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Die Bedeutung der Sexualitat fur eine Partnerschaft nimmt zwar mit zunehmendem Alter ab, ist aber auch noch in fortgeschritteneren Altersgruppen fur ca. die Halfte der Befragten von Bedeutung, wie eine reprasentative Umfrage aus Australien in einer 75–95 Jahre alten Population (n = 2783) zeigt (Tab. 1, Hyde et al. 2010)

ZusammenfassungDiagnose und Therapie männlicher Sexualstörungen zeitigten in den letzten 50 Jahren enorme Fortschritte. Beginnend mit der Entwicklung hydraulischer Penisimplantate 1973 stehen mittlerweile verschiedene effektive und gut verträgliche konservative Behandlungsmethoden wie die PDE-5-Hemmer Avanafil, Sildenafil, Tadalafil und Vardenafil, die transurethrale Applikation von PGE1 (MUSE), die Selbstinjektionstherapie mit den vasoaktiven Substanzen Alprostadil, Papaverin/Phentolamin (Bimix), PGE1/Papaverin/Phentolamin (Trimix/Triple Drug) oder VIP (Aviptadil)/Phentolamin-Invicorp) zur Verfügung. In jüngster Zeit hat die Li-ESWT eindrucksvolle Ergebnisse sowohl bei PDE-5i-Non-Respondern als auch Respondern sowie teilweise auch bei IPP gezeigt. In der Behandlung der Ejakulatio präcox stehen mit dem oralen Dapoxetin und dem topischen Xylocain/Prilocain Spray mittlerweile 2 effektive Medikamente zur Verfügung, welche in schweren EP-Fällen miteinander kombiniert werden können oder mit PDE-5-Hemmern bei Männern mit EP und ED. Hormonelle Störungen wie Hypogonadismus, Hyperprolaktinämien und Schilddrüsenstörungen können mit Sexualstörungen vergesellschaftet sein und mittels T-Substitution, Prolaktinhemmern oder schilddrüsenspezifischen Medikamenten erfolgreich behandelt werden. Während vaskuläre Eingriffe bei ED wie Dorsalvenenligaturen/Resektionen und arterielle Revskularisationsverfahren die 80er- und 90er-Jahre des letzten Jahrhunderts dominierten, gelten sie heute als überholt und werden bei schwerer organischer ED durch die modernen dreiteiligen aufblasbaren Penisimplantate ersetzt, deren mittlerweile hoher technischer Standard 10-Jahresüberlebensraten um die 70 % erlauben.

Introduction Peyronie’s disease (PD) is a progressive and devastating penile disorder that often results in severe penile curvature with penile shrinking, making vaginal insertion difficult or even impossible. Until now, in contrast to other penile disorders such as erectile dysfunction, PD is characterized by a paucity of conservative treatment options. Aim To investigate the current status quo in the management of PD across European experts in sexual medicine. Methods Members of the European Society of Sexual Medicine and of various andrology and urology societies across Europe, with the majority (78%) being urologists, were contacted via e-mail and newsletters and asked to fill in an online questionnaire. The survey comprised 56 items developed by an expert consensus of the educational committee of the European Society of Sexual Medicine. In the end, 401 participants responded to the entire survey, with 277 reporting treating PD patients themselves and knowing this penile entity very well. Main Outcome Measures Main outcome measures include description of current strategies regarding diagnosis and treatment of PD as reported by specialists in this field. Results Of the physicians treating PD patients, 94% performed penile palpation, and 74% perform ultrasonography. 45% assessed the degree of penile curvature by means of intravenous drug testing, but only 17% measured it accurately with a goniometer. Penile length, flaccid or in erect state, was measured by only 39% or 25%, respectively. Only 45% assessed testosterone. Primary treatment options were oral (65%), counseling (57%), and topical/local therapy (30%). Among oral drug users, tadalafil 5 mg was the most commonly used (57%), followed by vitamin E (40%). Regarding intralesional therapy, collagenase clostridium histolyticum was the leading drug (34%), followed by calcium channel blockers (17%). Considering surgical procedures, the original Nesbit technique was the preferred procedure (33%). 36% of the specialists expressed their dissatisfaction with the currently available treatment options, and 64% reported the impression that their patients were mostly dissatisfied with the treatment outcomes. Clinical Implications Innovative and presumably multi-modal treatment protocols for PD are urgently needed. Strengths & Limitations The survey represents 1 of the largest studies on the management of PD. The results are representative for the standard management of PD mostly among European Urologists with specialization in sexual medicine and may therefore not be generalizable to regions outside Europe or to other physicians treating PD. Conclusion Around one-third of experts and, from their perspective, around two-thirds of patients are dissatisfied with the currently available PD treatment options.

Introduction Besides erectile dysfunction, premature ejaculation (PE) is the most frequent male sexual disorder and shows a high level of bother and distress. The negative consequences of long-term and unsuccessfully treated PE on both patient and partner are well established in the literature and include personal distress, impairment of the partner’s sexual function, and interpersonal difficulties. Aim To outline the consequences of untreated PE and the advantages and disadvantages of currently available treatment options with a special focus on a new topical eutectic lidocaine/prilocaine metered dose spray (Fortacin; Lidocaine/Prilocaine, Recordati, Milan, Italy) which represents the second officially approved drug in this indication. Methods Narrative overview of the literature synthesizing the findings of literature retrieved from searches of computerized databases such as Web of Science, Medline, PubMed, and Google Scholar, hand searches, and authoritative texts. Combinations of keywords including premature ejaculation, ejaculatory control, intravaginal ejaculation latency time, IELT, PE, PDE5 inhibitors (PDE5i), SSRIs, topical anesthetics, lidocaine, prilocaine, and treatment were used. In the end, 59 studies published between 2000 and 2018 were considered relevant for this review. Main Outcome Measures Published studies on PE-related negative psychosocial outcomes, as well as advantages and disadvantages of currently available off-label and officially approved treatment options. Results Although a variety of treatment options for PE have shown marked improvements in stopwatch-measured intravaginal ejaculation latency time (IELT) and patient-reported outcomes as assessed by the Premature Ejaculation Profile (PEP), none of the investigated drugs has reached market approval. The only so far officially approved medication—dapoxetine—is characterized by high discontinuation rates of up to 90%, mostly because of high side effects, cost issues, efficacy below expectations, and the need for scheduling sexual intercourse. Conclusion With the official approval in Europe the new dose-metered lidocaine-prilocaine spray (Fortacin) may become a real first-line therapy option for PE and may offer a satisfactory and affordable solution, especially because of its unique galenic preparation, making its handling easy and customer friendly. In addition, it has the potential to significantly increase the currently low patients’ acceptance of available monotherapies and become an established second-line therapy for the severe PE patients with IELTs Porst H, Burri A. Novel treatment for premature ejaculation in the light of currently used therapies: A review. Sex Med Rev 2019; 7:129–140.

