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BackgroundLimited information is available on the performance characteristics of 2 questionnaires commonly used in clinical research, the Psychosexual Daily Questionnaire (PDQ) and the Derogatis Interview for Sexual Function (DISF)-II Assessment, especially in older men with low testosterone (T) and impaired sexual function.AimTo determine reliability of PDQ and DISF-II by assessing the correlation within and between domains in the questionnaires and to define clinically meaningful changes in sexual activity (PDQ question 4 [Q4]) and desire (DISF-II sexual desire domain [SDD]) domains.MethodsData from 470 men participating in the T Trials were used to calculate Spearman correlation coefficients of individual items and total score among questionnaires to determine convergent and construct validity. Clinically meaningful changes for sexual desire and activity were determined by randomly dividing the sample into training and validation sets. Anchor- and distribution-based clinically meaningful change criteria were defined in the training set, and selected changes were evaluated in the validation set.OutcomesValidity of the PDQ and DISF-II and clinically meaningful changes in sexual desire and activity were determined in older men in T Trials.ResultsModerate to strong correlations were shown within and between domains from different questionnaires. Using Patient Global Impression of Change as an anchor, clinically meaningful change in PDQ sexual activity was ≥0.6, and in DISF-SDD was ≥5.0. Applying these change cut-points to the validation set, a greater proportion of T-treated men achieved clinically meaningful improvement in their sexual desire and activity compared to placebo-treated men.Clinical implicationsThe PDQ-Q4 and DISF-II-SDD can be used to reliably assess clinically meaningful changes in sexual activity and sexual desire in hypogonadal men treated with T.Strengths & limitationsStrengths of this study include a large sample size, long trial duration, and inclusion of men with low libido and unequivocally low T levels. Limitations include using data from a single study that enrolled only older hypogonadal men, and only 1 anchor for both sexual desire and activity.ConclusionModerate to strong correlations were demonstrated within and between different sexual domains of the PDQ and DISF-II confirming construct and convergent validity. Clinically meaningful improvement in elderly hypogonadal men was change of ≥0.6 score in the PDQ-Q4 and ≥5.0 in the DISF-SDD. Improvements in sexual activity and desire in the T Trials were modest but clinically meaningful. Wang C, Stephens-Shields AJ, DeRogatis LR, et al. Validity and Clinically Meaningful Changes in the Psychosexual Daily Questionnaire and Derogatis Interview for Sexual Function Assessment: Results From the Testosterone Trials. J Sex Med 2018;15:997-1009.

We sought to determine whether posttraumatic stress disorder (PTSD) was associated with sexual health in returned warzone-deployed veterans from the recent Iraq and Afghanistan conflicts. We studied 1,581 males and females from the Veterans After-Discharge Longitudinal Registry, a gender-balanced U.S. Department of Veterans Affairs registry of health care-seeking veterans with and without PTSD. Approximately one quarter (25.1%) of males (n = 198) and 12.7% of females (n = 101) had a sexual dysfunction diagnosis and/or prescription treatment for sexual dysfunction. Both genders were more likely to have a sexual dysfunction diagnosis and/or prescription treatment if they had PTSD compared with those without PTSD (male: 27.3% vs. 21.1%, p = .054; female: 14.9% vs. 9.4%, p = .022). Among the 1,557 subjects analyzed here, males with PTSD had similar levels of sexual activity compared to those without PTSD (71.2% vs. 75.4%, p = .22), whereas females with PTSD were less likely to be sexually active compared to females without PTSD (58.7% vs. 72.1%, p < .001). Participants with PTSD were also less likely to report sex-life satisfaction (male: 27.6% vs. 46.0%, p < .001; female: 23.0% vs. 45.7%, p < .001) compared with those without PTSD. Although PTSD was not associated with sexual dysfunction after adjusting for confounding factors, it was significantly negatively associated with sex-life satisfaction in female veterans with a prevalence ratio of .71, 95% confidence interval [.57, .90].

IntroductionErectile dysfunction (ED) is associated with cardiovascular disease (CVD); however, the association between change in ED status over time and future underlying CVD risk is unclear.AimThe aim of this study was to investigate the association between change in ED status and Framingham CVD risk, as well change in Framingham risk.MethodsWe studied 965 men free of CVD in the Boston Area Community Health (BACH) Survey, a longitudinal cohort study with three assessments. ED was assessed with the five-item International Index of Erectile Function at BACH I (2002-2005) and BACH II (2007-2010) and classified as no ED/transient ED/persistent ED. CVD risk was assessed with 10-year Framingham CVD risk algorithm at BACH I and BACH III (2010-2012). Linear regression models controlled for baseline age, socio-demographic and lifestyle factors, as well as baseline Framingham risk. Models were also stratified by age (≥/< 50 years).Main outcome measuresFramingham CVD risk and change in Framingham CVD risk were the main outcome measures.ResultsTransient and persistent ED was significantly associated with increased Framingham risk and change in risk over time in univariate and age-adjusted models. In younger men, persistent ED was associated with a Framingham risk that was 1.58 percentage points higher (95% confidence interval [CI]: 0.11, 3.06) and in older men, a Framingham risk that was 2.54 percentage points higher (95% CI: -1.5, 6.59), compared with those without ED. Change in Framingham risk over time was also associated with transient and persistent ED in men

IntroductionMental health disorders are prevalent in the United States, Iraq, and Afghanistan war veterans. Mental illness, including posttraumatic stress disorder (PTSD) with or without psychiatric medications, can increase the risk for male sexual dysfunction, threatening quality of life.AimsWe sought to determine the prevalence and correlates of sexual dysfunction among male Iraq and Afghanistan veterans.MethodsWe performed a retrospective cohort study of 405,275 male Iraq and Afghanistan veterans who were new users of U.S. Department of Veterans Affairs healthcare from October 7, 2001 to September 30, 2009 and had 2-year follow-up.Main outcome measuresWe determined the independent association of mental health diagnoses and sexual dysfunction after adjusting for sociodemographic and military service characteristics, comorbidities, and medications.ResultsVeterans with PTSD were more likely to have a sexual dysfunction diagnosis, be prescribed medications for sexual dysfunction, or both (10.6%), compared with veterans having a mental diagnosis other than PTSD (7.2%), or no mental health diagnosis (2.3%). In a fully adjusted model, PTSD increased the risk of sexual dysfunction by more than threefold (adjusted risk ratio = 3.61, 95% CI = 3.48-3.75). Veterans with mental health disorders, particularly PTSD, were at the highest risk of sexual dysfunction when prescribed psychiatric medications (adjusted risk ratio = 4.59, 95% CI = 4.41-4.77).ConclusionsAmong U.S. combat veterans, mental health disorders, particularly PTSD, increased the risk of sexual dysfunction independent of the use of psychiatric medications.

