viagra, or were receiving nitrates or a nitric oxide donor were excluded. A treatment (Viagra or placebo) responder was defined as someone who responded "yes" to 2 end-of-treatment (EOT) questions indicating improved erections and sexual intercourse and had an EOT score ³22 on the Erectile Function domain of the International Index of Erectile Function. Change scores from baseline on the 2 domains (Sexual Relationship, Confidence), Confidence domain subscales (Self-Esteem, Overall Relationship), and Overall score of the SEAR questionnaire were analyzed between responders and nonresponders using an ANCOVA model (adjusting for center and baseline score).
Results: A total of 149 (mean ± SD: age, 54±12y; ED duration, 4.7±4.7y) and 151 patients (mean ± SD: age, 56±11y; ED duration, 4.3±4.5y) were randomized to placebo and Viagra, respectively. Overall, 169 of the intent-to-treat population (55 placebo, 114 Viagra) were treatment responders and 114 (84 placebo, 30 Viagra) were nonresponders. Responders had significantly greater improvements from baseline on all SEAR components (P <0.0001); nonresponders had no change or significant decrements. Adjusted mean change from baseline scores for Sexual Relationship (46.3), Confidence (48.9), Self-Esteem (50.5), Overall Relationship (45.5), and overall score (47.3) were significantly higher (P <0.0001) than corresponding nonresponder change scores (-5.21, -1.8, -1.0, -3.6, and -3.7, respectively).
Conclusions: Regardless of treatment, responders who reported improved erectile functioning also showed improvement in self-esteem, confidence, and relationships, whereas nonresponders who lacked improvement in erectile functioning showed no such improvements in these psychosocial factors. The results confirm the accuracy of the SEAR questionnaire for measuring changes in psychosocial factors as they relate to changes in erectile functioning.
See more of Poster Session - Utility Theory; Health Economics; Patient & Physician Preferences; Simulation; Technology Assessment
See more of The 26th Annual Meeting of the Society for Medical Decision Making (October 17-20, 2004)