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Comparison of the simplified International Index of Erectile Function (IIEF-5) in patients of erectile dysfunction with different pathophysiologies.

ABSTRACT: BACKGROUND: The simplified International Index of Erectile Function (IIEF-5) is a convenient, reliable and validated diagnostic tool for erectile dysfunction (ED). However, few studies focused on IIEF-5 in ED patients with different pathophysiological causes. ,We aim to compare the IIEF-5 score among ED patients with specific pathophysiologies in this study. METHODS: The IIEF-5 score of 3,327 ED patients (median age 39 years) was analyzed. The primary causes of ED were determined by comprehensive diagnostic procedures in the urology/andrology clinics in five training hospitals. Patients with uncertain pathophysiologic cause were excluded. RESULTS: 176 patients were excluded, 3151 patients with ED history between 0.5 year and 20 years, were enrolled. The causes of ED was classified as psychogenic (59.2%), vasoculogenic (21.3%), neurogenic (4.1%), anatomical/structural (2.8%), hormonal (7.1%) or drug-induced (5.5%). A significant difference was detected in the median IIEF-5 score between psychogenic ED and organic ED (15 (IQR 13, 17) versus 12 (IQR 9.5, 14.5), P < 0.001). There was no significant difference of IIEF-5 scores among the organic groups (P = 0.073), or between arteriogenic and venogenic groups (13 (IQR 10.5, 15.5) versus 13 (IQR 11-15), P = 0.912 (adjusted ? = 0.017)). However, the median IIEF-5 score of those with a mixed vascular cause was the lowest among vasculogenic patients (11 (IQR 8.5-13.5), scores for the three groups: P = 0.003.). CONCLUSIONS: The IIEF-5 scores of men with psychological ED are higher than those with organic causes, but there is no difference among patients with different organic pathophysiologies. Our data indicate that IIEF-5 is not a definitive diagnostic tool to discriminate the pathophysiological causes of ED.

SUBMITTER: Tang Z

PROVIDER: S-EPMC4094415 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Project description:IntroductionThe International Index of Erectile Function (IIEF) is the predominant patient-reported outcomes instrument for assessing male sexual function. There are obvious problems with the use of the IIEF in the assessment of an individual patient, such as for men who use injections and men who do not engage in intercourse.AimThe aim of the current study is to redesign the erectile function domain of the IIEF (IIEF6) to more accurately assess the individual patient.MethodsIn an observational study of men undergoing treatment for prostate cancer at a tertiary care institution, including 24,732 questionnaires completed by 6,780 individuals, IIEF6 scores were compared for patients using and not using erectile aids. Men not engaging in sexual intercourse were asked to describe the reason.Main outcome measureThe main outcome we were seeking was the IIEF6 scores.ResultsMean scores before erectile aids items were added was 17.7 compared with predicted scores of 18.3 vs 16.7 if patients reported their function with vs without the use of aids. No intercourse was reported for 35% of surveys. Reasons given were lack of ability or confidence in 53%, lack of willing and available partner in 28%, "other" in 17% (including respondent's or partner's health issues, low libido, preference for nonpenetrative sex or for sex with men). Doubling the sum of the 3 nonintercourse IIEF6 questions had excellent properties (difference of 0.06, limits of agreement -3.10 to 3.22).Clinical implicationsErectile function instruments must include items about erectile aids. Men who report that they have not attempted intercourse should not be assumed to have erectile dysfunction, but should be asked the reason why. For men who report lack of opportunity or preference for intercourse, the score of the 3 nonintercourse IIEF6 questions should be doubled.Strengths & limitationsThis is a large study of patients in a real-world setting. Although the study only includes radical prostatectomy patients, and although the study cohort is not fully representative of the US prostate cancer population as a whole, these issues would not affect the key findings.ConclusionThe IIEF6 can be redesigned to better assess the individual patient. Vickers AJ, Tin AL, Singh K, et al. Updating the International Index of Erectile Function: Evaluation of a Large Clinical Data Set. J Sex Med 2020;17:126-132.