Introduction Although links between ejaculatory control or intravaginal ejaculatory latency time and female sexual functioning have frequently been reported in the past, no study has investigated the importance of other male ejaculatory characteristics, such as ejaculation volume and intensity, for women’s sexuality. Aim To assess the importance of subjectively perceived ejaculation intensity and ejaculation volume for female sexual function and satisfaction. Methods This was a cross-sectional online survey including 240 sexually active, heterosexual women (median age 27.4 years), using study-specific questions and validated questionnaires. Main Outcome Measure Results are presented as means, percentages, and age-controlled partial correlation coefficients of the main study variables. Results 50.43% of women considered it very important that the partner ejaculates during intercourse. 18.3% of women preferred that the partner ejaculates before they reach orgasm, whereas for 53.5% this did not matter. 22.6% of women stated that they experienced a more intense orgasm when their partner ejaculated during vaginal intercourse. 17.4% reported that they definitely experienced a more intensive orgasm depending on the intensity of their partner’s ejaculation, whereas for 17.8% this did not matter at all. 20.9% of women did not feel that their orgasm was more intense depending on the subjectively felt ejaculate quantity, whereas the majority (37.9%) stated that it did not matter. 13.1% of women regarded the quantity of expelled ejaculate as an expression of their own sexual attractiveness. Women stating that they experienced more intense orgasms when the partner ejaculated, when the partner experienced a more intense ejaculation, and when he expelled a greater ejaculate quantity also reported better lifelong orgasmic function (r = 0.24, r = 0.15, r = .26, respectively) and more lifelong sexual satisfaction (r = .29, r = .15, r = 26, respectively). Clinical Implications The perception of ejaculatory characteristics can be related to the female partner’s sexual satisfaction and overall sexual functioning. Strength & Limitations This is the very first study to explore the importance of male ejaculation volume and intensity for women’s sexual functioning. Data are of self-report nature and ejaculation characteristics were not objectively measured but by women’s self-report. Conclusion Although male ejaculation and its different aspects seem to play an important role for women, the study demonstrates a considerable variability of women’s attitudes toward ejaculatory characteristics. Further research is required to examine the sources of this variability.

Background To date, neither the original English nor any of the translated versions of the Sexual Complaints Screener for Women (SCS-W) have been tested for their psychometric properties. Aim To evaluate the validity and utility of the German version of the SCS-W by assessing content, convergent, and discriminant validity. Methods A population sample of 309 women (mean age = 26.9 years) completed the online survey and had matching data available on the SCS-W and the Female Sexual Function Index (FSFI). Spearman bivariate correlations between the SCS-W and FSFI domain scores and exploratory factor analysis with principal component analysis were conducted. Outcomes Convergent validity was excellent for the domain of orgasm, good for satisfaction, dyspareunia, and the total questionnaire score, and acceptable for desire, lubrication, arousal, and vaginismus. Discriminant validity was present for all domains apart from arousal, lubrication, and vaginismus. Varimax rotation suggested an 8-factor model was the most robust. Clinical Implications This brief screener seems suitable to provide a brief overview of female patients' sexual problems in a clinical setting. Strengths and Limitations This is the 1st study to assess the psychometric properties of the German version of the SCS-W. However, available information on the psychometric properties of the German SCS-W was limited because the validity of the screener could not be counterchecked against a clinical diagnosis of female sexual dysfunction. Conclusion Our results provide preliminary evidence of good validity of the German version of the SCS-W. Overall, the SCS-W can offer support for clinicians who are less familiar with sexual medicine and who might not routinely discuss sexual issues with their patients.

Premature ejaculation (PE) is a common complaint of male sexual dysfunction affecting men and their partners and consequently causing significant personal and interpersonal distress. Increased sensitivity of the glans penis and abnormalities of the afferent-efferent reflex pathway within the ejaculatory process are involved in the occurrence of PE. Drugs that either selectively reduce penile sensitization or modify the afferent-efferent reflex are well established therapeutic options for PE. Fortacin™ is the first topical treatment to be officially approved for the treatment of primary PE in adult men, and is mentioned as an experimental aerosol (as TEMPE) in the current European Association of Urology guidelines. It was approved for use in the European Union and launched in the United Kingdom in November 2016. Fortacin™ is a eutectic-like mixture of lidocaine 150 mg/mL and prilocaine 50 mg/mL that meets the requirements of an ideal treatment for PE because it is fast acting (within 5 minutes), has durable effects, can be easily used “on-demand”, and shows minimal side-effects. The metered-dose spray delivery system allows the desensitizing agents to be deposited in a dose-controlled, concentrated film onto the glans penis consequently reducing its sensitivity. This is translated into a delaying of the ejaculatory latency time without adversely affecting the sensation of ejaculation and orgasmic pleasure. The efficacy and safety of Fortacin™ have been proven by means of increased ejaculatory latency, control, and sexual satisfaction in large scale studies demonstrating the significant benefits for both patients and their partners.

In the literature, a strong preference towards pharmacological management with oral phosphodiesterase type 5 (PDE5) inhibitors has been demonstrated in men with erectile dysfunction (ED) versus other methods. However, following pharmacological management, a large proportion of men with ED discontinue treatment prematurely. Therefore, a better understanding of the expectations from, and demands on modern ED management from both the patients and their partners is needed in order to identify factors that may improve outcomes, patient adherence, and patient satisfaction with therapy. Thus, we will present new findings on patient and partner satisfaction and preferences, and discuss how the current pharmacological armamentarium can answer these needs.

To evaluate the efficacy and safety of a new penile traction device (PTD), 'Penimaster PRO', in a group of patients with stable Peyronie's disease (PD) compared with a non-intervention group in a multicentre study.A total of 93 patients with chronic stable PD (without erectile dysfunction, with no significant pain, and with a unidirectional curvature of at least 45° being stable for3 months) were recruited and followed for a 12-week period. Of these patients, 47 were randomly assigned to the Penimaster PRO group (PG) and 46 to the non-intervention group (NIG). Patients were asked to apply the PTD 3-8 h a day for 12 consecutive weeks, with specific instructions regarding the progressive increase of traction force applied to the penis over time. The primary outcome of the study was the change in the degree of curvature measured in the fully erect state after intracavernosal injection of alprostadil at baseline, 1, 2 and 3 months. Other variables, such as the type of curvature, stretched penile length (SPL), Peyronie's Disease Questionnaire (PDQ) scores, erectile function domain of the International Index of Erectile function (IIEF-EF) score and adverse events (AEs) were also assessed in each visit.Forty-one patients in the PG and 39 in the NIG completed the study. There was an overall reduction in curvature of 31.2° (P0.001) at 12 weeks compared to baseline in the PG, representing a 41.1% improvement from baseline, which significantly correlated with the number of daily hours the device was applied in a dose-dependent manner. Those patients using the device4 h/day experienced a reduction of 15°-25° (mean 19.7°, 28.8% improvement; P0.05), while patients using the device6 h/day experienced greater curvature reduction, ranging from 20° to 50° (mean of 38.4°, 51.4% improvement; P0.001). In contrast, no significant changes in curvature were observed in the NIG. Furthermore, SPL increased significantly in the PG compared to baseline and compared with the NIG, ranging from 0.5 to 3.0 cm (mean 1.8 cm; P0.05). The IIEF-EF score also improved in patients in the PG (by a mean of 5 points). Mild AEs occurred in 43% of patients, such as local discomfort and glans numbness.The use of the Penimaster PRO PTD, a non-invasive treatment, should be offered to patients with stable PD for 3 consecutive months before performing any corrective surgery, as this provided a significant reduction in the curvature, an increase in penile length and a significant improvement of the symptoms and bother induced by PD.

