Global Assessment Question Research Articles

Kaempferia parviflora ethanol extract improves self-assessed sexual health in men: a pilot study

BackgroundSexual health positively correlates with overall wellbeing. Existing therapeutics to enhance male sexual health are limited by factors that include responsiveness, adherence and adverse effects. As the population ages, safe and effective interventions that preserve male sexual function are needed. Published research suggests that various preparations of Kaempferia parviflora, a plant in the Zingiberaceae (ginger) family, support cardiovascular health and may ameliorate erectile function. ObjectiveThe aim of this study was to examine the effects of KaempMax™, an ethanol extract of the K. parviflora rhizome, on erectile function in healthy middle-aged and older men. Design, setting, participants and interventionsWe conducted an open-label, one-arm study on 14 generally healthy males aged 50–68 years with self-reported mild erectile dysfunction, who were not using prescription treatments. Participants took 100 mg KaempMax™ daily for 30 days. Main outcome measuresEvaluations were conducted at baseline and on the final study assessment. Primary efficacy analyses included the International Index of Erectile Function (IIEF); secondary efficacy analyses included the Global Assessment Question about erectile function. ResultsThirteen participants completed the 30-day study. Supplementation with KaempMax™ resulted in statistically significant improvements in erectile function, intercourse satisfaction and total scores on the IIEF questionnaire. KaempMax™ was well tolerated and exhibited an excellent safety profile. ConclusionOur results suggest that KaempMax™ may improve erectile function in healthy middle-aged and older men. While the effects were not as pronounced as what might be seen with prescription medication, most participants found them satisfactory. Additional, longer and placebo-controlled clinical trials will be needed. Trial registrationClinicaltrials.gov identifier NCT03389867.

Evaluación de la función eréctil y la percepción de mejoría en pacientes españoles con disfunción eréctil

ObjectiveThis study has been carried out to assess the hardness of erection and the perception of improvement in erectile function with the treatments received during the last month. Material and methodDescriptive, observational, multicenter, cross-sectional study carried out in 30 urology sites in Spain. Patients diagnosed of erectile dysfunction receiving treatment during at least the last month have been enrolled. Hardness of erection has been assessed with the erection hardness score and improvement perception has been estimated with the global assessment question. ResultsA 63% of patients had a hardness of erection that was insufficient for penetration, but 75% of patients referred that their erectile function had improved with treatment. After adjustment for other factors, erection hardness score values were not significantly different among patients being treated with alprostadil topical cream, compared to patients being treated with the combination of phosphodiesterase 5 (PDE5) inhibitors plus alprostadil topical cream or with PDE5i other than sildenafil alone. However, patients treated with alprostadil topical cream had a significantly higher chance of referring an improvement in their erectile function compared to patients treated with PDE5i, despite the fact that they had received treatment for a shorter period of time. ConclusionHardness of erection is just another factor of erectile function, but it is not the only one influencing improvement perception by patients.

Effects of nutraceuticals on sexual satisfaction and lower urinary tract symptoms in a cohort of young-old men.

The aim of this study was to evaluate the effects of nutraceuticals containing multiple supplemental facts (Virherbe®/Rekupros®) on sexual satisfaction and lower urinary tract symptoms (LUTS) in young-old men. In an open-label trial, 40 males (mean age 66±13) with sexual disturbances and mild LUTS but without cognitive/motor impairment and clinical hypogonadism were enrolled. Sexual desire (SD; IIEF-SD domain) and satisfaction (Global Assessment Question; GAQ), the capacity to perform daily activities (evaluated by 6-min walking test [6MWT]), and International Prostate Symptoms Scores (IPSS) were evaluated before and after oral administration of 2 capsules/day of each supplement for 8weeks. The difference from baseline for SD was +2.6 (p<.05) and -4.2 points for IPSS (p<.05), with significance in subscales of urinary streaming/nocturia (p<.01), respectively; 6MWT increased from 507±44 versus 527±58meters (p<.001). GAQ scale-responses showed overall improvement in overall 75% population, with a significant improvement in QoL (p<.01). These changes returned to baseline at 1-month withdrawal follow-up. No adverse events were reported. These supplemental facts improved sexual desire, satisfaction with sex life, physical performance, and LUTS in young-old men, suggesting that they may be effective in patients in whom standard treatments are not suitable.

Topical alprostadil (Vitaros©) in the treatment of erectile dysfunction after non-nerve-sparing robot-assisted radical prostatectomy.

