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Introduction In 2000, the FDA began issuing advice about treatments for hypoactive sexual desire disorder (HSDD) in women. How its recommendations have evolved has not been reviewed. Its consistent preference for self-rating by patients over evaluation by an examining clinician has not been addressed. Objectives Recount the changes in FDA’s proposals about patient-reported outcomes and diagnostics. Compare the value of patient-reported measures and clinical interviews. Methods Historical review is based on draft guidances, publications, meetings, and prescribing information. Results The FDA has avoided clinician input into diagnosis and evaluation of the severity of HSDD in women. It abandoned its initial (2000) insistence on counts of satisfying sexual events to define efficacy in favor of symptom-related scales to evaluate desire and distress with daily self-ratings. By 2015, the FDA accepted the self-rated Female Sexual Function Index-Desire Domain (FSFI-D) to measure desire and the most relevant item of the Female Sexual Distress Scale-Revised (FSDS-R) to measure distress; retrospection for both is one month. The FDA rejected the one clinician-rated broad measure of HSDD, the Sexual Interest and Desire Inventory (SIDI-F), although well-validated and treatment-sensitive. Since 2005, the FDA has accepted the Decreased Sexual Desire Screener (DSDS) to diagnose HSDD by non-expert clinicians using self-ratings and exploring them in more depth in a clinical interview. Conclusion FDA’s decisions on how to measure HSDD in women may have stabilized on accepting 2 co-primary measures: the FSFI-D and the FSDS-R item on bother about low desire, and on accepting the DSDS for diagnosis. FDA’s rejection of clinician ratings of severity through interviews in clinical trials seems unsound because interviews can give broader assessments than (brief) self-ratings, although the agency’s logic was to avoid diagnostic controversies and help avoid overcommercialization. Semistructured clinical interviews for diagnosis (DSDS) and severity-rating (SIDI-F) are well validated and are recommended for clinical practice. Pyke RE. FDA Decisions on Measures of Hypoactive Sexual Desire Disorder in Women: A History, With Grounds to Consider Clinical Judgment. Sex Med Rev 2021;9:186–193.

Introduction Cognitive factors are conceptualized as playing a role in maintaining psychological disorders—including sexual dysfunction—by influencing the way in which individuals ascribe meaning, and ultimately respond, to sexual events. Objectives To systematically review and integrate the findings from studies on cognitive processing factors and sexual function and dysfunction in women and men. Methods A systematic search of major electronic databases was conducted from inception to July 2019 to identify peer-reviewed studies examining cognitive processing factors associated with sexual function and dysfunction. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Main Outcome Measure The main outcome measure was the association of cognitive processing variables with women's and men's sexual function and dysfunction. Results From 122 studies, 67 studies were deemed eligible for inclusion. Studies demonstrated a consistent association between cognitive processing factors and dimensions of sexual functioning in women and men. The main cognitive processing factors associated with sexual functioning include cognitive distraction and attentional focus, automatic thoughts and sexual cognitions, causal attributions to negative sexual events, efficacy expectations, and perceived performance demands. Specific associations between cognitive processing factors and particular male and female sexual dysfunctions were identified and discussed. Conclusion Overall, research supports the critical role of cognitive processing factors in predicting women's and men's sexual (dys)function. Evidence suggests that these dimensions should be systematically addressed during the assessment of sexual dysfunction and one of the main treatment targets of psychological interventions. Tavares IM, Moura CV, Nobre PJ. The Role of Cognitive Processing Factors in Sexual Function and Dysfunction in Women and Men: A Systematic Review. Sex Med 2020;8:403–430.

Introduction Sexual performance anxiety (SPA) is one of the most prevalent sexual complaints; yet, no diagnosis is recognized for either gender. Thus, research into treatment has been minimal. Aim Review the prevalence of SPA and its relation to sexual dysfunctions and anxiety disorders. Compare SPA to (non-sexual) performance anxiety and social anxiety (PA/SA). Apply pharmacologic principles to the known properties of drugs and phytotherapies to hypothesize treatments for SPA. Methods Review SPA and PA/SA through PubMed searches for relevant literature from 2000 to 2018. Main Outcome Measure Prevalence was estimated using population-representative surveys. For treatment results, controlled clinical trial results were prioritized over open-label trial results. Results SPA affects 9–25% of men and contributes to premature ejaculation and psychogenic erectile dysfunction (ED). SPA affects 6–16% of women and severely inhibits sexual desire. Cognitive behavior therapy and mindfulness meditation training have been proven effective for PA/SA and are recommended for SPA, but controlled studies are lacking. Phosphodiesterase type 5 inhibitors are effective for psychogenic ED and premature ejaculation, both of which include SPA as a major element. Drugs proven for PA/SA have adverse sexual and sedative effects, but serotonergic anxiolytics with prosexual effects (buspirone ± testosterone, trazodone ± bupropion) may have potential, and sage, passionflower, l -theanine, and bitter orange are anxiolytic. Nitric oxide boosters ( l -citrulline, l -arginine, Panax ginseng) have the potential for increasing genital tumescence and lubrication, and plant-based alpha-adrenergic antagonists may aid sexual arousal (yohimbine/yohimbe, Citrus aurantium/p-synephrine). Conclusion SPA causes or maintains most common sexual dysfunction. No treatments are well proven, although cognitive behavior therapy, mindfulness meditation training, and serotonergic anxiolytics (buspirone, trazodone, gepirone) have potential, and phosphodiesterase type 5 inhibitors are effective for psychogenic ED and premature ejaculation. Several phytotherapies also appear to have potential. Pyke RE. Sexual Performance Anxiety. J Sex Med 2020;8:183–190.

Introduction Treatment of hypoactive sexual desire disorder (HSDD) remains unfulfilled. The only approved medication, flibanserin (FLI), is highly underused owing to concerns about central nervous system (CNS) depression and interactions. Trazodone (TRZ), which is not often used for sexual problems, has evidence suggesting efficacy but similar concerns. Aim To explore whether the pharmacologic similarities between TRZ and FLI could allow treatment of HSDD without CNS depression. Methods A literature search on TRZ was performed for clinical effects and to facilitate pharmacologic considerations relating to doses for HSDD and CNS depression. Main Outcome Measure The main measures were threshold doses for sedative-hypnotic effects, and calculated doses for occupy 20% of agonist receptors and 70% of antagonist receptors, considering 5HT1A, 5HT2A, 5HT2C, and α1 receptors for sexual benefits and 5HT2A, α1, and histamine type 1 receptors for CNS depression. Results 3.5–19.2-mg extended-release (XR) TRZ daily (bioequivalent to 1.2–6.4-mg immediate-release [IR] TRZ 3 times a day) is estimated to be the minimum effective dose for improving sexual desire and arousal; 75 mg (25-mg IR) appears to be the threshold dose for CNS depression. Conclusion Although tested only in much larger dose strengths, the optimal dose of XR TRZ for HSDD according to receptor and PK data appears to be about 4–20 mg. HSDD or arousal problems might be treated without over-sedation with XR 150-mg TRZ matrix tablets quartered to 37.5 mg daily or 50-mg IR TRZ tablets quartered to 12.5 mg given 2–3 times daily or as needed for arousal problems. Interindividual sensitivity might require varying the dose. Mechanistically rational adjuncts (eg, bupropion or dopaminergics) might augment response. Pyke RE. Trazodone in Sexual Medicine: Underused and Overdosed? Sex Med Rev 2020;8:206–216.

Introduction Dysregulation of emotion (DE) is commonly seen in individuals suffering from compulsive sexual behavior (CSB), as well as represents a crucial element of its common comorbidities like mood, anxiety, and substance use disorders. Aim To investigate the links between CSB and DE. Methods A review of pertinent literature on CSB and DE was performed using EBSCO, PubMed, and Google Scholar databases. Main Outcome Measure Patterns of DE were evaluated as a common clinical feature, underlying mechanisms, as well as a target for psychological and pharmacological interventions in CSB. Results Across different conceptualizations of CSB, DE represents the core element of a failure to cope with sexual impulses, thoughts, urges, or resulting uncontrolled sexual behaviors. DE may contribute to the occurrence of CSB while for individuals affected by this condition, sexual arousal and release act as an easier/learned (yet uncontrolled and leading to negative consequences) way of coping with negative mood states. CSB may represent a delusive form of self-regulation. Experience of child sexual abuse and insecure attachment patterns are considered risk factors for CSB (likely to be mediated by DE) but require further investigation. DE is also positively associated with CSB symptom severity. Pharmacological treatments affecting mood regulation, anxiety, impulsivity, and regulation within the brain reward system have been reported to help people with CSB achieve better control over their sexual urges and behavior. However, the available data are scarce and well-powered randomized controlled trials are needed to support these observations. Although improvement in one's emotional self-regulation is considered as an important healing factor in treatment, its benefit in psychological therapies specific to CSB requires further investigation. Conclusion DE represents a core symptom of compulsive sexual behavior disorder and related comorbidities as well as a predisposing factor to the development of compulsive sexual behavior disorder. Addressing DE may facilitate better treatment outcomes for patients with CSB. Lew-Starowicz M, Lewczuk K, Nowakowska I, et al. Compulsive Sexual Behavior and Dysregulation of Emotion. J Sex Med 2020;8:191–205.

