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Introduction Phosphodiesterase type 5 ( PDE-5) inhibitor treatment for erectile dysfunction ( ED) is frequently discontinued; adherence may vary depending on the initial regimen. Aim To evaluate the effects of initiating treatment with tadalafil once a day ( OaD), tadalafil on demand (pro re nata [ PRN]), or sildenafil PRN on treatment adherence. Methods In this multicenter, open-label study, men (≥18 years) with ED, naïve to PDE-5 inhibitors, were randomized (1:1:1) to tadalafil 5 mg OaD, tadalafil 10 mg PRN, or sildenafil 50 mg PRN. An 8-week randomized treatment ( RT) period (dose adjustment possible) was succeeded by 16 weeks of pragmatic treatment (switches between PDE-5 inhibitors allowed). Main Outcome Measures Treatment adherence was measured as time to discontinuation of RT (any cause), estimated by Kaplan- Meier product-limit method. Treatment-group differences were estimated as hazard ratio ( HR; Cox proportional hazards). Results Seven hundred seventy patients (mean age 53 years) were randomized to tadalafil OaD (N = 257), tadalafil PRN (N = 252), and sildenafil PRN (N = 261). Kaplan- Meier estimates for patients discontinuing RT were 52.2, 42.0, and 66.7%, respectively. Median time to discontinuation of RT was significantly longer for tadalafil OaD and PRN (130 and >168 days) compared with sildenafil (67 days) ( HR [97.5% confidence interval]: 0.66 [0.51, 0.85] and 0.49 [0.37, 0.65]; P < 0.001). Reasons for discontinuation with significant differences between groups ( P < 0.05) included 'lack of efficacy (duration of erection)' (sildenafil 9.2% vs. tadalafil OaD 4.3%, PRN 2.8%), 'time constraints due to short window of action' (sildenafil 4.2% vs. tadalafil OaD 0%, PRN 0.4%), and 'feel medication controls my sexual life' (sildenafil 2.7% vs. tadalafil OaD 0%). No between-group differences were found in International Index of Erectile Function- Erectile Function domain change from baseline to end of RT (least squares mean: 9.4-10.0, P = 0.359) or discontinuations due to adverse events (1.2-1.6%). The most common adverse event (≥4%) was headache. Conclusions ED patients assigned to tadalafil OaD or PRN adhered significantly longer to initial treatment than patients assigned to sildenafil PRN. Improvement of erectile function and safety profiles were similar in all three treatment groups. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction. Testosterone (T) deficiency (TD) may significantly affect sexual function and multiple organ systems. Aim. To provide recommendations and Standard Operating Procedures (SOPs) based on best evidence for diagnosis and treatment of TD in men. Methods. Medical literature was reviewed by the Endocrine subcommittee of the ISSM Standards Committee, followed by extensive internal discussion over two years, then public presentation and discussion with other experts. Main Outcome Measure. Recommendations and SOPs based on grading of evidence-based medical literature and interactive discussion. Results. TD is the association of a low serum T with consistent symptoms or signs. T level tends to decline with age. T modulates sexual motivation and erection. It also plays a broader role in men's health. Recent studies have established associations between low T, male sexual dysfunctions and metabolic risk factors. Though association does not mean causation, low T is associated with reduced longevity, risk of fatal cardiovascular events, obesity, sarcopenia, mobility limitations, osteoporosis, frailty, cognitive impairment, depression, Sleep Apnea Syndrome, and other chronic diseases. The paper proposes a standardized process for diagnosis and treatment of TD, and updates the knowledge on T therapy (Tth) and prostate and cardiovascular safety. There is no compelling evidence that Tth causes prostate cancer or its progression in men without severe TD. Polycythemia is presently the only cardiovascular-related adverse-event significantly associated with Tth. But follow-up of controlled T trials is limited to 3 years. Conclusions. Men with sexual dysfunctions, and/or with visceral obesity and metabolic diseases should be screened for TD and treated. Young men with TD should also be treated. Benefits and risks of Tth should be carefully assessed in older men. Prospective, long-term, placebo-controlled, interventional studies are required before screening for TD in more conditions, including cardiovascular diseases, and considering correction of TD as preventive medicine. Buvat J, Maggi M, Guay A, and Torres LO. Testosterone deficiency in men: Systematic review and standard operating procedures for diagnosis and treatment. J Sex Med **;**:**-**. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction. Although the characteristics of premature ejaculation (PE) are established, the exact aetiology is largely unknown. Genetic, neurobiological, pharmacological, psychological, urological and endocrine factors have all been proposed. In addition PE and erectile dysfunction are often co-morbid. Aim. This article provides an overview of the proposed biological and psychological aetiologies of PE. Methods. Review of the literature. Main Outcome Measures. Current data on the pathophysiology of PE. Results. This review shows that most of the proposed biological and psychological aetiologies of PE are not evidence-based and/or that attempts to confirm them have given conflicting results. There are good data to support roles for genetic and psychological factors, either causal, or secondary to PE for the latter, in lifelong PE. Conversely, more evidence-based data support the responsibility of opioid substance withdrawal, prostatic inflammation or hyperthyroidism in some cases of acquired PE, in addition to a probable role of psychological factors. Conclusions. The determinants of PE are certainly complex and multifactorial, while each partner's reaction to the frustration caused by the sexual dysfunction may exacerbate or perpetuate it. It is important to understand, as far as possible, the aetiology in the individual patient to ensure appropriate assessment and treatment. It should be noted that identification of an aetiological factor does not necessarily mean the cause of the PE has been completely explained, and the patient may require a combination of treatment approaches. Buvat J. Pathophysiology of premature ejaculation. J Sex Med 2011;8(suppl 4):316-327. [ABSTRACT FROM AUTHOR]

Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45-80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤3 ng/mL. The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤3 ng/mL. [ABSTRACT FROM AUTHOR]

Introduction. Endocrine disorders may adversely affect men's sexual function. Aim. To provide recommendations based on best evidence for diagnosis and treatment of endocrine-related male sexual dysfunctions. Methods. The Endocrine Aspects of Male Sexual Dysfunctions Committee, including 11 members from eight countries and four continents, collaborated with the Endocrine subcommittee of the Standards Committee of the International Society for Sexual Medicine. Medical literature was reviewed in detail, followed by extensive internal committee discussion over 2 years, then public presentation and discussion with the other experts before finalizing the report. Main Outcome Measure. Recommendations based on grading of evidence-base medical literature and interactive discussion. Results. From animal studies, it is derived that testosterone modulates mechanisms involved in erectile machinery, including expression of enzymes that both initiate and terminate erection. In addition, testosterone is essential for sexual motivation. Whether these findings could be extrapolated to human erections is unclear. Testosterone plays a broad role in men's overall health. Recent studies have established strong associations between low testosterone and metabolic and cardiovascular imbalances. In some studies, low testosterone decreased longevity; however, longitudinal studies do not support the predictive value of low testosterone for further cardiovascular events. The article proposes a standardized process for diagnosis and treatment of endocrine-related male sexual dysfunctions, updating the knowledge on testosterone and prostate safety. There is no compelling evidence that testosterone treatment causes prostate cancer or its progression in men without severe testosterone deficiency (TD). The possible roles of prolactin and thyroid hormones are also examined. Conclusions. Men with erectile dysfunction, hypoactive sexual desire and retarded ejaculation, as well as those with visceral obesity and metabolic diseases, should be screened for TD and treated. Prospective interventional studies are required before screening for TD in more conditions, including cardiovascular diseases, and considering correction as preventive medicine as much data suggests. Buvat J, Maggi M, Gooren L, Guay AT, Kaufman J, Morgentaler A, Schulman C, Tan HM, Torres LO, Yassin A, and Zitzmann M. Endocrine aspects of male sexual dysfunctions. J Sex Med 2010;7:1627–1656. [ABSTRACT FROM AUTHOR]

Introduction. Sexual satisfaction is an important treatment objective for men with erectile dysfunction (ED). Aims. To evaluate potential associations between International Index of Erectile Function (IIEF) satisfaction at study endpoint and a range of baseline, on-treatment, and endpoint variables. Methods. An exploratory analysis was conducted involving 3,935 subjects with ED randomized to on-demand tadalafil (N = 2,824) or placebo (N = 1,111) in randomized, controlled trials across 28 countries. Patients achieving scores ≥16 on IIEF questions 7, 8, 13, and 14 at study endpoint were operationally defined as satisfied (vs. <16, not satisfied). Multivariate logistic regression and other analyses were conducted to ascertain correlates and potential predictors of improvements in the IIEF-erectile function domain (IIEF-EF). Main Outcome Measures. Satisfaction on the IIEF at study endpoint, on-treatment improvements in IIEF-EF, and endpoint sexual frequency. Results. Patients who were satisfied with sexual function were on average younger and had less severe ED, a shorter history of the condition, and no history of vascular disorders, hypertension, or diabetes mellitus/insulin use at baseline ( P < 0.01 vs. not satisfied for each). Satisfied patients were also more likely to experience a ≥4-point increase on the IIEF-EF domain on treatment (adjusted odds ratio [OR] = 22.4; 95% CI = 17.6–28.5; P < 0.0001) or IIEF-EF ≥26 at endpoint (adjusted OR = 41.0; 95% CI = 33.6–50.2; P < 0.0001). Satisfaction emerged as a strong correlate of a ≥4-point increase in the IIEF-EF on treatment; however, as a correlate of endpoint sexual frequency, baseline sexual frequency was stronger than endpoint satisfaction. Conclusions. Satisfaction is associated with certain baseline, on-treatment, and endpoint variables in ED patients. Further studies are needed to confirm these preliminary findings and explore their meaning for female partners. Althof SE, Buvat J, Gutkin SW, Belger M, Stothard DR, and Fugl-Meyer AR. Sexual satisfaction in men with erectile dysfunction: Correlates and potential predictors. J Sex Med 2010;7:203–215. [ABSTRACT FROM AUTHOR]

