Physical activity and PDE5 inhibitors in the treatment of erectile dysfunction: results of a randomized controlled study. Phosphodiesterase inhibitors in the treatment of erectile dysfunction in spinal cord-injured men Rho Inhibitor VX-210 in Acute Traumatic Subaxial Cervical Spinal Cord Injury: Design of the SPinal Cord Injury Rho INhibition InvestiGation (SPRING) Clinical Trial Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. Efficacy and safety of tadalafil for erectile dysfunction in patients with multiple sclerosis. 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 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 Erectile dysfunction as a predictor of cardiovascular events and death in diabetic patients with angiographically proven asymptomatic coronary artery disease: a potential protective role for statins and 5-phosphodiesterase inhibitors. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Efficacy and safety of tadalafil in men with erectile dysfunction following spinal cord injury. A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose,Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Up-titration of vardena fi l dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury. The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction. A 6-month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction Quality of life in patients with spinal cord injury receiving VIAGRA® (sildenafil citrate) for the treatment of erectile dysfunction A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. Sexual counseling improved erectile rehabilitation after non-nerve-sparing radical retropubic prostatectomy or cystectomy--results of a randomized prospective study.
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 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 Abstract Traumatic spinal cord injury ( SCI ) is associated with a lifetime of disability stemming from loss of motor , sensory , and autonomic functions ; these losses , along with increased comorbid sequelae , negatively impact health outcomes and quality of life . Early decompression surgery post-SCI can enhance patient outcomes , but does not directly facilitate neural repair and regeneration . Currently , there are no U.S. Food and Drug Administration – approved pharmacological therapies to augment motor function and functional recovery in individuals with traumatic SCI . After an SCI , the enzyme , Rho , is activated by growth-inhibitory factors and regulates events that culminate in collapse of the neuronal growth cone , failure of axonal regeneration , and , ultimately , failure of motor and functional recovery . Inhibition of Rho activation is a potential treatment for injuries such as traumatic SCI . VX-210 , an investigational agent , inhibits Rho . When administered extradurally after decompression ( corpectomy or laminectomy ) and stabilization surgery in a phase 1/2a study , VX-210 was well tolerated . Here , we describe the design of the SPRING trial , a multicenter , phase 2b/3 , r and omized , double-blind , placebo-controlled clinical trial to evaluate the efficacy and safety of VX-210 ( NCT02669849 ) . A subset of patients with acute traumatic cervical SCI is currently being enrolled in the United States and Canada .  Medical , neurological , and functional changes are evaluated at 6 weeks and at 3 , 6 , and 12 months after VX-210 administration . Efficacy will be assessed by the primary outcome measure , change in upper extremity motor score at 6 months post-treatment , and by secondary outcomes that include question -based and task-based evaluations of functional recovery 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 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 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 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 OBJECTIVES We sought to investigate whether erectile dysfunction ( ED ) is a predictor of future cardiovascular events and death in diabetic patients with silent coronary artery disease ( CAD ) and whether there are predictors of cardiovascular events and death among CAD diabetic patients with ED . BACKGROUND Case-control studies showed that ED is associated with CAD in diabetic patients , but no prospect i ve study is available . METHODS Type 2 diabetic men ( n = 291 ) with silent CAD angiographically documented were recruited .  Erectile dysfunction  was assessed by the International Index Erectile Function-5 question naire .  