Association of pupil responses with severity of erectile dysfunction in diabetes mellitus.

Purpose: To investigate the relation between erectile dysfunction (ED) severity and pupillary functions in patients with diabetes mellitus (DM). Methods: This prospective and observational study included 90 patients with type 2 DM and ED. Patients divided into three subgroups according to severity of ED: (i) Mild ED, (ii) Moderate ED and (iii) Severe ED groups. Thirty age-matched healthy subjects formed the control group. Main outcome measures were pupil diameter and average speed of pupil dilation. Static and dynamic pupillometry analysis was performed using the Sirius Topographer (CSO, Firenze, Italy). Results: Mean pupil diameter during static and dynamic pupillometry analysis were significantly greater in the control group than in the all study groups (P < 0.05). Mean pupil diameter in static pupillometry analysis was significantly different in each study group and pupil was more miotic in the Severe ED group than in the both Moderate and Mild ED groups (P < 0.05 for each). Dynamic pupillometry analysis revealed that mean pupil diameter and mean average dilation speed were significantly different in each study group throughout measurement period and the highest speed was observed in the Mild ED group and the lowest speed was observed in the severe ED group (P < 0.005 for each). Conclusion: Our study results suggest that abnormal pupil functions due to diabetic autonomic neuropathy may indicate the associated ED in patients with DM.

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application. OBJECTIVE: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15. METHODS: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient. RESULTS: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively. CONCLUSIONS: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version. TRIAL REGISTRATION: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388.

Association between sarcopenia and erectile dysfunction in males with type II diabetes mellitus.

BACKGROUND: The prevalence rates for both sarcopenia and erectile dysfunction (ED) gradually increase in middle-aged and elderly diabetic male population and they impair physical functioning, sexual functioning, and quality of life. The aim of the present study was to evaluate the sarcopenia in patients with diabetic ED. METHODS: The study included 98 male patients with type II diabetes mellitus (DM) aged 18-80 years. Blood chemistry and hormone levels were obtained. The International Index of Erectile Function (IIEF-5) questionnaire was administered to the patients. The patients were divided into three groups according to the IIEF-5 score; a score of 5-10 points indicated severe ED, a score of 11-20 indicated moderate ED, and a score of 21-25 points indicated no ED. The muscle mass, handgrip strength, timed up and go test, upper mid-arm circumference, calf circumference, and body mass index were obtained. The statistical analysis was performed using MedCalc Statistical Software version 12.7.7. All parameters were compared between the three groups. RESULTS: Of 98 patients included in the study, 84 patients had severe sarcopenia, 13 had moderate sarcopenia, while only one patient had normal muscle mass. The mean age was 56.59 ± 11.46 years. When patients were divided into three groups according to IIEF-5 score, 38 had severe ED, 39 had moderate ED, and 21 had no ED. There was a significant difference between the three groups in terms of handgrip strength, timed up and go test scores, upper mid-arm circumference, and calf circumference (p < .05 for all). CONCLUSIONS: Although muscle mass remains unchanged, muscle strength and physical performance decrease in diabetic ED patients. Diabetic patients with severe and moderate ED have lower muscle strength and physical performance.

[Penile erectile strength measurement band for differentiation and classification of erectile dysfunction].

