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Erectile Function Domain (erectile + function_domain)
Selected AbstractsORIGINAL RESEARCH,ED PHARMACOTHERAPY: Sildenafil Citrate 100 mg Starting Dose in Men with Erectile Dysfunction in an International, Double-Blind, Placebo-Controlled Study: Effect on the Sexual Experience and Reducing Feelings of Anxiety About the Next Intercourse AttemptTHE JOURNAL OF SEXUAL MEDICINE, Issue 10 2009Oleg B. Loran MD ABSTRACT Introduction., Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. Aim., Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. Methods., Men with ED (score ,25 on the Erectile Function domain of the International Index of Erectile Function) who had received ,6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). Main Outcome Measures., Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. Results., Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. Conclusions., Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose. Loran OB, Ströberg P, Lee SW, Park NC, Kim SW, Tseng LJ, Collins S, and Stecher VJ. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: Effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. J Sex Med 2009;6:2826,2835. [source] Prevalence of erectile dysfunction in patients with metabolic syndromeINTERNATIONAL JOURNAL OF UROLOGY, Issue 4 2006TEVFIK DEMIR Aim:, We wished to investigate the relationship between metabolic syndrome and erectile dysfunction (ED). Materials and methods:, A total of 268 patients were included in this study. All of the patients were asked to fill in an International Index for Erectile Function (IIEF) questionnaire. The presence of metabolic syndrome was determined when any three or more of the five risk factors were present according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP)-III. The relationship between risk factor for metabolic syndrome and ED status was determined according to logistic regression analysis. Results:, Eighty-nine patients (33%) constituted the metabolic syndrome group. IIEF-EF domain scores of patients with and without metabolic syndrome were 17.7 ± 7.9 and 21.7 ± 7.5, respectively (P < 0.001). Seventy-four percent of patients with metabolic syndrome and 50% of patients without metabolic syndrome had ED (P < 0.001; odds ratio 2.9; 95% CI 1.7,5.0). Erectile function domain scores significantly decreased as the number of metabolic risk factors increased (P < 0.001). Patients with the risk factor of fasting blood glucose (FBG), waist circumference (WC), or hypertension (HT) had lower erectile function domain scores than the patients with other metabolic risk factors. Logistic regression analysis revealed that FBG and WC were the most important criteria for ED. Conclusions:, Metabolic syndrome seems to be a potential risk factor for ED. We recommend patients with metabolic syndrome should be questioned about ED, and WC measurement might take part in the evaluation of ED. [source] Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE studyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2009M. T. Rosenberg Summary Objective:, The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument. Methods:, This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs. Results:, Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean ± SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 ± 1.00 min vs. 5.45 ± 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity. Conclusion:, Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo. [source] Enhanced External Counterpulsation in Patients with Coronary Artery Disease-Associated Erectile Dysfunction.THE JOURNAL OF SEXUAL MEDICINE, Issue 3 2007Part I: Effects of Risk Factors ABSTRACT Introduction., Recently it has been demonstrated that enhanced external counterpulsation (EECP) could improve erectile dysfunction (ED) in patients with refractory ischemic heart disease (IHD). Aim., To assess the effect of risk factors on the efficacy and the satisfaction rate of EECP in patients with coronary artery disease (CAD)-associated ED. Main Outcome Measures., To assess the effect of risk factors on EECP efficacy and satisfaction rate, we compared the pre- and post-EECP responses to erectile function domain, Q3, and Q4 in patients with and without risk factors. Overall satisfaction and global efficacy question (GEQ) were also assessed. Methods., A total of 44 male consecutive patients with intractable angina caused by coronary insufficiency which cannot be controlled by conventional therapy were enrolled in this study. Patients were screened and followed up for ED using erectile function domain of the International Index for Erectile Function. A thorough sexual, medical, and psychosocial history was taken from all patients. Results., All patients had severe diffuse triple vessels disease. They all had class III or IV angina. They were receiving the maximal antianginal pharmacotherapy. The mean age ± SD was 57.1 ± 5.6 years. Of the patients, 63.9% were below 60 years, and 86.4% were current or ex-smokers. There were significant differences between pre- and post-EECP regarding erectile function domain, Q3, and Q4. The sociodemographic variables were not significantly different among the studies groups and had not affected the GEQ or overall satisfaction. Overall satisfaction and GEQ were negatively influenced by smoking and presence of more than two risk factors. However, diabetes, hypertension, dyslipidemia, myocardial infraction, and obesity have not had such effects. Conclusions., The efficacy and satisfaction rate of EECP in patients with CAD-associated ED were negatively influenced by presence of risk factors; however, the global efficacy and the overall patients' satisfaction were encouraging. El-Sakka A, Morsy A, and Fagih B. Enhanced external counterpulsation in patients with coronary artery disease-associated erectile dysfunction. Part I: Effects of risk factors. J Sex Med 2007;4:771,779. [source] Vardenafil Restores Erectile Function to Normal Range in Men with Erectile DysfunctionTHE JOURNAL OF SEXUAL MEDICINE, Issue 1 2007Harin Padma-Nathan MD ABSTRACT Introduction., The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED). Aim., To assess the ability of vardenafil to restore normal erectile function in men with