The article analyzes the paper "Is Intracavernous Injection of Papaverine a Reliable Screening Test for Vascular Impotence?" by J. Buvat, M. Herbaut-Buvat, J. L. Dehaene, and A. Lemaire. It notes that the authors regarded the nocturnal penile tumescence test as the only investigation that is able to discriminate psychogenic from organic erectile dysfunction (ED). One cited lesson from the study is that pharmacological erection can stratify patients into groups with varying degrees of vascular disease which help guide therapy.

Introduction. The efficacy of phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction may depend on patient characteristics. Aim. To determine whether patient characteristics influence the efficacy of two tadalafil dosage regimens and to identify prognostic factors predictive of tadalafil efficacy. Methods. This was a multicenter, open-label study in which men with erectile dysfunction were randomized to tadalafil 20 mg either on demand or three times per week for a period of 5–6 weeks. After a 1-week washout period, patients were crossed over to the alternate regimen for another 5–6 weeks. Main Outcome Measures. Score of the Erectile Function (EF) domain of the International Index of Erectile Function Questionnaire (IIEF) and percentage of positive responses to questions 3 and 5 of the Sexual Encounter Profile (SEP) diary. Results. A total of 4,262 patients were randomized. A normal EF domain score (≥26) at the end of on-demand and three-times-per-week treatment was reported by 60.2% and 62.3% of patients, respectively. The percentage of patients who achieved a normal EF domain score and the percentages reporting positive responses to SEP3 and SEP5 depended on the severity of erectile dysfunction and the presence of certain comorbidities, irrespective of the tadalafil dosage regimen. On regression analysis, the two best predictors of tadalafil efficacy were the baseline score of the IIEF-EF domain and the baseline percentage of “Yes” responses to SEP2. Conclusions. On-demand and three-times-per-week dosage regimens of tadalafil 20 mg were equally efficacious in men with erectile dysfunction. Among the possible prognostic factors tested in this study, baseline disease severity scores were the strongest predictors of efficacy endpoint scores. Costa P, Buvat J, Holmes S, Weitckus S, Petto H, Hamidi K, and Varanese L. Predictors of tadalafil efficacy in men with erectile dysfunction: The SURE study comparing two dosing regimens. J Sex Med 2006;3:1050–1058. [ABSTRACT FROM AUTHOR]

Aim. The aim of this article is to evaluate the efficacy and safety of 20-mg tadalafil taken on demand or three times per week and its effect on the sexual activity of patients with diabetes mellitus and erectile dysfunction (ED). Methods. The scheduled use vs. on-demand regimen evaluation (SURE) was a randomized, crossover, open-label study with 4,262 patients in 14 European countries. The efficacy measures for the 762 patients with diabetes and ED included changes from baseline in the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and the proportion of “yes” responses to patient Sexual Encounter Profile (SEP) questions 2 (SEP2) and 3 (SEP3). The treatment satisfaction was measured with responses to SEP question 4 (SEP4) and SEP question 5 (SEP5), and sexual attempts data were collected. Patient preference for either regimen was determined by the treatment preference question (TPQ). Results. At end point on both regimens, the mean IIEF EF domain score was 22, and >40% of the patients had a normal EF domain score (≥26). The proportion of “yes” responses was ≥73% for SEP2 (penetration), ≥58% for SEP3 (successful intercourse), >46% for SEP4 (hardness of erection), and ≥45% for SEP5 (overall satisfaction). Efficacy was maintained up to 36 hours post-dosing. More than 70% of sexual attempts while on the three-times-per-week regimen and approximately 50% of the attempts on the on-demand treatment occurred >4 hours post-dosing. Tadalafil was well tolerated, with dyspepsia and headache as the most frequent adverse events reported. Treatment preference was 57.2% for on demand and 42.8% for three times per week. Conclusions. Tadalafil, when taken on demand or three times per week, is efficacious and safe in men with diabetes and ED. Buvat J, van Ahlen H, Schmitt H, Chan M, Kuepfer C, and Varanese L. Efficacy and safety of two dosing regimens of tadalafil and patterns of sexual activity in men with diabetes mellitus and erectile dysfunction: Scheduled use vs. on-demand regimen evaluation (SURE) study in 14 European countries. J Sex Med 2006;3:512–520. [ABSTRACT FROM AUTHOR]

