Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. Efficacy and safety of tadalafil for erectile dysfunction in patients with multiple sclerosis. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. Effects of three-times-per-week versus on-demand tadalafil treatment on erectile function and continence recovery following bilateral nerve sparing radical prostatectomy: results of a prospective, randomized, and single-center study. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: a multicenter, randomized, double-blind, placebo-controlled clinical trial. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy The multinational Men's Attitudes to Life Events and Sexuality (MALES) Study Phase II: understanding PDE5 inhibitor treatment seeking patterns, among men with erectile dysfunction. The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction. Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan. Efficacy and tolerability of udenafil in Turkish men with erectile dysfunction of psychogenic and organic aetiology: a randomized, double‐blind, placebo‐controlled study Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study). Phosphodiesterase inhibitors in the treatment of erectile dysfunction in spinal cord-injured men Physical activity and PDE5 inhibitors in the treatment of erectile dysfunction: results of a randomized controlled study. Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: a phase II clinical trial. Effects of daily low-dose treatment with phosphodiesterase type 5 inhibitor on cognition, depression, somatization and erectile function in patients with erectile dysfunction: a double-blind, placebo-controlled study Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study.
INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least " better " using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs.  placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated INTRODUCTION Data are sparse concerning the effects of phosphodiesterase type 5 ( PDE5 ) inhibitors for erectile dysfunction ( ED ) in subjects with multiple sclerosis ( MS ) . AIM To evaluate the efficacy and safety of tadalafil use in subjects with ED because of MS . METHODS Ninety-six MS patients with ED after a 4-week treatment-free period were given tadalafil  10 mg . All patients were re-evaluated after 4 weeks . Those with a score lower than 26 on the International Index of Erectile Function ( IIEF-15 ) and with less than 75 % of total successful sexual attempts assessed by the Sexual Encounter Profile Questions 2 and 3 ( SEP2 - 3 ) had their dosage of tadalafil increased to 20 mg , whereas responding subjects continued with 10 mg . Subsequently , all patients had a final follow-up visit after 8 weeks . MAIN OUTCOME MEASURES SEP2 - 3 , IIEF-15 question naire . The Life Satisfaction Checklist ( LSC ) question naire composed of eight questions was used prior to starting tadalafil and at the end of the 12-week treatment . RESULTS Ninety-two subjects completed the study . Seventy-two responded , 30 of whom used 10 mg . Two subjects discontinued the therapy because of moderate side effects : one suffered from headache and one from tachycardia . Responding patients reached a significant statistical improvement in all follow-ups compared with baseline on the erectile domain and overall sexual satisfaction scores of the IIEF-15 using the Wilcoxon test P < 0.01 . Furthermore , they showed statistical improvement through the Wilcoxon test P < 0.01 on the sexual life , family life , and partner relationship questions of the LSC compared with baseline . CONCLUSION Tadalafil is an effective and safe treatment for males with MS suffering from ED . Further studies are needed on MS patients to evaluate the efficacy and safety of long-term use , and to detect predictable parameters for the success of PDE5 inhibitors INTRODUCTION An optimal outcome of an erectile dysfunction ( ED ) treatment is to enable a return to normal erectile function ( as defined by an International Index of Erectile Function-Erectile Function [ IIEF-EF ] domain score ≥ 26 ) . As-needed ( PRN ) phosphodiesterase type 5 ( PDE5 ) inhibitor treatment does not always result in a return-to-normal erectile function . AIM The combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment . METHODS Men were ≥ 18 years of age , sexually active , reported a ≥ 3-month history of ED , and had been taking the maximum dose of sildenafil citrate , vardenafil , or tadalafil PRN . R and omization to once-daily therapy with tadalafil 2.5 mg to 5 mg ( N = 207 ) , tadalafil 5 mg ( N = 207 ) , or placebo  ( N = 209 ) for 12 weeks followed a 4-week maximum dose PRN PDE5 treatment and 4-week nondrug lead periods . Two identical double-blind , r and omized , placebo-controlled studies were conducted ; combined results are reported . MAIN OUTCOME MEASURE The main outcome measure was the percentage of subjects with a return-to-normal erectile function ( IIEF-EF domain score ≥ 26 ) when treated with tadalafil once daily compared with placebo . RESULTS In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor , a higher percentage of subjects treated with tadalafil  had an IIEF-EF domain score ≥ 26 at end point ( tadalafil 2.5- to 5-mg group [ 39 % ] ; tadalafil 5-mg group [ 40 % ] ) compared with the placebo group ( 12.1 % ; P < 0.001 ) . Tadalafil was generally well tolerated and adverse events observed were consistent with previous reports of tadalafil once daily . CONCLUSIONS Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment Abstract Background : Phosphodiesterase type 5 ( PDE5 ) inhibitors have discontinuation rates as high as 60 % in men with erectile dysfunction . Treatment satisfaction has been significantly associated with treatment continuation . Underst and ing key characteristics in terms of treatment preference , relationship , and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally . Objective : The objective was to identify subgroups of interest in the pooled data base of two observational studies conducted in Latin America ( LA ) and Middle East/North Africa ( MENA ) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline . Methods : Two identical prospect i ve , non-interventional , observational , studies in MENA ( N = 493 ) and LA ( N = 511 ) treated men with an ‘ on dem and ’ ( pro re nata , PRN ) PDE5 inhibitor ( sildenafil , tadalafil , vardenafil , or lodenafil ) during 6 months . In this post-hoc meta- analysis of two observational studies with equal design , pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations , satisfaction , self-esteem , and patient – partner relationships . Decision tree analyses , with and without weighting , were used to identify and describe key features . Results : In each analysis of patient expectations , patient – partner relationship , and self-esteem , we describe the two major subgroups at baseline for each decision tree . Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors ( 59 % ) highlighted the importance of treatment effect duration , second to partner satisfaction with treatment , while patients prescribed short-acting PDE5 inhibitors ( 32 % ) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion . Further insights regarding patients , partner relationship characteristics , and treatment expectations were identified . Conclusion : Our analyses have described key characteristics , such as self- and partner perceptions , sexual attitudes , and treatment expectations in relation to the patients ’ country and prescribed treatment , which might guide treatment decisions in MENA and LA men with ED INTRODUCTION Alpha1-blockers ( AB ) are the first-line monotherapy for lower urinary tract symptoms ( LUTS ) .  Phosphodiesterase type 5 ( PDE5 ) inhibitors are the first-line treatment for erectile dysfunction ( ED ) . Numerous studies have supposed a significant association between ED and LUTS , but a causal relationship can not be established . AIM The aim was to evaluate the efficacy of a combined therapy with an AB ( alfuzosin ) and PDE5 inhibitors ( tadalafil ) in patients with LUTS and ED . METHODS This was a r and omized , open-label , three-arm study . A total of 66 men complaining of ED and LUTS were included in the study . Patients were assessed at baseline and after 12 weeks of study treatment , and then underwent r and omized allocation to either alfuzosin 10 mg once a day ( 22 patients ) or tadalafil 20 mg on alternative days ( 21 patients ) , or a combination of both ( 23 patients ) . MAIN OUTCOME MEASURES All participants completed the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) and the International Prostatic Symptom Score ( IPSS ) . Other efficacy variables included maximum urinary flow rate ( Qmax ) and medium urinary flow rate ( Qave ) . RESULTS IIEF-EF tended to improve with alfuzosin alone ( + 15 % ) , while it was clearly improved with tadalafil alone ( + 36.3 % ) . The greatest improvement was experienced with the combination therapy ( + 37.6 % ) . Improvement in Qmax was observed in all groups , but patients receiving combination therapy had greater improvement ( 29.6 % ) than patients receiving either only alfuzosin ( 21.7 % ) or only tadalafil ( 9.5 % ) . IPSS was significantly improved in alfuzosin group ( 27.2 % ) , was more marked with the combination therapy ( 41.6 % ) , and a small increase , although not significant , was also observed with tadalafil ( 8.4 % ) . CONCLUSIONS Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores . A significant improvement was also observed in quality of life assessment s. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED , although present , were smaller Erectile dysfunction ( ED ) and urinary incontinence after bilateral nerve-sparing radical prostatectomy ( BNSRP ) still remain major causes of morbidity . Phosphodiesterase type 5 inhibitors ( PDE5-Is ) have a role in the treatment of ED after BNSRP . Several studies in patients with ED and lower urinary tract symptoms demonstrated that PDE5-Is could improve both erectile function and urinary symptoms . The aim of this study was to compare the efficacies of two dosing regimens of 20 mg tadalafil ( on-dem and and 3 times per week ) and to assess the role of tadalafil in recovery of erectile function and continence after BNSRP . We conducted a single-center , prospect i ve , r and omized controlled trial of three times per week versus on-dem and tadalafil 20 mg and a control group after BNSRP . A total of 129 preoperatively potent and continent patients were included in the study . The patients were evaluated at 6 weeks and 12 months postoperatively for erectile function and continence status . There was no significant difference between all three groups with respect to erectile function at 6 weeks after the surgery . Twelve months after the surgery , the International Index of Erectile Function score was significantly higher in the group using tadalafil 