title: Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. Vardenafil improves urodynamic parameters in men with spinal cord injury: results from a single dose, pilot study. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. Effects of tadalafil once daily on maximum urinary flow rate in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. 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. PDE5 inhibitors blunt inflammation in human BPH: a potential mechanism of action for PDE5 inhibitors in LUTS. Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. Effect of tadalafil once daily on prostate blood flow and perfusion in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, double-blind, multicenter, placebo-controlled trial.
abstract: 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 patients enrolled in a r and omized , double bind , placebo controlled study aim ed at investigating the efficacy of vardenafil ( 10 mg/day , for 12 weeks ) on BPH/LUTS . RESULTS In vitro treatment with tadalafil or vardenafil on hBPH reduced IL-8 secretion induced by either TNFα or metabolic factors , including oxidized low-density lipoprotein , oxLDL , to the same extent as a PDE5-insensitive PKG agonist Sp-8-Br-PET-cGMP . These effects were reverted by the PKG inhibitor KT5823 , suggesting a cGMP/PKG-dependency . Treatment with tadalafil or vardenafil  significantly suppressed oxLDL receptor ( LOX-1 ) expression . Histological evaluation of anti-CD45 staining ( CD45 score ) in prostatectomy specimens of BPH patients showed a positive association with MetS severity . Reduced HDL-cholesterol and elevated triglycerides were the only MetS factors significantly associated with CD45 score . In the MetS cohort there was a significant lower CD45 score in the vardenafil-arm versus the placebo-one Purpose The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) . While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies . We therefore sought to further assess nocturia based on data integrated from four tadalafil registration al studies . Methods Data were integrated from four r and omized , placebo-controlled  , double-blind , 12-week registration al studies of tadalafil for LUTS/BPH . Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) . Efficacy results were analyzed using analysis of covariance . Results For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2 . The mean treatment change was −0.4 with placebo and −0.5 with tadalafil ; the least-squares mean ( st and ard error ) treatment difference was −0.2 ( 0.05 ) , p = 0.002 . For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % . Conclusions A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinical ly meaningful . Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH OBJECTIVE To assess the efficacy and safety of tadalafil , a phosphodiesterase 5 ( PDE5 ) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) , in population subgroups , using pooled data from 4 international , r and omized , placebo-controlled studies in men with LUTS/BPH . METHODS The safety data base included 1500 men r and omized to tadalafil 5 mg once daily or placebo for 12 weeks . Changes in total International Prostate Symptom Score ( IPSS ) , IPSS- quality of life index , and BPH impact index were examined overall , and changes in IPSS or adverse events ( AEs ) were examined across subgroups of interest . Treatment-group differences were assessed using analysis of covariance . RESULTS Results of pooled data confirmed that tadalafil ( N = 752 ) result ed in significant improvements from baseline vs placebo ( N = 746 ) in IPSS ( mean difference -2.3 ; P < .001 ) , and also in BPH impact index and IPSS- quality of life index ( both P < .001 ) . Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity ( IPSS < 20/≥20 ) , age ( ≤65/>65 years ) , recent previous use of α-blockers or PDE5 inhibitors , total testosterone level ( < 300/≥300 ng/dL ) , or prostate-specific antigen predicted prostate volume ( < 40/≥40 mL ) . [ corrected ] Rates of treatment emergent AEs were comparable between subgroups of baseline age ( ≤65/>65 years ) , previous PDE5 inhibitor use , and the presence or absence of pre-existing diabetes , hypertension , or cardiovascular disease ( including hypertension ) , but somewhat higher for recent previous α-blocker use . CONCLUSION In these pooled data analyses , tadalafil 5 mg improved LUTS/BPH across subgroups of age , LUTS severity , testosterone levels , and prostate volume . Rates of AEs were similar across the subgroups assessed INTRODUCTION Tadalafil , a long-acting phosphodiesterase type 5 inhibitor , is approved for treating signs and symptoms of benign prostatic hyperplasia ( BPH ) and erectile dysfunction ( ED ) ; tamsulosin , an alpha-blocker , is approved for treating signs and symptoms of BPH . AIM To determine the effects of tadalafil or tamsulosin on sexual function , including ejaculation and orgasm , satisfaction , and erectile function , in sexually active men with ED and lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) . METHODS A r and omized , double-blind , placebo-controlled study of tadalafil 5 mg once daily for 12 weeks in men with