[Ectopic finding of malleable penile prosthesis extension Tip.] / Hallazgo ectópico de tip de extensión de prótesis peneana maleable.

OBJECTIVE: To report the finding of malleable penile prosthesis extension tips in an ectopic position. METHOD: We retrospectively analyzed two clinical cases of ectopic finding of prosthetic implant extension tips and performed a bibliographic review. RESULTS: In the cases described, conservative behavior was decided given the absence of signs, symptomatology and the efficacy of the normally positioned implant. CONCLUSION: The migration of the penile prosthetic implant is a very uncommon complication, more so the finding of a tip extension in an ectopic position. Reports in the literature on the behavior to follow in this type of complications are absent.

OBJETIVO: Comunicar el hallazgo en posición ectópica de los Tips de extensión de prótesis peneana maleable.MÉTODO: Se analizaron retrospectivamente dos casos clínicos de hallazgo ectópico de tip de extensión de implante protésico y se realizó una revisión bibliográfica. RESULTADOS: En los casos descritos se decidió conducta conservadora dada la ausencia de signos, sintomatología y a la eficacia del implante normoposicionado.CONCLUSIÓN: La migración del implante protésico peneano es una complicación muy infrecuente, más aun el hallazgo en posición ectópica de un tip de extensión. No se reportan informes en la literatura sobre la conducta a seguir ante este tipo de complicaciones.

Hallazgo ectópico de tip de extensión de prótesis peneana maleable / Ectopic finding of malleable penile prosthesis extension Tip

OBJETIVO: Comunicar el hallazgo en posición ectópica de los Tips de extensión de prótesis peneana maleable. MÉTODO: Se analizaron retrospectivamente dos casos clínicos de hallazgo ectópico de tip de extensión de implante protésico y se realizó una revisión bibliográfica. RESULTADOS: En los casos descritos se decidió conducta conservadora dada la ausencia de signos, sintomatología y a la eficacia del implante normoposicionado. CONCLUSIÓN: La migración del implante protésico peneano es una complicación muy infrecuente, más aún el hallazgo en posición ectópica de un tip de extensión. No se reportan informes en la literatura sobre la conducta a seguir ante este tipo de complicaciones

OBJECTIVE: To report the finding of malleable penile prosthesis extension tips in an ectopic position. METHOD: We retrospectively analyzed two clinical cases of ectopic finding of prosthetic implant extension tips and performed a bibliographic review. RESULTS: In the cases described, conservative behavior was decided given the absence of signs, symptomatology and the efficacy of the normally positioned implant. CONCLUSION: The migration of the penile prosthetic implant is a very uncommon complication, more so the finding of a tip extension in an ectopic position. Reports in the literature on the behavior to follow in this type of complications are absent

Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors.

INTRODUCTION: Low-intensity shockwave therapy (LISWT) has recently emerged as a promising method in the treatment of erectile dysfunction (ED). AIM: To assess the long-term results of the effectiveness and safety of LISWT in patients with ED who are non-responders to phosphodiesterase type 5 inhibitor (PDE5i) treatment. METHODS: This open-label, longitudinal, and observational study investigated an uncontrolled population of 50 consecutive patients whose ED was unresponsive to PDE5i treatment. Patients were treated with a four-session LISWT protocol. During active treatment and follow-up, all patients remained on their regular high on-demand or once-daily PDE5i dosing schedules. MAIN OUTCOME MEASURES: Effectiveness was assessed according to the International Index of Erectile Function erectile function domain, questions 2 and 3 of the Sexual Encounter Profile, Erection Hardness Scale, and Global Assessment Question scores at baseline and at 3, 6, 9, and 12 months after treatment. Patients were considered responders whenever they showed improvement in erection parameters in all four assessments and responded positively to the Global Assessment Question. Adverse events were recorded. Statistical variables were applied and findings were considered statistically significant at a P value less than < .05. RESULTS: Eighty percent (mean age = 64.8 years) completed the 12-month follow-up. Positive response rates were 60% of available subjects at the end of the study and 48% of the intent-to-treat population. After the 12-month follow-up, 91.7% of responders maintained their responses. No patient reported treatment-related adverse events. CONCLUSION: LISWT in patients with ED unresponsive to PDE5i treatment was effective and safe in 60% of patients treated. The efficacy response was maintained for 12 months in most patients.

Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo.

