De la definición al impacto social de la eyaculación precoz. Consenso de experto / From the definition to the social impact of premature ejaculation. Expert consensus

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[Effectiveness and treatment satisfaction in patients with erectile dysfunction in Spain: EDOS study]. / Efectividad y satisfacción con el tratamiento en pacientes con disfunción eréctil en España: estudio EDOS.

INTRODUCTION: Erectile dysfunction (ED) is a worldwide health problem with an ever increasing prevalence, affecting the quality of life of many patients. OBJECTIVE: The aim of this study was to describe treatment effectiveness and patient satisfaction with ED treatment in the Spanish cohort of the EDOS study. MATERIAL AND METHODS: This observational, pan-European study, assessed treatment effectiveness and patient satisfaction with ED treatment under routine clinical settings, using standard questionnaires. Men > or =18 years about to initiate or change ED treatment were enrolled. Patients were assessed at baseline, 3 and 6 months. RESULTS: A total of 1,029 patients were analyzed (12.8% of the total European sample). In general, the Spanish population characteristics are consistent with the overall population. At baseline 56.6% of patients received tadalafilo, 16.6% sildenafilo, 19.6% vardenafilo, and 7.2% received other treatments. At 3 months, a higher proportion of patients on tadalafil reported improved erections (GAQ 1: 96.5% tadalafil, 85.7% sildenafil and 87.2% vardenafil), satisfaction with treatment (EDITS: 84.2% tadalafil, 75.0% sildenafil and 76.0% vardenafil), and sexual self confidence (SF-PAIRS: 2.73 tadalafil, 2.39 sildenafil and 2.55 vardenafil), in comparison with sildenafil and vardenafil. At 6 months, differences between treatments were not significant. The mean+/-SD time elapsed from drug intake to sexual intercourse was higher for patients on tadalafil (18.6+/-26.4 h) compared to sildenafil (3.6+/-7.5) and vardenafil (8.6+/-19.4). CONCLUSION: The longer duration of action for tadalafil, and thus, the longer period of time between dosing and sexual intercourse may contribute to enhance sexual spontaneity, patient satisfaction with the treatment and greater self-confidence.

Efectividad y satisfacción con el tratamiento en pacientes con disfunción eréctil en España: Estudio EDOS / Effectiveness and treatment satisfaction in patients with erectile dysfunction in Spain: EDOS study

Introducción: La disfunción eréctil (DE) es un problema de salud mundial con una prevalencia creciente que afecta la calidad de vida de muchos pacientes. Objetivo: Analizar la efectividad y satisfacción con el tratamiento en la cohorte española de pacientes con DE incluidos en el estudio observacional de disfunción eréctil. Material y método: Estudio observacional, paneuropeo, que analizó la efectividad y satisfacción de los tratamientos para la DE en la práctica clínica habitual, utilizando cuestionarios estándares. Participaron varones ≥18 años que iniciaron o cambiaron su tratamiento para la DE. Los pacientes fueron evaluados en la visita basal, a los 3 y 6 meses. Resultados: Se analizaron 1.029 pacientes (12,8% de la muestra europea total). En general, las características de la población española son consistentes con las de la población global. En la visita basal 56,6% recibió tadalafilo, 16,6% sildenafilo, 19,6% vardenafilo y 7,2% otros tratamientos. A los 3 meses, una mayor proporción de pacientes con tadalafilo experimentó mejorías en la erección (cuestionario de evaluación global 1: 96,5% tadalafilo, 85,7% sildenafilo, 87,2% vardenafilo), se observó una mayor satisfacción con el tratamiento (inventario de satisfacción con el tratamiento para la DE: 84,2% tadalafilo, 75,0% sildenafilo y 76,0% vardenafilo) y mayor autoconfianza (escalas psicológicas y de relaciones interpersonales: 2,73 tadalafilo, 2,39 sildenafilo y 2,55 vardenafilo). A los 6 meses, las diferencias entre tratamientos no resultaron significativas. El tiempo medio±desviación estándar entre la toma del fármaco y la relación sexual fue mayor en los pacientes con tadalafilo (18,6±26,4h) vs. sildenafilo (3,6±7,5) y vardenafilo (8,6±19,4). Conclusiones: La mayor duración del efecto de tadalafilo y en consecuencia el mayor tiempo medio entre la toma y la relación sexual podría contribuir a aumentar la espontaneidad en las relaciones sexuales, la satisfacción con el tratamiento y mayor autoconfianza (AU)

