Eliciting preferences for drug treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. 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. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL): 6‐month results from the WATER II trial Update on AUA guideline on the management of benign prostatic hyperplasia. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Crossover comparison study on the therapeutic effects of tamsulosin hydrochloride and naftopidil in lower urinary tract symptoms associated with benign prostatic hyperplasia. 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. Naftopidil for the treatment of urinary symptoms in patients with benign prostatic hyperplasia 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. Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction. Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes. Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. 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. Ejaculatory Disorders Caused by Alpha-1 Blockers for Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Comparison of Naftopidil and Tamsulosin in a Randomized Multicenter Study [Comparison of naftopidil and silodosin in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, crossover study]. Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study. Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study. Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia. Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Sildenafil citrate in combination with tamsulosin versus tamsulosin monotherapy for management of male lower urinary tract symptoms due to benign prostatic hyperplasia: A randomised, double-blind, placebo-controlled trial Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia. Evaluation of Tadalafil effect on lower urinary tract symptoms of benign prostatic hyperplasia in patients treated with standard medication. Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. Celecoxib for treatment of nocturia caused by benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled study. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study.
PURPOSE There are 2 main medical preparations available for lower urinary tract symptoms result ing from benign prostatic hyperplasia ( BPH ) . Choosing between an alpha-blocker and a 5alpha-reductase inhibitor requires trade-offs between their attributes or characteristics . We investigated the relative importance of and trade-offs between the attributes of the 5alpha-reductase inhibitor dutasteride and alpha-blockers in community dwelling men using a vali date d technique . MATERIAL S AND METHODS A discrete choice experiment was administered to 211 men older than 40 years who were r and omly selected from the general United Kingdom population . Attributes investigated in the discrete choice experiment were time to symptom improvement , sexual and nonsexual side effects , the risks of acute urinary retention ( AUR ) and surgery , cost and prostate size decrease . Using regression analysis the relative importance of these attributes , the trade-offs that men are willing to make between these attributes and the willingness to pay for each attribute were estimated . RESULTS All attributes were important to respondents . The most important attribute was side effects . The least preferred side effects was impotence , followed by decreased libido and dizziness . Respondents were willing to wait 13 , 2 and 8 months longer for symptom improvement in exchange for decreased prostate size , and the risks of AUR and surgery , respectively . Men reporting moderate symptoms were less concerned about sexual side effects , time to symptom improvement and the risk of AUR compared with men reporting mild symptoms . CONCLUSIONS Given the attribute levels of BPH medical treatment , overall community dwelling men preferred the 5alpha-reductase inhibitor over alpha-blockers . In the interests of shared decision making it is important to consider the importance of eliciting the preferences of patients with 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 Safety and efficacy of tamsulosin and vardenafil are well established : however , there is no report regarding combined therapy with these drugs for  lower urinary tract symptoms ( LUTSs ) secondary to benign prostatic hyperplasia ( BPH ) . AIM To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a r and omized trial with 12-week follow-up . METHODS We conducted a r and omized , double-blind , placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin .  MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS-bother , International Index of Erectile Function , Version 5 ( IIEF-5 ) and Over Active Bladder question naire ( OAB-q ) scores , uroflowmetry data ( Qmax , Qave ) , and postvoiding residual urine were recorded after run-in ( baseline ) , and 2 and 12 weeks after treatment . Differences between vardenafil and placebo at different times were calculated with unpaired sample s t-test . Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance . RESULTS We found a between-group significant difference from baseline to 12 weeks in the following : ( i ) Qmax ( placebo : + 0.07 , vardenafil : + 2.56 , P = 0.034 ) ; ( ii ) Qave  ( placebo : -0.15 , vardenafil : + 1.02 , P = 0.031 ) ; ( iii ) irritative-IPSS subscores ( placebo : -1.67 , vardenafil : -3.11 , P = 0.039 ) ; and ( iv ) IIEF ( placebo : + 0.06 , vardenafil : + 2.61 , P = 0.030 ) . No patient reported any serious ( grade ≥ 2 ) adverse event ( AE ) . There were no differences in the incidence of common , treatment-related AEs between men undergoing combined therapy or tamsulosin alone . CONCLUSIONS The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function , as compared with tamsulosin alone . Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH OBJECTIVE To assess the effect of tamsulosin on the Sexual Health Inventory for Men ( SHIM ) score in men diagnosed with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . PATIENTS AND METHODS Analysis from the national data base of a programme of the Prostate Cancer Educational Council identified 7974 men who completed the American Urologic Association Symptom Score ( AUA-SS ) and SHIM question naires . The patients were divided into three groups ; group 1 , men taking tamsulosin ;  group 2 , men on other prescription medications for treating BPH symptoms ;  and group 3 , men not currently taking any BPH medications .  Linear regression was used to assess the association of tamsulosin and other alpha-blocker prescriptions for treating BPH symptoms with the decline in SHIM score . The interaction terms between AUA and the intake of tamsulosin was also adjusted for in the final analysis . RESULTS The median age of the men was 60 years . In groups 1 , 2 and 3 , ( 234 , 291 and 7449 men , respectively ) the mean ( sd ) AUA-SS was 13.0 ( 7.2 ) , 12.1 ( 7.2 ) and 6.9 ( 5.8 ) , and the mean SHIM scores 11.7 ( 6.8 ) , 12.7 ( 6.5 ) and 15.9 ( 6.0 ) , respectively . Adjusting for the AUA-SS , men in group 1 on tamsulosin had a significantly higher SHIM score with increasing AUA-SS score than men on other medications ( P < 0.01 ) , off setting the negative correlation between the AUA-SS and SHIM ( P < 0.01 ) . Moreover , men in group 1 were more likely to have a higher AUA-SS and lower SHIM score than men in the other two groups , suggesting more severe symptoms in these men . CONCLUSIONS Men taking tamsulosin to treat LUTS appear to be at an advantage over men taking other alpha-blockers when the effect of LUTS on sexual health is considered . Furthermore , this effect was more profound in patients with more severe LUTS than those with mild and moderate symptoms . Future prospect i ve trials are warranted to confirm this effect Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of  benign prostatic hyperplasia ( BPH )  . Taken as monotherapy , alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms . Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery . Direct comparison of the alpha-blocker terazosin with finasteride has been done , but only for a period of 1 year . The Medical Therapy of Prostatic Symptoms ( MTOPS ) trial is a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride , whether taken as a monotherapy or in combination , in preventing or delaying the progression of BPH . We describe in this paper the design of the MTOPS trial , the concept of BPH progression , the definition and methods of determining the primary outcome events and the proposed statistical analysis methods . A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of r and omized participants . Volunteers among r and omized participants are to undergo a biopsy of the prostate at predetermined time points during the trial . Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH Background The primary objectives of the treatment for the  lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels .  Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P<0.01 ) . A decrease in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation To present 6‐month safety and effectiveness data from a multicentre prospect i ve study of aquablation in men with lower urinary tract symptoms ( LUTS ) attributable to benign prostatic hyperplasia ( BPH ) with prostate volumes between 80 and 150 PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P < .01 ) . Also , Q(max ) and AFR significantly improved in both groups ( P < .01 ) . The improvements in IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile Benign prostatic hyperplasia ( BPH ) is a highly prevalent condition in aging men , which can be progressive and lead to acute urinary retention ( AUR ) and the need for surgery . It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors ( 5ARIs ) , both of which improve the symptoms of BPH . Long-term treatment with 5ARIs can also reduce the risk of developing AUR and the need for surgery . The l and mark Medical Therapy of Prostatic Symptoms ( MTOPS ) trial demonstrated that over 4 years the combination of the type 2-specific 5ARI , finasteride and the alpha-blocker doxazosin was more effective than either agent alone in reducing overall clinical progression . Since the initiation of MTOPS , it has been shown that patients with larger prostates and higher prostate-specific antigen ( PSA ) levels are at greater risk of BPH progression , and are therefore arguably more likely to benefit from combination therapy . The Combination of Avodart and Tamsulosin ( CombAT ) trial is a 4-year , global , multicenter , r and omized , double-blind , parallel-group study design ed to investigate the benefits of combination therapy with the dual 5ARI dutasteride and the alpha-blocker tamsulosin compared with each monotherapy in improving symptoms and long-term outcomes in men with moderate-to-severe symptoms of BPH and prostate enlargement .  