OBJECTIVE: To study the clinical application value of the penile erectile strength measurement (PESM) band in the differentiation of psychogenic from organic erectile dysfunction (ED). METHODS: Eighty ED patients unable to achieve or maintain adequate penile erection to complete sexual intercourse were included in the experimental group and another 40 healthy subjects with normal erectile function enrolled as controls. The ED cases were classified into mild, moderate and severe ED according to the IIEF-5 scores and divided into psychogenic and organic ED based on the results of the nocturnal penile tumescence (NPT) test. Then all the subjects underwent a three-night continuous monitoring with the PESM band and, according to the band fracture rate, the ED cases were also classified into psychogenic and organic ED. The rates of missed diagnosis, misdiagnosis and diagnostic coincidence of PESM were calculated with the results of NPT as the standard for differentiating psychogenic from organic ED. RESULTS: The results of NPT tests revealed 51 cases of psychogenic and 29 cases of organic ED in the experimental group. The band fracture rate in PESM was 95.0% in the mild, 80.9% in the moderate and 52.8% in the severe ED patients. Of the 51 cases of psychogenic ED detected by NPT test, 43 were diagnosed as psychogenic and the other 8 as organic ED with the PESM band, with a coincidence rate of 84.3%. Of the 29 cases of organic ED revealed by NPT test, 5 were diagnosed as psychogenic and the other 24 as organic ED by PESM, with a coincidence rate of 82.8%. Normal erectile function with three-level fracture of the band was observed in the PESM of the normal controls, which showed a coincidence rate of 100% with the results of NPT tests. Based on the standard of the NPT test, the rates of missed diagnosis, misdiagnosis and diagnostic coincidence of the PESM band in differentiating psychogenic from organic ED were 15.7%, 17.2%, and 83.8%, respectively, with a Kappa value of 0.656 (P <0.05). CONCLUSIONS: The penile erectile strength measurement band can be used as a screening tool for initial differentiation of psychogenic from organic ED.

Association between hand-grip strength and erectile dysfunction in older men.

OBJECTIVES: To evaluate the association between handgrip strength and erectile dysfunction (ED) in community-dwelling older men. METHODS: This cross-sectional study included 1771 participants of the Dong-gu Study. Handgrip strength was measured with a handheld dynamometer. ED was assessed with the Korean version of the International Index of Erectile Function (IIEF). ED was categorized as none to mild (IIEF-EF scores of 13-30) and moderate to severe (IIEF-EF scores of 0-12). Multivariable logistic regression was conducted with adjustment for potential confounders. RESULTS: The proportion of men with moderate to severe ED was 48.8%. The age-adjusted ED score increased with increasing quartile of handgrip strength (11.0, 12.4, 13.4, and 14.0 in the lowest, second, third, and highest quartiles, respectively). After adjustment for potential confounders, greater handgrip strength was associated with a lower risk of ED (odds ratio (OR): 0.82 per 5 kg; 95% confidence interval (CI): 0.74-0.90). In addition, a high level of moderate to vigorous physical activity was associated with a lower risk of ED (OR: 0.75; 95% CI: 0.61-0.93). CONCLUSION: In this study, aging men with greater handgrip strength had a lower risk of ED. This result suggests that reduced physical functioning may contribute to ED.

Nonresponders, partial responders, and complete responders to PDE5 inhibitors therapy according to IIEF criteria: validation of an anchor-based treatment responder classification.

INTRODUCTION: Despite widespread use of the International Index of Erectile Function (IIEF) in erectile dysfunction (ED) research, there are no published criteria for classifying ED treatment responders in clinical trials or patient management settings. A new classification for treatment response in men with ED has been developed and validated in a large clinical trial database. AIM: The study aims to test discriminant and convergent validity of the responder classification and examine the role of covariates. METHOD: Treatment assignment was used to test discriminant validity. The diary-based Sexual Encounter Profile (SEP) question ("Did your erection last long enough for you to have successful intercourse?") and Global Assessment Question (GAQ) ("Has the treatment you have been taking over the past study interval improved your erections?") were used to evaluate convergent validity. Chi-square and Cochran-Armitage trend tests were used to examine outcome associations. Logistic regression was used to further assess the relationship of outcomes controlling for covariates. MAIN OUTCOME MEASURE: The classification measure was developed and validated in a database from 17 clinical trials in 3,252 men with ED randomized to placebo or tadalafil. The treatment responder is defined as complete (erectile function [EF] ≥ 26); partial (EF < 26; met minimal clinically important difference [MCID] criteria); or nonresponder following treatment (EF < 26; did not meet MCID). RESULTS: The new responder definition performed consistently well in all prespecified tests of validity. Eighty-nine percent of subjects classified as complete responders were in the treatment group, and the responder definition was associated with changes on the SEP and GAQ measures, respectively (SEP odds ratio [OR] = 14, 95% confidence intervals [CI] 11-17; GAQ OR = 50, 95% CI 39-88; complete vs. nonresponders). CONCLUSIONS: We developed and validated a novel method of defining an ED treatment responder based on multiple IIEF criteria and using other measures (SEP, GAQ) for validation. The results have implications for understanding results of clinical trials in ED, and in monitoring response to treatment in the clinic.