Introduction: Erectile dysfunction (ED) is a worldwide health problem with an ever increasing prevalence, affecting the quality of life of many patients. Objective: The aim of this study was to describe treatment effectiveness and patient satisfaction with ED treatment in the Spanish cohort of the EDOS study. Material and methods: This observational, pan-European study, assessed treatment effectiveness and patient satisfaction with ED treatment under routine clinical settings, using standard questionnaires. Men ≥18 years about to initiate or change ED treatment were enrolled. Patients were assessed at baseline, 3 and 6 months. Results: A total of 1,029 patients were analyzed (12.8% of the total European sample). In general, the Spanish population characteristics are consistent with the overall population. At baseline 56.6% of patients received tadalafilo, 16.6% sildenafilo, 19.6% vardenafilo, and 7.2% received other treatments. At 3 months, a higher proportion of patients on tadalafil reported improved erections (GAQ 1: 96.5% tadalafil, 85.7% sildenafil and 87.2% vardenafil), satisfaction with treatment (EDITS: 84.2% tadalafil, 75.0% sildenafil and 76.0% vardenafil), and sexual self confidence (SF-PAIRS: 2.73 tadalafil, 2.39 sildenafil and 2.55 vardenafil), in comparison with sildenafil and vardenafil. At 6 months, differences between treatments were not significant. The mean±SD time elapsed from drug intake to sexual intercourse was higher for patients on tadalafil (18.6±26.4 h) compared to sildenafil (3.6±7.5) and vardenafil (8.6±19.4). Conclusion: The longer duration of action for tadalafil, and thus, the longer period of time between dosing and sexual intercourse may contribute to enhance sexual spontaneity, patient satisfaction with the treatment and greater self-confidence (AU)

Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database.

AIM: To review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED). METHODS: Data were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer's postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (> or = 65 and > or = 75 years). Special safety topics included cardiovascular risk, priapism, non-arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and alpha-blockers) and incorrect use. RESULTS: Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged > or = 65 years, and in those aged > or = 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse. CONCLUSION: This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.

[Prevalence of ejaculatory dysfunction secondary to alpha-blocker therapy in patients with benign prostatic hyperplasia]. / Prevalencia de disfunción eyaculatoria secundaria al tratamiento con alfa-bloqueantes en pacientes con hiperplasia benigna de próstata.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is characterized by lower urinary tract symptoms (LUTS) that may cause ejaculatory disorders, although they could be also a consequence of alpha-blocker treatment. OBJECTIVES: To determine the prevalence of ejaculatory dysfunction in patients with HBP undergoing alpha-blocker therapy. Secondary objectives were to evaluate the effect of different drugs on normal ejaculation and the relationship of dysfunction degree to prognostic factors and BPH severity. MATERIALS AND METHODS: Epidemiologic, transversal, uncontrolled and open-label study in 1.177 patients older than 40, who had been diagnosed of BPH/LUTS with more than 6 months of evolution and treated with the same alpha-blocker for at least the last 3 months. Severity of ejaculatory dysfunction was determined by the domain on ejaculation of the Male Sexual Health Questionnaire (MSHQ). Results were stratified by age and BPH severity, determined by the International Prostate Symptoms Score (IPSS). RESULTS: The prevalence of ejaculatory dysfunction has been estimated to be 82.6% in patients with BPH/LUTS treated with alpha-blockers. Although usually mild, the dysfunction is considered as bothersome by a high percentage of those who suffer it. Advanced age is the most influential factor in the severity of both ejaculatory abnormalities and prostate symptoms. Moreover, a solid correlation between these two parameters has been established. Finally, among the analyzed alpha-blockers, alfuzosin has been associated with the best sexual function. CONCLUSIONS: More than 80% of patients with BPH suffer ejaculatory abnormalities, which are closely related to the severity of prostate symptoms and increased age. When initiating alpha-blocker treatment, we should consider that alfuzosin is the one with less negative impact on ejaculatory function.

