INTRODUCTION:Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. AIM: In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. METHODS: This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in menaged >or=18 years with a clinical diagnosis of ED (score <or= 21 on the Sexual Health Inventory for Men). MAIN OUTCOME MEASURES: The primary outcome was the change in the SEAR Self-Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment. RESULTS: A total of 841 patients were included in the intent-to-treat efficacy analysis (559sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P < 0.0001) compared with placebo. This finding was also consistent for all SEAR components when stratified by each ED comorbidity. In the sildenafil group, the improvement in the mean Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001). CONCLUSIONS: The physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid hypertension, hyperlipidemia, benign prostatic hypertrophy, and/or depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED.
RCT Entities:
INTRODUCTION:Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. AIM: In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. METHODS: This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged >or=18 years with a clinical diagnosis of ED (score <or= 21 on the Sexual Health Inventory for Men). MAIN OUTCOME MEASURES: The primary outcome was the change in the SEAR Self-Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment. RESULTS: A total of 841 patients were included in the intent-to-treat efficacy analysis (559 sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P < 0.0001) compared with placebo. This finding was also consistent for all SEAR components when stratified by each ED comorbidity. In the sildenafil group, the improvement in the mean Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001). CONCLUSIONS: The physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid hypertension, hyperlipidemia, benign prostatic hypertrophy, and/or depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED.