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BackgroundThere are only a few studies about the prevalence and correlates of premature ejaculation (PE) among men who have sex with men (MSM).Aim(1) To estimate PE prevalence according to 3 assessment methods: self-reported time from penetration to ejaculation (ejaculation latency time [ELT]); Premature Ejaculation Diagnostic Tool (PEDT); and a direct question about the self-perception of ejaculation as being normal, too early (premature), or retarded. (2) To assess the agreement of the 3 assessment methods and identify factors associated with PE according to each method and their combination.MethodsWe evaluated data from 226 MSM who participated in a cross-sectional study about sexual behavior among men living in the metropolitan region of São Paulo, Brazil. They responded anonymously to an online survey between May 2019 and March 2020. We calculated the agreement of the 3 assessment methods and their association with other characteristics using logistic regression models.OutcomesOutcomes included the prevalence of PE according to the assessment methods and the association measures (PE vs sociodemographic characteristics and sexual behavior).ResultsThe prevalence of PE among MSM was 21.2% (95% CI, 16.1%-27.1%) according to the PEDT, 17.3% (95% CI, 12.6%-22.8%) per self-report, and 6.2% (95% CI, 3.4%-10.2%) by estimated ELT ≤2 minutes. The agreement among the 3 assessments was fair (kappa, 0.31; 95% CI, 0.25-0.37; P Clinical ImplicationsCombining tools to investigate PE allows the identification of characteristics associated with this condition and may result in improvement in the care of MSM.Strengths and LimitationsThis anonymous online survey provided the privacy necessary for participants to respond freely about sensitive questions, with a low risk of social adequacy bias. However, as it was a secondary analysis of a larger study, it could not evaluate comorbidities (eg, erectile dysfunction, prostatitis, depression) and the use of condoms.ConclusionThe prevalence of PE among MSM is high and varies according to the instrument used for the assessment, and the agreement among the 3 assessments was only fair.

Background Premature ejaculation (PE) prevalence can vary according to different definitions, assessment methods and populational demographics and culture. Aims To investigate the differences between men classified as having “probable PE” (PEDT≥11), “possible PE” (PEDT = 9 or 10) or “no PE” (PEDT≤8) according to the Premature Ejaculation Diagnostic Tool (PEDT) criteria in regard to sociodemographic characteristics, and sexual and relational behavior. To assess the agreement of prevalence of PE according to 3 assessment methods: (i) the ejaculation latency time (ELT) according to the participant's memory; (ii) PEDT and (iii) a direct question about the self-perception of ejaculation as being normal, too early (premature) or retarded. Methods In this web-based cross-sectional study, men aged ≥ 18 years living in the metropolitan region of São Paulo, Brazil, responded anonymously to an online survey. We used multinomial regression to estimate the association between PE according PEDT criteria and other features and the kappa coefficient to estimate agreement between the assessment methods. Outcomes Association between PEDT-PE, sociodemographic characteristics and sexual and relational behaviors; agreement between PEDT, ELT and self-perception of PE. Results Obesity, trying to hold back ejaculation, short or nonexistent foreplay and age Conclusion PE prevalence varies according to instruments and cut-offs used, with fair agreement between them. This finding shows that the methods evaluate different aspects of the EP syndrome and they must be combined to allow the discrimination between the different types of PE and treatments. Clinical approaches should consider the sexual behavior and relationship of the patient and their distress.

Background Erectile dysfunction (ED) after radical prostatectomy (RP) still represents a major issue. Considering the benefits recently described regarding the application of low-intensity extracorporeal shockwave therapy (LiESWT) in vasculogenic ED, questions arise about its role in the scenario of penile rehabilitation. Aim To compare the early introduction of phosphodiesterase-5 inhibitor (PDE5i) with a combination therapy enrolling both early PDE5i use and LiESWT in patients submitted to RP. Methods This study is a randomized clinical trial, open-label, with 2 parallel arms and an allocation ratio of 1:1. The study was registered in ReBEC (ensaiosclinicos.gov.br) Trial: RBR-85HGCG. Both arms started tadalafil at a dose of 5 mg/day right after the removal of the transurethral catheter, and the experimental group received 2,400 shocks/session-week distributed on 4 different penile regions. The full treatment consisted of 19,200 impulses across 8 weeks. Outcomes The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up. Any statistical difference in the IIEF-5 score between the arms was stated as the primary statistical end point. Results Between September 25, 2017, and December 3, 2018, 92 men were enrolled in the study. At last follow-up, we assessed 77 patients, 41 in the control group and 36 in the intervention group. A difference between groups was detected when accessing the final median IIEF-5 score (12.0 vs 10.0; P = .006). However, the primary clinical endpoint considering a difference ≥4-point between the arms has not been reached. When performing an exploratory analysis comparing the proportion of those individuals with an IIEF-5 score ≥17, no difference between groups was noted (17.1% vs 22.2%; P = .57). Clinical Implications So far, the benefits arising from LiESWT for penile rehabilitation after RP have been uncertain. Strengths & Limitations This is the first trial assessing the role of LiESWT on erectile function after RP. Our study protocol included only one session per week for the experimental group, raising a query if a more intensive application could achieve better results once a statistically significant difference was found between groups. We discontinue the PDE5i use at the last session, which may have interfered in the penile vascular rehabilitation, maybe compromising the results too. Conclusion After therapy with 19,200 impulses therapy across 8 weeks, we found an improvement of the IIEF-5 score, but it was not enough to be considered clinically significant. More studies are warranted before any recommendation on this topic.

Introduction Peyronie’s disease (PD) is a connective tissue disorder of the penis characterized by an abnormality in collagen structure of penile tunica albuginea. Aim We sought to investigate the prevalence, risk factors, and the relationship between erectile dysfunction (ED) and PD in male patients aged 30–80 years seeking urological care. Methods This is a cross-sectional study using data collected from October 2016 to October 2017 in an outpatient clinic associated with the Brazilian Public Health System. All men aged 30 to 80 years were invited to participate. Data collected were related to the clinical history and sexual habits of patients using the International Index of Erectile Function, in addition to the physical examination of the penis and laboratory parameters. Main Outcome Measure Descriptive statistics and multivariate logistic regression models tested the prevalence, risk factors, and the relationship between ED and PD in male patients. Results The study included 656 individuals, who were distributed as per age, marital status, race, educational level, and income. Of these participants, 86 (13.11%) presented with fibrous plaques compatible with PD at the physical examination. Among the risk factors evaluated, PD was associated with diabetes, smoking, and obesity in 43.02, 64.17, and 26.74% of patients, respectively. The presence of penile plaques compatible with PD was more prevalent in men with ED, history of penile trauma, and complaint of penile deformity. There was a higher prevalence of plaques in the distal penis. Conclusion The PD among the studied population was associated with risk factors such as diabetes, smoking, and obesity. Other clinical characteristics, such as history of penile trauma, penile deformity, and ED, were reported in patients with PD. There was a higher prevalence of plaques in the distal penis, specifically in the corona of the glans penis. The prevalence of PD was different from that in the published literature, our results show that numbers thus more studies are needed.

Background Peyronie's Disease (PD) is a connective tissue disorder that affects the tunica albuginea (TA) of the penis causing curvature and erectile dysfunction. The pathophysiology is not well understood and, for this reason, treatment options are limited. Objective The aim of the present study is to analyze and compare whether single or multiple instillations of plasma in the TA of rats is capable of triggering macroscopic, histopathological, and molecular changes consistent with PD. Material/methods Fifty male Wistar rats were divided into four groups: Group 1: a single instillation of plasma in the TA; Group 2: a single instillation of distilled water in the TA; Group 3: four instillations of plasma in the TA (1x per week); and Group 4: four instillations of distilled water in the TA (1× per week). Forty-five days after the last instillation a manual inspection of the corpus cavernosum, a penile erection test and a penectomy were performed to obtain material for histopathological and molecular analysis. Results It was observed that 31.25% of the rats that received repeated instillations of plasma presented penile curvature according to the erection test, while none of the rats from the control group or group with one instillation of plasma presented curvature. In the animals that received four instillations of plasma, the following differences were observed in relation to the control group: increase in fibrosis and the deposition of collagen I. The protein expression of heparanase (HPSE) and TGF-β increased in the groups that received a single or four instillations of plasma, and the protein expression of heparanase-2 (HPSE-2), metalloproteinases (MMP-2, MMP-9) and metalloproteinase inhibitor (TIMP-2) showed an increase in the group that received four instillations of plasma. There was a significant increase in the gene expression of HPSE, MMP-9, and TGF-β in the group that received four instillations of plasma. In the analysis of the glycosaminoglycans, an increase was observed in the secretion of galactosaminoglycans chondroitin sulfate and dermatan sulfate (CS/DS) in the group that received four instillations of plasma. Discussion Previous studies have demonstrated increased protein expression. of HPSE, MMP-9 and TGF-β with instillation of blood in the TA; however, there was no increase in gene expression. In the present study, the increase in the expression of TGF-β with plasma instillations, proved to be more reliable. The two models with plasma (one or four instillations) demonstrated significant histopathological and molecular changes when compared to the control group. However, only in the group with four plasma instillations there was a macroscopic change. The idea is that repeatedly extravasation of TGF-β present in plasma of predisposed individuals acts as a trigger for the development and maintenance of changes in the extracellular matrix that perpetuate an anomalous inflammatory process present in PD. Conclusion The present study shows that the repeated instillation of plasma is a low cost in vivo model for the study of PD.

Women undergoing assisted reproductive treatment are usually concerned about the side effects caused by high doses of gonadotropin. A common inquiry of patients is concerning the weight gain as a consequence. The aim of this study was to evaluate if controlled ovarian stimulation increase the weight of women undergoing IVF treatment. Study design This retrospective cohort study included 734 women undergoing IVF treatment between January 2017 and May 2018 and had body weight measured on the day of ovarian stimulation starting (basal-weight) and on the hCG trigger day (hCG-weight). The difference of hCG-weight and basal-weight was calculated and correlated to number of oocytes retrieved and ovarian stimulation protocol. For 358 women, two international validated questionnaires to evaluate the anxiety and binge eating were applied at the end of ovarian stimulation and also associated to the body weight gain.The basal-weight and hCG-weight were paired compared and demonstrate a statistically significant weight gain from basal to hCG-weight of a mean of 387.7 ± 720.4 g (p 0.001). The weight gain had a positive correlation with the number of oocytes retrieved (Pearson correlation, r = 0.181; p 0.001) but no correlation with the ovarian stimulation protocol. Regarding the questionnaires answered by patients, neither anxiety score (Pearson: r = -0,031; p = 0,561) nor binge eating score (Pearson: r = 0,069; p = 0,199) were correlated with weight gain from basal-weight to hCG- weight. However, patients who felt eating more during the treatment had a higher weight gain (p 0.001) independently of the number of oocytes retrieved.The weight gain is possibly a result from edema and is clinically irrelevant despite of the statistical significance and will probably be resolved in some days after oocytes retrieval. A small "weight gain" was observed and associated to the number of oocytes retrieved regardless of protocol and medication used in the ovarian stimulation.

