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Background: Limited 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., Aim: To 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., Methods: Data 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., Outcomes: Validity of the PDQ and DISF-II and clinically meaningful changes in sexual desire and activity were determined in older men in T Trials., Results: Moderate 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 Implications: The 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 & Limitations: Strengths 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., Conclusion: Moderate 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., (Copyright © 2018. Published by Elsevier Inc.)

Introduction: A detailed sexual history is the cornerstone for all sexual problem assessments and sexual dysfunction diagnoses. Diagnostic evaluation is based on an in-depth sexual history, including sexual and gender identity and orientation, sexual activity and function, current level of sexual function, overall health and comorbidities, partner relationship and interpersonal factors, and the role of cultural and personal expectations and attitudes., Aim: To propose key steps in the diagnostic evaluation of sexual dysfunctions, with special focus on the use of symptom scales and questionnaires., Methods: Critical assessment of the current literature by the International Consultation on Sexual Medicine committee., Main Outcome Measures: A revised algorithm for the management of sexual dysfunctions, level of evidence, and recommendation for scales and questionnaires., Results: The International Consultation on Sexual Medicine proposes an updated algorithm for diagnostic evaluation of sexual dysfunction in men and women, with specific recommendations for sexual history taking and diagnostic evaluation. Standardized scales, checklists, and validated questionnaires are additional adjuncts that should be used routinely in sexual problem evaluation. Scales developed for specific patient groups are included. Results of this evaluation are presented with recommendations for clinical and research uses., Conclusion: Defined principles, an algorithm and a range of scales may provide coherent and evidence based management for sexual dysfunctions., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Context: The Testosterone Trials are a coordinated set of seven trials to determine the efficacy of T in symptomatic men ≥65 years old with unequivocally low T levels. Initial results of the Sexual Function Trial showed that T improved sexual activity, sexual desire, and erectile function., Objective: To assess the responsiveness of specific sexual activities to T treatment; to relate hormone changes to changes in sexual function; and to determine predictive baseline characteristics and T threshold for sexual outcomes., Design: A placebo-controlled trial., Setting: Twelve academic medical centers in the United States., Participants: A total of 470 men ≥65 years of age with low libido, average T <275 ng/dL, and a partner willing to have sexual intercourse at least twice a month., Methods: Men were assigned to take T gel or placebo for 1 year. Sexual function was assessed by three questionnaires every 3 months: the Psychosexual Daily Questionnaire, the Derogatis Interview for Sexual Function, and the International Index of Erectile Function., Results: Compared with placebo, T administration significantly improved 10 of 12 measures of sexual activity. Incremental increases in total and free T and estradiol levels were associated with improvements in sexual activity and desire, but not erectile function. No threshold T level was observed for any outcome, and none of the 27 baseline characteristics predicted responsiveness to T., Conclusions: In older men with low libido and low T levels, improvements in sexual desire and activity in response to T treatment were related to the magnitude of increases in T and estradiol levels, but there was no clear evidence of a threshold effect.

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]., (Copyright © 2016 International Society for Traumatic Stress Studies.)

Purpose: Patient-reported outcome (PRO) measures are essential for assessing subjective patient experiences. Interactive voice response (IVR) data collection provides advantages for clinical trial design by standardizing and centralizing the assessment. Prior to adoption of IVR as a mode of PRO administration in the Testosterone Trials (TTrials), we compared IVR to paper versions of the instruments to be used., Methods: IVR versions of the FACIT-Fatigue scale and Psychosexual Daily Questionnaire, Question 4, were developed. In one pilot study, IVR versions of these scales were compared to paper versions in 25 men ≥ 65 years at each of two clinical sites. In another study, IVR versions of the SF-36 Vitality Scale (SF-36), Positive and Negative Affect Scale, and Patient Health Questionnaire were evaluated in comparison with previously validated paper versions in 25 men at two clinical sites. Both paper and IVR versions of each instrument were administered in counterbalanced order, and test-retest reliability was evaluated by repeated administration of the test. Bland-Altman plots were used to assess the degree of agreement. Test-retest correlations for each measure were also determined., Results: Satisfactory agreement was observed between IVR and paper versions of each study measure. Specifically, linear and highly positive associations were observed consistently across the study for IVR and paper versions of all study measures. These ranged from r = 0.91-0.99. Test-retest reliability for all measures was acceptable or better (r = 0.70-0.90)., Conclusions: The IVR versions of TTrials endpoints in these two studies performed consistently well in comparison with paper versions.