LUTS/BPH ; tamsulosin 0.4 mg once daily was an active control . MAIN OUTCOME MEASURES The International Index of Erectile Function ( IIEF ) question naire was administered at baseline and 4 , 8 , and 12 weeks . Analysis of orgasm and ejaculation was post hoc based on the IIEF-Orgasmic Function ( OF ) domain ( IIEF-Q9 [ ejaculatory frequency ] and Q10 [ orgasmic frequency ] ) . Other measures included IIEF-Intercourse Satisfaction ( IS ) , Overall Satisfaction ( OS ) , and Erectile Function ( EF ) domains . Changes from baseline to 12 weeks ( or last observation ) vs. placebo were analyzed using analysis of covariance . Higher IIEF scores indicate better functioning . RESULTS Of 511 study participants , 310 ( 60.7 % ) had ED and were sexually active . The IIEF-OF increased significantly through 12 weeks with tadalafil vs. placebo ( P = 0.048 ) , as did IIEF-Q9 ( P = 0.045 ) but not IIEF-Q10 ( P = 0.100 ) . Compared with placebo , IIEF-OF , Q9 , and Q10 decreased significantly with tamsulosin ( all P < 0.05 ) . The IIEF-IS and OS increased significantly at end point with tadalafil ( both P < 0.001 ) ; for tamsulosin , change was not significant for IS , while OS decreased significantly ( P = 0.009 ) . The IIEF-EF domain increased significantly vs. placebo with tadalafil ( P < 0.001 ) but not tamsulosin ( P = 0.699 ) . CONCLUSIONS Tadalafil 5 mg once daily significantly improved ejaculation and orgasm , intercourse and overall satisfaction , and erectile function . Men receiving tamsulosin 0.4 mg once daily experienced a decrease in both ejaculatory/orgasmic frequency and overall satisfaction vs. placebo , with no significant effect on erectile function INTRODUCTION Tadalafil ( TAD ) 5 mg coadministered with finasteride ( FIN ) 5 mg significantly improves lower urinary tract symptoms ( LUTS ) in men with benign prostatic hyperplasia ( BPH ) and prostatic enlargement . However , its effects on erectile/sexual function have yet to be fully described . AIM Assess the effects of TAD/FIN coadministration ( compared with placebo [PBO]/FIN ) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction ( ED ) . METHODS A r and omized , double-blind , PBO-controlled study of 695 men ( 610 sexually active ; 450 with baseline ED ; 404 sexually active with baseline ED ) conducted at 70 sites in 13 countries .  TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks . MAIN OUTCOME MEASURES International Index of Erectile Function ( IIEF ) domain and single-item scores ; proportions of patients who demonstrated minimal clinical ly important differences ( MCIDs ) in IIEF-Erectile Function domain scores ( IIEF-EF ; MCID defined as ≥4-point improvement ) ; and sexual dysfunction adverse events ( AEs ) . RESULTS Compared with PBO/FIN , TAD/FIN result ed in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED ( P ≤ 0.002 for all measures ) and among patients without baseline ED ( P ≤ 0.041 for all measures ) . Compared with PBO/FIN , significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4 , 12 , and 26 weeks of therapy ( P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints ) . The incidence of sexual AEs was low : five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs , including ED , decreased/lost libido , and ejaculation disorders . CONCLUSIONS TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated , regardless of the presence/absence of ED at treatment initiation OBJECTIVE To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged ≥45 years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms . METHODS After screening and washout , patients were r and omized to placebo ( n = 50 ) or tadalafil 5 mg ( n = 47 ) once daily for 8 weeks . Transrectal ultrasonography was performed at baseline , 4 , and 8 weeks . The primary efficacy measure was the prostate transition zone ( TZ ) resistive index ( RI ) . Secondary efficacy measures were RI in the peripheral zone and bladder neck , color pixel intensity ( CPI ) , and color pixel density ( CPD ) in all 3 regions . Outcomes were assessed using mixed-model repeated- measures analyses . RESULTS The overall treatment effect ( tadalafil vs placebo ) for the change from baseline through week 8 in prostate TZ RI was not statistically significant ( least squares mean change : placebo , -0.01 ; tadalafil , 0.00 ; P = .118 ) , nor was the change from baseline in prostate TZ CPI ( P = .564 ) or CPD ( P = .592 ) . Results were similar for all flow measures in prostate peripheral zone and bladder neck . The adverse event profile was consistent with previous studies with no new safety findings . CONCLUSION Tadalafil for 8 weeks in men with BPH-LUTS did not result in detectable decreases in arterial RI or increases in CPI or CPD in the prostate or bladder neck . Detection of changes may not be possible because of already low baseline RI , insufficient sensitivity of techniques used , or may have been confounded by method ologic variability across sites . Alternatively , other possible mechanisms not assessed in this study may be more prominently involved
target: 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
background: 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 .