Background Patients may remain dissatisfied after penile prosthesis implantation for the treatment of erectile dysfunction. Studies showing the results of standardized protocols for preoperative psychological evaluation are lacking. Purpose To estimate the rate of patients considered psychologically unfit for penile prosthesis implantation and to compare their characteristics with those considered fit after the implementation of a standardized psychological profile evaluation protocol for men with erectile dysfunction. Methods Cross-sectional evaluation of men referred for penile prosthesis implantation by their urologists, based on organic causes for the erectile dysfunction, including a semi-structured (sexual and relational anamnesis of the patient and their partner, information about expectations about the results of the penile prosthesis implantation and possible complications) and a structured instrument including validated tools for the evaluation of depression and/or anxiety symptoms. These were the Self Reporting Questionnaire (SRQ-20), the 36-Item Short-Form Health Survey for quality of life, and the Five-Factor Model (FFM) for behavioral tendencies. After at least 3 interviews, the psychology team rated the patients as fit or unfit for surgery. Unfit patients were those with any of a set of warning signals indicating risk for dissatisfaction even after penile implantation. Main outcome measure The prevalence of patients considered “unfit for surgery.” Results The quality of life scores were good, but 27.6% of patients (95% confidence interval, CI: 16.7–40.9%) were unfit for surgery. Being unfit was associated with obesity (P = .027), anxiety and/or depression symptoms (P Conclusion The preoperative evaluation protocol combining standardized and validated tools shows that more than one-quarter of patients with a medical indication for penile prosthesis implantation were not in good psychological conditions for the surgery. The development of psychological evaluation protocols can help identify patients in need of adequate care before penile implantation.

Background To evaluate demographic, clinical and pathological characteristics of small renal masses (SRM) (≤ 4 cm) in a Latin-American population provided by LARCG (Latin-American Renal Cancer Group) and analyze predictors of survival, recurrence and metastasis. Methods A multi-institutional retrospective cohort study of 1523 patients submitted to surgical treatment for non-metastatic SRM from 1979 to 2016. Comparisons between radical (RN) or partial nephrectomy (PN) and young or elderly patients were performed. Kaplan-Meier curves and log-rank tests estimated 10-year overall survival. Predictors of local recurrence or metastasis were analyzed by a multivariable logistic regression model. Results PN and RN were performed in 897 (66%) and 461 (34%) patients. A proportional increase of PN cases from 48.5% (1979–2009) to 75% (after 2009) was evidenced. Stratifying by age, elderly patients (≥ 65 years) had better 10-year OS rates when submitted to PN (83.5%), than RN (54.5%), p = 0.044. This disparity was not evidenced in younger patients. On multivariable model, bilaterality, extracapsular extension and ASA (American Society of Anesthesiologists) classification ≥3 were predictors of local recurrence. We did not identify significant predictors for distant metastasis in our series. Conclusions PN is performed in Latin-America in a similar proportion to developed areas and it has been increasing in the last years. Even in elderly individuals, if good functional status, sufficiently fit to surgery, and favorable tumor characteristics, they should be encouraged to perform PN. Intending to an earlier diagnosis of recurrence or distant metastasis, SRM cases with unfavorable characteristics should have a more rigorous follow-up routine.

Introduction Penile prosthesis infections remain challenging despite advancements in surgical technique, device improvements, and adoption of antibiotic prophylaxis guidelines. Aim To investigate penile prosthesis infection microbiology to consider which changes in practice could decrease infection rates, to evaluate current antibiotic prophylaxis guidelines, and to develop a proposed algorithm for penile prosthesis infections. Methods This retrospective institutional review board–exempt multi-institutional study from 25 centers reviewed intraoperative cultures obtained at explantation or Mulcahy salvage of infected three-piece inflatable penile prostheses (IPPs). Antibiotic usage was recorded at implantation, admission for infection, and explantation or salvage surgery. Cultures were obtained from purulent material in the implant space and from the biofilm on the device. Main Outcome Measures Intraoperative culture data from infected IPPs. Results Two hundred twenty-seven intraoperative cultures (2002–2016) were obtained at salvage or explantation. No culture growth occurred in 33% of cases and gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%) and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures. Antibiotic regimens at initial implantation were generally consistent with American Urological Association (AUA) and European Association of Urology (EAU) guidelines. However, the micro-organisms identified in this study were covered by these guidelines in only 62% to 86% of cases. Antibiotic selection at admissions for infection and salvage or explantation varied widely compared with those at IPP implantation. Conclusion This study documents a high incidence of anaerobic, Candida, and methicillin-resistant S aureus infections. In addition, approximately one third of infected penile prosthesis cases had negative cultures. Micro-organisms identified in this study were not covered by the AUA and EAU antibiotic guidelines in at least 14% to 38% of cases. These findings suggest broadening antibiotic prophylaxis guidelines and creating a management algorithm for IPP infections might lower infection rates and improve salvage success.

A bstract Introduction Peyronie’s disease is characterized by abnormal healing of the tunica albuginea (TA), resulting in the production of a fibrotic plaque that leads to penile curvature and considerable psychological impact. Precise knowledge of various surgical techniques is of fundamental importance for proper management of the patient. Aim To compare results (including surgical success on quality of life and sexual satisfaction and complications) between 2 different techniques: with TA incision vs without TA incision. Methods The search was performed according to PRISMA in PubMed and Embase through September 2018. Key words searched were [“Peyronie” or “Peyronie’s disease” or “penile curvature” or “penile induration”] and [“technique” or “surgery” or “surgical”] and [“quality of life” or “sexual quality of life” or “sexual satisfaction” or “outcome” or “outcomes”]. Main Outcome Measure Thirty-one articles were considered for this review. The main outcomes were reported descriptively. Results The most significant results included penile straightening (88.5% vs 70.9% favoring not opening TA), perception of a palpable nodule (13.2% vs 27.4% favoring not opening TA), and loss of sensibility (11% vs 20% favoring not opening TA). Neither a prospective randomized study nor a direct comparison study has been performed for these techniques. There is no consensus among the studies on how to measure results. Subjective criteria were primarily used for evaluation, and there is a paucity of objective tools to quantify the outcomes. Conclusion There is no consensus on which technique achieves better results or fewer complications; therefore, the decision on which technique to use is a matter of surgeon preference. Studies comparing distinctive techniques and either opening or not opening the tunica albuginea should be performed to support surgical decision making. In addition, guidelines that could assist in the standardization of criteria should be investigated in future studies, with the aim of better evaluating outcomes. Barbosa, ARG, Takemura LS, Cha JD, et al. Surgical Treatment of Peyronie’s Disease: Systematic Review of Techniques Involving or Not Tunica Albuginea Incision. Sex Med Rev 2020;8:324–332.