Background: For the treatment of female sexual dysfunction, the most relevant outcome measures are patient-reported treatment effects and changes in symptoms, underscoring the need for reliable, validated patient-reported outcome (PRO) instruments. The aim of this study was to evaluate the psychometric characteristics (validity and reliability) of the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) PRO measure, which was adapted from the validated FSDS-Revised (FSDS-R) questionnaire and added 2 questions involving arousal and orgasm. Methods: Psychometric analyses were based on the data from a multicenter phase 2b dose-finding study that compared the safety and efficacy of bremelanotide versus placebo and were conducted in the evaluable modified intent-to-treat population (N = 325) from that study. Psychometric evaluation of the new items in the FSDS-DAO included confirmatory factor analyses, tests of internal consistency and test–retest reliability, examinations of convergent and discriminant validity, and determination of responsiveness. The validity of the FSDS-DAO was evaluated based on previously developed instruments, including the Female Sexual Function Index (FSFI), General Assessment Questionnaire (GAQ), Women's Inventory of Treatment Satisfaction (WITS-9), and Female Sexual Encounter Profile-Revised (FSEP-R). Results: Confirmatory factor analyses demonstrated that the FSDS-DAO items fit very well (Bentler's comparative fit index of 0.929). Cronbach's α for the FSDS-DAO total score was ≥ 0.91 at Visits 1, 2, 5, and 12, demonstrating adequate internal consistency reliability. Test–retest reliability was acceptable with an intra-class coefficient of 0.61 and a Spearman's correlation coefficient score of 0.62 between Visits 1 and 2 (4 weeks). Acceptable construct validity was demonstrated by significant correlations with related PRO scales in the expected directions and magnitude. For example, participants reporting the worst levels of sexual function on the FSFI also showed the worst FSDS-DAO scores at Visits 5 and 12. The FSDS-DAO total score was responsive to change. Conclusions: Evidence supports the validity and reliability of the FSDS-DAO for assessing sexually related distress in women with female sexual arousal disorder and/or hypoactive sexual desire disorder; the addition of the arousal and orgasm items did not impact the validity and reliability of the measure. Clinical Trial Registration ClinicalTrials.gov NCT01382719. [ABSTRACT FROM AUTHOR]

Erectile dysfunction negatively affects men and women in relationships; however, the subjective experience of erectile dysfunction and phosphodiesterase-type 5 inhibitor therapy remains poorly understood. The authors therefore characterized participants’ subjective understanding of erectile dysfunction and phosphodiesterase-type 5 inhibitor therapy using individual interviews with affected heterosexual men (n= 58) and women (n= 65). Responses were characterized by 6 psychosocial domains: explanation of the experience, emotional responses, socially expected responses, value of sex, communication with the partner, and treatment expectations. The findings may aid clinicians in relating to men with erectile dysfunction and thus potentially improve effectiveness of therapy. [ABSTRACT FROM PUBLISHER]

Introduction Erectile dysfunction ( ED) is associated with cardiovascular disease ( CVD); however, the association between change in ED status over time and future underlying CVD risk is unclear. Aim The aim of this study was to investigate the association between change in ED status and Framingham CVD risk, as well change in Framingham risk. Methods We studied 965 men free of CVD in the Boston Area Community Health ( BACH) Survey, a longitudinal cohort study with three assessments. ED was assessed with the five-item International Index of Erectile Function at BACH I (2002-2005) and BACH II (2007-2010) and classified as no ED/transient ED/persistent ED. CVD risk was assessed with 10-year Framingham CVD risk algorithm at BACH I and BACH III (2010-2012). Linear regression models controlled for baseline age, socio-demographic and lifestyle factors, as well as baseline Framingham risk. Models were also stratified by age (≥/< 50 years). Main Outcome Measures Framingham CVD risk and change in Framingham CVD risk were the main outcome measures. Results Transient and persistent ED was significantly associated with increased Framingham risk and change in risk over time in univariate and age-adjusted models. In younger men, persistent ED was associated with a Framingham risk that was 1.58 percentage points higher (95% confidence interval [ CI]: 0.11, 3.06) and in older men, a Framingham risk that was 2.54 percentage points higher (95% CI: −1.5, 6.59), compared with those without ED. Change in Framingham risk over time was also associated with transient and persistent ED in men <50 years, but not in older men. Conclusions Data suggest that even after taking into account other CVD risk factors, transient and persistent ED is associated with Framingham CVD risk and a greater increase in Framingham risk over time, particularly in younger men. Findings further support clinical assessment of CVD risk in men presenting with ED, especially those under 50 years. Fang SC, Rosen RC, Vita JA, Ganz P, and Kupelian V. Changes in erectile dysfunction over time in relation to Framingham cardiovascular risk in the Boston Area Community Health (BACH) Survey. J Sex Med 2015;12:100-108 [ABSTRACT FROM AUTHOR]

OBJECTIVE--Sexual dysfunction is a prevalent problem in obese women with type 2 diabetes. This study examined the effects of intensive lifestyle intervention (ILI) in these women. RESEARCH DESIGN AND METHODS--Look AHEAD is a 16-center, randomized, controlled trial evaluating the health effects of ILI compared with a control group (diabetes support and education [DSE]). The Look AHEAD Sexual Function Ancillary study included 375 female participants at five Look AHEAD sites. Participants completed the Female Sexual Function Inventory (FSFI) and Beck Depression Inventory (BDI), and assessments of weight and cardiovascular risk factors at baseline and 1 year were made. RESULTS--At baseline, 50% of the 229 participants who reported being sexually active met criteria for female sexual dysfunction (FSD); only BDI score was related to FSD. One-year weight losses were greater in the ILI group than in the DSE group (7.6 vs. 0.45 kg; < 0.001). Among women with FSD at baseline, those in the ILI group (P = 60) compared with those in the DSE group (N =5 3 )were significantly more likely to remain sexually active (83 vs. 64%; P < 0.008), reported greater improvement in total FSFI scores and in most FSFI domains (P < 0.05), and were more likely to experience remission of FSD (28 vs. 11% < 0.04) at 1 year. No significant differences between ILI and DSE were seen in women who did not have FSD at baseline. CONCLUSIONS--Participation in ILI appeared to have beneficial effects on sexual functioning among obese women with diabetes, particularly in those who had FSD at baseline. [ABSTRACT FROM AUTHOR]

In a randomized experiment (N = 249; age 50 + years), this study examined if self-reports of erectile dysfunction (ED) and ejaculatory dysfunction (EjD) symptomatology were influenced by the mode of interview administration (computer-assisted self-interview [CASI], audio computer-assisted self-interview [ACASI], or computer-assisted personal interview [CAPI; involving an interviewer]). This study also examined if mode moderated person variables hypothesized to impact self-reports (social desirability, age, or depressive mood). No main or moderating effects of mode were found for self-reports of EjD symptoms. However, mode effects on reports of ED symptoms were observed, and these moderated age and social desirability effects on self-reports. Significantly more older (relative to younger) men reported high levels of ED symptoms when interview administration was by a live interviewer (CAPI) than with self-administration. Alternatively, significantly more younger men reported high levels of ED symptoms when administration was by an interviewer (CAPI) or by ACASI (vs. CASI). The Mode × Social Desirability effects were complex (see the Discussion section), showing hypothesized effects under ACASI and CAPI conditions, but an opposite effect under the CASI condition. The stability of self-reported ED symptoms did not vary by mode (based on test–retest comparisons); test–retest was significantly higher for EjD symptoms within the ACASI condition. The impact of mode of administration on self-reports of ED/EjD symptoms is less predictable and dramatic than one might conclude from prior research with other types of self-report outcomes. The findings are consistent with a small, but growing, body of studies that illustrate highly situational effects of interviewing, which may depend on a complex interplay between modes, person variables, and the interview topic/target items. Self-administered methods, in particular, may not be a universal solution to response bias. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction. While there is evidence of increased professional and public awareness of sexual problems, both male and female sexual dysfunctions remain underdiagnosed and undertreated by health care professionals around the world. Health care professionals (HCPs) are typically reluctant, disinterested, or unskilled in sexual problem management and regrettably are often disinclined to inquire about sexual issues. HCPs in all countries receive variable, nonstandardized, or inadequate training in sexual history taking and its treatment. Aim. This article presents a standard operating procedure (SOP) for taking a sexual history from men or women with sexual problems or performance concerns. Methods. Review of relevant evidence-based literature identified through a PubMed search, integrated with expert opinion. Results. Guidelines for taking a sexual history are presented along with the relevant domains, opening and follow-up questions. Conclusions. The SOP presented in this article offers HCPs a brief, structured, and uniform method for obtaining a sexual history from men or women seeking health care services. Sexual history taking should be based on three basic principles, which serve as the foundation for managing sexual problems in men and women. These include the following: (i) a patient-centered approach; (ii) evidenced-based diagnostic and treatment recommendations; and (iii) use of a unified management approach for men and women. Sexual history taking should always be conducted in a culturally sensitive manner, taking account of the individual's background and lifestyle, status of the partner relationship, and the clinician's comfort and experience with the topic. Sexual inquiry should be incorporated into all new patient encounters, when possible, if only to ask one or two broad questions such as the following: 'Are you sexually active? Do you have any sexual concerns or problems you would like to discuss?' Sexual history taking is a cornerstone of sexual medicine clinical practice. All patients should be provided an opportunity for frank and open discussion of sexual issues or concerns, conducted in an atmosphere of sensitivity and respect. Althof SE, Rosen RC, Perelman MA, and Rubio-Aurioles E. Standard operating procedures for taking a sexual history. J Sex Med **;**:**-**. [ABSTRACT FROM AUTHOR]

