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There is overwhelming evidence to suggest that male gender is at a higher risk of developing more severe Covid-19 disease and thus having poorer clinical outcomes. However, the relationship between testosterone (T) and Covid-19 remains unclear with both protective and deleterious effects on different aspects of the disease suggested. Here, we review the current epidemiological and biological evidence on the role of testosterone in the process of SARS-CoV-2 infection and in mediating Covid-19 severity, its potential to serve as a biomarker for risk stratification and discuss the possibility of T supplementation as a treatment or preventative therapy for Covid-19.
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COVID-19 , Masculino , Humanos , SARS-CoV-2 , Testosterona/uso terapêuticoRESUMO
BACKGROUND: This review explores the bioethical implementation of artificial intelligence (AI) in medicine and in ophthalmology. AI, which was first introduced in the 1950s, is defined as "the machine simulation of human mental reasoning, decision making, and behavior". The increased power of computing, expansion of storage capacity, and compilation of medical big data helped the AI implementation surge in medical practice and research. Ophthalmology is a leading medical specialty in applying AI in screening, diagnosis, and treatment. The first Food and Drug Administration approved autonomous diagnostic system served to diagnose and classify diabetic retinopathy. Other ophthalmic conditions such as age-related macular degeneration, glaucoma, retinopathy of prematurity, and congenital cataract, among others, implemented AI too. PURPOSE: To review the contemporary literature of the bioethical issues of AI in medicine and ophthalmology, classify ethical issues in medical AI, and suggest possible standardizations of ethical frameworks for AI implementation. METHODS: Keywords were searched on Google Scholar and PubMed between October 2019 and April 2020. The results were reviewed, cross-referenced, and summarized. A total of 284 references including articles, books, book chapters, and regulatory reports and statements were reviewed, and those that were relevant were cited in the paper. RESULTS: Most sources that studied the use of AI in medicine explored the ethical aspects. Bioethical challenges of AI implementation in medicine were categorized into 6 main categories. These include machine training ethics, machine accuracy ethics, patient-related ethics, physician-related ethics, shared ethics, and roles of regulators. CONCLUSIONS: There are multiple stakeholders in the ethical issues surrounding AI in medicine and ophthalmology. Attention to the various aspects of ethics related to AI is important especially with the expanding use of AI. Solutions of ethical problems are envisioned to be multifactorial.
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Inteligência Artificial , Oftalmologia , Retinopatia Diabética , Glaucoma/diagnóstico , Glaucoma/terapia , HumanosRESUMO
The current coronavirus disease (COVID-19) pandemic caused by novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a male bias in severity and mortality. This is consistent with previous coronavirus pandemics such as SARS-CoV and MERS-CoV, and viral infections in general. Here, we discuss the sex-disaggregated epidemiological data for COVID-19 and highlight underlying differences that may explain the sexual dimorphism to help inform risk stratification strategies and therapeutic options.