Background Post-radical prostatectomy urinary incontinence (PPI) negatively affects the quality of life of patients. Accurate identification of the problem by physicians is essential for adequate postoperative management. In this study we sought to access whether there is, for urinary incontinence, any discrepancy between medical reports and the perception of patients. Methods We performed a retrospective analysis of medical records of 337 patients subjected to radical retropubic prostatectomy (RRP) between 2005 and 2010. Sociodemographic variables were collected, as well as continence status over the course of treatment. Next, we contacted patients by phone to determine continence status at present and at time of their last appointment, as well as to apply ICIQ – SF questionnaire. Poisson regression model with robust variance was used to estimate the factors associated with discrepancy, using the stepwise backward strategy. Software used was Stata® (StataCorp, LC) version 11.0. Results There is discrepancy between medical reports and patients’ perceptions in 42.2% of cases. This discrepancy was found in 56% of elderly patients and 52% of men with low schooling, with statistical significance in these groups (p = 0.069 and 0.0001, respectively), whereas in multivariate regression analysis the discrepancy rate was significantly higher in black men (discrepancy rate of 52.6%) with low schooling (p = 0.004 and 0.043, respectively). Conclusion There is discrepancy between medical reports and the perception of black men with low schooling in respect to post-radical prostatectomy urinary incontinence and a need for more thorough investigation of this condition in patients that fit this risk profile.

Introduction Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. Aim To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. Methods A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. Main Outcome Measures This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. Results In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. Conclusion A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies.

Introduction Controversy exists as to whether erectile response to phosphodiesterase type 5 inhibitors is compromised in men with low total testosterone (TT) levels. This is amplified by reports of improved response to phosphodiesterase type 5 inhibitor therapy after coadministration of testosterone replacement therapy in hypogonadal men unresponsive to phosphodiesterase type 5 inhibitors. Aim To determine whether TT and luteinizing hormone levels influence efficacy of tadalafil for erectile dysfunction in men with concomitant lower urinary tract symptoms and benign prostatic hyperplasia. Methods This integrated analysis included 1,075 men randomized to once-daily tadalafil 5 mg (n = 540) or placebo (n = 535) for 12 weeks in three prospective clinical trials who had not received concomitant testosterone replacement therapy. Subjects were categorized at baseline by low vs normal TT levels (n = 1,049; 9.4 mIU/mL). Treatment-group differences in International Index of Erectile Function (IIEF) by hormone subgroups were assessed using analysis of covariance. Main Outcome Measures Changes in IIEF erectile function domain and other domain scores. Results The overall study population was comprised primarily of white men (>86%) with a mean age range of 64 to 70 years. Median baseline TT level in the integrated population was 355 ng/dL; levels were lower than 300 ng/dL (cutoff for normal) in 32.4% of men. Men with low TT levels reported diabetes (21.8%), cardiovascular disease (54.1%), and hypertension (49.1%) numerically more often than men with normal TT levels (10.6%, 43.2%, and 36.7%, respectively). Low TT and high luteinizing hormone levels were associated with numerically, but not statistically significantly, lower 12-week IIEF domain scores compared with those with normal levels. Changes in most 12-week IIEF domain scores showed that tadalafil was significantly more effective than placebo (P < .02). Conclusion Low TT levels at baseline did not negatively influence response to tadalafil in men of advancing age with concomitant lower urinary tract symptoms and benign prostatic hyperplasia and erectile dysfunction.

The advent of intracytoplasmic sperm injection (ICSI) has changed the human reproduction landscape by overcoming several limitations related to both male and female infertility factors. However, despite the development of new technologies, the live-birth rate with ICSI has not exceeded 30%. In order to improve assisted reproductive technology outcomes, advanced sperm function analysis have gained increased attention and the effects of sperm DNA fragmentation (SDF) on assisted repro-duction success are being extensively studied. Utilizing ejaculated sperm with an elevated SDF has been found to result in poor ICSI outcomes. Furthermore, studies have reported that testicular sperm has lower SDF level, when compared to ejacu-lated sperm. This has led a number of clinicians world-wide to offer testicular sperm retrieval for ICSI in non-azoospermic males with high SDF. This practice has remained controversial due to lack of high quality evidence.

Background: Little is known about the factors that influence the graduation of medical students in relation to the preparation of their approach to sexual health care. Teaching hours for sexual education in undergraduate medical courses are frequently insufficient to prepare them for their roles to treat this complex issue. This study aimed to evaluate the delivery of sexual education to medical students by assessing their knowledge, attitudes, and self-confidence to treat patients. Methods: A 1-day course was organized to tackle the main concerns of patients in respect to sexual health problems. The course was comprised of classes and time for students to discuss doubts with specialists. At the end of the course the knowledge of students on the subject and their confidence to care for patients with concerns on sexual issues were evaluated. Results: Seventy-four medical students participated in the 1-day educational program on sexual medicine that included lectures about different topics and discussion. At the end of the course, students answered questionnaires about how the course had possibly improved their confidence regarding dealing with sexual issues. The analysis of the opinions of the students suggested an improvement in self-confidence with regard to discussing sexual behavior with patients. Conclusions: The results demonstrated a necessity to increase knowledge and stimulate positive attitudes of students about sexuality thereby improving their ability to treat patients with sexuality problems.

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. Glina S, Sharlip ID, and Hellstrom WJG. Modifying risk factors to prevent and treat erectile dysfunction. J Sex Med 2013;10:115-119.