Symptoms and long-term outcomes ( AUR and surgery ) will be assessed as separate primary endpoints at 2 and 4 years , respectively . Eligible patients were at least 50 years old with prostate volume > or = 30 cm(3 ) and PSA level > or = 1.5 ng/mL. A total of 4838 subjects have been enrolled . This paper describes the rationale , design and baseline data of the CombAT study PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial .  Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial .  Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers There is no consensus on the evaluated efficacy of individual alpha(1)-blockers in the treatment of lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . This study compared the clinical benefits of tamsulosin hydrochloride with those of naftopidil in BPH . Men aged 54 - 84 years with a main complaint of BPH were r and omly assigned to receive consecutive treatment with tamsulosin then naftopidil ( T-N group , 25 patients ) , or naftopidil then tamsulosin hydrochloride ( N-T group , 20 patients ) . The therapeutic effects were compared in a crossover design . Administration was continued for 28 days in each treatment period . Both groups showed similar improvements during the first treatment period . However , during the second treatment period after crossover , therapeutic effects were greater in the N-T group . Tamsulosin was more effective than naftopidil on intermittency , nocturia and quality of life scores .  Tamsulosin and naftopidil have different efficacy profiles for LUTS associated with BPH 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 Naftopidil , approved only in Japan , is an α1-adrenergic receptor antagonist ( α1-blocker ) used to treat lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Different from tamsulosin hydrochloride and silodosin , in that it has higher and extremely higher affinity respectively , for the α1A-adrenergic receptor subtype than for the α1D type , naftopidil has distinct characteristics because it has a three times greater affinity for the α1D-adrenergic receptor subtype than for the α1A subtype . Although well- design ed large-scale r and omized controlled studies are lacking and the optimal dosage of naftopidil is not always completely determined , previous reports from Japan have shown that naftopidil has superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin . On the other h and , the incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may be lower than for tamsulosin and silodosin having high affinity for the α1A-adrenergic receptor subtype . However , it remains unknown if the efficacy and safety of naftopidil in Japanese is applicable to white , black and Hispanic men having LUTS/BPH in western countries 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 OBJECTIVES This pilot study was undertaken to assess the efficacy and safety of the alpha(1)-blocker alfuzosin 10 mg once daily ( OD ) , the PDE-5 inhibitor sildenafil 25 mg OD , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) and erectile dysfunction ( ED ) . MATERIAL AND METHODS Men aged 50 - 76 yr with previously untreated LUTS and ED were r and omized to receive alfuzosin ( n=20 ) , sildenafil ( n=21 ) , or the combination of both ( n=21 ) for 12 wk . Changes from baseline in International Prostate Symptom Score ( IPSS ) , voiding diary , maximum urinary flow rate ( Qmax ) , postvoid residual urine ( PVRU ) volume , and erectile function domain of the International Index of Erectile Function ( IIEF ) were assessed at week 12 . RESULTS Improvement of IPSS was significant with the three treatments but greatest with the combination ( -24.1 % ) compared with alfuzosin ( -15.6 % ) and sildenafil ( -11.8 % ) [ corrected ] alone ( p<0.03 ) . Frequency , nocturia , PVR , and Qmax were significantly improved with alfuzosin only and the combination . Improvement in IIEF was slight with alfuzosin ( 16.7 % ) , marked with sildenafil ( 49.7 % ) , and greatest with the combination ( 58.6 % ) . Likewise , increases in the frequency of penetration ( Q3 ) and of maintained erection ( Q4 ) were greater with the combination therapy ( 65.2 % and 68.2 % , respectively ) than with sildenafil ( 41.7 % and 59.1 % , respectively ) and alfuzosin ( 27.3 % and 33.3 % , respectively ) alone . All three treatments were well tolerated . CONCLUSIONS In this pilot study , the combination of alfuzosin 10 mg OD and sildenafil 25 mg OD is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH OBJECTIVES To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia ( BPH ) progression , including acute urinary retention ( AUR ) and prostate surgery . METHODS The Proscar Long-term Efficacy and Safety Study ( PLESS ) was a 4-year study design ed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms ( LUTS ) , clinical evidence of BPH , and no evidence of prostate cancer . A self-administered question naire was employed to quantify LUTS at baseline . Receiver operating characteristics ( ROC ) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes . The characteristics assessed included the overall symptom score ( Quasi-AUA SI ) , separate voiding and filling subscores , prostate volume ( PV ) and serum prostate-specific antigen ( PSA ) levels . RESULTS PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR . The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery ; however , PSA was more effective at predicting this outcome . To better evaluate symptoms as predictors of surgery , patients who experienced a preceding episode of AUR were excluded from the surgery analysis . In the absence of preceding AUR , the best predictors of future surgery were the Quasi-AUA SI and the filling subscore . CONCLUSIONS Among men with LUTS , clinical BPH and no history of AUR , the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery . PV and PSA were the best predictors of AUR , while PSA was the best predictor of prostate surgery ( for all indications ) OBJECTIVES Assess the efficacy and safety of once-daily tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms ( LUTS ) in Korean men with benign prostatic hyperplasia ( BPH ) . METHODS Following a 4-week placebo run-in period , 151 Korean men were r and omly assigned to receive once-daily tadalafil 5 mg , tamsulosin 0.2 mg , or placebo for 12 weeks . RESULTS The International Prostate Symptom Score ( IPSS ) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the tadalafil ( -5.8 ) and tamsulosin ( -5.4 ) groups compared with placebo ( -4.2 , P > 0.05 ) . Decreases in IPSS obstructive and irritative subscores , IPSS Quality of Life score , and BPH Impact Index from baseline to endpoint were largest in the tadalafil group followed by tamsulosin , though none separated significantly from placebo . Increases in maximum urinary flow rate were small and not significantly different than placebo ; the increase was largest in the tadalafil group ( 2.5 mL/sec ) , followed by the placebo ( 2.3 mL/sec ) and tamsulosin ( 2.1 mL/sec ) groups . The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5 , 13.7 and 3.9 % in the tamsulosin , tadalafil and placebo groups , respectively . CONCLUSIONS In this pilot study in Korean men , those with BPH and treated with tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS , which was numerically ( but not statistically ) significant compared with the placebo . Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events . Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed PURPOSE We examined data from the Medical Therapy of Prostatic Symptoms trial to determine the relationship between baseline TPV and the effect of medical therapy in men with LUTS secondary to BPH . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to placebo , 4 to 8 mg doxazosin , 5 mg finasteride or the combination of doxazosin and finasteride . Average treatment duration was 4.5 years The primary outcome was time to overall clinical progression of BPH , defined as a confirmed 4 point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency or recurrent urinary tract infection . Secondary outcomes were the need for invasive therapy for BPH , and changes in AUA SS and the maximum urinary flow rate with time . TPV was measured by transrectal ultrasound at baseline and study end . RESULTS In patients with a small prostate ( baseline TPV less than 25 ml ) combination therapy was no better than doxazosin alone for decreasing the risk of clinical progression of BPH and need for invasive therapy as well as improving AUA SS and the maximum urinary flow rate . However , in patients with moderate size ( 25 to less than 40 ml ) or enlarged ( 40 ml or greater ) gl and s combination therapy led to a clinical benefit in these outcomes that was superior to that of doxazosin or finasteride . CONCLUSIONS Combination therapy with doxazosin and finasteride led to a greater decrease in the risk of clinical progression of BPH than either drug alone in patients with LUTS with a baseline TPV of 25 ml or greater 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 : To investigate the incidence of ejaculatory disorders caused by naftopidil and tamsulosin in patients with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Material s and Methods : Ninety-five patients with LUTS/BPH who had International Prostate Symptom Scores ( IPSS ) of 8 or more were r and omly assigned to receive naftopidil ( 50 mg/day , n = 48 ) or tamsulosin ( 0.2 mg/day , n = 47 ) . Before and 12 weeks after treatment , a question naire was used to evaluate ejaculation . Results : Among men who had sexual activity during the 12 weeks , the proportion who reported an abnormal feeling on ejaculation was higher in the tamsulosin group ( 16.7 % ) than in the naftopidil group ( 7.4 % ) , although the difference was not significant ( p = 0.402 ) . The proportion of men who reported reduced ejaculatory volume after treatment was significantly higher in the tamsulosin group ( 96.0 % ) than in the naftopidil group ( 73.1 % , p = 0.0496 ) . On the other h and , the improvements in IPSS and the quality of life index were significantly higher in the tamsulosin group than in the naftopidil group . Conclusions : Tamsulosin may cause a higher incidence of ejaculatory disorders than naftopidil , although the efficacy of 0.2 mg tamsulosin may be better than that of 50 mg naftopidil We compared the efficacy , safety , and patient preferences for two α1-adrenoceptor ( AR ) antagonists with different affinity for AR subtypes , naftopidil ( Naf ) and silodosin ( Silo ) , for the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia ( male LUTS/BPH ) . New patients diagnosed with male LUTS/BPH were r and omly divided into either the Naf-Silo group or the Silo-Naf group ( Naf : 50 - 75 mg once daily for 2 weeks followed by 75 mg once daily for 4 weeks ; Silo : 2 - 4 mg twice daily for 2 weeks followed by 4 mg twice daily for 4 weeks ) . A survey was conducted to evaluate patient drug preferences after completion of the study and the reasons for the preferences . Naf and Silo  improved the total International Prostate Symptom Score ( IPSS ) compared with baseline . There was no significant difference between Naf and Silo in improvement in the IPSS total score . Adverse effects were more frequent with Silo than with Naf ( P=0 . 