The aim of the study is the evaluation of the efficacy and safety of the treatment with topical alprostadil (Vitaros©) in post-robot assisted radical prostatectomy (RARP) rehabilitation therapy of patients with erectile dysfunction (ED). Seventy-four patients were enrolled and underwent non-nerve-sparing RARP. age <75, preoperatively International Index of Erectile Function (IIEF-5) >16, erection hardness score (EHS) ⩾2, weekly sexual intercourse ⩾1, affirmative answers to Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3, Charlson Comorbidity Index (CCI) ⩽5, Eastern Cooperative Oncology Group (ECOG) performance status ⩽1, no moderate/severe cardiovascular disease. Vitaros was administered ⩾2 twice a week. At month 6, the IIEF-5 decreased from 20.5 preoperative to 18.1 post-treatment. EHS score decreased from a mean of 3.3 to a mean of 3.0. The quality of life score decreased from an average of 5.1 to 2.3. Weekly sexual intercourse decreased from an average of 2.1 to 1.7. Six patients dropped out; 89.7% patients showed a positive SEP-Q2 and 77.8% a positive SEP-Q3. All patients responded positively to Global Assessment Questions (GAQ)-1 and 97% to GAQ-2. Of all 68 analyzed patients, 13 (17.6%) switched to intracavernous injection therapy. In conclusion, Vitaros may become a viable alternative to common injective therapies in well-selected patients after RARP.

Ethnicity and age as factors in sildenafil treatment of erectile dysfunction.

Sildenafil has been evaluated in >16000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials. To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61years). Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials. Most had starting sildenafil doses of 50mg once daily, ~1hour before sexual activity, with adjustment to 100 or 25mg as needed. Change from baseline in International Index of Erectile Function erectile function (IIEF-EF) domain score assessed with analysis of covariance and a Global Assessment Question (GAQ; "Did the treatment improve your erections?") at endpoint assessed with logistic regression analysis. 4120 and 3714 men received sildenafil and placebo, respectively (2740 and 2671 White; 407 and 385 Black; 973 and 658 Asian). For sildenafil vs. placebo groups, overall treatment differences for IIEF-EF domain and GAQ were significant for each ethnic and age group (P<.0001); significant treatment-by-ethnicity and treatment-by-age interactions were also observed for change in IIEF-EF domain scores (P<.05), with differences significantly greater for White vs. Black (P<.0001), White vs. Asian (P=.0163), and Asian vs. Black (P=.0036) men. A significant treatment-by-ethnicity interaction was observed for GAQ (P=.0004). The OR comparison for GAQ was significantly greater (P=.0001) with sildenafil vs. placebo in White (OR=11.2) or Asian (OR=12.4) men vs. Black men (OR=5.1). Adverse-event rates were generally similar, with some age variations. Sildenafil is effective and well-tolerated regardless of ethnicity or age; however, treatment effects can vary.

PD69-04 SAFETY AND EFFICACY OF LOW-INTENSITY EXTRACORPOREAL SHOCKWAVE IN THE TREATMENT OF VASCULOGENIC ERECTILE DYSFUNCTION: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED SHAM-CONTROLLED CLINICAL TRIAL