Introduction Pelvic organ prolapse (POP) is a common condition among parous women and its prevalence increases with age. Vaginal pessaries are one of the management options for women with prolapse. In the current health climate, where there are controversy surrounding surgical procedures, an increasing number of women are considering a pessary over surgical management. Aim This article aims to provide an overview of POP, its associated symptoms, and the different types of pessaries available. It will go on to describe how sexual activity (SA) and sexual function (SF) needs to be considered as part of the pessary selection discussion, and common concerns expressed by women. Methods A literature review was undertaken to record the current evidence regarding SA and pessary use, and clinical practice and experience are discussed. Main Outcome Measures The main outcome of this study was to consider the preservation or restoration of SF in women using a pessary for prolapse. Results There are several pessaries available on the market that enable women to maintain SA, and for many of these it will not be noticeable to their partners. If, however, the woman or their partner finds the pessary uncomfortable or obstructing during intercourse, women can be trained to remove and reinsert their pessary as necessary. The evidence suggests that, for those women who are sexually active with their pessaries in situ, they are happy and continue with this form of management in the long term. Conclusion Health care professionals need to ensure that SF or the desire to be sexually active (in whatever form that may be) is assessed and discussed as part of routine care and is considered in all decision making. Rantell A. Vaginal Pessaries for Pelvic Organ Prolapse and Their Impact on Sexual Function. Sex Med Rev 2019;7:597–603.

Introduction 1 in every 7 Canadian men is affected by prostate cancer. Given impressive advances in detection, treatment, and survival rates, there is a considerable focus on survivors’ supportive care needs. Among the top unmet supportive care needs for prostate cancer survivors are concerns related to sexual health and intimacy. Aim To provide a rationale for introducing mindfulness- and acceptance-based approaches into the role of psychosexual interventions aimed at improving sexual satisfaction among prostate cancer survivors (and their partners). Methods A literature review was performed to examine the prevalence of sexual difficulties after prostate cancer treatment and the efficacy of current pharmacologic and psychological treatment approaches. Main Outcome Measure The main outcome measure was focused on sexual satisfaction in prostate cancer survivors. Results Current pharmacologic interventions for sexual difficulties after prostate cancer treatment are not fully meeting the needs of prostate cancer survivors and their partners. Conclusions cannot be drawn from existing psychological interventions because of methodologic inconsistencies. Additionally, the focus on erectile function as a measure of treatment effectiveness is likely to instill a greater sense of hopelessness and loss for prostate cancer survivors, which may exacerbate issues around sexual intimacy and satisfaction. An impressive body of evidence supports the role of mindfulness in improving women’s sexual functioning and there is preliminary evidence suggesting the efficacy of this approach for improving men’s sexual functioning. Conclusion We propose that psychosexual interventions that prioritize mindfulness and acceptance-based frameworks may help men to tune into sensations while challenging the foci on performance and erections, thereby increasing the potential for improvement to sexual satisfaction among prostate cancer survivors. Bossio JA, Miller F, O’Loughlin JI, et al. Sexual Health Recovery for Prostate Cancer Survivors: The Proposed Role of Acceptance and Mindfulness-Based Interventions. Sex Med Rev 2019;7:627–635.

Introduction Pelvic floor disorders (PFD) are extremely common; 1 in 3 parous women will experience urinary incontinence, 1 in 2 will develop pelvic organ prolapse, whereas 1 in 10 experience fecal incontinence. PFD are often associated with a significant reduction in women’s psychological, social, and sexual well-being. Aim To review the current literature on sexual dysfunction related to PFD. Methods A literature search was conducted using PubMed and key words including sexual dysfunction, prolapse, incontinence, pelvic floor dysfunction, and surgical repair. Main Outcome Measure The outcome was to identify the nature and severity of sexual dysfunction in women with PFD. Results The prevalence of sexual dysfunction is estimated to be around 30–50% in the general population, whereas in women with PFD, the reported incidence rises to 50–83%. The leading factors cited for the reduction in a woman’s sexual experience included worries about the image of their vagina for women with pelvic organ prolapse, dyspareunia and coital incontinence in women with urinary incontinence, and fear of soiling when dealing with anal incontinence. Pelvic floor muscle training has been associated with an improvement in sexual function. 11% of parous women will have surgery for pelvic organ prolapse, yet limited data are available on the impact of surgical intervention on sexual function. Native tissue repair of pelvic organ prolapse is associated with an improvement in sexual function, whereas posterior repair with levatorplasty and vaginal mesh repair can increase the risk of postsurgical dyspareunia. Subtotal hysterectomy is not associated with improved sexual function compared with traditional total hysterectomy. Conclusion It is clear there is an urgent need for further research on the effects of surgery for PFD on sexual function. To date, most studies have focused on anatomic rather than functional outcomes. Verbeek M, Hayward L. Pelvic Floor Dysfunction and Its Effect on Quality of Sexual Life. Sex Med Rev 2019;7:559–564.

Introduction Flibanserin, a multifunctional serotonin agonist and antagonist, is approved by the U.S. Food and Drug Administration (FDA) for treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women. During the FDA’s review of flibanserin, concerns were raised about the risks of hypotension, syncope, and sedation-related adverse events, which increase with alcohol use. Based on the results of an alcohol challenge study, the FDA required a boxed warning and alcohol contraindication in the flibanserin prescribing information, as part of a risk evaluation and mitigation strategy program. Aim To evaluate the adverse event profile of flibanserin in the context of that seen with other medications that affect serotonin in the brain and are commonly prescribed for women. Methods This was a review of data provided in the product prescribing information for flibanserin, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, other serotonergic antidepressants, and triptans. Main Outcome Measures The incidence of adverse events was assessed. Results The incidences of hypotension, syncope, and sedation-related adverse events (eg, dizziness, somnolence, fatigue) in studies of flibanserin were within the ranges observed for serotonergic antidepressants; the rates of these adverse events were generally lower with triptan medications. Other flibanserin-associated adverse events (eg, nausea, insomnia, dry mouth) occurred more commonly in patients taking antidepressant medications. Conclusion Although medications that affect the serotonin system have varying adverse event profiles (likely mediated by differences in serotonin-related mechanisms of action, specific brain structures affected, and effects on other neurotransmitter systems), the occurrence of central nervous system–related adverse events was not dissimilar between flibanserin and serotonergic antidepressants. Kingsberg SA, McElroy SL, Clayton AH. Evaluation of Flibanserin Safety: Comparison with Other Serotonergic Medications. Sex Med Rev 2019;7:380–392.

Introduction Persistent genital arousal disorder (PGAD) is a highly distressing and poorly understood condition characterized by unwanted sensations of genital arousal in the absence of subjective sexual desire. Research has shown that some individuals with PGAD also report orgasm, urinary, and pain symptoms, with 1 recent study specifically comparing a “painful persistent genital arousal symptom” group to a “non-painful persistent genital arousal symptom” group on various indicators given the highly frequent report of comorbid genitopelvic pain in their sample. Aim To review literature on PGAD focusing on the presence of pain symptoms. Methods A literature review through May 2018 was undertaken to identify articles that discuss pain characteristics in individuals with persistent sexual arousal syndrome, persistent genital arousal disorder, symptoms of persistent genital arousal, and restless genital syndrome. Main Outcome Measure A review of pain/discomfort associated with persistent genital arousal, and the proposal of a new theoretical framework of genitopelvic dysesthesias. Results PGAD is a distressing condition that is associated with a significant, negative impacts on psychosocial and daily functioning. Although it is clear that unwanted and persistent genital arousal is the hallmark symptom of PGAD, symptoms of pain and discomfort are also frequently reported. Based on the results of this review, a model of genitopelvic dysesthesias is proposed, with subcategories of unpleasant sensations that are based on patients' primary complaint: arousal, arousal and pain, or pain (and other sensations). Conclusion The proposed model can provide an important framework for conceptualizing conditions characterized by unpleasant genitopelvic sensations. A model such as this one can benefit highly misunderstood conditions that are questioned in terms of their legitimacy and severity—such as PGAD—by conceptualizing them as sensory disorders, which in turn can reduce stigma, unify research efforts, and potentially improve access to care. Pukall CF, Jackowich R, Mooney K, et al. Genital Sensations in Persistent Genital Arousal Disorder: A Case for an Overarching Nosology of Genitopelvic Dysesthesias? Sex Med Rev 2019;7:2–12.

