Opinion Paper: On the Diagnosis/Classification of Sexual Arousal Concerns in Women.

BACKGROUND: In the professional literature and among our professional societies, female sexual dysfunction nomenclature and diagnostic criterion sets have been the source of considerable controversy. Recently, a consensus group, supported by the International Society for Women's Sexual Health, published its recommendations for nosology and nomenclature, which included only one type of arousal dysfunction, female genital arousal disorder, in its classification system. Subjective arousal was considered an aspect of sexual desire and not part of the arousal phase. AIM: To advocate for the importance of including subjective arousal disorder in the diagnostic nomenclature in addition to the genital arousal subtype. METHODS: We reviewed how the construct of subjective arousal was included in or eliminated from the iterations of various diagnostic and statistical manuals. The Female Sexual Function Index (FSFI) was used to examine the relations among subjective arousal, genital arousal, and desire in women with and without sexual arousal concerns. MAIN OUTCOME MEASURES: Sexual arousal through a self-report Film Scale, physiologic sexual arousal through vaginal photoplethysmography in response to an erotic film, and the FSFI. RESULTS: The clinical literature and experience support differentiating subjective arousal from desire and genital arousal. Correlations between the FSFI domains representing desire and subjective arousal, although sufficient to suggest relatedness, share approximately 58% of the variance between constructs-a lower shared variance than FSFI domains representing subjective arousal and orgasm. Similarly, when looking at FSFI individual items best representative of sexual desire and subjective arousal, the large majority of the variance in subjective arousal was unexplained by desire. A third line of evidence showed no significant difference in levels of subjective arousal to erotic films between sexually functional women and women with desire problems. If desire and subjective arousal were the same construct, then one would expect to see evidence of low subjective arousal in women with low sexual desire. CLINICAL IMPLICATIONS: Optimized treatment efficacy requires differentiating mental and physical factors that contribute to female sexual dysfunction. STRENGTHS AND LIMITATIONS: Support for our conclusion is based on clinical qualitative evidence and quantitative evidence. However, the quantitative support is from only one laboratory at this time. CONCLUSION: These findings strongly support the view that female sexual arousal disorder includes a subjective arousal subtype and that subjective arousal and desire are related but not similar constructs. We advocate for the relevance of maintaining subjective arousal disorder in the diagnostic nomenclature and present several lines of evidence to support this contention. Althof SE, Meston CM, Perelman M, et al. Opinion Paper: On the Diagnosis/Classification of Sexual Arousal Concerns in Women. J Sex Med 2017;14:1365-1371.

Reexamining the Definitions of PE and DE.

Evidence-based definitions improve clinical practice and research. Nonetheless, the International Society of Sexual Medicine (ISSM) and the American Psychiatric Association's (DSM-5) definitions regarding lifelong and acquired premature ejaculation (PE) and delayed ejaculation (DE) require reexamination. Existing Intravaginal Ejaculation Latency Time (IELT) evidence, the ISSM position papers, and articles both supporting and critiquing the ISSM's definitions were reviewed. Disproportionately, the findings from those studies document that the majority of men's IELT range is approximately 4 to 10 minutes. Such robust quantitative evidence should become the basis for determining the temporal criterion when defining both PE and DE. Any bilateral deviation from that majority's ∼4- to 10-minute IELT range should meet the qualification for the temporal diagnostic criterion. However, for a man to be diagnosed with a disorder, a licensed health-care clinician (HCC) must also determine that the man suffers from "lack of control" and "distress." Diagnosis would include subtyping Lifelong or Acquired, Global or Situational, similar to the ISSM guidelines and specifying mild, moderate, or severe-similar to DSM-5 requirements. "Control" and "distress" should trump latency and convey greater weight in the diagnostic process. Loosened latency criteria could result in false positive diagnoses; however, requiring a licensed HCC to evaluate control and distress reduces that risk.

Toward a More Evidence-Based Nosology and Nomenclature for Female Sexual Dysfunctions-Part II.

INTRODUCTION: Current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definitions of sexual dysfunction do not identify all sexual problems experienced clinically by women and are not necessarily applicable for biologic or biopsychosocial management of female sexual dysfunction. A unified nomenclature system enables clinicians, researchers, and regulatory agencies to use the same language and criteria for determining clinical end points, assessing research results, and managing patients. AIM: To develop nomenclature with classification systems for female sexual desire, arousal, and orgasm disorders with definitions pertinent to clinicians and researchers from multiple specialties who contribute to the field of sexual medicine. METHODS: Key national and international opinion leaders diverse in gender, geography, and areas of expertise met for 2 days to discuss and agree to definitions of female sexual desire, arousal, and orgasm disorders and persistent genital arousal disorder. The attendees consisted of 10 psychiatrists and psychologists; 12 health care providers in specialties such as gynecology, internal medicine, and sexual medicine; three basic scientists; and one sexuality educator, representing an array of societies working within the various areas of sexual function and dysfunction. MAIN OUTCOME MEASURE: A unified set of definitions was developed and accepted for use by the International Society for the Study of Women's Sexual Health (ISSWSH) and members of other stakeholder societies participating in the consensus meeting. RESULTS: Current DSM-5 definitions, in particular elimination of desire and arousal disorders as separate diagnoses and lack of definitions of other specific disorders, were adapted to create ISSWSH consensus nomenclature for distressing sexual dysfunctions. The ISSWSH definitions include hypoactive sexual desire disorder, female genital arousal disorder, persistent genital arousal disorder, female orgasmic disorder, pleasure dissociative orgasm disorder, and female orgasmic illness syndrome. CONCLUSION: Definitions for female sexual dysfunctions that reflect current science provide useful nomenclature for current and future management of women with sexual disorders and development of new therapies.