Prevalencia de disfunción eyaculatoria secundaria al tratamiento con alfa-bloqueantes en pacientes con hiperplasia benigna de próstata / Prevalence of ejaculatory dysfunction secondary to alpha-blocker therapy in patients with benign prostatic hyperplasia

Introducción: La hiperplasia benigna de próstata (HBP) se acompaña de síntomas del tracto urinario inferior (STUI) que pueden causar alteraciones eyaculatorias, aunque éstas podrían ser además consecuencia del tratamiento con alfa-bloqueantes. Objetivos: Determinar la prevalencia de disfunción eyaculatoria en pacientes con HBP tratados con alfa-bloqueantes. Secundariamente, evaluar el efecto del tipo de fármaco y la relación de las alteraciones eyaculatorias con factores pronósticos y la gravedad de la HBP. Material y métodos: Estudio epidemiológico, transversal, no controlado y abierto en 1.177 pacientes ≥40 años diagnosticados de HBP/STUI con más de 6 meses de evolución, tratados con el mismo alfa-bloqueante durante como mínimo los últimos 3 meses. El grado de disfunción eyaculatoria se determinó mediante el dominio sobre eyaculación del Male Sexual Health Questionnaire (MSHQ). Los resultados se estratificaron según la edad y gravedad de la HBP, establecida mediante el International Prostate Symptoms Score (IPSS). Resultados: Se ha estimado una prevalencia de disfunción eyaculatoria del 82,6% en pacientes con HBP/STUI en tratamiento con alfa-bloqueantes. Aunque generalmente leve, un amplio porcentaje de quienes la sufren la consideran un problema. La edad avanzada es el factor más influyente en la gravedad tanto de las alteraciones eyaculatorias como de los síntomas prostáticos. Entre ambos parámetros se ha establecido una sólida correlación. Finalmente, entre los alfa-bloqueantes evaluados, la alfuzosina se ha asociado a una mejor función sexual. Conclusiones: Más del 80% de pacientes con HBP sufren alteraciones eyaculatorias, estrechamente relacionadas con la severidad de los síntomas prostáticos y la edad del individuo. Al establecer tratamiento con alfa-bloqueantes, deberíamos tener en cuenta que la alfuzosina es el que menos impacto tiene sobre la función eyaculatoria (AU)

Introduction: Benign prostatic hyperplasia (BPH) is characterized by lower urinary tract symptoms (LUTS) that may cause ejaculatory disorders, although they could be also a consequence of alpha-blocker treatment. Objectives: To determine the prevalence of ejaculatory dysfunction in patients with HBP undergoing alpha-blocker therapy. Secondary objectives were to evaluate the effect of different drugs on normal ejaculation and the relationship of dysfunction degree to prognostic factors and BPH severity. Materials and methods: Epidemiologic, transversal, uncontrolled and open-label study in 1.177 patients older than 40, who had been diagnosed of BPH/LUTS with more than 6 months of evolution and treated with the same alpha-blocker for at least the last 3 months. Severity of ejaculatory dysfunction was determined by the domain on ejaculation of the Male Sexual Health Questionnaire (MSHQ). Results were stratified by age and BPH severity, determined by the International Prostate Symptoms Score (IPSS). Results: The prevalence of ejaculatory dysfunction has been estimated to be 82.6% in patients with BPH/LUTS treated with alpha-blockers. Although usually mild, the dysfunction is considered as bothersome by a high percentage of those who suffer it. Advanced age is the most influential factor in the severity of both ejaculatory abnormalities and prostate symptoms. Moreover, a solid correlation between these two parameters has been established. Finally, among the analyzed alpha-blockers, alfuzosin has been associated with the best sexual function. Conclusions: More than 80% of patients with BPH suffer ejaculatory abnormalities, which are closely related to the severity of prostate symptoms and increased age. When initiating alpha-blocker treatment, we should consider that alfuzosin is the one with less negative impact on ejaculatory function (AU)

Cardiovascular outcomes among sildenafil users: results of the International Men's Health Study.

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.

Patterns of switching phosphodiesterase type 5 inhibitors in the treatment of erectile dysfunction: results from the Erectile Dysfunction Observational Study.

AIMS: This report describes patterns of treatment changes with the phosphodiesterase type 5 (PDE5) inhibitors tadalafil, sildenafil and vardenafil, and variables associated with those treatment changes, during the 6-month, prospective, pan-European Erectile Dysfunction Observational Study (EDOS). METHODS: EDOS observed 8047 men > or = 18 years old with erectile dysfunction (ED), who began or changed ED therapy as part of their routine healthcare. Patients could change ED treatment at any time during EDOS. Data were collected at baseline and at 3 (+/- 1) and 6 (+/- 1) months. Analyses included ED treatment-naïve patients with complete follow-up who were prescribed a PDE5 inhibitor at baseline (n = 4026). RESULTS: Most patients, regardless of what PDE5 inhibitor they were prescribed at baseline, continued on that same PDE5 inhibitor throughout the study. Continuation rates were approximately 89% in the tadalafil cohort, vs. 63-64% in the sildenafil and vardenafil cohorts. The variables most strongly associated with increased risk of switching were prescription of sildenafil or vardenafil, vs. tadalafil, at baseline (odds ratios 4.43 and 4.14 respectively; p < 0.0001). Of patients who switched from tadalafil to another treatment, nearly 25% had switched back to tadalafil by study end. In contrast, of patients who switched from sildenafil or vardenafil, < 10% from each cohort had switched back to their original treatment by study end. CONCLUSION: The data suggest that tadalafil treatment in treatment-naïve ED patients may increase their likelihood of treatment continuation. These findings should be interpreted conservatively due to the observational nature of the study.

[Development and psychometric validation of a new screening questionnaire for erectile dysfunction (SQUED questionnaire)]. / Desarrollo y validación psicométrica de un nuevo cuestionario de screening para la disfunción eréctil (cuestionario SQUED).

BACKGROUND: It is necessary to have simple tools to screen erectile dysfunction (ED) in an easy, reliable and valid manner. The objective of this study was to develop and validate a short diagnostic questionnaire for erectile dysfunction [SQUED), easy to use in the primary care setting. SUBJECTS AND METHOD: The development of SQUED included: concepts identification, item generation and evaluation of contents and face validity through interviews with subjects to assess comprehension and idiomatic adequacy. The psychometric validation was conducted in an epidemiologic, observational, comparative and multicenter study. Participants should complete the questionnaire in primary care setting and send to the specialist to confirm the diagnosis by an in depth interview and the application of IIEF questionnaire. Internal consistency, test-retest reliability and sensitivity and specificity of SQUED was evaluated. RESULTS: Out of 405 subjects enrolled, 316 (208 ED and 108 non-ED) were evaluable. The SQUED questionnaire showed a high internal consistency (Cronbach's alpha = 0.92) and a good test-retest reliability (Kappa index = 0.77). Furthermore, the questionnaire showed a good diagnostic capacity with high values of sensitivity and specificity, 0.87 and 0.78, respectively, in relation to the diagnosis made by urologists. The cutting point was established at a score of 12. DISCUSSION: The SQUED questionnaire is a simple, easy to use and reliable instrument. It can become a useful tool, and the shortest validated, for primary care physicians to easily screen for ED patients. Its simplicity should facilitate an easy cultural adaptation and validation into other languages.

Desarrollo y validación psicométrica de un nuevo cuestionario de screening para la disfunción eréctil (Cuestionario SQUED) / Development and psychometric validation of a new screening questionnaire for erectile dysfunction (squed questionnaire)

Introducción. Es necesario contar con herramientas sencillas que permitan detectar de forma válida y fiable la presencia de disfunción eréctil (DE). El objetivo de este estudio fue desarrollar y validar un cuestionario de cribado de la DE que fuera útil para usar en atención primaria (AP). Material y Métodos. El desarrollo del cuestionario SQUED (Short Questionnaire for Erectile Dysfunction) incluyó la identificación de conceptos y generación de ítems, evaluación del contenido y la validez aparente a partir de entrevistas con sujetos para valorar la compresión y adecuación del lenguaje. Para la validación psicométrica se realizó un estudio epidemiológico, observacional, comparativo y multicéntrico. Los participantes completaron el cuestionario en el ámbito de la AP y fueron derivados al especialista para la confirmación diagnóstica mediante entrevista clínica y la administración del International Index of Erectile Function (IIEF). Se evaluó la consistencia interna, la fiabilidad del test-retest y la sensibilidad y la especificidad del SQUED. Resultados. Participaron 405 sujetos, de los cuales 316 (208 con DE y 108 sin DE) fueron evaluables. El cuestionario SQUED mostró una alta consistencia interna (alfa de Cronbach = 0,92) y una buena fiabilidad test-retest (índice Kappa= 0,77). Además, el cuestionario mostró una alta capacidad diagnóstica con valores de sensibilidad y especificidad, 0,87 y 0,78, respectivamente, respecto al diagnóstico del urólogo. El punto de corte se estableció en una puntuación de 12. Discusión. El cuestionario SQUED es un instrumento sencillo, fácil de usar y fiable. Constituye una herramienta útil, y la más corta validada, para que los médicos de AP puedan identificar fácilmente pacientes con DE. Su sencillez debería hacer fácil el proceso de adaptación cultural y validación en otros idiomas

Background. It is necessary to have simple tools to screen erectile dysfunction (ED) in an easy, reliable and valid manner. The objective of this study was to develop and validate a short diagnostic questionnaire for erectile dysfunction (SQUED), easy to use in the primary care setting. Subjects and method. The development of SQUED included: concepts identification, item generation and evaluation of contents and face validity through interviews with subjects to assess comprehension and idiomatic adequacy. The psychometric validation was conducted in an epidemiologic, observational, comparative and multicenter study. Participants should complete the questionnaire in primary care setting and send to the specialist to confirm the diagnosis by an in depth interview and the application of IIEF questionnaire. Internal consistency, test-retest reliability and sensitivity and specificity of SQUED was evaluated. Results. Out of 405 subjects enrolled, 316 (208 ED and 108 non-ED) were evaluable. The SQUED questionnaire showed a high internal consistency (Cronbach’s alpha = 0.92) and a good test-retest reliability (Kappa index = 0.77). Furthermore, the questionnaire showed a good diagnostic capacity with high values of sensitivity and specificity, 0.87 and 0.78, respectively, in relation to the diagnosis made by urologists. The cutting point was established at a score of 12. Discussion. The SQUED questionnaire is a simple, easy to use and reliable instrument. It can become a useful tool, and the shortest validated, for primary care physicians to easily screen for ED patients. Its simplicity should facilitate an easy cultural adaptation and validation into other languages

[Efficacy and safety of two dosing regimens with Tadalafil in Spanish men with erectile dysfunction: results from the SURE study in 14 European countries]. / Eficacia y seguridad de Tadalafilo en dos regímenes de dosificación diferentes en pacientes españoles con disfunción eréctil: resultados procedentes del estudio SURE realizado en 14 países europeos.