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Imunidade Adaptativa , COVID-19/mortalidade , Imunidade Inata , SARS-CoV-2/patogenicidade , Caracteres Sexuais , Enzima de Conversão de Angiotensina 2/genética , Enzima de Conversão de Angiotensina 2/imunologia , COVID-19/imunologia , COVID-19/patologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/administração & dosagem , Feminino , Expressão Gênica , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Receptores Virais/genética , Receptores Virais/imunologia , SARS-CoV-2/imunologia , Índice de Gravidade de Doença , Fatores Sexuais , Análise de Sobrevida , Internalização do VírusRESUMO
OBJECTIVES: Thoracostomy tube (TT) connection to drainage device (DD) may be unintentionally disconnected, potentiating complications. Tape may strengthen this connection despite minimal data informing optimal practice. Our goal was to analyze the utility of cable ties for TT to DD connection. METHODS: On April 1, 2015, our trauma center supplanted use of tape or nothing with cable ties for securing TT to DD connection. We abstracted trauma registry patients with TTs placed from March 1, 2014 to May 31, 2016 and dichotomized as prior ("BEFORE") and subsequent ("AFTER") to the cable tie practice pattern change. We analyzed demographics, TT-specific details and outcomes. Primary outcome was TT to DD disconnection. Secondary outcomes included TT dislodgement from the chest, complications, length of stay (LOS), mortality, number of TTs placed and TT days. RESULTS: 121 (83.4% of abstracted) patients were analyzed. Demographics, indications for TT and operative rate were similar for BEFORE and AFTER cohorts. ISS was lower BEFORE (14.12 ± 2.35 vs 18.21 ± 2.71, p = 0.022); however, RTS and AIS for chest were similar (p = 0.155 and 0.409, respectively). TT to DD disconnections per TT days were significantly higher in the BEFORE cohort [6 (2.8%) vs. 1 (0.19%), p = 0.003], and dislodgements were statistically similar [0 vs 3 (0.57%), p = 0.36]. LOS, initial TTs placed and days per TT were similar, and median and mode of days per TT were the same. CONCLUSIONS: Cable ties secure connections between TT and DDs with higher fidelity compared to tape or nothing but may increase rates of TT dislodgement from the chest.
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Drenagem/instrumentação , Traumatismos Torácicos/cirurgia , Toracostomia/instrumentação , Adulto , Idoso , Desenho de Equipamento , Análise de Falha de Equipamento , Humanos , Escala de Gravidade do Ferimento , Tempo de Internação/estatística & dados numéricos , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Resistência à Tração , Traumatismos Torácicos/mortalidade , Centros de TraumatologiaRESUMO
Objective: Geriatric admissions to trauma centers have increased, and in 2013, our center integrated geriatrician consultation with the management of admitted patients. Our goal is to describe our experience with increasing geriatric fall volume to help inform organized geriatric trauma programs. Method: We retrospectively analyzed admitted trauma patients ≥65 years old, suffering falls from January 1, 2006, to December 31, 2017. We examined descriptive statistics and changes in outcomes after integration. Results: A total of 1,335 geriatric trauma patients were admitted, of which 1,054 (79%) had suffered falls. Falls increased disproportionately (+280%) compared with other mechanisms of injury (+97%). After 2013, patient discharge disposition to skilled nursing facility decreased significantly (-67%, p < .001), with a concomitant increase in safe discharges home with outpatient services. Regression analysis revealed association between integration of geriatrician consultation and outcomes. Discussion: Geriatrician consultation is associated with optimized discharge disposition of trauma patients. We recommend geriatrician consultation for all geriatric trauma activations.
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INTRODUCTION: Erectile dysfunction (ED) is prevalent in men with metabolic syndrome (MetS); therefore, it is important to characterize ED treatments in this population. AIMS: To investigate the safety and effectiveness of vardenafil in men with ED and MetS in a clinical setting. METHODS: REVITALISE is an international, prospective, single-arm, observational study in men with ED and MetS newly prescribed vardenafil. Vardenafil was prescribed at the discretion of the treating physician in line with the marketing authorization. Treatment effectiveness (International Index of Erectile Function [IIEF]) and health-related quality of life (Aging Males' Symptoms Scale) were assessed at treatment initiation, at an optional dose adjustment visit after approximately 4 weeks, and at the end of the observation period (approximately 12 weeks). MAIN OUTCOME MEASURES: The primary outcome was an intraindividual improvement in erectile function (EF), defined as an increase of at least four points in the EF domain of the IIEF. Secondary outcomes included assessing normal EF (IIEF-EF score ≥ 26), mild ED (IIEF-EF score = 22-25), and health-related quality of life. Treatment-emergent adverse events were monitored. RESULTS: In the intent-to-treat population (n = 1,832, mean age = 54.0 years, mean body mass index = 31.82 kg/m(2), Asian 36.8%, white 49.9%, 20.4% with severe ED, 75.6% with mild or moderate ED, 4.0% without ED), 82.4% reported an increase of at least four points in IIEF-EF score. Median IIEF-EF score increased from 15.0 (baseline) to 25.0 at 12 weeks (P < .0001). After treatment, 45.4% and 29.4% (intent-to-treat population) had normal EF and mild ED, respectively. Improvements in the sexual, psychological, and somatic subscales of the Aging Males' Symptoms Scale were found (P < .0001). Treatment-emergent adverse events were reported by 7.19% of patients; there were no serious adverse events related to vardenafil. CONCLUSION: In a clinical setting, men with ED and MetS treated with vardenafil reported improvements in EF and health-related quality of life; and the safety profile of vardenafil was acceptable. REVITALISE demonstrates that vardenafil represents a good treatment option for men with ED and MetS.
