Princeton IV consensus guidelines: PDE5 inhibitors and cardiac health.

BACKGROUND: In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug-drug interactions, but also a potential cardioprotective effect of these drugs. AIM: In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease. METHOD: A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus. OUTCOMES: Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors. RESULTS: An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug-drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non-PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non-PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed. CLINICAL IMPLICATIONS: Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease. STRENGTHS AND LIMITATIONS: Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting. CONCLUSION: The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors.

Disorders of Ejaculation: An AUA/SMSNA Guideline.

PURPOSE: Men who ejaculate before or shortly after penetration, without a sense of control, and who experience distress related to this condition may be diagnosed with premature ejaculation (PE), while men who experience difficulty achieving sexual climax may be diagnosed with delayed ejaculation (DE). The experience of many clinicians suggest that these problems are not rare and can be a source of considerable embarrassment and dissatisfaction for patients. The role of the clinician in managing PE and DE is to conduct appropriate investigation, to provide education, and to offer available treatments that are rational and based on sound scientific data. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by a methodology team at the Pacific Northwest Evidence-based Practice Center. A research librarian conducted searches in Ovid MEDLINE (1946 to March 1, 2019), the Cochrane Central Register of Controlled Trials (through January 2019) and the Cochrane Database of Systematic Reviews (through March 1, 2019). An update search was conducted on September 5, 2019. Database searches resulted in 1,851 potentially relevant articles. After dual review of abstracts and titles, 223 systematic reviews and individual studies were selected for full-text dual review, and 8 systematic reviews and 59 individual studies were determined to meet inclusion criteria and were included in the review. RESULTS: Several psychological health, behavioral, and pharmacotherapy options exist for both PE and DE; however, none of these pharmacotherapy options have achieved approval from the United States Food and Drug Administration and their use in the treatment of PE and DE is considered off-label. CONCLUSION: Disturbances of the timing of ejaculation can pose a substantial impediment to sexual enjoyment for men and their partners. The Panel recommends shared decision-making as fundamental in the management of disorders of ejaculation; involvement of sexual partner(s) in decision making, when possible, may allow for optimization of outcomes.

Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction.

INTRODUCTION: Phosphodiesterase type 5 inhibitors (PDE5Is) have demonstrated efficacy in the treatment of erectile dysfunction (ED). Although historically found to have limited drug-related adverse events, emerging data have suggested that PDE5Is might be associated with melanoma or recurrence of prostate cancer after radical prostatectomy. AIM: To summarize the literature on the safety of PDE5Is. METHODS: A literature review was performed through PubMed from 1990 through 2016 regarding ED. Keywords used for the search were erectile dysfunction, phosphodiesterase type 5 inhibitors, sildenafil, vardenafil, tadalafil, avanafil, safety, side effects, and adverse events, among others. MAIN OUTCOME MEASURES: Visual, auditory, cardiovascular, renal, hepatic, priapic, and oncologic outcomes associated with the intake of PDE5Is for the treatment of ED, in addition to drug interactions, abuse, overdose, and the phenomenon of counterfeit medications. RESULTS: PDE5Is are safe drugs for the management of ED. Although recent studies have shown an increased risk of non-arteritic ischemic optic neuropathy with PDE5Is, the magnitude of that risk is small. The possibility that PDE5Is cause sensorineural hearing loss remains uncertain. PDE5Is display a safe cardiovascular profile if used according to the Princeton III Consensus guidelines. There appears to be an association between PDE5I use and melanoma but the absence of a mechanism of causation raises doubt that the association is cause and effect. PDE5Is do not increase the risk of biochemical recurrence after prostate cancer management. PDE5I abuse and use of counterfeit medications present serious global health concerns. CONCLUSION: Current data strongly support the efficacy, tolerability, and overall safety of PDE5Is for the treatment of ED. PDE5Is probably cause a small increase in the risk of non-arteritic ischemic optic neuropathy. Evidence on increased rates of melanoma and prostate cancer recurrence is weak and controversial. PDE5Is should still be considered first-line therapy for the treatment of most etiologies of ED. Yafi FA, Sharlip ID, Becher EF. Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction. Sex Med Rev 2018;6:242-252.

Adult-Onset Hypogonadism.