OBJECTIVES: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. METHODS: An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. RESULTS: Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371). CONCLUSIONS: Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.

[Effectiveness of low-intensity extracorporeal shock wave therapy on patients with Erectile Dysfunction (ED) who have failed to respond to PDE5i therapy. A pilot study]. / Efectividad de las ondas de choque de Baja intensidad (LISW) en varones con disfunción eréctile (DE) no respondedores a IPDE5. studio piloto.

UNLABELLED: Low-intensity extracorporeal shock wave therapy (LIESWT) of the penis has recently emerged as a promising modality in the treatment of ED. OBJECTIVES: The objective of this paper is to assess the effectiveness and safety of LIESWT on patients with ED who have failed to respond to PDE5i treatment. METHODS: Open label, prospective, longitudinal observational study. The study involved an uncontrolled population of 25 patients. The treatment consisted in applying 20,000 shock waves during a period of four weeks. In each session the patient received 5000 shock waves of 0.09 mJ/mm2: 1800 were applied on the penis (900 on each corpus cavernosum), and 3200 were applied on the perineum (1600 on each crus). During the active treatment and follow-up phases, all patients remained on their regular high on demand or once-a-day dose PDE5i schedules. MAIN OUTCOME MEASURE: Effectiveness was assessed by IIEF-6, SEP2, SEP3 and GAQ. Patients were considered to be responders whenever they improved on all three erection assessment parameters and respond positively to the GAQ at three months post-treatment. Adverse events were recorded. Statistical variables were applied and findings were considered to be statistically significant whenever the P value was<0.05. RESULTS: Eighty percent (median age 63) of the patients (20/25) completed the study. Five patients were lost to follow-up and were excluded from the analysis. Sixty percent (60%) of the patients responded to the treatment, improved the 3 efficacy evaluating parameters and responded positively to the GAQ. The increase in mean IIEF-6 score was of 9 points after the third post-treatment month. There were no patients reporting treatment-related adverse events. CONCLUSIONS: LIESWT for men with ED and that are PDE5i non-responders was safe and effective and restoring PDE5i response in more than 50% of patients.A large-scale multicenter study is required to determine the benefits of this treatment for ED.

Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia.

PURPOSE: Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. MATERIALS AND METHODS: In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. RESULTS: Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate. CONCLUSIONS: The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.

Effectiveness of tadalafil 5 mg once daily in the treatment of men with lower urinary tract symptoms suggestive to benign prostatic hyperplasia with or without erectile dysfunction: results from naturalistic observational TadaLutsEd study.

INTRODUCTION: Naturalistic clinical trials provide data on the effectiveness of drugs in nonexperimental and everyday situations and are extremely helpful for decision-making purposes and for confirming experimental findings in clinical trials. No data have been published from naturalistic studies performed in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) with or without erectile dysfunction (ED) and treated with phosphodiesterase type 5 inhibitors. AIM: The aim of this study (TadaLutsEd Study) was to assess, in the context of medical practice, the effectiveness of tadalafil 5 mg once daily in patients with LUTS/BPH with or without erectile dysfunction. METHODS: The study was a 6-week uncontrolled, prospective, open-label, multicentric, observational study. The patient population involved sexually active males aged ≥ 50 years, diagnosed with LUTS/BPH with or without concomitant ED, and treated with tadalafil 5 mg daily in accordance with standard urological practice. MAIN OUTCOME MEASURES: Effectiveness was assessed through the self-administered International Prostate Symptom Score (IPSS) questionnaire; quality of life was evaluated through the IPSS quality of life section (IPSS-QoL). The patients were also evaluated with the International Index of Erectile Function (IIEF-5). Adverse events were recorded. Statistical analyses using paired data samples was applied (Wilcoxon signed-ranks test). RESULTS: Sixty-two patients (mean age 62.2 years) completed the treatment, of whom 85.5% showed improvement in their urinary symptoms. Pre- and post-treatment differences in the IPSS, IPSS-QoL, and IIEF-5 scores were statistically significant at 4.4, 1, and 5.4 points, respectively (P < 0.0001). Tadalafil was well tolerated, and adverse events were mild, with a discontinuation rate of 1.6%. CONCLUSION: According to study results, the use of tadalafil 5 mg once daily in a nonselected patient population with LUTS/BPH with or without ED led to improvements in terms of symptoms and quality of life and exhibited a safety profile similar to that obtained in controlled tadalafil clinical trials.