20 mg three times per week . However , there was no significant difference between the treated groups and the control group with respect to the continence status at 12 months after the surgery . There was no correlation between incontinence and ED after the surgery in all groups . Tadalafil 20 mg three times per week is an efficacious and well-tolerated treatment option for ED after BNSRP . Treatment with 20 mg tadalafil either three times per week or on dem and can not improve continence recovery after BNSRP compared with the control group BACKGROUND To date , no data have been available from large , well- design ed trials comparing on dem and and nightly dosing of phosphodiesterase type 5 ( PDE5 ) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction ( ED ) . OBJECTIVE To investigate the effect of early postoperative dosing with vardenafil , administered either nightly or on dem and , compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy ( NSRP ) surgery . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , double-dummy , multicentre , parallel group study conducted at 87 centres across Europe , Canada , South Africa , and the United States . For inclusion , patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain ( IIEF-EF ) score of > or = 26 at screening . A total of 628 men , aged 18 - 64 yr , were r and omised to treatment . Study design consisted of a 9-mo double-blind treatment period , a 2-mo single-blind washout period , and an optional 2-mo open-label period . INTERVENTION Patients received placebo , nightly vardenafil , or on dem and vardenafil . MEASUREMENTS Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or = 22 after the 2-mo washout period . Secondary variables included mean per-patient success rates for Sexual Encounter Profile ( SEP ) questions 2 and 3 . RESULTS AND LIMITATIONS No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or = 22 or in SEP3 success rates after the washout period . On-dem and vardenafil treatment result ed in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period . CONCLUSIONS In this study of men with ED following bilateral NSRP , vardenafil was efficacious when used on dem and , supporting a paradigm shift towards on dem and dosing with PDE5 inhibitors in this patient group . TRIAL REGISTRATION European clinical trials data base ( EudraCT ; available at http://eudract.emea.europa.eu/ ) . TRIAL REGISTRATION NUMBER 11336 Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction ( ED ) . Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 ( PDE5 ) therapy prefer tadalafil 20-mg ( on-dem and ) versus sildenafil 100-mg ( on-dem and ) . Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil . This open-label , r and omized , crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy . Eligible patients were r and omized to sequential 20-mg tadalafil/100-mg sildenafil ( n = 190 ) or 100-mg sildenafil/20-mg tadalafil ( n = 193 ) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase . Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale ( PAIRS ) , Drug Attributes Question naire ( DRAQ ) , and Sexual Life Quality Question naire ( SLQQ ) . When taking tadalafil versus sildenafil , men had a higher mean endpoint score on the PAIRS Spontaneity Domain  ( tadalafil = 2.86 vs sildenafil = 2.72 ; P < 0.001 ) , and a lower mean endpoint score on the Time Concerns Domain ( tadalafil = 2.41 vs sildenafil = 2.55 ; P < 0.001 ) . A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil ( tadalafil = 2.76 vs sildenafil = 2.72 ; P = 0.102 ) . The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug , and ability to get an erection every time . SLQQ results were comparable between treatment groups . These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial INTRODUCTION Mirodenafil is a newly developed selective phosphodiesterase type 5 ( PDE5 ) inhibitor for the treatment of erectile dysfunction ( ED ) . AIM To evaluate the efficacy , safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes . METHODS A multicenter , r and omized , double-blind , placebo-controlled , parallel-group , fixed-dose study was conducted with 112 subjects who were r and omized to either placebo or mirodenafil 100 mg on dem and for 12 weeks . MAIN OUTCOME MEASURES Primary efficacy variable was the erectile function ( EF ) domain scores of the International Index of Erectile Dysfunction ( IIEF ) question naire . Secondary efficacy variables included change in the scores of IIEF question 3 and 4 ( IIEF Q3 and Q4 ) from baseline , change in all domain scores in the IIEF from baseline , Sexual Encounter Profile questions 2 and 3 ( SEP2 and SEP3 ) , the Global Assessment Question ( GAQ ) and the Life Satisfaction Checklist ( LSC ) . RESULTS After 12 weeks of treatment , mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group ( 9.3 vs. 1.4 , P < 0.0001 ) . The changes from baseline in the mirodenafil group in IIEF Q3 ( 1.7 vs. 0.4 , P < 0.0001 ) and Q4 ( 1.7 vs. 0.3 , P < 0.0001 ) were higher compared with the placebo group . Differences between the mirodenafil and placebo groups were significant in the SEP2 ( 82.0 % vs. 55.2 % , P = 0.0003 ) , SEP3 ( 68.9 % vs. 22.3 % , P < 0.0001 ) . Difference in GAQ " YES " responses was also significant ( 76.9 % vs. 19.1 % , P < 0.0001 ) . Normal EF domain scores ( ≥ 26 ) at study end were achieved by 32.7 % and 9.4 % in the mirodeniafl and placebo groups , respectively ( P = 0.0031 ) . As for the LSC scores , the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group . Most treatment-associated AEs were mild that resolved spontaneously . CONCLUSIONS Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea AIM To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day ( OaD ) vs. tadalafil 20 mg or sildenafil 100 mg as needed ( pro re nata [ PRN ] ) in patients with erectile dysfunction ( ED ) . METHODS A r and omized , open-label , crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 ( PDE5 ) inhibitor PRN . Data were analyzed with a mixed effects model for crossover design . MAIN OUTCOME MEASURES The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales ( PAIRS ) between tadalafil OaD and sildenafil PRN . SECONDARY OUTCOMES INCLUDED : Time Concerns and Spontaneity domains of PAIRS , and the Self-Esteem and Relationship ( SEAR ) scale . RESULTS Men naive to tadalafil OaD were enrolled ( N = 378 ) , with 61 - 69 % prior PDE5 inhibitor use . There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN ( P < 0.001 ) . The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD , 0.5 ± 0.72 for tadalafil PRN , and 0.39 ± 0.67 for sildenafil PRN . The difference in least-squares mean was 0.12 ± 0.04 ( confidence interval [ CI ] = 0.04 , 0.19 ; P = 0.001 ) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 ( CI = -0.06 , 0.08 ; P = 0.872 ) between tadalafil OaD and tadalafil PRN . The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN ( P < 0.001 ) . There were no differences in SEAR scores between treatments . CONCLUSIONS Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence , Time Concerns , and Spontaneity . There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN . Changes in SEAR , the erectile function domain of the International Index of Erectile Function , and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar The study was to compare treatment preference , efficacy , and tolerability of sildenafil citrate ( sildenafil ) and tadalafil for treating erectile dysfunction ( ED ) in Chinese men naοve to phosphodiesterase 5 ( PDE5 ) inhibitor therapies .  This multicenter , r and omized , open-label , crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil . After a 4 weeks baseline assessment , 383 eligible patients were r and omized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension . Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Question naire ( PITPQ ) . Secondary efficacy was analyzed by PITPQ Question 2 , the International Index of Erectile Function ( IIEF ) erectile function ( EF ) domain , sexual encounter profile ( SEP ) Questions 2 and 3 , and the Drug Attributes Question naire . Three hundred and fifty men ( 91 % ) completed the r and omized treatment phase . Two hundred and forty-two per 350 ( 69.1 % ) patients preferred 20-mg tadalafil , and 108/350 ( 30.9 % ) preferred 100-mg sildenafil ( P < 0.001 ) as their treatment in the 8 weeks extension . Ninety-two per 242 ( 38 % ) patients strongly preferred tadalafil and 37/108 ( 34.3 % ) strongly the preferred sildenafil . The SEP2 ( penetration ) , SEP3 ( successful intercourse ) , and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups . For patients who preferred tadalafil , getting an erection long after taking the medication was the most reported reason for tadalafil preference . The only treatment-emergent adverse event reported by > 2 % of men was headache . After tadalafil and sildenafil treatments , more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil . Both sildenafil and tadalafil treatments were effective and safe OBJECTIVE The aim of Phase II of the Men 's Attitudes to Life Events and Sexuality ( MALES ) Study is to explore PDE5 inhibitor treatment seeking among men with erectile dysfunction ( ED ) . METHODS Phase II of the MALES study involved 2,912 men , aged 20 - 75 years , from 8 countries ( U.S. , U.K. , Germany , France , Italy , Spain , Mexico , and Brazil ) , who reported ED . Participants were recruited from the MALES Phase I sample [ 1 ] and via booster methods ( e.g. , physician referral , street interception ) , and completed self-report question naires concerning the characteristics of their ED , their efforts to seek PDE5 inhibitor treatment for their sexual dysfunction , and attitudinal and referent influences that potentially affect treatment-seeking . Statistical analyses focus on identification of correlates of PDE5 inhibitor treatment seeking . RESULTS PDE5 inhibitor utilization is strongly associated with ED sufferers ' assessment of the severity of their sexual dysfunction , with their belief that medication for ED is dangerous , and with their perceptions of whether physicians , other professionals , and spouses or family members are supportive of their seeking treatment . ED sufferers who evaluate their sexual dysfunction as severe , who believe that medication for ED is not dangerous , and who perceive support for treatment seeking from referent others , are more likely to utilize PDE5 inhibitor treatment . CONCLUSION Findings indicate that perceived ED severity , beliefs about ED medication , and referent influences are strongly correlated with utilization of PDE5 inhibitor therapy . These findings aid our underst and ing of factors that may incline men with ED to seek-or to avoid-PDE5 inhibitor therapy for their sexual dysfunction , and provide a basis for clinical and educational interventions to assist men with ED to seek appropriate treatment INTRODUCTION Udenafil