In August 2015, an expert colloquium commissioned by the Sexual Medicine Society of North America (SMSNA) convened in Washington, DC, to discuss the common clinical scenario of men who present with low testosterone (T) and associated signs and symptoms accompanied by low or normal gonadotropin levels. This syndrome is not classical primary (testicular failure) or secondary (pituitary or hypothalamic failure) hypogonadism because it may have elements of both presentations. The panel designated this syndrome adult-onset hypogonadism (AOH) because it occurs commonly in middle-age and older men. The SMSNA is a not-for-profit society established in 1994 to promote, encourage, and support the highest standards of practice, research, education, and ethics in the study of human sexual function and dysfunction. The panel consisted of 17 experts in men's health, sexual medicine, urology, endocrinology, and methodology. Participants declared potential conflicts of interest and were SMSNA members and nonmembers. The panel deliberated regarding a diagnostic process to document signs and symptoms of AOH, the rationale for T therapy, and a monitoring protocol for T-treated patients. The evaluation and management of hypogonadal syndromes have been addressed in recent publications (ie, the Endocrine Society, the American Urological Association, and the International Society for Sexual Medicine). The primary purpose of this document was to support health care professionals in the development of a deeper understanding of AOH, particularly in how it differs from classical primary and secondary hypogonadism, and to provide a conceptual framework to guide its diagnosis, treatment, and follow-up.

Definitions of Sexual Dysfunctions in Women and Men: A Consensus Statement From the Fourth International Consultation on Sexual Medicine 2015.

INTRODUCTION: Definitions of sexual dysfunctions in women and men are critical in facilitating research and enabling clinicians to communicate accurately. AIMS: To present the new set of definitions of all forms of sexual dysfunction in women and men adopted by the Fourth International Consultation on Sexual Medicine (ICSM) held in 2015. METHODS: Classification systems, including the International Classification of Diseases, 10th Edition and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and systems that focus on only specific types of sexual dysfunctions (e.g., the International Society for Sexual Medicine definition for premature ejaculation) were reviewed. MAIN OUTCOME MEASURES: Evidence-based definitions were retained, gaps in definitions were identified, and outdated definitions were updated or discarded. Where evidence was insufficient or absent, expert opinion was used. Some definitions were self-evident and termed clinical principles. RESULTS: The evidence to support the various classification systems was carefully evaluated. A more comprehensive analysis of this evidence can be found in two other articles in this journal that consider the incidence and prevalence and the risk factors for sexual dysfunction in men and women. These data were used to shape the definitions for sexual dysfunction that have been recommended by the 2015 ICSM. CONCLUSION: The definitions that have been adopted are those that are most strongly supported by the literature at this time or are considered clinical principles or consensus of experts' opinions. As more research and clinical studies are conducted, there likely will be modifications of at least some definitions.

Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015.

INTRODUCTION: The incidence and prevalence of various sexual dysfunctions in women and men are important to understand to designate priorities for epidemiologic and clinical research. AIM: This manuscript was designed to conduct a review of the literature to determine the incidence and prevalence of sexual dysfunction in women and men. METHODS: Members of Committee 1 of the Fourth International Consultation on Sexual Medicine (2015) searched and reviewed epidemiologic literature on the incidence and prevalence of sexual dysfunctions. Key older studies and most studies published after 2009 were included in the text of this article. MAIN OUTCOME MEASURES: The outcome measures were the reports in the various studies of the incidence and prevalence of sexual dysfunction among women and men. RESULTS: There are more studies on incidence and prevalence for men than for women and many more studies on prevalence than incidence for women and men. The data indicate that the most frequent sexual dysfunctions for women are desire and arousal dysfunctions. In addition, there is a large proportion of women who experience multiple sexual dysfunctions. For men, premature ejaculation and erectile dysfunction are the most common sexual dysfunctions, with less comorbidity across sexual dysfunctions for men compared with women. CONCLUSION: These data need to be treated with caution, because there is a high level of variability across studies caused by methodologic differences in the instruments used to assess presence of sexual dysfunction, ages of samples, nature of samples, methodology used to gather the data, and cultural differences. Future research needs to use well-validated tools to gather data and ensure that the data collection strategy is clearly described.

Risk Factors for Sexual Dysfunction Among Women and Men: A Consensus Statement From the Fourth International Consultation on Sexual Medicine 2015.