Lower urinary tract symptoms and erectile dysfunction from urological consultation in Argentina.

UNLABELLED: Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are often associated, and they both reduce the quality of life of those who suffer from these conditions. OBJECTIVES: Primarily, to determine the relationship of LUTS/BPH as an independent risk factor for suffering ED and, secondarily, the relationship of LUTS/BPH and ED according to the severity of the symptoms. METHODS: A descriptive, analytic, multicentre study was carried out in 580 patients consulting for prostatic control or LUTS. 305 patients, who met the inclusion/exclusion criteria, were included in the analysis. Erectile dysfunction and LUTS were assessed by IIEF5 and IPSS. The presence, predictors and degree of severity of ED were examined according to patients' age and comorbidities. Qualitative and continuous variables were considered for the statistical analysis and simple and multiple regression analyses were applied. A value of p < 0.05 was considered statistically significant. RESULTS: Mean age was 62 years (IQR 56-67) ED prevalence in patients with LUTS/BPH was 83.6%. Patients with ED were older, showed a higher prevalence of hypertension and higher IPSS scores (p < 0.05). Multivariate analysis for ED predictors showed that age, diabetes and IPSS score were significantly associated with ED (p < 0.05). CONCLUSIONS. According to our results, there is a high prevalence of ED in patients with LUTS/BPH, which are also independent risk factors for suffering ED. The presence of ED was more prevalent in moderate LUTS/BPH than in the severe LUTS/BPH. The importance of assessing the sexual health of men consulting for LUTS/BPH is emphasized.

Síntomas del tracto urinario inferior y disfunción eréctil en la consulta urológica en Argentina / Lower urinary tract symptoms and erectile dysfunction from urological consultation in Argentina

La disfunción eréctil (DE) y los síntomas del tracto urinario inferior atribuidos a hiperplasia prostática benigna (STUI/HPB) suelen asociarse y reducen la calidad de la vida de quienes la padecen. OBJETIVO: Determinar la relación de STUI/HPB como factor de riesgo independiente para padecer DE y secundariamente la relación de STUI/HPB y DE de acuerdo a la severidad de los síntomas. MÉTODO: Estudio descriptivo analítico multicéntrico en 580 pacientes que concurrieron a un consultorio urológico para control prostático o por STUI. Fueron considerados para el análisis 305 pacientes (52.6%) que cumplían con los criterios de inclusión/exclusión. La función eréctil y los STUI fueron evaluados con IIEF5 e IPSS. Se analizó la presencia, predictores y grados de severidad de DE en relación con edad y comorbilidades asociadas. Para el análisis estadístico se consideraron variables cualitativas y continuas y se aplico regresión logística simple y múltiple. Se consideró significación estadística un valor de p< 0,05. RESULTADOS: La edad media fue de 62 años (RIC 56-67). La prevalencia de DE en pacientes con STUI/HPB fue del 83,6 %. Los pacientes con DE fueron más añosos, con mayor prevalencia de hipertensión arterial y un score de IPSS mayor (p<0,05). El análisis multivariado para predictores de DE demostró que la edad, diabetes y el score de IPSS se asociaron significativamente a DE (p<0.05). La presencia de STUI/HPB moderados fue un predictor significativo de DE (p<0.05), no hallándose asociación significativa con la presencia de STUI/HPB severo (p=0,103). La severidad de la DE no estuvo asociada a la severidad de STUI/HPB. CONCLUSIONES: En nuestro grupo de pacientes la presencia de STUI/HPB constituyo un factor de riesgo independiente para padecer DE. La DE fue más prevalente en los pacientes con STUI moderados que en los severos. La prevalencia de DE en pacientes con STUI/HPB fue elevada (AU)

Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are often associated, and they both reduce the quality of life of those who suffer from these conditions. OBJECTIVES: Primarily, to determine the relationship of LUTS/BPH as an independent risk factor for suffering ED and, secondarily, the relationship of LUTS/BPH and ED according to the severity of the symptoms. METHODS: A descriptive, analytic, multicentre study was carried out in 580 patients consulting for prostatic control or LUTS. 305 patients, who met the inclusion/exclusion criteria, were included in the analysis. Erectile dysfunction and LUTS were assessed by IIEF5 and IPSS. The presence, predictors and degree of severity of ED were examined according to patients’ age and comorbidities. Qualitative and continuous variables were considered for the statistical analysis and simple and multiple regression analyses were applied. A value of p < 0.05 was considered statistically significant. RESULTS : Mean age was 62 years (IQR 56-67). ED prevalence in patients with LUTS/BPH was 83.6%. Patients with ED were older, showed a higher prevalence of hypertension and higher IPSS scores (p < 0.05). Multivariate analysis for ED predictors showed that age, diabetes and IPSS score were significantly associated with ED (p < 0.05). CONCLUSIONS. According to our results, there is a high prevalence of ED in patients with LUTS/BPH, which are also independent risk factors for suffering ED. The presence of ED was more prevalent in moderate LUTS/BPH than in the severe LUTS/BPH. The importance of assessing the sexual health of men consulting for LUTS/BPH is emphasized (AU)

Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial.

BACKGROUND: Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS). OBJECTIVE: To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled, 12-week trial enrolled men ≥45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) ≥13, and maximum urine flow rate (Q(max)) ≥4 to ≤15 ml/s. INTERVENTION: Tadalafil 5mg (n=161) or placebo (n=164), once daily. MEASUREMENTS: Analysis of covariance (ANCOVA) modeling evaluated change from baseline in continuous efficacy variables. Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test, and between-group differences in treatment-emergent adverse events (TEAEs) were assessed using the Fisher exact test. RESULTS AND LIMITATION: Tadalafil significantly improved IPSS results, from baseline to endpoint, compared to placebo (-5.6 vs -3.6; p=0.004). Reduction in IPSS results was apparent after 1 wk and significant after 4 wk (tadalafil -5.3 vs placebo -3.5; p=0.003). The BPH Impact Index (BII) was not assessed at week 1; however, BII improvement was apparent at 4 wk (tadalafil -1.8 vs placebo -1.2; p=0.029) and continued at 12 wk (tadalafil -1.8 vs placebo -1.3; p=0.057). Tadalafil significantly improved the International Index of Erectile Function-Erectile Function score in sexually active men with erectile dysfunction (ED; 6.7 vs 2.0; p<0.001) at 12 wk (not assessed at week 1). Few subjects reported one TEAE or more (p=0.44). For tadalafil, the most common TEAEs were headache (3.7%) and back pain (3.1%). Tadalafil did not significantly improve Q(max) or reduce postvoid residual volume. CONCLUSIONS: Tadalafil 5mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED. TRIAL REGISTRATION: This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242.

Risk factors of Peyronie's disease. What does our clinical experience show?

INTRODUCTION: Peyronie's disease (PD) is a localized fibrosis that affects the tunica albuginea of the penis. Its origin can be associated with coital penile trauma in men with autoimmune hypersensitivity and a presumed genetic predisposition. AIM: To identify clinical and traumatic risk factors in a patient population with PD, when compared to a control group. METHODS: From November 2007 to March 2010, 317 patients sought medical attention for PD. As control group, 147 consecutive patients, who came for a prostate exam, were studied. Clinical, traumatic, and sexual history of these patients was gathered. Risks factors were considered only if they had been present before the onset of PD symptoms. MAIN OUTCOME MEASURE: The International Index of Erectile Function and the International Prostate Symptoms Score. A univariate logistic regression model (chi-square) (odds ratios [ORs] and 95% confidence intervals [CI]) was used to estimate the association of risk factors with PD; and the Student's t-test was implemented for age. RESULTS: The mean age of patients with PD and control group was 56.7 and 58.8, respectively (P<0.923). The mean evolution time of the disease was 17.7 months (2-48). Erectile dysfunction (ED) and coital trauma constituted the only two independent risk factors for PD compared to the control group (P<0.05 and 0.002, respectively) with an OR of 1.5 (95% CI 1.0-2.3) and 2.69 (95% CI 1.41-5.21), respectively. Patients with ED and diabetes mellitus and with a mild-to-moderate ED also presented a higher predisposition (P=0.008 and 0.00001), with an OR of 3.64 (95% CI 1.33-10.79) and 5.58 (95% CI 3.03-10.42), respectively. CONCLUSION: Erectile dysfunction and coital trauma have proven to be independent risk factors for the development of PD.

Recreational use of phosphodiesterase type 5 inhibitors by healthy young men.