Project description:BACKGROUND:Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) scores. AIM:This analysis estimated the relationship between post-baseline IIEF-EFD scores and demographic variables, including co-morbidities, in men with ED receiving placebo in flexible-dose sildenafil studies. METHODS:Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the IIEF-EFD score was ?26 at the last visit. OUTCOMES:Variables assessed were age (<45, 45-64, ?65 years), race, body mass index, co-morbidities (cardiovascular disease/hypertension, diabetes mellitus, depression), date the last study dose was taken, study completion date, ED etiology (psychogenic, organic, mixed), history of cigarette smoking, ED duration, baseline IIEF-EFD score (?10, 11-16, ?17), and treatment duration. Stepwise multivariate logistic regression models assessed the odds of being a responder vs a non-responder for each variable. RESULTS:A total of 4,360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ?17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001). The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001). The frequency of common adverse events was similar between placebo responders and non-responders. CLINICAL TRANSLATION:These findings contribute to the improved understanding of predictors of placebo response in sildenafil clinical studies. Elucidation of these factors may contribute to the development of further interventions and treatment strategies and best practices for clinical trials. STRENGTHS AND CONCLUSIONS:Strengths of this analysis include the large and diverse population and the duration of follow-up. Limitations include those associated with retrospective analyses and the inability to ascertain to what extent other demographic factors might have contributed to the placebo responses or how these placebo responses might be related to the natural course of ED. CONCLUSIONS:Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation. Mulhall JP, Carlsson M, Stecher V, et al. Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo. J Sex Med 2018;15:866-872.

Project description:BackgroundPatient-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.ObjectiveThe aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15.MethodsThis 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.ResultsA 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.ConclusionsWe 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 registrationClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388.

Project description:PURPOSE:This study aims to objectively characterize the effect of successful nerve sparing (NS) during radical prostatectomy (RP) on postoperative urinary continence (UC) using International Index of Erectile Function (IIEF)-scores and a previously described Expanded Prostate Cancer Index Composite (EPIC) score cutoff value (COV) for UC. Several notable studies on this topic present conflicting outcomes. This is largely due to a lack of clear definitions and consensus regarding preserved erectile function (EF) and UC. METHODS:This study is comprised of all patients who underwent RP at the Kantonsspital Baden, Switzerland, between 2004 and 2013. Patients completed self-assessment questionnaires for UC (EPIC) and EF (IIEF) pre- and postoperatively (3, 6, 9, 12, 18, and 24 months; yearly thereafter). We used a previously described EPIC subscore COV, with "satisfactory continence" signified by a score >85. Statistical analysis was performed using Kaplan-Meier and Cox regression analyses for "surgeon-" and "IIEF-defined" NS definitions. RESULTS:Of 236 men with a median age of 63 years (interquartile range [IQR], 59-66 years) and median follow-up time of 48 months (IQR, 30-78 months), 176 underwent unilateral (n=33) or bilateral (n=143) NS RP. Fifty-four underwent non-NS (NNS) RP. Kaplan-Meier analyses identified the following risk factors for UC: age, prostate volume, cancer risk group, and NS status. In surgeon-defined NS RP cases, multivariate analysis for regaining continence demonstrated no significant difference (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.48-1.25; P=0.3). With successful IIEF-defined NS RPs, regression analysis demonstrated no significant difference (HR, 0.89; 95% CI, 0.59-1.35; P=0.58). Conclusions:In our population, analysis and comparison of surgeon- and IIEF-defined NS and NNS cohorts revealed that NS RP did not improve postoperative UC. The conservation of UC alone should not motivate surgeons or patients to pursue NS RP.

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Comparison of the simplified International Index of Erectile Function (IIEF-5) in patients of erectile dysfunction with different pathophysiologies.

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