Psychosexual therapy for delayed ejaculation based on the Sexual Tipping Point model.

The Sexual Tipping Point(®) (STP) model is an integrated approach to the etiology, diagnosis and treatment of men with delayed ejaculation (DE), including all subtypes manifesting ejaculatory delay or absence [registered trademark owned by the MAP Educational Fund, a 501(c)(3) public charity]. A single pathogenetic pathway does not exist for sexual disorders generally and that is also true for DE specifically. Men with DE have various bio-psychosocial-behavioral & cultural predisposing, precipitating, maintaining, and contextual factors which trigger, reinforce, or worsen the probability of DE occurring. Regardless of the degree of organic etiology present, DE is exacerbated by insufficient stimulation: an inadequate combination of "friction and fantasy". High frequency negative thoughts may neutralize erotic cognitions (fantasy) and subsequently delay, ameliorate, or inhibit ejaculation, while partner stimulation (friction) may prove unsatisfying. Assessment requires a thorough sexual history including inquiry into masturbatory methods. Many men with DE engage in an idiosyncratic masturbatory style, defined as a masturbation technique not easily duplicated by the partner's hand, mouth, or vagina. The clinician's most valuable diagnostic tool is a focused sex history (sex status). Differentiate DE from other sexual problems and review the conditions under which the man can ejaculate. Perceived partner attractiveness, the use of fantasy during sex, anxiety-surrounding coitus and masturbatory patterns require meticulous exploration. Identify important DE causes by juxtaposing an awareness of his cognitions and the sexual stimulation experienced during masturbation, versus a partnered experience. Assist the man in identifying behaviors that enhance immersion in excitation and minimize inhibiting thoughts, in order to reach ejaculation in his preferred manner. Discontinuing, reducing or altering masturbation is often required, which evokes patient resistance. Coaching tips are offered on how to ensure adherence to this suspension, manage resistance and facilitate success. Depending on motivation level, masturbation interruption may be compromised and negotiated. Encourage a man who continues to masturbate to alter style ("switch hands") and to approximate the stimulation likely to be experienced with his partner. Success will require most men to be taught to learn bodily movements and fantasies that approximate the thoughts and sensations experienced in masturbation. Fertility issues, as well as patient/partner anger are important causational factors, which often require individual and/or conjoint consultation. Drug treatment would benefit men particularly with severe DE, regardless of concomitant psychosocial-behavioral and cultural complications. When and if a safe effective medication for DE becomes available, this author's transdisciplinary perspective supports appropriate medication use when integrated with counseling. This approach emphasizes the utility of a biopsychosocial-cultural perspective combined with special attention to the patient's narrative. Treatment is patient-centered, holistic and integrates a variety of therapies as needed.

Treatment satisfaction of men and partners following switch from on-demand phosphodiesterase type 5 inhibitor therapy to tadalafil 5 mg once daily.

INTRODUCTION: Treatment satisfaction of men receiving phosphodiesterase 5 inhibitors (PDE5) for erectile dysfunction (ED) and their partners is essential to successful long-term therapy. AIM: This study aims to assess treatment satisfaction, in men with a partial response to on-demand (PRN) PDE5 and their female partners, following tadalafil 5 mg once daily or placebo. METHODS: The study was randomized, double-blind, parallel, and placebo-controlled in men primarily with mild to moderate ED. Treatment satisfaction was assessed following a 4-week maximum dose PRN lead-in, 4-week nondrug washout, and treatment through 12 weeks. Men were ≥18 years old with ED for ≥3 months and International Index of Erectile Function Erectile Function score of ≥17 and <26 at screening and <26 following PRN lead-in. MAIN OUTCOME MEASURES: Treatment satisfaction was assessed using the Treatment Satisfaction Scale (TSS) for patients and partners. TSS domain scores range from 0 to 100, with higher values indicating greater satisfaction. Statistical comparisons were made using analysis of covariance. RESULTS: Treatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners (all P < 0.001). For patients, mean scores for the TSS domains Confidence to Complete Sexual Activity and Satisfaction with Orgasm ranged from 53.7 to 57.8 after the PRN lead-in and 26.7 to 31.9 following the nondrug washout. Following randomized treatment, scores for tadalafil and placebo were 55.4 and 32.6, respectively, for Confidence to Complete Sexual Activity and 57.5 and 37.9, respectively, for Satisfaction with Orgasm. Results were comparable for other TSS domains and between men and their partners. CONCLUSIONS: Treatment satisfaction was comparable for tadalafil 5 mg once daily and PRN PDE5 for both patients and female partners, suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy.

