human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Purpose . To compare erectile function ( EF ) recovery of patients treated by early penile rehabilitation therapy ( PRT ) with sildenafil and with control group . Method . Forty men treated by bilateral nerve sparing radical prostatectomy ( NSRP ) and with a normal pre-operative EF were enrolled . Fourteen days after surgery , they were r and omised to a flexible-dose sildenafil group and to a control group . The International Index of Erectile Function ( IIEF ) question naire was completed before surgery and at 3 , 6 , 12 and 24 weeks after NSRP . Results . In the group treated , the mean IIEF score before surgery was 26.2 and 14.1 , 16.2 , 22.5 and 25.2 at 3 , 6 , 12 and 24 weeks after NSRP , respectively . In the control group , the respective scores were 26.5 and 12.4 , 15.8 , 15.3 and 17.4 . There was a significant difference in IIEF mean score ( 25 ± 6 vs. 17 ± 9 , p < 0.05 ) and in the potency rate ( 87 % vs. 56 % ) between the groups at 24 weeks after NSRP . The percentage of patients who were capable of having medication-unassisted intercourse was 54 % vs. 21 % ; 34 % vs. 18 % of patients had a normal EF with 72 % vs. 32 % of responders to sildenafil . Conclusions . PRT with PDE-5 inhibitors should be offered early after RP to allow the recovery of EF Four weeks after bilateral nerve-sparing radical retropubic prostatectomy , men with normal erectile function before surgery were r and omized to double-blind sildenafil ( 50 or 100 mg ) or placebo nightly for 36 weeks , followed by an 8-week drug-free period before assessment of erectile function . Enrollment was prematurely ceased and only 76 men completed because , assuming a placebo response rate similar to the published literature ( for example , 34 % in meta- analysis ) , the 25 % response at blinded interim review suggested a lack of treatment effect . On the contrary , spontaneous erectile function ( a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘ Were erections good enough for satisfactory sexual activity ? ’ ) occurred in only 4 % of the placebo group ( n=1 of 25 ) versus 27 % ( n=14 of 51 , P=0.0156 , Fisher 's exact test ) of the sildenafil group . Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections BACKGROUND The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors ( PDE5-Is ) on penile function after nerve-sparing radical prostatectomy ( NSRP ) remains unclear . OBJECTIVE The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on dem and versus placebo taken over 9 mo in improving unassisted erectile function ( EF ) following NSRP , as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain ( IIEF-EF ) score ≥ 22 after 6-wk drug-free washout ( DFW ) . Secondary measures included IIEF-EF , Sexual Encounter Profile question 3 ( SEP-3 ) , and penile length . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , double-dummy , placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate ( Gleason ≤ 7 ) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada . INTERVENTIONS 1:1:1 r and omisation to 9 mo of treatment with tadalafil 5 mg once daily , tadalafil 20 mg on dem and , or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily ( all patients ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Logistic regression , mixed-effects model for repeated measures , and analysis of covariance , adjusting for treatment , age , and country , were applied to IIEF-EF scores ≥ 22 , SEP-3 , and penile length . RESULTS AND LIMITATIONS Four hundred twenty-three patients were r and omised to tadalafil once daily ( n=139 ) , on dem and ( n=143 ) , and placebo ( n=141 ) . The mean age was 57.9 yr of age ( st and ard deviation : 5.58 yr ) ; 20.9 % , 16.9 % , and 19.1 % of patients in the tadalafil once daily , on dem and , and placebo groups , respectively , achieved IIEF EF scores ≥ 22 after DFW ; odds ratios for tadalafil once daily and on dem and versus placebo were 1.1 ( 95 % confidence interval [ CI ] , 0.6 - 2.1 ; p=0.675 ) and 0.9 ( 95 % CI , 0.5 - 1.7 ; p=0.704 ) . At the end of double-blind treatment ( EDT ) , least squares ( LS ) mean IIEF-EF score improvement significantly exceeded the minimally clinical ly important difference ( MCID : ΔIIEF-EF ≥ 4 ) in both tadalafil groups ; for SEP-3 ( MCID ≥ 23 % ) , this was the case for tadalafil once daily only . Treatment effects versus placebo were significant for tadalafil once daily only ( IIEF-EF : p=0.016 ; SEP-3 : p=0.019 ) . In all groups , IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment . At month 9 ( EDT ) , penile length loss was significantly reduced versus placebo in the tadalafil once daily group only ( LS mean difference 4.1 mm ; 95 % CI , 0.4 - 7.8 ; p=0.032 ) . CONCLUSIONS Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP , and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes . Unassisted EF was not improved after cessation of active therapy for 9 mo . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01026818 PURPOSE We evaluated the safety and efficacy of 100 and 200 mg avanafil for the treatment of adult males with erectile dysfunction after bilateral nerve sparing radical prostatectomy . MATERIAL S AND METHODS This was a double-blind , placebo controlled , parallel group , phase 3 study in males age 18 to 70 years with a history of erectile dysfunction of 6 months or more after bilateral nerve sparing radical prostatectomy . Patients were r and omized to 100 or 200 mg avanafil or placebo ( taken 30 minutes before sexual activity ) for 12 weeks . Primary end points included successful vaginal insertion ( Sexual Encounter Profile [ SEP ] question 2 ) , successful intercourse ( SEP3 ) and change in score on the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) question naire . RESULTS A total of 298 patients were r and omized and 84.6 % completed the study . At baseline 16.1 % were age 65 years or older and 71.5 % had severe erectile dysfunction  ( mean overall IIEF-EF domain score 9.2 ) . After 12 weeks there were significantly greater increases in SEP2 and SEP3 and change in mean IIEF-EF domain score with 100 and 200 mg avanafil vs placebo ( p < 0.01 ) . Following dosing with avanafil 36.4 % ( 28 of 77 ) of sexual attempts ( SEP3 ) at 15 minutes or less were successful vs 4.5 % ( 2 of 44 ) for placebo ( p < 0.01 ) . Avanafil was generally well tolerated . No serious adverse events were reported and fewer than 2 % of patients discontinued the study due to an adverse event . CONCLUSIONS Avanafil in 100 and 200 mg doses was effective and well tolerated in improving erectile function after prostatectomy . Results suggest a rapid onset of action and sustained duration of effect , with all 3 primary end points being achieved at both dose levels PURPOSE We evaluated the efficacy and safety of tadalafil 20 mg , taken on dem and , in men with erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy ( BNSRRP ) . MATERIAL S AND METHODS This r and omized , double-blind , placebo controlled multicenter study consisted of a 4-week treatment-free run-in period ( baseline ) followed by 12 weeks of treatment . A total of 303 men ( mean age 60 years ) with preoperative normal erectile function who had undergone a BNSRRP 12 to 48 months before study were r and omized ( 2:1 ) to tadalafil ( 201 ) or placebo ( 102 ) . The 3 co- primary end points were changes from baseline in the International Index of Erectile Function erectile function domain score , and the percentage of positive responses to Sexual Encounter Profile questions 2 ( successful penetration ) and 3 ( successful intercourse ) . The Global Assessment Question and the Erectile Dysfunction Inventory of Treatment Satisfaction question naire were secondary end points . We defined a priori a subgroup of 201 patients reporting evidence of postoperative tumescence , defined as 50 % or greater " yes " responses to Sexual Encounter Profile question 1 ( ability to achieve at least some erection ) during baseline intercourse attempts and stratified r and omization based on this criterion . RESULTS Patients receiving tadalafil reported greater improvement on all primary and secondary end points ( p < 0.001 ) compared to placebo . For all r and omized patients and for the subgroup with evidence of postoperative tumescence , the mean International Index of Erectile Function erectile function domain score increased for patients receiving tadalafil ( mean + /- SEM 5.3 + /- 0.5 and 5.9 + /- 0.7 , respectively , p < 0.001 vs placebo for both ) . For all r and omized patients who received tadalafil , the mean percentage of successful penetration attempts was 54 % and the mean percentage of successful intercourse attempts was 41 % . For the subgroup with evidence of postoperative tumescence these values were 69 % and 52 % , respectively . Of all patients r and omized to tadalafil 62 % and of the subgroup patients r and omized to tadalafil 71 % reported improved erections . Patients receiving tadalafil reported greater treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction than those receiving placebo .  