Introduction With the worldwide increase in penile augmentation procedures and claims of devices designed to elongate the penis, it becomes crucial to study the scientific basis of such procedures or devices, as well as the management of a complaint of a small penis in men with a normal penile size. Aim The aim of this work is to study the scientific basis of opting to penile augmentation procedures and to develop guidelines based on the best available evidence for the management of men complaining of a small penis despite an actually normal size. Methods We reviewed the literature and evaluated the evidence about what the normal penile size is, what patients complaining of a small penis usually suffer from, benefits vs. complications of surgery, penile stretching or traction devices, and outcome with patient education and counseling. Repeated presentation and detailed discussions within the Standard Committee of the International Society for Sexual Medicine were performed. Main Outcome Measure Recommendations are based on the evaluation of evidence‐based medical literature, widespread standards committee discussion, public presentation, and debate. Results We propose a practical approach for evaluating and counseling patients complaining of a small‐sized penis. Conclusions Based on the current status of science, penile lengthening procedure surgery is still considered experimental and should only be limited to special circumstances within research or university institutions with supervising ethics committees. Ghanem H, Glina S, Assalian P, and Buvat J. Position paper: Management of men complaining of a small penis despite an actually normal size. J Sex Med 2013;10:294-303.

Introduction There is no universal gold standard diagnostic test to differentiate psychogenic from organic erectile dysfunction (ED). Cavernosography/cavernosometry has been used to evaluate veno-occlusive dysfunction (VOD) in men with a proposed organic ED. Aim To develop evidence-based guidelines for the performance and interpretation of cavernosography/cavernosometry. Methods Review the methodology behind cavernosography/cavernosometry and evaluate the evidence that supports its use and interpretation of results. Main Outcome Measure Expert opinion based on review of the literature, extensive internal committee discussion, public presentation, and debate. Results The detailed technique of cavernosography/cavernosometry is described. An evidence-based perspective to the use and interpretation of cavernosometry is presented. Conclusion The positive predictive value of cavernosometry still needs further assessment. It is unknown how many potent men would test positive for VOD (false positive). Glina S and Ghanem H. SOP: Corpus cavernosum assessment (cavernosography/cavernosometry). J Sex Med **;**:**–**.

Introduction Today, we have a clear concept of sexual medicine and how to define this medical discipline. But historically, the unification of sexuality and medicine was not a given condition. Medicine was mainly focused on human reproduction and how to prevent and treat sexually transmitted diseases. Hardly any other aspect would have met the interest of medical doctors for centuries. Methods Historical review that can only highlight developments and milestones of sexual medicine and is not intended to be encyclopedic. Results Perhaps, the first true medicalization of sexuality was the dreadful anti-masturbation campaign led by doctors, beginning with Tissot, since the middle of the 18th century. In the 2nd half of the 19th century, first pioneers like the physician Paolo Mantagazza were systematically addressing issues related to human sexuality. This highly developing scientific field and medical community were destroyed after 1933 by the political influence of the national socialists in Europe. After World War II, a new era started with the works of Alfred Kinsey and other sexologists mainly in the United States of America. Conclusions The term sexual medicine was established around 1970, most likely in Europe, and subsequently resulted in a new worldwide academic and clinical speciality. Schultheiss D, and Glina S. Highlights from the history of sexual medicine.

Introduction This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. Aim Expanding information on LC efficacy and safety. Main Outcome Measures International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). Methods A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. Results IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] ± standard deviation [SD]): placebo = 13.9 ± 5.2 and 14.8 ± 7.8; LC 40 mg = 13.6 ± 5.3 and 18.6 ± 8.0; LC 80 mg = 13.4 ± 4.9 and 20.6 ± 7.7 (analysis of variance [ anova ] P anova P anova P Conclusions LC showed a satisfactory efficacy–safety profile for oral therapy of ED. Glina S, Fonseca GN, Bertero EB, Damiao R, Rocha LCA, Jardim CRF, Cairoli CE, Teloken C, Torres LO, Faria GE, da Silva MB, and Pagani E. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: A phase III clinical trial.

I n 1982 in a letter to the editor of The Lancet [1], Virag exposed to the English literature the ability of an intracavernous injection of papaverine to induce an erection. He stated that an accidental intracavernous injection of that drug during an arterial epigastric cavernous anastomosis [2], a vascular procedure proposed to treat vasculogenic erectile dysfunction (ED), had produced a rigid erection for 2 hours. After this finding, Virag decided to study the effect of papaverine in the physiology of erection. He studied 15 patients with organic ED and 10 with non-organic ED. Eighty milligrams of papaverine were injected into one corpora cavernosa and continuous recording of intracavernous pressure (ICP) was done through a 21 G needle inserted in the contralateral corpora cavernosa. Duplex ultrasound and pulse plethysmography were used for continuous monitoring of penile arterial vessels. In same cases, selective bilateral internal iliac angiography was performed. After papaverine injection, there was an ICP increase; this increase was higher when patient were under general anesthesia (mean of 70 mm Hg against 40 mm Hg without anesthesia). An increase on arterial flow was seen by duplex ultrasound, pulse plethysmography, and angiography; the peak effect was seen after 2–15 minutes after injection and lasted from 10 to 120 minutes. According to Virag, 7 out of 15 patients with organic ED reported improvement on their erections in the days following the study. All of seven had arterial ED. There was no improvement on patients with non-organic ED. Based on those results, Virag started a “conservative therapy” in 30 patients with ED who had Doppler and arteriographic evidence of penile arterial insufficiency, including 12 with diabetes mellitus. Patients received an intracavernous injection of 80 mg of papaverine and after 15 minutes, an infusion of saline with 1% of heparin via an infusion pump until they reached a rigid erection which was maintained for 15 minutes. The procedure was performed without anesthesia and was repeated after 2 months and every third month after that. Of the 14 patients who had at least two procedures, called by Virag as artificial erections, four returned to their “normal sexual life,” nine reported significant improvement in their penile rigidity, and one had no change in his erectile function. Virag concluded that papaverine was a powerful smooth-muscle relaxant, possibly acting as phosphodiesterase inhibitor or with an antinicotinic effect; to him, artificial erections were associated to vasodilation of pudendal arteries branches and with a possible “mechanical action” at the level of cavernous tissue. Sidney Glina