Introduction. A validated cutpoint for the total Female Sexual Function Index scale score exists to classify women with and without sexual dysfunction. However, there is no sexual desire (SD) domain-specific cutpoint for assessing the presence of diminished desire in women with or without a sexual desire problem. Aims. This article defines and validates a specific cutpoint on the SD domain for differentiating women with and without hypoactive sexual desire disorder (HSDD). Methods. Eight datasets (618 women) were included in the development dataset. Four independent datasets (892 women) were used in the validation portion of the study. Main Outcome Measures. Diagnosis of HSDD was clinician-derived. Receiver-operator characteristic (ROC) curves were used to develop the cutpoint, which was confirmed in the validation dataset. Results. The use of a diagnostic cutpoint for classifying women with SD scores of 5 or less on the SD domain as having HSDD and those with SD scores of 6 or more as not having HSDD maximized diagnostic sensitivity and specificity. In the development sample, the sensitivity and specificity for predicting HSDD (with or without other conditions) were 75% and 84%, respectively, and the corresponding sensitivity and specificity in the validation sample were 92% and 89%, respectively. Conclusions. These analyses support the diagnostic accuracy of the SD domain for use in future observational studies and clinical trials of HSDD. Gerstenberger EP, Rosen RC, Brewer JV, Meston CM, Brotto LA, Wiegel M, and Sand M. Sexual desire and the female sexual function index (FSFI): A sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. J Sex Med 2010;7:3096–3103. [ABSTRACT FROM AUTHOR]

Introduction. Hypoactive sexual desire disorder (HSDD) is a clinically challenging disorder in women. Little is known about the natural history of the disorder and long-term consequences. A longitudinal registry can address these needs. Aim. To design and implement a registry study of HSDD in women to characterize the natural history of HSDD and current treatment practices. Methods. A longitudinal multicenter registry study has been initiated at clinical sites across the United States. A total of 1,500 women (approximately 1,000 premenopausal, 500 postmenopausal) with clinically-diagnosed HSDD, confirmed by the Decreased Sexual Desire Screener, will be recruited over 24 months at up to 40 clinical sites. Participants will be followed with in-clinic or remote, computer-assisted follow-up. Data from the initial implementation phase was analyzed to assess feasibility of the protocol. A qualitative substudy (N = 40) was conducted to assess content validity of the participant questionnaire. Main Outcome Measures. The primary outcome measure for the Registry study is a patient-based global impression of change in HSDD. Secondary outcome measures are derived from two sources: (i) self-administered questionnaire completed by the participant, and (ii) medical history review completed by the clinician. The questionnaire includes validated measures of sexual function, quality of life, relationship factors, and physical and mental health, as well as newly developed questions on treatments and medications. Results. As of February 12, 2009, 290 women (209 premenopausal, 81 postmenopausal) had been recruited from 15 clinical sites. Results of the initial implementation phase and qualitative substudy on the participant questionnaire show that the Registry protocol is highly feasible and the questionnaire consisting of previously validated scales and selected new items has high content validity. Conclusions. As the first longitudinal registry study in female sexual dysfunction, the HSDD Registry will contribute to a broader understanding of the impact and treatment needs of women with clinically diagnosed HSDD. Rosen RC, Connor MK, and Maserejian NN. The HSDD registry for women: a novel patient registry for women with generalized acquired hypoactive sexual desire disorder. J Sex Med 2010;7:1747–1756. [ABSTRACT FROM AUTHOR]

Introduction. The challenge in the field of sexual medicine is to develop evidence-based principles for clinical evaluation and create a uniform, widely accepted diagnostic and treatment approach for all sexual problems and dysfunctions, for both genders. Aim. To provide recommendations for the broad approach for assessing sexual problems in a medical practice setting; to develop an evidence-based diagnostic and treatment algorithm for men and women with sexual dysfunctions. Methods. The PubMed literature was reviewed. Expert opinion was based on the grading of evidence-based medical literature and the Delphi consensus process. Results. The Committee determined three principles for clinical evaluation and management: (i) adoption of a patient-centered framework, with emphasis on cultural competence in clinical practice; (ii) application of evidence-based medicine in diagnostic and treatment planning; (iii) use of a unified management approach in evaluating and treating sexual problems in both men and women. The International Consultation in Sexual Medicine-5 stepwise diagnostic and treatment algorithm was developed for that purpose. According to this algorithm, sexual, medical, and psychosocial history is mandatory, whereas physical examination and laboratory tests are highly recommended in most cases. Furthermore, the Brief Sexual Symptom Checklist (BSSC) for Men and BSSC for Women, and more recently the Sexual Complaints Screener (SCS) for Men and SCS for Women, were all endorsed for screening purposes. A classification system was also defined; clinically, sexual dysfunctions are categorized in three types according to their etiology (Type I: psychogenic; Type II: organic; Type III: mixed). Final recommendations on specialized diagnostic tests were based on level of evidence. Conclusions. A unified diagnostic and management strategy in sexual medicine, irrespective of condition and gender, would improve patients' sexual well-being. It would also lead to the development of academic curricula to provide practicing physicians across specialties with the needed skills to meet contemporary patients' needs in sexual medicine health-care delivery. Hatzichristou D, Rosen RC, Derogatis LR, Low WY, Meuleman EJH, Sadovsky R, and Symonds T. Recommendations for the clinical evaluation of men and women with sexual dysfunction. J Sex Med 2010;7:337–348. [ABSTRACT FROM AUTHOR]

The article discusses a study which investigated the prevalence of sexual disorders of desire, arousal and orgasm in U.S. women with depression. The study utilized data from the Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE) study. It concluded that sexual disorder is associated with depression. Study authors emphasized the need to evaluate depression and sexual problems in routine clinical practice.