Introduction Hypoactive Sexual Desire Disorder (HSDD) / Female Sexual Interest/Arousal Disorder (FSIAD) impacts health-related quality of life (HRQoL) of women and their partners, yet existing measures fail to adequately capture relevant concepts (ie, what is essential to measure including symptoms/impacts) important to women with HSDD/FSIAD. Objectives To identify HRQoL tools used to assess women with HSDD/FSIAD, and to evaluate their psychometric properties (ie, reliability, validity, and responsiveness). Methods We conducted searches in PubMed, Embase and PsychINFO from June 5, 1989 to September 30, 2020 for studies in women with HSDD/FSIAD and psychometric analyses (English only). Principles of the Preferred Reporting Items for Systematic reviews and Meta-Analyses, the COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist and other psychometric criteria were applied. Based on this search, 56 papers were evaluated including 15 randomized-controlled trials, 11 observational/single arm/open label studies, and 30 psychometric studies. Results Of the 18 measures identified, the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) were included in most studies (> 50%). General HRQoL instruments were not used in any of the clinical trials; the SF-12, SF-36 and EQ-5D-5L were reported in two observational studies. No instruments achieved positive quality ratings across all psychometric criteria. The FSFI, FSDS-R, Sexual Event Diary (SED) and the Sexual Desire Relationship Distress Scale (SDRDS), were the only measures to receive a positive rating for content validity. Conclusion Reliable and valid HRQoL measures that include sexual desire and distress are needed to provide a more systematic and comprehensive assessment of HRQoL and treatment benefits in women with HSDD/FSIAD. While inferences about HRQoL are limited due to the lack of uniformity in concepts assessed and limited psychometric evaluation of these measures in women with HSDD/FSIAD, opportunities exist for the development of reliable and validated tools that comprehensively measure the most relevant and important concepts in women with HSDD/FSIAD. Lim-Watson MZ, Hays RD, Kingsberg S, et al. A systematic literature review of health-related quality of life measures for women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder. Sex Med Rev 2021;XX:XXX–XXX.

Introduction Current information-processing models of sexual arousal imply that both controlled and automatic affective-motivational processes are critically involved in sexual responding and suggest that dysfunctional automatic processes may be involved in the development and persistence of sexual dysfunctions. Because (dysfunctional) automatic processes and responses cannot be adequately captured by common self-report measures, implicit performance-based measures have been developed to index these processes. Objectives This review provides an overview of studies that used implicit tasks in clinical sexual research, and critically evaluates the contribution and promise of these measures to improve our understanding of the mechanisms involved in sexual dysfunctions. Methods 6 electronic main databases (AMED, MEDLINE, PsycArticles, Psychology & Behavioral Sciences Collection, PsycINFO, and SocINDEX) were searched for studies involving implicit measurement techniques to measure automatic processes in clinical sex research. Results A series of studies examined if lowered (or heightened) attention for sex stimuli may be involved in low sexual arousal, low desire, and genital pain. Preliminary evidence showed that lowered attention is involved in low sexual arousal. The pattern with regard to desire and genital pain was mixed which may be due to heterogeneity in assessment instruments. A limited number of studies examined automatic memory associations with sexual cues. Preliminary evidence showed negative (sex-threat/sex-disgust) associations in women with genito-pelvic pain or penetration disorder, less positive associations in women with hypoactive sexual desire disorder, and sex-positive and sex-failure associations in men with sexual distress. Thus far, no studies have examined lowered (or heightened) automatic sexual approach tendencies related to sexual dysfunctions. Conclusion Implicit measures showed some promise as tools to index automatic sex-relevant cognitive mechanisms in sexual dysfunctions. Yet, more systematic research and the development of psychometrically sound measures are critical for a more comprehensive evaluation of the relevance of implicit measures in clinical sex research and their usefulness as indices of individual differences in clinical practice. Hinzmann J, Borg C, de Jong PJ. Implicit Measures in Clinical Sex Research: A Critical Evaluation. Sex Med Rev 2020;8:531–541.

Introduction Although basic science and clinical research indicate that the vascular physiopathology of male and female sexual dysfunction (FSD) is similar, to date the association between FSD and cardiovascular (CV) diseases has been only marginally explored. Aim To discuss the potential reasons for differences in the role of CV diseases and risk factors in sexual function in women vs men in the 2nd part of a 2-part review. Methods A thorough literature search of peer-reviewed publications on the topic was performed using the PubMed database. Main Outcome Measures We present a review of the main factors that could account for this gap: (i) actual physiologic discrepancies and (ii) factors related to the inadequacy of the methodologic approach used to investigate CV risk in patients with FSD. A summary of the available methods to assess female sexual response, focusing on genital vascularization, is reported. Results The microanatomy and biochemistry of the male and female peripheral arousal response are similar; in contrast, there are differences in the interplay between the metabolic profile and sex steroid milieu, in the relative weighting of cardiometabolic risk factors in the pathogenesis of CV disease, and their clinical presentation and management. CV diseases in women are under-recognized, leading to less aggressive treatment strategies and poorer outcomes. Moreover, evaluation of hemodynamic events that regulate the female sexual response has thus far been plagued by methodologic problems. Conclusion To clarify whether sexuality can be a mirror for CV health in women, the female genital vascular district should be objectively assessed with standardized and validated methods. Studies designed to establish normative values and longitudinal intervention trials on the effect of the treatment of CV risk factors on FSD are urgently needed. Maseroli E, Scavello I, Vignozzi L. Cardiometabolic Risk and Female Sexuality—Part II. Understanding (and Overcoming) Gender Differences: The Key Role of an Adequate Methodological Approach. Sex Med Rev 2018;6:525–534.

Background The Female Sexual Function Index–desire subscale is the standard measure for clinical trials of hypoactive sexual desire disorder (HSDD), but lacks items assessing sexually related behaviors and attitudes toward partner. Counting satisfying sexual events is criticized, but sexual behavior remains important. Mean treatment differences cannot define clinical significance; responder and remitter analyses help. We reviewed measures on sexual desire and sexual behavior relevant to HSDD, and how to assess clinical significance. Methods We conducted a literature review of measures of sexual desire comparing expert-proposed criteria for dysfunctional desire, expert-developed scales, and scales from patient input. Commonly recognized symptoms of HSDD were identified. Results of HSDD trials and scale validation studies were evaluated to extract responder and remitter values. The utility of distribution-based measures of responders and remitters was assessed. Outcomes Symptom relevance was evaluated as the proportion of symptom sets that included the item; responder and remitter cut points were determined by distribution-based methods. Results 12 Validated rating scales, 5 scales primarily derived from expert recommendations and 7 scales initially from patient input, and 5 sets of diagnostic criteria for conditions like HSDD were compared. Content varied highly between scales despite compliance with U.S. Food and Drug Administration recommendations for patient-reported outcomes. This disunity favors an expert-recommended scale such as the Elements of Desire Questionnaire with each of the common items, plus a measure of frequency of sexual activity, eg, item in the Patient Reported Outcomes Measurement Information System. Registrational drug trials, but not psychological treatment trials, usually give responder/remitter analyses, using dichotomized global impressions or anchor-based definitions. Distribution-based methods are more uniformly applicable to define responder and remitter status. Conclusions The Female Sexual Function Index–desire subscale measures the most relevant element of sexual desire, but it would be meaningful to include 4 or 5 more sexual symptoms as end points: sexual thoughts/fantasies, frequency of sexual activity, receptivity, initiations, and possibly avoidance of sexual situations. The Elements of Desire Questionnaire and a measure of sexual frequency may suffice. Responder and remitter analyses show the clinical relevance of a treatment and enable comparisons across trials. Pyke RE, Clayton AH. Assessment of Sexual Desire for Clinical Trials of Women With Hypoactive Sexual Desire Disorder: Measures, Desire-Related Behavior, and Assessment of Clinical Significance. Sex Med Rev 2018;6:367–383.