Purpose: Sexual dysfunction in schizophrenia patients is common. In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians. Illness- or treatment-related sexual dysfunction in this patient population has been never studied. This study describes the prevalence and correlates of sexual dysfunction and its impact on quality of life (QOL) in patients with schizophrenia treated in primary care in China., Method: A total of 607 patients with schizophrenia treated in 22 randomly selected primary care services in China formed the study sample. Patients' socio-demographic and clinical characteristics including sexual function and QOL were recorded using a standardized protocol and data collection., Results: Sexual dysfunction was present in 69.9% of all patients; 60.7% in males and 80.6% in females. Multiple logistic regression analysis revealed that female gender, being single, older age and use of first-generation antipsychotics were independently and significantly associated with more sexual dysfunction accounting for 23.5% of its variance (P<0.001). Unexpectedly, sexual dysfunction was not associated with lower QOL., Conclusions: High rate of sexual dysfunction was reported in the majority of patients with schizophrenia treated in primary care in China. Given its negative impact on social adjustment, QOL and treatment adherence, efforts should be made to address sexual dysfunction in this patient population., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The relationship between obesity and impairments in male sexual functioning is well documented. Relatively few studies have investigated changes in sexual functioning and sex hormones in men who achieve significant weight loss with bariatric surgery. The objective of this study was to assess changes in sexual functioning, sex hormones, and relevant psychosocial constructs in men who underwent bariatric surgery., Methods: A prospective cohort study of 32 men from the Longitudinal Assessment of Bariatric Surgery-2 (LABS) investigation who underwent a Roux-en-Y gastric bypass (median body mass index [25th percentile, 75th percentile] 45.1 [42.0, 52.2]) and completed assessments between 2006 and 2012. Bariatric surgery was performed by a LABS-certified surgeon. Sexual functioning was assessed by the International Index of Erectile Functioning (IIEF). Hormones were assessed by blood assay. Quality of life (QoL), body image, depressive symptoms and marital adjustment were assessed by questionnaire., Results: Men lost, on average, (95% confidence interval) 33.3% (36.1%, 30.5%) of initial weight at postoperative year 1, 33.6% (36.8%, 30.5%) at year 2, 31.0% (34.1%, 27.9%) at year 3, and 29.4% (32.7%, 26.2%) at year 4. Participants experienced significant increases in total testosterone (P<.001) and sex hormone binding globulin (SHBG) (P<.001) through postoperative year 4. Although men reported improvements in sexual functioning after surgery, these changes did not significantly differ from baseline, with the exception of overall satisfaction at postoperative year 3 (P = .008). Participants reported significant improvements in physical domains of health-related quality of life (HRQoL), all domains of weight-related QOL, and body image, but not in the mental health domains of HRQoL or relationship satisfaction., Conclusions: Men who lost approximately one third of their weight after Roux-en-Y gastric bypass experienced significant increases in total testosterone and SHBG. They did not, however, report significant improvements in sexual functioning, relationship satisfaction, or mental health domains of HRQoL. This pattern of results differs from that of women who have undergone bariatric surgery, who reported almost uniform improvements in sexual functioning and psychosocial status., (Copyright © 2015 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain)., Methods: A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels., Results: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning., Conclusion: In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.

This invited commentary responds to recent criticisms of two validated and widely used sexual function questionnaires, the Female Sexual Function Index (FSFI) and the International Index of Erectile Function (IIEF) (Forbes, Baillie, & Schniering, 2014 ). We take issue with the conceptual arguments presented, selective review of published literature on both instruments, and conclusions drawn from methodologically flawed findings from an Internet-based study in a nonrepresentative group of Australian men and women. Alternative perspectives on the IIEF and FSFI are presented.

Importance: Obesity has been associated with impairments in sexual function and untoward changes in reproductive hormones in women. Relatively few studies have investigated changes in these domains following bariatric surgery., Objective: To investigate changes in sexual functioning, sex hormone levels, and relevant psychosocial constructs in women who underwent bariatric surgery., Design, Setting, and Participants: A prospective cohort study of 106 women from phase 2 of the Longitudinal Assessment of Bariatric Surgery who underwent bariatric surgery (median [interquartile range] body mass index, 44.5 [41.4-49.7]). Assessments were completed between 2006 and 2012., Interventions: Bariatric surgery was performed by a surgeon certified by the Longitudinal Assessment of Bariatric Surgery (85 women underwent a Roux-en-Y gastric bypass, and 21 women underwent laparoscopic adjustable gastric banding)., Main Outcomes and Measures: Sexual functioning was assessed by use of the Female Sexual Function Index. Hormones were assessed by use of a blood assay. Quality of life, body image, depressive symptoms, and marital adjustment were assessed by use of validated questionnaires., Results: Women lost a mean 32.7% (95% CI, 30.7%-34.7%) of initial body weight at postoperative year 1 and a mean 33.5% (95% CI, 31.5%-35.6%) at postoperative year 2. Two years following surgery, women reported significant improvements in overall sexual functioning and specific domains of sexual functioning: arousal, lubrication, desires, and satisfaction. They also experienced significant changes at 2 years in all hormones of interest. Women reported significant improvements in most domains of quality of life, as well as body image and depressive symptoms, within the first year after surgery, with these improvements being maintained through the second postoperative year., Conclusions and Relevance: Women who underwent bariatric surgery had significant improvements in overall sexual functioning, in most reproductive hormones of interest, and in psychosocial status. Improvements in sexual health can be added to the list of health benefits associated with bariatric surgery., Trial Registration: clinicaltrials.gov Identifier: NCT00670098.

