What Women Want? The State of the Art regarding the Treatment of Young Women with Hypoactive Sexual Desire Disorder.

BACKGROUND: Hypoactive sexual desire disorder (HSDD) in premenopausal women involves biological, psychological, and social aspects. In the European Society for Sexual Medicine meeting in Rotterdam in February 2023, several leading experts in the field discussed the multifaceted nature of this disorder and the state of the art regarding treatment at a round table. This review reflects the information discussed at this event and further discusses current controversies. SUMMARY: HSDD is the most prevalent female-estimated sexual disorder reported by 28% of the 40% premenopausal women with sexual dysfunction. Flibanserin and bremelanotide are the only approved medications to treat HSDD in the USA, and none are approved in Europe. Lybrido, Lybridos, and Lorexys are under development. There are several psychological factors with impact in sexual desire, including depression and sexual abuse. Feminine sexual scripts, the pleasure gap, and structural inequalities also affect sexual desire. Evidence strongly supports the value of combining medical and psychological approaches in the treatment of HSDD, but there is ongoing controversy regarding the pharmacological treatment of young women with HSDD. However, some women seem open and would like to have access to drug treatment. KEY MESSAGES: The treatment of HSDD in young women requires a mixed treatment approach that addresses the disorder's complexity. Despite clinicians seeming to be divided between using pharmacological and/or psychosocial approaches, some women might respond better to one type of intervention over the others. This calls for the development of tools that assess the best approach for each person, including their will and informed choice.

The role of testosterone in male sexual function.

Sexual function, and testosterone (T) levels, progressively decline in aging men. Associated morbidities and metabolic disorders can accelerate the phenomenon. The specific contribution of low T to sexual function impairment in aging men has still not been completely clarified. Similarly, the role of T replacement therapy (TRT), as well as the combination of TRT with phosphodiesterase type 5 inhibitors (PDE5i) for patients with erectile dysfunction (ED), is still conflicting. Here we aim to summarize and critically discuss all available data supporting the contribution of low T to sexual impairment observed with aging as well as the possible role of TRT. Available data on men with sexual dysfunction show that reduced sexual desire is the most important correlate of male hypogonadism. Conversely, aging and associated morbidities substantially attenuate the relationship between ED and T. TRT is effective in improving sexual function in middle-aged and older subjects but its role is small and extremely variable. Lifestyle interventions can result in similar outcomes to those of TRT. In conclusion, it is our opinion that PDE5i along with lifestyle measures should be considered the first approach for treating ED even in subjects with milder T deficiency. When these interventions fail or are difficult to apply, TRT should be considered.

Diabetes is most important cause for mortality in COVID-19 hospitalized patients: Systematic review and meta-analysis.

The presence of SARS-CoV-2 was officially documented in Europe at the end of February 2020. Despite many observations, the real impact of COVID-19 in the European Union (EU), its underlying factors and their contribution to mortality and morbidity outcomes were never systematically investigated. The aim of the present work is to provide an overview and a meta-analysis of main predictors and of country differences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-associated mortality rate (MR) in hospitalized patients. Out of 3714 retrieved articles, 87 studies were considered, including 35,486 patients (mean age 60.9 ± 8.2 years) and 5867 deaths. After adjustment for confounders, diabetes mellitus was the best predictors of MR in an age- and sex-dependent manner, followed by chronic pulmonary obstructive diseases and malignancies. In both the US and Europe, MR was higher than that reported in Asia (25[20;29] % and 20[17;23] % vs. 13[10;17]%; both p < 0.02). Among clinical parameters, dyspnea, fatigue and myalgia, along with respiratory rate, emerged as the best predictors of MR. Finally, reduced lymphocyte and platelet count, along with increased D-dimer levels, all significantly contributed to increased mortality. The optimization of glucose profile along with an adequate thrombotic complications preventive strategy must become routine practice in diseased SARS-CoV-2 infected patients.

Sex Disparities in COVID-19 Severity and Outcome: Are Men Weaker or Women Stronger?

The coronavirus disease 2019 (COVID-19) outbreak, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global public health issue which has profound effects on most aspects of societal well-being, including physical and mental health. A plethora of studies globally have suggested the existence of a sex disparity in the severity and outcome of COVID-19 patients, mainly due to mechanisms of virus infection, immune response to the virus, development of systemic inflammation, and consequent systemic complications, particularly thromboembolism. Epidemiological data report a sex difference in the severity of COVID-19, with a more favorable course of the disease in women compared to men regardless of age, although the rate of SARS-CoV-2 infection seems to be similar in both sexes. Sex hormones, including androgens and estrogens, may not only impact virus entry and load, but also shape the clinical manifestations, complications, and ultimately the outcome of the disease. The current review comprehensively summarizes the current literature on sex disparities in susceptibility and outcome of COVID-19 as well as the literature underpinning the pathophysiological and molecular mechanisms, which may provide a rationale to a sex disparity. These mechanisms include sex hormone influence on factors that facilitate virus entry and priming, immune and inflammatory response, as well as coagulation and thrombosis diathesis. Based on present evidence, women appear to be relatively protected from COVID-19 because of a more effective immune response and a less pronounced systemic inflammation, with consequent moderate clinical manifestations of the disease, together with a lesser predisposition to thromboembolism. Conversely, men appear to be particularly susceptible to COVID-19 because of a less effective immune response with consequent severe clinical manifestations of the disease, together with a greater predisposition to thromboembolism. In the elderly, generally characterized by the phenomenon of inflammaging, sex disparities in overall mortality following SARS-CoV-2 infection are even more palpable as elderly men appear to be more prone to severe COVID-19 because of a greater predisposition to infections, a weaker immune defense, and an enhanced thrombotic state compared to women. The information revealed from the review highlights potential novel therapeutic approaches employing the administration of hormonal or antihormonal therapy in combination with antiviral drugs in COVID-19 patients.

Self-Reported Shorter Than Desired Ejaculation Latency and Related Distress-Prevalence and Clinical Correlates: Results From the European Male Ageing Study.

BACKGROUND: Few data have looked at the occurrence and clinical correlates of self-reported shorter than desired ejaculation latency (rapid ejaculation, RE) and its related distress in the general population. AIM: To determine the prevalence and clinical correlates of self-reported RE and RE- related distress in middle age and older European men. METHODS: Subjects were recruited from population samples of men aged 40-79 years across 8 European centers. OUTCOMES: Self-reported RE and its related distress were derived from the European male Aging Study (EMAS) sexual function questionnaire (EMAS-SFQ). Beck's depression Inventory (BDI) was used for the quantification of depressive symptoms, the Short Form 36 health survey (SF-36) for the assessment of the quality of life, the International Prostate Symptom Score (IPSS) for the evaluation of lower urinary tract symptoms. RESULTS: About 2,888 community dwelling men aged 40-79 years old (mean 58.9 ± 10.8 years) were included in the analysis. Among the subjects included, 889 (30.8%) self-reported RE. Among them, 211 (7.3%) claimed to be distressed (5.9% and 1.4% reported mild or moderate-severe distress, respectively). Increasing levels of RE-related distress were associated with a progressive worse sexual functioning, higher risk of ED and with couple impairment, along with a higher prevalence of depressive symptoms (all P < 0.05). Furthermore, a worse quality of life and higher IPSS score were associated with RE-related distress (all P < 0.05). The aforementioned results were confirmed even when patients using drugs possibly interfering with ejaculation or those without a stable relationship were excluded from the analysis. CLINICAL IMPLICATIONS: RE is a frequent condition in men from the general population; however, its related distress is relatively modest. Nonetheless, men with any degree of self-reported RE show increasing levels of depression, worse quality of life and worse couple satisfaction. STRENGTHS & LIMITATIONS: This is the first study estimating the prevalence of self-reported RE and its related distress, along with their biological and psychological correlates, in a population sample of European middle age and older men. However, is should be recognized that the diagnosis of RE was derived from patient reports and not supported by Intra-ejaculatory-Latency-Time (IELT) measurements. CONCLUSION: Self-reported RE is relatively common in European men aged more than 40 years. The reported limited RE-related distress may explain the relatively low number of medical consultations for RE. RE-related distress is associated with worse sexual function, couple impairment, and more LUTS resulting in a worse quality of life and mood disturbances. Corona G, Rastrelli G, Bartfai G, et al. Self-Reported Shorter Than Desired Ejaculation Latency and Related Distress-Prevalence and Clinical Correlates: Results From the European Male Ageing Study. J Sex Med Rev 2021;18:908-919.