Headache ( 21 % ) , dyspepsia ( 13 % ) and myalgia ( 7 % ) were the most commonly reported adverse events . CONCLUSIONS Tadalafil 20 mg , taken on-dem and , was an efficacious and well tolerated treatment for erectile dysfunction following BNSRRP OBJECTIVE To evaluate the change in penile size r bilateral nerve sparing retropubic radical prostatectomy ( BNSRRP ) and possible effect of Tadalafil . MATERIAL S AND METHODS A total of 65 patients underwent BNSRRP and they were evaluated prospect ively for a whole year of follow-up . The patients were r and omized to control without rehabilitation ( Group 1 ) or Tadalafil rehabilitation group ( Group 2 ) . The patients were evaluated at months 3 , 6 and 12 postoperatively for erectile function , penile measurements ( flaccid penile length , penile length at maximum erection , penile circumference at flaccid status , and penile circumference at maximum erection ) , penile abnormalities and general health status . Statistical analysis was performed by Chi-Square test and significance was defined as p value < 0.05 . RESULTS In Group 1 there was significant decrease in penile measurements at month 3 compared to preoperative measurements . There was decrease in all parameters at month 6 compared to month 3 but only the decrease in penile length at maximum erection was significant . There were no significant differences between postoperative months 6 and 12 for all measurements . In Group 2 there was a tendency to decrease in all measurements at month 3 compared to baseline . There was no significant difference for penile measurements between postoperative 3rd and 6th months and between 6th month and the first year . CONCLUSION Although further large sample d trials are needed to describe the possible positive effect of tadalafil or other PDE5-I 's on penile size after BNSRRP , tadalafil rehabilitation is effective in preserving penile size especially in the early postoperative period after BNSRRP OBJECTIVE To examine the preference for 2 dosing regimens ( on dem and or 3 times/week ) for tadalafil , a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction ( ED ) . DESIGN AND METHODS SURE is a 14 European country , multicenter , crossover , and open-label study 
    Output:
    
agent
By network meta- analysis , sildenafil seems to be the most efficiency with a slightly higher rate of treatment-emergent adverse events ( TEATs ) , whereas tadalafil had the lowest TEATs .
Compared with placebo , PDE5-Is manifested significantly improved treatment outcomes .
Overall , regular regimen demonstrated statistically pronounced better potency than on-dem and .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Purpose . To compare erectile function ( EF ) recovery of patients treated by early penile rehabilitation therapy ( PRT ) with sildenafil and with control group . Method . Forty men treated by bilateral nerve sparing radical prostatectomy ( NSRP ) and with a normal pre-operative EF were enrolled . Fourteen days after surgery , they were r and omised to a flexible-dose sildenafil group and to a control group . The International Index of Erectile Function ( IIEF ) question naire was completed before surgery and at 3 , 6 , 12 and 24 weeks after NSRP . Results . In the group treated , the mean IIEF score before surgery was 26.2 and 14.1 , 16.2 , 22.5 and 25.2 at 3 , 6 , 12 and 24 weeks after NSRP , respectively . In the control group , the respective scores were 26.5 and 12.4 , 15.8 , 15.3 and 17.4 . There was a significant difference in IIEF mean score ( 25 ± 6 vs. 17 ± 9 , p < 0.05 ) and in the potency rate ( 87 % vs. 56 % ) between the groups at 24 weeks after NSRP . The percentage of patients who were capable of having medication-unassisted intercourse was 54 % vs. 21 % ; 34 % vs. 18 % of patients had a normal EF with 72 % vs. 32 % of responders to sildenafil . Conclusions . PRT with PDE-5 inhibitors should be offered early after RP to allow the recovery of EF Four weeks after bilateral nerve-sparing radical retropubic prostatectomy , men with normal erectile function before surgery were r and omized to double-blind sildenafil ( 50 or 100 mg ) or placebo nightly for 36 weeks , followed by an 8-week drug-free period before assessment of erectile function . Enrollment was prematurely ceased and only 76 men completed because , assuming a placebo response rate similar to the published literature ( for example , 34 % in meta- analysis ) , the 25 % response at blinded interim review suggested a lack of treatment effect . On the contrary , spontaneous erectile function ( a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘ Were erections good enough for satisfactory sexual activity ? ’ ) occurred in only 4 % of the placebo group ( n=1 of 25 ) versus 27 % ( n=14 of 51 , P=0.0156 , Fisher 's exact test ) of the sildenafil group . Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections BACKGROUND The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors ( PDE5-Is ) on penile function after nerve-sparing radical prostatectomy ( NSRP ) remains unclear . OBJECTIVE The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on dem and versus placebo taken over 9 mo in improving unassisted erectile function ( EF ) following NSRP , as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain ( IIEF-EF ) score ≥ 22 after 6-wk drug-free washout ( DFW ) . Secondary measures included IIEF-EF , Sexual Encounter Profile question 3 ( SEP-3 ) , and penile length . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , double-dummy , placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate ( Gleason ≤ 7 ) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada . INTERVENTIONS 1:1:1 r and omisation to 9 mo of treatment with tadalafil 5 mg once daily , tadalafil 20 mg on dem and , or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily ( all patients ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Logistic regression , mixed-effects model for repeated measures , and analysis of covariance , adjusting for treatment , age , and country , were applied to IIEF-EF scores ≥ 22 , SEP-3 , and penile length . RESULTS AND LIMITATIONS Four hundred twenty-three patients were r and omised to tadalafil once daily ( n=139 ) , on dem and ( n=143 ) , and placebo ( n=141 ) . The mean age was 57.9 yr of age ( st and ard deviation : 5.58 yr ) ; 20.9 % , 16.9 % , and 19.1 % of patients in the tadalafil once daily , on dem and , and placebo groups , respectively , achieved IIEF EF scores ≥ 22 after DFW ; odds ratios for tadalafil once daily and on dem and versus placebo were 1.1 ( 95 % confidence interval [ CI ] , 0.6 - 2.1 ; p=0.675 ) and 0.9 ( 95 % CI , 0.5 - 1.7 ; p=0.704 ) . At the end of double-blind treatment ( EDT ) , least squares ( LS ) mean IIEF-EF score improvement significantly exceeded the minimally clinical ly important difference ( MCID : ΔIIEF-EF ≥ 4 ) in both tadalafil groups ; for SEP-3 ( MCID ≥ 23 % ) , this was the case for tadalafil once daily only . Treatment effects versus placebo were significant for tadalafil once daily only ( IIEF-EF : p=0.016 ; SEP-3 : p=0.019 ) . In all groups , IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment . At month 9 ( EDT ) , penile length loss was significantly reduced versus placebo in the tadalafil once daily group only ( LS mean difference 4.1 mm ; 95 % CI , 0.4 - 7.8 ; p=0.032 ) . CONCLUSIONS Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP , and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes . Unassisted EF was not improved after cessation of active therapy for 9 mo . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01026818 PURPOSE We evaluated the safety and efficacy of 100 and 200 mg avanafil for the treatment of adult males with erectile dysfunction after bilateral nerve sparing radical prostatectomy . MATERIAL S AND METHODS This was a double-blind , placebo controlled , parallel group , phase 3 study in males age 18 to 70 years with a history of erectile dysfunction of 6 months or more after bilateral nerve sparing radical prostatectomy . Patients were r and omized to 100 or 200 mg avanafil or placebo ( taken 30 minutes before sexual activity ) for 12 weeks . Primary end points included successful vaginal insertion ( Sexual Encounter Profile [ SEP ] question 2 ) , successful intercourse ( SEP3 ) and change in score on the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) question naire . RESULTS A total of 298 patients were r and omized and 84.6 % completed the study . At baseline 16.1 % were age 65 years or older and 71.5 % had severe erectile dysfunction  ( mean overall IIEF-EF domain score 9.2 ) . After 12 weeks there were significantly greater increases in SEP2 and SEP3 and change in mean IIEF-EF domain score with 100 and 200 mg avanafil vs placebo ( p < 0.01 ) . Following dosing with avanafil 36.4 % ( 28 of 77 ) of sexual attempts ( SEP3 ) at 15 minutes or less were successful vs 4.5 % ( 2 of 44 ) for placebo ( p < 0.01 ) . Avanafil was generally well tolerated . No serious adverse events were reported and fewer than 2 % of patients discontinued the study due to an adverse event . CONCLUSIONS Avanafil in 100 and 200 mg doses was effective and well tolerated in improving erectile function after prostatectomy . Results suggest a rapid onset of action and sustained duration of effect , with all 3 primary end points