Objective: Little is known about the natural history of hypoactive sexual desire disorder (HSDD). We examined the sociodemographic, relationship, help seeking, sexual function, and medical characteristics of women with a clinical diagnosis of generalized, acquired HSDD by menopause status., Methods: This study was a cross-sectional baseline data analysis from the HSDD Registry for Women (N = 1,574, from 33 US clinical sites). HSDD was clinically diagnosed and confirmed. Validated measures of sexual function, relationship factors, and health, as well as newly developed questions on help seeking were assessed using the questionnaire., Results: Participants were predominantly married or living with a partner (81.7%) and represented a range of race/ethnic backgrounds and ages (mean ± SD, 42.9 ± 11.9 y). Most (56.8%) described their HSDD severity as "moderate to severe," with 26.5% rating the problem severe. Nonetheless, most women (69.8%) reported being happy in their relationship, and 61.8% were satisfied with their partner communication. Postmenopausal women had lower Female Sexual Function Index total scores, indicating worse sexual function (14.0 ± 7.5) than premenopausal women (16.7 ± 6.8, P < 0.001), although both groups had similarly low scores on the sexual desire domain (3.4 ± 1.3 vs 3.3 ± 1.4). Less than half of the overall sample had sought professional help, among whom hormonal treatments had been used by 23.7% of postmenopausal women and by 7.6% of premenopausal women., Conclusions: Most women with HSDD were in long-term partner relationships with high levels of overall relationship satisfaction. Postmenopausal women were more likely to seek help for their disorder, despite similarly high levels of distress associated with HSDD. Further research is needed to examine treatment outcomes.

Introduction: Over the past 20 years our knowledge of premature ejaculation (PE) has significantly advanced. Specifically, we have witnessed substantial progress in understanding the physiology of ejaculation, clarifying the real prevalence of PE in population-based studies, reconceptualizing the definition and diagnostic criterion of the disorder, assessing the psychosocial impact on patients and partners, designing validated diagnostic and outcome measures, proposing new pharmacologic strategies and examining the efficacy, safety and satisfaction of these new and established therapies. Given the abundance of high level research it seemed like an opportune time for the International Society for Sexual Medicine (ISSM) to promulgate an evidenced-based, comprehensive and practical set of clinical guidelines for the diagnosis and treatment of PE., Aim: Develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts. Method.  Review of the literature., Results: This article contains the report of the ISSM PE Guidelines Committee. It affirms the ISSM definition of PE and suggests that the prevalence is considerably lower than previously thought. Evidence-based data regarding biological and psychological etiology of PE are presented, as is population-based statistics on normal ejaculatory latency. Brief assessment procedures are delineated and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients., Conclusion: Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. Therefore, it is strongly recommended that these guidelines be re-evaluated and updated by the ISSM every 4 years., (© 2010 International Society for Sexual Medicine.)

Introduction: The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and other validated PE patient-reported measures., Aim: The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty., Methods: Data from a randomized, double-blind, 24-week phase 3 trial in 1,162 men with PE who received dapoxetine (30 mg or 60 mg) or placebo on demand provided the basis for the analysis. Patients were ≥18 years, in a stable monogamous relationship for ≥6 months, met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision criteria for PE for ≥6 months, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes., Main Outcome Measures: The CGIC asked patients to rate improvement or worsening of their PE compared with the start of the study using a 7-point response scale; other patient-reported measures were control over ejaculation, satisfaction with sexual intercourse, interpersonal difficulty, and personal distress related to ejaculation. Stopwatch-measured IELT was recorded. Associations between CGIC and change in other measures at study end point were assessed., Results: The magnitude of IELT increased for each category of improvement on the CGIC: 1.63, 4.03, and 7.15 minutes for slightly better, better, and much better, respectively. Higher CGIC ratings were correlated with greater improvement in control (r = 0.73), satisfaction (r = 0.62), greater reduction in distress (r = -0.52), and interpersonal difficulty (r = -0.39). Total variance accounted for was 57.4%: control (48.7%), satisfaction (4.5%), IELT (2.8%), and distress (1.15%)., Conclusions: The analyses support the validity of the CGIC measure in men with PE. The CGIC can provide clinicians in practice with a valid and brief outcome assessment of their patient's condition.

Introduction: Phosphodiesterase type 5 inhibitors (PDE5), such as sildenafil, tadalafil, and vardenafil, have revolutionized the treatment of erectile dysfunction. Few successes, in contrast, have been reported for the use of these agents in treatment of sexual arousal problems in women., Aim: To review research examining efficacy of PDE5 in women, critique the methods and models employed, and integrate the findings within a broader, gender-specific understanding of female sexual response., Methods: A conceptual and methodological review of all published studies examining PDE5 efficacy in female samples., Main Outcome Measures: Study methods, populations, outcome measures, study results., Results: A total of 16 studies were reviewed. Studies using self-reported measures of sexual functioning showed mixed results whereas studies examining physiological effects of PDE5 on genital vasocongestion consistently report significant effects on genital sexual response., Conclusions: The lack of efficacy of PDE5 treatment in women is likely attributable to gender differences in the concordance between physiological and psychological components of sexual response. Discordance between genital and subjective measures of sexual response in women may be augmented by PDE5 effects on genital vasocongestion in some populations, rendering successful treatment unlikely via pharmacological treatment alone.