RESULTS During a follow-up period of 47.2 + /- 21.8 months ( range 4 to 82 months ) , 49 patients experienced major adverse cardiac events ( MACE ) . The difference in ED prevalence between patients with and those without MACE was significant ( 61.2 % vs. 36.4 % ; p = 0.001 ) . Cox regression analysis showed that ED predicted MACE ( hazard ratio [ HR ] 2.1 ; 95 % confidence interval [ CI ] 1.6 to 2.6 ; p < 0.001 ) . Among patients with CAD and ED , the Kaplan-Meier method showed that the statin ( Mantel log-rank test : 3.921 ; p = 0.048 ) and 5-phosphodiesterase ( 5-PDE ) inhibitor use ( Mantel log-rank test : 4.608 ; p = 0.032 ) were associated with a lower rate of MACE . Cox regression analysis showed that statin use ( HR 0.66 ; 95 % CI 0.46 to 0.97 ; p = 0.036 ) reduced MACE . Treatment with 5-PDE inhibitors did not enter the model , but its p value was very near to the significant level ( HR 0.68 ; 95 % CI 0.46 to 1.01 ; p = 0.056 ) . CONCLUSIONS Our data first show that ED is a powerful predictor of cardiovascular morbidity and mortality in diabetic patients with silent CAD and that the treatment with statins and 5-PDE inhibitors might reduce the occurrence of MACE among CAD diabetic patients with ED BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology . Current analyses were based on 17 clinical trials of tadalafil . Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies . CONCLUSIONS The context ualization of treatment-related changes in terms of clinical ly relevant improvement is essential to underst and ing treatment efficacy , to interpreting results across studies , and to managing patients effectively . This analysis provides , for the first time , anchor-based estimates of MCIDs in the EF domain score of the IIEF OBJECTIVE To determine the efficacy and safety of tadalafil when taken on dem and by men with erectile dysfunction ( ED ) secondary to traumatic spinal cord injury ( SCI ) . DESIGN AND SETTING Multicenter , r and omized , double-blind , placebo-controlled , flexible dose-titration , parallel-group study in clinical practice s in Europe . Patients Enrolled patients had ED secondary to SCI ( all spinal levels ) and sustained 6 months or longer before visit 1 . INTERVENTIONS After a 4-week run-in period , patients were r and omly assigned to tadalafil , 10 mg , ( n = 142 ) or placebo  ( n = 44 ) for a 12-week , on-dem and treatment period with assessment s at 4-week intervals . The dose of tadalafil was maintained or titrated ( 10 or 20 mg ) at 4 and 8 weeks . MAIN OUTCOME MEASURES Efficacy was measured using the International Index of Erectile Function ( IIEF ) , Sexual Encounter Profile ( SEP ) , and Global Assessment Question ( GAQ ) . Treatment-emergent adverse events and vital signs were collected at each visit . RESULTS Mean age was 38 years .  Mean baseline IIEF erectile function domain score was 13.4 , and following 12 weeks of treatment , 22.6 for tadalafil and 13.6 for placebo ( P < .001 ) . After treatment , the tadalafil group compared with the placebo group was significantly greater ( P < .001 ) in mean per-patient percentage of successful penetration attempts ( SEP question 2 ; 75.4 % vs 41.1 % ) and intercourse attempts ( SEP question 3 ; 47.6 % vs 16.8 % ) ; percentage of improved erections ( GAQ question 1 ; 84.6 % vs 19.5 % ) ; and ejaculatory frequency ( IIEF question 9 ; P = .03 ) . The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache ( 8.5 % vs 4.5 % ) and urinary tract infection ( 7.7 % vs 6.8 % ) . CONCLUSIONS Tadalafil ( 10 mg and 20 mg ) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI Abstract Background / objective : To show the efficacy , safety , and tolerability of sildenafil in men with erectile dysfunction ( ED ) associated with complete or incomplete spinal cord injury ( SCI ) and to assess its effects on quality of life ( Qol ) using the Life-Satisfaction Check List . Methods : This was a placebo-controlled , multicenter , r and omized , double-blind , flexible-dose , 2-way crossover study with a 2-week washout period between each phase . Patients with ED attributable to SCI(Sexual Health Inventory-Male score ≤21 ) received 50 to 100 mg sildenafil ( n = 24 ) or placebo ( n = 26 ) . Results : Compared with placebo , sildenafil produced higher levels of successful sexual stimulation , intercourse success , satisfaction with sexual life and sexual relationship , erectile function , overall sexual satisfaction , and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score , with no clinical ly relevant effects onvital signs . Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI , producing significant improvements , compared with placebo , in a number of measures only in patients with incomplete SCI . All patients who expressed a preference selected sildenafil over placebo , although the drug had no effect on patient Qol .  