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
CONTEXT Several pre clinical reports , r and omized controlled trials , systematic review s , and posthoc analyses corroborate the role of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in the treatment of men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic enlargement ( BPE ) .
OBJECTIVE Up date of the latest evidence on the mechanisms of action , evaluate the current meta-analyses , and emphasize the results of pooled data analyses of PDE5-Is in LUTS/BPE .
PATIENT SUMMARY We review ed recent literature on phosphodiesterase type 5 inhibitors in men with lower urinary tract symptoms associated with prostatic enlargement .
Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies.
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
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
CONTEXT Several pre clinical reports , r and omized controlled trials , systematic review s , and posthoc analyses corroborate the role of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in the treatment of men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic enlargement ( BPE ) .
OBJECTIVE Up date of the latest evidence on the mechanisms of action , evaluate the current meta-analyses , and emphasize the results of pooled data analyses of PDE5-Is in LUTS/BPE .
PATIENT SUMMARY We review ed recent literature on phosphodiesterase type 5 inhibitors in men with lower urinary tract symptoms associated with prostatic enlargement .