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.

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 α(1)-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.

Although knowledge of the neurophysiology and neuropharmacology of ejaculation has increased in the last decade, our understanding of the pathophysiology of the different types of ejaculatory dysfunction (EjD) remains limited. Epidemiological studies provide strong evidence of a relationship between lower urinary tract symptoms (LUTS) and EjD in aging men. Clinical trial results indicate that treatments for LUTS suggestive of benign prostatic hyperplasia (BPH) can be associated with EjD side effects. The present article provides an overview of current knowledge on the physiology of ejaculation, possible common pathophysiologic mechanisms for EjD and LUTS, with a focus on LUTS/BPH, and the effects of different BPH treatments on ejaculation.

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.

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.

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 > or =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, approximately 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.

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 alpha(1A)-subtype nonsuperselective quinazoline alpha(1)-blockers alfuzosin, doxazosin, and terazosin appeared to be associated with better ejaculatory function than were the alpha(1A)-subtype superselective sulfonamide alpha(1)-blocker tamsulosin, 5alpha-reductase inhibitors, and alpha(1)-blocker plus 5alpha-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.

Erectile dysfunction (ED) and benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS) share many epidemiologic and clinical similarities. First-line therapy for both conditions include oral medications (alpha blockers, phosphodiesterase inhibitors). The impetus to develop and use questionnaires to characterize these two conditions is based on the trend away from invasive diagnostic testing to the use of patient-reported outcomes or validated self-administered questionnaires. The International Prostate Symptom Score, the International Index of Erectile Function, the Male Sexual Health Questionnaire (MSHQ) and the MSHQ short form are similar patient-reported assessment questionnaires used for research or clinical evaluation of BPH/LUTS, ED and ejaculatory dysfunction. These patient-based self-administered questionnaires are likely to assume an ever increasing important role in the future, as oral BPH therapies are considered for the treatment of ED and oral ED therapies are considered for the treatment of BPH/LUTS.

Objective: To examine associations between abuse (physical, sexual, and emotional) in childhood and adolescence/adulthood and sexual activity and dysfunction in women., Design: We analyzed data from the Boston Area Community Health Survey, a community-based epidemiologic study of urologic and sexual symptoms and risk factors in a racially and ethnically diverse random sample of women aged 30-79 years (N = 3,205 women)., Setting: Boston area community., Patient(s): Participants were community residents., Intervention(s): Data were observational; no interventions were made., Main Outcome Measure(s): Sexual activity and dysfunction rates were assessed by means of a validated questionnaire (the Female Sexual Function Index)., Result(s): Abuse history was not significantly associated with likelihood of sexual activity. Among those who were sexually active with a partner, a history of each of three types of abuse approximately doubles the odds of female sexual dysfunction. Specifically, childhood emotional (odds ratio [OR] 2.13, 95% confidence interval [CI] 1.28-3.56), adult sexual (OR 1.94, 95% CI 1.23-3.08), and adult emotional abuse (OR 1.86, 95% CI 1.15-3.01) were all significantly and positively associated with sexual dysfunction after adjusting for covariates (including depression). Analyses of the six female sexual dysfunction domains showed that the relationships were strongest for pain and satisfaction., Conclusion(s): These findings extend those from previous studies by identifying an association between female sexual dysfunction and multiple types of abuse, even after adjusting for depression.

Introduction: The medical literature contains several definitions of premature ejaculation (PE). The most commonly quoted definition, the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision, and other definitions of PE are all authority based rather than evidence based, and have no support from controlled clinical and/or epidemiological studies., Aim: The aim of this article is to develop a contemporary, evidence-based definition of PE., Methods: In August 2007, the International Society for Sexual Medicine (ISSM) appointed several international experts in PE to an Ad Hoc Committee for the Definition of Premature Ejaculation. The committee met in Amsterdam in October 2007 to evaluate the strengths and weaknesses of current definitions of PE, to critique the evidence in support of the constructs of ejaculatory latency, ejaculatory control, sexual satisfaction, and personal/interpersonal distress, and to propose a new evidence-based definition of PE., Results: The committee unanimously agreed that the constructs that are necessary to define PE are rapidity of ejaculation, perceived self-efficacy and control, and negative personal consequences from PE. The committee proposed that lifelong PE be defined as ". . . a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration, and the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy." This definition is limited to men with lifelong PE who engage in vaginal intercourse. The panel concluded that there are insufficient published objective data to propose an evidence-based definition of acquired PE., Conclusion: The ISSM definition of lifelong PE represents the first evidence-based definition of PE. This definition will hopefully lead to the development of new tools and Patient Reported Outcome measures for diagnosing and assessing the efficacy of treatment interventions and encourage ongoing research into the true prevalence of this disorder and the efficacy of new pharmacological and psychological treatments.

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.

