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-wee...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.展开更多
BACKGROUND End-stage renal disease(ESRD)is associated with a multitude of physical,psychological,and social health challenges,including a profound impact on sexual and reproductive health.Among males with ESRD,erectil...BACKGROUND End-stage renal disease(ESRD)is associated with a multitude of physical,psychological,and social health challenges,including a profound impact on sexual and reproductive health.Among males with ESRD,erectile dysfunction(ED)is highly prevalent due to factors such as underlying comorbidities,including diabetes and hypertension,and the physiological effects of long-term dialysis.Kidney transplantation(KTx)has been proposed as a potential intervention to mitigate the effects of ED by restoring renal function and improving hormonal balance.However,the evidence surrounding the effectiveness of KTx in improving sexual function,specifically erectile function(EF),remains inconclusive.This systematic review and meta-analysis aim to evaluate the effects of KTx on sexual dysfunction(SexDys),particularly ED,in male ESRD patients.AIM To evaluate the benefits and potential harms of KTx compared to other forms of renal replacement therapy in improving EF in adult males with ESRD,assessed using the international index of EF(IIEF),to survey the prevalence of SexDys in this population,and to assess the correlation between various factors and SexDys through regression analysis.METHODS A systematic search of PubMed,EMBASE,Cochrane Library,Scopus,Clinical-Trials.gov,and Google Scholar was conducted,following the PRISMA 2020 guidelines.Prospective and retrospective cohort studies,as well as cross-sectional studies assessing EF pre-and post-transplantation,were included.These studies used validated tools such as the IIEF to measure EF.Meta-analyses were performed using a random-effects model to estimate standardized mean differences(SMD)and hazard ratios(HR)with 95%confidence intervals(CI).Heterogeneity was assessed using the I²statistic,and publication bias was evaluated with a funnel plot and the Egger’s test.RESULTS A total of 2419 studies were identified,with 362 abstracts screened and 193 full-text articles reviewed.Ultimately,11 studies were included for qualitative analysis and 7 for quantitative synthesis.The random effects model for SMD yielded a combined estimate of 0.43(95%CI:-0.20-1.07),indicating a small but non-significant improvement in EF post-transplantation.The heterogeneity across studies was substantial(I²=90%),reflecting significant variability in outcomes.Subgroup analysis showed greater improvements in EF among living-donor transplant recipients compared to those receiving organs from deceased donors.Despite this trend,the overall result for changes in EF was not statistically significant(P=0.15).Additionally,the combined HR from the meta-analysis was 2.87(95%CI:1.76-4.69),suggesting that KTx significantly increases the likelihood of improved EF,though variability between studies persisted(I²=63%).CONCLUSION While KTx offers some promise for improving EF in male ESRD patients,the overall evidence remains inconclusive due to high heterogeneity between studies and a lack of statistical significance in the combined results.Despite this,individual studies suggest that KTx may lead to significant improvements in EF for certain subgroups,particularly living-donor recipients.Future research should focus on larger,well-designed cohort studies with standardized outcome measures to provide more definitive conclusions.Addressing SexDys as part of routine care for ESRD patients undergoing KTx is crucial to improving their overall quality of life.However,adjunct therapies such as phosphodiesterase type 5 inhibitors may be necessary for those who do not experience adequate improvements post-transplantation.展开更多
Previous published studies have shown an improvement of penile hemodynamic parameters after low-intensity extracorporeal shockwave therapy(Li-ESWT).However,the clinical significance of these findings remains unclear,a...Previous published studies have shown an improvement of penile hemodynamic parameters after low-intensity extracorporeal shockwave therapy(Li-ESWT).However,the clinical significance of these findings remains unclear,and definitive selection criteria for Li-ESWT based on preexisting comorbidities have yet to be established.This was an observational study of 113 patients with ED,evaluated between January 2019 and December 2021 in Andrology Unit at the Department of Urology and Renal Transplantation,University of Foggia(Foggia,Italy).Penile dynamic Doppler was performed to evaluate vascular parameters and 5-item version of the International Index of Erectile Dysfunction(IIEF-5)questionnaire was administered to assess the severity of ED.This was repeated 1 month after treatment.Patients with a peak systolic velocity(PSV)<30 cm s−1 were considered eligible for Li-ESWT.Our protocol consisted of 8 weekly sessions with 1500 strokes distributed in 5 different locations along the penis.After treatment,a significant mean(±standard deviation[s.d.])PSV increase of 5.0(±3.4)cm s−1 was recorded and 52/113(46.0%)patients reached a PSV>30 cm s−1 at posttherapeutic penile dynamic Doppler.A clinically significant IIEF-5 score improvement was observed in 7 patients,21 patients,and 2 patients with mild-to-moderate,moderate,and severe pretreatment ED,respectively.No different outcomes were assessed based on smoking habits,previous pelvic surgery,or use of oral phosphodiesterase-5 inhibitor(PDE5i).On the other side,only 1(6.7%)in 15 patients with diabetes mellitus showed an IIEF-5 score improvement after Li-ESWT.Shockwave treatment determined a significant increase in PSV and correlated IIEF-5 improvement in ED patients.This advantage seemed particularly evident for moderate ED and was not affected by smoking habits,previous pelvic surgery,and use of PDE5i.Conversely,diabetic patients did not benefit from the treatment.展开更多