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II1 Apr 2017PD69-04 SAFETY AND EFFICACY OF LOW-INTENSITY EXTRACORPOREAL SHOCKWAVE IN THE TREATMENT OF VASCULOGENIC ERECTILE DYSFUNCTION: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED SHAM-CONTROLLED CLINICAL TRIAL Zhongcheng Xin, Ruili Guan, Wanshou Cui, Xiaodong Zhang, Long Tian, Yi Xie, Hongen Lei, Jihong Liu, and Tao Wang Zhongcheng XinZhongcheng Xin More articles by this author , Ruili GuanRuili Guan More articles by this author , Wanshou CuiWanshou Cui More articles by this author , Xiaodong ZhangXiaodong Zhang More articles by this author , Long TianLong Tian More articles by this author , Yi XieYi Xie More articles by this author , Hongen LeiHongen Lei More articles by this author , Jihong LiuJihong Liu More articles by this author , and Tao WangTao Wang More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.3145AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To evaluate the safety and efficacy of Low-intensity Extracorporeal Shockwave (LI-ESWT) in the Treatment of Vasculogenic Erectile Dysfunction. METHODS A multi-center, double-blind, randomized sham-controlled clinical trial was conducted. 70 patients (46 cases for LI-ESWT treatment group and 24 cases for the placebo group) at age 20-70 years, who had mild or moderate Vasculogenic ED evaluated with the International Index of Erectile Function erectile function domain (IIEF-EF) were recruited for this study. Screening, treatment and results were performed in sequence. 4 weekly sessions for the treatment stage: A total of 5000 shockwaves were applied for each treatment and 4 areas were conducted including: 900 shockwaves in right and left crura, and 1600 shockwaves in each site. Effectiveness was assessed according to the International Index of Erectile Function erectile function domain (IIEF-EF), questions 2 and 3 of the Sexual Encounter Profile (SEP), Global Assessment Question (GAQ) scores, and Erection Hardness Scale (EHS) at baseline and at 1 and 3 months after treatment. The study was approved by Peking University First Hospital ethics committee, and all patients signed an informed consent form. RESULTS For Full Analysis Set (FAS) and Per-Protocol Set (PPS), the average IIEF-EF increased significantly from 18.04±3.94 (17.90±3.77) at baseline to 22.02±4.13 (21.95±4.06) at 1 months post treatment, and was 22.54±3.98 (22.49±3.90) at the 3 months follow-up. The success rate by LI-ESWT is 67.39% (73.17%) after 1months post treatment VS 20.83% (23.81%) in the placebo group and is 69.57% (73.17%) after 3 months post treatment VS 20.83% (23.81%) in the placebo group by FAS (PPS). SEP, GAQ, EHS analysis were also significantly improved compared to the placebo controls (p<0.05). No side effects were reported in this study. CONCLUSIONS LI-ESWT in patients with mild or moderate Vasculogenic ED is a feasible, noninvasive and effective way for improving male ED. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1345-e1346 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Zhongcheng Xin More articles by this author Ruili Guan More articles by this author Wanshou Cui More articles by this author Xiaodong Zhang More articles by this author Long Tian More articles by this author Yi Xie More articles by this author Hongen Lei More articles by this author Jihong Liu More articles by this author Tao Wang More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Changes in quality of life after elective surgery: an observational study comparing two measures.

Our main objective was to compare the change in a validated quality of life measure to a global assessment measure. The secondary objectives were to estimate the minimum clinically important difference (MCID) and to describe the change in quality of life by surgical specialty. This prospective cohort study included 7902 adult patients undergoing elective surgery. Changes in the Veterans RAND 12-Item Health Survey (VR-12), composed of a physical component summary (PCS) and a mental component summary (MCS), were calculated using preoperative and postoperative questionnaires. The latter also contained a global assessment question for quality of life. We compared PCS and MCS to the global assessment using descriptive statistics and weighted kappa. MCID was calculated using an anchor-based approach. Analyses were pre-specified and registered (NCT02771964). By the change in VR-12 scores, an equal proportion of patients experienced improvement and deterioration in quality of life (28% for PCS, 25% for MCS). In contrast, by the global assessment measure, 61% reported improvement, while only 10% reported deterioration. Agreement with the global assessment was slight for both PCS (kappa = 0.20, 57% matched) and MCS (kappa = 0.10, 54% matched). The MCID for the overall VR-12 score was approximately 2.5 points. Patients undergoing orthopedic surgery showed the most improvement in quality of life measures, while patients undergoing gastrointestinal/hepatobiliary or urologic surgery showed the most deterioration. Subjective global quality of life report does not agree well with a validated quality of life instrument, perhaps due to patient over-optimism.

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

IntroductionLow-intensity shockwave therapy (LISWT) has recently emerged as a promising method in the treatment of erectile dysfunction (ED).AimTo 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.MethodsThis 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 MeasuresEffectiveness 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.ResultsEighty 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.ConclusionLISWT 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.

Exercise improves the effects of testosterone replacement therapy and the durability of response after cessation of treatment: a pilot randomized controlled trial.

The effects of the combination of exercise and TRT on symptoms of late-onset hypogonadism (LOH) and the durability of response after cessation of TRT were investigated. A total of fifty patients with erectile dysfunction (ED) who had a sedentary lifestyle and low serum total testosterone (T) levels were enrolled and followed for 20 weeks. Patients were randomly divided into two groups; all of them received T gel for 12 weeks and it was discontinued for 8 weeks. Patients assigned to Group II were offered a supervised exercise program for 20 weeks. Measurement of serological testing was performed and self-assessment questionnaires and Global Assessment Question (GAQ) were asked. Baseline characteristics and the initial symptom scores showed no significant difference between the two groups. Serum total T levels and the symptom scores were increased at 12 weeks in both groups, and Group II showed better results with statistical significance. There was a decrease in T levels and worsening of symptom scores at week 20 compared to week 12 in both groups, and Group II showed better results with statistical significance. On the GAQ, Group II showed higher ratio of “yes” at week 12 and the same tendency was sustained at week 20 with significant difference between two groups. The combination of exercise and TRT showed significant improvements in serum T levels and LOH symptoms compared to TRT alone. In addition, these improvements were maintained in the combination group with continuous exercise, even after cessation of TRT.