is a potent selective phosphodiesterase type 5 ( PDE5 ) inhibitor newly developed for the treatment of erectile dysfunction ( ED ) . AIM This study was performed to evaluate the efficacy and safety of udenafil therapy in patients with ED . METHODS In this multicenter , double-blind , placebo-controlled , fixed-dose , parallel-group phase III trial , 167 patients with ED of diverse origin and severity were r and omized to take placebo or udenafil at fixed doses of 100 or 200 mg as needed for 12 weeks . MAIN OUTCOME MEASURES Primary efficacy variable was change from baseline in erectile function ( EF ) domain scores of the International Index of Erectile Dysfunction ( IIEF ) question naire . Secondary efficacy variables include change from baseline in scores on the IIEF Questions 3 and 4 ( IIEF Q3 and Q4 ) , change from baseline in all domain scores of the IIEF , patients ' responses to questions 2 and 3 of the Sexual Encounter Profile ( SEP2 and SEP3 ) , and patients ' responses to the Global Assessment Question ( GAQ ) . Any adverse events were also recorded during the trial . RESULTS After 12 weeks of treatment , the patients treated with udenafil showed significantly greater change from baseline in the IIEF-EF domain score compared with placebo ( placebo , 0.20 ; 100-mg udenafil , 7.52 ; and 200-mg udenafil , 9.93 , respectively ) ( P < 0.0001 ) . Compared with placebo , udenafil significantly enhanced the rates of successful penetration ( SEP Q2 ) and maintenance of erection ( SEP Q3 ) ( P < 0.0001 ) . Furthermore , significantly greater proportions of udenafil treatment groups responded positively to the GAQ compared with the placebo group ( GAQ : placebo , 25.9 % ; 100-mg udenafil , 81.5 % ; and 200-mg udenafil , 88.5 % , respectively ) ( P < 0.0001 ) . Treatment-related adverse events were generally mild to moderate with facial flushing and headache being the most common . CONCLUSIONS Udenafil is an effective and well-tolerated therapy for ED of broad-spectrum etiology and severity AIM Vardenafil is a selective and highly potent phosphodiesterase type 5 ( PDE5 ) inhibitor for the treatment of erectile dysfunction ( ED ) , with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED . The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED . METHODS This was a prospect i ve , double blind , r and omized clinical trial design ed to evaluate the efficacy and safety of vardenafil . Following a 4-week treatment-free observation period , 283 eligible patients were r and omized to 12 weeks treatment with vardenafil 5 mg , 10 mg , 20 mg , or placebo . Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function ( IIEF ) . RESULTS All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF question naire , either at 12 weeks or at the ' last observation carried forward ' ( LOCF , P < 0.0001 ) . Q3 scores were improved to 4.06 with vardenafil 5 mg , 4.53 with vardenafil 10 mg , and 4.64 with vardenafil 20 mg , versus 3.17 with placebo . Comparable scores for Q4 were 3.47 , 4.15 and 4.31 versus 2.31 for placebo . Up to 86 % of patients achieved improved erections as assessed by the global assessment question ( GAQ ) . Reported adverse event rates were 35.3 % , 45.3 % and 54.5 % with vardenafil 5 mg , 10 mg and 20 mg , respectively , versus 21.1 % in the placebo group . No serious adverse drug reactions were reported . The most common treatment-emergent adverse events were transient headache , flushing and rhinitis , which were mostly mild . CONCLUSION Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED . The results of our trial show that up to nearly 90 % of patients achieve improved erections with the administration of vardenafil Udenafil is a potent phosphodiesterase type‐5 inhibitor ( PDE5 ) previously shown in studies conducted in population s of Eastern‐Asian ethnicity , to significantly improve sexual function , in addition to a favourable safety profile . The purpose of this study was to evaluate the efficacy and safety of udenafil for the treatment of erectile dysfunction ( ED ) , for the first time in a non‐Eastern‐Asian population . In this multicentre , r and omized , double‐blind , parallel , placebo‐controlled  study conducted in five centres in Turkey , 118 eligible subjects were r and omized to receive udenafil 100 mg taken as on‐dem and or matching placebo for an 8‐week treatment period . The primary efficacy variable was the change from baseline of the International Index of Erectile Function Question naire – Erectile Function Domain ( IIEF – EFD ) score , secondary efficacy variables were changes from baseline in IIEF Question naire Domains ' 2–5 scores ( Intercourse Satisfaction , Orgasmic Function , Sexual Desire , Overall Sexual Satisfaction ) and IIEF Question naire Gr and Total score , changes from baseline in penetration success rates ( SEP2 ) and intercourse completion rates ( SEP3 ) and evaluation of responses to the global assessment question ( GAQ ) . Patients treated with udenafil demonstrated significantly higher increase in the IIEF – EFD scores compared with placebo‐treated subjects [ 4.0 ( 95 % CI : 1.3–6.6 ; p = 0.003 ) ] . Similarly , greater improvements were observed in the scores for SEP2 [ 0.65 ( 95 % CI : 0.02–1.3 , p = 0.043 ) ] , SEP3 [ 0.9 ( 95 % CI : 0.3–1.5 , p = 0.003 ) ] and two other IIEF Question naire Domains ( Domain 4 : Sexual Desire , Domain 5 : Overall Sexual Satisfaction ) . The proportion of positive responses to the GAQ was greater in