Introduction. Endocrine disorders of sex steroid hormones may adversely affect men's sexual function. Aim. To provide expert opinions/recommendations concerning state-of-the-art knowledge for the pathophysiology, diagnosis and treatment of endocrinologic sexual medicine disorders. 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 scientific and debate process. Concerning the Endocrine committee, there were eight experts from seven countries. Main Outcome Measure. Expert opinions/recommendations are based on grading of evidence-based medical literature, extensive internal committee discussion over 2 years, public presentation and deliberation. Results. Hypogonadism is a clinical and biochemical syndrome characterized by a deficiency in serum androgen levels which may decrease sexual interest, quality of erections and quality of life. Biochemical investigations include testosterone and either bioavailable or calculated free testosterone; prolactin should be considered when hypogonadism has been documented. If clinically indicated, androgen therapy should maintain testosterone within the physiological range avoiding supraphysiologic values. Digital rectal examination and determination of serum prostate specific antigen values are mandatory prior to therapy and regularly thereafter. Androgen therapy is usually long-term requiring regular follow-up, frequent monitoring of blood levels and beneficial and adverse therapeutic responses. Conclusions. Safe and effective treatments for endocrinologic sexual medicine disorders examined by prospective, placebo-controlled, multi-institutional clinical trials are needed. [ABSTRACT FROM AUTHOR]

Introduction Sexual dysfunction is common in patients after radical prostatectomy (RP) for prostate cancer. Aim To provide the International Consultation for Sexual Medicine (ICSM) 2015 recommendations concerning prevention and management strategies for post-RP erectile function impairment in terms of preoperative patient characteristics and intraoperative factors that could influence erectile function recovery. Methods A literature search was performed using Google and PubMed databases for English-language original and review articles published up to August 2016. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) based on a thorough analysis of the literature and committee consensus. Results Nine recommendations are provided by the ICSM 2015 committee on sexual rehabilitation after RP. Recommendation 1 states that clinicians should discuss the occurrence of postsurgical erectile dysfunction (temporary or permanent) with every candidate for RP (expert opinion, clinical principle). Recommendation 2 states that validated instruments for assessing erectile function recovery such as the International Index of Erectile Function and Expanded Prostate Cancer Index Composite questionnaires are available to monitor EF recovery after RP (LE = 1, GR = A). Recommendation 3 states there is insufficient evidence that a specific surgical technique (open vs laparoscopic vs robot-assisted radical prostatectomy) promotes better results in postoperative EF recovery (LE = 2, GR = C). Recommendation 4 states that recognized predictors of EF recovery include but are not limited to younger age, preoperative EF, and bilateral nerve-sparing surgery (LE = 2, GR = B). Recommendation 5 states that patients should be informed about key elements of the pathophysiology of postoperative erectile dysfunction, such as nerve injury and cavernous venous leak (expert opinion, clinical principle). Conclusions This article discusses Recommendations 1 to 5 of the ICSM 2015 committee on sexual rehabilitation after RP. Salonia A, Adaikan G, Buvat J, et al. Sexual Rehabilitation After Treatment for Prostate Cancer—Part 1: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med 2017;14:285–296. [ABSTRACT FROM AUTHOR]