The aim of the present study was to investigate which PD specific factors (e.g., degree of penile curvature, levels of pain) cause most distress and to further explore whether there are specific subgroups of patients that report particularly high levels of psychological distress. Data were available for N = 119 men with a clinical diagnosis of PD presenting at a private Uro-Andrology in Germany. The strongest complaint of men with PD was being bothered by the look of the penis as opposed to being distressed by the pain (3.48 vs. 2.11). 75.4% reported having significantly less intercourse due to PD and for 61.4% this was very bothersome. Plaque size correlated positively with the level of symptom bother (r = 0.73, p

Erectile dysfunction (ED) can be improved by changing certain lifestyle factors such as sedentary lifestyle, unhealthy food, nicotine and alcohol abuse, or optimal management of risk factors/concomitant diseases causing or aggravating ED such as dyslipidaemia, hypertension, diabetes mellitus, depression, BPH/LUTS, or hypogonadism.First choice in the medical therapy of ED are PDE-5 inhibitors such as sildenafil, vardenafil, and tadalafil used p.r.n, or on a daily low-dose regimen regarding tadalafil, especially in patients suffering from ED and BPH/LUTS. Yohimbine and L-arginine may be considered in patients with mild PE, which also applies for topical alprostadil. Both transurethral alprostadil and self-injection therapy with alprostadil, papaverine/phentolamine, or the trimix combination consisting of all three compounds is mostly reserved for those patients non-or poorly responding to PDE-5 inhibitors. Finally, combination therapy with PDE-5 inhibitors and transurethral alprostadil or intracavernous self-injection therapy can be able to rescue non-responders to either monotherapy.

Women's perceptions of the men's ejaculatory behavior, as well as the impact premature ejaculation (PE) has on the couple's functioning, are important factors that need to be considered.This survey investigated women's perception and importance of ejaculatory function, as well as the specific aspects of PE that cause distress. In addition, the survey further identified the factors with a greater impact on intimacy, relationship, and sexual behavior.The 1,463 females belonging to a web panel from three different countries (Mexico, Italy, and South Korea), aged 20-50 years, participated in the survey. A combination of validated and self-constructed questionnaires to assess women's perception of PE, relationship satisfaction and quality, and sexual functioning and satisfaction were used.Descriptive statistics in form of proportions and percentages, correlation, and regression analyses.A significant correlation between the importance of ejaculatory control and felt distress could be observed (rho = 0.55, P 0.001). Women reporting less sexual problems considered ejaculatory control more important and reported more PE-related distress (rho = 0.23 and 0.11, respectively; P 0.001 for both). The male's lack of attention and focus on performance was the most frequently reported reasons for sexual distress (47.6%) followed by "the short time between penetration and ejaculation" (39.9%), and "the lack of ejaculatory control" (24.1%). Almost a quarter of women reported that the man's ejaculatory problem had previously led to relationship breakups (22.8%). Women considering duration to be important were more likely to report breakups.The study highlights the detrimental effects of PE on relationship and sexual satisfaction in the female partner and how it can lead to the termination of the relationship. Most notably, this is the first study to report that an important source of female distress are not only parameters related to performance such as control or duration but rather inappropriate attention focus and the negligence of other forms of sexual activities.

SUMMARY Aims: This was the first observational study evaluating treatment continuation, effec- tiveness and tolerability of tadalafil 5 mg once daily (TAD-OaD) in patients who chose and paid for treatment of erectile dysfunction (ED) in routine clinical practice. Meth- ods: Men ≥ 18 years with ED, treated previously with phosphodiesterase type 5 (PDE5)-inhibitor on-demand (PRN) or treatment-na€ive, were enrolled at 59 sites. For patients prescribed TAD-OaD at baseline (T1), change in erectile function (IIEF-EF and GAQ) was documented after 1-3 (T2) and 4-6 (T3) months. The primary outcome was the probability to switch/discontinue from TAD-OaD, estimated by Kaplan-Meier (KM) product-limit method. Changes in IIEF-EF were evaluated using a mixed model for repeated measures adjusting for patient baseline characteristics. Results: Of 975 men enrolled (median age 56.8 years, 33.7% with previous PDE5-inhibitor use), 778 were prescribed TAD-OaD, 135 TAD-PRN and 62 sildenafil or vardenafil PRN. During the 6- month longitudinal observation, 107 patients (13.8% of 778) switched or discontinued TAD-OaD-treatment. KM-rates (95%CI) for continuing TAD-OaD at 2, 4 and 6 months were 94.0% (92.3, 95.7), 88.3% (85.9, 90.6) and 86.3% (83.7, 88.9), respectively. The 25th percentile of time to switch/discontinuation of TAD-OaD was estimated as 31.1 weeks (lower 95%CI 30.3 weeks). At T3, IIEF-EF scores had increased by 7.1 (LSmean; 95%CI 5.8, 8.5) points; 91.3% of patients reported improved erections. The most frequently reported AE was headache (10 patients; 1.3%); no new/unexpected safety signals were observed. Conclusion: Under routine conditions, and when patients were involved in treatment decision-making, more than 86% of men starting/ switching to tadalafil once daily (OaD) at baseline continued tadalafil OaD treatment for ≥ 6 months. What's known PDE5 inhibitor on-demand treatment for erectile dysfunction (ED) is frequently discontinued; adherence may vary depending on the initial regimen. What's new Under routine conditions, and when patients were involved in treatment decision-making, more than 86% of men starting/switching to tadalafil once daily (OaD) at baseline continued tadalafil OaD treatment for 6 months.

This analysis explores tadalafil once-daily treatment for 12 wk in clinical subpopulations of men with erectile dysfunction (ED).Assess the efficacy and safety of once-daily tadalafil 2.5mg and 5mg in patients with different ED characteristics and comorbidities.This analysis integrated data from six randomized, double-blind, placebo-controlled studies that assigned 1913 men with ≥3-mo history of ED either to once-daily placebo (n=596), tadalafil 2.5mg (n=394), or tadalafil 5mg (n=923). Clinical factors examined included: ethnicity, age, obesity, alcohol consumption, smoking, comorbidities, concomitant medication, and ED characteristics (etiology, duration, severity).Descriptive statistics were reported for efficacy and safety, including International Index of Erectile Function Erectile Function Domain (IIEF-EF) scores and Sexual Encounter Profile question 3 (SEP3) responses. Clinical factors were included in analysis of covariance models using last observation carried forward for SEP3 and IIEF-EF scores.Both tadalafil doses significantly improved SEP3 responses (least-squares [LS] mean change: 17.8% and 23.6%, respectively) and IIEF-EF scores (LS mean change: 4.2; 5.4) compared with placebo (p0.01). Treatment with 2.5mg and 5mg tadalafil resulted in IIEF-EF LS mean improvements ≥4 (minimal clinically important difference [MCID]) in patients with hypertension (4.3 [95% confidence interval (CI), 2.9-5.7]; 4.7 [95% CI, 3.5-5.8]), cardiac disorder (7.0 [95% CI, 4.7-9.3]; 6.3 [95% CI, 4.4-8.2]), or hyperlipidemia (5.3 [95% CI, 3.4-7.1]; 5.8 [95% CI, 4.3-7.4]). Obese patients (4.7 [95% CI, 3.4-6.0]), smokers (4.8 [95% CI, 3.0-6.7]), and psychogenic ED (7.3 [95% CI, 5.0-9.6]) reached MCID only after treatment with 5mg tadalafil. Severity-specific MCID (IIEF-EF change ≥7) was achieved by 44.5% of patients with severe baseline ED treated with tadalafil 5mg, compared with 11.6% of placebo-treated patients. No unexpected safety findings were observed. These analyses were performed on integrated data and can only provide descriptive results to guide further investigations.Treatment with tadalafil 2.5mg or 5mg once daily was well tolerated and resulted in clinically important improvements in patients with mild (54.3% and 74.8%, respectively), moderate (51.3% and 63.1%, respectively), or severe (33.7% and 44.5%, respectively) ED.

