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: INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score  ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated PURPOSE We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment . MATERIAL S AND METHODS We performed a single center , r and omized , double-blind , placebo controlled trial in 25 patients with spinal cord injury who had erectile dysfunction and micturition disorders . A baseline urodynamic test was performed as well as a second urodynamic test 1 to 3 hours after the administration of 20 mg vardenafil and placebo in 15 and 10 cases , respectively . In all patients st and ard oral oxybutynin administration was not discontinued . Statistical assessment included the 3 urodynamic parameters maximum detrusor pressure during voiding , maximum cystometric capacity and detrusor overactivity volume . RESULTS Placebo administration did not affect urodynamic parameters . After vardenafil administration maximum detrusor pressure was significantly decreased ( 59.3 vs 52.1 cm H(2)O , p < 0.001 ) and maximum cystometric capacity considerably improved ( 233.5 vs 272 ml , p < 0.001 ) . The most dramatic variations were observed for detrusor overactivity volume ( 174 vs 218 ml , p < 0.0001 ) . In 7 patients with American Spinal Injury Association classification A and spinal cord injury above T6 we observed the most significant improvement in the evaluated urodynamic items , including maximum detrusor pressure 57 vs 52 cm H(2)O ( p = 0.039 ) , maximum cystometric capacity 253 vs 296 ml ( p = 0.004 ) and detrusor overactivity volume 177 vs 229 ml ( p = 0.003 ) . CONCLUSIONS This trial demonstrates that in spinal cord injured patients a single 20 mg vardenafil administration achieved a significant decrease in maximum detrusor pressure , an improvement in maximum cystometric capacity and a remarkable increase in detrusor overactivity volume value INTRODUCTION Lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) and erectile dysfunction are common disorders of advancing age . AIM To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH . METHODS In this prospect i ve r and omized study , 133 men complaining of LUTS due to BPH were included . Forty-five patients received tamsulosin 0.4 mg/day alone ( Group A ) , 44 patients received tadalafil 10 mg/day ( Group B ) , and combination therapy ( tamsulosin and tadalafil both ) was instituted in 44 patients ( Group C ) . After a 2-week medication free run-in period , they were evaluated for International Prostatic Symptom Score ( IPSS ) , International Index of Erectile Function score ( IIEF5 ) , quality of life ( IPSS QoL ) , maximum urinary flow rate ( Qmax ) , post-void residual urine ( PVR ) volume , and safety parameters before and at 3 months of treatment . MAIN OUTCOME MEASURES There were primary ( IPSS , IPSS QoL index , Qmax , and PVR ) and secondary ( erectile function [ EF ] domain scores from IIEF5 ) efficacy end points . Safety assessment included laboratory tests and patient 's reporting of adverse event . RESULTS A significant improvement in IPSS score was observed in all the 3 groups A , B , and C ( -50.90 % , P < 0.05 ; -33.50 % , P < 0.05 ; and -53.90 % , P < 0.05 , respectively ) . IIEF5 score increased significantly in these three groups ( + 39.28 % , P < 0.05 ; + 45.96 % , P < 0.05 ; and + 60.23 % , P < 0.05 , respectively ) . A significant increase in Qmax and decrease in PVR were also observed ( 33.99 % , P < 0.05 ; 29.78 % , P < 0.05 ; and 37.04 % , P < 0.05 ) and ( -60.90 % , P < 0.05 ; -49.45 % , P < 0.05 ; and -62.97 % , P < 0.05 , respectively ) . The QoL scores improved significantly ( -73.35 % , P < 0.05 ; -70.26 % , P < 0.05 ; and -79.65 % , P < 0.05 , respectively ) . Side effects were dyspepsia , heartburn , headache , flushing , myalgia , and backache . Adverse effect dropout was 3.7 % . No participant experienced any severe or serious adverse events . CONCLUSIONS In patients with LUTS due to BPH , tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS . Their EF also improves with these medications . The improvement is better with combination therapy compared with single agent alone PURPOSE Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia . We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international , placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS After a 4-week placebo lead-in period 1,500 men were r and omized to tadalafil 5 mg or placebo for 12 weeks . Data were analyzed using ANCOVA . Maximum urinary flow rate values were rank transformed for analysis . RESULTS Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197 .  Tadalafil 5 mg significantly increased maximum urinary flow vs placebo ( median 1.1 vs 0.4 ml per second , p = 0.003 ) . At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second ( p = 0.142 ) in 731 patients , at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second ( p = 0.011 ) in 428 , and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second ( p = 0.186 ) in 38 for placebo and tadalafil , respectively . The difference was 0.3 , 1.0 and 2.2 ml per second , respectively . At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second ( p = 0.246 ) , at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second ( p = 0.044 ) , and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second ( p = 0.189 ) for placebo and tadalafil , respectively . Tadalafil improved I-PSS ( International Prostate Symptom Score ) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups ( each p < 0.001 ) . CONCLUSIONS This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo . The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume PURPOSE Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction . We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction . MATERIAL S AND METHODS Four separate analyses used integrated data from 4 r and omized , double-blind , placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS ( International Prostate Symptom Score ) improvement was due to improvement in IIEF-EF ( International Index of Erectile Function-Erectile Function domain score ) . Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms . RESULTS A total of 1,496 men , of whom 77 % had erectile dysfunction , received at least 1 dose of tadalafil 5 mg once daily or placebo . The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 ( p < 0.0001 ) in total I-PSS vs -2.2 ( p = 0.0007 ) for men without erectile dysfunction . The correlation between change from baseline in total I-PSS and IIEF-EF was weak ( r(2 ) = 0.08 , p < 0.0001 ) . The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement ( 2.25 ) was derived from a direct treatment effect of 1.57 ( 70 % , p < 0.001 ) and an indirect treatment effect of 0.67 ( 30 % via IIEF-EF improvement , p < 0.001 ) . Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct ( 92.5 % , p < 0.001 ) vs indirect ( 7.5 % , p = 0.32 ) treatment effects via IIEF-EF improvement . CONCLUSIONS Regardless of the analytical approach , self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia , supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction BACKGROUND Metabolic syndrome ( MetS ) and benign prostate hyperplasia (BPH)/low urinary tract symptoms ( LUTS ) are often comorbid . Chronic inflammation is one of the putative links between these diseases . Phosphodiesterase type 5 inhibitors ( PDE5i ) are recognized as an effective treatment of BPH-related LUTS . One proposed mechanism of action of PDE5 is the inhibition of intraprostatic inflammation . In this study we investigate whether PDE5i could blunt inflammation in the human prostate . METHODS Evaluation of the effect of tadalafil and vardenafil on secretion of interleukin 8 ( IL-8 , a surrogate marker of prostate inflammation ) by human myofibroblast prostatic cells ( hBPH ) exposed to different inflammatory stimuli . We preliminary evaluate histological features of prostatic inflammatory infiltrates in BPH 
    Output:
    
agent
Pooled data analyses revealed that tadalafil 5 mg once daily allows the clinical ly-meaningful improvement of LUTS and nocturnal voiding frequency independent of both erectile dysfunction severity and improvement .
PDE5-Is are safe and effective in improving both LUTS and erectile function in appropriately selected men with LUTS/BPE .
We found evidence to confirm that phosphodiesterase type 5 inhibitors are a valid treatment option for men affected by bothersome urinary symptoms with or without erectile dysfunction
***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: INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score  ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated PURPOSE We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment . MATERIAL S AND METHODS We performed a single center , r and omized , double-blind , placebo controlled trial in 25 patients with spinal cord injury who had erectile dysfunction and micturition disorders . A baseline urodynamic test was performed as well as a second urodynamic test 1 to 3 hours after the administration of 20 mg vardenafil and placebo in 15 and 10 cases , respectively . In all patients st and ard oral oxybutynin administration was not discontinued . Statistical assessment included the 3 urodynamic parameters maximum detrusor pressure during voiding , maximum cystometric capacity and detrusor overactivity volume . RESULTS Placebo administration did not affect urodynamic parameters . After vardenafil administration maximum detrusor pressure was significantly decreased ( 59.3 vs 52.1 cm H(2)O , p < 0.001 ) and maximum cystometric capacity considerably improved ( 233.5 vs 272 ml , p < 0.001 ) . The most dramatic variations were observed for detrusor overactivity volume ( 174 vs 218 ml , p < 0.0001 ) . In 7 patients with American Spinal Injury Association classification A and spinal cord injury above T6 we observed the most significant improvement in the evaluated urodynamic items , including maximum detrusor pressure 57 vs 52 cm H(2)O ( p = 0.039 ) , maximum cystometric capacity 253 vs 296 ml ( p = 0.004 ) and detrusor overactivity volume 177 vs 229 ml ( p = 0.003 ) . CONCLUSIONS This trial demonstrates that in spinal cord injured patients a single 20 mg vardenafil administration achieved a significant decrease in maximum detrusor pressure , an improvement in maximum cystometric capacity and a remarkable increase in detrusor overactivity volume value INTRODUCTION Lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) and erectile dysfunction are common disorders of advancing age . AIM To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH . METHODS In this prospect i ve r and omized study , 133 men complaining of LUTS due to BPH were included . Forty-five patients received tamsulosin 0.4 mg/day alone ( Group A ) , 44 patients received tadalafil 10 mg/day ( Group B ) , and combination therapy ( tamsulosin and tadalafil both ) was instituted in 44 patients ( Group C ) . After a 2-week medication free run-in