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 .
Effects of tadalafil once daily on maximum urinary flow rate in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
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
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 .