I n 1941, Huggins and Hodges [1] published this classical article which established for the first time the relationship between testosterone (T) and prostate cancer (PCa). The goals of Huggins and Hodges were to present the values of serum phosphatases in normal men and patients with carcinoma of the prostate. Furthermore, they wanted to demonstrate that the serum levels of acid phosphatase were reduced in metastatic PCa by decreasing the activity of androgens and increased after androgens injections. Authors argued that there were evidences that the activity of phosphatases, mainly the acid one, in serum was found to provide objective indices of activity of PCa [2]. They evaluated alkaline and acid phosphatases of 40 normal men who served as controls to determine the normal range of enzymes levels, 21 men with benign prostatic hypertrophy, and of 47 men with carcinoma of the prostate. Eight patients who had carcinoma of the prostate with bone metastases and with moderate or great elevation of both phosphatases levels were submitted to bilateral orchiectomy. Five patients were injected with stilbestrol 1 mg or estradiol benzoate 1.66 to 3.32 mg daily, and two patients were injected with T propionate 1.25 mg daily before castration. In one patient, T was injected after castration. They also evaluated phosphatase levels in the cerebrospinal fluid of three patients and in the spermatocele fluid of one patient concurrently with the serum levels. They made serial observations of serum phosphatases 1 week before and 4 weeks after bilateral orchiectomy in four normal adult dogs. They found that of the 47 patients with PCa with or without bone metastases, 23 had both phosphatases levels in the range of the controls. Of the remaining 24, all had elevated levels of both alkaline and acid phosphatases. Of 25 patients with radiographic evidence of bone metastasis, 19 had elevated levels of both phosphatases. Alkaline phosphatase alone was increased in two cases, while acid phosphatase was within normal limits, and neither enzyme was increased in other four cases. There was no X-ray evidence of metastasis in 20 patients; in 16 men, both acid and alkaline phosphatases were normal; in three men, alkaline phosphatase was elevated, but in none of this group, the acid phosphatase level was increased. The authors did not report phosphatase levels in men with benign prostatic hypertrophy. After bilateral orchiectomy, the levels of acid phosphatase rapidly decreased (7 to 12 days); its levels usually persisted in a range slightly above or below the upper limits of the normal values and it was maintained at this value with slight fluctuation during the period of observation which in the longest case was 180 days. A rise was always observed in the value of alkaline phosphatase following castration followed by a decrease to or toward normal range. Serum phosphatases were within normal range in four dogs and therewere no changes after castration. © 2010 International Society for Sexual Medicine

K et al. published this landmark paper [1] in 1976 with the aim of proposing the monitoring of nocturnal penile erections as “the” tool that might remove the bias in the diagnosis of erectile dysfunction. In the Introduction authors stated that the diagnosis and treatment of impotence remained, at that time, “essentially an art, if not a myth,” because of a belief that impotence was only result of psychological disturbances. They wrote that nocturnal erections had been known for almost 30 years and in the last 10 years their group had concluded that the normality of nocturnal penile tumescence (NPT) was a reliable and objective indicator of the psychological or organic basis of erectile dysfunction (ED); an abnormal NPT indicated an organogenic ED, whereas a normal NPT lead to the diagnosis of psychogenic ED. The objective of the paper was to describe their first 100 patients and to present NPT data on patients with psychogenic and organogenic ED. Most of the patients had been referred for prosthesis implantation with Dr. Brantley Scott. NPT recording was part of an extensive “medical, neurological, endocrinological, psychiatric, and psychological evaluation” that the patient underwent before the surgery itself. For NPT recording patients usually spent three nights in the Sleep Disorder Center, where three electroencephalography channels, two eye movement channels, two penile circumference channels, and two perineal muscle activity channels were monitored continuously throughout each night. Penile circumference was monitored with mercury-filled strain gauges placed at the tip and at the base of the penis. On one evaluation night a patient was awakened during a typical erection the degree of the erectile response. The examiner tested at that moment the buckling tendency of the penis and photographed the erect penis. Based on the data on penile circumference change and rigidity, the patient’s NPT was classified as normal, borderline normal, abnormally diminished, or absent. From the sample of 100 patients, authors selected 11 patients with ED and diabetes who had exhibited absent or abnormal NPT and 11 patients with ED, age-matched with the first group, without known medical diseases and whose nocturnal erections were normal. They also selected for comparison 11 age-matched normal individuals who had undergone three consecutive nights of NPT monitoring. The diabetic patients had significantly less nocturnal erections and spent less time with full erections than other patients and normal control subjects. The maximum penile circumference change exhibited by diabetic patients was approximately one-fifth that of individuals of the other two groups. In the discussion, authors claimed that their study provided the first objective data on the organic impairment of erection of diabetic patients. They concluded that “NPT recording © 2009 International Society for Sexual Medicine

Introduction Psychosocial manifestations of erectile dysfunction (ED) differ across cultures. Understanding the treatment response to ED medications within cultural groups can aid in resource allocation and in developing treatment strategies. Aim Evaluate the effect of sildenafil treatment on self-esteem, confidence, and sexual relationship satisfaction in Brazilian men with ED. Main Outcome Measure The Self-Esteem and Relationship (SEAR) questionnaire, a validated, 14-question instrument developed to specifically address self-esteem and relationship issues within the context of ED. Methods Men aged 18 years or older with a clinical diagnosis of ED (≤21 on the Sexual Health Inventory for Men) and in a stable relationship with a partner during the study were eligible. The primary end point was a change from baseline in the self-esteem subscale of the SEAR questionnaire. Thirteen Brazilian sites participated in a randomized, double-blind, placebo-controlled trial of sildenafil treatment for ED. Patients were randomized to receive either 50 mg of sildenafil (adjustable to 25 mg or 100 mg based on patient response) or matching placebo approximately 1 hour before anticipated sexual activity but not more than once a day. Results At the end of double-blind treatment, 63 and 66 patients in the placebo and sildenafil groups, respectively, from 13 Brazilian sites were assessed for efficacy. Brazilian patients receiving sildenafil had significantly greater improvements in their scores on the SEAR self-esteem subscale (42.9 [95% confidence interval 35.7–50.0]) compared with placebo (21.1 [95% confidence interval 13.7–28.6]; P Conclusions The psychosocial parameters in Brazilian men with ED assessed by the SEAR questionnaire showed significant improvements in self-esteem, confidence, and relationships after treatment with sildenafil. Glina S, Damiao R, Abdo C, Afif-Abdo J, Tseng L-J, and Stecher V. Self-esteem, confidence, and relationships in Brazilian men with erectile dysfunction receiving sildenafil citrate: A randomized, parallel-group, double-blind, placebo-controlled study in Brazil.