Aims: Lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are a common problem in ageing men and are accompanied by sexual dysfunction (SD) in 40-70% of men evaluated in large-scale epidemiological studies. One year after the 2003 American Urological Association (AUA) guideline on BPH management was published, a survey of US urologists (UROs) and primary care physicians (PCPs) was conducted to ascertain physician knowledge of the AUA guideline and practice patterns regarding LUTS/BPH diagnosis, treatment and association with SD., Methods: A 19-question qualitative survey, sponsored by the American Foundation of Urologic Disease, was mailed April 2004 to 7500 UROs and 17,500 PCPs, with responses collected until May 2004., Results: A total of 788 surveys were returned (437 UROs; 351 PCPs). Only 62% of PCPs were aware of and only 41% of PCPs used the AUA-Symptom Index/International Prostate Symptom Score (AUA-SI/IPSS) to assess LUTS compared with 97% and 81% of UROs respectively. Alpha-blocker monotherapy was the treatment of choice for both UROs and PCPs. Compared with UROs, PCPs reported higher rates of SD in association with LUTS or BPH (37% vs. 27%) and BPH pharmacotherapy (27% vs. 21%). UROs and PCPs reported higher rates of SD side effects [ejaculatory dysfunction (EjD) and erectile dysfunction (ED)] for tamsulosin (EjD: UROs 22%, PCPs 12%; ED: UROs 7%, PCPs 10%) and doxazosin (EjD: UROs 14%, PCPs 10%; ED: UROs 7%, PCPs 12%) than for alfuzosin (EjD: UROs 6%, PCPs 4%; ED: UROs 4%, PCPs 5%)., Conclusions: The results suggest that many PCPs are not using the AUA-SI/IPSS to assess LUTS in their ageing male patients. Both UROs and PCPs appear to be underestimating the prevalence of SD in men with LUTS/BPH relative to prevalence rates reported in large-scale epidemiological studies.

Objectives: An abridged version of the 25-item Male Sexual Health Questionnaire (MSHQ) was developed and validated (MSHQ-EjD Short Form) for assessing ejaculatory dysfunction (EjD)., Methods: The MSHQ was administered to 1245 men in the Men's Sexual Health Population Survey, 179 gay/bisexual men in the Urban Men's Health Study, and 6909 men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in the BPH Registry & Patient Survey. Factor analysis, scale reliability, construct and discriminant validity, and the correlation between the MSHQ-EjD Short Form and the MSHQ ejaculatory function domain were assessed., Results: Factor loadings of greater than 0.5 were demonstrated for four ejaculatory function items (force, volume, frequency, and delay). The force and volume of ejaculation had the greatest factor loadings (range 0.77 to 0.81), followed by frequency of ejaculation (0.64 and 0.66). These three ejaculatory function items had a high degree of internal consistency (Cronbach alpha > or = 0.78) and test-retest reliability (r = 0.72). The three items discriminated between men with none/mild LUTS and those with moderate/severe LUTS (P <0.001). After adjusting for age, depression, and erectile function, the odds ratio for a diagnosis of moderate/severe LUTS was 0.68 (95% confidence interval 0.49 to 0.96; P <0.05). The three items had a correlation coefficient of 0.95 with the 7-item MSHQ ejaculatory function domain. The MSHQ ejaculation bother item, an independent domain, showed moderate correlation with the three ejaculatory function items (r = -0.41 and r = -0.45)., Conclusions: The results of our study have shown that the MSHQ-EjD Short Form, with three ejaculatory function items and one ejaculation bother item, has excellent psychometric properties and should be a useful instrument for assessing EjD in clinical and research settings.

Objectives: This study evaluated the associated comorbidities and patient satisfaction with treatment options for premature ejaculation (PE), a common sexual dysfunction., Methods: A comprehensive, Internet-based survey (the PE Prevalence and Attitudes [PEPA] survey) was conducted among men ages 18-70 in the United States, Germany, and Italy (n=12,133). Men were classified as having PE based on self-report of low or absent control over ejaculation, resulting in distress for them or their sexual partner or both., Results: The prevalence of PE was 22.7% (24.0% in the United States, 20.3% in Germany, and 20.0% in Italy) and did not vary significantly with age among men over age 24 yr. Men with PE were more likely to self-report other sexual dysfunctions (e.g., anorgasmia, low libido, erectile dysfunction) and psychological disturbances (e.g., depression, anxiety, excessive stress) than men without PE (p<0.05 for all). Men with PE were most aware of (>70%) and most likely to have used (>50%) special positions during sex, interrupted stimulation, masturbation, and having intercourse more often than usual to manage their PE. Only 9.0% of men with PE reported having consulted a physician for the condition; 81.9% had to initiate the conversation about PE and 91.5% reported little or no improvement as a result of seeking treatment., Conclusion: PE is a highly prevalent sexual problem, with significant sexual and psychological comorbidities. Most men with PE do not seek assistance from their physician, and most of those who do are not satisfied with the results.

Background: No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation., Methods: We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094., Findings: 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%)., Interpretation: On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.