INTRODUCTION: This article presents a review of previous research concerning risk factors for sexual dysfunction in women and men. AIM: The aim is to evaluate past research studies to determine the contribution of all risk factors to the development and maintenance of sexual dysfunction among women and men. METHODS: Studies were organized under a biopsychosocial framework, with the bulk of studies of women and men having investigated the role of biological factors. MAIN OUTCOME MEASURES: The outcome measures were the data on factors for sexual dysfunction. RESULTS: Many more studies investigated risk factors for sexual dysfunction in men than in women. For women and men, diabetes, heart disease, urinary tract disorders, and chronic illness were significant risk factors for sexual dysfunction. Depression and anxiety and the medications used to treat these disorders also were risk factors for sexual dysfunction in women and men. In addition, substance abuse was associated with sexual dysfunction. Many other social and cultural factors were related to sexual dysfunction in women and men. CONCLUSION: Psychosocial factors are clearly risk factors for sexual dysfunction. Women and men with sexual dysfunction should be offered psychosocial evaluation and treatment, if available, in addition to medical evaluation and treatment. The impact of social and cultural factors on sexual function requires substantially more research. The evidence that erectile dysfunction is a harbinger of other forms of cardiovascular disease is strong enough to recommend that clinical evaluation for occult cardiovascular disease should be undertaken in men who do not have known cardiovascular disease but who develop organic erectile dysfunction, especially in men younger than 70 years.

Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors.

INTRODUCTION: Nonarteritic anterior ischemic optic neuropathy (NAION), a rare visual disorder, has been reported in men using phosphodiesterase type 5 inhibitors (PDE5i) for erectile dysfunction. AIM: We examined whether intermittent use of PDE5i is associated with acute NAION onset within approximately five half-lives following drug ingestion. METHODS: One hundred two ophthalmology centers in the United States and Europe identified potential cases of NAION. An expert adjudication committee conducted a blind review of the records of those with recent PDE5i use to classify cases as Definite, Possible, or not NAION. Subjects provided information on PDEi use via telephone interview. Each NAION case's PDE5i exposure immediately prior to onset was compared against his recent patterns of use in an observational case-crossover design. A sample size of 40 cases with intermittent PDE5i exposure in the 30 days prior to NAION onset was needed to detect an odds ratio (OR) of 3.0 with 80% power. MAIN OUTCOME MEASURES: The daily relative risk for acute NAION on days within five half-lives of PDE5i use vs. other days was estimated via an OR obtained from conditional logistic regression. RESULTS: Among 43 Definite NAION cases with PDE5i exposure in the prior 30 days, the OR was 2.15 (95% confidence interval [CI]: 1.06, 4.34). When 21 Possible NAION cases were included (n = 64), the OR was 2.36 (95% CI: 1.33, 4.19). CONCLUSIONS: We found an approximately twofold increased risk of acute NAION within five half-lives of PDE5i use compared with use in a more prior time period. Bias from inaccurate recall of exposure was unlikely to have substantially affected the results. Based on our results, we estimate that weekly use of PDE5i adds three NAION cases per 100,000 men 50 years and older annually.

Modifying risk factors to prevent and treat erectile dysfunction.

INTRODUCTION: Erectile dysfunction (ED) is a common complaint in men over 40 years of age and prevalence rates increase with age. Comorbidities such as heart disease, diabetes, dyslipidemia, hypertension, and depression have been described as primary risk factors for the development of ED. Additionally, a number of modifiable lifestyle factors, including physical activity, smoking, alcohol consumption, diabetes control, and obesity, have been associated with ED. AIM: The association of modifiable behavioral factors with ED, mainly among men without recognized comorbidities, opens the possibility for intervention strategies to prevent and potentially improve erectile function in patients suffering with ED. CONCLUSION: While intriguing, most of the literature and evidence is not completely scientifically compelling as to how modifying lifestyle risk factors can improve erectile function. Weight loss may reverse ED through other mechanisms, namely, decreased inflammation, increased serum testosterone levels, and improved mood and self-esteem. Currently, the evidence at hand recommends that patient education should be aimed at increasing exercise, reducing weight to achieve a body mass index less than 30 kg/m(2), and stopping smoking to improve or restore erectile function, mainly in men without established comorbidities. When comorbidities are present, lifestyle modifications may be important in preventing or reducing sexual dysfunction. These modifications may include precise glycemic control in diabetic men and the use of pharmacologic therapies for hypertension and depression, which are less likely to cause sexual side effects.