002 ) . No significant difference in patient preference for the drugs was observed . These findings indicate that Naf and Silo provide similar clinical efficacy , with no difference in patient preference for the drugs , although adverse effects were significantly more frequent with Silo than with Naf OBJECTIVE To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia ( LUTS/BPH ) . METHODS Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score ( IPSS ) of ≥8 were enrolled in the r and omized crossover study and divided into silodosin-preceding ( S-T ) and tamsulosin-preceding ( T-S ) groups . The S-T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks . The T-S group received the reverse treatment sequence . A washout period prior to drug crossover was not included . Subjective and objective efficacy parameters including IPSS , quality of life ( QOL ) index , uroflowmetry , and safety were compared between the two groups . RESULTS Thirty of 34 men ( S-T group n = 16 ; T-S group n = 14 ) completed the study . Both drugs significantly improved all IPSS items and QOL index in the first treatment period . Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods . Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period . Adverse events occurred more frequently with silodosin than with tamsulosin ; however , none of the adverse events required treatment discontinuation . Ejaculation disorders occurred in three participants ( 10 % ) and were associated with silodosin use . CONCLUSION Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus , may represent an effective , safe , and affordable treatment option BACKGROUND The present study investigated the efficacy , safety , and utility of starting an alpha(1d)-selective antagonist , naftopidil , at 75 or 25 mg/day in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . METHODS In this prospect i ve comparative study , the subjects comprised 153 patients with LUTS associated with BPH . Patients were r and omized to receive either 25 mg/day ( Group LD ) or 75 mg/day ( Group HD ) of naftopidil for 4 weeks . The lower urinary tract disease symptom score ( LUTDSS ) , the International Prostate Symptom Score ( IPSS ) , the Quality of life assessment index , the maximum flow rate ( Q(max ) ) , and the residual urine volume were compared between the groups . RESULTS In both groups , the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified . However , the improvement in the Q(max ) was significantly better for Group HD than for Group LD . The overall efficacy did not differ significantly between the groups . The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD . The frequency of adverse reactions did not differ significantly between the groups . CONCLUSIONS Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms , particularly in improving voiding symptoms . The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients This prospect i ve study evaluated the safety of tadalafil 5 mg taken once a day in terms of hypotensive side effects and whether it improves lower urinary tract symptoms ( LUTS ) and restores sexual function in patients with erectile dysfunction who are receiving concomitant α-blocker ( AB ) therapy for benign prostatic hyperplasia ( BPH ) . A total of 158 LUTS/BPH patients receiving AB therapy for ≥3 months were given tadalafil 5 mg once a day . Before treatment with tadalafil ( V1 ) , and 4 weeks ( V2 ) and 12 weeks ( V3 ) after starting  tadalafil , blood pressure , heart rate , International Prostate Symptom Score ( IPSS ) , maximal urine flow rate ( Qmax ) , postvoiding residual urine volume , and International Index of Erectile Function ( IIEF-5 ) score were measured . Of the 158 LUTS/BPH patients , a total of 119 completed the trial . Blood pressure ( systolic and diastolic ) and heart rate did not change . IPSS and IIEF-5 scores improved significantly , but Qmax and postvoiding residual urine volume did not ; however , in the 39 men with a low baseline Qmax ( ≤10 mL/s ) , Qmax rose significantly from 7.97 ± 1.44 mL/s ( baseline ) to 8.91 ± 1.60 mL/s ( V3 ; P = .012 ) . The remaining patients ( baseline Qmax > 10 mL/s ) did not change . At V2 and V3 , adverse side effects were observed in 10 men ( 7.30 % ) and 6 men ( 5.04 % ) , respectively . Facial flushing was the most common adverse side effect ( 6 men at V2 and 4 men at V3 ) , followed by headache ( 2 men each at V2 and V3 ) and dizziness ( 2 men at V2 ) . Two patients dropped out of the study because of adverse side effects . In conclusion , tadalafil 5 mg once a day in combination with AB appeared to have few adverse effects on hypotensive events and can improve LUTS and restore sexual function OBJECTIVES To investigate the benefit of alpha1-adrenoceptor antagonist naftopidil