the udenafil compared to the placebo group ( 72.2 % vs. 49.1 % , p = 0.014 ) . The most frequent treatment‐emergent adverse events were headache , flushing and rhinorrhea , all of mild or moderate severity . This is the first study to demonstrate in a non‐Eastern‐Asian population  that udenafil 100 mg taken as on‐dem and can effectively improve erectile function and is well tolerated INTRODUCTION Addition of testosterone ( T ) may improve the action of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels . AIMS To confirm this add-on effect of T in men optimally treated with PDE5-Is  and to specify the baseline T levels at which such an effect becomes significant . METHODS A multicenter , multinational , double-blind , placebo-controlled study of 173 men , 45 - 80 years , nonresponders to treatment with different PDE5-Is , with baseline total T levels ≤ 4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day ( OAD ) for 4 weeks ; if not successful , they were r and omized in a double-blind , placebo-controlled design to receive placebo or a 1 % hydroalcoholic T gel ( 50 mg/5 g gel ) , to be increased to 10 mg T if results were clinical ly unsatisfactory . Main Outcomes Measures . Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses ( Sexual Encounter Profile 3 question ) . RESULTS Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups . In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL , no additional effect of T administration to men optimally treated with PDE5-Is was encountered . The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤ 3 ng/mL. CONCLUSIONS The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks . Furthermore , addition of T to this PDE5-I regimen is beneficial , but only in hypogonadal men with baseline T levels ≤ 3 Study design : Open , before – after study . Objective : To assess the efficacy and safety of phosphodiesterase type 5 ( PDE5 ) inhibitors for erectile dysfunction ( ED ) in spinal cord-injured ( SCI ) patients . Setting : Home- and clinic-based assessment s in the outpatient department at the Centre Bouffard Vercelli , Cerbère France . Methods : Clinic trials with Sildenafil ( Viagra ® )  on 120 patients , Tadalafil ( Cialis ® ) on 54 patients and Vardenafil ( Levitra ® ) on 66 patients were performed . Flexible doses of PDE5 inhibitors were given depending on efficacy and tolerability , from 50 to 100 mg for Sildenafil , and from 10 to 20 mg for Vardenafil and Tadalafil . Each trial was performed after a week 's interval . The efficacy was self-assessed by the patients on a six-point quantitative scale assessment . The response to treatment was assessed at home in 90 patients ( 57 patients on Sildenafil , 12 patients on Vardenafil and 21 patients on Tadalafil )  using the International Index of Erectile Function ( IIEF ) . Results : In clinic trials , PDE5 inhibitors were effective ( rigidity enough for penetration ) in 85 % of the patients on Sildenafil , 74 % of the patients on Vardenafil and 72 % of the patients on Tadalafil .  The mean duration of erection was 34 , 28 and 26 min , respectively . Adverse effects were mild , usually attenuated with continued dosing . More than 70 % of the patients on Vardenafil and Tadalafil required higher doses of 20 mg , whereas 50 mg of Sildenafil was effective in 55 % of the patients . Two-thirds of our patients on Tadalafil reported a duration of action longer than 24 h. The presence of an upper motor neuron lesion was significantly associated with therapeutic success , lower motor neuron lesions and cauda equina patients were poor responders . Other variables such as completeness of lesion had no impact . In the follow-up visits , the IIEF global scores and three IIEF domains ( erectile function , intercourse satisfaction and overall satisfaction ) were significantly improved in all patients . Patients on Sildenafil showed a significant improvement of orgasmic function , ejaculation ( Question 9 ) and orgasm ( Question 10 ) . Conclusion : Sildenafil , Vardenafil and Tadalafil are all effective and well-tolerated treatments for ED in SCI patients . Although no statistical analysis could be applied on these data , these results might indicate that Sildenafil is more effective in treating ED . Clinic trials are important for proper dose titration and appropriate education of the patients INTRODUCTION Physical activity ( PhA ) has proven to be a protective factor for normal erectile function in numerous epidemiological studies . AIM The aim of this study was to establish if PhA could have a therapeutic role in the treatment of  erectile dysfunction ( ED ) . METHODS This was a r and omized , open-label study . A total of 60 patients complaining of ED were studied . Patients were assessed at baseline and after 3 months of study treatment . At baseline , patients were r and omized to receive phosphodiesterase type 5 inhibitor ( PDE5i ) alone ( group A ) or PDE5i plus regular ( ≥3 hours/week ) , aerobic , non-agonistic PhA ( group B ) . MAIN OUTCOME MEASURES All subjects completed the International Index of Erectile Function ( IIEF-15 ) question naire and performed total testosterone ( TT ) . RESULTS Mean PhA was 3.4 hours/week in group B vs. 0.43 in group A ; mean energy expenditure in group B was 1,868 kcal/ week or 22.8 metabolic equivalent (MET)/week . IIEF restoration of ED occurred in 77.8 % ( intervention group ) vs. 39.3 % ( control ) ( P < 0.004 ) . The IIEF-15 score result ed in statistical