A review of analytical methods for the determination of four new phosphodiesterase type 5 inhibitors in biological samples and pharmaceutical preparations

The introduction of oral phosphodiesterase type 5 inhibitor therapy in 1998 revolutionized the treatment of erectile dysfunction. Erectile dysfunction is the most common sexual problem in men. It often has a profound effect on intimate relationships and quality of life. The analysis of pharmaceuticals is an important part of the drug development process as well as for routine analysis and quality control of commercial formulations. Whereas the determination of sildenafil citrate, vardenafil and tadalafil are well documented by a variety of methods, there are few publications about the determination of udenafil, lodenafil carbonate, mirodenafil and avanafil. The paper presents a brief review of the action mechanism, adverse effects, pharmacokinetics and the most recent analytical methods that can determine drug concentration in biological matrices and pharmaceutical formulations of these four drugs.

A introdução da terapia oral com inibidores da fosfodiesterase tipo 5, em 1998, revolucionou o tratamento da disfunção erétil. A disfunção erétil é o problema sexual mais comum em homens. Muitas vezes tem um efeito profundo nas relações íntimas e na qualidade de vida. A análise de produtos farmacêuticos é uma parte importante do processo de desenvolvimento de fármacos, bem como para a análise de rotina e controle de qualidade das formulações comerciais. Enquanto a determinação do citrato de sildenafila, vardenafila e tadalafila está bem documentada por uma variedade de métodos, existem poucas publicações sobre a determinação de udenafila, carbonato de lodenafila, mirodenafila e avanafila. O artigo apresenta uma breve revisão do mecanismo de ação, efeitos adversos, farmacocinética e os mais recentes métodos analíticos, que podem determinar a concentração do fármaco em matrizes biológicas e formulações farmacêuticas destes quatro fármacos.

Aspectos fisiopatológicos, clínicos y terapéuticos de la disfunción eréctil en el anciano / Sexual dysfunction in the elderly. Pathophysiological and medical issues. Treatment of erectile dysfunction

La disfunción eréctil (DE) es una condición que no solo afecta de forma negativa a la capacidad sexual del anciano sino también a su calidad de vida, involucrando a su pareja. Fomentar la búsqueda de ayuda profesional por parte del anciano con este problema clínico, es un reto educacional importante que necesita ser dirigido a través de iniciativas médicas, sociales y políticas. La patogénesis exacta de la DE es desconocida, aunque se presume un origen multifactorial; la enfermedad vascular es la causa más frecuente, siendo la disfunción endotelial el denominador fisiopatológico común. Se ha postulado que la DE es un síntoma centinela de acontecimientos cardiovasculares clínicos y su detección debiera conducir a una investigación e intervención sobre los factores de riesgo cardiovascular. Por lo tanto, cuando una persona mayor se presenta con DE, debe realizarse una historia y exploración física minuciosas así como análisis adecuados con el objetivo de detectar patologías asociadas

Erectile dysfunction (ED) is a very distressing condition that not only negatively affects the elderly man¡äs sexual ability, but also his overall quality of life and that of his partner. Encouraging men, alone or as a couple, to seek professional help is a major educational challenge which needs to be met by medical, social and political initiatives. The exact pathogenesis of ED remains unknown, but is presumed to be multifactorial; vascular disease is the most frequent cause with endothelial dysfunction being the common denominator. It has been postulated that ED is a sentinel symptom of cardiovascular clinical events and should prompt investigation and intervention for cardiovascular risk factors. Therefore, when a patient presents with ED, a thorough history and physical examination should be performed, as well as appropriate laboratory tests aimed at detecting associated diseases(AU)

Male sexual dysfunction.

Male sexual dysfunction is a common entity in primary care practice. The 3 most common types are erectile dysfunction, premature ejaculation, and decreased libido. Clinicians must be comfortable and skilled in taking a complete sexual, social, and medical history and performing a physical examination in persons complaining of sexual dysfunction. Treatment of male sexual dysfunction may include medications and individual or couples psychotherapy. Treatment should be aimed at reducing emotional and physical morbidity in the patient and his partner.