OBJECTIVE To assess, using the psychometrically validated Male Sexual Health Questionnaire (MSHQ), the prevalence of ejaculatory dysfunction (EjD) and bother due to EjD in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), and to assess predictors of EjD in this population. PATIENTS AND METHODS In all, 5999 sexually active men with LUTS completed the International Prostate Symptom Score (IPSS) which rates LUTS severity, and the MSHQ long-form, which evaluates seven EjD symptoms and bother due to EjD. Concomitant intake of medical treatments for BPH and previous BPH-related surgery were collected. The impact of treatments on EjD was compared to a control group (i.e. no previous BPH-related surgery and no medical treatment for BPH). The relationship between EjD, bother due to EjD and selected clinical characteristics was analysed using multiple regression analysis. RESULTS EjD was highly prevalent and bothersome in men with LUTS, with decreased force of ejaculation (77.9%) and decreased amount of semen (74.4%) being the most commonly reported symptoms. LUTS severity was the strongest predictor of EjD and bother due to EjD. EjD was considered a problem by 35.6%, 51.6% and 64.1% of men with mild, moderate and severe LUTS, respectively ( P < 0.001). EjD (except pain/discomfort on ejaculation) and bother due to EjD were also strongly related to age. Men with previous BPH-related surgery and men treated with a 5α-reductase inhibitor plus an α1-blocker or tamsulosin alone showed the highest rates of dry ejaculation (67.4%, 57.2% and 52.3%, respectively) compared to controls (31.6%, P < 0.001). Conversely, in men treated with alfuzosin, most EjD symptoms were significantly lower than in controls. Bother due to EjD was also significantly lower with alfuzosin than in controls (34.4% vs 53.1%, P < 0.001) while there was no significant difference for other treatments. CONCLUSIONS EjD is highly prevalent and bothersome in sexually active men with LUTS, and is strongly related to LUTS severity and age. Treatment options for BPH do not have the same effect on EjD. EjD should be considered in the initial evaluation and clinical management of men with LUTS. [ABSTRACT FROM AUTHOR]

Introduction. Sexual distress is an important component of diagnostic criteria for sexual dysfunctions, but little is known about the factors associated with sexual distress in women with low sexual desire. Aim. To investigate the correlates of sexual distress in women with self-reported low sexual desire. Methods. The Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking study was a cross-sectional, nationally representative, mailed survey of U.S. adult women. There were 31,581 respondents (response rate 63.2%) to the 42-item questionnaire that measured sexual function, sexual distress, demographic, and health-related factors. Multivariable logistic regression was used to explore the correlates of distress. Main Outcome Measures. Low sexual desire was defined as a response of “never” or “rarely” to the question, “How often do you desire to engage in sexual activity?” Sexual distress was measured with the Female Sexual Distress Scale (range 0–48), with a score of 15 or higher indicating presence of distress. Results. Of 10,429 women with low desire, 2,868 (27.5%) had sexual distress (mean age 48.6 years, 81% with a current partner). Women without distress were 10 years older on average, and 44% had a current partner. Having a partner was strongly related to distress (odds ratio 4.6, 95% confidence interval 4.1–5.2). Other correlates were age, race, current depression, anxiety, lower social functioning, hormonal medication use, urinary incontinence, and concurrent sexual problems (arousal or orgasm). Dissatisfaction with sex life was more common in women with low desire and distress (65%) than in those without distress (20%). Conclusions. Age has a curvilinear relationship with distress, and the strongest correlate of sexual distress was having a current partner. Sexual distress and dissatisfaction with sex life are strongly correlated. Distress is higher in women with low sexual desire in a partner relationship; further research on this factor is needed. Rosen RC, Shifren JL, Monz BU, Odom DM, Russo PA, and Johannes CB. Correlates of sexually related personal distress in women with low sexual desire. J Sex Med 2009;6:1549–1560. [ABSTRACT FROM AUTHOR]

Background. Current screening instruments for hypogonadism lack adequate specificity and diagnostic accuracy. A new self-administered questionnaire of hypogonadism symptoms is being developed to address this need. The process for questionnaire development and results from the first (qualitative) phase are presented. Methods. Qualitative interviews were conducted based on a new conceptual model of hypogonadism and according to standards for questionnaire development. An item pool was generated from focus groups and in-depth interviews with two groups of hypogonadal patients, treated (N = 26) and untreated (N = 26), and age-equivalent controls (N = 28). Standardized scoring of the qualitative interviews was used to confirm conceptual domains in the model and to generate questionnaire items for further validation. Results. Key domains identified in both patients and controls included: (a) physical function; (b) bodily signs and symptoms; (c) sexual function and libido; (d) sleep function; (e) mood and affective function; (f) memory and cognitive function. The final domain is distress or bother associated with hypogonadism symptoms. This domain was only relevant to the patient groups. Conclusions. The first stage in the design of a new hypogonadism screener has been completed. Seven domains were identified and draft items were developed in each domain according to current standards of patient-reported outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- This study aimed to investigate the prevalence and risk factors associated with sexual dysfunction in a well-characterized cohort of women with type 1 diabetes. RESEARCH DESIGN AND METHODS -- The study was conducted in women enrolled in the long-term Epidemiology of Diabetes Interventions and Complications (EDIC) study, a North American study of men and women with type 1 diabetes. At year 10 of the EDIC study, 652 female participants were invited to complete a validated self-report measure of sexual function, standardized history and physical examinations, laboratory testing, and mood assessment. RESULTS -- Of the sexually active women with type 1 diabetes in the EDIC study, 35% met criteria for female sexual dysfunction (FSD). Women with FSD reported loss of libido (57%); problems with orgasm (51%), lubrication (47%), and arousal (38%); and pain (21%). Univariate analyses revealed a positive association between FSD and age (P = 0.0041), marital status (P = 0.0016), menopausal status (P = 0.0019), microvasculopathy (P = 0.0092), and depression (P = 0.0022). However, in a multivariate analysis, only depression (P = 0.004) and marital status (P = 0.003) were significant predictors of FSD. CONCLUSIONS -- FSD is common in women with type 1 diabetes and affects all aspects of sexual function and satisfaction. Depression is the major predictor of sexual dysfunction in women with type 1 diabetes. These findings suggest that women with type 1 diabetes should be routinely queried about the presence of sexual dysfunction and possible co-association with depression. [ABSTRACT FROM AUTHOR]

OBJECTIVE To investigate the association between urological symptoms and self-reported measures of sexual activity, desire and function in large representative samples of men and women in the Boston Area Community Health (BACH) survey. SUBJECTS AND METHODS The BACH survey is a racially and ethnically diverse random sample of 5503 community-dwelling residents aged 30–79 years, of Boston, MA, USA. Urological symptoms and sexual function were assessed in men and women at baseline using validated self-report measures, i.e. the International Prostate Symptom Score (IPSS), International Index of Erectile Function, and Female Sexual Function Index. Bivariate and multivariate analyses were conducted to assess the degree of association of sexual function measures with LUTS and other common urological problems in men and women in the BACH sample, controlling for the effects of age, medical comorbidities, and lifestyle factors. RESULTS Urological symptoms were associated with a significant decrease in sexual activity and function in both men and women. Women were more likely to report low sexual desire than men. Low sexual desire was associated with depression, nocturia and prostatitis in men. Erectile dysfunction in men was significantly associated with LUTS, nocturia and prostatitis in bivariate associations, and with prostatitis in multivariate analyses, controlling for the effects of diabetes and other comorbidities. In the multivariate analysis in women, sexual dysfunction was primarily associated with depression and inversely with alcohol use. CONCLUSION Sexual activity and function were diminished in both men and women with urological symptoms, although women reported more sexual problems overall than men, and the profile of risk factors and comorbidities was different across genders. [ABSTRACT FROM AUTHOR]