A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction

ABSTRACTObjectives: Esomeprazole 20 mg once daily has been shown to be effective for treating frequent heartburn over 14 days in subjects who are likely to self-treat with over-the-counter medications. These analyses were conducted to assess durability of effects and symptomatic rebound after cessation of treatment, treatment satisfaction, and rescue antacid use with esomeprazole 20 mg once daily for 14 days.Methods: Adults with frequent heartburn (≥ two days/week in the past four weeks) were randomly assigned to 14 days of double-blind treatment with esomeprazole 20 mg or placebo in two identical multicenter studies. All subjects entered a 1-week single-blind placebo follow-up period after treatment. The results of the primary efficacy endpoints were reported previously. The percentage of heartburn-free days during the 1-week follow-up, use of rescue antacids, and treatment satisfaction, measured with the Global Assessment Questions instrument, are described.Results: The percentage of heartburn-free days was maintained during the 1-week follow-up period; the proportion was 43% among esomeprazole subjects in these studies, suggesting no evidence of symptomatic rebound. Rescue antacid use generally decreased compared with the run-in period in the 14-day treatment and 1-week follow-up periods. Significantly more subjects taking esomeprazole were “very satisfied” or “satisfied” with treatment versus placebo (Study 1: 78% vs. 63%, respectively, P = 0.0038; Study 2: 81% vs. 60%, respectively, P = 0.0002).Conclusions: Subjects who are likely to self-treat their frequent heartburn with over-the-counter medications reported satisfaction with esomeprazole 20 mg. Esomeprazole’s treatment effect was maintained for ≥ one week after treatment ended, with no sign of symptomatic rebound. These trials were registered at ClinicalTrials.gov: NCT01370525; NCT01370538.

Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction.

Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials. To assess the efficacy and safety of sildenafil vs placebo according to age subgroups (<65, 65-74, and ≥75years) in 11,364 men with erectile dysfunction using pooled data from 48 randomized, double-blinded, placebo-controlled, parallel-group, flexible-dose trials. Most trials had a 12-week treatment duration. The starting sildenafil dose was 50 mg, taken 1 hour before sexual activity, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Men taking nitrate therapy or nitric oxide donors and men with severe cardiac failure, unstable angina, or recent stroke or myocardial infarction were excluded. Efficacy analyses included all subjects with baseline and at least one postrandomization evaluation. Safety analyses included subjects who received study medication. The International Index of Erectile Function and a global assessment question ("Did the treatment improve your erections?"). Mean International Index of Erectile Function scores for question 3 (frequency of penetration), question 4 (maintenance of erections after penetration), and the erectile function domain were statistically significantly improved with sildenafil vs placebo for each age subgroup; orgasmic function, intercourse satisfaction, sexual desire, and overall satisfaction domain scores also were statistically significantly improved with sildenafil vs placebo. The percentage of men reporting improved erections on the global assessment question was statistically significantly higher with sildenafil vs placebo for all age subgroups; the percentage with sildenafil tended to decrease with increasing age (<65 years, 80%; 65-74 years, 69%; ≥75 years, 59%). The most common adverse events with sildenafil were headache and flushing in each age subgroup. Sildenafil is an effective and well-tolerated treatment for erectile dysfunction regardless of patient age, including men at least 75 years old.

095 Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction

Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction (ED) in randomized controlled trials. However, published data are limited on the treatment response to sildenafil in men with ED according to age ≥65 years. We assessed the efficacy and safety of sildenafil versus placebo according to age subgroups (<65, 65–74, and ≥75 years) in 11,364 men with ED using pooled data from 48 randomized, double-blind, placebo-controlled, parallel-group, flexible-dose trials. Most trials had a 12-week treatment period. The starting sildenafil dose was 50 mg, taken 1 hour before sexual activity, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Men taking nitrate therapy/nitric oxide donors and men with severe cardiac failure, unstable angina, or recent stroke or myocardial infarction were excluded. Efficacy analyses included all subjects with baseline and ≥1 post-randomization evaluation. Safety analyses included all subjects who received study drug. The primary efficacy outcomes were the change from baseline to week 12 in International Index of Erectile Function (IIEF) scores and a Global Assessment Question (GAQ; “Did the treatment improve your erections?”) at week 12.