Introduction Sexual dysfunction is common in patients after radical prostatectomy (RP) for prostate cancer. Aim To provide the International Consultation for Sexual Medicine (ICSM) 2015 recommendations concerning management strategies for post-RP erectile function impairment and to analyze post-RP sexual dysfunction other than erectile dysfunction. Methods A literature search was performed using Google and PubMed database for English-language original and review articles published up to August 2016. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Nine recommendations are provided by the ICSM 2015 committee on sexual rehabilitation after RP. Recommendation 6 states that the recovery of postoperative erectile function can take several years (LE = 2, GR = C). Recommendation 7 states there are conflicting data as to whether penile rehabilitation with phosphodiesterase type 5 inhibitors improves recovery of spontaneous erections (LE = 1, GR = A). Recommendation 8 states that the data are inadequate to support any specific regimen as optimal for penile rehabilitation (LE = 3, GR = C). Recommendation 9 states that men undergoing RP (any technique) are at risk of sexual changes other than erectile dysfunction, including decreased libido, changes in orgasm, anejaculation, Peyronie-like disease, and changes in penile size (LE = 2, GR = B). Conclusion This article discusses Recommendations 6 to 9 of the ICSM 2015 committee on sexual rehabilitation after RP. Salonia A, Adaikan G, Buvat J, et al. Sexual Rehabilitation After Treatment For Prostate Cancer–Part 2: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med 2017;14:297–315. [ABSTRACT FROM AUTHOR]

Introduction Testosterone deficiency (TD), also known as hypogonadism, is a condition affecting a substantial proportion of men as they age. The diagnosis and management of TD can be challenging and clinicians should be aware of the current literature on this condition. Aim To review the available literature concerning the diagnosis and management of TD and to provide clinically relevant recommendations from the Fourth International Consultation for Sexual Medicine (ICSM) meeting. Methods A literature search was performed using the PubMed database for English-language original and review articles published or e-published up to January 2016. Main Outcome Measures Levels of evidence (LoEs) and grades of recommendations are provided based on a thorough analysis of the literature and committee consensus. Results Recommendations were given for 12 categories of TD: definition, clinical diagnosis, routine measurement, screening questionnaires, laboratory diagnosis, threshold levels for the biochemical diagnosis of TD, prostate cancer, cardiovascular disease, fertility, testosterone (T) formulations, alternatives to T therapy, and adverse events and monitoring. A total of 42 recommendations were made: of these, 16 were unchanged from the Third ICSM and 26 new recommendations were made during this Fourth ICSM. Most of these recommendations were supported by LoEs 2 and 3. Several key new recommendations include the following: (i) the clinical manifestations of TD occur as a result of decreased serum androgen concentrations or activity, regardless of whether there is an identified underlying etiology [LoE = 1, Grade = A]; (ii) symptomatic men with total T levels lower than 12 nmol/L or 350 ng/dL should be treated with T therapy [LoE = 1, Grade = C]; (iii) a trial of T therapy in symptomatic men with total T levels higher than 12 nmol/L or 350 ng/dL can be considered based on clinical presentation [LoE = 3, Grade = C]; (iv) there is no compelling evidence that T treatment increases the risk of developing prostate cancer or that its use is associated with prostate cancer progression [LoE = 1, Grade = C]; and (v) the weight of evidence indicates that T therapy is not associated with increased cardiovascular risk [LoE = 2, Grade = B]. Conclusion TD is an important condition that can profoundly affect the sexual health of men. We provide guidance regarding its diagnosis and management. Men with TD who receive treatment often experience resolution or improvement in their sexual symptoms and non-sexual health benefits. [ABSTRACT FROM AUTHOR]

Introduction. The International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) assess efficacy of phosphodiesterase type 5 (PDE5) inhibitor treatment of erectile dysfunction (ED). Aims. To determine the degree that multiplicity of satisfaction questions in ED treatment evaluation instruments are congruent, to better understand the concept of sexual “satisfaction,” and to identify factors that correlate with improvement. Methods. Questionnaire data from 4,174 placebo- or tadalafil-treated patients with ED were analyzed. Principal component analysis (PCA) was performed on IIEF and SEP satisfaction questions. Spearman correlation coefficients were determined. Data from 431 of the 4,174 patients who completed EDITS questionnaires were analyzed. Logistic regression was used to investigate improvement of each IIEF satisfaction question. Results. PCA rotated on three factors explained 91% of total variance and separated IIEF Q6 (intercourse frequency) from a SEP and a remaining IIEF factor. All correlations between and among questions were close (ρ = 0.62–0.98; P < 0.0001), except for those with IIEF Q6 (ρ = 0.28–0.34; P < 0.0001). In a sub-sample, PCA of five IIEF, two SEP, and three EDITS questions identified four factors that explained 90% of all variance: EDITS questions, IIEF questions except Q6, SEP questions, and IIEF Q6. Greater improvement in IIEF-EF domain score was consistently and positively associated with satisfaction measures ( P < 0.0001). Conclusions. Factor analysis detected close relationships among satisfaction questions in IIEF, SEP, and EDITS instruments, each of which, apart from IIEF Q6 (intercourse frequency), appeared to be an independent measure of satisfaction. Cultural differences may explain different satisfaction correlations with baseline ED severity in different regions. Clinicians may make use of the correlation between intercourse frequency (Q6) and satisfaction when prescribing a PDE5 inhibitor for ED, by explaining that the inhibitor should enable more frequent intercourse. Fugl-Meyer A, Althof S, Buvat J, Paget M-A, Sotomayor M, and Stothard D. Aspects of sexual satisfaction in men with erectile dysfunction: A factor analytic and logistic regression approach. J Sex Med 2009;6:232–242. [ABSTRACT FROM AUTHOR]

Summary of Committee. Results of this study have been presented in part at the American Urological Association Meeting, May 2002, Orlando, FL (Donatucci C, Eardley I, McVary KT, Thibonnier J, and the Vardenafil Study Group. Vardenafil improves erectile function of aetiology or baseline severity in men with erectile dysfunction. J Urol 2002;167:178). Conflict of Interest. Dr. Segerson and Mr Homering are employees of Bayer. Background. Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods. Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results. Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37–41% of patients had severe ED, 30–34% moderate, 22% mild-to-moderate and 6–8% mild ED. At baseline, 46–51% of patients were considered to have an organic cause for ED, 13–16% psychogenic ED, and 36–38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements ( P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusions. Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity. [ABSTRACT FROM AUTHOR]

Conflict of Interest. Supported by Bayer Corporation, Bayer AG, GlaxoSmithKline. Francesco Montorsi, MD—Disclosures: Consultant/Advisor, Investigator, and Lecturer for Bayer Corporation, GlaxoSmithKline, Pfizer, Lilly Icos and American Medical Systems. Harin Padma-Nathan, MD—Disclosures: Consultant/Advisor, Investigator, and Lecturer for Bayer Corporation, GlaxoSmithKline, Pfizer, and Lilly Icos. Jaques Buvat, MD—Disclosures: Consultant/Advisor, Investigator, and Lecturer for Bayer Corporation, Pfizer, and Lilly Icos. Hartwig Schwaibold, MD—Disclosures: Consultant/Advisor, Investigator, and Lecturer for Bayer Corporation, GlaxoSmithKline, Pfizer, and Lilly Icos. Manfred Beneke, PhD—Disclosures: Employee, Bayer Vital GmbH. Tiemo Joerg Bandel, MD—Disclosures: Employee, Bayer HealthCare AG. Ernst Ulbrich, MD—Disclosures: Employee, Bayer Vital GmbH. Hartmut Porst, MD—Disclosures: Consultant/Advisor, Investigator, and Lecturer for Bayer AG, GlaxoSmithKline, Pfizer, and Lilly Icos. 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 = 0.025) 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 ≤ 15, ≤ 20, ≤ 25 and ≤ 30 minutes between dosing and erection adequate for penetration, 75–77% of these intercourse attempts were successful (SEP3 positive) by patients receiving vardenafil 10/20 mg, compared to 45–47% of attempts by those who received placebo. Vardenafil 10/20 mg was generally well-tolerated with headache (7%/12% vs. 1%) and flushing (6%/9% vs. < 1%) reported more frequently than with placebo. No patient discontinued vardenafil therapy due to adverse events. Conclusion. In this large, at-home study, the onset of action of vardenafil with subsequent intercourse completion was recognized as early as 10 minutes after dosing. [ABSTRACT FROM AUTHOR]

Introduction Treatment of erectile dysfunction is based on pharmacotherapy for most patients. Aim To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods A review of the literature was undertaken by the committee members. All related articles were critically analyzed and discussed. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Ten recommendations are provided. (i) Phosphodiesterase type 5 (PDE5) inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction (LE = 1, GR = A). (ii) There are no significant differences in efficacy, safety, and tolerability among PDE5 inhibitors (LE = 1, GR = A). (iii) PDE5 inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use (LE = 3, GR = C). (iv) Intracavernosal injection therapy with alprostadil is an effective and well-tolerated treatment for men with erectile dysfunction (LE = 1, GR = A). (v) Intracavernosal injection therapy with alprostadil should be offered to patients as second-line therapy for erectile dysfunction (LE = 3, GR = C). (vi) Intraurethral and topical alprostadil are effective and well-tolerated treatments for men with erectile dysfunction (LE = 1, GR = A). (vii) Intraurethral and topical alprostadil should be considered second-line therapy for erectile dysfunction if available (LE = 3, GR = C). (viii) Dose titration of PDE5 inhibitors to the maximum tolerated dose is strongly recommended because it increases efficacy and satisfaction from treatment (LE = 2, GR = A). (ix) Treatment selection and follow-up should address the psychosocial profile and the needs and expectations of a patient for his sexual life. Shared decision making with the patient (and his partner) is strongly recommended (LE = 2, GR = A). (x) Counterfeit medicines are potentially dangerous. It is strongly recommended that physicians educate their patients to avoid taking any medication from unauthorized sources (LE = 2, GR = A). The first seven recommendations are the same as those from the Third International Consultation for Sexual Medicine and the last three are new recommendations. Conclusion PDE5 inhibitors remain a first-line treatment option because of their excellent efficacy and safety profile. This class of drugs is continually developed with new molecules and new formulations. Intracavernosal injections continue to be an established treatment modality, and intraurethral and topical alprostadil provide an alternative, less invasive treatment option. [ABSTRACT FROM AUTHOR]

