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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 ≥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 ≥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 ≥26 at endpoint (adjusted OR = 41.0; 95% CI = 33.6–50.2; P < 0.0001). Satisfaction emerged as a strong correlate of a ≥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. Althof SE, Buvat J, Gutkin SW, Belger M, Stothard DR, and Fugl-Meyer AR. Sexual satisfaction in men with erectile dysfunction: Correlates and potential predictors. J Sex Med 2010;7:203–215. [ABSTRACT FROM AUTHOR]

Introduction. The International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) assess efficacy of phosphodiesterase type 5 (PDE5) inhibitor treatment of erectile dysfunction (ED). Aims. To determine the degree that multiplicity of satisfaction questions in ED treatment evaluation instruments are congruent, to better understand the concept of sexual “satisfaction,” and to identify factors that correlate with improvement. Methods. Questionnaire data from 4,174 placebo- or tadalafil-treated patients with ED were analyzed. Principal component analysis (PCA) was performed on IIEF and SEP satisfaction questions. Spearman correlation coefficients were determined. Data from 431 of the 4,174 patients who completed EDITS questionnaires were analyzed. Logistic regression was used to investigate improvement of each IIEF satisfaction question. Results. PCA rotated on three factors explained 91% of total variance and separated IIEF Q6 (intercourse frequency) from a SEP and a remaining IIEF factor. All correlations between and among questions were close (ρ = 0.62–0.98; P < 0.0001), except for those with IIEF Q6 (ρ = 0.28–0.34; P < 0.0001). In a sub-sample, PCA of five IIEF, two SEP, and three EDITS questions identified four factors that explained 90% of all variance: EDITS questions, IIEF questions except Q6, SEP questions, and IIEF Q6. Greater improvement in IIEF-EF domain score was consistently and positively associated with satisfaction measures ( P < 0.0001). Conclusions. Factor analysis detected close relationships among satisfaction questions in IIEF, SEP, and EDITS instruments, each of which, apart from IIEF Q6 (intercourse frequency), appeared to be an independent measure of satisfaction. Cultural differences may explain different satisfaction correlations with baseline ED severity in different regions. Clinicians may make use of the correlation between intercourse frequency (Q6) and satisfaction when prescribing a PDE5 inhibitor for ED, by explaining that the inhibitor should enable more frequent intercourse. Fugl-Meyer A, Althof S, Buvat J, Paget M-A, Sotomayor M, and Stothard D. Aspects of sexual satisfaction in men with erectile dysfunction: A factor analytic and logistic regression approach. J Sex Med 2009;6:232–242. [ABSTRACT FROM AUTHOR]

Introduction. Tadalafil is a phosphodiesterase type 5 inhibitor with documented efficacy in the treatment of erectile dysfunction (ED). Aim. To compare the efficacy and tolerability of tadalafil 10 mg and 20 mg in men with severe ED. Methods. A prespecified subgroup analysis was conducted to compare the efficacy of tadalafil 10 and 20 mg measured by the International Index of Erectile Function (IIEF) erectile function (EF) domain and Sexual Encounter Profile (SEP) among patients with severe ED (EF domain score = 1–10) in a Japanese placebo-controlled study (PCT). We also analyzed the efficacy of the two doses in men with severe ED post hoc by pooling data from three tadalafil clinical trials that evaluated these doses using a similar study design (three placebo-controlled trials), and evaluated (post hoc) the presence of organic comorbidities in patients with different levels of response to tadalafil 10 or 20 mg. Main Outcome Measures. Mean change in the IIEF-EF domain and mean per-patient changes in percent “yes” responses to SEP Question 2 (SEP2) and Question 3 (SEP3). Results. Patients with severe ED in the Japanese study experienced numerically greater increases (improvements) when taking tadalafil 20 mg compared with 10 mg in the IIEF-EF domain (14.3 vs. 12.4; P = 0.355), SEP2 (60% vs. 57%; P = 0.781), and SEP3 (61% vs. 49%, P = 0.196). When sufficiently powered, these observations reached statistical significance in the three PCTs: patients with severe ED experienced greater increases when taking tadalafil 20 mg compared with 10 mg in the IIEF-EF domain (13.6 vs. 10.4; P = 0.014) and SEP3 (56% vs. 43%, P = 0.019). Both doses were well tolerated. Conclusions. Patients with severe ED, and especially those with an organic comorbidity, may derive greater clinical benefits from tadalafil 20 mg compared with 10 mg. Marumo K, Imaoka T, Fujimoto K, Watts S, Stothard D, and McGill J. A comparison of the efficacy and tolerability of tadalafil 10 mg and 20 mg in Japanese patients with severe erectile dysfunction. J Sex Med 2007;4:745–752. [ABSTRACT FROM AUTHOR]