Introduction: Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of alpha-melanocyte-stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R., Aim: To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premenopausal women with sexual arousal disorder., Main Outcome Measures: Change in vaginal pulse amplitude during neutral and erotic videos after treatment with bremelanotide or placebo and subjects' perceptions of physiological and sexual response within 24 hours of treatment with bremelanotide or placebo., Methods: Eighteen premenopausal women with a primary diagnosis of female sexual arousal disorder were randomly assigned to receive a single intranasal dose of 20 mg bremelanotide or matching placebo in a double-blind manner during the first in-clinic treatment session, and the alternate medication during the second in-clinic treatment session. During each session, subjects viewed a 20-minute neutral video followed by a 20-minute sexually explicit video. Vaginal photoplethysmography was used to monitor vaginal vasocongestion and questionnaires were used to evaluate perceptions of sexual response within the following 24-hour period., Results: More women reported moderate or high sexual desire following bremelanotide treatment vs. placebo (P = 0.0114), and a trend toward more positive responses regarding feelings of genital arousal occurred after bremelanotide compared with placebo (P = 0.0833). Among women who attempted sexual intercourse within 24 hours after treatment, significantly more were satisfied with their level of sexual arousal following bremelanotide, compared with placebo (P = 0.0256). Vaginal vasocongestion did not change significantly while viewing erotic videos following bremelanotide administration compared with placebo., Conclusion: This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at-home study.

Sexual dysfunction is common among individuals with chronic illnesses and is associated with distress and reduced quality of life. Because of the long-term, often irreversible nature of sexual dysfunction in chronic illness and limitations of pharmacological treatments, there is a need to understand cognitive and behavioral coping processes in this population. We present a model of coping with sexual dysfunction that focuses on the construct of flexibility, including the definition of sexual functioning and its centrality to overall self-concept. We describe how this model can be applied in a comprehensive approach to treating sexual dysfunction in individuals with chronic illnesses.

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 > or = 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.

Purpose of Review: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is a condition that commonly affects older men and is often associated with sexual dysfunction. Recent evidence of an association between LUTS/BPH and sexual dysfunction will be reviewed, as well as the effects of pharmacological treatment options for symptomatic LUTS/BPH on sexual function., Recent Findings: Large-scale epidemiological studies conducted worldwide have provided strong evidence for an association between LUTS, erectile dysfunction and ejaculatory dysfunction. In multivariate analyses controlling for age, comorbidities, and lifestyle factors, LUTS have been clearly demonstrated to be an independent risk factor for erectile and ejaculatory dysfunction. Various pathophysiological mechanisms have been proposed for the association between LUTS and male sexual dysfunction. These include autonomic hyperactivity, alterations in Rho/Rho kinase pathway, endothelial (nitric oxide synthase/nitric oxide) dysfunction, pelvic ischemia, and age-related hormone imbalances. Owing to the link between LUTS/BPH and male sexual dysfunction, patients presenting with one of these conditions should be routinely screened for the other condition. In addition, because medical and surgical treatments for LUTS/BPH are commonly associated with sexual side effects, patients with LUTS/BPH should be monitored for treatment-related sexual outcomes., Summary: LUTS/BPH is an independent risk factor for sexual dysfunction in aging men. Further studies are needed to define the mechanism(s) underlying the link between LUTS/BPH and male sexual dysfunction. Additional studies of combination therapy for LUTS/BPH, sexual dysfunction, and other age-associated comorbidities are needed to establish new approaches to the optimal management of these conditions in aging men.

Introduction: There are limited data concerning the sexual function of women whose male partners receive pharmacological treatment for erectile dysfunction (ED)., Aim: One objective of this research was to prospectively compare the efficacy of vardenafil vs. placebo administered to men with ED in improving men's and women partners' sexual function and satisfaction. Another goal was to assess the relationship of erectile function changes in men with ED receiving treatment with sexual function changes in women partners not directly receiving treatment., Methods: A randomized, double-blind, placebo-controlled, multi-institutional comparison of vardenafil vs. placebo was performed in 229 couples (treated man with ED>6 months and untreated woman partner). Co-primary outcomes for which this research was statistically powered were Sexual Encounter Profile (SEP3) (treated man with ED) and Sexual Life Quality Questionnaire (mSLQQ-QOL) (untreated woman partner)., Main Outcome Measures: Erectile function changes in men with ED receiving vardenafil vs. placebo were compared at last observation carried forward (LOCF) in SEP3, International Index of Erectile Function (IIEF-EF) and Erection Quality Scale (EQS). Sexual function at LOCF in women partners was determined by mSLQQ-QOL and Female Sexual Function Index (FSFI)., Results: Compared with placebo at LOCF, vardenafil significantly increased least square (LS) mean scores in: (i) overall per-treated male SEP3 success rate, IIEF-EF, and EQS; and (ii) mSLQQ-QOL, total FSFI and sexual desire, subjective arousal, lubrication, orgasm and satisfaction FSFI domains in untreated women partners. Treatment-related improvement in erectile function as assessed by IIEF-EF and EQS was correlated reliably with improvement in women partners' FSFI total and individual domain scores., Conclusions: Vardenafil is an effective ED treatment in men that also significantly improves sexual function/satisfaction in untreated women partners. Women partners' sexual function improvements relate significantly and consistently to treatment-related improvements in men's erectile function. ED management should emphasize both members of the couple.