Background Ejaculation consists of the emission of semen from seminal vesicles and prostate, followed by expulsion. Ejaculatory dysfunction may take several forms including premature ejaculation, delayed or anejaculation, retrograde ejaculation, and painful ejaculation. Ejaculation is what we can see whereas orgasm is what we feel. The presence of ejaculate does not indicate the ability to experience orgasm. Hence, for the purpose of this work we consider orgasm and ejaculation as 2 separate neurobiological phenomena. Aim To review the role of advanced investigative techniques such as perineal ultrasound in the diagnosis and management of ejaculation and ejaculatory dysfunction. Methods We performed a PubMed search for key words individually and in combination: “ejaculation,” “ejaculatory dysfunction,” “delayed ejaculation,” “painful ejaculation,” “retrograde ejaculation,” “perineal ultrasound,” and “transrectal ultrasound.” We also share our local experience using perineal ultrasound in assessing ejaculation. Outcomes Perineal ultrasound can be used as an aid in the investigation of ejaculatory dysfunction. Results Evaluation of ejaculatory function hinges on a detailed psychosexual history and appropriate physical examination. Function of the ejaculatory center in the spine is androgen dependent; thus, hormonal evaluation is an important aspect of the workup. Disorders of ejaculation and orgasm require evaluation of neuromuscular reflexes activated during sexual activity. Dynamic ultrasonographic (US) ejaculatory-orgasmic studies allow for reproducible and detailed descriptions of the sexual response. Transrectal ejaculatory studies are useful in uncovering reasons for lack of antegrade semen emission, especially in men with poor sperm production or after vasectomy. Dynamic US studies contribute clinical utility in its non-invasive nature and can provide insight to the dynamic processes surrounding pelvic floor functioning in men. Conclusions Perineal US for men with delayed ejaculation or anejaculation, painful ejaculation, or retrograde ejaculation may be helpful in select cases. Further research using this modality may help advance our understanding of ejaculatory dysfunction. Forbes CM, Flannigan R, Paduch DA. Perineal Ultrasound: a Review in the Context of Ejaculatory Dysfunction. Sex Med Rev 2018;6:419–428.

Introduction Current sex therapy and sexual medicine protocols often ignore the existential dilemmas associated with sexual dysfunction and other problematic sexual problems. This oversight is especially apparent when assessing and treating the controversial phenomenon of hypersexuality, or “sexual addiction.” A deeper understanding of the existential concept of death anxiety could offer an alternative treatment paradigm that might lead to a more effective treatment outcome. Aim To explore the relation between the existential phenomenon of death anxiety and hypersexuality (ie, sexual addiction) and present an evaluation and treatment paradigm that is rooted in existential psychotherapy, a form of psychotherapy that is a deeply life-affirming and dynamic approach to therapy that focuses on concerns rooted in the individual’s existence. Methods A review of the literature focusing on the topics of hypersexuality, death anxiety, and existential psychotherapy was undertaken and a treatment paradigm is offered. Main Outcome Measures Current treatment protocols for hypersexuality and sexual addiction were reviewed, as were current concepts in existential therapy. These were integrated into an assessment and treatment paradigm. Results Although sexual medicine and traditional sex therapy techniques can often alleviate sexual suffering, there are times when a more in-depth psychotherapy is needed to get to the root cause and ultimate assuagement of the presenting sexual symptoms. Existential psychotherapy is one such form of treatment that allows clinicians to probe the subterranean depths of the human psyche and make meaning of one’s sexual behavior and its vagaries. Conclusion Although certainly not all cases of hypersexuality are precipitated by a confrontation with mortality and death, there are cases in which sex is imbued with meaning as an antidote to the fear of death. Existential therapy is a form of treatment that could be particularly effective in many of these cases. Watter DN. Existential Issues in Sexual Medicine: The Relation Between Death Anxiety and Hypersexuality. Sex Med Rev 2018;6:3–10.

Introduction The process of approval for flibanserin (trade name Addyi) has been associated with controversy since before its approval on August 18, 2015. This argument centered on challenges to the validity of the diagnosis of hypoactive sexual desire disorder in women and the safety and efficacy of the drug. Aim To explore the process of Food and Drug Administration (FDA) approval for flibanserin and delve further into the research, concerns, and various roadblocks to its approval. Methods A literature review was undertaken using the terms flibanserin and hypoactive sexual desire disorder and relevant commentary from supporters and critics regarding the medication and difficulties leading up to approval. Main Outcome Measures Review of the process of FDA approval of a medication to treat hypoactive sexual desire disorder and research published exploring the efficacy and safety of flibanserin. Results Before flibanserin, there were no drugs approved to treat hypoactive sexual desire disorder, which has a reported estimated incidence of 10% of women. For studying the effectiveness of flibanserin, the FDA required satisfying sexual events as the primary end point, although this end point does not measure level of desire or the associated distress. The satisfying sexual event measurement was significant across all three flibanserin trials in premenopausal women, as was an increase in desire according to the Female Sexual Function Index desire domain and a decrease in distress as recorded with the Female Sexual Distress Scale–Revised, Item 13. Safety concerns centered on the incidence of sedation, syncope, hypotension, and the interaction of flibanserin with alcohol and CYP3A4 inhibitors. Additional targeted challenge studies were mandated by the FDA. Conclusion The process of approval of flibanserin was lengthy. This was due in part to it being the first drug in its class and one with no clear guidance on study design from the FDA or roadmap for development and approval. Dooley EM, Miller MK, Clayton AH. Flibanserin: From Bench to Bedside. Sex Med Rev 2017;5:461–469.

Introduction Flibanserin is a postsynaptic 5-HT-1A agonist and 5-HT-2A antagonist for the treatment of generalized acquired hypoactive sexual desire disorder in premenopausal women. Aim To review and evaluate the efficacy and safety of flibanserin. Methods We review and critique the appropriateness of the co-primary and secondary end points used in the flibanserin pivotal trial research program. We review the efficacy and safety parameters of this drug based on the published literature and related sources. Main Outcome Measures Pivotal trial primary and secondary end points and safety profile data from the flibanserin development program. Results Our review identified instances of poor fit of two primary trial pivotal trial end points with the hypoactive sexual desire disorder construct: satisfying sexual events and electronic daily diary assessments of the most intense level of sexual desire experienced each day. Efficacy findings of the flibanserin pivotal trials program were positive for satisfying sexual events, not positive for electronic daily diary assessments of the most intense level of sexual desire experienced, and positive for secondary end points of the Female Sexual Function Index desire domain and overall measurements and the Female Sexual Distress Scale–Revised desire-specific and overall measurements. Safety data from the clinical trial program showed a reasonable safety profile. Conclusion Flibanserin has demonstrated efficacy on appropriate measurements of the hallmarks of hypoactive sexual desire disorder—experience of absent or decreased sexual desire that is persistent over time and distressing—and the safety profile of flibanserin is acceptable. Fisher WA, Pyke RE. Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder. Sex Med Rev 2017:5;445–460.

Introduction The 2 most well-known classification systems that include sexual medicine diagnoses are the International Classification of Diseases and Statistics (ICD) and the Diagnostic and Statistical Manual of Mental Disorders (DSM). Sexual medicine experts from international societies representing an array of disciplines have revised and redefined female sexual dysfunctions (FSDs) to reflect current scientific evidence and the state of the art. Aim To summarize the evidence and interactive and chronological process by which sexual medicine societies’ consensus groups developed the current nomenclature, classifications, and definitions for FSDs. Methods We review the contributions and collaborations of the Fourth International Consultation in Sexual Medicine (ICSM), the International Society for the Study of Women’s Sexual Health (ISSWSH), and the World Association of Sexual Health in conjunction with the World Health Organization. Main Outcome Measures The ICSM and ISSWSH diagnostic systems are contrasted with the DSM classification. We discuss innovations and strengths; relevant evidence regarding epidemiology, etiology, and risk factors; and key differences. We describe how sexual medicine expertise informed FSD codes in the ICD-11 classification. Results ICSM and ISSWSH published evidence-based guidelines on the definitions, nomenclature, and diagnostic criteria for FSD that diverge from the DSM psychiatric compendia. These definitions and nomenclature recommend the separation of female sexual desire and arousal disorders, elaborate on subtypes of arousal problems, broaden the scope of sexual pain definitions, and provide a greater understanding of etiologies and risk factors for FSDs. Conclusions These collaborations among sexual medicine experts and their role in the ICD-11 development process provide confidence that the ICD-11 Sexual Dysfunction codes are based on current scientific evidence for diagnosing and coding FSDs in clinical settings worldwide, can serve as endpoints in clinical trials, and will provide specificity for treatment outcomes for FSD therapies. Parish SJ, Cottler-Casanova S, Clayton AH, et al. The Evolution of the Female Sexual Disorder/Dysfunction Definitions, Nomenclature, and Classifications: A Review of DSM, ICSM, ISSWSH, and ICD. Sex Med 2021;9:36–56.

Introduction Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss. Aim To understand possible mechanisms by which flibanserin may produce weight loss. Methods A literature review was performed using Medline database for relevant publications on the mechanisms of action by which flibanserin may provide weight loss and the links between sexual function and weight management. Main Outcome Measures Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to flibanserin and weight loss. Results Based on flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between flibanserin treatment and weight loss include modulation of peripheral 5-HT2A receptors and factors such as improved mood and improved sleep. Conclusion Mechanisms of flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;7:575–586.