on the quality of life ( QOL ) of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH/LUTS ) . METHODS A total of 99 men with BPH/LUTS were prospect ively recruited . The Short Form-8 ( SF-8 ) was used for generic QOL assessment and each parameter was compared with the norm in these patients . Longitudinal changes were evaluated using the SF-8 and the International Prostatic Symptoms Score ( I-PSS ) at baseline , 4 and 8 weeks after naftopidil administration . The relationship between SF-8 and I-PSS was analyzed . RESULTS Five of eight components in the SF-8 were significantly lower than the Japanese national norm at baseline . SF-8 score was improved by naftopidil at 4 and 8 weeks in general health ( GH ) and physical component summary ( PCS ) in the patients in their 70s . Mental health ( MH ) and mental component summary ( MCS ) were improved at 8 weeks in patients in their 60s . When analyzing the whole cohort , SF-8 GH , role emotional ( RE ) and MH had improved at 8 weeks , which was similar to the norm , and bodily pain ( BP ) results were better . Compared with the baseline , total I-PSS , storage/voiding symptoms and QOL index scores improved significantly under naftopidil . Each component of I-PSS ( except for hesitancy ) correlated with SF-8 sub-scales ( except for BP ) to some extent . CONCLUSIONS BPH/LUTS impairs generic QOL , which is improved by naftopidil treatment . SF-8 can be a useful instrument to assess the efficacy of BPH/LUTS treatment because its simplicity to complete and analyze , and its meaningful relationship to I-PSS OBJECTIVES To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) by a r and omized crossover method . METHODS BPH patients with the complaint of LUTS were included in this study , and were r and omly divided into two groups : a silodosin-preceding group ( 4 weeks of twice-daily administration of silodosin at 4 mg , followed by 4 weeks of once-daily administration of tamsulosin at 0.2 mg ) or a tamsulosin-preceding group ( 4 weeks ' administration of tamsulosin , followed by 4 weeks ' administration of silodosin ) . No drug withdrawal period was provided when switching the drug . RESULTS In the first treatment period , both drugs significantly improved the International Prostate Symptom Score total score , but the improvement by silodosin was significantly superior to that by tamsulosin . After crossover treatment , significant improvement was observed only with silodosin treatment . Moreover , intergroup comparison of changes revealed that silodosin showed significant improvement of straining and nocturia with first and crossover treatments , respectively , compared with tamsulosin . Silodosin also significantly improved quality of life ( QOL ) score in both treatment periods , while tamsulosin significantly improved QOL score only in the first treatment period . The most frequent adverse drug reaction was ejaculatory disorder with silodosin ; however , the incidence of dizziness with silodosin was similar to that with tamsulosin . CONCLUSIONS In BPH/LUTS patients , silodosin exhibits excellent efficacy in improving subjective symptoms in both initial and crossover treatment , and it appears to improve the QOL of patients OBJECTIVE The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy , in patients with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . METHODS Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score ( IPSS ) 8 or higher , were r and omized to receive 10 mg alfuzosin ( n = 25 ) , 10 mg tadalafil ( n = 25 ) or the combination of both the drugs ( n = 25 ) once daily for 3 months . Symptoms were assessed at baseline , 6 weeks and 3 months . The primary endpoint was the change in IPSS from the baseline . Secondary endpoints were changes in IPSS storage and voiding subscores , peak urinary flow rate , residual urine volume , IPSS quality of life score and erectile domain score . RESULTS There were significant improvements in all IPSS scores , peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups ( P < 0.003 ) . Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume ( P < 0.005 ) . Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate ( P = 0.22 ) , similar to tadalafil in improvement on erectile function ( P = 0.22 ) and better than each monotherapy in improving the IPSS quality of life ( P ≤ 0.015 ) . CONCLUSION Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH Abstract Objective : To assess the additive effect of sildenafil citrate to tamsulosin in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) in men with or without erectile dysfunction ( ED ) . Patients and methods : In all , 150 men with untreated LUTS/BPH with or without ED were r and omised to receive sildenafil 25 mg once daily ( OD ) or placebo OD ( night time ) combined with tamsulosin 0.4 mg OD ( day time ) for 6 months . Changes from pre-treatment scores in International Prostate Symptom Score ( IPSS ) , IPSS- quality of life ( QoL ) score , maximum urinary flow rate ( Qmax ) , and the five-item version of the International Index of Erectile Function question naire ( IIEF-5 ) were assessed at 3 and 6 months . Safety profiles were assessed by physical examination and monitoring clinical adverse events . Results : Group A comprised of men who received tamsulosin and sildenafil ( 75 men ) , whilst those in Group B received tamsulosin and placebo ( 75 ) . The IPSS was