Introduction The demand for female genital plastic surgery (FGPS) has increased over the last few decades. Yet, to date, there are no objective explicit measurements to define “abnormal” appearance of genital organs. Using the results of this study, we aimed to produce a statement of the European Society for Sexual Medicine (ESSM) on FGPS practice. Aims To evaluate the prevalence of demand for FGPS and to explore the attitudes of sexual medicine specialists toward indications for FGPS. Methods Attendees of the 2012 Annual Congress of the ESSM in Amsterdam, the Netherlands, were asked to participate in a survey during the congress. Main Outcome Measure A 25-item self-report, closed-question questionnaire subdivided into three sections: sociodemographic data, professional background, and personal attitudes toward FGPS. Results Overall, a total of 360 physicians (mean age 48 years; range 23–72) from different medical disciplines completed the survey. There were diverse responses among participants regarding the definition of abnormal labial appearance and the techniques for labial reduction they perform. Overall, 65% responded that FGPS is frequently or occasionally demanded by the patients they treat. Likewise, most physicians (63%) reported that they never perform FGPS. Conversely, only 14% reported that they either frequently or occasionally perform FGPS. Almost one-third of participants believe that FGPS (labial surgery) improves sexual function. Fifty-two percent of participants answered that they believe that self image is the main reason for women to ask for labial surgery. Conclusions Self-image was regarded as the main factor in the demand for FGPS. Many practitioners in the field of sexual medicine recommend that women be referred for consultation with a psychiatrist or psychologist before undergoing FGPS. Lowenstein L, Salonia A, Shechter A, Porst H, Burri A, and Reisman Y. Physicians' attitude toward female genital plastic surgery—A multinational survey. J Sex Med 2014;11:33–39.

Background: Several drugs are approved for the treatment of lower urinary tract symptoms (LUTS) in men, but these are mostly used by clinicians as monotherapies. The combination of different compounds, each of which targets a different aspect of LUTS, seems appealing. However, only few clinical trials have evaluated the effects of combination therapies. Objective: This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS. Evidence acquisition: PubMed and Cochrane databases were used to identify clinical trials and meta-analyses on male LUTS combination therapy. The search was restricted to studies of level of evidence >= 1b. A total of 49 papers published between January 1988 and March 2012 were identified. Evidence synthesis: The alpha(1)-adrenoceptor antagonist (alpha(1)-blocker)/5 alpha-reductase inhibitor (5-ARI) combination provides the most data. This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for >1 yr; when given for 6 yr. The alpha(1)-blocker/muscarinic receptor antagonist (antimuscarinic) combination was most frequently assessed as an add-on therapy to already existing alpha(1)-blocker therapy. Inconsistent data derive from heterogeneous study populations and different study designs. Currently, the alpha(1)-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy. The combination seems to be safe in men with postvoid residual 4 mo concerning safety and efficacy of this combination. The alpha(1)-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports. More studies are needed before definitive conclusions can be drawn. Conclusions: An alpha(1)-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for >1 yr. Based on short-term follow-up studies, add-on of antimuscarinics to alpha(1)-blockers is an option when postvoid residual is

Introduction Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4‐week placebo run‐in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures International Prostate Symptom Score (IPSS), IPSS subscores, Quality‐of‐Life Index (IPSS‐QoL), BPH Impact Index (BII), and International Index of Erectile Function‐Erectile Function (IIEF‐EF) Domain score were used in this study. Results Tadalafil (N = 505) significantly improved total IPSS vs. placebo (N = 521); mean changes from baseline were −6.0 and −3.6, respectively ( P P No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF‐EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF‐EF Domain score during treatment were weakly correlated ( r = −0.229). Treatment‐emergent adverse events were consistent with previous reports. Conclusions Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF‐EF Domain score were weakly correlated. Porst H, Roehrborn CG, Secrest RJ, Esler A, and Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: Analyses of pooled data from four randomized, placebo‐controlled tadalafil clinical studies. J Sex Med 2013;10:2044–2052.

Introduction New diagnostic criteria for lifelong premature ejaculation (PE) have been proposed by the International Society of Sexual Medicine (ISSM), including an intravaginal ejaculatory latency time (IELT) of less than about 1 minute, lack of control over ejaculation, and PE-related distress or bother. Aim The aim of this study was to review evidence supporting the efficacy and safety of oral agents for the treatment of PE in the context of the new ISSM criteria. Methods The PubMed database was searched for randomized, double-blind, placebo-controlled studies of oral agents in PE that included stopwatch measurements of IELT. Main Outcome Measures The main outcome measure used for this study was a review of the efficacy and safety data of oral agents for PE aligned with ISSM criteria. Results Since the latest meta-analyses using similar criteria (conducted in 2004 and 2005 for selective serotonin reuptake inhibitors [SSRIs] and phosphodiesterase type 5 [PDE-5] inhibitors, respectively), eight studies evaluated SSRIs vs. placebo, one compared SSRIs, two evaluated PDE-5 inhibitors, and one evaluated an SSRI/PDE-5 inhibitor combination. New agents included dapoxetine (five studies) and tramadol (one study). Six studies enrolled men who met an approximation of the ISSM criteria. Although evidence suggests that most SSRIs, tramadol, and dapoxetine increase IELT to varying degrees, few studies included control over ejaculation and PE-related distress or bother as enrollment criteria or used validated patient-reported outcome instruments to evaluate these parameters. Among studies that provided comprehensive adverse event data, safety and tolerability observations in men with PE were generally similar to those observed in other populations; however, with the exception of dapoxetine, known SSRI-class effects (e.g., withdrawal syndrome) were not evaluated in men with PE. Conclusions This systematic review of well-controlled clinical trials in PE has demonstrated that while many oral agents, particularly SSRIs, tramadol, and dapoxetine, have proven effective and safe for the treatment of men with PE, few have been evaluated for their effects on the specific elements of the ISSM criteria.

Introduction With increasing interest and clinical research in male sexual disorders, it has become clear that not only psychological but also organic, neurobiological, and genetic factors may play an important role in premature ejaculation (PE). Aim This article provides an overview of the different treatment options both for lifelong (primary, “congenital”) and acquired (secondary) PE. Methods Review of the literature. Main Outcome Measures Currently used treatment options for PE. Results Treatments reviewed include psychological/behavioral/sexual counseling therapy, topical anesthetics, dapoxetine, and other selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and phosphodiesterase-5 (PDE-5) inhibitors. Conclusions Before starting any therapy for PE, correct diagnosis has to be made considering the patient's reported intravaginal ejaculatory latency time (IELT) and the duration and type of PE. Concomitant erectile dysfunction (ED) should be either ruled out or proven by appropriate means. In uncomplicated cases of PE with stable partnerships, medical treatment represents the first-choice option with a high likelihood of success. Dapoxetine, where available, or other SSRIs provide suitable therapeutic options with a good risk/benefit profile for patients. In complicated (“difficult-to-treat”) PE patients, a combination of medication and sexual counseling should be considered the first treatment option. Combination therapies of PDE-5 inhibitors and PE-related medications should be offered to patients suffering from comorbid PE and ED, with ED treatment starting first. In those patients with severe PE—IELTs of

Introduction. Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being. Aim. To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. Methods. An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures. New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations. Results. Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to men's and women's individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronie's disease; and priapism. Conclusions. Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective. Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson K-E, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, Eardley I, Fugl-Meyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, and Wasserman M. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2010;7:3572-3588.