general ED. Methods., In two fixed-dose, parallel-group, double-blind, placebo-controlled, pivotal studies, patients received vardenafil (5, 10, or 20 mg) or placebo for 12/26 weeks. Main Outcome Measure., In this retrospective analysis, the percentage of patients "returning to normal" erectile function at week 12 (as defined by scores ,26 on erectile function domain of International Index of Erectile Function [IIEF-EF]) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED. Results., Vardenafil 5, 10, and 20 mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12 weeks, compared with 10% of patients receiving placebo (P < 0.0001). Return to normal IIEF-EF domain scores was noted irrespective of severity, etiology, age, and duration of ED, and was observed even in challenging-to-treat subgroups. With vardenafil 20 mg, 39% of men with severe ED at baseline, 45,49% of men with ED of mixed or organic etiology, 35% of men aged ,65 years, and 43% of men with ED of ,3 years of duration returned to normal erectile function at week 12. Mean per-patient SEP3 (question 3 on the Sexual Encounter Profile) success rates in patients achieving IIEF-EF domain scores ,26 ranged from 87% to 95%. Conclusion., Vardenafil improves the IIEF-EF domain score to the normal range in a substantial proportion of men with ED. Padma-Nathan H, Montorsi F, Giuliano F, Meuleman E, Auerbach S, Eardley I, McCullough A, Homering M, and Segerson T for the North American and European Vardenafil Study Group. Vardenafil restores erectile function to normal range in men with erectile dysfunction. J Sex Med 2007;4:152,161. [source] Improving the Sexual Quality of Life of Couples Affected by Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled Trial of VardenafilTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2005William A. Fisher PhD ABSTRACT Introduction., Erectile dysfunction (ED) has a dual negative impact on men and their female partners; both are likely to face a drop in sexual quality of life and challenges to their intimate relationship as couples' sexual activities are curtailed by the loss of erectile function. Aim., The primary objective of this study was to compare the efficacy of vardenafil vs. placebo in terms of success of maintenance of erection in men with ED and improvement of their female partner's sexual quality of life. Methods., This was a randomized, double-blind, multicenter, flexible-dose, parallel-group comparison of vardenafil vs. placebo for 12 weeks in men (,18 years) with ED of ,,6 months duration, and their female partners. Main Outcome Measures., Changes in patient's overall response rate to Sexual Encounter Profile question 3 (SEP3) "Did your erection last long enough for you to have sexual intercourse?" and female partner's response to the quality of life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL) at last observation carried forward (LOCF) were considered the primary efficacy measures. In addition, patient's response to SEP2 "Were you able to insert your penis into your partner's vagina?," the erectile function domain of the International Index of Erectile Function (IIEF-EF) and patient's mSLQQ-QOL score were also assessed. Results., Compared with placebo, vardenafil significantly improved overall least square (LS) mean per-patient SEP3 success rate (28% vs. 68%; P < 0.0001) and partner's LS mean (standard error [SE]) mSLQQ-QOL score at LOCF (32.14 [3.24] vs. 65.80 [3.10]; P < 0.0001). In addition, compared with placebo, vardenafil also improved overall LS mean per-patient SEP2 success rate (47% vs. 80%; P < 0.0001), LS mean (SE) IIEF-EF scores at LOCF (12.7 [0.8] vs. 22.8 [0.8]; P < 0.0001) and patient's LS mean (SE) mSLQQ-QOL (28.37 [3.46] vs. 63.85 [3.28]; P < 0.0001) at LOCF. Conclusions., Vardenafil improved erectile function in men with ED and improved the sexual quality of life of the couple. Fisher WA, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Goldstein I, Bangerter K, Bandel T-J, Derogatis LR, and Sand M for the Vardenafil Study Group. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005;2:699,708. [source] Prostatic Specific Antigen in Patients with Hypogonadism: Effect of Testosterone ReplacementTHE JOURNAL OF SEXUAL MEDICINE, Issue 2 2005Ahmed I. El-Sakka MD ABSTRACT Introduction., The effect of parenteral testosterone replacement therapy on prostatic specific antigen (PSA) level or the development or growth of prostate cancer is unclear. Aim., To assess the effect of testosterone replacement on PSA level in patients with hypogonadism associated with erectile dysfunction (ED). Methods., A total of 187 male patients above the age of 45 with hypogonadism associated with ED were enrolled in this study. Patients were screened for ED by the erectile function domain of the International Index of Erectile Function (IIEF). Patients underwent routine laboratory investigations, plus total testosterone, and PSA assessment. Replacement treatment with parenteral testosterone every 2,4 weeks for 1 year was instituted. Total testosterone and PSA serum levels were assessed every 3 months during the treatment course. Results., Mean age ± SD was 62.8 ± 11.4. Of the patients 87.7% were sexually active. Of the patients 10.2% had mild, 40.6% had moderate and 49.2% had severe ED. Of the study population, 62.5% had ED complaints for less than 5 years and 84.5% had gradual onset of their complaint. The majority of the patients (91.4%) had either progressive or stationary course while the minority reported regressive course and improvement of the condition. There was a significant increase of the post-treatment testosterone level in comparison to pretreatment level (P < 0.05). No significant increase in the post-treatment PSA level in comparison to pretreatment (P > 0.05). No significant difference between pre- and post-treatment categories of PSA level (normal, borderline, high) in relation to the severity of ED (P > 0.05). There was no significant association between PSA level and the duration of testosterone replacement therapy in the study population (P > 0.05). Conclusion., The current study demonstrated that the level of PSA was not significantly changed after 1 year of testosterone replacement therapy in patients with hypogonadism associated with ED. [source] | ||||||||||