Considerations for diagnostic criteria for erectile dysfunction in DSM V.

INTRODUCTION: The Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., text revision (DSM-IV-TR) criteria for erectile disorder have been criticized as multiple grounds including that the criteria lack precision, that the requirement of marked distress is inappropriate, and that the specification of etiological subtypes should be deleted. AIM: The goal of this manuscript is to review evidence relevant to diagnostic criteria for erectile disorder published since 1990. METHOD: Medline searches from 1990 forward were conducted using the terms erectile disorder and impotence. Early drafts of proposed alterations in diagnostic criteria were submitted to advisors. MAIN OUTCOME MEASURE: Evidence regarding modification of criteria for DSM V diagnostic criteria for erectile dysfunction was judged by whether existing data justified the adoption of precise criteria which would lead to homogenous groups for research. Another outcome measure was whether data exist to reliably differentiate fluctuations in normal function from pathological states. RESULTS: The literature review revealed a large literature concerning erectile disorder but minimal evidence concerning an operational definition for this disorder. CONCLUSIONS: It is recommended that erectile disorder be precisely defined in order to clearly differentiate alterations in normal function from a condition requiring medial intervention and to facilitate clinical research. It is specifically proposed that erectile dysfunction be defined as failure to obtain and maintain an erection sufficient for sexual activity or decreased erectile turgidity on 75% of sexual occasions and lasting for at least 6 months. It is also recommended that erectile disorder be defined independently of distress.

IIEF-15: unsuitable for assessing erectile function of young men?

INTRODUCTION: The prevalence of erectile dysfunction (ED) is mainly studied in older males, whereas we measured prevalence of ED in young healthy males using a validated questionnaire. AIM: Assessing the prevalence of ED in young adult men using the International Index of Erectile Function (IIEF-15) and creating a benchmark for ED in this young age group for further research. METHODS: Male students were randomly asked to participate. Men with history of sexual dysfunction or urologic disease were excluded. Age, having a relationship and the IIEF-15 were filled out anonymously and in private. Outcomes of all domains were separately analysed based on relationship and intercourse frequency. MAIN OUTCOME MEASURES: ED measured by the IIEF-15. RESULTS: One hundred and fifty-one students, aged 21.8 years (17-35, SD 2.98) participated and 14 were excluded. Of 137 students, 81% reported to have an intimate relationship. ED appeared to be present in 46 students (33.6%). The answer "no sexual activity," resulting in a 0-score, was given inconsistently. Outcomes were analysed for students who gave this answer at least once compared with those who never did. Nobody had ED in the group "without 0-scores" (n = 91). All students in the group "with (inconsistent) 0-scores" (n = 46) had ED. Students with a relationship had ED in 24.3% compared with 73.1% in those without a relationship (P < 0.001). CONCLUSION: When men with inconsistently answered IIEF-15 questionnaires are excluded, a 0% prevalence of ED is found in this age-group. The current scoring method however does not state that these questionnaires should be excluded, and results in a prevalence of ED of 34%. Possibly, the scoring method of the IIEF-15 needs to be reviewed when this questionnaire is used in young, healthy men in order to accurately measure the prevalence of ED.

Remembered International Index of Erectile Function domain scores are not accurate in assessing preoperative potency in candidates for bilateral nerve-sparing radical retropubic prostatectomy.