Sildenafil was well tolerated , with a profile comparable to that of placebo . Conclusions : Compared with placebo , treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI , especially in those with incomplete injury , and was theagent of choice in those who expressed a preference AIM Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction ( ED ) . Efficacy of vardenafil has been demonstrated in various ED population s , but that in Japanese patients with spinal cord injury ( SCI ) has not been assessed . METHODS This was an open-label , multicenter , flexible dose , 12-week study in patients with ED due to SCI . Following a 4-week observation period , patients received vardenafil 10 mg for 4 weeks , and based on efficacy , tolerability and patient preference , doses for the remaining 8 weeks were decided by investigators . The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function . RESULTS Ten patients took 10 mg all through the study , while 22 patients took 20 mg after completing 4 weeks ' treatment with 10 mg . The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward ( LOCF ) in the former group and from 10.3 to 22.5 in the latter group , respectively . Importantly , there was a 5.0 point increase in erectile function domain score after up-titration in the latter group . Drug-related adverse events were observed in 22 % of patients including hot flushes ( 9 % ) and headache ( 6 % ) , but these were transient and mild in intensity . Serious adverse events and adverse events leading to discontinuation of the study drug were not reported . CONCLUSIONS Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI . Of interest , erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg 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 Abstract Background : Erectile dysfunction ( ED ) negatively impacts quality of life .  Phosphodiesterase type 5 inhibitors ( PDE5Is ) are effective in treating ED ; however , rates of discontinuation remain high . Objectives : To assess on-dem and PDE5I treatment persistence and adherence through 6 months in Middle Eastern and North African ( MENA ) men with ED in a prospect i ve , non-interventional , observational trial . Research design and methods : Enrolled men were ≥18 years old from Saudi Arabia , Egypt , and the United Arab Emirates , PDE5I naïve , and sexually active .  PDE5Is were selected per routine clinical practice . Persistence was defined as use of ≥1 dose during the prior 4 weeks , adherence as compliance with dosing instructions during the most recent dose . Logistic regression models were used to identify factors associated with persistence and adherence . Main outcome measures : Persistence and Adherence Question naire ; Partner Relationship Question naire ; Self-Esteem and Relationship Question naire ; International Index of Erectile Function ( IIEF ) ; Erectile Dysfunction Inventory of Treatment Satisfaction . Results : Patients ’ ( n = 493 ) mean age was 49.8 years , mean BMI was 29.3 , and the majority ( n = 354 , 71.8 % ) were from Saudi Arabia .  Tadalafil was the most prescribed PDE5I ( 69.6 % ) , versus sildenafil ( 15.4 % ) , or vardenafil ( 15.0 % ) . Patients ’ mean IIEF – Erectile Function scores improved from moderate to mild and Erection Hardness Scores ( SD ) improved from 1.8 ( 1.0 ) at baseline to 3.5 ( 0.7 ) at 6 months . At 6 months , 64.9 % of patients were treatment persistent ( tadalafil , 68.8 % , sildenafil , 65.8 % , and vardenafil , 45.9 % ) and 59.6 % were adherent . Factors significantly predictive ( p < 0.05 ) of persistence at 6 months included age , employment status , and ED severity . Factors significantly predictive of adherence were age , employment status , and duration of ED . Interpretation of differences between drugs was limited by substantial differences in prescription rates between countries . Conclusions : At 6 months , 64.9 % of men were treatment persistent . In this study , age , employment status , ED severity , and duration of ED were associated with persistence and /or adherence Study design : A multicenter , r and omized , double-blind , placebo-controlled , flexible-dose , two-way crossover study conducted June 1996 through January 1997 . Objectives : To evaluate the effect of sildenafil citrate ( VIAGRA ® ) on the quality of life ( QoL ) of men with erectile dysfunction ( ED ) caused by spinal cord injury ( SCI ) . Setting : Study centers in Australia , Belgium , France , Germany , Norway , Sweden and the United Kingdom . Methods : Questions 13 and 14 of the 15-item International Index of Erectile Function ( IIEF ) addressed QoL issues directly related to ED in 178 men with SCI . A 5-item question naire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments , including the Medical Outcomes Survey ( MOS ) Short Form-12 , Psychological General Well-Being Index , and MOS Family Survey , assessed general QoL issues . Results : Significant improvements were seen for overall satisfaction with sex life ( IIEF Q13 ) , sexual relationship with partner ( IIEF Q14 ) , and concerns about erectile problems ( P<0.0001 ) . Improvements were reported in scores for the generic QoL parameters of mental health , well-being , depression , and anxiety ( P<0.05 sildenafil versus placebo ) . Conclusion : Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.Sponsorship : This study was funded by Pfizer Multiple lines of evidence have vali date d the Rho pathway as important in controlling the neuronal response to growth inhibitory proteins after central nervous system ( CNS ) injury . A drug called BA-210 ( trademarked as Cethrin ( ® ) ) blocks activation of Rho and has shown promise in pre- clinical animal studies in being used to treat spinal cord injury ( SCI ) . This is a report of a Phase I/IIa clinical study design ed to test the safety and tolerability of the drug , and the neurological status of patients following the administration of a single dose of BA-210 applied during surgery following acute SCI . Patients with thoracic ( T2-T12 ) or cervical ( C4-T1 ) SCI were sequentially recruited for this dose-ranging ( 0.3 mg to 9 mg Cethrin ) , multi-center study of 48 patients with complete American Spinal Injury Association assessment ( ASIA ) A. Vital signs ; clinical laboratory tests ; computed tomography ( CT ) scans of the spine , head , and abdomen ; magnetic resonance imaging ( MRI ) of the spine , and ASIA assessment were performed in the pre- study period and in follow-up periods out to 1 year after treatment . The treatment-emergent adverse events that were reported were typical for a population of acute SCI patients , and no serious adverse events were attributed to the drug . The pharmacokinetic analysis showed low levels of systemic exposure to the drug , and there was high inter-patient variability . Changes in ASIA motor scores from baseline were low across all dose groups in thoracic patients ( 1.8±5.1 ) and larger in cervical patients ( 18.6±19.3 ) . The largest change in motor score was observed in the cervical patients treated with 3 mg of Cethrin in whom a 27.3±13.3 point improvement in ASIA motor score at 12 months was observed . Approximately 6 % of thoracic patients converted from ASIA A to ASIA C or D compared to 31 % of cervical patients and 66 % for the 3-mg cervical cohort . Although the patient numbers are small , the observed motor recovery in this open-label trial suggests that BA-210 may increase neurological recovery after complete SCI . Further clinical trials with Cethrin in SCI patients are planned , to establish evidence of efficacy AIM The efficacy of prostagl and in E1 (PGE1)-intracavernous injection ( ICI ) therapy for erectile dysfunction ( ED ) after non-nerve-sparing ( NNS ) radical pelvic surgery depends on patient compliance . The purpose of this study was to verify the utility of sexual counseling in ICI in terms of treatment efficacy , compliance , and dropout rate . METHODS In this prospect i ve r and omized study , 57 patients with ED after NNS radical prostatectomy or cystectomy were divided : 29 patients ( group SC+ ) were treated with sexual counseling and PGE1-ICI therapy ; the others 28 ( group SC- ) were treated with only ICI . At the start of the study all patients were administered the International Index of Erectile Function ( IIEF ) question naire and ICI training test ; follow-up ( at 3 , 6 , 9 , 12 , 18 months ) was achieved by home Sildenafil test and ambulatory IIEF test ; sexual counseling was provided only to group SC+ . RESULTS The mean IIEF score at the end of study was 26.5 ( SC+ ) vs. 24.3 ( SC- ) ( P < 0.05 ) ; eight patients ( SC+ , 27.5 % ) became responders to home Sildenafil vs. five ( SC- , 17.8 % ) ( P < 0.05 ) ; no dropout cases occurred ( SC+ ) vs. eight ( SC- , 28.5 % ) ( P < 0.05 ) . Moreover , we recorded best IIEF scores in group SC+ in sexual satisfaction ( P < 0.05 ) , sexual desire ( P < 0.05 ) , orgasmic function , and general satisfaction . Mean PGE1 doses were better in group SC+ ( P < 0.05 ) . ICI-oriented sexual counseling was utilized to motivate couples , to improve sexual intercourses , to correct mistakes in ICI administration . At the end of follow-up 21 patients ( SC+ ) declared themselves satisfied vs. 12 ( SC- ) . CONCLUSIONS ICI-oriented sexual counseling in ICI increased the efficacy of treatment , the compliance , and Sildenafil responders rate , decreased the dropout rate
Conclusions : This systematic review and meta- analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo , as measured by response to GEQ , SEP2 , SEP3 and incidence of adverse events .
PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI
Study design : Systemic review Objective : We carried out a systematic review and meta- analysis to assess the efficacy and safety of phosphodieterase-5 ( PDE5 ) inhibitors on erectile dysfunction ( ED ) secondary to spinal cord injury ( SCI ) .