Erectile Dysfunction and Decreased Libido in Klinefelter Syndrome: A Prevalence Meta-Analysis and Meta-Regression Study.

BACKGROUND: Only few studies have assessed sexual dysfunction in men with Klinefelter syndrome (KS). AIM: To define pooled prevalence estimates and correlates of erectile dysfunction (ED) and decreased libido (DL) in KS. METHODS: A thorough search of Medline, Embase and Web of Science was performed to identify suitable studies. Quality of the articles was scored using the Assessment Tool for Prevalence Studies. Data were combined using random effect models and the between-studies heterogeneity was assessed by the Cochrane's Q and I2. The sources of heterogeneity were investigated by meta-regression and sub-group analyses. Funnel plot, Begg's rank correlation and trim-and-fill test were used to assess publication bias. MAIN OUTCOME MEASURE: The pooled prevalence of ED and DL in KS as well as 95% confidence intervals (CIs) were estimated from the proportion of cases of sexual dysfunction and the sample size. Variables that could affect the estimates were identified by linear meta-regression models. RESULTS: Sixteen studies included collectively gave information about ED and DL in 482 and 368 KS men, respectively, resulting in a pooled prevalence of 28% (95% CI: 19%-36%) for ED and 51% (95% CI: 36%-66%) for DL, with a large heterogeneity. The trim-and-fill adjustment for publication bias produced a negligible effect on the pooled estimates. At the meta-regression analyses, a higher prevalence of ED was significantly associated with an older age but not with lower testosterone levels. In series with a mean age >35 years, the ED prevalence estimate increased up to 38% (95% CI: 31%-44%) with no heterogeneity (I2=0.0%, P=0.6). On the contrary, the prevalence of DL increased significantly as testosterone levels decreased, without a significant relationship with age. CLINICAL IMPLICATIONS: While DL would largely reflect an androgen deficiency, in older men with KS, erectile function should be assessed irrespective of testosterone levels. STRENGTH & LIMITATIONS: This is the first meta-analysis defining pooled prevalence estimates and correlates of ED and DL in KS. Nevertheless, caution is required when interpreting results, due to the high risk of bias in many studies, as well as the dearth of data about psychosocial and/or psychosexological variables and age at the diagnosis. CONCLUSIONS: ED and DL represent common clinical complaints in KS. While the prevalence of ED would increase with age, DL gets more common as serum testosterone decreases. Further studies are warranted to elucidate the pathogenetic mechanism(s) underlying the age-dependent increase in the prevalence of ED, apparently unrelated to the androgenic status. A Barbonetti, S D'Andrea, W Vena, et al. Erectile Dysfunction and Decreased Libido in Klinefelter Syndrome: A Prevalence Meta-Analysis and Meta-Regression Study. J Sex Med 2021;18:1054-1064.

Recommendations on the diagnosis, treatment and monitoring of testosterone deficiency in men.

The relative proportional increase of the elderly population within many countries will become one of the most significant social transformations of the twenty-first century and, for the first time in history, persons aged 65 or above outnumbered children under five years of age globally. One in four persons living in Europe and Northern America will be aged 65 or over. One of the goals of ISSAM is to raise awareness of the special health needs of older men. Since a significant number of aging men will eventually become testosterone deficient, the Hypogonadism panel of ISSAM updates its guidelines.

Metabolic Syndrome and Reproduction.

Metabolic syndrome (MetS) and infertility are two afflictions with a high prevalence in the general population. MetS is a global health problem increasing worldwide, while infertility affects up to 12% of men. Despite the high prevalence of these conditions, the possible impact of MetS on male fertility has been investigated by a few authors only in the last decade. In addition, underlying mechanism(s) connecting the two conditions have been investigated in few preclinical studies. The aim of this review is to summarize and critically discuss available clinical and preclinical studies on the role of MetS (and its treatment) in male fertility. An extensive Medline search was performed identifying studies in the English language. While several studies support an association between MetS and hypogonadism, contrasting results have been reported on the relationship between MetS and semen parameters/male infertility, and the available studies considered heterogeneous MetS definitions and populations. So far, only two meta-analyses in clinical and preclinical studies, respectively, evaluated this topic, reporting a negative association between MetS and sperm parameters, testosterone and FSH levels, advocating, however, larger prospective investigations. In conclusion, a possible negative impact of MetS on male reproductive potential was reported; however, larger studies are needed.