Lower urinary tract symptoms (LUTS) include storage, voiding, and postmicturition symptoms, and occur commonly in both men and women. Findings from two recent epidemiological studies, the Epidemiology of LUTS study and the Boston Area Community Health survey, further extend the understanding of the prevalence of individual LUTS, the overlap of LUTS in men and women, the associations of LUTS with other comorbid conditions, the impact of LUTS on health-related quality of life (HRQL), and the relationships between frequency and bother of LUTS and treatment-seeking behaviour. Examining the clinical implications of these findings might provide directions to physicians for managing their patients with LUTS. For example, common findings of separate patient groups spanning a spectrum from those with typically one urinary symptom of mild to moderate severity to those with multiple more severe LUTS and frequent comorbidities might further encourage the diagnosis and treatment of comorbid conditions as a standard part of the management of patients with LUTS. Likewise, understanding that the impact of LUTS on HRQL and the degree of bother, rather than the frequency of LUTS, are significant drivers for treatment seeking might aid in assisting patients to make decisions about treatment. [ABSTRACT FROM AUTHOR]

OBJECTIVE To evaluate the overall treatment benefit of dapoxetine for premature ejaculation (PE), with specific emphasis on improvements in personal distress and interpersonal difficulty related to ejaculation. Although these factors are key elements of numerous sets of diagnostic criteria for PE, they have rarely been evaluated as outcome measures in clinical trials. PATIENTS AND METHODS In this randomized, double-blind, placebo-controlled, phase III trial we enrolled men aged ≥18 years, from the USA and Canada, who had a Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, diagnosis of PE (1238 men). Men were randomized to receive placebo or dapoxetine 60 mg as needed or once daily for 9 weeks. The once-daily treatment arm was included for analysis of withdrawal symptoms (primary endpoint; presented elsewhere). Patients completed the Premature Ejaculation Profile (PEP) on day 1 (before dosing), and on days 28 and 63 (or study endpoint), which comprised the outcome measures for perceived control over ejaculation, satisfaction with sexual intercourse, and personal distress and interpersonal difficulty related to ejaculation. The patient-reported global impression of change in PE was reported on day 63 (or study endpoint). Treatment benefit measures included the composite criteria of at least a two-category increase in perceived control over ejaculation and at least a one-category decrease in personal distress related to ejaculation from baseline at study endpoint. RESULTS At baseline, ≈5% of patients in any treatment group reported ‘not at all’ or ‘a little bit’ of personal distress related to ejaculation, which increased to 54.3% of those receiving dapoxetine (vs 35.3% with placebo; P < 0.001). Similarly, 43.0% and 40.9% of men in the placebo and dapoxetine groups, respectively, reported ‘not at all’ or ‘a little bit’ of interpersonal difficulty related to ejaculation at baseline, which increased to 76.8% and 64.2% of those with dapoxetine and placebo, respectively ( P < 0.001). The percentage of men who achieved the composite criteria with dapoxetine ‘as needed’ was 47.6%, vs 21.7% with placebo (difference from placebo, 25.9%; P < 0.001). The distribution of responses for the PEP among men who achieved the composite criteria was similar to that reported for men without PE in a previous observational study in the USA. The most common adverse events were nausea, dizziness, headache, diarrhoea and insomnia, which were more common with dapoxetine than with placebo. CONCLUSION Dapoxetine reduced the personal distress and interpersonal difficulty associated with PE, and was associated with patient-reported improvements in their condition. The percentage of patients who achieved a composite of a two-category or greater increase in perceived control over ejaculation and a one-category or greater decrease in personal distress related to ejaculation was substantially greater than with placebo, as were all outcome measures. [ABSTRACT FROM AUTHOR]

Objectives: The severity of lower urinary tract symptoms (LUTS) has correlated with erectile dysfunction (ED) and ejaculatory dysfunction (EjD) in large-scale epidemiologic studies. ED and EjD are also side effects of some medical therapies for LUTS suggestive of benign prostatic hyperplasia (LUTS/BPH). These relationships were examined in a physician office-based population of men enrolled in the BPH Registry. Methods: Enrolled men with LUTS/BPH who completed the International Prostate Symptom Score (IPSS), IPSS bother question, 5-item International Index of Erectile Function, and the 3 ejaculatory function items of the Male Sexual Health Questionnaire-EjD short form at baseline were eligible. The relationship between sexual dysfunction and LUTS/BPH and BPH medical therapies were examined using multivariate analyses. Results: Of 6924 men enrolled, 5042 (mean age 65 years) completed all 4 baseline assessments. Of 3084 sexually active men, age, total IPSS, IPSS bother score, hypertension, diabetes, and black race/ethnicity were independent predictors of both ED and EjD (all P < .05). For the subset of 1362 men receiving BPH medical therapy, a significant association (P < .0001) was demonstrated for ED and EjD with specific BPH medical therapies. The α1A-subtype nonsuperselective quinazoline α1-blockers alfuzosin, doxazosin, and terazosin appeared to be associated with better ejaculatory function than were the α1A-subtype superselective sulfonamide α1-blocker tamsulosin, 5α-reductase inhibitors, and α1-blocker plus 5α-reductase inhibitor combination therapy. Conclusions: These results have provided additional evidence of the link between LUTS/BPH and sexual dysfunction in aging men and support clinical trial results indicating different rates of sexual side effects for BPH medical therapies. [Copyright &y& Elsevier]

Introduction. There are no validated scales for assessing the psychosocial impact of Peyronie's disease (PD), which affects approximately 5–10% of men over age 50. Aim. To develop a psychometrically valid outcome measure for assessing psychosocial and sexual consequences of PD. To conduct a qualitative study of men with PD and age-matched controls, and design a new patient-reported outcome measure of PD. Methods. An expert advisory panel identified relevant topics and conceptual areas to be addressed based on clinical experience and literature reviews. A conceptual model was developed to serve as a discussion guide for qualitative interviews with geographically and ethnically diverse PD subjects and controls. Interviews were conducted in a focus-group format by a trained interviewer and were recorded and transcribed for qualitative analysis according to grounded theory concepts. Main Outcome Measure. Focus-group interviews. Results. Focus-group interviews were conducted with 64 men (28 PD patients, 36 controls) in 13 separate focus groups over a 3-month period. Blinded analysis of the interview transcripts identified four core domains: (i) physical appearance and self-image; (ii) sexual function and performance; (iii) PD-related pain and discomfort; and (iv) social stigmatization and isolation. Based on feedback from participants and experts, a new outcome questionnaire was developed to assess core domain responses in a structured, self-report format. Conclusions. This qualitative study helped to refine and broaden the focus of the conceptual model for further assessment. It also confirmed that PD has a major impact on sexual and psychological function in these patients. Rosen R, Catania J, Lue T, Althof S, Henne J, Hellstrom W, and Levine L. Impact of Peyronie's disease on sexual and psychosocial functioning: Qualitative findings in patients and controls. J Sex Med 2008;5:1977–1984. [ABSTRACT FROM AUTHOR]

