Introduction It is now increasingly recognized that sexual health is important to overall good health and well-being. Aim The Global Better Sex Survey (GBSS) explored the sexual aspirations and unmet needs of men and women worldwide. Main Outcome Measures Participant responses to survey questions. Methods Data were collected during 2005 in 27 countries by phone, door-to-door, and street-intercept interview. Data were weighted by demographic characteristics to accurately reflect the general population of each country. Results Of the 12,563 respondents (men=6,291, women=6,272), 46% of men and 48% of women were younger than 40 years, 41% were 40–59 years, and 11% were 60 years or older. Nearly all men (91%) and women (94%) were married, living with a partner, or in a relationship. All aspects of sex (intercourse, foreplay, orgasm, attraction to partner) were important to men and women. Nearly half (48%) of men surveyed reported some degree of erectile dysfunction (ED). A significant proportion of men (65%) were not very satisfied with their erection hardness (63% of women were not very satisfied with their partner's erection hardness). An association existed between satisfaction with erection hardness and satisfaction with sex life, love and romance, and overall health. Only 7% of men reported using a prescription medication for ED. However, 74% of men were willing to take medication to improve their erections if they thought they had ED; 64% of women would support such a decision. Conclusions The GBSS reports the sexual needs and desires of men and women worldwide. Erectile function and the effect of ED on aspects of the sexual experience emerged as the most pressing concerns among male participants.

Introduction Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. Aim We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). Methods This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men ≥18 years of age in Mexico, Brazil, Australia, and Japan. Main Outcome Measures The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. Results Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60–0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. Conclusions Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Introduction Erection hardness is a fundamental component of erectile function, and is a very specific and easily monitored outcome. The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness. Aims The aim of this article is to report the psychometric validation of the EHS. Methods The dataset (N=307) was from a multinational sildenafil trial (efficacy in the treatment of erectile dysfunction [ED]) with a 2-week screening phase, a 6-week double-blind, placebo-controlled treatment phase, and a 6-week open-label extension. Main Outcome Measures Test–retest reliability (intraclass correlation coefficient), quality and distribution of responses, known-groups validity (ability to differentiate between ED severity groups defined by the International Index of Erectile Function [IIEF] questionnaire), convergent validity (Pearson correlation coefficients with domain scores of the IIEF and the Quality of Erection Questionnaire [QEQ]), treatment responsiveness, and clinically important difference. Results The EHS demonstrated good test–retest reliability, acceptable quality and distribution of responses, known-groups validity against the IIEF (including clear differentiation between normal and impaired erectile function), moderate-to-strong convergent validity against the prespecified domains of the IIEF and QEQ, and high treatment responsiveness. Conclusion The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. Psychometric analysis supports the use of the EHS as a simple, reliable, and valid tool for the assessment of erection hardness in clinical trials research.

Introduction There are no psychometrically validated assessment tools designed to solely and specifically evaluate satisfaction with the quality of erections. Aim To develop and psychometrically analyze the Quality of Erection Questionnaire (QEQ), a new patient-reported measure developed to evaluate men’s satisfaction with the quality of their erections. Methods The questionnaire was developed through in-depth qualitative interviews of men with erectile dysfunction (ED) in the United States and Australia. An exploratory methodology study was conducted on 65 men with ED. Subsequently, the psychometric properties were confirmed in a larger dataset of 558 men with ED from two combined clinical trials. Main Outcome Measures Identification of potential redundancy or outliers in items (Pearson inter-item correlations); exploratory factor analysis (unrotated and varimax rotated); internal consistency (Cronbach’s alpha); convergent validity (Pearson correlation coefficients between the QEQ total score and domain scores of the International Index of Erectile Function); known-groups validity (ability of the QEQ scores to differentiate between ED severity groups); test–retest reliability (Pearson correlation coefficient). Results The QEQ demonstrated excellent convergent and known-groups validity. Additional analysis demonstrated high internal consistency (Cronbach’s alpha, 0.92). Item analysis demonstrated a unidimensional structure and suggested that satisfaction with hardness may be the key driver for satisfaction with overall quality of erections (r = 0.8). The smaller exploratory study demonstrated good test–retest reliability (r = 0.82). Conclusion The QEQ is a six-item, patient-reported measure with a unidimensional structure, which produces a total score that may be transformed to a 0–100 scale. Psychometric analysis confirmed reliability and validity of the QEQ, which solely and specifically evaluates satisfaction of men with the quality of their erections. The QEQ is a potentially useful measure for monitoring and evaluating treatment in those who are bothered by, or concerned about, their erectile function.

Introduction The Erection Hardness Score (EHS), recently validated, was developed in 1998 as a simple (one-item) method to quantify erection outcome data. Although it is intuitive that erection hardness and successful sexual intercourse (SSI) are related, the link has not been directly established. Objective To evaluate the relationship between erection hardness (assessed by EHS) and SSI, establishing the EHS as a clinically useful tool. Methods The data set (N = 307) was from a multinational, double-blind, placebo-controlled trial (with open-label extension) of sildenafil citrate in men with erectile dysfunction. Main Outcome Measures Event-based modeling used every intercourse attempt and the EHS to estimate the odds ratio of SSI between adjacent EHS categories. Mean-based modeling used mean EHS per patient to determine its relationship to percentage of SSI. Mediation-based modeling used mean EHS and mean percentage of SSI over the double-blind phase to estimate the direct effect of sildenafil treatment on SSI and the indirect effect of sildenafil treatment on SSI via erection hardness. Results The odds of SSI for EHS 3 (hard enough for penetration but not completely hard) were 41.9 times (95% confidence interval [CI], 33.0–53.2; P < 0.0001) that for EHS 2 (hard but not hard enough for penetration), and the odds of SSI for EHS 4 (completely hard and fully rigid) were 23.7 times (95% CI, 19.5–28.9; P < 0.0001) that for EHS 3. The percentage of SSI increased approximately curvilinearly with the increase in mean EHS, from almost 60% at EHS 3 to 78.5% at EHS 3.5 and to 93.1% at EHS 4. The indirect effect of sildenafil treatment on SSI via erection hardness accounted for almost 90% of the total effect on SSI (P < 0.0001). Conclusion The close and direct relationship between erection hardness and SSI supports the broader use of the EHS—a simple, valid, reliable, and responsive measure—in clinical practice.