Die Ejaculatio praecox ist eine der haufigsten Sexualstorungen des Mannes. Sie tritt primar oder sekundar auf. Die primare Form beruht vermutlich insbesondere auf genetischen Veranderungen des Serotonin-Transportersystems. Die sekundare Form ist dagegen meist mit anderen Erkrankungen assoziiert. Kennzeichen der Ejaculatio praecox sind eine verkurzte intravaginale Ejakulationslatenzzeit, mangelnde Kontrolle uber die Ejakulation, hoher Leidensdruck und partnerschaftliche Probleme. Die Therapie erfolgt neben sexualtherapeutischen Verfahren heute oft medikamentos, sowohl oral als auch lokal.

Introduction Premature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited. Aim To present integrated analyses of baseline characteristics and treatment outcomes from phase 3 dapoxetine trials in men with acquired or lifelong PE and mild or no ED. Methods Data were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ≥18 years, in a stable monogamous relationship for ≥6 months, met DSM-IV-TR criteria for PE for ≥6 months, had an International Index of Erectile Function EF domain score ≥21, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes. Main Outcome Measures Demographics, sexual history, and PE symptomatology at baseline, and mean IELT and patient-reported outcomes (PROs) at study end (week 12), were analyzed for men with acquired or lifelong PE and mild or no ED (EF score 21–25 vs. ≥26). Results Baseline characteristics except duration of PE were similar in men with acquired and lifelong PE, with no other differentiating features by ED status. Dapoxetine treatment improved significantly mean IELT (arithmetic and geometric) and PRO responses (perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, and interpersonal difficulty) for acquired and lifelong subtypes, but presence of mild ED diminished PRO responsiveness in both subtypes, particularly those with lifelong PE. Conclusions Baseline characteristics and treatment outcomes were generally similar in men with acquired and lifelong PE. The presence of mild ED appears to be associated with a more modest treatment response, irrespective of lifelong or acquired PE subtype. Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, and Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: Integrated analyses of two phase 3 dapoxetine trials.

Introduction. Over the past 20 years our knowledge of premature ejaculation (PE) has significantly advanced. Specifically, we have witnessed substantial progress in understanding the physiology of ejaculation, clarifying the real prevalence of PE in population-based studies, reconceptualizing the definition and diagnostic criterion of the disorder, assessing the psychosocial impact on patients and partners, designing validated diagnostic and outcome measures, proposing new pharmacologic strategies and examining the efficacy, safety and satisfaction of these new and established therapies. Given the abundance of high level research it seemed like an opportune time for the International Society for Sexual Medicine (ISSM) to promulgate an evidenced-based, comprehensive and practical set of clinical guidelines for the diagnosis and treatment of PE. Aim. Develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts. Method. Review of the literature. Results. This article contains the report of the ISSM PE Guidelines Committee. It affirms the ISSM definition of PE and suggests that the prevalence is considerably lower than previously thought. Evidence-based data regarding biological and psychological etiology of PE are presented, as is population-based statistics on normal ejaculatory latency. Brief assessment procedures are delineated and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients. Conclusion. Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. Therefore, it is strongly recommended that these guidelines be re-evaluated and updated by the ISSM every 4 years. Althof SE, Abdo CHN, Dean J, Hackett G, McCabe M, McMahon CG, Rosen RC, Sadovsky R, Waldinger M, Becher E, Broderick GA, Buvat J, Goldstein I, El-Meliegy AI, Giuliano F, Hellstrom WJG, Incrocci L, Jannini EA, Park K, Parish S, Porst H, Rowland D, Segraves R, Sharlip I, Simonelli C, and Tan HM. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med 2010;7:2947-2969.

Introduction With once-daily administration of tadalafil, dosing and sexual activity would no longer need to be temporally linked for patients with erectile dysfunction (ED). Aim To evaluate long-term safety and efficacy of tadalafil 5 mg dosed once daily for the treatment of ED. Methods Patients ≥18 years of age with ED of any functional severity or etiology received tadalafil 5 mg once daily for 1 (N = 234) or 2 (N = 238) years during the open-label extensions of two previously reported studies. Patients who completed the 1-year open-label extension concluded with a 4-week ED treatment-free period. Baseline was defined as prior to receiving any study drug. Main Outcome Measures Safety measures included adverse events, electrocardiograms, and clinical laboratory measures. Efficacy measures included the International Index of Erectile Function (IIEF)-Erectile Function (-EF), -Intercourse Satisfaction (-IS), and -Overall Satisfaction (-OS) domain scores, and the Global Assessment Questions (GAQ1: improved erections; GAQ2: improved ability to engage in sexual activity). Results Overall, 208/234 (88.9%) and 139/238 (58.4%) patients completed the 1- and 2-year open-label extensions, respectively. No study drug-related serious adverse events were observed. Treatment-emergent adverse events observed in ≥5% of the patients during the first year of either open-label extension were dyspepsia, headache, back pain, and influenza. No clinically meaningful abnormalities associated with tadalafil were observed for electrocardiograms or clinical laboratory measures. Mean IIEF domain scores improved from baseline to the conclusions of the 1- and 2-year open-label extensions, respectively: -EF, +10.4 and +10.8; -IS, +4.0 and +3.7; and -OS, +3.0 and +3.2. At the conclusion of the 2-year open-label extension, 95.7% and 92.1% of the patients reported positive responses to GAQ1 and GAQ2, respectively. Conclusions In these long-term, open-label, once-daily dosing studies, tadalafil 5 mg was well tolerated and effective, making it a viable alternative to the current on-demand dosing of tadalafil for men with ED. Porst H, Rajfer J, Casabe A, Feldman R, Ralph D, Vieiralves LF, Esler A, Wolka AM, and Klise SR. Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction. J Sex Med 2008;5:2160–2169.

Background Phosphodiesterase (type) 5 (PDE5) inhibitors are currently administered on demand for treatment of erectile dysfunction (ED). Once-daily dosing has been suggested to benefit patients. Objective To determine whether daily vardenafil use provides added clinical benefits to patients compared with on-demand dosing. Design, Setting, and Participants In this placebo-controlled, double-blind, multicentre parallel-group study, men with mild-to-moderate ED were randomised to 24 wk of treatment, followed by a 4-wk washout. Intervention Patients were randomised to receive once-daily vardenafil 10mg plus on-demand placebo for 12 or 24 wk, or once-daily placebo plus on-demand vardenafil 10mg for 24 wk. Measurements Primary efficacy variable was the between-group difference in change in International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to end of washout. Secondary variables included change from baseline in proportion of positive respondents to Sexual Encounter Profile questions and in satisfaction with treatment as assessed with the Treatment Satisfaction Scale (TSS). Results and Limitations LS mean changes from baseline in IIEF-EF scores were 2.02, 2.29, and 2.63 for vardenafil 12 wk once daily, 24 wk once daily, and 24 wk on demand, respectively. After washout, the trend was towards improved IIEF-EF scores in the on-demand group (20.58 [±0.96]) versus both once-daily groups (12 wk, 19.88 [±0.93]; 24 wk, 20.11 [±0.94]). Furthermore, there were no significant between-group differences in the percentage of patients with "normal" erectile function. TSS analyses demonstrated no significant differences between treatment groups. This study recruited patients with mild-to-moderate ED; therefore, the results may not be the same as in patients with severe ED. Conclusions Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration.