The importance of psychosexual counselling in the re-establishment of organic and erotic functions after penile prosthesis implantation.

Although many studies about penile prosthesis implantation (PPI) have been published so far, only a small amount of them take into account patients and partners outcome in terms of satisfaction and erotic function. The aim of this study is to explore the value of psycosexual counselling in and the sexual and erotic function of penile prosthesis recipients. Thirty patients and their partners were randomised into two groups. In arm A (case group) patients and their partners underwent a multistep psychosexual counselling before and after surgery. In arm B (control group) surgery was performed without the specific psychosexual counselling scheme. Specific questionnaires (International Index of Erectile Function (IIEF) and the Sexual Daydreaming Scale (SDS)) were administered before surgery and 12 months afterwards. Twenty-four months postoperatively patients were asked to complete the Global Assessment Questions (GAQ) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), while their partners were asked to answer to the EDITS partner's section. Between January 2009 and October 2011, we enrolled 30 patients undergoing PPI in our institution (15 in each arm). Twenty-four months postoperative follow-up is available for all of them. No significant differences between the two groups in terms of baseline questionnaires scores were observed. Mean IIEF score was significantly higher in case group (arm A 68.3, arm B 53.4, P-value<0.001). At 12 months after PPI the improvement of erotic function according to SDS was significantly higher in the study group for both patients and their partners. Improvement in satisfaction rates were confirmed at 24 months, with statistically significant scores for EDITS in arm A patients and partners as compared with arm B. PPI with a pre- and postoperative psychosexual counselling scheme resulted in better postoperative sexual activity and erotic function for both patients and partners than PPI alone.

The Impact of Illicit Use of Amphetamine on Male Sexual Functions.

Data concerning the impact of amphetamine on male sexual functions are limited, although amphetamine has been used as an aphrodisiac. This cross-sectional study was to assess the impact of illicit use of amphetamine on male sexual functions. Male illicit drug users in a Drug Abstention and Treatment Center were recruited to complete a self-administered questionnaire, and data were compared with age-matched controls. The International Index of Erectile Function (IIEF) and global assessment questions were used to assess sexual functions. Of 1,159 amphetamine mono-illicit drug users, the mean age was 31.9 ± 7.5 (18-57) years, and mean duration of drug use was 30.7 ± 52.2 (median 9, range 0.1-252) months. Half of them reported that drug use had no impact on their sexual functions. The other half reported drug impacts as reduced erectile rigidity and sexual life satisfaction, enhanced orgasmic intensity, and prolonged ejaculation latency time more often than the opposite effects, while they reported enhanced or reduced effect equally on sexual desire. Dosing frequency of amphetamine was associated with its impact on sexual functions, but duration of its use had little association with that. Compared with 211 age-matched controls, the amphetamine mono-illicit drug users had lower IIEF scores in the domains of erectile function, orgasmic function, and overall satisfaction, but there are no significant differences in intercourse satisfaction and sexual desire scores. The prevalence of erectile dysfunction (ED) was significantly higher in the drug users than in the controls (29.3% vs. 11.9%). The odds ratio of ED for amphetamine use was 2.1 (95% confidence interval 1.2-3.6) after adjustment for other risk factors. The impact of illicit use of amphetamine on male sexual functions varied among users, and their ED prevalence was higher than the controls.

The Efficacy of Combination Treatment with Injectable Testosterone Undecanoate and Daily Tadalafil for Erectile Dysfunction with Testosterone Deficiency Syndrome