being achieved at both dose levels PURPOSE We evaluated the efficacy and safety of tadalafil 20 mg , taken on dem and , in men with erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy ( BNSRRP ) . MATERIAL S AND METHODS This r and omized , double-blind , placebo controlled multicenter study consisted of a 4-week treatment-free run-in period ( baseline ) followed by 12 weeks of treatment . A total of 303 men ( mean age 60 years ) with preoperative normal erectile function who had undergone a BNSRRP 12 to 48 months before study were r and omized ( 2:1 ) to tadalafil ( 201 ) or placebo ( 102 ) . The 3 co- primary end points were changes from baseline in the International Index of Erectile Function erectile function domain score , and the percentage of positive responses to Sexual Encounter Profile questions 2 ( successful penetration ) and 3 ( successful intercourse ) . The Global Assessment Question and the Erectile Dysfunction Inventory of Treatment Satisfaction question naire were secondary end points . We defined a priori a subgroup of 201 patients reporting evidence of postoperative tumescence , defined as 50 % or greater " yes " responses to Sexual Encounter Profile question 1 ( ability to achieve at least some erection ) during baseline intercourse attempts and stratified r and omization based on this criterion . RESULTS Patients receiving tadalafil reported greater improvement on all primary and secondary end points ( p < 0.001 ) compared to placebo . For all r and omized patients and for the subgroup with evidence of postoperative tumescence , the mean International Index of Erectile Function erectile function domain score increased for patients receiving tadalafil ( mean + /- SEM 5.3 + /- 0.5 and 5.9 + /- 0.7 , respectively , p < 0.001 vs placebo for both ) . For all r and omized patients who received tadalafil , the mean percentage of successful penetration attempts was 54 % and the mean percentage of successful intercourse attempts was 41 % . For the subgroup with evidence of postoperative tumescence these values were 69 % and 52 % , respectively . Of all patients r and omized to tadalafil 62 % and of the subgroup patients r and omized to tadalafil 71 % reported improved erections . Patients receiving tadalafil reported greater treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction than those receiving placebo .  Headache ( 21 % ) , dyspepsia ( 13 % ) and myalgia ( 7 % ) were the most commonly reported adverse events . CONCLUSIONS Tadalafil 20 mg , taken on-dem and , was an efficacious and well tolerated treatment for erectile dysfunction following BNSRRP OBJECTIVE To evaluate the change in penile size r bilateral nerve sparing retropubic radical prostatectomy ( BNSRRP ) and possible effect of Tadalafil . MATERIAL S AND METHODS A total of 65 patients underwent BNSRRP and they were evaluated prospect ively for a whole year of follow-up . The patients were r and omized to control without rehabilitation ( Group 1 ) or Tadalafil rehabilitation group ( Group 2 ) . The patients were evaluated at months 3 , 6 and 12 postoperatively for erectile function , penile measurements ( flaccid penile length , penile length at maximum erection , penile circumference at flaccid status , and penile circumference at maximum erection ) , penile abnormalities and general health status . Statistical analysis was performed by Chi-Square test and significance was defined as p value < 0.05 . RESULTS In Group 1 there was significant decrease in penile measurements at month 3 compared to preoperative measurements . There was decrease in all parameters at month 6 compared to month 3 but only the decrease in penile length at maximum erection was significant . There were no significant differences between postoperative months 6 and 12 for all measurements . In Group 2 there was a tendency to decrease in all measurements at month 3 compared to baseline . There was no significant difference for penile measurements between postoperative 3rd and 6th months and between 6th month and the first year . CONCLUSION Although further large sample d trials are needed to describe the possible positive effect of tadalafil or other PDE5-I 's on penile size after BNSRRP , tadalafil rehabilitation is effective in preserving penile size especially in the early postoperative period after BNSRRP OBJECTIVE To examine the preference for 2 dosing regimens ( on dem and or 3 times/week ) for tadalafil , a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction ( ED ) . DESIGN AND METHODS SURE is a 14 European country , multicenter , crossover , and open-label study 
    Output:
    