INTRODUCTION: In recent years, PDE5 inhibitors (PDE5i) use has become more popular among men without ED to enhance sexual performance. However, reports in the literature are scarce. AIM: The aim of this study was to evaluate the recreational use of PDE5i in healthy young men. MAIN OUTCOME MEASURES: We evaluated the recreational use of PDE5i among young and healthy men, their main reasons for use, how they were obtained these drugs, and the combination with alcohol or other drugs. METHODS: Descriptive, transversal study consisting in 400 brief surveys with structured multiple choice and open questions. Nonprobability samples (quota samples) included young men between 18 and 30 years of age in a public area (high schools, universities, and gyms) between August and November 2009. Collecting the questionnaires in a sealed box enforced confidentiality. The survey included demographic and sexual health data and PDE5i use characteristics. For statistical analysis we used Fisher's exact and Mann-Whitney tests. RESULTS: A total of 321 questionnaires were appropriate for the purposes of evaluation. Mean age and standard deviation were 25.1±3.3 years old. Regarding PDE5i use, 69 men (21.5%) mentioned trying the pill (being sildenafil the most commonly used one) at least one time in their lives and 37 (53.4%) men combined it with alcohol or drugs. Referred sources of acquisition PDE5i were 75.4% (N=52) from a friend, 17.4% (N=15) from a pharmacy/drugstore without a medical prescription, 4.3% (N=3) prescribed by a physician and 2.9% (N=2) through Internet. There were several reasons for taking PDE5i related to sexual confidence, erection quality, and better sexual performance. CONCLUSION: According to our results, 21.5% of healthy men between 18 and 30 years old used PDE5i as a recreational drug, mostly associated with alcohol or other drugs without medical control. This could have led to misuse and a public health problem. Further studies are needed to evaluate not only PDE5i recreational use prevalence, but also psychosocial determinants, long term safety, misuse, and abuse related to it.

Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH. Pilot study.

INTRODUCTION: The high incidence of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment. Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia) BPH. AIM: To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study. MAIN OUTCOMES MEASURES: International Prostate Symptoms Score (IPSS), IPSS Quality of Life (IPSS-QOL), maximum flow rate (Qmax), post-void residual volume (PVR), International Index of Erectile Function-Erectile Function Domain (IIEF-EF), Global Assessment Quality (GAQ). For the statistical analysis, a Tukey-Kramer multicomparison test was used. METHODS: A randomized, double-blind, crossover study was conducted from September 2007 to February 2008 in one center. Thirty men, older than 50 years old, with a history of LUTS/BPH of at least 6 months, were randomized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days, and then switched to the other treatment mode for other 45 days. RESULTS: Twenty-seven patients completed the study. Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination. Both regimens similarly improved the Qmax and decreased the PVR volume from baseline (P < 0.001) with no significant differences between tamsulosin alone vs. tamsulosin and tadalafil (P > 0.05). The IIEF improved with tamsulosin plus tadalafil (P < 0.001) but not with tamsulosin alone (P > 0.05). The GAQ showed that all patients preferred the combination scheme. Both treatments were well tolerated. CONCLUSION; Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated. Large-scale, randomized, placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED.

Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction.

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

Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.

INTRODUCTION: Available information on the efficacy and safety of tadalafil on Latin American men comes from reports where data is mixed with other populations. AIM: To assess the efficacy and safety of tadalafil in Latin American men with erectile dysfunction (ED). METHODS: Integrated analyses of data from four 12-week, randomized, double-blind, parallel, placebo-controlled trials conducted in Latin America that assessed the efficacy and safety of tadalafil in 406 Latin American men with ED of diverse etiology and severity assigned to placebo (N = 113), 10-mg tadalafil (N = 39), or 20-mg tadalafil (N = 254). MAIN OUTCOME MEASURES: Efficacy was assessed by International Index of Erectile Function Erectile Function (IIEF-EF) domain, questions 2 to 5 of the Sexual Encounter Profile and the first Global Assessment Question. Adverse events (AEs) reported by all enrolled patients were collected. RESULTS: Latin American patients treated with 10 or 20 mg of tadalafil had a significant mean improvement of 4.92 and 9.78, respectively, in the IIEF-EF domain score from baseline compared with 2.24 on placebo (P = 0.003 and P < 0.001, respectively, vs. placebo). At both doses, the mean success rate for penetration was 75 and 86%, respectively, compared with 56% on placebo (P < or = 0.001), the mean success rate for intercourse was 55% and 78%, compared with 36% on placebo (P < 0.001 vs. placebo), and 62% and 91% of patients, respectively, reported improved erections at the end point, vs. 43% on placebo (P = 0.160 and P < 0.001, respectively, vs. placebo). The most frequent AEs were headache, dyspepsia, and back pain. CONCLUSIONS: 10 or 20 mg tadalafil was an effective, safe, and well-tolerated therapy for Latin American men with ED of diverse etiology despite of ED severity.