Introduction. Premature ejaculation (PE) has been associated with a range of negative psychological effects, including anxiety, depression, and distress in men and their female partners. Aim. To review evidence of the psychosocial concomitants of premature ejaculation in recent observational studies, and to consider the psychosocial and quality of life outcomes associated with PE, including effects on the partner relationship. Main Outcome Measure. Psychosocial and quality of life consequences related to premature ejaculation. Methods. A literature search was performed to retrieve publications relating to management or treatment of PE or male sexual dysfunction. Publications were included if they reported the impact of PE on the man, his partner or relationship, or the impact of male sexual dysfunction and included PE in the analysis. Results. Eleven observational studies were selected. All these studies found evidence for an association between PE and adverse psychosocial and quality of life consequences, including detrimental effects on the partner relationship. Comparative analyses were restricted by major differences across the studies. Conclusions. PE significantly negatively impacts men and their partners and may prevent single men forming new partner relationships. Men are reluctant to seek treatment from their physicians, although they may be more encouraged to do so through their partner's support and the availability of effective treatments. There is a need for validated diagnostic screening criteria and validated, reliable, brief patient-reported outcome measures that can be used to assess men with PE and their partners. These factors would allow further studies with more complete and accurate assessment of the impact of PE. Rosen RC, and Althof S. Impact of premature ejaculation: The psychological, quality of life and sexual relationship consequences. J Sex Med 2008;5:1296–1307. [ABSTRACT FROM AUTHOR]

Purpose: A recent observational study characterized intravaginal ejaculatory latency time and single item patient reported outcome measures in a large population of males with and without premature ejaculation, as well as their female partners. In the current analysis we assessed the relative influence of those measures in identifying premature ejaculation as diagnosed by the clinician. Materials and Methods: Data were from a 4-week, multicenter, observational study of men with (207) and without (1,380) premature ejaculation (diagnosed using The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision criteria), as well as their female partners. Estimated and measured intravaginal ejaculatory latency time, age, and responses to single item (control over ejaculation, personal distress, satisfaction with sexual intercourse and interpersonal difficulty) and multiple item (male and female Golombok-Rust Inventory of Sexual Satisfaction, male Self-Esteem and Relationship questionnaire, and Short Form 36) measures were evaluated with stepwise logistic regression analysis. Results: Self-estimated and stopwatch measured intravaginal ejaculatory latency time were interchangeable, correctly assigning premature ejaculation status with 80% sensitivity and 80% specificity, increasing to 80% sensitivity and 96% specificity when combined with single item patient reported outcomes. Subject reported control over ejaculation and personal distress most strongly indicated premature ejaculation status. Partner personal distress was more influential in determining premature ejaculation status than estimated or measured intravaginal ejaculatory latency time, and single item measures were more influential than multiple item measures. Age was not influential in assigning premature ejaculation status. Conclusions: Neither self-estimated nor stopwatch measured intravaginal ejaculatory latency time alone was optimal for assigning premature ejaculation status. Subject and partner responses to single item measures, particularly control over ejaculation and personal distress, were important. Results suggest that a combination of estimated intravaginal ejaculatory latency time and the 4 single item patient reported outcome measures can adequately identify premature ejaculation status. [Copyright &y& Elsevier]

Introduction. Recent reports have linked the use of phosphodiesterase type 5 (PDE-5) inhibitors with increased rates of high-risk sexual behavior and HIV transmission in some individuals. Aim. A National Institute of Mental Health (NIMH)-funded, multidisciplinary conference was convened to evaluate scientific research, clinical and ethical considerations, and public policy implications of this topic. Main Outcome Measures. Published and unpublished findings on effects of PDE-5 inhibitors on sexual behavior; published guidelines and management recommendations. Methods. Leading investigators in relevant disciplines (e.g., public health, epidemiology, medical ethics, urology, psychology) participated in a 2-day meeting, including representatives of government, scientific, and regulatory agencies (the Centers for Disease Control, Food and Drug Administration, NIMH, and the National Institute on Drug Abuse). Panelists provided critical reviews of substantive areas of research, followed by question and answer sessions on each topic. On the second day, working groups were convened to identify critical gaps and priorities in three major areas: (i) research and evaluation needs; (ii) prevention strategies and clinical management issues; and (iii) policy and prevention implications. Results. Research needs and priorities were categorized into four specific areas: (i) basic and clinical/laboratory research; (ii) epidemiology and risk factors; (iii) social-behavioral processes and interventions; and (iv) prevention/policy and educational needs. Identified gaps in the available data include populations at risk (e.g., risk among heterosexuals, risk profiles among subpopulations of men who have sex with men) and the specific role of PDE-5 inhibitors in HIV seroconversion. Specific areas of emphasis were the need for safer sex counseling, comprehensive sexually transmitted infection (STI) screening and follow-up when indicated, avoidance of potentially dangerous drug interactions, and potential benefits of testosterone replacement for HIV-positive men with decreased androgen and other symptoms of hypogonadism. Conclusions. A conference was convened on the topic of PDE-5 inhibition and HIV risk. This “white paper” summarizes the findings of the conference and recommendations for future research. Rosen RC, Catania JA, Ehrhardt AA, Burnett AL, Lue TF, McKenna K, Heiman JR, Schwarcz S, Ostrow DG, Hirshfield S, Purcell DW, Fisher WA, Stall R, Halkitis PN, Latini DM, Elford J, Laumann EO, Sonenstein FL, Greenblatt DJ, Kloner RA, Lee J, Malebranche D, Janssen E, Diaz R, Klausner JD, Caplan AL, Jackson G, Shabsigh R, Khalsa JH, and Stoff DM. The Bolger Conference on PDE-5 inhibition and HIV risk: Implications for health policy and prevention. J Sex Med 2006;3:960–975. [ABSTRACT FROM AUTHOR]

Sexual dysfunction is a highly prevalent condition in ageing men that considerably affects their quality of life, although it is a frequently neglected aspect of healthcare. The main predictors of sexual dysfunction are age and cardiovascular comorbidities such as hypertension, heart disease, hypercholesterolaemia and diabetes. Recently, the severity of lower urinary tract symptoms (LUTS) has also been identified as a crucial risk factor for sexual dysfunction, independent of age and comorbidities. Despite the increased prevalence of sexual dysfunction with age, health-related problems and psychological factors, there is evidence that many older men remain sexually active. Currently available self-administered questionnaires assessing male sexual dysfunction focus almost exclusively on erectile function. There is evidence from recent large-scale epidemiological studies that ejaculatory dysfunction (EjD) is almost as prevalent as erectile dysfunction (ED), affecting nearly half of men aged ≥ 50 years. Other domains such as orgasm, desire, and satisfaction with sex life are important and should be considered. There is thus a need to develop and validate more comprehensive and multidimensional instruments for assessing sexual dysfunction in ageing men. A new instrument, the Male Sexual Health Questionnaire (MSHQ), was developed and validated to assess these specific aspects of male sexual dysfunction . It consists of a 25-item self-administered questionnaire including three core domains (erection, ejaculation, satisfaction with sex life) and additional items related to sexual activity, desire and bother related to sexual dysfunction. The MSHQ scale has excellent psychometric properties and is well suited for use in clinical and research settings. A short form of the MSHQ scale is currently under development. [ABSTRACT FROM AUTHOR]