Introduction Sexual function after colorectal surgery is a largely ignored topic. In patients being treated for colon and rectal cancers, the risk of sexual dysfunction after surgery is high and is influenced by multiple factors. Aim To examine the factors involved with sexual dysfunction after colorectal surgery and review gender-specific sexual complaints most reported on in the literature. Methods A comprehensive review of peer-reviewed publications on the topic was performed through a PubMed search. Key search terms and phrases included colorectal surgery, sexual dysfunction, risk factors, cancer, erectile dysfunction, dyspareunia, and counseling. Main Outcome Measures The main outcome measures were gender-specific sexual complaints after colorectal surgery and risk factors involved. Results The type of excision and surgical technique strongly influences sexual dysfunction risk, where newer nerve-preserving techniques seem to be associated with better sexual outcomes in contrast to more extensive surgeries. Adjunctive radiotherapy negatively affects sexual health when combined with surgical resection. The most common postoperative sexual complaints reported by men include erectile dysfunction, ejaculatory dysfunction, and dysorgasmia, whereas for women dyspareunia and poor lubrication are common. Conclusions Sexual morbidity after treatment for colorectal cancer is common and inadequately addressed by healthcare providers in the preoperative setting. Towe M, Huynh LM, El-Khatib F, et al. A Review of Male and Female Sexual Function Following Colorectal Surgery. Sex Med Rev 2019;7:422–429.

Introduction The socio-sexual climate in Western cultures is changing at an astounding rate. Never before have societal expectations about gender roles shifted so radically, transforming our understanding of what it means to be a sexual man or woman today. We have observed that confusion regarding masculine and feminine roles within long-term committed relationships can represent challenges for the treatment of sexual dysfunction. Despite the relevance to sexual medicine, sexual medicine specialists have largely avoided this controversial topic. Aim To review the current literature relating to heterosexual gender roles and sexual intimacy, to offer perspective and context on this issue, and to propose an approach to the man, woman, or couple based in evolutionary theory that we have found useful in our extensive clinical experiences. Methods We reviewed the English-language peer-reviewed literature, primarily from 2000 through 2015, that addressed the impact of heterosexual gender role expression on sexual intimacy in long-term committed relationships. Main Outcome Measures Main outcomes include a review of the applicable literature and an assessment of the literature’s relevance for patients and practitioners of sexual medicine. An alternative context for understanding heterosexual gender expression grounded in evolutionary theory is provided, as is a new treatment perspective based on our work as a sex therapist and an urologist. Results The impact of gender expression on sexual experience might be impossible to ascertain fully because it is difficult to quantify in research, independently and especially in combination. Furthermore, existing research is fraught with challenges and inadequacies. Conclusion Although we acknowledge and affirm the critical importance of gender equality, modern conceptualizations of gender in the literature ignore pertinent evolutionary adaptations and might be minimally applicable to sexual medicine patients. More research is needed. We propose that equality of genders does not necessarily mean similarity of genders, at least in sexual medicine.

Introduction Delayed ejaculation (DE) is a poorly defined disorder that entails the delay or absence of orgasm that results in personal distress. Numerous causes of DE exist, and management must be tailored to the specific etiology to maximize treatment success. Management strategies include psychological and sexual therapy, pharmacotherapy, and penile vibratory stimulation. Aim This article intends to review the pathophysiology and treatment options for DE discussed in the literature to date. Methods A review of the literature was performed to identify and evaluate the existing data on treatment success for the various forms of DE management. Main Outcome Measures Each treatment option was evaluated for method of administration, data supporting its success for DE, and potential risks or side effects. Results Different psychosexual therapy strategies have been described for DE but with limited data to describe efficacy. There is no medication for DE approved by the United States Food and Drug Administration. The quality of evidence supporting the off-label use of medications for DE is low. However, there are numerous medications reported in the literature suggested to treat the condition. Cabergoline and bupropion are the two most commonly used. In addition, penile vibratory stimulation has been described as an adjunct treatment option for DE. Conclusion There are different treatment options reported for DE, all with limited evidence supporting their efficacy. Identifying the etiology of the DE is important to appropriately target therapy. A multimodal approach combining psychosexual therapy with medications and/or penile vibratory stimulation will likely provide the best outcomes.

Introduction Phase-specific diagnoses, such as hypoactive sexual desire disorder, are the norm in sexual medicine. Epidemiologic surveys and clinical trials show the value of this structure for understanding and treating premenopausal sexual dysfunction; however, postmenopausal women have sexual dysfunction in >1 phase, for example, in desire and arousal. Objective To evaluate the evidence for mixed or global sexual dysfunction in women, identify associated comorbidities, and determine the best available treatment. Methods Literature review of epidemiologic surveys and clinical trials to quantitate overlap in sexual dysfunction and render conclusions about treatments. Main Outcome Measures The main outcome measures were the Changes in Sexual Functioning Questionnaire and the Female Sexual Function Index. Results Overlap of sexual dysfunction in women is low to moderate before menopause, but it is high after menopause. Data suggest that clinical trials of postmenopausal women diagnosed with hypoactive sexual desire disorder actually entered patients with mixed or global sexual dysfunction and that benefits were pan-phasic rather than concentrated on desire. Whether local/vaginal products for the genitourinary syndrome of menopause impact all phases of sexual dysfunction is under study. Women treated for breast or gynecologic cancer or taking antidepressants also have global sexual dysfunction. Treatment options are limited but support mindfulness-based cognitive behavioral therapy and others. Other strategies include adding or switching to a serotonin 1A receptor agonist (eg, buspirone, flibanserin), a serotonin 2A receptor antagonist (eg, flibanserin, trazodone), or a norepinephrine-dopamine reuptake inhibitor (eg, bupropion). Elimination of hormonal contraception in premenopausal women and adding hormonal therapies in postmenopausal women may be necessary. Conclusions Practitioners should be alert to overlap of sexual dysfunction in women. Focusing diagnostics and treatment on individual phases of sexual function is appropriate in premenopausal patients, but global sexual dysfunction is more likely in women taking antidepressants or cancer chemotherapy or during and after the menopausal transition. More safe, broadly effective treatments for mixed sexual dysfunction are needed for these populations of women. Pyke RE, Clayton AH. Lumping, Splitting, and Treating: Therapies Are Needed for Women With Overlapping Sexual Dysfunctions. Sex Med Rev 2019;7:551–558.

Background Treatments for colorectal and anal cancers can have a detrimental impact on sexual function. Type of treatment, which may include surgery, radiation, and/or chemotherapy, varies by disease site and severity. Treatment and long-term side effects can impact sexual function and intimacy for patients and their partners. Aim To review the literature regarding treatment for colorectal/anal cancer and its impact on female sexual function, and to provide an assessment of medical outcomes and patient-reported outcomes (PROs) of women with a history of colon, rectal, or anal cancer seeking sexual health treatment. Methods We performed a PubMed search to identify peer-reviewed, English-language articles published between 2008 to 2018, using the following search terms: “colorectal cancer,” or “rectal cancer,” or “anal cancer” and “sexual function,” or “sexual dysfunction.” We also assessed the medical outcomes and PROs from our recent cross-sectional cohort study of 99 women with a history of colon, rectal, or anal cancer seeking sexual health treatment. Main Outcome Measures Sexual function, quality of life, and PROs after colorectal/anal cancer. Results A total of 23 studies were identified. Study designs included 15 cross-sectional survey studies, 5 longitudinal studies, 2 psychoeducational interventions, and 1 pilot study. 10 studies included only women, and 13 included both men and women. The literature and our cohort confirmed that women with colorectal/anal cancer experience changes in sexual function after diagnosis and throughout the continuum of care; however, the scarcity of data in this area indicates a need for additional intervention trials and longitudinal studies. Conclusions Research studies with large sample sizes and long study durations are needed to help us better understand the needs of female survivors of colorectal/anal cancer. Women with colorectal/anal cancer need simple strategies and resources to address concerns of sexual function after cancer treatment. Such interventions have been shown to enhance survivorship and quality of life. Canty J, Stabile C, Milli L, et al. Sexual Function in Women with Colorectal/Anal Cancer. Sex Med Rev 2019;7:202–222.

