Kyle Hvidsten

Importance of and Satisfaction with Sex Among Men and Women Worldwide: Results of the Global Better Sex Survey

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 partners 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.

The Erection Hardness Score and Its Relationship to Successful Sexual Intercourse

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.

Sildenafil citrate use and the incidence of nonarteritic anterior ischemic optic neuropathy.

Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in men after taking sildenafil or other phosphodiesterase 5 inhibitors for erectile dysfunction (ED). The incidence of NAION in men receiving sildenafil treatment for ED was estimated using pooled safety data from global clinical trials and European observational studies. Based on clinical trial data in more than 13,000 men and on more than 35,000 patient‐years of observation in epidemiologic studies, we estimated an incidence of 2.8 cases of NAION per 100,000 patient‐years of sildenafil exposure. This is similar to estimates reported in general US population samples (2.52 and 11.8 cases per 100,000 men aged ≥50 years). The data cited herein do not suggest an increased incidence of NAION in men who took sildenafil for ED.

ORIGINAL RESEARCH—OUTCOMES ASSESSMENT: Development and Validation of the Quality of Erection Questionnaire

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 mens 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 (Cronbachs 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 (Cronbachs 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). CONCLUSIONS 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.

ORIGINAL RESEARCH—OUTCOMES ASSESSMENTORIGINAL RESEARCH—OUTCOMES ASSESSMENT: Development and Validation of the Quality of Erection Questionnaire

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 mens 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 (Cronbachs 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 (Cronbachs 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). CONCLUSIONS 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.

Evaluating the Sexual Experience in Men: Validation of the Sexual Experience Questionnaire

INTRODUCTION The absence of a single brief measure that assesses function and health-related quality of life (HRQoL) hinders evaluation of the sexual experience in men with erectile dysfunction (ED). AIM To psychometrically analyze the Sexual Experience Questionnaire (SEX-Q). METHODS Two data sets were studied. A randomized, double-blind, placebo-controlled trial of flexible-dose sildenafil for ED treatment provided the final clinical trial data set (213 men enrolled, 4 of whom did not receive treatment) and the interim clinical trial data set (190 men screened and 165 men enrolled). The survey data set consisted of 902 respondents to a U.S. community health survey, of whom two-thirds had ED and one-third did not. MAIN OUTCOME MEASURES Quality and distribution of responses, comparative fit, item-level discriminant testing, internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficient), known-groups validity (vs. International Index of Erectile Function [IIEF] ED severity groups), convergent validity (Pearson correlation coefficients with scores on the IIEF, Self-Esteem and Relationship [SEAR] questionnaire, and Quality of Erection Questionnaire [QEQ]), responsiveness, and clinically important difference (CID). RESULTS The original 15 items were reduced to 12 items in three domains (erection, individual satisfaction, and couple satisfaction), which demonstrated good quality responses for all items; a strong factor structure; excellent internal consistency; good test-retest reliability; clear known-groups validity across the severity groups; moderate to strong convergent validity against the IIEF, SEAR, and QEQ; and high treatment responsiveness. The estimated CID ranged from 16.0 to 22.3 across domains. CONCLUSIONS The SEX-Q is the first questionnaire to solely and exclusively combine functional and HRQoL concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience, making it a potentially useful measure for clinical trial research.

Factors that predict changing the type of phosphodiesterase type 5 inhibitor medication among men in the UK.

To evaluate predictors of changing the type of phosphodiesterase type 5 (PDE5) inhibitor (switching) among men with erectile dysfunction (ED) in the UK, the largest consumer of PDE5 inhibitors in Europe, as switching medication is often associated with higher resource use, and there are three oral PDE5 inhibitor medications currently available.