Male and female sexual dysfunction in diabetic subjects: Focus on new antihyperglycemic drugs.

The association between diabetes mellitus (and its micro- and macro-vascular complications) and erectile dysfunction is widely known and the presence of hypogonadism may further complicate sexual dysfunction and quality of life, given the association between hypogonadism and reduced libido, ejaculatory disorders, and depressive symptoms. However, the recent introduction of novel antidiabetic agents with a wide range of mechanism of action may have a significant impact both on male and female sexuality directly (by inducing side effects as urinary tract infections) and indirectly (improving metabolic status and reducing diabetes complications behind sexual dysfunctions). To date only few papers are reporting the sexual effects of these treatments and, often, these are not comparable in their results. Conversely, female sexual dysfunctions are somehow under-investigated. Data on prevalence is heterogeneous and specific pathogenic mechanisms, as well as the burden of psychological factors, are still heatedly debated. The aim of this narrative review is to summarize current knowledge and stressing out the need to diagnose male and female sexual dysfunctions also in light of the impact of treatments with novel antidiabetic agents. This would highlight the still unmet needs for sexual care in a diabetes care setting and could represent an incentive for future discussions, as well as a required theoretical starting point for studies on this subject.

Testosterone Therapy: What We Have Learned From Trials.

INTRODUCTION: The role of testosterone (T) replacement therapy (TRT) in men is still conflicting. In particular, safety concerns and cardiovascular (CV) risk related to TRT have not been completely clarified yet. Similarly, the clear beneficial effects of TRT are far to be established. AIM: To systematically and critically analyze the available literature providing evidence of the benefit-risk ratio derived from TRT in aging men. METHODS: A comprehensive PubMed literature search was performed to collect all trials, either randomized controlled trials (RCTs) or observational studies, evaluating the effects of TRT on different outcomes. MAIN OUTCOME MEASURE: Whenever possible, data derived from RCTs were compared with those resulting from observational studies. In addition, a discussion of the available meta-analyses has been also provided. RESULTS: Data derived from RCT and observational studies clearly documented that TRT can improve erectile function and libido as well as other sexual activities in men with hypogonadism (total T < 12 nM). Conversely, the effect of TRT on other outcomes, including metabolic, mood, cognition, mobility, and bone, is more conflicting. When hypogonadism is correctly diagnosed and managed, no CV venous thromboembolism or prostate risk is observed. CLINICAL IMPLICATIONS: Before prescribing TRT, hypogonadism (total T < 12 nM) must be confirmed through an adequate biochemical evaluation. Potential contraindications should be ruled out, and an adequate follow-up after the prescription is mandatory. STRENGTH & LIMITATIONS: When correctly diagnosed and administered, TRT is safe, and it can improve several aspects of sexual function. However, its role in complicated vasculogenic erectile dysfunction is limited. Conversely, TRT is not recommended for weight reduction and metabolic improvement. Further well-powered studies are advisable to better clarify TRT for long-term CV risk and prostate safety in complicated patients as well as in those curatively treated for prostate cancer. CONCLUSION: TRT results in sexual function improvement when men with hypogonadism (total T < 12 nM) are considered. Positive data in other outcomes need to be confirmed. Corona G, Torres LO, Maggi M. Testosterone Therapy: What We Have Learned From Trials. J Sex Med 2020;17:447-460.

Family History for Cardio-Metabolic Diseases: A Predictor of Major Adverse Cardiovascular Events in Men With Erectile Dysfunction.