OBJECTIVE: [corrected] To compare the efficacy and safety of tadalafil 20 mg administered 3 times/week (SCH) vs. on demand (OD) in a cohort of Spanish men with erectile dysfunction (ED), since Tadalafil period of responsiveness lasts up to 36 hours post-dosing. MATERIAL AND METHODS: The 418 Spanish patients participating in the European multicenter, crossover, open-label SURE clinical trial (comprising 4262 men) were randomly assigned to one of the treatment sequences: tadalafil 20 mg SCH for 5-6 weeks followed by tadalafil 20 mg OD for 5-6 weeks, or the inverse sequence. At completion, patients were asked to select the regimen they preferred to receive in an extension phase. RESULTS: In both regimens, tadalafil led to a similar improvement in erectile function compared to baseline. However, the SCH regimen showed statistically significant higher scores for several IIEF questions (i.e. sexual desire domain). Normal erectile function (IIEF EF domain score > or = 26) was achieved by 69.3% of patients on SCH and 64.3 % on OD, with a sexual intercourse success rate (SEP3) of 75.6% and 72.2% respectively (p<0.05). Nevertheless, more patients preferred to receive tadalafil OD for the extension phase (55.9% vs 44.1%, p<0.05). Tadalafil was well tolerated in both regimens. The most common TEAEs (> or = 5%) were headache, dyspepsia and back pain. There were no clinically significant differences in the incidence of TEAEs between regimens. CONCLUSIONS: Tadalafil 20 mg is efficacious and well tolerated for the treatment of ED, regardless the regimen of administration (OD or SCH). Patients can choose the pattern of administration that fits better with their expectations.

Eficacia y seguridad de Tadalafilo en dos regímenes de dosificación diferentes en pacientes españoles con disfunción eréctil: Resultados procedentes del estudio SURE realizado en 14 países europeos / Efficacy and safety of two dosing regimens with tadalafil in spanish men with erectile dysfunction: results from the sure study in 14 european countries

Fundamento y objetivo: Comparar eficacia y seguridad de tadalafilo 20 mg administrado 3 veces/semana ('pautado') vs. 'a demanda' en una cohorte de españoles con disfunción eréctil (DE) aprovechando que su efecto permanece hasta 36 horas postdosis. Material y método: Los 418 españoles participantes en el estudio europeo SURE (multicéntrico, cruzado y abierto en 4.262 pacientes), se distribuyeron aleatoriamente a una de las siguientes secuencias: tadalafilo 20 mg 'a demanda' (D) durante 5-6 semanas seguido de tadalafilo 20 mg pautado, 3 veces por semana (P) otras 5-6 semanas; o la inversa. Al finalizar los pacientes eligieron el régimen que preferían en una extensión del estudio. Resultados: Tadalafilo en ambos regímenes mejoró la función eréctil (FE) respecto a la basal. El régimen P obtuvo significativamente mejores puntuaciones que el D en ciertos dominios del cuestionario IIEF (p.ej. deseo sexual), y más pacientes (69,3% vs 64,3%, P5%) relacionados con el tratamiento fueron cefalea, dispepsia y dolor de espalda. No hubo diferencias significativas en la incidencia de los mismos. Conclusiones: Tadalafilo 20 mg es eficaz en el tratamiento de la DE en cualquiera de los regímenes de administración ('a demanda' ó 3 veces/semana) empleado, siendo bien tolerado. Los pacientes pueden escoger la pauta de administración mas adecuada

Objetive: To compare the efficacy and safety of tadalafil 20 mg administered 3 times/week (SCH) vs. on demand (OD) in a cohort of Spanish men with erectile dysfunction (ED), since Tadalafil period of responsiveness lasts up to 36 hours post-dosing. Material and methods: The 418 Spanish patients participating in the European multicenter, crossover, open-label SURE clinical trial (comprising 4262 men) were randomly assigned to one of the treatment sequences: tadalafil 20 mg SCH for 5-6 weeks followed by tadalafil 20 mg OD for 5-6 weeks, or the inverse sequence. At completion, patients were asked to select the regimen they preferred to receive in an extension phase. Results: In both regimens, tadalafil led to a similar improvement in erectile function compared to baseline. However, the SCH regimen showed statistically significant higher scores for several IIEF questions (i.e. sexual desire domain). Normal erectile function (IIEF EF domain score ≥26) was achieved by 69.3% of patients on SCH and 64.3 % on OD, with a sexual intercourse success rate (SEP3) of 75.6% and 72.2% respectively (p<0.05). Nevertheless, more patients preferred to receive tadalafil OD for the extension phase (55.9% vs 44.1%, p<0.05). Tadalafil was well tolerated in both regimens. The most common TEAEs (≥5%) were headache, dyspepsia and back pain. There were no clinically significant differences in the incidence of TEAEs between regimens. Conclusions: Tadalafil 20 mg is efficacious and well tolerated for the treatment of ED, regardless the regimen of administration (OD or SCH). Patients can choose the pattern of administration that fits better with their expectations

[Psychological impact of erectile dysfunction on self-esteem and self-confidence]. / Repercusiones psicológicas de la disfunción eréctil sobre la autoestima y autoconfianza.