Effects of ACE inhibition and beta-blockade on female genital structures in spontaneously hypertensive rats.

INTRODUCTION AND AIM: This study evaluated the possible differences between an angiotensin converting enzyme (ACE) inhibitor and a beta-blocker concerning their potential protective role on female external genitalia in spontaneously hypertensive rats (SHR). MAIN OUTCOME MEASURES: Morphological changes in the clitoris after antihypertensive treatments. METHODS: For 6 months, SHR received no treatment; SHR + ramipril (RAM), SHR + atenolol (AT), and control Wistar Kyoto (WKY) rats received no treatment. Clitorises were processed for immunohistochemistry using anti-alpha-smooth muscle actin (alpha-SMA), anti-collagen I and III, anti-transforming growth factor beta(1) (TGFbeta(1)), and anti-endothelial nitric oxide synthase (eNOS) antibodies. RESULTS: SHR + RAM and SHR + AT presented significantly lower blood pressure in both groups vs. untreated SHR. Compared with WKY, alpha-SMA was increased in the arteries and in the cavernous spaces of the clitoris together with a marked increase in wall/lumen ratio in clitoral vessels in untreated SHR. All these alterations were diminished in SHR + AT (P < 0.01). SHR + RAM presented differences with respect to SHR + AT in the reduction of these variables. TGFbeta(1) expression in the vessel wall from the clitoris and collagen I and III deposition in the interstitium from the clitoris in untreated SHR were significantly more (P < 0.01) than in WKY. While SHR + AT showed a mild decrease in these variables, SHR + RAM presented a significant reduction (P < 0.01) in TGFbeta(1) expression interstitial fibrosis and in both types of collagens. Positive immunostaining of eNOS in the sinusoidal endothelium from the clitoris was less (P < 0.01) in untreated SHR (3.4 +/- 1.3%) and SHR + AT (5.1 +/- 1.2%) than in SHR + RAM (17.2 +/- 1.6%) and WKY (15.9 +/- 1.7%). Untreated SHR and SHR + AT presented more surrounding connective tissue at the perineurium in the clitoris (P < 0.01) than SHR + RAM. CONCLUSION: ACE inhibition provided a considerable protective role on the female external genitalia structures in SHR by a mechanism that may be, at least in part, independent of the degree of blood pressure lowering.

Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30). RESULTS: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events. CONCLUSIONS: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

A double-blind randomized placebo control study comparing the objective and subjective changes in female sexual response using sublingual apomorphine.

INTRODUCTION: Female sexual dysfunction and its therapeutic approach is a growing area. AIM: We aimed to assess the subjective and objective changes of the female sexual response, in patients with orgasmic sexual dysfunction using 3 mg SL Apomorphine (APO). METHODS: Twenty-four patients (mean age 32 years old, SD: 9.69) were included in a prospective randomized cross-over protocol. Sexual response was evaluated objectively (duplex ultrasound) and subjectively (self-reported questionnaire) following vibrator stimuli with the addition of 3 mg SL APO or placebo. MAIN OUTCOME MEASURE: Sexual response objective (PSV, EDV, RI) and subjective (arousal and lubrication degree and orgasm achievement). Adverse events were also recorded. RESULTS: Clitoral hemodynamical changes, particularly peak systolic velocity (PSV), were significantly higher with APO (P = 0.003), mean increase of PSV poststimulus was 72.50% with placebo (from 9.7 cm/second to 17.0 cm/second) and 139.14% with APO (from 9.7 cm/second to 21.4 cm/second). SUBJECTIVE CHANGES (AROUSAL AND LUBRICATION) WERE ALSO SIGNIFICATIVE WITH APO (P < 0.05). CONCLUSION: According to our observations, APO seemed to produce more subjective and objective changes in the sexual arousal phase of women with orgasmic sexual dysfunction than placebo. Future research is needed to evaluate the place of this drug in the treatment of the female sexual dysfunction.