BACKGROUND: Family history (FH) of cardiovascular (CV) disease is a known CV risk factor. However, it is rarely considered for CV risk stratification. Furthermore, FH for metabolic diseases is generally overlooked. AIM: To evaluate, in a population of men with erectile dysfunction (ED), whether FH for cardio-metabolic diseases could provide insights into metabolic and sexual features and predict the occurrence of forthcoming major adverse CV events (MACE). METHODS: A consecutive series of 4,693 individuals (aged 51.3 ± 13.3 years) attending an Andrology outpatient clinic for ED was studied. A subset of these (n = 1,595) was evaluated retrospectively for MACE occurrence. OUTCOMES: Several metabolic and sexual function-related parameters were studied. For the retrospective study, information on an incident MACE was collected over a mean follow-up of 4.2 ± 2.5 years. RESULTS: A greater number of cardio-metabolic FH factors were associated with a worse metabolic profile, including higher waist circumference, triglycerides, glucose, glycosylated hemoglobin, and diastolic blood pressure, as well as lower high-density lipoprotein cholesterol. An increased number of FH factors were associated with worse erectile function (odds ratio = 1.14[1.07;1.23], P < .0001), impaired penile dynamic peak systolic velocity, and lower testosterone levels. In the retrospective study, a positive cardiometabolic FH was associated with a significantly higher incidence of MACEs, even after adjusting for age and comorbidities (hazard ratio = 1.51[1.06-2.16], P = .023). Interestingly, when dividing the sample into high- and low-risk categories according to several CV risk factors (age, previous MACEs, high-density lipoprotein cholesterol, and comorbidities), FH was confirmed as a predictor of incident MACE only among the low-risk individuals. CLINICAL IMPLICATIONS: Investigating FH for cardio-metabolic diseases is a quick and easy task that could help clinicians in identifying, among individuals with ED, those who deserve careful evaluation of CV and metabolic risk factors. Moreover, considering FH for CV risk stratification could predict MACEs in individuals who, according to conventional CV risk factors, would be erroneously considered at low risk. STRENGTHS & LIMITATIONS: The large sample size and the systematic collection of MACEs through an administrative database, with no risk of loss at follow-up, represent strengths. The use of administrative database for MACE collection may lead to some misclassifications. The specific population of the study limits the generalizability of the results. CONCLUSION: FH is simple and inexpensive information that should be part of the CV risk assessment in all men with ED because it helps in the identification of those who need lifestyle and risk factor modifications and whose risk would otherwise be overlooked. Rastrelli G, Yannas D, Mucci B, et al. Family History for Cardio-Metabolic Diseases: A Predictor of Major Adverse Cardiovascular Events in Men With Erectile Dysfunction. J Sex Med 2020;17:2370-2381.

E-Sexual Health: A Position Statement of the European Society for Sexual Medicine.

BACKGROUND: Opportunities and pitfalls of e-health have been described and assessed in various health domains, but in the field of sexual health, the respective literature is limited. AIM: The aim of this document is to present the European Society of Sexual Medicine's (ESSM) current position statement on e-sexual health. METHODS: This statement article is an expert opinion-based proposal that was developed under the auspices of the ESSM with input from the e-sexual health subcommittee of the ESSM Scientific Committee. OUTCOMES: ESSM statements were provided on four domains: health information for patients, e-learning for professionals, health interventions, and health research. RESULTS: e-Sexual health is the use of information and communication technologies for sexual health including sexual health care, surveillance, education, knowledge, and research. Quality indicators have to be applied on Web pages that provide sexual health information, e-learning can increase educational opportunities for professionals, online treatment interventions can be effective but needs to be available to the public, and online health research can provide access to difficult to reach populations. CLINICAL IMPLICATIONS: The ESSM acknowledges the necessity for the use of information and communication technologies to meet the sexual health needs of citizens and patients and also the professional needs of sexual healthcare providers, in an evidence-based manner. STRENGTHS & LIMITATIONS: ESSM statements on this topic were provided based on expert opinion and summarize the ESSM position in this field. CONCLUSION: The ESSM believes that e-sexual health can provide opportunities for the improvement of the sexual health of the population. Kirana PS, Gudeloglu A, Sansone A, et al. E-Sexual Health: A Position Statement of the European Society for Sexual Medicine. J Sex Med 2020;17;1246-1253.

Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine.

INTRODUCTION: Radiofrequency (RF)-based treatment has been introduced as an esthetic alternative treatment for various medical indications without the scientific backup of a satisfactory body of evidence. Furthermore, the United States Food and Drug Administration issued a warning regarding the safety of energy-based technologies for indications such as vaginal "rejuvenation," cosmetic vaginal treatment, vaginal conditions related to menopause, and symptoms of urinary incontinence and sexual function on July 30, 2018. AIM: To perform a thorough review of the existing literature regarding RF-based vaginal devices for the treatment of female genitourinary indications and summarize the evidence available in a few short statements. METHODS: A thorough review of the literature regarding RF treatments for gynecological indications was performed based on several databases. Studies that included at least 15 patients were eligible for analysis. MAIN OUTCOME MEASURE: Efficacy of RF devices for different genitourinary indications. RESULTS: Although a high level of heterogeneity of studies poses a serious challenge, the committee reached a decision on several statements related to the use of RF-based devices for genitourinary indications. CLINICAL IMPLICATIONS: RF-based vaginal treatments have not been studied thoroughly enough in order to establish decisive recommendations regarding their safety and efficacy. STRENGTH & LIMITATIONS: These position statements have been established by a group of experts. The lack of strong evidence makes it difficult to give decisive recommendations. CONCLUSIONS: Further randomized controlled trials with proper methodology and design are required to establish both benefits and possible harm these treatments may have in both short and long term for all the different indications studied. Otero JR, Lauterbach R, Aversa A, et al. Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine. J Sex Med 2020;17:393-399.