I n 1973, Michal et al. published the first article [1] proposing corpus cavernosum revascularization through a direct arterial anastomosis to the cavernous body for the treatment of “chronic erective impotence.” The article was published in Czech and presented two experimental series and a case report of a patient with a history of 6 years of erectile dysfunction. In the experimental series, the authors had performed a direct anastomosis with the popliteal artery and femoralis superficialis artery to the corpus spongiosum and corpus cavernosum of dogs. The anastomosis to the corpus spongiosum had remained patent for more than 2 months and those to the corpus cavernosum for more than 3 weeks. The authors considered that the anastomosis to the cavernous body occluded because there was a disproportion of the flow between incoming arteries and the drainage of the corpus cavernosum; they stated that “there was a high-pressure system with limited possibility of drainage.” However, Michal et al. presented a patient who had been submitted to an end-to-side anastomosis between the epigastric artery and the corpus cavernosum, at the level of the pubic symphisis. They reported that the patient had resumed frequent spontaneous erections and that this result justified the use of this intervention in the treatment of “chronic impotence.” This work is one of the landmark articles in modern sexual medicine. Sidney Glina, MD Chair, Classic Citation

Introduction Is cavernosometry a useful tool in treating men with erectile dysfunction? Methods Five people with expertise and/or interest in the area of cavernosometry 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 While one urologist feels dynamic infusion cavernosography and cavernosometry seem to have found their place in history, another believes it is time to separate these tests and look at cavernosometry alone and its relevance to the use of duplex Doppler ultrasound, both useful tools in assessing surgical candidates. Three clinicians agree that cavernosography and cavernosometry have a role in specific cases, particularly before revascularization surgery. Conclusion Cavernosometry may not be a useful tool for the average clinician treating erectile dysfunction, but serves a purpose for the specialist. Vardi Y, Glina S, Mulhall JP, Menchini F, and Munarriz R. Cavernosometry: Is it a dinosaur?

Introduction It is now increasingly recognized that sexual health is important to overall good health and well-being. Aim The Global Better Sex Survey (GBSS) explored the sexual aspirations and unmet needs of men and women worldwide. Main Outcome Measures Participant responses to survey questions. Methods Data were collected during 2005 in 27 countries by phone, door-to-door, and street-intercept interview. Data were weighted by demographic characteristics to accurately reflect the general population of each country. Results Of the 12,563 respondents (men = 6,291, women = 6,272), 46% of men and 48% of women were younger than 40 years, 41% were 40–59 years, and 11% were 60 years or older. Nearly all men (91%) and women (94%) were married, living with a partner, or in a relationship. All aspects of sex (intercourse, foreplay, orgasm, attraction to partner) were important to men and women. Nearly half (48%) of men surveyed reported some degree of erectile dysfunction (ED). A significant proportion of men (65%) were not very satisfied with their erection hardness (63% of women were not very satisfied with their partner's erection hardness). An association existed between satisfaction with erection hardness and satisfaction with sex life, love and romance, and overall health. Only 7% of men reported using a prescription medication for ED. However, 74% of men were willing to take medication to improve their erections if they thought they had ED; 64% of women would support such a decision. Conclusions The GBSS reports the sexual needs and desires of men and women worldwide. Erectile function and the effect of ED on aspects of the sexual experience emerged as the most pressing concerns among male participants. Mulhall J, King R, Glina S, and Hvidsten K. Importance of and satisfaction with sex among men and women worldwide: Results of the Global Better Sex Survey.

I n 1952, Giuseppe Conti published a long paper (45 pages) [1] in which he detailed his anatomic findings on the human penis and proposed a theory to explain the erection phenomenon. In the introduction Conti explained that he conducted the research at the anatomical school of Padua, which had been interested since 1915 in “the structural characteristics of the vessels walls but extended to all the mechanisms that favored, retarded, or diverted the flow of the blood.” Conti justified that he had chosen the research on the blood vessels of the human penis because of the “enormous functional importance of the dynamics of circulation in this organ.” He examined 20 human penises from men ranging in age from newborn to 77 years. The specimens were obtained from autopsied cadavers 24 hours after their death; individuals with visible macroscopic changes of the external genitalia or whose histories might indicate possible lesions of the penis were excluded. Conti made various sections from the pendulous portion of the penis and the glans; the sections were in series, making possible to follow structures for as far as 3–4 mm. The author divided his manuscript into chapters. Chapter 1 was dedicated to introduction, chapter 2 to material and methods. In chapter 3, Conti started with a general consideration of the arteries of the penis and their divisions (artery of the penis, bulbourethral artery, urethral artery, cavernous artery, and dorsal artery). As a result of his observations, Conti stated that he had found, along the entire course of the dorsal artery and the cavernous artery, structures that regulate the blood flow. They were little endoarterial bands formed of muscle and connective tissue (cushions). In chapter 4, Conti summarized his observations on the deep dorsal vein and its collaterals. He had found that “the walls of the veins in the deep network of the penis very often include muscular cushions projecting into the lumen” and “they were more frequent where smaller veins entered into a larger vein; at those points the cushions often had a sphincter-like structure.” In chapter 5, the author gave an explanation of the mechanism of erection based on his findings: “in the flaccid penis, the muscles of the arterial cushions are contracted and the vascular lumen is greatly reduced. During erection, on the other hand, the muscles of the arterial cushions relax. At the same time, the muscles of the venous cushions contract, closing the lumen of the veins, thus preventing the outflow of blood.” Chapter 6 was devoted to the corpus cavernosum and corpus spongiosum. The first was described as a sponge, formed by cavities forming numerous intercommunicating sinuses. Its walls were formed by muscular and connective tissue and lined with endothelium. In the peripheral portion of the corpus cavernosum, located directly beneath the albuginea, Conti described “bloodcontaining spaces which should probably be considered veins.” He classified the sinuses of the corpus cavernosum as a venous segment of arteriovenous anastomoses. According to Conti, the corpus spongiosum was clearly differentiated from the corpus cavernosum; its morphology varied from the dorsal portion of the urethra to the ventral portion and with age. Its sinuses were surrounded by columns with sparse muscular tissue in the newborn. With age, those columns were populated with muscular tissue and a network of elastic fibers. Conti stated that the © 2008 International Society for Sexual Medicine

*Department of Urology, Instituto H. Ellis, Sao Paulo, Brazil; Department of Urology, The James Buchanan Brady Urological Institute, The Johns Hopkins Hospital and The Johns Hopkins University School of Medicine, Baltimore, MD, USA; Division of Urology, University of Buenos Aires, Argentina; Division of Urology, University of Western Ontario, Canada; Department of Urology, Tulane University, New Orleans, LA, USA

G et al. decided to do this phase one study due to the need for an effective medical treatment for Peyronie’s Disease (PD), particularly for “Symptomatic men who are unhappy with their lot but wary of the risks and rigors of a reconstructive operation” [1]. They had shown in a previous study [2] that purified clostridium collagenase in vitro dissolved plaque tissue without any action on elastic tissue, vascular smooth muscle or the myelin. In this classic article, they studied 31 men with mean age of 55.5 (22–67) years with a history of PD for a mean interval of 22.2 (260) months. Ten of them had been submitted to other treatments including radiotherapy and intralesional corticosteroids with no improvement. One patient had undergone an unsuccessful plaque excision and grafting. Mean curvature was 42° (11–190). Fourteen patients still had pain at the beginning of the study and 4 were not able to have intercourse due to pain or penile deformity. Objective evaluation of the curvature was done by “tracing of the erect penis on the vertical and horizontal planes” at the beginning of the study and 4 weeks after treatment. It is not clear in the articler whether this drawing was done at home by the patient or at the office, with any pharmacologic or sexual stimulation. Plaques were measured manually and classified as small or impalpable (less than 8 mm), moderate (8–5 mm) and large (>15 mm). Six, 12, and 13 patients had small, moderate, and large size plaques. Collagenase was injected intralesionally with a 1.0 cc tuberculin syringe with a 23-gauge needle. Injection was done daily for three days under local anesthesia; lidocaine was infiltrated into the injection site in 22 patients and in the remaining 9 patients it was injected into corpora cavernosa. The collagenase was used in concentrations of 470620 mg/mL in the first 15 patients and 910 mg/ml in the remainder. The first six patients received collagenase only, the other 25 received baminopropionitrile fumarate topically (7 patients) or orally (17 patients). This drug was used as an adjuvant therapy due to its ability to prevent fibrosis formation in the healing process. Objective improvement was seen in 20 patients; plaques disappeared or were significantly altered in 4 patients and penile curvature decreased 20–100% in the remaining 16. Pain was eliminated in 13 of the 14 patients. Three out of four regained ability to have penetration. Injections were well tolerated; 21 patients had ecchymosis and two complained of pain. One patient had an albuginea rupture during intercourse two weeks after treatment, which was believed to be collagenase related. Authors commented in the discussion that the main aspect of the study was the ability to prove the safety of intralesional collagenase, even not impairing the possibility to do a surgery on the failure cases, what had happened in two cases of this group. Interestingly, the article was followed by two editorial comments by Leonard M. Zinman and Charles J. Devine who had raised the need for further studies for clarifying long-term results and the possible systemic and immunological effects of the collagenase. Sidney Glina, MD Editor, Classic Citations © 2007 International Society for Sexual Medicine

Guideline is information intended to advise people on how something should be done or what something should be, according to Cambridge Dictionary (1). In a medical context, “guidelines are a series of suggestions, issued by official bodies or by independent experts, for the conduct of medical practice. They include advice on the treatment of particular disorders or on effective ways of dealing with any clinical or human-relational problem” (2).

Introduction The introduction of safe and effective therapies for sexual dysfunctions depend upon appropriate clinical protocol design, study procedures, data collection and analysis. Aim To provide recommendations/guidelines concerning state-of-the-art knowledge for standards for clinical trials in sexual dysfunction in men, particularly in the areas of erectile dysfunction and rapid ejaculation. Methods An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Male Sexual Dysfunction Committee, there were six experts from four countries. Main Outcome Measure Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. Results Drug development requires a multiphased approach. Phase 1 studies investigate multiple-dose safety, tolerability and pharmacokinetic issues. Phase 2 programs explore dose ranging (lowest effective, maximally tolerated and toxic doses). Phase 3 trials provide the substantial evidence including drug–drug interaction data and studies in special populations. Clinical studies require validated outcome assessment instruments conducted in defined but representative patient populations. Daily diaries or per-event questionnaires are patient-reported outcomes that assist in retrospective questionnaire interpretation. A qualified biostatistician should calculate the sample power for the trial, type of statistical model and design employed, use of covariate or subgroup analyses, and calculation of effect sizes. Conclusions More research is needed in developing standards for use in the development of clinical trials and outcomes assessment researching either erectile dysfunction or rapid ejaculation.

Introduction Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described. Aim Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED). Methods A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks. Main Outcome Measures International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs). Results Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P Conclusions TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.