improvement in intervention group in all the domains but one ( orgasm ) : erectile function 24.7 vs. 26.8 ( P = 0.003 ) ; confidence ( Q15 ) 3.53 vs. 4.07 ( P = 0.006 ) ; sexual desire 6.46 vs. 7.18 ( P = 0.028 ) ; intercourse satisfaction 9.85 vs. 11.25 ( P = 0.001 ) ; total satisfaction 7.17 vs. 8.07 ( P = 0.009 ) ; total score 56.2 vs. 61.07 ( P = 0.007 ) . TT was statistically similar in the two groups ; separate analysis in each group showed statistical increase in group B 4.24 vs. 4.55 ( P = 0.012 ) . At multivariate logistic regression analysis , PhA was the only independent variable for normal erection ( P = 0.010 ) ( 95 % confidence interval [ CI ] 0.036 - 0.643 ) , higher sexual satisfaction ( P = 0.022 ) ( 95 % CI 0.084 - 0.821 ) and normal total IIEF-15 score ( P = 0.023 ) ( 95 % CI 0.85 - 0.837 ) . CONCLUSION In this r and omized controlled pilot study , PDE5i plus PhA was more effective than PDE5i alone in the treatment of ED INTRODUCTION Mirodenafil is a newly developed oral phosphodiesterase type 5 inhibitor , currently under investigation as a treatment for erectile dysfunction ( ED ) . AIM We investigated the efficacy and safety of on dem and mirodenafil therapy at fixed doses ( 50 and 100 mg ) in Korean men with a broad range of ED . METHODS A multicenter , r and omized , double-blind , placebo-controlled , parallel-group , fixed-dose study was conducted with 223 subjects who were r and omized to placebo or mirodenafil at fixed doses of 50 or 100 mg for 12 weeks on an " as needed " basis . MAIN OUTCOME MEASURES Primary efficacy measures were scores on the International Index of Erectile Function ( IIEF ) Question 3 ( Q3 ) and Question 4 ( Q4 ) . Secondary efficacy measures included all domain scores of the IIEF , Sexual Encounter Profile Question 2 ( SEP2 ) , Sexual Encounter Profile Question 3 ( SEP3 ) , the Global Assessment Question ( GAQ ) , and the Life Satisfaction Checklist ( LSC ) . Safety assessment s included laboratory tests , vital signs , physical examination , 12-lead electrocardiogram recordings , and patients ' reporting of adverse events . RESULTS Mirodenafil 50 and 100 mg groups showed a significantly greater increase in IIEF Q3 ( P = 0.0001 , P < 0.0001 , respectively ) and Q4 scores ( both P < 0.0001 ) at the end point compared with the placebo group . And mirodenafil in both doses significantly improved the scores of all five domains of the IIEF , SEP2 , and SEP3 as well as the percentages of patients responding positively to the GAQ compared with the placebo group . As for LSC scores , the two mirodenafil groups showed significantly greater improvements in items regarding life as a whole , sexual life , and partner relationship than the placebo group . Most treatment-associated adverse events were of mild intensity , resolving spontaneously . CONCLUSIONS Mirodenafil , in doses of 50 or 100 mg , significantly improved erectile function and were well tolerated in a representative population of Korean men with broad-spectrum ED of various etiologies and severities Sildenafil ( Viagra , UK-92,480 ) is a novel oral agent under development for the treatment of  penile erectile dysfunction .  Erection is dependent on nitric oxide and its second messenger , cyclic guanosine monophosphate ( cGMP ) . However , the relative importance of phosphodiesterase ( PDE ) isozymes is not clear . We have identified both cGMP- and cyclic adenosine monophosphate-specific phosphodiesterases ( PDEs ) in human corpora cavernosa in vitro . The main PDE activity in this tissue was due to PDE5 , with PDE2 and 3 also identified . Sildenafil is a selective inhibitor of PDE5 with a mean IC50 of 0.0039 microM. In human volunteers , we have shown sildenafil to have suitable pharmacokinetic and pharmacodynamic properties ( rapid absorption , relatively short half-life , no significant effect on heart rate and blood pressure ) for an oral agent to be taken , as required , prior to sexual activity . Moreover , in a clinical study of 12 patients with erectile dysfunction without an established organic cause , we have shown sildenafil to enhance the erectile response ( duration and rigidity of erection ) to visual sexual stimulation , thus highlighting the important role of PDE5 in human penile erection . Sildenafil holds promise as a new effective oral treatment for penile erectile dysfunction INTRODUCTION Oral treatment with phosphodiesterase type 5 inhibitor ( PDE5 ) is considered the first-line treatment for patients with erectile dysfunction ( ED ) .  Lodenafil carbonate ( LC ) is a novel PDE5 . AIM This is a phase II , prospect i ve , r and omized , double-blind , and placebo controlled clinical trial of LC . MAIN OUTCOME MEASURES Efficacy end points were International Index of Sexual Function ( IIEF ) erectile domain , IIEF questions 3 and 4 , and Sexual Encounter Profile ( SEP ) questions 2 and 3 , before and after the use of LC or placebo . METHODS Seventy-two men older than 18 years , with ED for at least 6 months with stable sexual relationship were enrolled . Patients were r and omized to placebo or LC 80 mg , 40 mg , or 20 mg and followed for 4 weeks . RESULTS IIEF erectile domain scores before and after the use of medications were ( mean + /- st and ard deviation [ SD ] ) : placebo : 11.9 + /- 3.4 and 12.6 + /- 5.5 ; LC 20 mg : 15.8 + /- 4.1 and 18.9 + /- 6.6 ; LC 40 mg : 11.9 + /- 4.4 and 15.4 + /- 8.1 ; LC 80 mg : 14.2 + /- 4.7 and 22.8 + /- 6.0 ( ANOVA P < 0.01 ) . The SEP-2 scores before and after the use of medications were ( Mean + /- SD ) : placebo : 71.0 + /- 33.1 and 51.2 + /- 43.1 ; LC 20 mg 70.3 + /- 34.2 and 75.5 + /- 31.5 ; LC 40 mg : 48.4 + /- 42.1 and 60.8 + /- 42.5 ; LC 80 mg : 68.6 + /- 33.5 and 89.6 + /- 26.0 . The SEP-3 scores were : placebo 23.3 + /- 27.6 and 33.6 + /- 42.3 ; LC 20 mg : 32.3 + /- 38.9 and 51.2 + /- 41.7 ; LC 40 mg : 39.7 + /- 44.7 and 46.7 + /- 41.1 ; LC 80 mg * 17.2 + /- 29.5 and 74.3 + /- 36.4 ( * P < 0.05 for difference to placebo ) . CONCLUSIONS The drug was well tolerated . Adverse reactions were mild and self-limited and included headache , rhinitis , flushing , color visual disorders , and dyspepsia . This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated Phosphodiesterase type 5 ( PDE5 ) inhibitors have recently been shown to have cognitive-enhancing effects in animal models and in our previous pilot study . To investigate the efficacy of daily low-dose treatment with a PDE5 inhibitor on cognitive function , depression and somatization in patients with erectile dysfunction ( ED ) , 8-week , double-blind , placebo-controlled study enrolled 60 male patients with ED for ≥3 months without cognitive impairment . Forty-nine patients completed the study . Patients were r and omized to receive either daily low-dose udenafil 50 mg or placebo for 2 months . The International Index of Erectile Function-5 ( IIEF-5 ) , the Korean version of the Mini-Mental State Examination ( K-MMSE ) for general cognitive function and the Seoul Neuropsychological Screening Battery for comprehensive neuropsychological examination , the Physical Health Question naire-9 ( PHQ-9 ) for depression and the Physical Health Question naire-15 ( PHQ-15 ) for somatization were administered at baseline and at 2 months . The change in the mean IIEF-5 was significantly higher in the udenafil group than the placebo group ( 6.08±4.72 vs 2.20±3.50 , P=0.008 ) . The changes in the PHQ-9 and PHQ-15 were −2.04±3.14 and −2.17±2.87 in the udenafil group , and 1.20±1.63 and 0.56±2.48 in the placebo group ( both , P<0.001 ) . The changes in the K-MMSE and Digit Span Forward were 1.25±1.26 and 0.92±1.02 in the udenafil group , and −0.52±1.19 and −0.24±1.13 in the placebo group ( both , P<0.001 ) . However , there were no differences in the other neuropsychological tests . Daily dosing with a PDE5 inhibitor seems to improve cognitive function , depression and somatization , as well as erectile function , in patients with ED INTRODUCTION There is partial evidence to support the use of phophodiesterase-5 inhibitor ( PDE5-I ) for the treatment of  premature ejaculation ( PE ) . AIM We compared on-dem and dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction ( ED ) . METHODS Our prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial enrolled 118 subjects with lifelong PE without ED . PE was diagnosed using Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision . Patients were divided into two groups : dapoxetine 30 mg plus placebo ( group A , n=56 ) and dapoxetine 30 mg plus mirodenafil 50 mg ( group B , n=62 ) . MAIN OUTCOME MEASURES During 12 weeks , intravaginal ejaculatory latency time ( IELT ) and the time from foreplay to beginning intercourse ( FTIT ) with a stopwatch , and Premature Ejaculation Profile ( PEP ) were measured . Overall sexual act time ( OSAT ; sum of FTIT and IELT ) was calculated . Any treatment-emergent adverse events ( TEAEs ) were also recorded . RESULTS Over 12 weeks , IELT , OSAT , and PEP index score significantly improved in group B compared with group A ( increased geometric mean IELT in group A and B=3.6 and 6.1 minutes , P=0.026 ; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes , P=0.012 ; increased median PEP index score in group A and B=1.0 and 1.3 , P=0.046 ) . However , there was no significant difference between two groups with respect to improvement of FTIT ( P=0.147 ) . TEAEs did not differ between groups ( all P>0.05 ) , and there was no serious adverse event in any subjects . CONCLUSIONS Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT , OSAT , and PEP index score , and similar TEAEs , compared with that of dapoxetine only . Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED
The results of the included studies are inconclusive , though they show a trend towards a larger effect of combined treatment compared with PI or PDE5-I treatment alone .
The meta- analysis found that , overall , combined treatment was more efficacious for ED symptoms than PDE5-I treatment or PI alone .
Combined treatment was more efficacious than PDE5-I use alone on sexual satisfaction .
No differences were found between PDE5-Is and PI as st and -alone treatments .
The combination of PI and PDE5-Is is a promising strategy for a favorable outcome in ED and can be considered as a first-choice option for ED patients .
INTRODUCTION Erectile dysfunction ( ED ) is an increasing health problem that dem and s effective treatment .
There is evidence that phosphodiesterase-5 inhibitors ( PDE5-Is ) and psychological intervention ( PI ) are effective treatment options ; however , little is known about their comparative efficacy and the efficacy of combined treatments .
AIM The aim of this systematic review and meta- analysis is to evaluate the comparative efficacy of PI , PDE5-Is , and their combination in the treatment of ED .
MAIN OUTCOME MEASURES Primary outcome was ED symptoms , and secondary outcome was sexual satisfaction of the patient .