Introduction. Erectile dysfunction (ED) is a highly prevalent disorder associated with a significant burden of illness. The prevalence and incidence of ED are strongly age-related, affecting more than half of men >60 years. The first Princeton Consensus Conference (Princeton I) in 1999 developed guidelines for safe management of cardiac patients regarding sexual activity and the treatment of ED. Aim. The second conference (Princeton II) was convened to update the recommendations based on the expanding knowledge base and new treatments available. This article reviews and expands on the Princeton II guidelines to address sexual dysfunction and cardiac risk. Methods. A consensus panel of experts reviewed recent multinational studies in safety and drug interaction data for three phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Results. Erectile dysfunction is an early symptom or harbinger of cardiovascular disease, due to the common risk factors and pathophysiology mediated through endothelial dysfunction. Major comorbidities include diabetes, hypertension, hyperlipidemia and heart disease. Any asymptomatic man who presents with ED that does not have an obvious cause (e.g., trauma) should be screened for vascular disease and have blood glucose, lipids, and blood pressure measurements. Ideally, all patients at risk but asymptomatic for coronary disease should undergo an elective exercise electrocardiogram to facilitate risk stratification. Lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease, is literature-supported. Conclusions. The recognition of ED as a warning sign of silent vascular disease has led to the concept that a man with ED and no cardiac symptoms is a cardiac (or vascular) patient until proven otherwise. Men with ED and other cardiovascular risk factors (e.g., obesity, sedentary lifestyle) should be counseled in lifestyle modification. Jackson G, Rosen RC, Kloner RA, and Kostis JB. The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med 2006;3:28–36. [ABSTRACT FROM AUTHOR]

OBJECTIVE To determine, using the Asian Survey of Aging Males (ASAM), the prevalence of lower urinary tract symptoms (LUTS) and sexual disorders in Asian men aged 50–80 years, and to investigate the relationship between LUTS and sexual dysfunction, as community-based studies have shown a relationship between LUTS and sexual dysfunction. SUBJECTS AND METHODS The ASAM survey was conducted in selected cities in five Asian countries, using a combination of face-to-face and mail-survey methods. The survey evaluated demographics, urinary symptoms (using the International Prostate Symptom Score, IPSS, and bother score), functional problems (using the Danish Prostatic Symptoms Score, DAN-PSS-Sex, and International Index of Erectile Function, IIEF) and comorbidity factors. In all, 1155 men aged 50–80 years completed the survey. RESULTS The prevalence of LUTS varied among the countries, ranging from 14% in Singapore to 59% in the Philippines. Moderate to severe LUTS were reported by 36% of men aged 50–59 years, 50% aged 60–69 years and 60% aged 70–79 years. About three-quarters of all respondents (72%) aged 50–80 years were sexually active. Erectile dysfunction was reported by 63% of men in the study, of whom 57% were bothered by their symptoms. Ejaculation disorders were present in 68% of respondents (52% reported bothersomeness) and pain on ejaculation was experienced by 19% of the men in the study (88% reported bothersomeness). Sexual disorders increased with age and increasing severity of their LUTS. Erectile and ejaculation problems were more common in subjects with diabetes or hypertension; these two groups showed the same relationship between LUTS severity and sexual disorders. CONCLUSION These results confirmed that sexual activity is common in Asian men aged 50–80 years, even at an advanced age. They also confirmed the correlation between LUTS and sexual dysfunction. [ABSTRACT FROM AUTHOR]

Abstract: Sexuality is an essential aspect of a couple''s relationship and has a significant impact on life satisfaction. Benign prostatic hyperplasia (BPH) is a condition that commonly affects older men and is often associated with lower urinary tract symptoms (LUTS) and sexual dysfunction. Men with moderate-to-severe LUTS are at increased risk for sexual dysfunction, including moderate-to-severe erectile dysfunction (ED), ejaculatory dysfunction (EjD), and hypoactive desire (HD). The results of several recent large-scale studies have shown a consistent and strong relationship between LUTS and both ED and EjD. It appears that the pathophysiological mechanisms of LUTS and the related prostatic enlargement of BPH as well as certain treatments for this condition may have an impact on both the erection and ejaculation components of the sexual response. Validated questionnaires that assess sexual function provide clinicians with valuable information to help guide treatment selection decisions. Effective medical therapies for LUTS associated with BPH include α1-adrenergic receptor antagonists (i.e., alfuzosin, doxazosin, tamsulosin, and terazosin) and 5α-reductase inhibitors (i.e., finasteride and dutasteride). The side effects of these medications, including sexual dysfunction, are important distinguishing features. The successful management of patients with LUTS associated with BPH should include assessments of sexual function and monitoring of medication-related sexual side effects. For men with LUTS and sexual dysfunction, an appropriate integrated management approach, based on each patient''s symptoms and outcome objectives, is warranted. [Copyright &y& Elsevier]

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;Rosen et al., 2000). 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, inaddition 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. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To validate a new, self-administered questionnaire for assessing key domains of sexual function and satisfaction in aging men with urogenital health concerns. Methods: The initial items were identified by patient interviews, review of current reports, and expert panel solicitation. The resulting 25-item questionnaire was subjected to psychometric evaluation and refinement using two discriminant validity studies in aging men with urogenital symptoms compared with age-matched controls. Psychometric tests of reliability, discriminant, and criterion validity were performed. Results: Qualitative testing revealed adequate comprehension and content validity of the initial item set. Two domains of sexual function (ejaculation, erection) were identified in the first discriminant validity study, each of which showed a high degree of internal consistency (alpha = 0.81 and alpha = 0.90, respectively) and test-retest reliability (r = 0.86 and r = 0.87, respectively). Both sexual function domains discriminated well between men with and without urogenital manifestations of lower urinary tract symptoms (LUTS) and sexual dysfunction (P <0.001). An additional domain of sexual satisfaction was added in the second validation study, with similarly high internal consistency (alpha = 0.90) and test-retest reliability (r = 0.88). Tests of convergent and divergent validity, including correlations with standardized scales for depression (Center for Epidemiologic Studies–Depressed Mood Scale), sexual function (International Index of Erectile Function), and life satisfaction (Fugl-Meyer), confirmed the criterion validity of the new measure. Conclusions: The Male Sexual Health Questionnaire assesses sexual function and satisfaction in older men with urogenital symptoms of LUTS and sexual dysfunction. This new instrument has excellent psychometric properties and is well suited for use in clinical and research settings. [Copyright &y& Elsevier]

Conflict of Interest. Dr. Saikali is an employee of ICOS. Drs. Watkins and Pullman are employees of Lilly. Introduction. Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at-home setting has not been evaluated. Aim. The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg. Methods. The multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase-2 study enrolled men at least 21 years old with a minimum 3-month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8–10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse. Main Outcome Measures. The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one-minute intervals using a step-down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method. Results. Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing ( P = 0.012). Response to tadalafil 10 mg approached significance ( P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg ( P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg ( P = 0.042). Fifty-two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo ( P = 0.038). Conclusions. This stopwatch-based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg. [ABSTRACT FROM AUTHOR]

Introduction. The optimal approach for identification and evaluation of the sexual problems in men and women in primary care or general medicine practice has not been consensed. Aim. To provide recommendations/guidelines concerning state-of-the-art knowledge for clinical evaluation and management strategies in the evaluation and treatment of sexual dysfunction in men and women, emphasizing evidence-based medicine and a patient-centered framework. Methods. An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Clinical Evaluation and Management Strategies Committee, there were 12 experts from five countries. Main Outcome Measure. Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. Results. Three concepts underlie sexual medicine management: (i) adoption of a patient-centered framework for evaluation and treatment; (ii) application of the principles of evidence-based medicine in diagnostic and treatment planning; and (iii) use of a unified management approach in men and women. When taken together, these three principles provide a balanced and integrated approach to sexual dysfunction management. Common algorithms for diagnosis and management of men and women with sexual dysfunction, brief sexual symptom checklists, basics in history and physical examination, indications for specialized referral and development of a follow-up strategy are presented. Conclusions. More research is needed in understanding the role of evidence-based and patient-centered medicine in the clinical evaluation and management strategies of men and women with sexual dysfunction. [ABSTRACT FROM AUTHOR]