BACKGROUND AND OBJECTIVE: Erectile dysfunction (ED) is caused by a large range of organic, psychological, psychiatric, interpersonal and pharmacological factors. Numerous scientific publications mention the loss of self-esteem as a collateral effect of ED, with a very probable affectation of the subject's self-confidence. The objective of this study was to evaluate the self-esteem and self-confidence of subjects with ED and to compare them with a group of non-ED subjects. SUBJECTS AND METHOD: An epidemiological, cross-sectional, observational, comparative and multicentric study was conducted. General Practitioners selected 405 men older than 18 years in which they suspected ED. All the participants had to complete the self administered form of the Spanish version of the Rosenberg self-esteem scale and the Spanish culturally adapted version of the Johnson and McCoy self-confidence scale. After that, patients were referred to the urologist in order to confirm the ED diagnosis. RESULTS: The statistical analysis of the data showed that the subjects with ED obtained significantly lower scores in the self-confidence and self-esteem scales than the non-ED subjects (p < 0.01). DISCUSSION: The results of this study show the loss of self-confidence and self-esteem that suffer patients with ED.

Repercusiones psicológicas de la disfunción eréctil sobre la autoestima y autoconfianza / Psychological impact of erectile dysfunction on self-esteem and self-continence

Introducción: La disfunción eréctil (DE) está causada por una amplia gama de factores orgánicos, psicológicos, psiquiátricos, interpersonales y farmacológicos. En numerosas publicaciones se menciona la pérdida de autoestima como un efecto colateral de la DE siendo muy probable también una afectación de la autoconfianza del sujeto. El objetivo del siguiente estudio fue evaluar la autoestima y autoconfianza de sujetos con DE y compararla con un grupo de sujetos sin DE. Material y Métodos: Estudio epidemiológico, transversal, observacional, comparativo y multicéntrico. Se seleccionaron 405 sujetos varones mayores de 18 años en los que el médico de Atención Primaria sospechara que pudieran padecer DE. Todos los participantes debían cumplimentar de forma autoaplicada la versión española del cuestionario de autoestima de Rosenberg y la adaptación cultural al español del Cuestionario de autoconfianza de Johnson y McCoy. Después fueron remitidos a un urólogo que confirmaba el diagnóstico de DE (“gold Standard”).Resultados: El análisis estadístico mostró que los sujetos afectados de DE obtenían puntuaciones significativamente inferiores en las escalas de autoconfianza y autoestima que los sujetos sin DE (p< 0.01).Discusión: Los resultados ponen de manifiesto la pérdida de autoconfianza y autoestima que sufren los pacientes afectados de DE (AU)

Background and objective: Erectile dysfunction (ED) is caused by a large range of organic, psychological, psychiatric, interpersonal and pharmacological factors. Numerous scientific publications mention the loss of self-esteem as a collateral effect of ED, with a very probable affectation of the subject´s self-confidence. The objective of this study was to evaluate the self-esteem and self-confidence of subjects with ED and to compare them with a group of non-ED subjects. Subjects and Method: An epidemiological, cross-sectional, observational, comparative and multicentric study was conducted. General Practitioners selected 405 men older than 18 years in which they suspected ED. All the participants had to complete the self administered form of the Spanish version of the Rosenberg self-esteem scale and the Spanish culturally adapted version of the Johnson and McCoy self-confidence scale. After that, patients were referred to the urologist in order to confirm the ED diagnosis. Results: The statistical analysis of the data showed that the subjects with ED obtained significantly lower scores in the self-confidence and self-esteem scales than the non-ED subjects (p< 0.01). Discussion: The results of this study show the loss of self-confidence and self-esteem that suffer patients with ED

Core document on erectile dysfunction: key aspects in the care of a patient with erectile dysfunction.

