Raymond C. Rosen

CONTEXT: While recent pharmacological advances have generated increased public interest and demand for clinical services regarding erectile dysfunction, epidemiologic data on sexual dysfunction are relatively scant for both women and men. OBJECTIVE: To assess the prevalence and risk of experiencing sexual dysfunction across various social groups and examine the determinants and health consequences of these disorders. DESIGN: Analysis of data from the National Health and Social Life Survey, a probability sample study of sexual behavior in a demographically representative, 1992 cohort of US adults. PARTICIPANTS: A national probability sample of 1749 women and 1410 men aged 18 to 59 years at the time of the survey. MAIN OUTCOME MEASURES: Risk of experiencing sexual dysfunction as well as negative concomitant outcomes. RESULTS: Sexual dysfunction is more prevalent for women (43%) than men (31%) and is associated with various demographic characteristics, including age and educational attainment. Women of different racial groups demonstrate different patterns of sexual dysfunction. Differences among men are not as marked but generally consistent with women. Experience of sexual dysfunction is more likely among women and men with poor physical and emotional health. Moreover, sexual dysfunction is highly associated with negative experiences in sexual relationships and overall well-being. CONCLUSIONS: The results indicate that sexual dysfunction is an important public health concern, and emotional problems likely contribute to the experience of these problems.

The Female Sexual Function Index (FSFI) is a brief, multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity (Meston, 2003 Meston, C. M. 2003. Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. Journal of Sex & Marital Therapy, 29: 39–46. [Taylor & Francis Online], [Web of Science ®] , [Google Scholar]; Rosen et al., 2000 Rosen, R. C., Brown, C., Heiman, J., Leiblum, S., Meston, C. M., Shabsigh, R., Ferguson, D. and D'Agostino, R. 2000. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Journal of Sex & Marital Therapy, 26: 191–208. [Taylor & Francis Online], [Web of Science ®] , [Google Scholar]). The present study was designed to cross-validate the FSFI in several samples of women with mixed sexual dysfunctions (N = 568) and to develop diagnostic cut-off scores for potential classification of women's sexual dysfunction. Some of these samples were drawn from our previous validation studies (N = 414), and some were added for purposes of the present study (N = 154). The combined data set consisted of multiple samples of women with sexual dysfunction diagnoses (N = 307), including female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), female sexual orgasm disorder (FSOD), dyspareunia/vaginismus (pain), and multiple sexual dysfunctions, in addition to a large sample of nondysfunctional controls (n = 261). We conducted analyses on the individual and combined samples, including replicating the original factor structure using principal components analysis with varimax rotation. We assessed Cronbach's alpha (internal reliability) and interdomain correlations and tested discriminant validity by means of a MANOVA (multivariate analysis of variance; dysfunction diagnosis x FSFI domain), with Bonferroni-corrected post hoc comparisons. We developed diagnostic cut off scores by means of standard receiver operating characteristics–curves and the CART (Classification and Regression Trees) procedure. Principal components analysis replicated the original five-factor structure, including desire/arousal, lubrication, orgasm, pain, and satisfaction. We found the internal reliability for the total FSFI and six domain scores to be good to excellent, with Cronbach alpha's > 0.9 for the combined sample and above 0.8 for the sexually dysfunctional and nondysfunctional samples, independently. Discriminant validity testing confirmed the ability of both total and domain scores to differentiate between functional and nondysfunctional women. On the basis of sensitivity and specificity analyses and the CART procedure, we found an FSFI total score of 26.55 to be the optimal cut score for differentiating women with and without sexual dysfunction. On the basis of this cut-off, we found 70.7% of women with sexual dysfunction and 88.1% of the sexually functional women in the cross-validation sample to be correctly classified. Addition of the lubrication score in the model resulted in slightly improved specificity (from .707 to .772) at a slight cost of sensitivity (from .881 to .854) for identifying women without sexual dysfunction. We discuss the results in terms of potential strengths and weaknesses of the FSFI, as well in terms of further clinical and research implications.

BACKGROUND: Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. METHODS: In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. RESULTS: In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.