Introduction In 2014, the International Society for Sexual Medicine ( ISSM) convened a panel of experts to develop an evidence-based process of care for the diagnosis and management of testosterone deficiency ( TD) in adult men. The panel considered the definition, epidemiology, etiology, physiologic effects, diagnosis, assessment and treatment of TD. It also considered the treatment of TD in special populations and commented on contemporary controversies about testosterone replacement therapy, cardiovascular risk and prostate cancer. Aim The aim was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of diagnosis and management of TD for clinicians without expertise in endocrinology, such as physicians in family medicine and general urology practice. Method A comprehensive literature review was performed, followed by a structured, 3-day panel meeting and 6-month panel consultation process using electronic communication. The final guideline was compiled from reports by individual panel members on areas reflecting their special expertise, and then agreed by all through an iterative process. Results This article contains the report of the ISSM TD Process of Care Committee. It offers a definition of TD and recommendations for assessment and treatment in different populations. Finally, best practice treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with TD. Conclusion Development of a process of care is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to new insights into the pathophysiology of TD, as well as new, efficacious and safe treatments. We recommend that this process of care be reevaluated and updated by the ISSM in 4 years. Dean JD, McMahon CG, Guay AT, Morgentaler A, Althof SE, Becher EF, Bivalacqua TJ, Burnett AL, Buvat J, El Meliegy A, Hellstrom WJG, Jannini EA, Maggi M, McCullough A, Torres LO, and Zitzmann M. The International Society for Sexual Medicine's process of care for the assessment and management of testosterone deficiency in adult men. J Sex Med 2015;12:1660-1686. [ABSTRACT FROM AUTHOR]

ABSTRACT 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 **;**:**-**. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction. Erectile dysfunction (ED) impacts on both members of the couple. Female partners of men with ED are more likely to report reduced sexual quality of life than women whose partners do not have ED. Aim. To assess vardenafil efficacy in men with ED and determine the effects of treatment on their female partner's sexual quality of life. Methods. Study participants comprised men aged 18-64 years with ED and their female partners. Eligible men had ED of ≥6 months' duration and a female partner who was motivated to support their ED treatment. Eligible women had a total Female Sexual Function Index score >23.55, indicating absence of significant sexual dysfunction. Following a 4-week screening period, men were randomized to treatment with vardenafil 10 mg or placebo, which could be titrated to 20 or 5 mg after 4 weeks. Main Outcomes Measures. Primary efficacy variables were question 3 of the Sexual Encounter Profile questionnaire (SEP3) and the quality-of-life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL). Results. The intent-to-treat population included 343 couples, with 168 and 175 men receiving vardenafil or placebo, respectively. Vardenafil treatment significantly improved both erection maintenance and the female partners' sexual quality of life. Least squares (LS) mean SEP3 overall success rates after 12 weeks of treatment were 9.5 (baseline) vs. 67.2 (week 12) and 12.4 (baseline) vs. 24.2 (week 12) in the vardenafil and placebo groups, respectively ( P < 0.0001). In female partners, LS mean mSLQQ-QOL scores were 28.8 (baseline) vs. 68.2 (last observation carried forward [LOCF]) in the vardenafil group and 24.6 (baseline) vs. 40.5 (LOCF) in the placebo group ( P < 0.0001). Conclusions. Vardenafil treatment of men with ED improved both their erectile function and the sexual quality of life of their female partners. Martín-Morales A, Graziottin A, Bou Jaoudé G, Debruyne F, Buvat J, Beneke M, and Neuser D. Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: A randomized, double-blind, placebo-controlled study. J Sex Med 2011;8:2831-2840. [ABSTRACT FROM AUTHOR]

Dapoxetine has been evaluated for the on-demand treatment of premature ejaculation (PE) in five phase 3 studies in various populations worldwide and has recently been approved in several countries. To present integrated efficacy and safety data from phase 3 trials of dapoxetine. Data were from five randomized, multicenter, double-blind, placebo-controlled studies conducted in over 25 countries. Men (N = 6,081) ≥18 years who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE; four studies required a baseline intravaginal ejaculatory latency time (IELT) of ≤2 minutes. Dapoxetine 30 and 60 mg on demand (prn; 1-3 hours before intercourse) were evaluated for either 12 or 24 weeks in four studies; one study evaluated dapoxetine 60 mg daily (qd; included in safety assessments only) or prn for 9 weeks. End points included stopwatch-measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs). Average IELT (mean [standard deviation], geometric mean [standard error]) increased from baseline (across groups, 0.9 [0.49] minutes, 0.8 [1.01] minutes) to a significantly greater extent with dapoxetine 30 (3.1 [3.91] minutes, 2.0 [1.03] minutes) and 60 mg (3.6 [3.85] minutes, 2.3 [1.03] minutes) vs. placebo (1.9 [2.43] minutes, 1.3 [1.02] minutes; P < 0.001 for all) at week 12 (geometric mean fold increase, 2.5, 3.0, and 1.6, respectively). All PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo ( P < 0.001 for all). The most common AEs included nausea, dizziness, and headache, and evaluation of validated instruments demonstrated no anxiety, akathisia, suicidality, or changes in mood with dapoxetine use and no discontinuation syndrome following abrupt withdrawal. In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. [ABSTRACT FROM AUTHOR]

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. To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. 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. 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. 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. Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction. The validated Quality of Erection Questionnaire (QEQ) evaluates satisfaction with erection quality. Aim. To collate QEQ data, including correlations between QEQ outcomes and outcomes assessing emotional well-being, treatment satisfaction, and erection hardness after sildenafil citrate treatment. Methods. In four trials, men older than 18 years and with erectile dysfunction, a stable sexual partner, and no recent phosphodiesterase type 5 inhibitor use were randomized to double-blind flexible-dose sildenafil or placebo (1:1 ratio) for 6 or 10 weeks (two trials), fixed-dose 50 mg, 100 mg, and placebo (1:1:1 ratio) for 8 weeks (one trial), and 50 mg and 100 mg (1:1 ratio) for 4 weeks after 4 weeks of single-blind sildenafil 50 mg. Exclusion criteria included recent significant cardiovascular disease, use of nitrates, nitric oxide donors, cytochrome P450 3A4 inhibitors, or other erectile dysfunction treatment, and sildenafil hypersensitivity or previous severe or serious treatment-related adverse event. Main Outcomes Measures. Scores on the QEQ, QEQ Question 5 (satisfaction with erection hardness), the Self-Esteem and Relationship Questionnaire, and the Erectile Dysfunction Inventory of Treatment Satisfaction; the percentage of occasions with Erection Hardness Score 3 (EHS 3, hard enough for penetration but not completely hard) and/or EHS 4 (completely hard and fully rigid); and Pearson correlation coefficients. Results. 1,296 men (18–80 years) were randomized. Except for the percentage of occasions with EHS 3, all outcomes improved in men treated with sildenafil and correlated positively with the change in QEQ scores in all trials. Conclusions. Satisfaction with the quality of erections, which is easily monitored with the QEQ, correlated positively with measures of emotional well-being and treatment satisfaction and with the change in percentage of erections that were completely hard and fully rigid, but not with the change in percentage of erections that were hard enough for penetration but not completely hard. Kaminetsky JC, Depko AJ, Ströberg P, Buvat J, Tseng L-J, and Stecher VJ. In men with erectile dysfunction, satisfaction with quality of erections correlates with erection hardness, treatment satisfaction, and emotional well-being. J Sex Med 2009;6:800–808. [ABSTRACT FROM AUTHOR]

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. McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJG, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen RC, Rowland DL, and Segraves R. An evidenced-based definition of lifelong premature ejaculation: Report of the International Society for Sexual Medicine (ISSM) Ad Hoc Committee for the definition of premature ejaculation. J Sex Med 2008;5:1590–1606. [ABSTRACT FROM AUTHOR]

Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil.To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence.This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale.Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (allP < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50–65% over the 4–12 week study period compared with 17–28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005).A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence. [ABSTRACT FROM AUTHOR]