Introduction Benign prostatic hyperplasia (BPH) is associated with bothersome lower urinary tract symptoms (LUTS) and reduced patient quality of life (QoL). Phosphodiesterase (type) 5 (PDE5) inhibitors such as vardenafil are commonly used for the treatment of erectile dysfunction (ED), but have also been shown to improve the symptoms of BPH. This randomised, double-blind, placebo-controlled study investigated the effects of vardenafil on LUTS and QoL in men with BPH/LUTS, with or without concomitant ED. Methods Men aged 45–64 yr with BPH/LUTS and an International Prostate Symptom Score (IPSS) ≥12 were randomised to receive either 10mg vardenafil or placebo twice daily. LUTS were assessed with the use of two primary efficacy parameters, IPSS score and maximum urinary flow rate (Q max ), as well as postvoid residual (PVR) urine volume; ED was measured with the use of the erectile function (EF) domain score of the International Index of Erectile Function (IIEF-EF); and QoL was assessed with the Urolife™ QoL-9 questionnaire. Results After 8 wk of treatment, there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (−5.9 and −3.6, respectively; p =0.0013). Nominally significant improvements in irritative and obstructive IPSS subscores ( p =0.0017 and p =0.0081, respectively), EF ( p =0.0001), and Urolife QoL-9 ( p max and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. Vardenafil was generally well tolerated, with most adverse events considered mild or moderate in severity. Conclusions Vardenafil treatment significantly improved LUTS, EF, and QoL in men with BPH/LUTS. Vardenafil may be considered a promising treatment option for men with symptoms secondary to BPH.

Summary Aim: To assess the incidence of serious cardiovascular disease (CVD) events [i.e. myocardial infarction (MI) and stroke] and all-cause mortality in men with erectile dysfunction (ED) who received prescriptions for sildenafil. Methods: The International Men’s Health Study (IMHS) was a prospective, observational cohort study of patients with ED and a new or existing prescription for sildenafil. Baseline and follow-up questionnaires provided information on demographics, CVD risk factors and ED. Postevent questionnaires were mailed to patients following possible nonfatal CVD events to collect information related to exposure to sildenafil/ED treatments before the event. Results: Thirty-five CVD events were reported in 30 patients in the analysis set (n = 3813). The incidence of all-cause mortality, MI and stroke was 0.4, 0.6 and 0.1 per 100 patient-years of observation respectively. Among the six men who reported using sildenafil in the month before a nonfatal CVD event, two reported use in the 24 h before the event. Conclusion: The results of the IMHS support previous reports that ED and CVD are often comorbid and share risk factors.

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.

Introduction There are no psychometrically validated assessment tools designed to solely and specifically evaluate satisfaction with the quality of erections. Aim To develop and psychometrically analyze the Quality of Erection Questionnaire (QEQ), a new patient-reported measure developed to evaluate men’s satisfaction with the quality of their erections. Methods The questionnaire was developed through in-depth qualitative interviews of men with erectile dysfunction (ED) in the United States and Australia. An exploratory methodology study was conducted on 65 men with ED. Subsequently, the psychometric properties were confirmed in a larger dataset of 558 men with ED from two combined clinical trials. Main Outcome Measures Identification of potential redundancy or outliers in items (Pearson inter-item correlations); exploratory factor analysis (unrotated and varimax rotated); internal consistency (Cronbach’s alpha); convergent validity (Pearson correlation coefficients between the QEQ total score and domain scores of the International Index of Erectile Function); known-groups validity (ability of the QEQ scores to differentiate between ED severity groups); test–retest reliability (Pearson correlation coefficient). Results The QEQ demonstrated excellent convergent and known-groups validity. Additional analysis demonstrated high internal consistency (Cronbach’s alpha, 0.92). Item analysis demonstrated a unidimensional structure and suggested that satisfaction with hardness may be the key driver for satisfaction with overall quality of erections ( r = 0.8). The smaller exploratory study demonstrated good test–retest reliability ( r = 0.82). Conclusions The QEQ is a six-item, patient-reported measure with a unidimensional structure, which produces a total score that may be transformed to a 0–100 scale. Psychometric analysis confirmed reliability and validity of the QEQ, which solely and specifically evaluates satisfaction of men with the quality of their erections. The QEQ is a potentially useful measure for monitoring and evaluating treatment in those who are bothered by, or concerned about, their erectile function. Porst H, Gilbert C, Collins S, Huang X, Symonds T, Stecher V, and Hvidsten K. Development and validation of the Quality of Erection Questionnaire.

Background To explore the impact of patient-characteristics and relevant comorbidities on treatment continuation rates, effectiveness, and satisfaction in patients with erectile dysfunction (ED) who started or switched to tadalafil 5 mg once daily (TAD-OaD) at baseline. Methods In the EDATE observational study, phosphodiesterase-type-5 (PDE5)-inhibitor pretreated or naïve ED patients who started or switched to TAD-OaD were prospectively followed for 6 months. Time to discontinuation of TAD-OaD was estimated using the Kaplan-Meier product-limit method at Months 2, 4, and 6 in subgroups stratified by age (18 − 65 years and >65 years), PDE5-inhibitor pretreatment, ED-severity (mild, moderate, severe), and presence or absence of relevant comorbidities (BPH, diabetes, CVD, hypertension, dyslipidemia). LSmean change from baseline in International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores and associated 95 % CIs were assessed using a mixed-model for repeated measures. Visit, ED etiology, and subgroups were included as fixed-effects. Results Overall, 778 patients received prescriptions for initiating or switching to TAD-OaD at baseline. At Month 2, >90 % of patients remained on TAD-OaD, except those aged >65 years (86.7 %) and patients with severe ED (89.0 %). More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %), continued TAD-OaD at Month 6. There was a significant LSmean negative effect on IIEF- EF domain-score improvement for BPH (LSmean effect [95 % CI]: −2.77 [−4.98, −0.55], p = 0.014), previous PDE5-inhibitor treatment (−2.13 [−3.33,-0.94], p 65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS. Conclusions Under routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions. Trial Registration The study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_741. Electronic supplementary material The online version of this article (doi:10.1186/s12894-015-0107-5) contains supplementary material, which is available to authorized users.

Androgen deficiency syndrome is a commonly diagnosed condition. The aim of this study was to investigate common clinical practices of specialists in the field of sexual medicine regarding androgen replacement treatment for men and women. Attendees of the 16th Annual Congress of the European Society of Sexual Medicine held in January 2014 in Istanbul, Turkey, were asked to participate in a survey during the congress days. A 24-item self-report, closed-question questionnaire was distributed. Three sections were accessed: sociodemographic data, professional background and personal practice patterns regarding androgen substitution in men and women. A total of 133 physicians (mean age 47 years; range 25-79) completed the survey. Responses were inconsistent regarding the lab tests used for primary evaluation of male androgen deficiency. The majority of participants (62%) recommended testosterone replacement therapy for symptomatic men with testosterone levels

This study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours before sexual intercourse.A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for6 months who failedor=50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout.383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (or=18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2-10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p0.001). Vardenafil was generally well tolerated.The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated.