Standard operating procedures for priapism.

AIM: To provide standard operating procedures for the diagnosis and management of priapism. METHODS: Review of the literature. MAIN OUTCOME MEASURES: Reduction of priapism and preservation of erectile function. RESULTS: Priapism is a persistent penile erection that continues hours beyond, or is unrelated to, sexual stimulation. Priapism requires prompt evaluation and usually requires emergency management. There are two types of priapism: (i) ischemic (veno-occlusive or low flow), which is found in 95% of cases, and (ii) nonischemic (arterial or high flow). Stuttering (intermittent) priapism is a recurrent form of ischemic priapism. To initiate appropriate management, the physician must determine whether the priapism is ischemic or nonischemic. Necessary diagnostic steps are an accurate history, physical examination, and cavernous blood gas analysis and/or color duplex ultrasonography of the corpora cavernosa. Management of ischemic priapism should achieve resolution as promptly as possible. Initial treatment is therapeutic aspiration with or without irrigation of the corpora. If this fails, intracavernous injection of sympathomimetic drugs is the next step. Surgical shunts should be performed if nonsurgical treatment has failed. The initial management of nonischemic priapism should be observation. Selective arterial embolization is recommended for the management of nonischemic priapism in patients who request treatment. The goal of management for a patient with recurrent (stuttering) priapism is prevention of future episodes. CONCLUSION: Management of priapism has become increasingly successful as scientific understanding of the pathophysiology and molecular biology of priapism improves. The key to further success in the treatment of priapism is basic research of this uncommon but potentially devastating condition.

Vasectomy: AUA guideline.

PURPOSE: The purpose of this guideline is to provide guidance to clinicians who offer vasectomy services. MATERIALS AND METHODS: A systematic review of the literature using the search dates January 1949-August 2011 was conducted to identify peer-reviewed publications relevant to vasectomy. The search identified almost 2,000 titles and abstracts. Application of inclusion/exclusion criteria yielded an evidence base of 275 articles. Evidence-based practices for vasectomy were defined when evidence was available. When evidence was insufficient or absent, expert opinion-based practices were defined by Panel consensus. The Panel sought to define the minimum and necessary concepts for pre-vasectomy counseling; optimum methods for anesthesia, vas isolation, vas occlusion and post-vasectomy follow up; and rates of complications of vasectomy. This guideline was peer reviewed by 55 independent experts during the guideline development process. RESULTS: Vas isolation should be performed using a minimally-invasive vasectomy technique such as the no-scalpel vasectomy technique. Vas occlusion should be performed by any one of four techniques that are associated with occlusive failure rates consistently below 1%. These are mucosal cautery of both ends of the divided vas without ligation or clips (1) with or (2) without fascial interposition; (3) open testicular end of the divided vas with MC of abdominal end with FI and without ligation or clips; and (4) non-divisional extended electrocautery. Patients may stop using other methods of contraception when one uncentrifuged fresh semen specimen shows azoospermia or ≤ 100,000 non-motile sperm/mL. CONCLUSIONS: Vasectomy should be considered for permanent contraception much more frequently than is the current practice in the U.S. and many other nations. The full text of this guideline is available to the public at http://www.auanet.org/content/media/vasectomy.pdf.

Sexual function and depressive symptoms among female North American medical students.

INTRODUCTION: Depression and sexual dysfunction are often comorbid. AIM: We explored the relationship between sexuality, sexual dysfunction, and depressive symptoms in female medical students in North America. MAIN OUTCOME MEASURE: Female North American medical students were invited to participate in an internet survey. The CES-D was utilized to screen for depressive symptoms and an abbreviated Spielberger State-Trait Anxiety Index (STAI) was used to quantify anxiety symptoms. METHODS: Subjects completed an ethnodemographic survey, a sexuality survey, and modified instruments for the quantification of sexual function (the Female Sexual Function Index [FSFI] and the Index of Sexual Life [ISL]). Multivariable logistic regression was used to explore the relationship between sexuality and depressive symptoms. RESULTS: There were 1,241 female subjects with complete data on CES-D and STAI. Mean age was 25.4 years. Depressive symptoms (CES-D>16) were present in 46% of respondents and were more common in subjects with anxiety symptoms. Subjects who were Caucasian, younger than 28, heterosexual, and in a relationship were least likely to report depressive symptoms. High risk of female sexual dysfunction (HRFSD) was significantly associated with greater likelihood of depressive symptoms (odds ratio [OR] 2.25, P<0.001). After adjusting for ethnodemographic and sexual history factors, HRFSD remained significantly positively associated with depressive symptoms (OR 1.85, P<0.001). Analysis of FSFI and ISL domains indicated that depressive symptoms were most directly associated with worse orgasmic function, interference in sex life from stress and lack of partner, and lower general life satisfaction (P<0.05). Interestingly, greater ISL-sexual satisfaction was associated with greater odds of depressive symptoms (OR 1.40, P=0.01). CONCLUSION: Depressive symptoms are common in female medical students. HRFSD is associated with depressive symptoms, although the relationship is complex when psychosocial factors are included in the multivariate model. Attention to sexuality factors from student health providers may enhance quality-of-life, academic achievement, and patient care.

Urologic aspects of HIV infection.

Although lifespan has dramatically improved in the human immunodeficiency virus-positive (HIV+) population, HIV and its treatment continue to be a source of substantial morbidity in many organ systems, including the genitourinary tract. As the number of long-term survivors increases with advances in antiretroviral therapy, age-associated urologic symptoms are also becoming increasingly relevant considerations for people living with HIV. Primary care physicians have a major role to play in maintaining the genitourinary health of their HIV+ patients. This role is of great importance not just for the well-being of the individual patient but for the public health, as the genitourinary tract is a common vector for HIV transmission. In this article the authors review the management of the genitourinary system in patients with HIV infection. Particular consideration is given to urinary tract infections, lower urinary tract symptoms, renal insufficiency, sexual and fertility problems, and cancers of the genitourinary tract. Management algorithms are outlined and indications for referral to a urologist are emphasized.

Sexual function and depressive symptoms among male North American medical students.

INTRODUCTION: The role of sexuality as an association of medical student well-being has not been extensively studied. AIM: We explored the relationship between depressive symptoms, sexuality, and sexual dysfunction in male North American medical students. MAIN OUTCOME MEASURE: North American medical students were invited to participate in an Internet-based survey. The Center for Epidemiological Studies Depression Scale (CES-D) was utilized to screen for depressive symptoms. METHODS: Subjects completed an ethnodemographic survey, a sexuality survey, and instruments for the quantification of anxiety, sexuality, and psychosocial function. Descriptive statistics, odds ratios (ORs), and logistic regression were used to analyze our data. RESULTS: There were 844 male subjects with complete data on the CES-D and the Spielberger State-Trait Anxiety Index. Depressive symptoms (CES-D ≥ 16) were present in 37% of respondents and were more common in subjects with greater levels of anxiety. Subjects who were in sexual relationships and/or had frequent sexual activity were less likely to be depressed compared to other subjects. Erectile dysfunction (ED) was associated with significantly greater likelihood of depressive symptoms (OR 2.90 and 9.27 for depressive symptoms in men with mild or moderate/severe ED relative to men without ED, P < 0.01). After adjusting for ethnodemographic and sexual history factors, ED remained significantly positively associated with depressive symptoms (OR 2.87 and 6.59 for depressive symptoms in men with mild or moderate/severe ED relative to men without ED after adjustment, P ≤ 0.01). Inclusion of data related to psychosocial/relationship factors in the multivariate model eliminated the significant association between ED and depressive symptoms (OR 1.59 and 2.29 for depressive symptoms in men with mild or moderate/severe ED relative to men without ED after adjustment with the Self-Esteem and Relationship quality instrument, P > 0.05), suggesting that psychosocial factors were more strongly associated with depressive symptoms than erectile function. CONCLUSION: Healthy sexuality and relationships may be protective against depressive symptoms in medical students. Attention to these factors may enhance medical student well-being.

The impact of infertility on family size in the USA: data from the National Survey of Family Growth.

BACKGROUND: Investigators have postulated that family size may be influenced by biologic fertility potential in addition to sociodemographic factors. The aim of the current study is to determine if a diagnosis of infertility is associated with family size in the USA. METHODS: We analyzed data from the male and female samples of the 2002 National Survey of Family Growth using multivariable logistic regression models to determine the relationship between infertility and family size while adjusting for sociodemographic and reproductive characteristics. RESULTS: In the survey, 4409 women and 1739 men met the inclusion criteria, of whom 10.2% and 9.7%, respectively, were classified as infertile, on the basis of having sought reproductive assistance. Infertile females had a 34% reduced odds of having an additional child compared with women who did not seek reproductive assistance. For each additional 6 months it took a woman to conceive her first child, the odds of having a larger family fell by 9% and the odds of having a second child were reduced by 11%. A diagnosis of male infertility reduced the odds of having a larger family more than a diagnosis of female infertility. CONCLUSIONS: A diagnosis of infertility, especially male factor, is associated with reduced odds of having a larger family, implicating a biologic role in the determination of family size in the USA.

An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation.

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

Tadalafil is efficacious and well tolerated in the treatment of erectile dysfunction (ED) in men over 65 years of age: results from Multiple Observations in Men with ED in National Tadalafil Study in the United States.

INTRODUCTION: Erectile dysfunction is increasingly common with advancing age, yet sexual activity and intimacy are important to elderly men. AIM: To assess the efficacy and tolerability of tadalafil in men over the age of 65 years. METHOD: In this multicenter open-label study, 188 men (mean age = 71.6 years) who were over age 65 and did not have diabetes mellitus or clinical depression received tadalafil 20 mg, taken on demand, for up to 12 weeks. MAIN OUTCOME MEASURES: Efficacy was assessed using the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP). Psychosocial outcomes were evaluated using the Psychological and Interpersonal Relationship Scale (PAIRS). RESULTS: Tadalafil treatment significantly improved all domains of the IIEF from baseline, including the erectile function (EF) domain (change = 8.8, end point = 21.6; P < 0.001). Mean per-patient percentage of "yes" responses to SEP questions concerning successful penetration (SEP2; change = 33.5%, end point = 73.5%; P < 0.001) and successful intercourse (SEP3; change = 39.6%, end point = 59.6%; P < 0.001) also improved significantly from baseline. Forty percent of the patients with baseline EF scores < 26 had normal EF (IIEF-EF domain scores > or = 26) at end point, and 81% reported improved erections in the Global Assessment Questionnaire. At least 56% of attempts at sexual intercourse were successfully completed (SEP3) at all time intervals up to 36 hours after tadalafil administration. The patients also experienced significant improvement in both the sexual self-confidence and spontaneity domains of the PAIRS. Tadalafil was well tolerated, with < 5% of the patients discontinuing because of adverse events. CONCLUSION: Tadalafil 20 mg was effective and well tolerated in elderly men with ED.

Male circumcision and HIV prevention.

INTRODUCTION: Growing evidence has linked circumcision with some protection against HIV infection. Should nations with a high HIV infection rate encourage male circumcision? METHODS: Four people with expertise and/or interest in the area of circumcision and HIV were asked to contribute their opinions. MAIN OUTCOME MEASURE: To provide food for thought, discussion, and possible further research in a poorly discussed area of sexual medicine. RESULTS: Three clinical trials in Africa showed the benefit of circumcision in reducing HIV incidence in men. Sadeghi-Nejad cites these, but balances this with the pandemic in India, and the cultural implications of circumcision. Pollack cites these studies as well, but reinforces the World Health Organization and UNAIDS recommendations that male circumcision should not replace safe sex. As a Nigerian, Aisuodionoe-Shadrach discusses the indirect ways in which circumcision can reduce the spread of HIV, and advocates the surgery, although he proposes infant circumcision may be wiser. Ira Sharlip, President of the International Society for Sexual Medicine, explains some of the physiology involved while again citing the three recent African studies. He questions who would be circumcised and who would perform the procedure if pro-circumcision policies were adopted. CONCLUSION: While three clinical trials in Africa were halted after it became evident that circumcision was beneficial in protecting against HIV, further information on the health risks and benefits of male circumcision is needed. Ethical decisions need to be made and medical recommendations developed before circumcision can be considered for HIV prevention.