Laser-Based Devices for Female Genitourinary Indications: Position Statements From the European Society for Sexual Medicine (ESSM).

BACKGROUND: Laser-based technologies have been commercially marketed as "wonder treatments" without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal "rejuvenation" or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function. AIM: To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence. METHODS: A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients. OUTCOMES: Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed. RESULTS: Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications. CLINICAL IMPLICATIONS: Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established. STRENGTHS & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSION: It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.

Clinical Recommendations From the European Society for Sexual Medicine Exploring Partner Expectations, Satisfaction in Male and Phalloplasty Cohorts, the Impact of Penile Length, Girth and Implant Type, Reservoir Placement, and the Influence of Comorbidities and Social Circumstances.

INTRODUCTION: To date, several aspects of inflatable penile prosthesis (IPP) surgical procedure have been poorly studied. AIM: The aim of this study was to review the evidence associated with IPP implantation and provide clinical recommendations on behalf of the European Society for Sexual Medicine (ESSM). Overall, 130 peer-reviewed studies and systematic reviews, which were published from 2007-2018 in the English language, were included. METHODS: MEDLINE and EMBASE were searched for randomized clinical trials, meta-analyses, and open-label prospective and retrospective studies. MAIN OUTCOME MEASURE: The panel provided statements exploring patients and partner expectations, satisfaction in male and phalloplasty cohorts, the impact of penile length, girth and implant type, reservoir placement, the influence of comorbidities, and social circumstances. Levels of evidence were provided according to the Oxford 2011 criteria and graded as for the Oxford Centre for Evidence-Based Medicine recommendations. RESULTS: In the preoperative setting, it is fundamental to identify and interact with difficult patients with the intention of enhancing the surgeon's ability to establish the surgeon-patient relationship, reduce physical and legal risk, as well as enhancing patient satisfaction. To address this need, the mnemonic Compulsive, Unrealistic, Revision, Surgeon Shopping, Entitled, Denial, and Psychiatric ("CURSED") has been suggested to identify patients who are at high risk of dissatisfaction. The current recommendations suggest improving glycemic control in patients with diabetes. Available evidence suggests evaluating transplant recipients with the criteria of Barry, consisting of stable graft function for >6 months, avoidance of intra-abdominal reservoir placement, and low-dose immunosuppression. HIV status does not represent a contraindication for surgery. Smoking, peripheral vascular disease, and hypertension may be associated with an increased risk of revision surgery. Patients with spinal cord injury may receive IPP. Patients aged ≥70 years, as well as obese patients, can be offered IPP. The IPP implantation can be performed in patients with stable Peyronie's disease. Ectopic high submuscular reservoir placement can be considered as an alternative method. CLINICAL IMPLICATIONS: There is a relevant lack of high-level data and definite conclusions in certain areas remain difficult to draw. STRENGTH & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. Because of lack of sufficient prospective data, some of the included studies are retrospective and this could be stated as a limitation. CONCLUSION: This ESSM position statement provides recommendations on optimization of patient outcome by patient selection, and individualized peri- and intra-operative management. ESSM encourages centers to collaborate and to create prospective, multicenter registries in order to address this topic of increasing importance. Osmonov D, Christopher AN, Blecher GA, et al. Clinical Recommendations from the European Society for Sexual Medicine Exploring Partner Expectations, Satisfaction in Male and Phalloplasty Cohorts, the Impact of Penile Length, Girth and Implant Type, Reservoir Placement, and the Influence of Comorbidities and Social Circumstances. J Sex Med 2020;17:210-237.

Sodium-glucose co-transporter-2 drugs: are we sure they are useful only in the treatment of diabetes?