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Peyronie's disease results in a fibrous inelastic scar or hard plaque of the tunica albuginea of the penis that causes penile curvature deformity during erection that can be painful, distressing, and an impediment to sexual intercourse. In this article, the authors examine the knowledge gaps and research needs regarding the effect of Peyronie's disease on the patient's physical and psychological quality of life and on interpersonal relationships. On PubMed, the authors used the search terms Peyronie's disease, psychological, psychotherapy, male sexual dysfunction, partner, comorbid disease, satisfaction, and pain. Four categories describing the effect of Peyronie's disease were identified: (a) sexual dysfunction due to pain and altered penile shape, (b) psychological effects, (c) partner and relationship effects, and (d) effects of treatment options for Peyronie's disease. Results indicate that the examination of interventions aimed at education, coping, relationship distress, and sex therapy that may significantly improve patient quality of life is a core unmet need in Peyronie's disease. For many patients, the effect of Peyronie's disease is functional and psychological. Both aspects should be evaluated and treated in patients, which may require a referral. The physical pain, emotional distress and isolation, and partner and relationship discord that may be present require more attention.
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Disfunção Erétil/etiologia , Induração Peniana/complicações , Qualidade de Vida , Parceiros Sexuais , Disfunção Erétil/psicologia , Feminino , Nível de Saúde , Humanos , Masculino , Induração Peniana/psicologia , Disfunções Sexuais Fisiológicas/etiologiaRESUMO
An association between erectile dysfunction and cardiovascular disease has long been recognized, and studies suggest that erectile dysfunction is an independent marker of cardiovascular disease risk. Therefore, assessment and management of erectile dysfunction may help identify and reduce the risk of future cardiovascular events, particularly in younger men. The initial erectile dysfunction evaluation should distinguish between predominantly vasculogenic erectile dysfunction and erectile dysfunction of other etiologies. For men believed to have predominantly vasculogenic erectile dysfunction, we recommend that initial cardiovascular risk stratification be based on the Framingham Risk Score. Management of men with erectile dysfunction who are at low risk for cardiovascular disease should focus on risk-factor control; men at high risk, including those with cardiovascular symptoms, should be referred to a cardiologist. Intermediate-risk men should undergo noninvasive evaluation for subclinical atherosclerosis. A growing body of evidence supports the use of emerging prognostic markers to further understand cardiovascular risk in men with erectile dysfunction, but few markers have been prospectively evaluated in this population. In conclusion, we support cardiovascular risk stratification and risk-factor management in all men with vasculogenic erectile dysfunction.
