INTRODUCTION:Sexual satisfaction is an important treatment objective for men with erectile dysfunction (ED). AIMS: To evaluate potential associations between International Index of Erectile Function (IIEF) satisfaction at study endpoint and a range of baseline, on-treatment, and endpoint variables. METHODS: An exploratory analysis was conducted involving 3,935 subjects with ED randomized to on-demand tadalafil (N = 2,824) orplacebo (N = 1,111) in randomized, controlled trials across 28 countries. Patients achieving scores > or =16 on IIEF questions 7, 8, 13, and 14 at study endpoint were operationally defined as satisfied (vs. <16, not satisfied). Multivariate logistic regression and other analyses were conducted to ascertain correlates and potential predictors of improvements in the IIEF-erectile function domain (IIEF-EF). MAIN OUTCOME MEASURES: Satisfaction on the IIEF at study endpoint, on-treatment improvements in IIEF-EF, and endpoint sexual frequency. RESULTS: Patients who were satisfied with sexual function were on average younger and had less severe ED, a shorter history of the condition, and no history of vascular disorders, hypertension, or diabetes mellitus/insulin use at baseline (P < 0.01 vs. not satisfied for each). Satisfied patients were also more likely to experience a > or =4-point increase on the IIEF-EF domain on treatment (adjusted odds ratio [OR] = 22.4; 95% CI = 17.6-28.5; P < 0.0001) or IIEF-EF > or =26 at endpoint (adjusted OR = 41.0; 95% CI = 33.6-50.2; P < 0.0001). Satisfaction emerged as a strong correlate of a > or =4-point increase in the IIEF-EF on treatment; however, as a correlate of endpoint sexual frequency, baseline sexual frequency was stronger than endpoint satisfaction. CONCLUSIONS: Satisfaction is associated with certain baseline, on-treatment, and endpoint variables in ED patients. Further studies are needed to confirm these preliminary findings and explore their meaning for female partners.
RCT Entities:
INTRODUCTION: Sexual satisfaction is an important treatment objective for men with erectile dysfunction (ED). AIMS: To evaluate potential associations between International Index of Erectile Function (IIEF) satisfaction at study endpoint and a range of baseline, on-treatment, and endpoint variables. METHODS: An exploratory analysis was conducted involving 3,935 subjects with ED randomized to on-demand tadalafil (N = 2,824) or placebo (N = 1,111) in randomized, controlled trials across 28 countries. Patients achieving scores > or =16 on IIEF questions 7, 8, 13, and 14 at study endpoint were operationally defined as satisfied (vs. <16, not satisfied). Multivariate logistic regression and other analyses were conducted to ascertain correlates and potential predictors of improvements in the IIEF-erectile function domain (IIEF-EF). MAIN OUTCOME MEASURES: Satisfaction on the IIEF at study endpoint, on-treatment improvements in IIEF-EF, and endpoint sexual frequency. RESULTS:Patients who were satisfied with sexual function were on average younger and had less severe ED, a shorter history of the condition, and no history of vascular disorders, hypertension, or diabetes mellitus/insulin use at baseline (P < 0.01 vs. not satisfied for each). Satisfied patients were also more likely to experience a > or =4-point increase on the IIEF-EF domain on treatment (adjusted odds ratio [OR] = 22.4; 95% CI = 17.6-28.5; P < 0.0001) or IIEF-EF > or =26 at endpoint (adjusted OR = 41.0; 95% CI = 33.6-50.2; P < 0.0001). Satisfaction emerged as a strong correlate of a > or =4-point increase in the IIEF-EF on treatment; however, as a correlate of endpoint sexual frequency, baseline sexual frequency was stronger than endpoint satisfaction. CONCLUSIONS: Satisfaction is associated with certain baseline, on-treatment, and endpoint variables in ED patients. Further studies are needed to confirm these preliminary findings and explore their meaning for female partners.