A psychological perspective on male rejuvenation.

Male rejuvenation, defined as a process in men to both limit the impact of aging on body image and experience greater virility, is growing among middle-aged and older men. While rejuvenation was primarily in the domain of the younger male athlete with the use of performance enhancing hormones or in the aging woman through the use of cosmetic surgery, it is now more common among middle-aged and older men. Male rejuvenation can occur both through aesthetic surgical means and hormonal manipulation through anabolic steroid use. In this article, the authors review the psychological issues and perceptions surrounding male aesthetic surgeries and the resulting alteration of perception by peers and family; highlight the motives and desires behind the use of anabolic hormones at often supra-physiologic levels, and the intent to improve body image; and clarify the needs that remain to be examined in future research in this field.

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.

The Subjective Sexual Arousal Scale for Men (SSASM): preliminary development and psychometric validation of a multidimensional measure of subjective male sexual arousal.

INTRODUCTION: Sexual arousal is a multifaceted process that involves both mental and physical components. No instrument has been developed and validated to assess subjective aspects of male sexual arousal. AIM: To develop and psychometrically validate a self-administered scale for assessing subjective male sexual arousal. METHODS: Using recommendations of the Food and Drug Administration (FDA) guidance on patient-reported outcome instruments, important aspects of male sexual arousal were identified via qualitative research (focus groups and interviews) of U.S. men with erectile dysfunction (ED) and healthy controls. After a preliminary questionnaire was developed by a panel of experts, a quantitative study of men with ED and controls was conducted to psychometrically validate the Subjective Sexual Arousal Scale for Men (SSASM). MAIN OUTCOME MEASURES: To develop a male sexual arousal scale and determine its factor structure, reliability, and construct validity. RESULTS: Five aspects of male sexual arousal were identified from the qualitative focus groups and cognitive interviews. Men's preferred language for describing sexual arousal and preferred response formats were incorporated into the questions. Factor analysis of data from the quantitative study of 304 men aged 21 to 70 years identified five domains with eigenvalues >1: sexual performance (six items), mental satisfaction (five items), sexual assertiveness (three items), partner communication (three items), and partner relationship (three items). The five domains had a high degree of internal consistency (Cronbach's alpha values 0.88-0.94). Test-retest reliability over a 2- to 4-week period was high-moderately high (r values 0.75-0.88) for the five domain scores. Correlations between SSASM domain scores and standardized scale scores for social desirability, general health, life satisfaction, and sexual function demonstrated the construct validity of the scale. CONCLUSIONS: Preliminary validation data suggest that the 20-item SSASM scale may be useful as a multidimensional, reliable, self-administered instrument for assessing subjective sexual arousal in men of different ages.

Erectile dysfunction and depression: screening and treatment.

The comorbid conditions erectile dysfunction (ED) and depression are highly prevalent in men. Multiple regression analysis to control for all other predictors of ED indicate that men with high depression scores are nearly twice as likely to report ED than nondepressed men. Depression continues to be among the most common comorbid problems in men with ED, both in the community and in clinical samples. This article reviews the current knowledge about the relationship between ED and depression, the effect of treatments for depression on ED, ways to improve screening for depression, and treatment of ED in patients with this comorbidity.

Standards for clinical trials in sexual dysfunction in women: research designs and outcomes assessment.

INTRODUCTION: Clinical trial design in female sexual dysfunction (FSD) is an evolving science, with some areas of controversy. AIM: To develop an evidence-based, expert consensus-report on design of FSD clinical research. METHODS: Literature review including the Food and Drug Administration (FDA) clinical trial guidelines with critique by six experts from three countries, modified after public presentation and debate. MAIN OUTCOME MEASURE: Expert opinion and recommendations were based on grading of evidence based literature, internal committee dialogue, open presentation, and debate. RESULTS: Design of clinical research for regulatory approval is driven by FDA guidelines. Diagnostic and Statistical Manual-IV definitions and consideration of comorbidity of sexual disorders may complicate patient selection and outcomes. Measures for study end points include satisfying sexual events utilizing a daily diary, sexual distress, and patient-reported outcomes measures of the construct under study. Currently, trial duration is recommended to be 6 months for efficacy trials to allow for modification of behavioral adaptations to changes in desire. Important issues include safety assessments, generalizability, having a representative study population, stratification by reproductive status, partner assessment, contextual and interpersonal factors, symptom duration and severity, management of placebo response, and drug dosing. Statistical analysis should include assessment of change from baseline to end point between study drug and placebo, determination of statistically significant change vs. clinically meaningful effects, linear mapping of all measures of the same construct, and determination of responders and remitters. CONCLUSIONS: Future trials should include clear population definitions, direct and indirect measures of the specific FSD construct, and procedures to allow generalizability of diagnosis and treatment to the target population.