Introduction: The assessment and diagnosis of female sexual dysfunction (FSD) are in a state of transition because of evolving concepts of female sexuality and suggested changes to the FSD diagnostic framework., Aim: To review the problems with current FSD diagnosis., Methods: Multidisciplinary experts from five countries were assembled to convene a "Postmenopausal FSD Roundtable on specific topics related to FSD.", Main Outcome Measure: Expert opinion was based on a review of evidence-based medical literature, presentation, and internal discussion., Results: Current FSD diagnosis is challenging because of poorly defined distinctions between normal and abnormal, a limited ability to integrate subjective and objective findings and an inability to incorporate contextual factors that play a significant role in sexual behavior. The availability of self-administered questionnaires (SAQs) that assess various domains of female sexual function, as well as those developed specifically for postmenopausal women, suggests that a more structured approach to assessment and diagnosis may be possible. Several SAQs reflecting proposed changes to the FSD diagnostic framework by the American Foundation for Urologic Disease (AFUD), including the Sexual Function Questionnaire (SFQ) and the Female Sexual Distress Scale (FSDS), have been introduced and recently incorporated into a Structured Diagnostic Method (SDM). Recent regulatory decisions and events affecting the development of FSD interventions have highlighted the lack of consensus with regard to clinically meaningful FSD outcomes, as well as shortcomings in a U.S. Food and Drug Administration draft document that provides the primary guidance for conducting FSD clinical studies in the United States., Conclusions: Given the high cost and inherent risk of clinical studies, continued development efforts toward FSD therapies are unlikely to proceed in the absence of significant changes in regulatory guidance that reflect the current understanding of FSD and incorporate validated assessment tools.

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 alpha(1)-adrenergic receptor antagonists (i.e., alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-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.

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.

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.

Introduction: There are few published guidelines for the management of sexual dysfunctions in men and women, despite the prevalence and lack of attention to these problems. Disorders of sexual function in men include erectile dysfunction, orgasm/ejaculation disorders, priapism, and Peyronie's disease., Aim: To provide evidence-based and expert-opinion consensus guidelines for the clinical management of men's sexual dysfunctions., Methods: An International Consultation in collaboration with major urological and sexual medicine societies assembled over 200 multidisciplinary experts from 60 countries into 17 consultation committees. Committee members established the scope and objectives for each chapter. Following intensive review of available data and publications, committees developed evidence-based guidelines in each area., Main Outcome Measure: New algorithms and guidelines for assessment and treatment of men's sexual dysfunction were developed. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of the medical literature, in addition to cultural and ethical considerations., Results: Recommendations and guidelines for men's sexual dysfunction are presented. These guidelines were developed as evidence-based, patient-centered, and multidisciplinary in focus. For the clinical assessment and diagnosis of ED, a basic evaluation was recommended for all patients, with optional and specialized testing reserved for special cases. A new treatment algorithm is proposed. This algorithm provides a clinically relevant guideline for managing ED in the large majority of men. New treatment guidelines and algorithms are provided for men's orgasm and ejaculation disorders, including premature ejaculation, retrograde and delayed ejaculation. Finally, expert opinion-based guidelines for the clinical management of priapism and Peyronie's disease are provided., Conclusions: Additional research is needed to validate and extend these guidelines. Nonetheless, this summary encompasses the recommendations concerning men's sexual dysfunctions presented at the 2nd International Consultation on Sexual Medicine in Paris, France, June 28-July 1, 2003.

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.

Objective: To better evaluate efficacy in clinical trials of drugs as potential treatments for female sexual dysfunctions (FSD), a brief, multidimensional measure of female sexual function was developed., Methods: Data from semistructured interviews with 82 women with or without FSD, aged 19-65 years, generated a pool of 61 items that addressed aspects of female sexual function. On review by a panel, individual items were selected for face validity and clinical relevance. Thirty-one items were used as a sexual function questionnaire (SFQ-V1) in two multicenter, phase II clinical trials totaling 781 women with FSD. Normative data were generated from a sample of 201 women without FSD., Results: Factor analysis produced seven domains of female sexual function: desire, physical arousal-sensation, physical arousal-lubrication, enjoyment, orgasm, pain, and partner relationship. The internal consistency of the domains ranged from 0.65 to 0.91, and test-retest reliability ranged from 0.21 to 0.71 for Cohen's weighted kappa and 0.42 to 0.78 for Pearson's correlation coefficient. There was a significant difference between the baseline mean SFQ domain scores of patients with FSD compared with those of women without FSD (p < 0.0001). End-of-study SFQ scores were significantly different for women who reported improvement vs. women who reported no improvement (p < 0.001)., Conclusions: The SFQ produced seven domains of female sexual function with excellent internal consistency, moderate to good reliability, excellent discriminant validity, and sensitivity. The results suggest that the SFQ may be a valuable new tool for evaluating and diagnosing subsets of FSD and, ultimately, for evaluating treatments of these disorders.

Sexual dysfunction is highly prevalent in both sexes. Considerable progress has been made in the development of new pharmacologic treatments since the approval of sildenafil in 1998. A variety of oral erectogenic agents are available or are in late-phase development, including centrally active dopamine agonists (e.g., sublingual apomorphine), peripheral nonselective alpha-blockers (e.g., oral phentolamine), and other phosphodiesterase type-5 inhibitors (e.g., vardenafil). These drugs have recently been evaluated for the treatment of female sexual arousal disorder, although results to date have been inconclusive. Pharmacologic therapies have also been proposed for the treatment of premature ejaculation and hypoactive sexual desire disorder. Strong evidence exists for the value of serotonergic drugs (e.g., selective serotonin reuptake inhibitors) in the treatment of premature ejaculation. Further research is needed, particularly on the effects of these drugs on female sexual dysfunction.

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.

Sexual dysfunction has been identified in numerous controlled trials to be a frequent accompaniment to antihypertensive therapy. Issues of cause and effect are confused because hypertension itself can cause sexual dysfunction. It seems probable, however, that use of certain classes of blood pressure-lowering agents, notably non-cardioselective beta blockers such as propranolol, thiazide diuretics such as chlorthalidone and centrally-acting adrenergic agonists, is associated with an increased risk of sexual dysfunction. The implications of these data for compliance with antihypertensive therapy are considered.

Antihypertensive drugs are commonly associated with adverse side effects in both clinical and laboratory studies. We investigated the sexual sequelae of several major classes of antihypertensive drugs (e.g., beta blockers, central alpha agonists, diuretics) in normal males and in hypertensive patients. We compared the effects of four widely used agents (methyldopa, propranolol, atenolol, hydrochlorothiazide-triamterene) and placebo, in a selected sample of 21 sexually dysfunctional male hypertensives, 13 of whom completed all five phases of the study. Each study drug was administered for a 1-month treatment period, followed by a 2-week, single-blind washout phase, according to a randomized, Latin square crossover design. Dependent variables for the study included a broad range of hormonal, NPT, and self-report measures of sexual response. Results indicated a lack of consistent drug effects on measures of sexual response, although more frequent sexual and nonsexual side effects were observed with methyldopa and propranolol. As in our previous studies, age was negatively correlated with both hormonal and NPT measures, whereas changes in blood pressure were not significantly related to sexual function scores. Results do not support the hypothesis that sexually dysfunctional males are at greater risk for adverse sexual sequelae when treated with centrally active agents or diuretics.

The search for an effective aphrodisiac has been a perennial pursuit of most societies throughout history. In the past decade, attention has focused increasingly on the prosexual effects of oral pharmacological agents with central neurotransmitter actions. The role of various dopaminergic, adrenergic, and serotonergic agents, in particular, has been intensively investigated in both human and animal studies. Some of these drugs have been considered for their potential role in the treatment of sexual dysfunction, while others have contributed to our understanding of basic neurophysiological processes in sexual arousal. This review provides a critical evaluation of current laboratory and clinical research on the "new aphrodisiacs," including studies in both patient populations and normal volunteers. Several conceptual and methodological problems are addressed, such as the definition and measurement of sexual response, the need to separate specific and nonspecific drug effects on sexual response, and the lack of studies in women. Although no single drug has proven to be clinically safe and reliably effective for human use, several promising candidates have been identified. Overall, research on prosexual drugs has contributed significantly to our understanding of basic mechanisms in sexual response, as well as providing new treatment options for common sexual disorders.

Few studies have investigated the prevalence of sexual dysfunction in nonclinical samples. In the present study, a standardized sexual function questionnaire was administered to 329 healthy women, aged 18-73 years, all of whom were enrolled in a Women's Wellness Center. About two-thirds of the sample were married or living with a partner, and most women were employed outside of the home. A broad range of sexual behavior frequencies were observed, with 48.5% reporting at least weekly intercourse, compared to 28.4% who were not sexually active at the time of study. Among the most common sexual problems reported were anxiety or inhibition during sexual activity (38.1%), lack of sexual pleasure (16.3%), and difficulty in achieving orgasm (15.4%). Other common problems were lack of lubrication (13.6%) and painful intercourse (11.3%), each of which was significantly more prevalent in the postmenopausal group. Despite these difficulties, 68.6% of the sample rated their overall sexual relationship as satisfactory. Age and relationship status were significant predictors of sexual satisfaction, with older women and singles reporting a higher incidence of sexual problems. Educational level, religious affiliation, and employment status were not predictive of sexual dysfunction in the present study.

This study reports the rationale and results of a ten-session group composed os six couples with mixed sexual dysfunctions. Dysfunctions included premature ejaculation, primary and situational orgasmic dysfunction, situational impotence, and incompatible sex drives. A variety of pretreatment behavioral and attitudinal measures were administered, including a Life History Questionaire, Sexual Assessment Inventory, Marital Adjustment Scale, and Sexual Interaction, orgasmic attainment, ejaculatory control, and enhanced self-acceptance, particularly for females (SII changes). The consistency between outcome measures was also a noteworthy finding. The results suggest increased use of mixed short-term groups, particularly when cost-effectiveness accountability is important. One contraindication for such groups is, however, severe marital discord, as evidenced by Locke-Wallace mean scores of 80 or less.