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Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/diagnóstico , Impotência Vasculogênica/etiologia , Índice Tornozelo-Braço , Aterosclerose/complicações , Aterosclerose/diagnóstico , Biomarcadores/sangue , Cálcio/metabolismo , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/fisiopatologia , Espessura Intima-Media Carotídea , Vasos Coronários/metabolismo , Endotélio Vascular/fisiopatologia , Humanos , Masculino , Fatores de RiscoRESUMO
PURPOSE: Many men with "late-onset hypogonadism" (LOH) experience lower urinary tract symptoms (LUTS) that can be distressing and may decrease quality of life. LUTS often appear in men when testosterone levels begin to decline, which could be a significant association. We investigated whether testosterone replacement could alleviate LUTS in men with LOH. METHODS: Two hundred and sixty-one hypogonadal patients (mean age 59.5 years) presenting with erectile dysfunction, having also been evaluated for LUTS, received a single testosterone undecanoate injection at day 1, at week 6 and quarterly thereafter. Parameters, including International Prostate Symptom Score (IPSS), post-voiding residual urine volume, transrectal ultrasound, prostate volume and prostate-specific antigen were measured at each treatment visit. Two hundred and fifty-nine patients were included in the full analysis set. These were subsequently divided into weight losers (L ≥ 5 % weight loss at last visit from baseline) and non-losers (NL). t test analyses were used to compare the IPSS means of these subgroups. The potentially confounding effect on IPSS of using the phosphodiesterase-5 inhibitor (PDE5i) vardenafil was also accounted for. RESULTS: Mean IPSS showed a significant decrease with time following initiation of testosterone treatment (p < 0.05). No significant differences were observed in either IPSS between L and NL groups or in mean IPSS between vardenafil users and non-users. CONCLUSION: Testosterone replacement is associated with improvements in LUTS which are not confounded by weight loss or PDE5i. The mechanisms of this association require further investigation.
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Eunuquismo/complicações , Terapia de Reposição Hormonal , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Sintomas do Trato Urinário Inferior/etiologia , Testosterona/uso terapêutico , Idade de Início , Idoso , Disfunção Erétil/tratamento farmacológico , Humanos , Imidazóis/uso terapêutico , Estudos Longitudinais , Sintomas do Trato Urinário Inferior/epidemiologia , Masculino , Pessoa de Meia-Idade , Piperazinas/uso terapêutico , Estudos Prospectivos , Sistema de Registros , Sulfonas/uso terapêutico , Resultado do Tratamento , Triazinas/uso terapêutico , Dicloridrato de VardenafilaRESUMO
INTRODUCTION: Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear. AIM: To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline. METHODS: Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5 mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period. MAIN OUTCOME MEASURES: Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models. RESULTS: Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (± standard deviation) age was 58.2 ± 10.7 years; and most subjects had ED for ≥ 1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (each P < 0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo. CONCLUSIONS: The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline.
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Carbolinas/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Idoso , Coito , Relação Dose-Resposta a Droga , Esquema de Medicação , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Índice de Gravidade de Doença , TadalafilaRESUMO
PURPOSE: In the United States more men are diagnosed with cancer than women. We quantified the differential mortality rates of nonsex specific cancers between the sexes and compared cancer stage distributions. MATERIALS AND METHODS: In this descriptive epidemiological study we obtained the incidence of new cancer cases, cancer deaths and stage distributions for the last 10 years in the United States from SEER (Surveillance, Epidemiology and End Results) program results. Sex specific cancers were excluded from study. We compared male-to-female relative mortality rate for all cancers as well as the average male-to-female relative mortality rate weighted by cancer incidence in the last 10 years. Sex specific stage distributions were also compared with the Kendall τ-c test. RESULTS: The male-to-female relative mortality rate for any cancer was 1.060 (95% CI 1.055-1.065). The average male-to-female relative mortality rate for the same cancer was 1.126 (95% CI 1.086-1.168). The discrepancy in incidence and mortality rates was stable for the last 10 years. Of the top 10 most common cancers men had an unfavorable stage distribution in all except colorectal, bladder and brain cancers. CONCLUSIONS: Men are more likely to have nonsex specific cancer than women and more likely to die of the cancer even after controlling for the incidence. This discrepancy has been stable for the last decade. For 7 of the 10 most commonly occurring nonsex specific cancers, representing 78% of all incident cancers, men are more likely to be diagnosed with advanced stage.