Introduction Data from head‐to‐head clinical trials of phosphodiesterase type 5 (PDE5) inhibitors are scarce, making it difficult for clinicians to differentiate among these agents to select the most appropriate treatment for their patients with erectile dysfunction (ED). Aim This randomized, double‐blind, crossover head‐to‐head clinical trial compared patient preference, efficacy, and safety of vardenafil and sildenafil in men with ED and diabetes, hypertension, and/or hyperlipidemia. Methods Prospective analysis was performed on two studies in which 1,057 men were randomized to vardenafil 20 mg (N = 530) or sildenafil 100 mg (2 × 50 mg encapsulated tablets) (N = 527) for 4 weeks. Following a 1‐week washout, patients switched treatment for 4 weeks. Main Outcome Measures Patients were asked about overall preference: “Overall, which medication do you prefer?”, plus 11 other preference questions relating to their ED treatment. Efficacy assessments after each treatment period included the erectile function (EF) domain score of the International Index of Erectile Function (IIEF); Sexual Encounter Profile (SEP) diary questions SEP2 and SEP3; Global Assessment Question (GAQ); and Treatment Satisfaction Scale (TSS). Data regarding adverse events were collected throughout the study. Results A total of 931 men (mean age 57.9 years) were included in the intent‐to‐treat (ITT) population. Non‐inferiority of vardenafil over sildenafil was achieved for overall preference (vardenafil 38.9%; sildenafil 34.5%; and no preference 26.6%). Additionally, the change from baseline in the EF domain score of the IIEF achieved nominal significance for vardenafil over sildenafil (10.00 vs. 9.40; P = 0.0052). Patients also had a higher percentage of positive responses for vardenafil for SEP2, SEP3, GAQ, and 12 of 19 questions on the TSS. Both drugs were well tolerated. Conclusions This randomized, double‐blind, head‐to‐head trial in ED patients with cardiovascular risk factors demonstrated noninferiority of vardenafil for overall preference. Vardenafil achieved nominal statistical superiority over sildenafil for several frequently used efficacy measures. Both drugs were well tolerated. Rubio‐Aurioles E, Porst H, Eardley I, and Goldstein I for the Vardenafil–Sildenafil Comparator Study Group. Comparing vardenafil and sildenafil in the treatment of men with erectile dysfunction and risk factors for cardiovascular disease: A randomized, double‐blind, pooled crossover study. J Sex Med 2006;3:1037–1049.

Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy.This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30).For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events.Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

To evaluate the reliability, efficacy, and safety of vardenafil, 10 mg, for patients with erectile dysfunction.Vardenafil-naive patients completed a 4-week treatment-free run-in phase and a 1-week single-dose vardenafil (10 mg) open-label challenge phase. Responders to vardenafil in the challenge phase were randomized to 12 weeks of double-blind, fixed-dose treatment with vardenafil at 10 mg or placebo. Diary responses to Sexual Encounter Profile (SEP) questions about erections and attempts at sexual activity were collected after 4, 8, and 12 weeks of randomized treatment. Adverse events were monitored throughout the study.During the open-label challenge phase, the proportions of patients with a first-time success for penetration (SEP2) and maintenance of erection (SEP3) were 87% and 74%, respectively. Of 600 patients challenged with a single dose of vardenafil at 10 mg, 260 were randomized to vardenafil and 263 to placebo. During the double-blind phase, the reliability of penetration and maintenance rates for patients successful during the challenge phase were significantly greater with vardenafil compared with placebo (83.4% vs 55.8% [SEP2] and 76.6% vs 42.1% [SEP3], respectively). At week 12, patients in the vardenafil group had a consistently higher least squares mean (SE) on the erectile function domain score of the International Index of Erectile Function than patients in the placebo group (23.5 [0.4] vs 15.8 [0.4], respectively [last observation carried forward]) and a greater proportion of positive responses to the Global Assessment Question (80.8% vs 32.3%, respectively [last observation carried forward]) at each assessment (Pc.001). Vardenafil was generally well tolerated; most adverse events were mild to moderate, with headache and flushing reported most frequently.During this 12-week study, vardenafil produced consistently higher reliability of penetration and maintenance of erection rates compared to placebo and was generally well tolerated in patients with erectile dysfunction.

Introduction. Vardenafil, a potent and selective oral PDE5 inhibitor, is efficacious and generally well-tolerated in men with erectile dysfunction (ED). Of considerable interest to patients and physicians is an understanding of the time required after dosing to attain penile erection sufficient for successful sexual intercourse. Aim. To determine the earliest time to onset of action of vardenafil 10 and 20 mg leading to successful intercourse compared to placebo in men with ED. Methods. A prospective, randomized, double-blind, parallel-group, at-home study of 732 men with ED (mean age 55.5 years) was conducted at 64 sites in North America and Europe. Following a 4-week run-in period, patients were randomized to either vardenafil 10 (N = 237) or 20 mg (N = 248) or placebo (N = 247) to be taken on demand over 4 weeks. Using a stopwatch, patients recorded the elapsed time from dosing to attainment of an erection perceived to be adequate for penetration that led to intercourse completion. Earliest time of onset was defined as the fastest time among the first four doses for each patient. Time points from 25 to 5 minutes were tested for significance (alpha = 0.02 5) using a backward stepping procedure. Results. Mean baseline erectile function domain score (13.4) indicated moderate ED. Within 25 minutes after dosing, 50%/53% of men on vardenafil 10/20 mg had at least one erection in the first four doses perceived to be sufficient for penetration with subsequent intercourse completion compared to 26% on placebo (P < 0.0001). A statistically superior response to vardenafil vs. placebo was observed in these responders at all times >= 10 and >= 11 minutes (P < 0.025) in the 10 and 20 mg groups, respectively. In a retrospective analysis using time intervals of

Summary of Committee. For the complete report please refer to Sexual Medicine: Sexual Dysfunctions in Men and Women, edited by T.F. Lue, R. Basson, R. Rosen, F. Giuliano, S. Khoury, F. Montorsi, Health Publications, Paris 2004. ABSTRACT Introduction. Advances in understanding of the biochemistry and physiology of penile erection have led to breakthroughs in pharmacotherapy of erectile dysfunction. Aim. To provide recommendations/guidelines concerning state-of-the-art knowledge for the putative molecular and cellular mechanisms of action of centrally and peripherally acting drugs currently utilized in pharmacotherapy of erectile dysfunction. 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 two-year period. Concerning the Pharmacotherapy for Erectile Dysfunction Committee there were 25 experts from 10 countries. Main Outcome Measure. Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. Results. Selective and potent oral PDE5 inhibitors have significantly more affinity than cGMP and form broader molecular interactions with multiple amino acids, thereby blocking access to cGMP in the catalytic sites of the PDE5 enzyme. PDE5 inhibitors, which vary as to biochemical potency, selectivity and pharmacokinetics, lead to cGMP elevation and relaxation facilitation of penile corpus cavernosum smooth muscle cells following sexual stimulation. Various centrally acting drugs influence sexual behaviour. In particular, the dopaminergic substance apomorphine is a central enhancer that acts in the paraventricular nucleus of the hypothalamus as a dopamine (D2) receptor agonist, induces and increases penile erection responses via disinhibition, following sexual stimulation. Conclusions. There is a need for more research in the pharmacotherapeutic development of central and peripheral agents for safe and effective erectile dysfunction treatment.