Introduction Care-seeking for sexual dysfunction is limited by embarrassment, efficacy/safety concerns, and cost. Nutritional supplements (NSs) are low-cost but unproven. Aim To provide hypotheses on whether effective NS combinations for sexual dysfunction can be created following known pharmacology principles and tested with sufficient rigor in Internet-based “exo-clinical” trials (XCTs). Methods PubMed and Google searches were conducted to review the feasibility of XCTs of NS combinations for sexual dysfunction. Findings were synthesized into recommendations for XCTs to treat the most common sexual problems. Main Outcome Measure The hierarchy of references used for making recommendations was controlled clinical trials over uncontrolled trials. The frequency of sexual dysfunction was determined in population-representative national surveys. Results XCTs of cognitive behavioral therapy show conclusive efficacy for anxiety and depression. 5 small XCTs showed efficacy for female sexual dysfunction and erectile dysfunction (ED), and 2 XCTs of NS for other medical problems substantiated feasibility. To test the feasibility of XCTs for the most common forms of sexual dysfunction—ED, hypoactive sexual desire disorder (HSDD), and sexual performance anxiety—protocol outlines were generated for frugal XCTs; the total estimated subject time burden is ≤1 hour. Conclusion An XCT is a cost-effective method of evaluating new treatments, including sexual dysfunction and common mental disorders, if compliance is maintained by regular outreach while minimizing the time burden on subjects and handling consent and privacy issues appropriately. NS combinations might expand the opportunities for relief of sexual dysfunction if formulated with pharmacologically active doses of NS with already supported efficacy and safety. The feasibility of XCTs of NS combinations for sexual dysfunction might be tested most productively in men with ED, in women with HSDD, and in men and women with sexual performance anxiety. Pyke RE. Exo-Clinical Trials of Nutritional Supplements for Sexual Dysfunction: Precedents, Principles, and Protocols. Sex Med Rev 2019;7:251–258.

Introduction 5-Alpha reductase inhibitors (5-ARIs) are widely used in the treatment of benign prostatic hyperplasia (BPH) and androgenic alopecia (AGA). Aim To examine all available data on the effects of 5-ARIs on sexual functioning in AGA treatment and to assess whether 5-ARIs increase the risk of sexual dysfunction. Methods A literature review of publications at PubMed related to the subject was used. Main Outcome Measure We assessed erectile dysfunction, ejaculation impairment, and decreased libido. Results 5-ARIs may cause side effects such as erectile dysfunction, ejaculation problems, and decreased libido in patients. Their long-term impact and precise mechanism have not been clarified. Data from studies on 5-ARIs are important for drug selection and patient counseling. More training and awareness is needed for clinicians and patients to recover many patients from sexual adverse effects. Conclusion 5-ARIs used in the treatment of AGA have well-defined side effects, which can negatively affect sexual life. It is unknown and unpredictable which men using these drugs may be subject to these side effects and when these effects may appear. Studies have been insufficient to provide a clear answer to this question. Coskuner ER, Ozkan B, Culha MG. Sexual Problems of Men With Androgenic Alopecia Treated With 5-Alpha Reductase Inhibitors. Sex Med Rev 2019;7:277–282.

Background Regarding hypoactive sexual desire disorder (HSDD) in women, some reviewers judge the effect size small for medications vs placebo, but substantial for cognitive behavior therapy (CBT) or mindfulness meditation training (MMT) vs wait list. However, we lack comparisons of the effect sizes for the active intervention itself, for the control treatment, and for the differential between the two. Aim For efficacy trials of HSDD in women, compare effect sizes for medications (testosterone/testosterone transdermal system, flibanserin, and bremelanotide) and placebo vs effect sizes for psychotherapy and wait-list control. Methods We conducted a literature search for mean changes and SD on main measures of sexual desire and associated distress in trials of medications, CBT, or MMT. Effect size was used as it measures the magnitude of the intervention without confounding by sample size. Outcomes Cohen d was used to determine effect sizes. Results For medications, mean (SD) effect size was 1.0 (0.34); for CBT and MMT, 1.0 (0.36); for placebo, 0.55 (0.16); and for wait list, 0.05 (0.26). Clinical Translation Recommendations of psychotherapy over medication for treatment of HSDD are premature and not supported by data on effect sizes. Active participation in treatment conveys considerable non-specific benefits. Caregivers should attend to biological and psychosocial elements, and patient preference, to optimize response. Conclusions Few clinical trials of psychotherapies were substantial in size or utilized adequate control paradigms. Medications and psychotherapies had similar, large effect sizes. Effect size of placebo was moderate. Effect size of wait-list control was very small, about one quarter that of placebo. Thus, a substantial non-specific therapeutic effect is associated with receiving placebo plus active care and evaluation. The difference in effect size between placebo and wait-list controls distorts the value of the subtraction of effect of the control paradigms to estimate intervention effectiveness. Pyke RE, Clayton AH. Effect Size in Efficacy Trials of Women With Decreased Sexual Desire. Sex Med Rev 2018;6:358–366.

Background Pelvic surgeries are recognized to cause dysfunction of the male sexual response, which consists of erection, emission, expulsion, and orgasm. However, the least attention has been paid to male orgasmic dysfunction after invasive pelvic surgery. Aim To describe the available literature on post-pelvic surgery orgasmic dysfunction disorders. Methods A literature search was performed on PubMed using the search strings related to dysfunction of the male sexual cycle and orgasm after pelvic surgery. Outcomes Orgasmic dysfunction after pelvic procedures in urologic, colorectal, and vascular surgeries was assessed. Results Radical prostatectomy was the most common procedure where orgasmic dysfunction was quantified. Anorgasmia post-operatively occurred in patients in a range of 5–70%. Dysorgasmia occurred less frequently from 7–14%. The prevalence of climacturia was highly variable occurring in 20–93% of patients. Radical cystectomy resulted in anorgasmia 33–62% of the time and climacturia ranged from 6–45%. Studies involving colorectal surgeries were less likely to assess for dysorgasmia and climacturia, but anorgasmia rates ranged from 0–52%. Most current studies do not differentiate between ejaculatory and orgasmic dysfunction. However, more recent studies have started to distinguish between the 2 disorders and publish more specific data on what components of the male sexual response has been affected by the specific surgery. Conclusions The male sexual response, specifically the male orgasm, is difficult to quantify in a non-obtrusive setting and can exhibit variability between patients and between sexual encounters in the same patient. Data involving the outcome of male orgasmic dysfunction after pelvic surgery are sparse, limiting health professionals’ ability to appropriately counsel patients. Future work needs to standardize outcome assessment for orgasmic disorders, which, in turn, can be used across all surgical specialties. Haney NM, Alzweri LM, Hellstrom WJG. Male Orgasmic Dysfunction Post-Radical Pelvic Surgery. Sex Med Rev 2018;6:429–437.

Background Female sexual dysfunction (FSD) is a highly prevalent condition. Nevertheless, the scientific literature has only recently begun to accumulate evidence for treatment modalities that address the underlying etiologies of FSD. Aim The purpose of this systematic review is to elucidate what treatments are effective across the various symptom complexes of FSD. Methods Utilizing Meta-analysis of Observational Studies in Epidemiology guidelines, we conducted a systematic review of PubMed, EMBASE, clinicaltrials.gov , and the Cochrane Review databases. Eleven search strings, encompassing the terms “female sexual dysfunction” and “treatment,” in combination with “vulvovaginal atrophy,” “vaginismus,” “vaginal atrophy,” “vulvodynia,” “vestibulitis,” “hypoactive sexual desire,” “arousal disorder,” “sexual pain disorder,” “genitourinary syndrome of menopause,” and “orgasmic disorder” were utilized. 605 Relevant articles were retrieved. A total of 103 original studies met inclusion criteria. Outcomes We assess peer-reviewed literature. Results 42 Treatment modalities were utilized, including 26 different classes of medications. Although outcome measures varied, the most substantial improvement across multiple studies was noted with various hormonal regimens. The most common treatments included hormonal therapy (25 studies), phosphodiesterase type-5 inhibitors (9 studies), botulinum toxin A (5 studies), and flibanserin (5 studies). The psychotherapeutic approach was detailed in 36 articles while 3 studies utilized homeopathic treatments. Numerous treatments showed efficacy in a single case series, including the promising results associated with the micro-ablative carbon-dioxide laser. Despite the marked improvement in specific FSD domains, neither pharmacologic treatments nor psychotherapeutic interventions demonstrate consistent disease resolution. Conclusions Treatment of FSD is multi-factorial; medications alone do not resolve FSD. The wide variability of treatment and outcome measures across the literature attests to the complexity of FSD and the need for a treatment algorithm that addresses all 4 domains of FSD. Weinberger JM, Houman J, Caron AT, et al. Female Sexual Dysfunction: A Systematic Review of Outcomes Across Various Treatment Modalities. Sex Med Rev 2019;7:223–250.