significantly improved in Group A compared to Group B , at −29.3 % vs −13.7 % ( P = 0.039 ) at 3 months and −37 % vs −19.6 % ( P = 0.043 ) at 6 months after treatment . Qmax significantly improved in both groups compared with before treatment ( P < 0.001 ) . The IIEF-5 scores improved more in Group A than in Group B , at 58.7 % vs 11.7 % at 3 months and 62.4 % vs 12.4 % at 6 months after treatment ( both P < 0.001 ) . Conclusion : Sildenafil citrate combined with tamsulosin  improved LUTS , erectile function , and patient QoL more than tamsulosin monotherapy with the merit of a comparable safety profile in patients with LUTS/BPH OBJECTIVES To compare the efficacy and safety of finasteride 5 mg in older ( 65 years old or older ) versus younger ( 45 to younger than 65 years old ) men with benign prostatic hyperplasia ( BPH ) . METHODS The Proscar Long-Term Efficacy and Safety Study ( PLESS ) was a 4-year , r and omized , double-blind , placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH , enlarged prostates , and no evidence of prostate cancer . The endpoints included urinary symptoms , prostate volume , occurrence of acute urinary retention and /or BPH-related surgery , and safety . RESULTS In both age cohorts , finasteride treatment led to a 51 % reduction ( P < 0.001 ) in the relative risk for acute urinary retention and /or BPH-related surgery , a significant ( P < 0.001 ) and durable improvement in symptom score , and a significant ( P < 0.001 ) and sustained reduction in prostate volume . Within each age cohort , no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events . Significant differences were evident between the placebo and finasteride groups in the incidence of the typical , known , drug-related adverse events , but no specific differences were associated with age . No drug interactions of clinical importance were observed in the finasteride-treated patients . CONCLUSIONS The present analysis from PLESS demonstrates that in both older ( 65 years old or older ) and younger men with symptomatic BPH and enlarged prostates , finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery . In addition , the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed OBJECTIVES To evaluate safety and efficacy of tadalafil on  lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) in patients treated with st and ard medication . MATERIAL S AND METHODS In this case-controlled r and omized clinical trial , from November 2008 to August 2009 , 132 patients with obstructive and irritative urinary tract symptoms due to BPH , IPSS ≥ 8 , no indication for surgical intervention and that reached plateau levels of response to treatment were selected . These patients were r and omly allocated in two groups ( each containing 66 patients ) . The treatment group received st and ard treatment of BPH and tadalafil ( 10 mg nightly ) ; the placebo group received only st and ard treatment of BPH . IPSS , maximum urinary flow rate ( Qmax ) and quality of life were assessed before and after a 3-month period of study . RESULTS Before treatment , mean IPSS , Qmax and quality of life values in the treatment and placebo groups were 13.06 ± 4.37 and 13.66 ± 4.25 , 8.92 ± 2.96 mL/s and 9.09 ± 2.91 mL/s , 2.93 ± 0.86 and 2.66 ± 0.78 , respectively . After treatment , mean IPSS , Qmax , and quality of life values in treatment group were 7.66 ± 3.99 , 9.99 ± 4.76 mL/s and 1.80 ± 0.98 , respectively . These findings were compared to corresponding values of the placebo group ( 11.37 ± 3.64 , 8.73 ± 2.22 mL/s and 2.19 ± 0.53 , respectively ) : IPSS and quality of life were significantly different but Qmax did n't show a significant change . CONCLUSIONS Tadalafil  improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH , but does n't have any significant effect on Qmax . Therefore , this drug may be effectively used in combination with st and ard medical therapies for BPH OBJECTIVE This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia ( BPH ) . METHODS The study was a r and omized , placebo-controlled , double blind trial comparing three doses ( low , medium , and high ) of a new uro-selective alpha-blocker with an active comparator . A total of 536 men aged 40 years and older with lower urinary tract symptoms ( LUTS ) result ing from BPH were r and omized into the study . Patients ' perceptions of satisfaction with efficacy , dosing , and side effects were explored using a vali date d disease-specific instrument , the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ) . The TSS-BPH was administered at the end of the study or at withdrawal . RESULTS Compared with placebo , the medium and high doses showed the greatest efficacy on the primary endpoint , the International Prostate Symptom Score ( IPSS ) . Patient satisfaction with efficacy at these doses was significantly better than that for placebo . Nevertheless , adverse events were most frequent in the high dose group . Satisfaction with side effects was significantly worse than placebo for this group , and this was reflected in the total scores on the TSS-BPH , with patients being most satisfied overall with the medium dose . CONCLUSIONS Exploring patients ' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects , and can be used to inform the selection of doses for later trials . This is especially useful for products that require adherence with medication over long periods of time INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH-LUTS ) commonly coexist in aging men .  Tadalafil , a phosphodiesterase type 5 inhibitor approved for treating ED , is currently being evaluated for treating BPH-LUTS . AIMS This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy . METHODS Men were ≥ 45 years old , sexually active , and experiencing ED for ≥ 3 months and BPH-LUTS for > 6 months . R and omization ( baseline ) followed a 4-week placebo lead-in ; changes from baseline were assessed via analysis of covariance and compared to placebo . A gatekeeping procedure controlled for multiple comparisons of co- primary and key secondary measures at end point ( last post-baseline observation ) . MAIN OUTCOME MEASURES The co- primary measures were the International Index of Erectile Function-erectile function ( IIEF-EF ) domain and International Prostate Symptom Score ( IPSS ) score ; key secondary measures were the Sexual Encounter Profile Question 3 ( SEP Q3 ) and BPH Impact Index ( BII ) . Treatment-emergent adverse events , serious adverse events , orthostatic vital signs , clinical laboratory and uroflowmetry parameters , and postvoid residual volume were assessed . RESULTS Tadalafil 2.5 mg ( N = 198 ) and 5 mg ( N = 208 ) significantly improved IIEF-EF domain scores ( both P < 0.001 ) vs. placebo ( N = 200 ) at end point . For IPSS , improvements were significant with tadalafil 5 mg ( P < 0.001 ) , but not 2.5 mg , for observations from 2 weeks through end point ( least-squares mean ± st and ard error change from baseline at end point , placebo -3.8 ± 0.5 , tadalafil 2.5 mg -4.6 ± 0.4 , and 5 mg -6.1 ± 0.4 ) . Tadalafil 5 mg significantly improved SEP Q3 and BII ( P < 0.001 ) . Overall , tadalafil was well tolerated with no clinical ly adverse changes in orthostatic vital signs or uroflowmetry parameters . CONCLUSIONS Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated OBJECTIVES Nocturia is a well-recognized symptom of benign prostatic hyperplasia ( BPH ) , which is commonly treated by alpha(1)-blockers and /or 5alpha-reductase inhibitors . However , the effectiveness of these drugs for nocturia has been reported to be only 25%-39 % . The aim of this study was to investigate the efficacy of celecoxib , a cyclooxygenase-2 inhibitor , in the treatment of patients with BPH complaining of nocturia . METHODS This was a prospect i ve , r and omized , double-blind , placebo-controlled study . A total of 80 men with lower urinary tract symptoms and BPH were entered into the study and were r and omized to receive celecoxib , 100 mg at 9 pm vs placebo for 1 month . The inclusion criteria also included a total International Prostate Symptom Score > 8 and complaints of > or=2 voids nightly . The efficacy and safety of the treatment were assessed by changes in the urinary flow and symptoms between baseline and 1 month of follow-up . RESULTS In the celecoxib group ( n = 40 ) , the mean nocturnal frequency ( + /-SD ) decreased from 5.17 + /- 2.1 to 2.5 + /- 1.9 ( P < .0001 ) , and the mean International Prostate Symptom Score ( + /-SD ) decreased from 18.2 + /- 3.4 to 15.5 + /- 4.2 ( P < .0001 ) . In the control group ( n = 40 ) , the mean nocturnal frequency ( + /-SD ) decreased from 5.30 + /- 2.4 to 5.12 + /- 1.9 ( P > .05 ) , and the mean International Prostate Symptom Score ( + /-SD ) decreased from 18.4 + /- 3.1 to 18 + /- 3.9 ( P > .05 ) . A statistically significant difference was found between the 2 groups ( P < .0001 ) . No statistically significant differences were found in the changes in the peak flow rate between the celecoxib and control groups or in celecoxib group between baseline and 1 month ( P > .05 ) . No significant side effects were reported . CONCLUSIONS Celecoxib is effective in the treatment of patients with BPH complaining of refractory nocturia . Our results suggest a novel treatment option for this common condition BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 )
Based on improvement of mean International Prostate Symptom Score and quality of life scores , the effectiveness of the newer ABs was not different from the older ABs ( moderate strength of evidence [ SOE ] ) , but had more AEs ( low SOE ) .
Antimuscarinics/AB combination therapy had similar outcomes  as AB monotherapy ( all moderate SOE ) , but often had more AEs .
Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone .
Evidence was insufficient for the beta-3 adrenoceptor agonist .
For all newer agents , the evidence was generally insufficient to assess long-term efficacy , prevention of symptom progression , or AEs .
None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment .
Given the lack of superior outcomes , the studies ' short time-horizon , and less assurance of their safety , their current value in treating LUTS attributable to BPH appears low .
We found none of the new drugs to be better but there was more concern about side effects
CONTEXT Alpha-blockers ( ABs ) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms ( LUTS ) attributed to benign prostatic hyperplasia ( BPH ) .
Recently , newer drugs have shown promise for this indication .
OBJECTIVE To assess the comparative effectiveness and adverse effects ( AEs ) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta- analysis .
PATIENT SUMMARY In this paper , we review ed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate .