The World Association for Sexual Health's Declaration on Sexual Pleasure: A Technical Guide.

This article provides technical guidance on the content, meaning, and application of the World Association of Sexual Health (WAS) Declaration on Sexual Pleasure to various stakeholders and practitioners working in the area of sexuality, sexual health, and sexual rights. A growing body of work shows that sexual pleasure is integral to broader health, mental health, sexual health, well-being and rights and indeed can lead to improvements in health. Yet, more research is needed to identify the best ways to incorporate sexual pleasure to achieve sexual health for different outcomes and populations. In the first part of this article, we deconstruct each statement from the WAS Declaration on Sexual Pleasure and provide key evidence from the literature supporting these statements. In the latter part of the article, we provide guidance on how to include sexual pleasure as a fundamental part of sexual health and sexual rights work. We include a series of case studies and highlight key actions and principles for advocacy, implementation, and quality assurance in terms of law and policy, comprehensive sexuality education, health care services and dissemination of knowledge. This technical document seeks to inspire our partners and collaborators to embark on a journey toward a pleasure-based approach to sexual health and sexual rights. Our hope is that the literature, guidance and case studies provided here can ignite ongoing advocacy and collaboration to embrace sexual pleasure in all settings.

The 2018 Revision to the Process of Care Model for Management of Erectile Dysfunction.

INTRODUCTION: Erectile dysfunction (ED) is a common condition the treatment of which over the years has expanded from specialty care settings to various other clinical settings. A Process of Care Model was developed in 1999 to provide primary care physicians with guidance in the diagnosis and management of ED. AIM: This update to the Process of Care Model aims to reflect current ED management practices, because the study of ED has changed since 1999. METHODS: Updates to the Process of Care Model were developed during a meeting of international experts from diverse disciplines. The updated model is data-driven, evidence-based, and relevant to a wide range of healthcare providers. MAIN OUTCOME MEASURES: This article summarizes the results of the expert meeting and focuses on ED management. The evaluation of ED is discussed in a separate article. RESULTS: The updated model presents modification of risk factors and correction of comorbidities frequently associated with ED as critical parts of patient management. Patients should be encouraged to make positive lifestyle changes such as improving diet and increasing physical exercise. Lifestyle changes may be accompanied by the first-line medical therapies of sexual counseling and therapy, which takes into consideration patient sexual dynamics and pharmacotherapy with phosphodiesterase 5 inhibitors (PDE5Is). CLINICAL IMPLICATIONS: The updated model provides guidance regarding risk factors associated with ED, their modification, sexual counseling, and PDE5I selection, dosing, and patient education. STRENGTHS AND LIMITATIONS: This update leverages the extensive clinical expertise and experience of the authors to provide updated, comprehensive guidance for ED management. The model reflects the views and experiences of a limited number of contributors; however, these authors draw upon a diverse array of clinical specialties and are regarded as experts in their fields. Additionally, no meta-analyses were performed to further support the ED evaluation guidelines presented. CONCLUSION: Effective management of ED may be achieved through a combination of patient risk factor modification and first-line therapy, taking into consideration any patient comorbidities known to be associated with ED. Treatment goals should be individualized to restore sexual satisfaction to the patient and/or couple and improve quality of life based on the patient's expressed needs and desires. Mulhall JP, Giraldi A, Hackett G, et al. The 2018 Revision to the Process of Care Model for Management of Erectile Dysfunction. J Sex Med 2018;15:1434-1445.

The 2018 Revision to the Process of Care Model for Evaluation of Erectile Dysfunction.

BACKGROUND: Erectile dysfunction (ED) is a common condition that may affect men of all ages; in 1999, a Process of Care Model was developed to provide clinicians with recommendations regarding the evaluation and management of ED. AIM: To reflect the evolution of the study of ED since 1999, this update to the process of care model presents health care providers with a tool kit to facilitate patient interactions, comprehensive evaluation, and counseling for ED. METHODS: A cross-disciplinary panel of international experts met to propose updates to the 1999 process of care model from a global perspective. The updated model was designed to be evidence-based, data-driven, and accessible to a wide range of health care providers. OUTCOMES: This article summarizes the resulting discussion of the expert meeting and focuses on ED evaluation. The management of ED is discussed in an article by Muhall et al (J Sex Med 2018;15:1280-1292). RESULTS: A comprehensive approach to the evaluation of ED is warranted because ED may involve both psychological and organic components. The updated process of care model for evaluation was divided into core and optional components and now focuses on the combination of first-line pharmacotherapy and counseling in consideration of patient sexual dynamics. CLINICAL IMPLICATIONS: Patient evaluation for ED should encompass a variety of aspects, including medical history, sexual history, physical examination, psychological evaluation, laboratory testing, and possibly adjunctive testing. STRENGTHS & LIMITATIONS: This update draws on author expertise and experience to provide multi-faceted guidance for the evaluation of ED in a modern context. Although a limited number of contributors provided input on the update, these experts represent diverse fields that encounter patients with ED. Additionally, no meta-analyses were performed to further support the ED evaluation guidelines presented. CONCLUSION: Comprehensive evaluation of ED affords health care providers an opportunity to address medical, psychological/psycho-social, and sexual issues associated with ED, with the ultimate goal being effective management and possibly resolution of ED. While some or all techniques described in the updated model may be needed for each patient, evaluation should in all cases be thorough. Mulhall JP, Giraldi A, Hackett G, et al. The 2018 Revision to the Process of Care Model for Evaluation of Erectile Dysfunction. J Sex Med 2018;15:1280-1292.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: IV. Unique Aspects of Clinical Trials in Female Sexual Dysfunction.

The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction.

This series of articles, Standards for Clinical Trials in Male and Female Sexual Dysfunction, began with the discussion of a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for the selection of study population and study duration in male and female sexual dysfunction. The second article in this series discussed fundamental principles in development, validation, and selection of patient- (and partner-) reported outcome assessment. The third and present article in this series discusses selected aspects of sexual dysfunction that are that are unique to male sexual dysfunctions and relevant to the conduct of clinical trials of candidate treatments for men.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical trial design for women.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective.

Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction.

BACKGROUND: Phosphodiesterase type 5 (PDE5) inhibitors have discontinuation rates as high as 60% in men with erectile dysfunction. Treatment satisfaction has been significantly associated with treatment continuation. Understanding key characteristics in terms of treatment preference, relationship, and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally. OBJECTIVE: The objective was to identify subgroups of interest in the pooled database of two observational studies conducted in Latin America (LA) and Middle East/North Africa (MENA) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline. METHODS: Two identical prospective, non-interventional, observational, studies in MENA (N = 493) and LA (N = 511) treated men with an 'on demand' (pro re nata, PRN) PDE5 inhibitor (sildenafil, tadalafil, vardenafil, or lodenafil) during 6 months. In this post-hoc meta-analysis of two observational studies with equal design, pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations, satisfaction, self-esteem, and patient-partner relationships. Decision tree analyses, with and without weighting, were used to identify and describe key features. RESULTS: In each analysis of patient expectations, patient-partner relationship, and self-esteem, we describe the two major subgroups at baseline for each decision tree. Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors (59%) highlighted the importance of treatment effect duration, second to partner satisfaction with treatment, while patients prescribed short-acting PDE5 inhibitors (32%) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion. Further insights regarding patients, partner relationship characteristics, and treatment expectations were identified. CONCLUSION: Our analyses have described key characteristics, such as self- and partner perceptions, sexual attitudes, and treatment expectations in relation to the patients' country and prescribed treatment, which might guide treatment decisions in MENA and LA men with ED.

A 6 month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Latin American men with erectile dysfunction.

OBJECTIVES: To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence. METHODS: Men from Brazil, Mexico, and Venezuela with ED who were naïve to PDE5Is were prescribed sildenafil, tadalafil, vardenafil, or lodenafil on-demand dosing and asked to provide information about PDE5I use at baseline and at 1, 3, and 6 months. Patients were persistent if they used ≥1 dose during the 4 week period prior to each evaluation. Patients were adherent if they complied with dosing instructions during most recent dose. Main outcome measures included Persistence and Adherence Questionnaire (PAQ), Partner Relationship Questionnaire (PRQ), Self-Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence and adherence. RESULTS: A total of 511 men were enrolled; most had mild to moderate ED (77.1%); 317 patients (62.0%) were prescribed tadalafil, 116 (22.7%) sildenafil, 75 (14.7%) vardenafil, and 3 (0.6%) lodenafil (not further analyzed). A total of 340 patients (66.5%) were 'persistent' at 6 months; 345 (67.5%) were 'adherent'. Persistence and adherence were associated with age, education level, and ED duration. Reasons for non-persistence included medication cost and lack of efficacy. Study limitations included its design, brief observation period, its bias observed toward tadalafil selection; its dependence on patient self-reporting, limited number of factors that were analyzed for persistence/adherence association, its small number of participating patients and Latin American countries, and inherent differences in PDE5I preference and medical practices. CONCLUSION: Approximately two-thirds of PDE5I-naïve, Latin American men with ED were persistent and adherent after 6 months of therapy. Factors like education level, ED severity, and ED duration were associated with persistence and adherence; additional study is warranted to investigate the predictive value of these factors.

Standard operating procedures for taking a sexual history.

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.

Standard operational procedures for low sexual desire in men.

INTRODUCTION: Low sexual desire in men is a condition that has received little attention; nevertheless it occurs with high frequency. Clinicians are in need of clear guidelines to address this problem. AIM: To develop standardized operational procedures to be implemented with men presenting low sexual desire/interest (LSD/I). METHODS: Review of relevant evidence-based literature and published guidelines, integrated with expert opinion. MAIN OUTCOME: Operational procedures for LSD/I that are recommended for clinical practice with various degrees of support from published evidence. RESULTS: A new classification scheme is proposed; LSD/I is proposed as an umbrella term for which hypoactive sexual desire disorder (HSDD) is only a subtype. The following standard operational procedures are described: (i) Detection of LSD/I: screening for LSD/I, screening for LSD/I in patients with other sexual dysfunctions; (ii) Diagnosis and assessment of etiology: diagnostic criteria for LSD/I, assessment of depression status, assessment of relationship status, assessment of endocrinologic status, diagnostic criteria for HSDD in men; (iii) TREATMENT: treatment of LSD/I secondary to low testosterone, treatment of LSD/I secondary to elevated prolactin, treatment of LSD/I secondary to other endocrinologic disorders, treatment of LSD/I secondary to depressive illness and or anxiety disorders, treatment of LSD/I secondary to relationship conflict and treatment of HSDD. A diagnostic and treatment algorithm is presented. CONCLUSIONS: LSD/I is a common condition that should be identified in patients; it is recommended that this condition be actively investigated by the clinician. Once the diagnosis of LSD/I in men is confirmed, a thorough search for possible causes needs to include both biological and psychological causes. TREATMENT should be etiologically oriented.

A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction.

AIM: To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). METHODS: A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. MAIN OUTCOME MEASURES: The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. SECONDARY OUTCOMES INCLUDED: Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. RESULTS: Men naive to tadalafil OaD were enrolled (N = 378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P < 0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD, 0.5 ± 0.72 for tadalafil PRN, and 0.39 ± 0.67 for sildenafil PRN. The difference in least-squares mean was 0.12 ± 0.04 (confidence interval [CI] = 0.04, 0.19; P = 0.001) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 (CI = -0.06, 0.08; P = 0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P < 0.001). There were no differences in SEAR scores between treatments. CONCLUSIONS: Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

Education in sexual medicine: proceedings from the international consultation in sexual medicine, 2009.

INTRODUCTION: Sexual problems in men and women are common; and physicians endorse many barriers to addressing these issues, including lack of knowledge about the diagnosis and management of sexual problems and inadequate training in sexual health communication and counseling. AIM: To update the recommendations published in 2004, from the International Consultation on Sexual Medicine (ICSM) relevant to the educational aspects of sexual health in undergraduate, graduate, and postgraducate medical education. METHODS: A third international consultation in collaboration with the major sexual health organizations assembled over 186 multidisciplinary experts from 33 countries into 25 committees. Three experts from three countries contributed to this committee's review of Education in Sexual Medicine. MAIN OUTCOME MEASURE: Expert opinion was based on a comprehensive review of the medical literature, committee discussion, public presentation, and debate. RESULTS: A comprehensive review about the current state of undergraduate, graduate, and postgraduate sexual health education worldwide is provided. Recommendations about ideal sexual health curricula across training levels are provided. Best methods for achieving optimal training approaches to sexual health communication and interviewing, clinical skills and management, and counseling are described. CONCLUSIONS: Current sexual health education for undergraduate and practicing physicians is inadequate to meet the advancing science and technology and increasing patient demand for high-quality sexual health care. There is a need for enhanced training in medical institutions responsible for physician sexual health training worldwide. Future training programs at all levels of medical education should incorporate standardized measures of sexual health clinical skills acquisition and assessments of the impact on patient outcomes into the design of educational initiatives.

Impact of tadalafil once daily in men with erectile dysfunction--including a report of the partners' evaluation.

OBJECTIVES: To evaluate the effect of tadalafil 5 mg taken once daily on efficacy (erection achievement and penetration) and overall sexual satisfaction in men with erectile dysfunction (ED) and their female partners. METHODS: This retrospective analysis included data pooled from 2 multicenter, randomized, double-blind, placebo-controlled trials that included 505 couples (tadalafil, n=373; placebo, n=132) in which the men received tadalafil 5 mg once daily or placebo for 12 weeks. Individual Sexual Encounter Profile (SEP) diaries were completed independently by the male subject and his female partner after each sexual intercourse attempt. The mean per-subject/per-partner percentage of "yes" responses to SEP diary questions were assessed, as was agreement between subjects' and partners' responses. RESULTS: Subjects and partners in the tadalafil-treated group reported significantly greater improvements in the man's ability to achieve some erection, vaginal penetration, and overall sexual satisfaction compared with the placebo-treated group (P<.001). For all intercourse attempts, the mean per-couple percentage of agreement for those in the tadalafil and placebo groups, respectively, was high for erection achievement (99.0% and 96.6%), vaginal penetration (98.6% and 97.4%), and overall satisfaction (84.3% and 82.8%). CONCLUSIONS: Tadalafil 5 mg taken once daily as treatment for ED improved overall satisfaction for men and their female partners. This analysis demonstrates the high concordance among couples in their responses to the man's treatment for ED.