INTRODUCTION: The reliability of reported postoperative data in patients undergoing nerve-sparing radical retropubic prostatectomy is often limited because the degree of sexual function (SF) has not been assessed objectively both before and after treatment. Most reports include only a retrospective chart review, and there is a question of whether such data are accurate. AIM: To test the agreement between a remembered International Index of Erectile Function (IIEF) score, which targeted SF regarding a period preceding the surgery by 6 months and a real-time IIEF, 4 weeks prior to surgery, in candidates for bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP). METHODS: From May 2005 to May 2006, 333 consecutive patients were candidates for BNSRRP at our institution. Upon admission on the day prior to surgery, each patient was asked to complete a set of validated questionnaires including both a remembered and a real-time IIEF. Two-tailed Student's t-test, chi2 test, Pearson correlation coefficient, multivariate regression analyses, and interrater agreement (kappa) were used to test the agreement between the two assessments. MAIN OUTCOME MEASURES: Assessing the preoperative SF characteristics of candidates for a BNSRRP, and testing the reliability of a remembered IIEF with the interrater agreement (kappa) test. RESULTS: Mean scores for the remembered IIEF were overall better than the real-time IIEF scores, as supported by direct comparison of the mean IIEF domain scores. Univariate correlation analysis and multivariate regression analysis indicated a significant correlation in the quality of the SF during the two periods. However, the remembered IIEF scores did not show a good statistical agreement with those of the real-time assessment, as demonstrated by the interrater agreement analysis. CONCLUSIONS: Because of the lack of significant agreement between remembered and real-time IIEF scores, the present findings indicate that remembered IIEF should not be used to assess SF in a real-life clinical setting in candidates for BNSRRP.

Baseline prevalence of erectile dysfunction in a prostate cancer screening population.

INTRODUCTION: Erectile dysfunction (ED) is common in older men and can be worsened by prostate cancer (PCa) treatment. True ED rates before PCa treatment are mandatory, in order to assess the rate of ED attributable to PCa treatment. Data derived from population-based studies or from patients surveyed after PCa diagnosis, as well as just prior to treatment may not represent a valid benchmark, as health profiles of the general population might be different to those undergoing PCa screening or as anxiety may worsen existent ED. AIM: To circumvent these limitations, we assessed the baseline rate of ED in PCa diagnosis-free men participating in a PCa awareness event. METHODS: ED was classified according to the International Index of Erectile Function (IIEF) score as absent (IIEF: 25-30), mild (22-24), mild to moderate (17-21), moderate (11-16), or severe (

Confirmatory factor analysis of the German version of the international index of erectile function (IIEF): a comparison of four models.

INTRODUCTION: The International Index of Erectile Function (IIEF) is the most widely used instrument to assess erectile function in research and clinical practice. However, there are heterogeneous results concerning the factor structure of this questionnaire. The original model assumes five factors (erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction). Others suggested four factors (composite domain of erectile dysfunction and intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction) or only two factors (sexual function and sexual desire). Because of the high intercorrelation between the different domains, a one-factor model is also plausible. AIMS: This study assesses and compares these four models of the German version of the IIEF. METHODS: It was examined which of the models fit best our data from 261 German men in cardiovascular rehabilitation participating in the SPARK study (Sexuality of Patients in the Rehabilitation of Cardiovascular Diseases). Contrary to the former exploratory studies, we used confirmatory factor analysis. MAIN OUTCOME MEASURES: Local and global goodness-of-fit measures were calculated. RESULTS: The results show that two items (ability to maintain erection and intercourse frequency) could not be represented sufficiently through any of the four models. Based on the global goodness-of-fit indexes, our data proved to be fairly congruent with the original five-factor model and were acceptably represented by a four-factor model as well. CONCLUSIONS: The original five-factor structure could be confirmed. Due to high intercorrelations, the different domains cannot optimally be discriminated and should be interpreted with caution. Further research is needed to clarify the association between the domains of male sexual function.

Subclinical erectile dysfunction: proposal for a novel taxonomic category in sexual medicine.

The definition of erectile dysfunction currently used and accepted worldwide does not encompass all possible changes to male erection. Partial, temporary, or episodic absence of erection is not considered as true erectile dysfunction. This leads to a lack of diagnosis and therapy and perhaps even the risk of the subsequent development of overt impotence. The lack of an evidence-based diagnosis of such a condition may be due to the widespread, pernicious self-prescription of erection drugs, obtained from the illegal market. To define the pathological condition of men experiencing a lack of erection who are unaffected by erectile dysfunction, we propose herein a new taxonomic category, based on new sexological criteria. In addition, we suggest research into biochemical markers to define this condition, which we have named subclinical erectile dysfunction.