Standardization of vascular assessment of erectile dysfunction: standard operating procedures for duplex ultrasound.

INTRODUCTION: In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability. AIM: This SOP describes CDDU procedure with focus on establishing uniformity and normative parameters. MAIN OUTCOME MEASURE: Measure intra-arterial diameter, peak systolic velocity, end-diastolic velocity, and resistive index for each cavernosal artery. METHODS: After initial discussion with the patient about his history and International Index of Erectile Function evaluation describe procedural steps to the patient. Perform the CDDU in a relaxed state, scanning the entire penis (in B-mode image) using a 7.5- to 12-MHz linear array ultrasound probe. An intracorporal injection of a single or combination of vasoactive agents (e.g., prostaglandin E1, phentolamine, and papaverine) is then administered and CDDU performed at various time points, preferably with audiovisual sexual stimulation (AVSS). RESULTS: Monitor penile erection response (tumescence and rigidity) near peak blood flow. Self-stimulation or AVSS leaving the patient alone in room or redosing may be considered to decrease any anxiety and help achieve a maximum rigid erection. CONCLUSION: Considering the complexity and heterogeneity of CDDU evaluation, this communication will help in standardization and establish uniformity in such data interpretation. When indicated, invasive diagnostic testing involving (i) penile angiography and (ii) cavernosography/cavernosometry to establish veno-occlusive dysfunction may be recommended to facilitate further treatment options.

A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction.

AIM: To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). METHODS: A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. MAIN OUTCOME MEASURES: The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. SECONDARY OUTCOMES INCLUDED: Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. RESULTS: Men naive to tadalafil OaD were enrolled (N = 378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P < 0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD, 0.5 ± 0.72 for tadalafil PRN, and 0.39 ± 0.67 for sildenafil PRN. The difference in least-squares mean was 0.12 ± 0.04 (confidence interval [CI] = 0.04, 0.19; P = 0.001) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 (CI = -0.06, 0.08; P = 0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P < 0.001). There were no differences in SEAR scores between treatments. CONCLUSIONS: Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

Transversal European survey on testosterone deficiency diagnosis.

BACKGROUND: Despite being one of the relevant public health threats among ageing men, testosterone deficiency syndrome (TDS) is under-recognized and under-diagnosed. OBJECTIVE: To assess current clinical practices of European physicians regarding diagnosis and management of TDS compared with current guidelines. METHODS: Postal survey conducted June-November 2008 in France, Germany, Italy and Spain among urologists, endocrinologists and general practitioners to collect information regarding knowledge of TDS. RESULTS: Among 801 respondents, the majority of endocrinologists and urologists had received training on TDS, either initially or as part of continuous medical education. TDS was recognized by 86.5% of physicians as a true clinical entity, and estimated the prevalence at 10-15% of the male population; 73.5% considered that symptoms and a low level of testosterone were required for diagnosis. Treatment preferences were quarterly intramuscular injections (26.3% of physicians), percutaneous gels (23.9%), matrix patch (21.2%), semi-monthly injections (15.4%) and oral therapy (13.4%). Adverse effects of testosterone replacement therapy, such as benign prostatic hyperplasia and prostate cancer, were a concern for physicians. CONCLUSIONS: TDS management appeared to be close to that recommended in international guidelines. Signs and symptoms of testosterone deficiency were fairly well known, but some diagnostic and treatment variations were observed.

Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study).

OBJECTIVE: This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS). RESEARCH DESIGN AND METHODS: The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12). RESULTS: TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate. CONCLUSIONS: Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.

[Directed clinical history and physical examination in patients with erectile dysfunction. Clinical features we cannot forget]. / Historia clínica dirigida y exploración física en pacientes con disfunción eréctil: Aspectos clínicos que no podemos olvidar.

OBJECTIVES: We aim in this work to establish directions for data collection in the chart of the patient with erectile dysfunction (ED), to characterize the presenting problem, reveal possible associated risk factors, evaluate the need of additional complementary tests, and decide if a multidisciplinary approach is necessary. METHODS: Bibliographic review about directions and recommendations on initial and clinical management of ED. CONCLUSIONS: Sexual history is the most important part of the basic routine with a patient with ED, and the purpose of the andrologist is to identify the type of sexual dysfunction, time of start, severity, duration, and treatment expectations.

The EPIFARM study: an observational study in 574 community pharmacies in Spain characterizing patient profiles of men asking for erectile dysfunction medication.

INTRODUCTION: Community pharmacists may be an important first point of contact for erectile dysfunction (ED) patients, but to date there are no reports of the characteristics of men approaching pharmacists for ED advice or treatment. AIM: To characterize the profiles of men with and without phosphodiesterase-5 inhibitors (PDE5i) prescription asking for ED treatment at the pharmacy. METHODS: A multicenter, observational, cross-sectional study was conducted in Spanish community pharmacies September-November 2008. Of men asking for ED advice or treatment, each investigator recruited one with and one without PDE5i prescription. Study pharmacists completed a questionnaire of patient demographic, clinical, and behavioural data including the Sexual Health Inventory for Men. MAIN OUTCOME MEASURES: Demographic characteristics and responses to questionnaires. RESULTS: Five hundred and seventy-four pharmacists recruited 1,147 patients; 1,113 were included for analysis. There were no statistical differences between the groups regarding weight, hypertension, diabetes mellitus, hypercholesterolemia, dyslipidemia, depression, or stress. There were no statistical differences in severity of ED (P=0.7892) or proportion of men without ED in each group (P=0.5755). ED symptoms had been present for a mean of 26 months in both groups before first consultation with a healthcare professional. The visit to the pharmacy was the first discussion about ED for 60.2% of the nonprescription group, and 50% of those who had previously discussed ED had done so with a pharmacist in the first instance. In the nonprescription group, 85.1% of men asked for a PDE5i. CONCLUSIONS: Many men approached a community pharmacist for ED treatment and those with and without a PDE5i prescription had an equivalent ED severity and comorbidity profile. Community pharmacists should be trained in current concepts underlying the diagnosis and management of ED to enable them to educate men and encourage them to seek further medical care, increasing the chance of early detection of undiagnosed comorbidities such as cardiovascular disease.

Cancer and sexual problems.

INTRODUCTION: There are many data on sexual problems subsequent to cancer and its treatment, although the likelihood of problems in specific individuals depends on multiple variables. AIMS: To gain knowledge about the risks of sexual problems among persons with cancer and to provide recommendations concerning their prevention and optimal treatment. METHODS: A committee of multidisciplinary specialists was formed as part of a larger International Consultation working with urologic and sexual medicine societies over a 2-year period to review the result of chronic illness management on sexual function and satisfaction. The aims, goals, data collection techniques, and report format were defined by a central committee. MAIN OUTCOMES MEASURES: Expert consensus was based on evidence-based medical and psychosocial literature review, extensive group discussion, and an open presentation with a substantial discussion period. RESULTS: Cancer and cancer treatments have both direct and indirect effects on physiologic, psychological, and interpersonal factors that can all impact negatively on sexual function and satisfaction. Data on the likelihood of specific sexual problems occurring with cancer and its management vary depending on prediagnosis function, patient response, support from the treatment team, specific treatments used, proactive counseling, and efforts to mitigate potential problems. This summary details available literature concerning the pathophysiologic and psychological impacts of cancer diagnosis and treatment on sexual function, plus recommendations for their prevention and management. CONCLUSIONS: Cancer and its management have a significant negative impact on sexual function and satisfaction. These negative effects can be somewhat mitigated by understanding prediagnosis sexual functioning level, counseling, careful treatment choices, and, when indicated, therapy post-treatment using educational, psychological, pharmacologic, and mechanical modalities.

Vardenafil for the treatment of erectile dysfunction: an overview of the clinical evidence.

Many men with erectile dysfunction (ED) also have associated underlying cardiovascular and metabolic conditions, for which they are likely to be taking medication. Therefore, cardiovascular safety and potential drug interactions are two of the major concerns when using PDE-5 inhibitors in these patients. The PDE-5 inhibitor, vardenafil, is characterized by a rapid onset of action, increased duration of erection, high rates of first-dose success and reliable efficacy that can be maintained with continued use. In both clinical trials and real-life observational studies, vardenafil has demonstrated a favorable efficacy and safety profile in men with ED, including those with associated underlying conditions such as diabetes, hypertension and dyslipidemia. Importantly, the concomitant use of medication for these conditions is not associated with any noteworthy changes in the efficacy and safety of vardenafil. The evidence presented in this review supports the use of vardenafil as a first-line treatment for men with ED, including those with underlying conditions.