The aim of this Core Document of the Spanish Consensus on Erectile dysfunction (ED) is to offer guidance to the nonspecialist physician in the management of patients with ED. ED is one of the most frequent chronic health problems in men older than 40 y of age and may also act as a sentinel symptom for other important underlying diseases. Its etiology can be classified into organic, psychogenic, or mixed. In most cases, the underlying cause of ED is usually a chronic health problem (such as diabetes, hypertension, atherosclerosis, and so on) or an adverse drug effect. The initial step in the management is to assess erectile function in patients with risk factors for ED. Once ED has been established, a detailed sexual, medical, and social history, including a review of medications used, is the most important aspect of a patient's assessment. Generally, examination should be limited to the cardiovascular, neurological, and urogenital systems. Fasting glucose and blood lipid profile should be performed in every man with ED, and free testosterone levels in men older than 50 y or if hypogonadism is suspected; other diagnostic tests are optional and should be requested on an individualized basis. In many cases, the most likely cause of ED can be identified based on the above information. Therapeutic intervention should be patient-oriented and based on the expectations and wishes of the patient and his partner, who should be included in discussions whenever possible. Basic interventions common to any type of ED include sexual counseling, lifestyle modifications, treatment of associated medical conditions, and switching to alternative drugs with lower risk of ED. In certain cases, an etiologic treatment may be performed (sex therapy, revascularization surgery, and hormonal therapy). Most patients with ED will benefit from symptomatic treatments; first-line therapy may be prescribed by physicians who are not specialists in ED, and includes oral agents such as inhibitors of phosphodiesterase type 5, currently considered the drugs of choice for initial treatment of ED. Intracavernous drugs are the second-line therapy, and surgical treatments, such as implantation of penile prostheses, are reserved for urologists/andrologists who specialize in ED. Referral may be appropriate where indicated by age, clinical findings, or the patient's request.

Specific aspects of erectile function in urology/andrology.

The urologist/andrologist is the specialist responsible for diagnosis and treatment of health problems related to the genitourinary tract, and his or her participation in comprehensive care for a patient with erectile dysfunction (ED) is fundamental and often indispensable. The urologists/andrologists should characterize the origin of ED because of their knowledge and familiarity of all diagnostic tests and second- and third-line therapy. The origin of ED is important to determine for various reasons, such as young people suitable for etiologic treatment, medicolegal reasons, or patients' wishes for a better understanding of their condition. A review of the diagnostic tests available as well as indications for second- and third-line therapy is presented. The close relationship between ED and urological disorders, such as benign prostatic hyperplasia, prostate cancer and their treatments, and renal failure, in association with penile conditions like Peyronie's disease, priapism, and possible androgen deficiency in men older than 50 years, places the urologist at the center of integrated treatment of male ED.

Sexualidad del hombre a partir de los 50 / No disponible

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Male erectile dysfunction and health-related quality of life.

OBJECTIVE: The purpose of this work was to assess the health-related quality of life factors associated with erectile dysfunction (ED). METHODS: 2476 non-institutionalised Spanish males, age ranging from 25 to 70 years, were interviewed. ED was defined using two instruments: a simple self-assessment question (ED-sq) and the International Index of Erectile Function (IIEF). Health-related quality of life (HRQoL) was measured through the SF-36 questionnaire. RESULTS: The severity of ED (measured both through the ED-sq and with the IIEF) increased as the scores of the scales of the SF-36 decreased (Mantel-Hänszel chi(2)-test statistic range: [26-305]; p<0.001). The two summary components (physical and mental) showed a downward trend, more for the physical than for the mental component. CONCLUSION: We found a clear pattern of negative association between self-perceived erectile dysfunction and HRQoL. This association was clearer when ED-sq (rather than IIEF) was used, and stronger for the physical summary component than for the mental one.