Both testosterone therapy and chronic treatment with phosphodiesterase type 5 inhibitors (PDE5Is) have positive effects on the histology of penile corpora and erectile function. However, few clinical studies have evaluated the efficacy of combination therapy with both testosterone replacement and chronic PDE5Is. This study was designed to evaluate the efficacy and safety of combination treatment with long-acting injectable testosterone undecanoate (TU) and a once-daily tadalafil 5 mg for erectile dysfunction with testosterone deficiency syndrome. Sixty patients were consecutively enrolled and followed for 36 weeks. Thirty patients were randomly assigned to group I and received 1,000 mg of parenteral TU on day 1, followed by additional injections at weeks 6 and 18 with on-demand tadalafil 10-20 mg during the 30 weeks of treatment. The remaining 30 patients received the same dose and schedule of TU as group I, and were prescribed once-daily tadalafil 5 mg during 30 weeks. Serological tests were performed, and the International Index of Erectile Function (IIEF), Aging Males' Symptoms (AMS) questionnaires, and Global Assessment Question (GAQ) were administered to the patients. Total IIEF and AMS scores were significantly improved during the 30 weeks of treatment in both groups. When IIEF scores were compared between the two groups, group II showed better symptom scores than group I at weeks 6 and 30. A similar pattern was observed when comparing AMS scores between the groups. At week 36, changes in IIEF and AMS scores that indicated worsened symptoms compared with week 30 were observed in both groups; group II showed better symptom scores than group I. On the GAQ, the ratio of patients reporting improvement in erectile function was significantly higher in group II than group I. The combination of long-acting injectable TU and once-daily tadalafil 5 mg produced a significant improvement in erectile function. Moreover, the improvement in erectile function was well maintained, even after the cessation of treatment.

Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: A randomized, double-blind, placebo-controlled trial

Nerve-preserving surgery has been provided for patients with rectal cancer; however, sexual dysfunction remains a common complication of rectal cancer surgery. This study explored the efficacy of udenafil to treat erectile dysfunction in male patients who underwent total mesorectal excision (TME) for rectal cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial involving 80 male patients who had decreased International Index of Erectile Function-5 (IIEF-5) scores after TME for rectal cancer. Patients received placebo (50 mg) or udenafil (50 mg) for 12 weeks. The primary outcome variable was the change in IIEF-5 scores. The secondary outcome variables were Sexual Encounter Profile (SEP) questions 2 (Q2) and 3 (Q3), and the Global Assessment Question (GAQ). Baseline IIEF-5 scores, SEP Q2 and Q3 responses, and spontaneous erection rates were consistent in both groups. At the end of treatment, the change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group (mean IIEF-5 score, 4.8 ± 4.0 vs 2.0 ± 1.7; P < .05). Responses to SEP Q2, SEP Q3, and GAQ were significantly higher in the udenafil group than they were in the placebo group (SEP Q2, P = .025; SEP Q3, P = .044; GAQ, P < .001). Treatment-related adverse events (n = 4) were all mild in severity. Oral udenafil was deemed safe and effective for the treatment of erectile dysfunction in patients who underwent TME for rectal cancer.

Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study.

Low-intensity shockwaves (LISW) are known to produce revascularization and have been in evaluation and in use to treat erectile dysfunction (ED). The present single-arm pilot study is aimed to assess the safety and efficacy of a dedicated shockwave device (Renova) on vasculogenic ED patients. Fifty-eight patients with mild to severe ED were treated by LISW and their erectile function was evaluated by the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), Sexual Encounter Profile and Global Assessment Questions questionnaires, at baseline and at 1, 3 and 6 months post treatment. The average IIEF-EF increased significantly from 14.78 at baseline to 21.93 at 3 months post treatment and stabilized at 22.26 at 6 months post treatment. Out of 58 patients, 47 (81%) had a successful treatment. No adverse events were reported during the treatment and the follow-up duration. In conclusion, it suggests that the performance of LISW could add a new advanced treatment for ED.

Comparison of the efficacy and safety of once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction.

We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction (ED). A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile (SEP) diary Question 2 and 3 (Q2 and Q3) were randomized into 200 mg on-demand (n = 80) or 50 mg once-daily (n = 81) dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function (IIEF) erectile function domain (EFD) score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate (EFD ≥ 26). Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment (P < 0.0001). There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. Daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.

The CORD Standardized Letter of Evaluation: Have We Achieved Perfection or Just a Better Understanding of Our Limitations?

The CORD Standardized Letter of Evaluation: Have We Achieved Perfection or Just a Better Understanding of Our Limitations?

THU0451 The Formulation of the Patient Global Assessment Question Influences the Classification of Patients with Rheumatoid Arthritis (RA) into Acr/Eular Remission: an Analysis of Patients Enrolled in ESPOIR and Comedra

BackgroundThe recently developed ACR/EULAR Boolean remission criteria for rheumatoid arthritis (RA) include not only remission for joint accounts and CRP, but also for patient global assessment (assessed by a patient...