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Neoplasias/mortalidade , Feminino , Humanos , Masculino , Fatores de Risco , Distribuição por Sexo , Estados Unidos/epidemiologiaRESUMO
The Princeton Consensus (Expert Panel) Conference is a multispecialty collaborative tradition dedicated to optimizing sexual function and preserving cardiovascular health. The third Princeton Consensus met November 8 to 10, 2010, and had 2 primary objectives. The first objective focused on the evaluation and management of cardiovascular risk in men with erectile dysfunction (ED) and no known cardiovascular disease (CVD), with particular emphasis on identification of men with ED who may require additional cardiologic work-up. The second objective focused on reevaluation and modification of previous recommendations for evaluation of cardiac risk associated with sexual activity in men with known CVD. The Panel's recommendations build on those developed during the first and second Princeton Consensus Conferences, first emphasizing the use of exercise ability and stress testing to ensure that each man's cardiovascular health is consistent with the physical demands of sexual activity before prescribing treatment for ED, and second highlighting the link between ED and CVD, which may be asymptomatic and may benefit from cardiovascular risk reduction.
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Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , Disfunção Erétil/diagnóstico , Disfunção Erétil/terapia , Tolerância ao Exercício , Humanos , Estilo de Vida , Masculino , Guias de Prática Clínica como Assunto , Prevenção Primária , Encaminhamento e Consulta , Medição de Risco , Comportamento de Redução do Risco , Comportamento Sexual , Testosterona/sangueRESUMO
INTRODUCTION: Within a study evaluating the redesigned AMS 700MS inflatable penile prosthesis (IPP) (American Medical Systems, Minnetonka, MN, USA), one site used new length measurement technique (NLMT), a more aggressive dilation and measurement of the corpora cavernosa on a stretched penis, to address penile shortening. AIM: To compare cylinder size and patient satisfaction, between a NLMT and traditional sizing for IPP implantation. METHODS: Fourteen men received IPPs using NLMT, and 55 with traditional sizing. Nationwide sales data from 2005 to 2008 for AMS 700 IPPs was obtained from AMS for comparison; additional surveys captured patient satisfaction. MAIN OUTCOME MEASURE: Demographic data, cylinder sizes, and patient satisfaction were compared between the NLMT and standard techniques. RESULTS: The Fisher's exact test (P<0.001) showed a significant difference between the cylinder sizes with NLMT as compared with standard techniques. Of the 14 NLMT patients, 71.4% (10) received cylinders>21 cm long and 28.6% (4) received cylinders<21 cm long, as compared with 12.7% (7) and 87.3% (48), respectively, for patients implanted by traditional techniques. There were ethnic differences between the samples: 42.9% (6) NLMT patients were of African-American descent, as compared with 10.9% (6) in the standard technique group. However, longer cylinders were utilized more often, with 83.3% (5) of African-Americans treated using the NLMT; as compared with 33.3% (2) of the standard technique group. Nationwide data reveal 12.3% of patients routinely receive 21 cm cylinders. At 6 months postimplantation, patient satisfaction with NLMT was no different than standard techniques. There were no distal erosions, complications, infections, or pain concerns reported through 24 months among the NLMT patients. CONCLUSIONS: The NLMT resulted in a larger number of subjects implanted with larger cylinders. Satisfaction with performance and complication rates for NLMT patients was comparable to those implanted using standard techniques.