Introduction Childhood sexual abuse (CSA) has been identified as a potent risk factor for sexual dysfunction. Certain characteristics of the abuse experience, such as repeated abuse, appear to affect the risk of developing sexual dysfunction. Despite the robust findings that CSA can be detrimental to sexual function, there is little consensus on the exact mechanisms that lead to these difficulties. Aim To summarize the most up-to-date research on the relation between CSA and women's sexual function. Methods The published literature examining the prevalence of sexual dysfunction among women with CSA histories, various types of sexual dysfunctions, and mechanisms proposed to explain the relation between CSA and later sexual difficulties was reviewed. Main outcome measures Review of peer-reviewed literature. Results Women with abuse histories report higher rates of sexual dysfunction compared with their non-abused peers. The sexual concerns most commonly reported by women with abuse histories include problems with sexual desire and sexual arousal. Mechanisms that have been proposed to explain the relation between CSA and sexual dysfunction include cognitive associations with sexuality, sexual self-schemas, sympathetic nervous system activation, body image and esteem, and shame and guilt. Conclusion Women with CSA histories represent a unique population in the sexual health literature. Review of mechanisms proposed to account for the relation between CSA and sexual health suggests that a lack of positive emotions related to sexuality, rather than greater negative emotions, appears to be more relevant to the sexual health of women with CSA histories. Treatment research has indicated that mindfulness-based sex therapy and expressive writing treatments are particularly effective for this group. Further research is needed to clarify the mechanisms that lead to sexual dysfunction for women with abuse histories to provide more targeted treatments for sexual dysfunction among women with abuse histories. Pulverman CS, Kilimnik CD, Meston CM. The Impact of Childhood Sexual Abuse on Women's Sexual Health: A Comprehensive Review. Sex Med Rev 2018;6:188-200.

Introduction Erectile dysfunction is recognized as an opportunity for preventing cardiovascular (CV) events, and assessing the impairment of penile vascular flow by Doppler ultrasound is an important tool to ascertain CV risk. Conversely, the role of genital vascular impairment in the pathophysiology of female sexual dysfunction (FSD) remains contentious. Aim To focus on the current scientific support for an association between CV risk factors and female sexual health in the 1st part of a 2-part review. Methods A thorough literature search of peer-reviewed publications on the associations between CV risk factors and FSD and their underlying mechanisms was performed using the PubMed database. Main Outcome Measures We present a summary of the evidence from clinical studies and discuss the possible mechanisms providing the pathophysiologic bases of vasculogenic FSD syndromes. Results The peripheral sexual response in women is a vascular-dependent event, and evidence suggests that cardiometabolic-related perturbations in endothelial function can determine vascular insufficiency in female genital tissues. Although epidemiologic and observational studies demonstrate that the prevalence of FSD is higher in women with diabetes mellitus, a cause-effect relation between these clinical conditions cannot be assumed. Evidence on the effect of obesity, metabolic syndrome, and polycystic ovary syndrome on sexual function in women is controversial. Data on the associations of dyslipidemia and hypertension with FSD are limited. Conclusion Common cardiometabolic alterations could affect vascular function in the female genital tract. Based on limited data, there is an association between CV risk factors and female sexual health in women; however, this association appears milder than in men. Maseroli E, Scavello I, Vignozzi L. Cardiometabolic Risk and Female Sexuality—Part I. Risk Factors and Potential Pathophysiological Underpinnings for Female Vasculogenic Sexual Dysfunction Syndromes. Sex Med Rev 2018;6:508–524.

Introduction Muslim women are an increasingly underserved population in the United States and worldwide. Diagnosis and treatment of female sexual dysfunction bring unique challenges because of the conservative nature of those practicing the religion. Several cultural and religious codes of conduct affect sexual behavior and the dysfunction that can ensue. Aim To assess and describe the types of sexual dysfunction that have been found in Muslim women internationally and encourage a better understanding of their issues to enhance health care delivery. Methods A comprehensive review of the literature through Ovid and PubMed was performed in search of articles reviewing female sexual dysfunction, Muslim women, and Islam. Main Outcome Measures A brief explanation and review of the interpretations of sexuality within Islam are discussed. The link is made between conservative sexual relations and interpretations and the types of sexual dysfunction experienced. Female sexual dysfunction is explored in relation to how female chastity is extolled and how cultural procedures continue despite the ethical and health concerns related to them. Results Most Muslim women experience sexual dysfunction similar to other women, including arousal, desire, and orgasmic disorders related to organic and psychologic factors. Sexual pain disorders might be more prevalent in this population, particularly concerning unconsummated marriage. There are special concerns related to maintaining virginity and preserving the hymen until marriage. Female genital cutting, practiced by some Muslim countries, has potential sexual consequences. Conclusion Understanding Islamic views on sexuality and how they can affect sexual dysfunction in Muslim women is critical in opening lines of communication with patients and approaching female sexual dysfunction impartially. Although some issues that arise might introduce ethical dilemmas for the provider, having the cultural competence to address these issues will facilitate improved health care delivery. Rahman S. Female Sexual Dysfunction Among Muslim Women: Increasing Awareness to Improve Overall Evaluation and Treatment. Sex Med Rev 2018;6:535–547.

Background At midlife and beyond, both men and women face organic changes that can affect sexual functioning. For women, ovarian exhaustion causes estrogen deficiency, leading to genitourinary syndrome of menopause, which may include vaginal dryness, irritation/itching, inadequate lubrication, and dyspareunia. Hypoactive sexual desire disorder also can result from biopsychosocial factors. For men, erectile dysfunction prevalence increases with age, and some men develop testosterone deficiency. Aim In this narrative review, we summarize the literature on how menopause and andropause can affect the sexual health of both the patient and partner and describe a new paradigm (“couplepause”) for addressing the sexual health needs of the aging couple as a whole. Methods We combined a literature review conducted using PubMed with insights garnered from our own clinical experiences. Outcomes We reviewed publications relating to couples-based approaches to sexual dysfunction, male perceptions of female sexual dysfunction, female perceptions of male sexual dysfunction, interactions between male and female sexual dysfunctions, sexual dysfunction and midlife changes in homosexual couples, and impact of pharmacologic treatments for sexual dysfunctions on the couple’s sexual health. Results Both members of a couple may experience age-related changes concurrently and interdependently. In such cases, it is unhelpful, and sometimes detrimental, to treat the symptoms for only one member of the couple without also treating the other. Therefore, as an evolution of the couple-oriented approaches of Masters and Johnson and others, we introduce the concept of couplepause and the need for a new diagnostic and therapeutic paradigm that addresses the sexual health needs of the aging couple as a whole rather than treating the individual patient in isolation. Conclusion Taking a couple-oriented approach to evaluate and manage couplepause in the latter half of life can dramatically and simultaneously help both members of the couple to improve sexual satisfaction and intimacy. Jannini EA, Nappi RE. Couplepause: A New Paradigm in Treating Sexual Dysfunction During Menopause and Andropause. Sex Med Rev 2018;6:384–395.

Introduction Despite the growing popularity of traditional Chinese medicine (TCM) in the Western world, biomedical students and practitioners struggle to understand TCM and how it relates to their standard diagnosis and treatment practices. Aims To describe the fundamentals of TCM theory and practice relevant to sexual dysfunction; to review and critique the current state of TCM research within Western biomedical literature; and to identify sites for improvement of future research and for collaborative integration of TCM and biomedicine in practice. Methods Information about TCM from an insider perspective was obtained from English-language textbooks and lectures intended to teach Western students its theory and practice. PubMed search using Medical Subject Heading terms for Western sexual diagnoses and TCM treatments was performed in April and October 2017 to represent the evidence for TCM in Western biomedical literature. Articles in non-English languages and without human subjects were excluded. Main Outcome Measures 27 studies were included in this review. The most commonly studied intervention was acupuncture. An equal number of studies addressed sexual dysfunction in men and women, but only women were included in studies of physically passive mindfulness meditation. Results Compared with Western biomedicine, TCM offers a more interdisciplinary and individualized approach to disease and its treatment. This embrace of individual idiosyncrasy in diagnosis and treatment presents a challenge to Western biomedical research norms that rely almost exclusively on quantitative methods that compare large and homogeneous groups with a fixed diagnosis and treatment regimen. Conclusion TCM offers a very different understanding of the human body, health, and disease from Western biomedicine. There is value in the study and application of these 2 medical systems, particularly for biopsychosocial problems of sexual dysfunction. However, this must be done cautiously, with attention to appropriate study design, to avoid shallow and unscientific cultural appropriation of TCM practices. Chubak B, Doctor A. Traditional Chinese Medicine for Sexual Dysfunction: Review of the Evidence. Sex Med Rev 2018;6:410–418.