period , they were evaluated for International Prostatic Symptom Score ( IPSS ) , International Index of Erectile Function score ( IIEF5 ) , quality of life ( IPSS QoL ) , maximum urinary flow rate ( Qmax ) , post-void residual urine ( PVR ) volume , and safety parameters before and at 3 months of treatment . MAIN OUTCOME MEASURES There were primary ( IPSS , IPSS QoL index , Qmax , and PVR ) and secondary ( erectile function [ EF ] domain scores from IIEF5 ) efficacy end points . Safety assessment included laboratory tests and patient 's reporting of adverse event . RESULTS A significant improvement in IPSS score was observed in all the 3 groups A , B , and C ( -50.90 % , P < 0.05 ; -33.50 % , P < 0.05 ; and -53.90 % , P < 0.05 , respectively ) . IIEF5 score increased significantly in these three groups ( + 39.28 % , P < 0.05 ; + 45.96 % , P < 0.05 ; and + 60.23 % , P < 0.05 , respectively ) . A significant increase in Qmax and decrease in PVR were also observed ( 33.99 % , P < 0.05 ; 29.78 % , P < 0.05 ; and 37.04 % , P < 0.05 ) and ( -60.90 % , P < 0.05 ; -49.45 % , P < 0.05 ; and -62.97 % , P < 0.05 , respectively ) . The QoL scores improved significantly ( -73.35 % , P < 0.05 ; -70.26 % , P < 0.05 ; and -79.65 % , P < 0.05 , respectively ) . Side effects were dyspepsia , heartburn , headache , flushing , myalgia , and backache . Adverse effect dropout was 3.7 % . No participant experienced any severe or serious adverse events . CONCLUSIONS In patients with LUTS due to BPH , tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS . Their EF also improves with these medications . The improvement is better with combination therapy compared with single agent alone PURPOSE Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia . We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international , placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS After a 4-week placebo lead-in period 1,500 men were r and omized to tadalafil 5 mg or placebo for 12 weeks . Data were analyzed using ANCOVA . Maximum urinary flow rate values were rank transformed for analysis . RESULTS Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197 .  Tadalafil 5 mg significantly increased maximum urinary flow vs placebo ( median 1.1 vs 0.4 ml per second , p = 0.003 ) . At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second ( p = 0.142 ) in 731 patients , at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second ( p = 0.011 ) in 428 , and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second ( p = 0.186 ) in 38 for placebo and tadalafil , respectively . The difference was 0.3 , 1.0 and 2.2 ml per second , respectively . At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second ( p = 0.246 ) , at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second ( p = 0.044 ) , and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second ( p = 0.189 ) for placebo and tadalafil , respectively . Tadalafil improved I-PSS ( International Prostate Symptom Score ) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups ( each p < 0.001 ) . CONCLUSIONS This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo . The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume PURPOSE Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction . We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction . MATERIAL S AND METHODS Four separate analyses used integrated data from 4 r and omized , double-blind , placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS ( International Prostate Symptom Score ) improvement was due to improvement in IIEF-EF ( International Index of Erectile Function-Erectile Function domain score ) . Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms . RESULTS A total of 1,496 men , of whom 77 % had erectile dysfunction , received at least 1 dose of tadalafil 5 mg once daily or placebo . The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 ( p < 0.0001 ) in total I-PSS vs -2.2 ( p = 0.0007 ) for men without erectile dysfunction . The correlation between change from baseline in total I-PSS and IIEF-EF was weak ( r(2 ) = 0.08 , p < 0.0001 ) . The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement ( 2.25 ) was derived from a direct treatment effect of 1.57 ( 70 % , p < 0.001 ) and an indirect treatment effect of 0.67 ( 30 % via IIEF-EF improvement , p < 0.001 ) . Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct ( 92.5 % , p < 0.001 ) vs indirect ( 7.5 % , p = 0.32 ) treatment effects via IIEF-EF improvement . CONCLUSIONS Regardless of the analytical approach , self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia , supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction BACKGROUND Metabolic syndrome ( MetS ) and benign prostate hyperplasia (BPH)/low urinary tract symptoms ( LUTS ) are often comorbid . Chronic inflammation is one of the putative links between these diseases . Phosphodiesterase type 5 inhibitors ( PDE5i ) are recognized as an effective treatment of BPH-related LUTS . One proposed mechanism of action of PDE5 is the inhibition of intraprostatic inflammation . In this study we investigate whether PDE5i could blunt inflammation in the human prostate . METHODS Evaluation of the effect of tadalafil and vardenafil on secretion of interleukin 8 ( IL-8 , a surrogate marker of prostate inflammation ) by human myofibroblast prostatic cells ( hBPH ) exposed to different inflammatory stimuli . We preliminary evaluate histological features of prostatic inflammatory infiltrates in BPH 
    Output:
    