Sexual dysfunction(SD)is a prevalent but very commonly ignored aspect in the treatment of liver diseases and cirrhosis.The etiology of SD is multifactorial and therefore treatment strategies are complex,especially in ...Sexual dysfunction(SD)is a prevalent but very commonly ignored aspect in the treatment of liver diseases and cirrhosis.The etiology of SD is multifactorial and therefore treatment strategies are complex,especially in females.Phosphodiesterase inhibitors are useful and effective in erectile dysfunction in males but in females,no single drug is available for SD,therefore multimodal treatment is required depending upon the cause.The foremost and fundamental requirement in both genders is to be stress-free and have adequate control of liver diseases.Improved quality of life is helpful in improving SD and vice versa is also true.Therefore,patients suffering from liver diseases should come forward and ask for treatment for SD,and physicians should actively enquire about SD while history taking and evaluating these patients.SD results in deterioration of quality of life,and both are modifiable and treatable aspects of liver diseases,which are never addressed actively,due to social taboos and fears of SD treatment in the presence of liver diseases.The diagnosis of SD does not require costly investigations,as the diagnosis can be established based on validated questionnaires available for both genders,therefore detailed targeted history taking using questionnaires is essential.Data are emerging in this area but is still at an early stage.More studies should be dedicated to SD in liver diseases.展开更多
Background: Sexual 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 po...Background: Sexual 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. Objective: The aim of this study was to examine the effects of KaempMaxTM, an ethanol extract of the K. parvi]lora rhizome, on erectile function in healthy middle-aged and older men. Design, setting, participants and interventions: We 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 pre- scription treatments. Participants took 100 mg KaempMaxTM daily for 30 days. Main outcome measures: Evaluations 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. Results: Thirteen participants completed the 30-day study. Supplementation with KaempMaxTM resulted in statistically significant improvements in erectile function, intercourse satisfaction and total scores on the IIEF questionnaire. KaempMaxTM was well tolerated and exhibited an excellent safety profile. Conclusion: Our results suggest that KaempMaxTM 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 med- ication, most participants found them satisfactory. Additional, longer and placebo-controlled clinical tri- als will be needed. Trial registration: Clinicaltrials.gov identifier Ncr03389867.展开更多
文摘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.
文摘BACKGROUND End-stage renal disease(ESRD)is associated with a multitude of physical,psychological,and social health challenges,including a profound impact on sexual and reproductive health.Among males with ESRD,erectile dysfunction(ED)is highly prevalent due to factors such as underlying comorbidities,including diabetes and hypertension,and the physiological effects of long-term dialysis.Kidney transplantation(KTx)has been proposed as a potential intervention to mitigate the effects of ED by restoring renal function and improving hormonal balance.However,the evidence surrounding the effectiveness of KTx in improving sexual function,specifically erectile function(EF),remains inconclusive.This systematic review and meta-analysis aim to evaluate the effects of KTx on sexual dysfunction(SexDys),particularly ED,in male ESRD patients.AIM To evaluate the benefits and potential harms of KTx compared to other forms of renal replacement therapy in improving EF in adult males with ESRD,assessed using the international index of EF(IIEF),to survey the prevalence of SexDys in this population,and to assess the correlation between various factors and SexDys through regression analysis.METHODS A systematic search of PubMed,EMBASE,Cochrane Library,Scopus,Clinical-Trials.gov,and Google Scholar was conducted,following the PRISMA 2020 guidelines.Prospective and retrospective cohort studies,as well as cross-sectional studies assessing EF pre-and post-transplantation,were included.These studies used validated tools such as the IIEF to measure EF.Meta-analyses were performed using a random-effects model to estimate standardized mean differences(SMD)and hazard ratios(HR)with 95%confidence intervals(CI).Heterogeneity was assessed using the I²statistic,and publication bias was evaluated with a funnel plot and the Egger’s test.RESULTS A total of 2419 studies were identified,with 362 abstracts screened and 193 full-text articles reviewed.Ultimately,11 studies were included for qualitative analysis and 7 for quantitative synthesis.The random effects model for SMD yielded a combined estimate of 0.43(95%CI:-0.20-1.07),indicating a small but non-significant improvement in EF post-transplantation.The heterogeneity across studies was substantial(I²=90%),reflecting significant variability in outcomes.Subgroup analysis showed greater improvements in EF among living-donor transplant recipients compared to those receiving organs from deceased donors.Despite this trend,the overall result for changes in EF was not statistically significant(P=0.15).Additionally,the combined HR from the meta-analysis was 2.87(95%CI:1.76-4.69),suggesting that KTx significantly increases the likelihood of improved EF,though variability between studies persisted(I²=63%).CONCLUSION While KTx offers some promise for improving EF in male ESRD patients,the overall evidence remains inconclusive due to high heterogeneity between studies and a lack of statistical significance in the combined results.Despite this,individual studies suggest that KTx may lead to significant improvements in EF for certain subgroups,particularly living-donor recipients.Future research should focus on larger,well-designed cohort studies with standardized outcome measures to provide more definitive conclusions.Addressing SexDys as part of routine care for ESRD patients undergoing KTx is crucial to improving their overall quality of life.However,adjunct therapies such as phosphodiesterase type 5 inhibitors may be necessary for those who do not experience adequate improvements post-transplantation.
文摘Previous published studies have shown an improvement of penile hemodynamic parameters after low-intensity extracorporeal shockwave therapy(Li-ESWT).However,the clinical significance of these findings remains unclear,and definitive selection criteria for Li-ESWT based on preexisting comorbidities have yet to be established.This was an observational study of 113 patients with ED,evaluated between January 2019 and December 2021 in Andrology Unit at the Department of Urology and Renal Transplantation,University of Foggia(Foggia,Italy).Penile dynamic Doppler was performed to evaluate vascular parameters and 5-item version of the International Index of Erectile Dysfunction(IIEF-5)questionnaire was administered to assess the severity of ED.This was repeated 1 month after treatment.Patients with a peak systolic velocity(PSV)<30 cm s−1 were considered eligible for Li-ESWT.Our protocol consisted of 8 weekly sessions with 1500 strokes distributed in 5 different locations along the penis.After treatment,a significant mean(±standard deviation[s.d.])PSV increase of 5.0(±3.4)cm s−1 was recorded and 52/113(46.0%)patients reached a PSV>30 cm s−1 at posttherapeutic penile dynamic Doppler.A clinically significant IIEF-5 score improvement was observed in 7 patients,21 patients,and 2 patients with mild-to-moderate,moderate,and severe pretreatment ED,respectively.No different outcomes were assessed based on smoking habits,previous pelvic surgery,or use of oral phosphodiesterase-5 inhibitor(PDE5i).On the other side,only 1(6.7%)in 15 patients with diabetes mellitus showed an IIEF-5 score improvement after Li-ESWT.Shockwave treatment determined a significant increase in PSV and correlated IIEF-5 improvement in ED patients.This advantage seemed particularly evident for moderate ED and was not affected by smoking habits,previous pelvic surgery,and use of PDE5i.Conversely,diabetic patients did not benefit from the treatment.
文摘Sexual dysfunction(SD)is a prevalent but very commonly ignored aspect in the treatment of liver diseases and cirrhosis.The etiology of SD is multifactorial and therefore treatment strategies are complex,especially in females.Phosphodiesterase inhibitors are useful and effective in erectile dysfunction in males but in females,no single drug is available for SD,therefore multimodal treatment is required depending upon the cause.The foremost and fundamental requirement in both genders is to be stress-free and have adequate control of liver diseases.Improved quality of life is helpful in improving SD and vice versa is also true.Therefore,patients suffering from liver diseases should come forward and ask for treatment for SD,and physicians should actively enquire about SD while history taking and evaluating these patients.SD results in deterioration of quality of life,and both are modifiable and treatable aspects of liver diseases,which are never addressed actively,due to social taboos and fears of SD treatment in the presence of liver diseases.The diagnosis of SD does not require costly investigations,as the diagnosis can be established based on validated questionnaires available for both genders,therefore detailed targeted history taking using questionnaires is essential.Data are emerging in this area but is still at an early stage.More studies should be dedicated to SD in liver diseases.
文摘Background: Sexual 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. Objective: The aim of this study was to examine the effects of KaempMaxTM, an ethanol extract of the K. parvi]lora rhizome, on erectile function in healthy middle-aged and older men. Design, setting, participants and interventions: We 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 pre- scription treatments. Participants took 100 mg KaempMaxTM daily for 30 days. Main outcome measures: Evaluations 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. Results: Thirteen participants completed the 30-day study. Supplementation with KaempMaxTM resulted in statistically significant improvements in erectile function, intercourse satisfaction and total scores on the IIEF questionnaire. KaempMaxTM was well tolerated and exhibited an excellent safety profile. Conclusion: Our results suggest that KaempMaxTM 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 med- ication, most participants found them satisfactory. Additional, longer and placebo-controlled clinical tri- als will be needed. Trial registration: Clinicaltrials.gov identifier Ncr03389867.