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Satisfação do Paciente , Implante Peniano/métodos , Fatores Etários , Disfunção Erétil/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Implante Peniano/instrumentação , Prótese de PênisRESUMO
INTRODUCTION: Using the Massachusetts Male Aging Study (MMAS) data from the years 1987-1995, we previously demonstrated high rates of both progression (33%) and regression (35%) of self-reported severity of erectile dysfunction (ED). These results have not been replicated using more recent data-relevant in light of the introduction of phosphodiesterase type 5 inhibitors (PDE5i) to treat ED-nor compared with those from other populations. AIM: To estimate age-specific progression and regression of ED severity among subjects with at least mild self-reported ED. METHODS: We used the two most recent data collection waves from the MMAS (baseline in 1995-1997 and follow-up in 2002-2004, approximately 7 years of follow-up) and data from the Men's Attitudes to Life Events and Sexuality (MALES) study (baseline in 2001 and follow-up in 2004, approximately 3 years of follow-up); 367 MMAS and 617 MALES subjects contributed data. MMAS participants were a population-based sample of men living in Boston, Massachusetts, United States. MALES subjects were obtained from a multinational convenience sample. MAIN OUTCOME MEASURES: ED was measured using the validated single-question self-report of ED severity ("none,""minimal,""moderate," or "complete"). ED progression was defined as worsening of ED over time, whereas regression was defined as a lessening of ED severity. Logistic regression analyses were adjusted for age, body mass index (MMAS only), and use of PDE5i. RESULTS: In MMAS and MALES, 21% (confidence interval [CI]: 17%, 25%) and 25% (22%, 29%) of subjects, respectively, exhibited regression; 51% (45%, 57%) in MMAS and 28% (23%, 33%) in MALES exhibited ED progression. A minority of subjects (14% in MMAS and 28% in MALES) reported use of PDE5i. The proportion of subjects reporting progression increased with age. The higher rate of progression in MMAS may be due in part to the shorter follow-up time (â¼3 years) in MALES. CONCLUSIONS: Among subjects with some level of self-reported ED, progression and regression are common over a several-year period. Strategies for therapy and intervention for ED should acknowledge this basic evolution with time.
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Disfunção Erétil/fisiopatologia , Adulto , Idoso , Progressão da Doença , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Remissão EspontâneaRESUMO
OBJECTIVES: ⢠To review all the various techniques and their results and efficiencies to provide practicing urologists with some guidance for choice of technique ⢠To discuss improvements of varicocelectomy techniques in the last 15 years and their impact on results of surgery. PATIENTS AND METHODS: ⢠A PubMed English literature review of literature from 1995 to present. RESULTS: ⢠Pregnancy rates were highest with microsurgical subinguinal technique ⢠Varicocele recurrence rates were lowest with microsurgical subinguinal technique ⢠Hydrocele formation rates were lowest with microsurgical inguinal technique ⢠Surgical complications were highest in the laparoscopic technique ⢠Varicocelectomy by itself or in conjunction with IVF is cost effective CONCLUSIONS: ⢠Microsurgical subinguinal or microsurgical inguinal techniques offer best outcomes ⢠Varicocelectomy is a cost effective treatment modality for infertility ⢠Further research is needed to explore new developments in varicocelectomy.
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Varicocele/cirurgia , Humanos , Masculino , Resultado do Tratamento , Procedimentos Cirúrgicos Urológicos Masculinos/métodosRESUMO
INTRODUCTION: Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. AIMS: To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. METHODS: A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45-80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤ 4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures. Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). RESULTS: Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤ 3 ng/mL. CONCLUSIONS: The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤ 3 ng/mL.
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Carbolinas/administração & dosagem , Disfunção Erétil/tratamento farmacológico , Terapia de Reposição Hormonal , Hipogonadismo/tratamento farmacológico , Inibidores da Fosfodiesterase 5/administração & dosagem , Testosterona/administração & dosagem , Administração Tópica , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Método Duplo-Cego , Quimioterapia Combinada , Terapia de Reposição Hormonal/efeitos adversos , Humanos , Hidrogéis , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Tadalafila , Testosterona/efeitos adversosRESUMO
OBJECTIVE: Hypogonadism (HG) is a clinical disorder consisting of reduced testosterone (T) levels and characteristic signs and symptoms of low T. Current instruments used to assess hypogonadal symptoms in men lack adequate measurement properties. To present data on the quantitative validation of a new self-report instrument (HG Screener) developed to identify men with symptoms of HG. DESIGN: This is a psychometric validation study conducted at 16 clinical sites across the Unites States. Subjects completed two visits separated by 2-4 weeks. PATIENTS: One hundred and thirty-one men (82 hypogonadal patients with total T≤10·4 nmol/l and 49 controls with total T>10·4 nmol/l) aged 21-75 years were enrolled. MEASUREMENTS: Self-reported assessments including the HG Screener (at both visits) along with seven validated questionnaires. RESULTS: The results of a factor analysis identified five functional factors or domains. The resulting instrument contains 25 items consisting of 18 functional items in five core domains (sexual function, mood, memory, sleep function and fatigue) and seven physical symptom items. Overall, the new instrument was found to have strong psychometric properties, including acceptable discriminant, construct and content validity, as well as good internal consistency and test-retest reliability. CONCLUSIONS: A new screening tool (HG Screener) for identifying men with HG has been developed and validated according to FDA standards. This new instrument possesses acceptable psychometrics and is available for clinical or research use.