The sodium-glucose co-transporter-2 (SGLT2) inhibitors are a new class of oral anti-diabetic drugs acting through the inhibition of renal reabsorbtion of glucose. Three important randomized clinical trial in diabetic patients receiving SGLT2 inhibitors (vs. placebo), demonstrated a significant reduction of major adverse cardiovascular events, but only in patients with known atherosclerotic disease, and a clear-cut and early reduction in hospital admissions for heart failure in patients in primary as well as secondary prevention settings. This latter information prompted the design of a recent study the DAPA-HF (Dapagliflozin And Prevention Of Adverse-outcomes In Heart Failure) trial, comparing dapagliflozin vs. placebo, and showing a significant reduction of clinical relevant episodes of heart failure in patients with reduced left ventricular ejection fraction, regardless the presence of diabetes mellitus. The mechanism by which the SGLT2 inhibitors exert their anti-heart failure action is not well understood but appears to be independent from its hypoglycaemic action. These results, along with the scarcity of adverse side effects of the drug, render dapagliflozin a new tool in the treatment of heart failure.

The Masturbation Erection Index (MEI): validation of a new psychometric tool, derived from the six-item version of the International Index of Erectile Function (IIEF-6) and from the Erection Hardness Score (EHS), for measuring erectile function during masturbation.

OBJECTIVES: To validate a psychometric instrument, the Masturbation Erection Index (MEI) able to evaluate erectile function (EF) during masturbation. In fact, although the evaluation of EF during masturbation is pivotal in evaluating erectile dysfunction (ED), to date no specific psychometric tools have been developed to measure it both in the routine clinical practice and in the experimental setting. PATIENTS AND METHODS: Of 560 men attending our andrological outpatient clinic for the first time, 99 (17.7%) had ED. As a control group, we enrolled 102 sexually healthy men. All the men were requested to complete both the six-item version of the International Index of Erectile Function (IIEF-6) and the MEI. The MEI was used together with a standardised tool, the Erection Hardness Score (EHS). The MEI was validated in terms of content validity. Test-retest reliability was assessed using the intraclass correlation coefficient (ICC). Internal consistency was evaluated by Cronbach's α. The comparability between the MEI and IIEF-6 in measuring EF was tested by Bland-Altman analysis. The concordance correlation coefficient (CCC) between the two questionnaires was also determined. RESULTS: Internal consistency of the MEI was >0.93. Test-retest reliability was 0.982 (95% confidence interval [CI] 0.975-0.987). Bland-Altman analysis showed a good level of agreement between the IIEF-6 and MEI in the whole ED population, with stronger agreement in the organic-ED subpopulation. The estimated area under the curve of the MEI was 0.983 (P < 0.001; 95% CI 0.954-0.996), with a score of ≤27 as the optimal threshold to discriminate between the presence and absence of ED during self-induced masturbation. The CCC, Pearson ρ and bias correction factor (Cb) were 0.951 (95% CI 0.936-0.962), 0.968, and 0.982, respectively. CONCLUSION: The MEI showed good internal consistency and a good level of agreement with the IIEF-6. Hence, the MEI fulfills the major psychometric requirements for measuring EF during masturbation.

Impact of Metabolically Healthy Obesity in Patients with Andrological Problems.

BACKGROUND: Although the pathogenic role of metabolically complicated obesity (MCO) in erectile dysfunction (ED), major adverse cardiovascular events (MACE), and male infertility has been widely studied, that of metabolically healthy obesity (MHO) has been poorly investigated. AIM: To assess the role of MHO in the pathogenesis of ED, prediction of MACE, and male reproductive health. METHODS: A consecutive series of 4,945 men (mean age, 50.5 ± 13.5 years) with sexual dysfunction (SD) (cohort 1) and 231 male partners of infertile couples (mean age, 37.9 ± 9.1 years; cohort 2) were studied. A subset of men with SD (n = 1,687) was longitudinally investigated to evaluate MACE. All patients underwent clinical, biochemical, erectile function, and flaccid penile color Doppler ultrasound (PCDU) assessment. Infertile men also underwent scrotal and transrectal ultrasound; semen analysis, including interleukin (IL-) 8; and prostatitis-like symptom assessment. MHO was defined as body mass index >30 kg/m2 with high-density lipoprotein cholesterol level >40 mg/dL and absence of diabetes or hypertension. The rest of the obesity sample was defined as MCO. MHO or MCO were compared with the rest of the sample, defined as normal weight (NW) individuals. OUTCOMES: Clinical, biochemical, erectile, and PCDU assessment in MHO, MCO and NW men in both cohorts; longitudinal MACE incidence assessment in cohort 1. RESULTS: In cohort 1, 816 men (16.5%) were obese, 181 (3.7%) were MHO, and 635 (12.8%) were MCO. In cohort 2, 68 men (28.4%) were obese, 19 (8.2%) were MHO, and 49 (21.2%) were MCO. After adjusting for confounders, in both samples, the men with MHO and MCO had lower total testosterone levels and worse PCDU parameters compared with the NW men. However, only MCO men had worse erectile function compared with NW men. In the longitudinal study, both MHO and MCO men independently had a higher incidence of MACE compared with NW men (P < .05 for both). In cohort 2, MHO and MCO men had a larger prostate volume, and MCO men also had higher ultrasound and biochemical (IL-8) features of prostatic inflammation compared with NW men, but no differences in prostatitis-like symptoms or seminal parameters. CLINICAL IMPLICATIONS: MHO men should be considered at high cardiovascular risk like MCO men and followed-up for erectile dysfunction and prostate abnormalities overtime. STRENGTHS & LIMITATIONS: The study simultaneously examined several endpoints with validated instruments within 2 different male populations, 1 with SD and 1 with infertility. As for limitations, there is no consensus in the scientific community regarding the definition of MHO, and the results are derived from patients with SD or infertility, which could have different characteristics than the general male population. CONCLUSION: MHO is associated with subclinical ED, increased cardiovascular risk, and prostate enlargement. Lotti F, Rastrelli G, Maseroli E, et al. Impact of Metabolically Healthy Obesity in Patients with Andrological Problems. J Sex Med 2019:16;821-832.

Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM).

INTRODUCTION: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings. AIM: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine. METHODS: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS. OUTCOMES: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations. RESULTS: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooled-data analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time. CLINICAL IMPLICATIONS: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice. STRENGTHS AND LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSIONS: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505.

Hormonal Contraception and Female Sexuality: Position Statements from the European Society of Sexual Medicine (ESSM).

INTRODUCTION: Hormonal contraception is available worldwide in many different forms. Fear of side effects and health concerns are among the main reasons for not using contraceptives or discontinuing their use. Although the safety and efficacy of contraceptives have been extensively examined, little is known about their impact on female sexual function, and the evidence on the topic is controversial. AIM: To review the available evidence about the effects of hormonal contraceptives on female sexuality in order to provide a position statement and clinical practice recommendations on behalf of the European Society of Sexual Medicine. METHODS: A comprehensive review of the literature was performed. MAIN OUTCOME MEASURE: Several aspects of female sexuality have been investigated, including desire, orgasmic function, lubrication and vulvovaginal symptoms, pelvic floor and urological symptoms, partner preference, and relationship and sexual satisfaction. For each topic, data were analyzed according to the different types of hormonal contraceptives (combined estrogen-progestin methods, progestin-only methods, and oral or non-oral options). RESULTS: Recommendations according to the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence criteria and specific statements on this topic, summarizing the European Society of Sexual Medicine position, were developed. CLINICAL IMPLICATIONS: There is not enough evidence to draw a clear algorithm for the management of hormonal contraception-induced sexual dysfunction, and further studies are warranted before conclusions can be drawn. A careful baseline psychological, sexual, and relational assessment is necessary for the health care provider to evaluate eventual effects of hormonal contraceptives at follow-up. STRENGTHS & LIMITATIONS: All studies have been evaluated by a panel of experts who have provided recommendations for clinical practice. CONCLUSION: The effects of hormonal contraceptives on sexual function have not been well studied and remain controversial. Available evidence indicates that a minority of women experience a change in sexual functioning with regard to general sexual response, desire, lubrication, orgasm, and relationship satisfaction. The pathophysiological mechanisms leading to reported sexual difficulties such as reduced desire and vulvovaginal atrophy remain unclear. Insufficient evidence is available on the correlation between hormonal contraceptives and pelvic floor function and urological symptoms. Both S, Lew-Starowicz M, Luria M, et al. Hormonal Contraception and Female Sexuality: Position Statements from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1681-1695.