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OBJECTIVES To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in men naive to phosphodiesterase 5 (PDE5) inhibitor therapy. PATIENTS AND METHODS This was an open-label, crossover study of sildenafil and tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary. RESULTS Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose tadalafil (P < 0.001) for the 8-week extension. The IIEF erectile function domain scores were 14.2 at baseline, 23.9 at endpoint on sildenafil, and 24.3 at endpoint on tadalafil (P = 0.08, sildenafil vs tadalafil). The mean per patient percentage success scores for SEP2 (penetration) were: baseline (46%), sildenafil (post-baseline 82%) and tadalafil (post-baseline 85%; P = 0.06, sildenafil vs tadalafil), and for SEP3 (successful intercourse) were: baseline (19%), sildenafil (post-baseline 72%), and tadalafil (post-baseline 77%; P = 0.003, sildenafil vs tadalafil). The only treatment-emergent adverse events that were reported by > 5% of men were headache and flushing. CONCLUSIONS In men with ED who were naive to PDE5 inhibitor therapy, sildenafil and tadalafil were both effective and well tolerated. After treatment with sildenafil and tadalafil, 29% of men chose sildenafil and 71% chose tadalafil for ED therapy during an 8-week extension.

Context: Penile curvature can be congenital or acquired. Acquired curvature is secondary due to La Peyronie (Peyronie's) disease. Objective: To provide clinical guidelines on the diagnosis and treatment of penile curvature. Evidence acquisition: A systematic literature search on the epidemiology, diagnosis, and treatment of penile curvature was performed. Articles with the highest evidence available were selected and formed the basis for assigning levels of evidence and grades of recommendations. Evidence synthesis: The pathogenesis of congenital penile curvature is unknown. Peyronie's disease is a poorly understood connective tissue disorder most commonly attributed to repetitive microvascular injury or trauma during intercourse. Diagnosis is based on medical and sexual histories, which are sufficient to establish the diagnosis. Physical examination includes assessment of palpable nodules and penile length. Curvature is best documented by a self-photograph or pharmacologically induced erection. The only treatment option for congenital penile curvature is surgery based on plication techniques. Conservative treatment for Peyronie's disease is associated with poor outcomes. Pharmacotherapy includes oral potassium para-aminobenzoate, intralesional treatment with verapamil, clostridial collagenase or interferon, topical verapamil gel, and iontophoresis with verapamil and dexamethasone. They can be efficacious in some patients, but none of these options carry a grade A recommendation. Steroids, vitamin E, and tamoxifen cannot be recommended. Extracorporeal shock wave treatment and penile traction devices may only be used to treat penile pain and reduce penile deformity, respectively. Surgery is indicated when Peyronie's disease is stable for at least 3 mo. Tunical shortening procedures, especially plication techniques, are the first treatment options. Tunical lengthening procedures are preferred in more severe curvatures or in complex deformities. Penile prosthesis implantation is recommended in patients with erectile dysfunction not responding to pharmacotherapy. Conclusions: These European Association of Urology (EAU) guidelines summarise the present information on penile curvature. The extended version of the guidelines is available on the EAU Web site (www.uroweb.org/guidelines/). (C) 2012 European Association of Urology. Published by Elsevier B. V. All rights reserved.

Context: A large body of epidemiologic data suggests a causal relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Recently reported studies on phosphodiesterase type 5 inhibitors (PDE5-Is) and LUTS have further contributed to the understanding of mechanisms involved in this relationship and of potential treatment options. Objective: A nonsystematic descriptive review was performed to summarize the literature concerning the role of PDE5-Is in men with LUTS, particularly looking at data derived from clinical trials in relation to the different PDE5-Is or their association with alpha-blockers. Evidence acquisition: A comprehensive electronic search was conducted in October 2010 using the Medline database to identify all publications relating to ED and BPH and treatment with sildenafil, vardenafil, tadalafil, udenafil, UK-369003, and combination therapy with alfuzosin and tamsulosin. Evidence synthesis: In studies in which either ED or LUTS was the entry criterion, sildenafil appears to improve both erectile function and LUTS in subjects with ED. Placebo-controlled trials of tadalafil and vardenafil showed improvement of LUTS secondary to benign prostatic hyperplasia (BPH), but none of the studies showed a significant effect on urodynamic measures. Exploratory studies with UK-369003 showed improvements in LUTS and ED. Sildenafil or tadalafil associated with alfuzosin or tamsulosin showed greater benefits for the combination therapy for both LUTS and ED. The coadministration of udenafil and an alpha-blocker in patients with BPH and ED also appeared to improve both LUTS and ED severity. Conclusions: Consistent evidence of improvements in LUTS has been shown with PDE5-Is, either alone or in combination with alpha-blockers. However, effects on urodynamics or objective measures of urinary flow are lacking. Further areas of research include investigation of mechanism of PDE5-Is, urodynamic studies, identification of new efficacy end points, head-to-head comparison with standard of care, potential benefit of add-on treatment, and long-term outcomes. (C) 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.

OBJECTIVES To determine if baseline characteristics, treatment efficacy, psychosocial outcomes or tolerability were associated with patient preference for sildenafil citrate (sildenafil) or tadalafil for treating erectile dysfunction (ED) in men naive to phosphodiesterase 5 inhibitor therapy. PATIENTS AND METHODS In an open-label, crossover study of sildenafil (25, 50 or 100 mg) and tadalafil (10 or 20 mg), dosed as needed, after a 4-week baseline assessment, 367 men with ED were randomly assigned to sildenafil followed by tadalafil or vice versa (8-week dose optimization and 4-week assessment phase for each treatment period). Patients completing both periods chose which treatment they preferred for an 8-week extension phase. Bivariate logistic regression and stepwise logistic regression were used to determine if any baseline characteristics or post-baseline measurements were associated with the patients’ treatment preference. Baseline variables examined were age, race, ED aetiology/duration, body mass index, smoking status, alcohol consumption, vital signs, comorbid medical conditions, and baseline scores for the International Index of Erectile Function (IIEF) domains, Psychological and Interpersonal Relationship Scales (PAIRS) domains, and Sexual Encounter Profile (SEP) diary questions. Post-baseline variables examined were therapy sequence, dosage, and differences in IIEF and PAIRS domains, SEP scores, in number/timing of sexual attempts and in the severity of side-effects (overall patient perception). RESULTS Of 291 patients completing both treatments and indicating a preference, 85 (29%) preferred sildenafil and 206 (71%) preferred tadalafil. Variables were individually analysed using bivariate analysis; one baseline characteristic (presence/absence of hyperlipidaemia) and 13 post-baseline measurements were significantly associated with the patients’ treatment preference. Variables were analysed as a group using stepwise logistic regression; a set of six post-baseline factors was identified as significantly associated with patient preference. Dosage choice, reductions in the PAIRS time concerns domain, IIEF intercourse satisfaction domain improvements, smaller side-effect severity scores, more sexual attempts, and increased SEP4 scores (satisfaction with erection hardness) during the tadalafil or sildenafil treatment periods were all significantly associated with preference for tadalafil or sildenafil. CONCLUSIONS We identified no baseline characteristics that prospectively distinguish patients who will prefer tadalafil or sildenafil. Patient differences in time concerns, dosage choice, intercourse satisfaction, treatment tolerability, number of sexual attempts and satisfaction with erection hardness were the set of factors most significantly associated with treatment preference, and the preference observed for tadalafil (71%) or sildenafil (29%) might be substantially accounted for by differences in these factors during the tadalafil and sildenafil treatment periods.

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.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).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 (P0.001) 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.Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.