Sildenafil is the oral phosphodiesterase-5 inhibitor that revolutionized treatment for erectile dysfunction. We investigated a potential association of the G protein beta 3 subunit (GNB3) C825T polymorphism, a determinant of intracellular signal transduction, with the drug response to sildenafil in patients with erectile dysfunction.In 113 men with erectile dysfunction and 111 healthy male controls genotype status of the GNB3 C825T polymorphism was determined by polymerase chain reaction and restriction analysis. Patients with erectile dysfunction received sildenafil at a dose of 25 to 100 mg. according to the individual erectile response. Drug response was measured by interviewing the patient according to the erection scale of 0 to 5.The GNB3 genotype distribution of patients with erectile dysfunction exactly matched that of healthy controls. Analysis of the response to sildenafil revealed a significant association of C825T allele status with the erectile response to sildenafil. In the group with TT genotype we observed a 90.9% response but only a 50.9% and 48.9% response in patients with the CC and TC genotype, respectively. The odds ratio for a positive erectile response was 10.0 (95% CI 1.2 to 81.1) for patients with the TT versus the TC/CC genotype (p = 0.01).The response to sildenafil is significantly associated with GNB3 C825T genotype status in patients with erectile dysfunction.

Erectile dysfunction may compromise quality of life for more than 30 million European men (and their partners). Although more likely with advancing age, erectile insufficiency can be effectively and safely treated and is no longer considered an inevitable consequence of aging. One potential treatment, the investigational agent tadalafil, is a potent, selective, reversible inhibitor of phosphodiesterase type 5 with a favorable pharmacokinetic profile that may translate into practical advantages. These advantages include a broad window of therapeutic responsiveness, which may relieve some men of the pressure to perform within a specific time frame and reduce the amount of planning of sexual activity. Plasma tadalafil concentrations are not affected by age, comorbidities (e.g. diabetes), food or alcohol. This profile should render treatment regimens convenient and uncomplicated, with consistent, "real-world" efficacy in a broad patient spectrum. In randomized, double-blind, placebo-controlled studies tadalafil, taken as needed before sexual activity without restrictions on food/alcohol intake, significantly enhanced erectile function (versus placebo), leading to successful intercourse in over 70% of attempts at more than 30minutes to 24hours after dosing and approximately 60% at 36hours. Tadalafil was well tolerated; headache and dyspepsia were the most common treatment-emergent adverse effects.

H can a couple in which the man is unable to control his ejaculation be defined? This situation is the “asynchronous” couple in which quantitative sex is still possible, but the quality of sexual relationship is lost. We have, obviously, a much more scientific and evidence-based definition of premature ejaculation (PE), which will be used throughout this special issue of the Journal of Sexual Medicine. However, for practicing clinicians who are dealing with patients’ perceptions, the translation of the technical term “PE” as sexual asynchrony would be an efficient way to understand this particular dysfunctional couple. After Masters and Johnson [1], we learned to consider, irrespective of who is the symptomatic partner, the couple as the real patient of any sexual dysfunction. However, for PE, there is something beyond this consideration and more specific. Although the lost control over the mechanism of ejaculation is to be considered—objectively— a male symptom, this unique male symptom is almost completely female-related or partnerrelated. Thus, the asynchronous couple is one where the man ejaculates prematurely with respect to the physiology of the pleasure of their partner. As a matter of evidence, PE is a common—if not the most common—sexual dysfunction [2], characterized by reduced ejaculatory latency and a perceived lack of control over ejaculation, generating a distress that can severely compromise the sexual health of the couple [3]. PE is a true medical need and its treatment is definitively not a recreational issue. In fact, this condition cannot be considered purely a psychological or “lifestyle” problem but rather a multidimensional disorder comprising a biologic dysfunction with psychosocial components [4]. Nevertheless, psychological aspects are an important consideration in PE, as in all sexual dysfunctions [5]. PE is a hot (if not the hottest) topic in sexual medicine. There has been a steady rise in the number of articles on PE over recent years (Figure 1). This increased interest in PE can be attributed largely to recent advances in the treatment of PE and the development of diagnostic tools and evidence-based treatment guidelines. A major breakthrough in the treatment of PE has been the development of the first oral drug specifically tailored for men with PE: the short-acting selective serotonin reuptake inhibitor dapoxetine (Priligy, Janssen Pharmaceutica NV, Turnhout, Belgium). The approval of dapoxetine for the treatment of PE offers new hope to the “asynchronous couple” to synchronize their pleasure. Its approval was supported by the largest clinical development program of any drug in PE to date, comprising five randomized, placebo-controlled Phase III trials and, so far, involving 6,081 men with PE. At this exciting juncture, we are delighted to bring you this compilation of informative articles in this special issue supplement, authored by renowned experts in the area of sexual medicine, that provide a useful and practical guide to managing PE. In the first article, Alessandra Graziottin and Stanley Althof consider the negative impact of PE on the man, his partner, and their overall relationship. They highlight the importance of recognizing that PE is a couple’s problem, and provide a rationale for managing the “couple with PE” (i.e., the asynchronous couple) by including both the man and his partner in its management. Despite the close association between ejaculation and erection, these two events are distinct 301

Introduction Since 2007, the European Society of Sexual Medicine has held an annual 2-week educational residential program at Oxford. The Oxford School of Sexual Medicine provides knowledge and skills learning opportunities for healthcare professionals. Aim The aim of the current study was to evaluate the impact of Oxford School courses on the daily practice and medical careers of fellows from different countries. Methods All participants in the Oxford School programs were invited to anonymously complete a self-administered questionnaire. Main Outcome Measures The questionnaire comprised three sections: socio-demographic characteristics of the respondents; four Likert-scale score items inquiring about professional background; and 17 closed and two open questions to evaluate the impact of Oxford School on the respondents’ practices. Differences in proportions of categorical variables between respondent subgroups were assessed using Pearson χ2 test. Results The mean age of the 54 fellows who participated in the study was 44 years (range 28–63 years), 71% were men and 29% were women. Fifty (92%) were physicians, two (4%) psychologists, and two (4%) were sex therapists. Following participation in the Oxford School course, significantly more participants reported spending 50% or more of their clinical time practicing sexual medicine than prior to the course (59% [32] vs. 27% [15], P Conclusion Educational activities in sexual medicine, such as the Oxford School, may contribute to the advancement of clinical practice, teaching activities, and clinical research of healthcare providers who are interested in sexual medicine.

Vardenafil, a novel selective phosphodiesterase type 5 inhibitor, was evaluated in its first large-scale at-home trial. A total of 601 men with mild to severe erectile dysfunction (ED) were enrolled in this multi-centre, randomized, double-blind, placebo-controlled trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF). In the intent-to-treat population (n=580), the changes from baseline for 5, 10 and 20 mg vardenafil (1.2, 1.3 and 1.5, respectively) were all improved (P