Sexual dysfunction is a common problem in women after spinal cord injuries (SCIs). Recently, the use of anxiety-provoking stimulation has been explored as a means of improving sexual responses in able-bodied sexually functional and dysfunctional women. In this laboratory-based study, we assessed the sexual and autonomic responses of women with SCIs with varying degrees of preservation of sympathetic innervation to their genitals to respond to anxiety-provoking audiovisual (AV) stimulation. Subjects were 45 women with SCIs and 11 able-bodied women. For purposes of analysis, SCI subjects were grouped on the basis of the degree of preservation of sensation in the T11-L2 dermatomes. Results revealed that women with low sensory scores in these dermatomes achieved higher vaginal pulse amplitude (VPA) responses to audiovisual erotic stimulation after anxiety preexposure than after neutral preexposure; however, women with SCIs and the greatest degree of preservation of sensory function in the T11-L2 dermatomes, as well as able-bodied controls, did not. Moreover, these same 2 groups of subjects had a decrease in VPA responses during baseline periods in which an anxiety-provoking video sequence was shown, but not during the neutral sequence. It is concluded that these findings are due to the proximity of sensory and autonomic neurologic elements in the spinal cord. Moreover, they demonstrate the differential effects of sympathetic stimulation on genital sexual arousal. [ABSTRACT FROM AUTHOR]

Objectives: To review currently available self-report instruments for the assessment of male sexual function; to consider their utility for comprehensive assessments across all domains of sexual function, and suitability for wide-scale administration in clinical trial programmes.Methods: Several assessment scales in current use are reviewed: the International Index of Erectile Function (IIEF), Danish Prostatic Symptom Scale (DAN-PSS), the Urolife Questionnaire, the International Continence Society Sexual Function Scale and the Brief Male Sexual Function Inventory (BMSFI).Results: Available instruments have been designed, primarily, to assess erectile dysfunction (ED). Their ability to elicit and capture information on ejaculatory disorders, and other components of sexual satisfaction in men is less satisfactory, despite the evidence for widespread deficits in these domains experienced by men with lower urinary tract symptoms (LUTS).Conclusions: Assessment of all sexual function domains needs to be considered in the treatment choice for BPH and/or LUTS. More comprehensive scales to assess all domains of sexual function, including ejaculatory disorders (EjD), are required to help manage an increasing population of ageing men. [Copyright &y& Elsevier]

Objectives: Lower urinary tract symptoms (LUTS), which are often caused by benign prostatic hypertrophy (BPH), and sexual dysfunction are common in older men, with an overall prevalence of >50% in men aged ≥50 years. Men with LUTS have been reported to experience sexual dysfunction, including ejaculatory loss, painful ejaculation, and erectile dysfunction. This study was conducted to investigate the relationship between LUTS and sexual problems in aging men.Methods: A large-scale, multinational survey was conducted in the US and six European countries to systematically investigate the relationship between LUTS and sexual dysfunction in older men. Detailed questionnaires were mailed to a national representative sample of men aged 50 to 80 years in each country. Selection was made on the basis of age, occupation, geographic region, and population density. LUTS and sexual function were assessed by validated symptom scales, including the International Prostate Symptom Score, the Danish Prostatic Symptom Score, and the International Index of Erectile Function. Subjects also completed a health and demographics questionnaire.Results: A total of 34,800 surveys were mailed out, 14,254 were completed and returned, and 12,815 were deemed evaluable and included in the analysis. Results were consistent from one country to another. Although 90% of the men had LUTS, only 19% had sought medical help for urinary problems and only 11% were medically treated. Sexual activity was reported by 83% of the sample, with 71% reporting at least one episode of sexual activity during the previous 4 weeks. Sexual disorders and their bothersomeness were strongly related to both age and severity of LUTS. The relationship between sexual problems and LUTS is independent of comorbidities such as diabetes, hypertension, cardiac disease, and hypercholesterolemia.Conclusions: Sexual activity is common in a majority of men over age 50 and is an important component of overall quality of life. The presence and severity of LUTS are independent risk factors for sexual dysfunction in older men. These results highlight the clinical importance of evaluating LUTS in patients with sexual dysfunction, and the need to consider sexual issues in the management of patients with benign prostatic hypertrophy. [Copyright &y& Elsevier]

Objective: To review validated methods for the assessment of female sexual function in clinical trials. Design: Evaluation of recent peer-review literature on sexual function assessment in women. Setting: International conference on androgen insufficiency in women. Patient(s): Women with sexual dysfunction due to androgen insufficiency or other causes. Intervention(s): None. Main Outcome Measure(s): Measures of sexual function in women. Result(s): Design and measurement problems in the assessment of sexual functioning in women have limited clinical trials in female sexual dysfunction. Objective measures, such as vaginal photoplethysmography or Duplex ultrasound, have been used in some studies but lack standardization and are unsuitable for use in large-scale clinical trials. A variety of interview methods, validated questionnaires, and event log measures have been used for assessing sexual function in recent trials of androgen replacement therapy. Each of these methods has distinct advantages and disadvantages, although validated questionnaires have provided the most reliable findings to date. Recent Food and Drug Administration guidelines on assessment of female sexual function in clinical trials are critically reviewed. Conclusion(s): Despite their prevalence and clinical significance, sexual problems in women have often been neglected in clinical trials. A major obstacle in the design of clinical trials in this area has been the need for sensitive and reliable measures of outcome. Of the currently available measures, self-reported event logs or questionnaires are best suited for research or clinical assessment of female sexual function. [ABSTRACT FROM AUTHOR]

Female sexual dysfunction (FSD) presents several unique challenges in the design and interpretation of multicenter clinical trials. This paper discusses the issue of baseline differences between study populations, using the demographic data of a recent publication describing the validation of a new questionnaire for the evaluation of FSD. [ABSTRACT FROM AUTHOR]

This study evaluated the efficacy and safety of three doses of topical alprostadil USP (prostaglandin E[sub 1]) cream in 8 patients with Female Sexual Arousal Disorder (FSAD). Each patient was administered a single intravaginal dose of placebo followed by escalating intravaginal doses of the active drug at 2-week intervals. Alprostadil's effectiveness in enhancing subjective and physiological arousal during visual sexual stimulation was supported by patient ratings and physician assessments of vaginal erythema and transudate volume. Photoplethysmography measurement of vaginal pulse amplitude was not able to demonstrate treatment sensitivity in the present study. Adverse events included mild cases of vaginal itching and burning. The data support further investigation of the use of alprostadil for FSAD. [ABSTRACT FROM AUTHOR]

The article presents report of the International Consensus Development Conference on Female Sexual Dysfunction. Female sexual dysfunction is a multicausal and multidimensional problem combining biological, psychological and interpersonal determinants. It is age related, progressive and highly prevalent, affecting 20% to 50% of women. Based on epidemiological data from the National Health and Social Life Survey a third of women lack sexual interest and nearly a fourth do not experience orgasm. Approximately 20% of women report lubrication difficulties and 20% find sex not pleasurable. Female sexual dysfunction has a major impact on quality of life and interpersonal relationships. For many women it has been physically disconcerting, emotionally distressing and socially disruptive. In contrast to the widespread interest in research and treatment of male sexual dysfunction, less attention has been paid to the sexual problems of women. Few studies have investigated the psychological and physiological underpinnings of female sexual dysfunction and fewer treatments are available for women than for men.