Introduction Post-orgasmic illness syndrome (POIS) is a rare but debilitating cluster of postejaculatory symptoms affecting men. It is a chronic disorder manifesting as a constellation of flulike and allergic symptoms within seconds, minutes, or hours after ejaculation. POIS can be followed by mental sequelae such as diminished concentration and irritability. POIS negatively affects the life of patients by limiting sexual encounters, dampening romantic prospects, creating internal struggles to avoid eroticism, and affecting patients' schedules. First described in 2002, the prevalence and incidence of POIS are still unknown owing to a paucity of studies but is likely under-reported. There are approximately 50 cases of POIS in the literature. Despite the debilitating effects of POIS, the pathophysiology of POIS is still not well elucidated. Aim To provide an update on the current literature on POIS, provide updated information on the pathophysiology of POIS, and discuss potential management options. Methods Comprehensive review of literature pertaining to POIS. Main outcome measures The symptoms, classification, pathophysiology, diagnostic considerations, and management of POIS were reviewed. Results There are 5 preliminary diagnostic criteria for diagnosing this condition. POIS is categorized as primary or secondary. The autoimmune-allergy hypothesis is the most accepted hypothesis explaining the pathogenesis of POIS. A competing hypothesis involves a disorder involving endogenous μ-opioid receptors. Another hypothesis invokes impairment of the cytokine and neuroendocrine responses. There are no known treatment modalities for POIS; patients have been symptomatically treated with antihistamines, selective serotonin reuptake inhibitors, and benzodiazepines. A trial of hyposensitization therapy with autologous semen was successful. A trial of non-steroidal anti-inflammatory medication helped 1 patient described in a single case report, but failed to successfully treat other patients. Conclusions POIS is a rare condition that is underdiagnosed and under-reported. Further studies are warranted to investigate the prevalence, pathophysiology, and treatment of this debilitating condition. Nguyen HMT, Bala A, Gabrielson AT, Hellstrom WJG. Post-Orgasmic Illness Syndrome: A Review. Sex Med Rev 2018;6:11-15.

Introduction Recent advances in neuroimaging offer an unprecedented window into the female sexual brain. The small samples and poor statistical power of individual functional magnetic resonance imaging studies have limited what can be gleaned about the systematic brain network that is involved in female sexual desire and female sexual dysfunction (eg, hypoactive sexual desire disorder [HSDD]). Aim To quantitatively determine the brain network involved in HSDD. Methods Systematic retrospective review and statistical meta-analysis of pertinent neuroimaging literature. Main Outcome Measures Review of published literature on functional magnetic resonance imaging studies illustrating brain regions associated with female sexual desire and female HSDD. Results HSDD is associated with a specific fronto-limbic-parietal dysfunction characterized by (i) lower blood oxygen level-dependent responses in the sexual desire brain network and (ii) higher blood oxygen level-dependent responses in the self-referential brain network. Conclusion The meta-analytic results are in line with a top-down neurofunctional model of HSDD in which inspecting, monitoring, and evaluating oneself (rather than sensory experience) before or during sexual activities interfere with sexual desire. These results raise new questions regarding the necessity and sufficiency of dysfunctional activation in the sexual desire and self-referential brain networks, whose answers bear on the development and evaluation of personalized treatments for HSDD. Cacioppo S. Neuroimaging of Female Sexual Desire and Hypoactive Sexual Desire Disorder. Sex Med Rev 2017;5:434–444.

Introduction Urinary incontinence (UI) and sexual dysfunction are common conditions often undiagnosed and untreated in women and are associated with decreased quality of life. Aim To evaluate the relation between UI and female sexual dysfunction (FSD), considering incontinence type and the psychosocial and physiologic aspects of sexual function. Methods PubMed search of terms related to UI and FSD from 1979 to 2016 generated 603 published references, of which 26 were included. Nine additional studies came from bibliographic review. Main Outcome Measure Rates and types of sexual dysfunction. Results In cross-sectional and case-control studies, UI was associated with increased rates and severity of FSD. Coital UI occurred in 24% to 66% of women with UI. Impaired body image, fear of coital UI, avoidance of sex, and complete abstinence were more common in women with UI. Deficits in desire, lubrication, satisfaction, and increased pain were found across numerous studies. Mixed UI was associated with more FSD than urgency UI and stress UI. Multiple studies suggest urgent UI is more bothersome than stress UI. Coital UI was associated with a urodynamic diagnosis other than genuine stress incontinence in 25% to 50%. Leakage at penetration was associated with stress UI; leakage at orgasm was associated more often with detrusor overactivity. Conclusion Women's UI is associated with increased rates of sexual dysfunction, suggesting concurrent screening is warranted. Clarifying timing of coital leakage would facilitate targeted treatment. Standardization of FSD measurements could better elucidate the relation between UI and FSD. Duralde ER, Rowen TS. Urinary Incontinence and Associated Female Sexual Dysfunction. Sex Med Rev 2017;5:470–485.

Introduction Sexual dysfunctions are well-known side effects of selective serotonin reuptake inhibitor (SSRI) use. Altered libido, erectile dysfunction, vaginal dryness, ejaculatory disorders, and orgasmic problems are frequently reported by patients treated with SSRIs. Moreover, these antidepressant-emergent sexual dysfunctions do not always resolve after discontinuation of the medication and can persist indefinitely. These complaints are termed post-SSRI sexual dysfunctions (PSSD). Aim To examine the existence of this clinical entity, possible theoretical mechanisms, possible risk factors, and possible treatment modalities. Methods Through literature research and clinical experience, the available information about PSSD is reviewed. Main Outcome Measures Summary of the current literature with insights into possible causes and management options. Results There are some indications that antidepressant-emergent sexual dysfunctions do not always resolve after discontinuation of the medication and can persist indefinitely in some individuals. Although some or all sexual side effects that start with the use of SSRIs might continue after stopping the medication, other sexual complaints can develop. Decreased capacity to experience sexual pleasure is the most frequent characteristic of this syndrome. Conclusion The research and understanding of PSSD remain limited and not well understood; however, the data support the existence of PSSD, which can have a substantial effect on the quality of life of these patients. More research is warranted to show the cause and possible mechanisms of PSSD that could lead to the correct diagnosis and treatment. Reisman Y. Sexual Consequences of Post-SSRI Syndrome. Sex Med Rev 2017;X:XXX–XXX.

Introduction Persistent genital arousal disorder (PGAD) is a condition characterized by symptoms of physiologic (typically genital) sexual arousal in the absence of perceived subjective sexual arousal. The physiologic arousal can last hours or days, or it can occur constantly, and it does not typically remit after orgasm(s). The symptoms are usually described as distressing, intrusive, and unwanted. Aim To review the available literature on PGAD. Methods A literature review through April 2016 was undertaken using terms persistent genital arousal disorder, persistent sexual arousal syndrome, and restless genital syndrome. Main Outcome Measures The main outcome is a review of the conceptualization of PGAD, its prevalence, proposed etiologies and treatments, and its impact on psychosocial and sexual functioning. Results Much of the research on the potential etiologies and treatments of PGAD is published in the form of case studies. Several etiologies of PGAD have been proposed; however, a cause or causes have not been confirmed. A range of treatments has been explored primarily in case studies, from electroconvulsive therapy to oral medication, with variable success rates. Psychologically based treatments have been suggested but have yet to be evaluated. Online surveys have found initial evidence supporting the negative impact of PGAD on mental health and sexual functioning; however, more research is needed in this area. Conclusion Although PGAD was first conceptualized 15 years ago, it remains a very under-researched condition. Currently, little is known about its biopsychosocial correlates, etiologies, or successful treatments. Future research directions are identified.

Introduction Hypoactive Sexual Desire Disorder (HSDD) is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Revised (DSM-IV-TR) as persistent deficient sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty. In the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-5), HSDD has been subsumed by Female Sexual Interest/Arousal Disorder. However, decades of research based on DSM-IV-TR HSDD criteria form the foundation of our understanding of the essential symptom of distressing low sexual desire, its epidemiology, clinical management, and treatment. Aim This publication reviews the state of knowledge about HSDD. Methods A literature search was performed using terms HSDD and female sexual dysfunction (FSD). Main Outcome Measures Physicians acknowledge that FSD is common and distressing; however, they infrequently address it, citing low confidence, time constraints, and lack of treatment as barriers. Results HSDD is present in 8.9% of women ages 18 to 44, 12.3% ages 45 to 64, and 7.4% over 65. Although low sexual desire increases with age, distress decreases; so prevalence of HSDD remains relatively constant across age. HSDD is associated with lower health-related quality of life; lower general happiness and satisfaction with partners; and more frequent negative emotional states. HSDD is underdetected and undertreated. Less than half of patients with sexual problems seek help from or initiate discussions with physicians. Patients are inhibited by fear of embarrassing physicians and believe that physicians should initiate discussions. The Decreased Sexual Desire Screener, a tool for detecting and diagnosing HSDD, is validated for use in general practice. Conclusion Women can benefit from intervention in primary care, behavioral health and sexual medicine settings. Psychotherapeutic and pharmacological interventions aim to enhance sexual excitatory process and decrease inhibitory processes. Flibanserin, the first centrally acting daily medication for HSDD, was recently approved in the US for premenopausal women.