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Hipogonadismo/diagnóstico , Psicometria/métodos , Adulto , Idoso , Cromatografia Líquida , Humanos , Hipogonadismo/sangue , Hipogonadismo/fisiopatologia , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Espectrometria de Massas em Tandem , Testosterona/sangueRESUMO
BACKGROUND: Men with erectile dysfunction often have concurrent medical conditions. Conversely, men with these conditions may also have underlying erectile dysfunction. The prevalence of unrecognized erectile dysfunction in men with comorbidities commonly associated with erectile dysfunction was determined in men invited to participate in a double-blind, randomized, placebo-controlled trial of sildenafil citrate. METHODS: Men ≥30 years old presenting with ≥1 erectile dysfunction risk factor (controlled hypertension, hypercholesterolemia, smoking, metabolic syndrome, stable coronary artery disease, diabetes, depression, lower urinary tract symptoms, obesity [body mass index ≥30 kg/m2] or waist circumference ≥40 inches), and not previously diagnosed with erectile dysfunction were evaluated. The screening question, "Do you have erectile dysfunction?," with responses of "no," "yes," and "unsure," and the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) were administered. RESULTS: Of 1084 men screened, 1053 answered the screening question and also had IIEF-EF scores. IIEF-EF scores indicating erectile dysfunction occurred in 71% (744/1053), of whom 54% (399/744) had moderate or severe erectile dysfunction. Of 139 answering "yes," 526 answering "unsure," and 388 answering "no," 96%, 90%, and 36%, respectively, had some degree of erectile dysfunction. The mean±SD (range) number of risk factors was 2.9 ± 1.7 (3-8) in the "yes" group, 3.2 ± 1.7 (3-9) in the "unsure" group, and 2.6 ± 1.5 (2-8) in the "no" group. CONCLUSION: Although awareness of having erectile dysfunction was low, most men with risk factors had IIEF-EF scores indicating erectile dysfunction. Erectile dysfunction should be suspected and assessed in men with risk factors, regardless of their apparent level of awareness of erectile dysfunction. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00343200.
Assuntos
Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus/epidemiologia , Disfunção Erétil , Obesidade/epidemiologia , Piperazinas , Sulfonas , Doenças Urológicas/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Método Duplo-Cego , Disfunção Erétil/diagnóstico , Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/epidemiologia , Disfunção Erétil/psicologia , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 5/administração & dosagem , Inibidores da Fosfodiesterase 5/efeitos adversos , Piperazinas/administração & dosagem , Piperazinas/efeitos adversos , Placebos , Purinas/administração & dosagem , Purinas/efeitos adversos , Fatores de Risco , Enquadramento Psicológico , Índice de Gravidade de Doença , Citrato de Sildenafila , Sulfonas/administração & dosagem , Sulfonas/efeitos adversos , Inquéritos e Questionários , Resultado do TratamentoRESUMO
INTRODUCTION: Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being. AIM: To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. METHODS: An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures. New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations. RESULTS: Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to men's and women's individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronie's disease; and priapism. CONCLUSIONS: Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective.