title: Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: 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. An open, comparative, multicentre clinical study of combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients with erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia. Simultaneous administration of vardenafil and tamsulosin does not induce clinically significant hypotension in patients with benign prostatic hyperplasia. Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH. Pilot study. Effect of dutasteride on the risk of prostate cancer. Efficacy of propiverine ER with or without α-blockers related to maximum urinary flow rate in adult men with OAB: results of a 12-week, multicenter, non-interventional study [Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction. Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. Effect of tolterodine extended release with or without tamsulosin on measures of urgency and patient reported outcomes in men with lower urinary tract symptoms. 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. Randomized Controlled Trial to Treat Benign Prostatic Hyperplasia with Overactive Bladder Using an Alpha-blocker Combined with Anticholinergics. Sustained-Release Alfuzosin, Finasteride and the Combination of Both in the Treatment of Benign Prostatic Hyperplasia Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Tamsulosin and chlormadinone for the treatment of benign prostatic hyperplasia. The Kobe University YM617 Study Group. The effects of tamsulosin and sildenafil in separate and combined regimens on detailed hemodynamics in patients with benign prostatic enlargement. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Cooperative Study Trial. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study Sildenafil citrate and tamsulosin combination is not superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy normotensive men. Solifenacin as add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms--ASSIST, randomized controlled study. Update on AUA guideline on the management of benign prostatic hyperplasia. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. The influence of finasteride on the development of prostate cancer. Comparative Study of Therapeutic Effect of Dibenyline, Finasteride, and Combination Drugs for Symptomatic Benign Prostatic Hyperplasia Effects of serum PSA on efficacy of tolterodine extended release with or without tamsulosin in men with LUTS, including OAB. Effect of vardenafil on blood pressure profile of patients with erectile dysfunction concomitantly treated with doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia. The influence of baseline parameters on changes in international prostate symptom score with dutasteride, tamsulosin, and combination therapy among men with symptomatic benign prostatic hyperplasia and an enlarged prostate: 2-year data from the CombAT study. Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms: effects of prostate size.
abstract: OBJECTIVE To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men . PATIENTS AND METHODS In this multicenter , double-blind trial performed between March 29 , 2004 , and June 22 , 2005 , 420 men aged 45 years or older with a total International Prostate Symptom Score ( IPSS ) of 13 or more and IPSS for storage of 8 or more were r and omized to receive tamsulosin ( 0.4 mg/d ) with either extended-release oxybutynin ( 10 mg/d ) or placebo for 12 weeks . Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions . Postvoid residual volume and peak flow rates at weeks 4 , 8 , and 12 were measured . The primary end point was change from baseline in total IPSS after 12 weeks of treatment . Secondary outcomes included change in IPSSs for storage and quality of life . RESULTS Tamsulosin combined with extended-release oxybutynin result ed in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 ( P=.03 ) and 12 ( P=.006 ) weeks of treatment , and improved IPSS for storage and quality of life at all assessment points ( P<.01 ) . The incidence of postvoid residual volume higher than 300 mL was 2.9 % ( 6/209 ) in patients receiving combination therapy compared with 0.5 % ( 1/209 ) in patients receiving tamsulosin alone ( P=.12 ) . Occurrence of peak flow rates below 5 mL/s was 3.8 % ( 8/209 ) for combination therapy and 5.7 % ( 12/209 ) for tamsulosin alone ( P=.49 ) . CONCLUSION In men with substantial storage symptoms , combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy 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 ) This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ( ED ) and lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH/LUTS ) . The trial was conducted in hospitals in Beijing , Shanghai , Changsha , Wuhan and Guangzhou , five major cities in China . A total of 250 patients diagnosed with ED and BPH/LUTS aged 50 - 75 years , and who had International Index of Erection Function-5 ( IIEF-5 ) scores ≤21 and International Prostate Symptom Score ( IPSS ) ≥10 points , were enrolled and r and omly divided into Group A ( 168 cases ; doxazosin GITS 4 mg once daily plus sildenafil 25 - 100 mg on dem and ) and Group B ( 82 cases ; sildenafil 25 - 100 mg on dem and ) . Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life ( QoL ) question naire , and adverse effects were evaluated during the treatment period . There were no statistically significant differences in mean age , and IIEF-5 , IPSS and QoL scores pre-treatment between the two groups . After treatment , IIEF-5 , IPSS and QoL scores were significantly improved in Group A , while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment . There were no significant differences in side effects between the two groups . The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy OBJECTIVES To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia ( BPH ) undergoing stable tamsulosin therapy . METHODS In this Phase 1 , placebo-controlled , two-stage , two-way , crossover study , 22 patients undergoing stable ( longer than 4 weeks ) tamsulosin therapy for BPH ( 18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily ) received vardenafil 10 mg ( or placebo ) , followed by vardenafil 20 mg ( or placebo ) , simultaneously with tamsulosin . The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and st and ing blood pressure and heart rate for up to 6 hours after dosing . RESULTS In patients receiving vardenafil 10 mg , the mean maximal change from baseline versus placebo in supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and heart rate was -4.5 mm Hg ( 95 % confidence interval [ CI ] -8.2 to -0.8 ) , -2.3 mm Hg ( 95 % CI -4.9 to 0.4 ) , and 3.7 beats per minute ( 95 % CI 1.1 to 6.3 ) , respectively . In patients receiving vardenafil 20 mg , the mean maximal change from baseline versus placebo in supine SBP , DBP , and heart rate was -4.0 mm Hg ( 95 % CI -6.3 to -1.8 ) , -2.9 mm Hg ( 95 % CI -5.6 to -0.2 ) , and 0.8 beats per minute ( 95 % CI -1.2 to 2.9 ) , respectively . These hemodynamic changes were similar to those obtained in the st and ing position . Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in st and ing DBP ; 1 vardenafil 10-mg patient had a st and ing SBP drop of 30 mm Hg or more . No patient exhibited symptomatic hypotension ( SBP less than 85 mm Hg with dizziness ) . Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness , but never had an SBP of less than 95 mm Hg . No serious adverse events were reported . CONCLUSIONS In this study , no evidence was found that coadministered vardenafil and tamsulosin induced clinical ly significant hypotension in patients with BPH INTRODUCTION The high incidence of erectile dysfunction ( ED ) and lower urinary tract symptoms ( LUTS ) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment . Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia ) BPH . AIM To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study . MAIN OUTCOMES MEASURES International Prostate Symptoms Score ( IPSS ) , IPSS Quality of Life ( IPSS-QOL ) , maximum flow rate ( Qmax ) , post-void residual volume ( PVR ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF ) , Global Assessment Quality ( GAQ ) . For the statistical analysis , a Tukey-Kramer multicomparison test was used . METHODS A r and omized , double-blind , crossover study was conducted from September 2007 to February 2008 in one center . Thirty men , older than 50 years old , with a history of LUTS/BPH of at least 6 months , were r and omized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days , and then switched to the other treatment mode for other 45 days . RESULTS Twenty-seven patients completed the study . Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination . Both regimens similarly improved the Qmax and decreased the PVR volume from baseline ( P < 0.001 ) with no significant differences between tamsulosin alone vs. tamsulosin and tadalafil ( P > 0.05 ) . The IIEF improved with tamsulosin plus tadalafil ( P < 0.001 ) but not with tamsulosin alone ( P > 0.05 ) . The GAQ showed that all patients preferred the combination scheme . Both treatments were well tolerated . CONCLUSION ; Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated . Large-scale , r and omized , placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo .  Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 . Purpose Comparison of efficacy of propiverine extended release ( ER ) 30 mg o.d . in the treatment of male OAB administered as monotherapy ( MT ) or add-on to α-blockers ( combination treatment , CT ) in relation to maximum urinary flow ( Qmax ) in a non-interventional study . Methods Men ≥40 years with OAB symptoms , Qmax ≥10 ml/s , prostate volume < 40 ml , post-void residuals ( PVR ) < 100 ml , and IPSS < 20 were included . OAB symptoms , IPSS , and PVR were recorded before and after 12 weeks of treatment . Participants were stratified by Qmax ( group A ≥15 ml/s , group B < 15 ml/s ) and CT vs. MT . Safety parameters were monitored . Results A total of 2,219 men participated and were involved in safety analysis ; 1,849 men ( mean age 66 years ) fulfilled the inclusion criteria and were involved in efficacy analysis . In group A , 291 men  received MT and 479 CT ; in group B , 184 men  received MT and 895 CT . OAB symptoms improved significantly in all groups throughout the study without differences between MT and CT . IPSS improvement in group B was less with MT than with CT ( −3.9 vs. −5.2 ; P < 0.001 ) , whereas IPSS improvement was similar in group A ( −4.6 vs. −5.1 ) . Mean PVR change was not clinical ly relevant , but two men ( 0.1 % ) experienced urinary retention . Conclusions Under real-life conditions , treatment of OAB symptoms with propiverine ER is equally effective in men with MT or CT regardless of baseline Qmax . In men with reduced Qmax , IPSS improvement is significantly smaller with MT . The incidence of urinary retention during propiverine ER treatment is low OBJECTIVE In the treatment of the symptoms of benign prostatic hyperplasia ( BPH ) , a French guideline opposes the use of drugs in conjunction , in the absence of proven utility . The OCOS trial therefore compared one of the possible drug combinations ( tamsulosin and Serenoa repens ) with tamsulosin alone , to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH . MATERIAL AND METHODS In this double-blind , r and omised trial , patients had to have an IPSS ( International Prostate Symptom Score ) > or = 13 and a Qmax between 7 and 15 mL/s .  Tamsulosin ( 0.4 mg ) was to be administered once a day for 52 weeks , with , twice daily , a placebo ( TAM ) or Serenoa repens 160 mg ( TAM + SR ) . RESULTS 352 patients were recruited by 47 centres ; 329 ( average age 65 ) were r and omised : 161 into the TAM group and 168 into the TAM + SR group . No statistically significant difference was found between the two groups , neither for the major end-point [ change in total IPSS between the baseline value and the final evaluation ( TAM : -5.2 ; TAM + SR : -6.0 ; p = 0.286 ) ] , nor for the secondary end-points [ changes in the voiding scores ( p = 0.239 ) and in filling scores ( p = 0.475 ) of the IPSS , Qmax ( p = 0.564 ) , percentage of respondents according to the IPSS ( p = 0.361 ) , improvement in quality of life ( IPSS-QoL : p = 0.091 ; UROLIFE BPH QoL : p = 0.442 ) , safety ] . CONCLUSION The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients : the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy .  Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p < 0.001 ) . Patient reported outcome measures showed no significant between group differences . CONCLUSIONS Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin 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 PURPOSE We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average micturition volume ( 32.3 % vs 19.2 % , p = 0.004 ) , and storage ( 41.3 % vs 32.6 % , p = 0.029 ) and urgency ( p = 0.019 ) International Prostate Symptom Score symptoms were more significant in group 2 . Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention . Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 ( p = 0.002 ) . Overall adverse event rates were higher in group 2 ( p = 0.002 ) , although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups . CONCLUSIONS This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction Although ethnicity-based differences in prostate size and physiology have been reported , results of benign prostatic hyperplasia ( BPH ) treatment trials in predominantly Caucasian patients are assumed to be applicable to non-Caucasian population s. This post hoc analysis investigated whether an Asian sub population of men with moderate-to-severe BPH in the CombAT study achieves treatment responses in line with those of the overall study population . In this double-blind , r and omized , parallel-group trial , 325 Asian men were assigned to treatment with 0.5 mg dutasteride once daily , 0.4 mg tamsulosin once daily or the combination . Decrease in international prostate symptom score ( IPSS ) at month 24 from baseline ( the primary endpoint ) was significantly greater with combination treatment compared with tamsulosin ( P<0.05 ) , and numerically , but not statistically significantly , greater compared with dutasteride .  Mean IPSS was reduced from baseline by 7.5 ( ±0.84 ) in the combination group , by 6.3 ( ±0.86 ) in the dutasteride group and by 4.5 ( ±0.78 ) in the tamsulosin group , result ing in respective mean IPSS at months 24 of 11.4 ( ±0.60 ) , 12.7 ( ±0.70 ) and 14.3 ( ±0.74 ) . The adverse event profile was similar to that observed in the overall CombAT population , and drug-related adverse events were more common with combination therapy ( 26 % ) than with tamsulosin ( 15 % ) or dutasteride ( 9 % ) . No unexpected adverse events emerged . In conclusion , in Asian men with moderate-to-severe lower urinary tract symptoms and an enlarged prostate  , combination therapy achieved significantly greater improvements from baseline BPH symptoms , flow rate , quality of life , reduced prostate volume and improved treatment satisfaction compared with tamsulosin monotherapy PURPOSE We evaluated the effectiveness of single or combination drug therapy on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 3,047 men with lower urinary tract symptoms/benign prostatic hyperplasia enrolled in the Medical Therapy of Prostatic Symptoms trial were r and omly assigned to receive doxazosin alone , finasteride alone , combination therapy or placebo . Treatment effectiveness was assessed according to intent to treat by mean reduction in self-reported nightly nocturia at 1 and 4 years . A subgroup analysis by age ( younger than 70 vs 70 years old or older ) was also performed . RESULTS Of the men 2,583 reported 1 or more episodes of nocturia and finished 12 or more months of the trial .  Mean nocturia was similar in all groups at baseline . Mean nocturia was reduced at 1 year by 0.35 , 0.40 , 0.54 and 0.58 in the placebo , finasteride , doxazosin and combination groups , respectively . Reductions with doxazosin and combination therapy were statistically greater than with placebo ( p < 0.05 ) . At 4 years nocturia was also significantly reduced in patients treated with doxazosin and combination therapy ( p < 0.05 vs placebo ) . In men older than 70 years ( 495 ) all drugs significantly reduced nocturia at 1 year ( finasteride 0.29 , doxazosin 0.46 and combination 0.42 ) compared to placebo ( 0.11 , p < 0.05 ) . CONCLUSIONS Doxazosin and combination therapy reduced nocturia more than placebo , but the net benefit of active drug compared to placebo was often modest with a net difference of less than 0.20 fewer nightly nocturia episodes at 1 and 4 years . Findings in men 70 years old or older were similar , with an even smaller effect observed for finasteride PURPOSE We evaluated the efficacy of tolterodine extended release and /or tamsulosin on micturition related urgency episodes , urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials . MATERIAL S AND METHODS Men 40 years old or older with an International Prostate Symptom Score of 12 or greater , frequency ( 8 or more voids per 24 hours ) and urgency ( 3 or more episodes per 24 hours ) with or without urgency urinary incontinence were r and omized to placebo , 4 mg tolterodine extended release , 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin  for 12 weeks . Subjects completed 5-day diaries ; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline , and weeks 1 , 6 and 12 ; Overactive Bladder Question naire at baseline , and weeks 6 and 12 ; Perception of Treatment Satisfaction question at weeks 1 , 6 and 12 ; and Willingness to Continue question at week 12 . Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater . Urgency severity was measured using frequency-urgency sum , defined as the sum of urgency ratings for all micturitions . RESULTS Compared with placebo , tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1 , 6 and 12 . It also improved Patient Perception of Bladder Condition scores at weeks 1 , 6 and 12 ; improved Urgency Perception Scale and Overactive Bladder Question naire , Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12 ; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12 , and willingness to continue at week 12 . CONCLUSIONS Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials 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 OBJECTIVES TAABO was a r and omized , controlled trial to evaluate the efficacy and safety of combination therapy of tamsulosin ( TAM ) with propiverine ( PROP ) in men with both benign prostatic hyperplasia and overactive bladder . METHODS It enrolled men 50 years or older who had an international prostate symptom score ( IPSS ) of 8 or higher , an urgency item score of 1 or higher , and a quality of life ( QOL ) score of 2 or higher . After 8 weeks of TAM 0.2 mg/day , patients who met the inclusion criteria ( 8 micturitions per 24 h and 1 urgency per 24 h , evaluated by bladder diary ) and were eligible for 12-weeks of continued Treatment II . Five hundred and fifteen patients were enrolled . Thereafter , 214 patients were assigned r and omly to receive either TAM alone ( n = 67 ) , TAM plus PROP 10 mg ( n = 72 ) , or TAM plus PROP 20 mg ( n = 75 ) in Treatment II . The primary efficacy end point was a change in micturitions per 24 h documented in the bladder diary . The change from baseline in urgency episodes per 24 h , IPSS , IPSS/QOL subscore , urinary flow rate and postvoid residual volume were assessed as secondary efficacy measures . RESULTS A total of 141 men ( 47 TAM , 49 TAM plus PROP 10 mg , and 45 TAM plus PROP 20 mg patients ) were assessed by week 12 . Compared with the TAM , TAM plus PROP 10 mg patients experienced significantly fewer micturitions ( P = 0.0261 ) , urgencies ( P = 0.0093 ) per 24 h , lower IPSS storage ( P = 0.0465 ) , and IPSS urgency ( P = 0.0252 ) subscores . CONCLUSIONS These results suggest that combining TAM and 10 mg of PROP for 12 weeks provides added benefit for men with both benign prostatic hyperplasia and overactive bladder Objectives : To assess the additive benefit of combining an α1-blocker and a 5α-reductase inhibitor . Methods : This European , r and omized , double-blind , multicenter trial involved 1.051 patients with lower urinary tract symptoms related to benign prostatic hyperplasia . Patients received sustained release ( SR ) alfuzosin ( n = 358 ) , a selective α1-blocker given at a dose of 5 mg twice daily without dose titration ; finasteride ( n = 344 ) , 5 mg once daily , or both drugs ( n = 349 ) , for 6 months . Primary efficacy criteria were symptomatic improvement ( International Prostate Symptom Score : I-PSS ) and maximum flow rate ( Qmax ) . Safety was assessed by monitoring adverse events . Results : Symptomatic improvement was significantly higher from the 1st month of treatment with SR alfuzosin , alone or in combination ; mean changes in I-PSS versus baseline at end-point were –6.3 and –6.1 , respectively , compared with –5.2 with finasteride alone ( SR alfuzosin vs. finasteride , p = 0.01 ; combination vs. finasteride , p = 0.03 ) . The percentages of patients with a decrease in I-PSS of at least 50 % were 43 , 42 and 33 % for SR alfuzosin , the combination and finasteride , respectively ( SR alfuzosin vs. finasteride , p = 0.008 ; combination vs. finasteride , p = 0.009 ) . In the overall population , increases in Qmax were greater with SR alfuzosin and the combination , compared with finasteride alone after 1 month of therapy , but changes at end-point were similar in the three treatment groups . In those 47 % of patients likely to be obstructed ( baseline Qmax < 10 ml/s ) , however , mean increases in Qmax were significantly higher with SR alfuzosin , alone or in combination , whatever the  visit . Finasteride , alone or in combination , significantly impaired sexual function . The incidence of postural symptoms was low and similar in the three treatment groups . Conclusion : In this 6-month trial , SR alfuzosin was more effective than finasteride , with no additional benefit in combining both drugs OBJECTIVE To investigate the effect of combination therapy with dutasteride plus tamsulosin compared with each monotherapy on patient-reported health outcomes over 4 years in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) because of benign prostatic hyperplasia ( BPH ) . METHODS CombAT was a 4-year international , double-blind , r and omised , parallel-group trial in men ( n = 4844 ) with moderate-to-severe symptoms of BPH and at increased risk of disease progression [ age > or = 50 years , International Prostate Symptom Score ( IPSS ) > or = 12 , prostate volume > or = 30 cc , serum prostate-specific antigen > or = 1.5 ng/ml to < or = 10 ng/ml and maximum urinary flow rate 5 - 15 ml/s with minimum voided volume > or = 125 ml ] . Subjects were r and omised to receive 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . The primary endpoint at 4 years was the time to event and proportion of subjects with acute urinary retention or undergoing BPH-related prostate surgery . Secondary endpoints included the health- outcomes measures , BPH Impact Index ( BII ) , IPSS question 8 ( IPSS Q8 ) and the Patient Perception of Study Medication ( PPSM ) question naire . RESULTS At 4 years , combination therapy result ed in significantly superior improvements from baseline in BII and IPSS Q8 than either monotherapy ; these benefits were observed from 3 months onwards compared with dutasteride and from 9 months ( BII ) or 12 months ( IPSS Q8 ) onwards compared with tamsulosin . Also at 4 years , the PPSM question naire showed that a significantly higher proportion of patients was satisfied with , and would request treatment with , combination therapy compared with either monotherapy . CONCLUSIONS Combination therapy ( dutasteride plus tamsulosin ) provides significantly superior improvements in patient-reported quality of life and treatment satisfaction than either monotherapy at 4 years in men with moderate-to-severe BPH symptoms The recent introduction of selective alpha-adrenoceptor blockers adds a further therapeutic option for the treatment of benign prostatic hyperplasia ( BPH ) .  Tamsulosin , a selective alpha 1-blocker , has proved effective in relieving irritative and obstructive symptoms caused by BPH . To investigate whether the combination of tamsulosin with the anti- and rogenic drug chlormadinone is of further therapeutic benefit , 80 patients r and omly received tamsulosin 0.2 mg daily , chlormadinone 50 mg daily or a combination of tamsulosin 0.2 mg and chlormadinone 50 mg daily for 16 weeks . Greater improvement in subjective symptoms of BPH was obtained with either tamsulosin alone or in combination with chlormadinone than with chlormadinone alone . However , the greatest improvement in objective uroflowmetric data was obtained with chlormadinone in combination with tamsulosin . Thus , the combination of tamsulosin with chlormadinone appears to be more beneficial than either of these agents used as monotherapy . Further investigation is required to fully evaluate the therapeutic effects of this combination . After the trial period one-third of the chlormadinone and tamsulosin/chlormadinone-treated patients needed no further treatment due to the satisfactory relief of symptoms . At 12 months follow-up , however , one-fourth of the patients had undergone transurethral resection of the prostate ( TUR-P ) regardless of medication . This suggests a limitation of the medical treatment of BPH PURPOSE We measured the detailed hemodynamic effects of tamsulosin and sildenafil separately and together in patients with benign prostatic enlargement . MATERIAL S AND METHODS The supine effects of and responses to passive orthostasis ( 60 degrees for 8 minutes ) were measured in 16 patients with benign prostatic enlargement with the finger blood pressure method and whole-body impedance cardiography . The medications , 100 mg sildenafil ( single doses ) and 0.4 mg tamsulosin ( once daily for up to 14 days ) , were administered in a r and omized , double-blind , crossover fashion . RESULTS Supine systolic arterial pressure decreased with sildenafil ( mean + /- SEM -11 + /- 2 mm Hg ) and sildenafil plus tamsulosin ( -14 + /- 2 mm Hg ) more than with placebo ( -2 + /- 4 mm Hg , p < 0.05 ) . In comparison to placebo sildenafil plus tamsulosin decreased the systemic vascular resistance index ( 328 + /- 129 vs -241 + /- 134 dyn.sec/cm.m , p = 0.01 ) . Tamsulosin alone did not cause any significant changes in comparison to placebo .  Heart rate , diastolic arterial pressure , stroke index , cardiac index and arterial pulse wave velocity were not affected to a statistically significant degree by any of the treatments compared to placebo . Upon head-up tilt the drugs caused only 1 significant change in that diastolic arterial pressure was significantly higher ( -2.7 vs -8.0 mm Hg , p = 0.04 ) in the placebo group than in the tamsulosin plus sildenafil group . CONCLUSIONS Tamsulosin does not disturb hemodynamics in patients with benign prostatic enlargement . Sildenafil decreases blood pressure with the patient supine but not during head-up tilt . The combination treatment also decreases the systemic vascular resistance index in the supine position 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 BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy OBJECTIVES To evaluate the efficacy and tolerability of the selective alpha(1)-adrenergic antagonist doxazosin and the 5-alpha-reductase inhibitor finasteride , alone and in combination , for the symptomatic treatment of benign prostatic hyperplasia . METHODS In a prospect i ve , double-blind , placebo-controlled trial , 1095 men aged 50 to 80 years were r and omized to treatment for 52 weeks with doxazosin , finasteride , the combination of doxazosin and finasteride , or placebo . The dose of finasteride ( or its matched placebo ) was 5 mg/day . Doxazosin ( or its matched placebo ) was initiated at 1 mg/day , and titrated up to a maximum of 8 mg/day over approximately 10 weeks according to the response of the maximal urinary flow rate ( Qmax ) and International Prostate Symptom Score ( IPSS ) . The IPSS and Qmax were assessed at baseline and at weeks 10 , 14 , 26 , 39 , and 52 or at the endpoint . RESULTS An intent-to-treat analysis of 1007 men showed doxazosin and doxazosin plus finasteride combination therapy produced statistically significant improvements in total IPSS and Qmax compared with placebo and finasteride alone ( P < 0.05 ) . Finasteride alone was not significantly different statistically from placebo with respect to total IPSS and Qmax . All treatments were generally well tolerated . CONCLUSIONS Doxazosin was effective in improving urinary symptoms and urinary flow rate in men with benign prostatic hyperplasia , and was more effective than finasteride alone or placebo . The addition of finasteride did not provide further benefit to that achieved with doxazosin alone BACKGROUND Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder ( OAB ) . OBJECTIVE To evaluate the efficacy of tolterodine extended release ( ER ) in men on alpha-blocker therapy . DESIGN , SETTING , AND PARTICIPANTS This double-blind trial included men aged > or = 40 yr with frequency , urgency , and at least moderate problems reported on the Patient Perception of Bladder Condition ( PPBC ) , despite being on a stable dose of alpha-blocker for > or = 1 mo . INTERVENTIONS Subjects were r and omized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy . MEASUREMENTS At baseline and week 12 , subjects completed the PPBC , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Question naire ( OAB-q ) , and 5-d bladder diaries using the five-point Urinary Sensation Scale ( USS ) . Frequency-urgency sum was defined as the sum of USS ratings for all micturitions . RESULTS AND LIMITATIONS PPBC improvement from baseline to week 12 was reported by 63.6 % and 61.6 % of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker , respectively ; this treatment difference , which was the primary end point , was not statistically significant ( p>0.6699 ) . At week 12 , subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions ( -1.8 vs -1.2 ; p=0.0079 ) and daytime micturitions ( -1.3 vs -0.8 ; p=0.0123 ) ; 24-h urgency episodes ( -2.9 vs -1.8 ; p=0.0010 ) , daytime urgency episodes ( -2.2 vs -1.4 ; p=0.0017 ) , and nocturnal urgency episodes ( -0.5 vs -0.3 ; p=0.0378 ) ; frequency-urgency sum ( -7.8 vs -5.1 ; p=0.0065 ) ; IPSS storage subscale ( -2.6 vs -2.1 ; p=0.0370 ) ; and OAB-q symptom bother scale ( -17.9 vs -14.4 ; p=0.0086 ) and coping domain ( 15.4 vs 12.4 ; p=0.0491 ) . Acute urinary retention requiring catheterization occurred in < 1 % of either group . There were no clinical ly meaningful changes in postvoid residual volume or maximum urinary flow rate .  CONCLUSIONS Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables , IPSS Storage scores , and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews .  A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed PURPOSE We evaluate the efficacy of medical therapy on nocturia in men with benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS We performed a secondary analysis of data from the VA Cooperative Study Program Trial in which 1,229 men with BPH 45 to 80 years old were r and omly assigned to receive terazosin , finasteride , combination or placebo . RESULTS The 1,078 men who completed 12 months of the trial are included in this study . Of those men 1,040 ( 96.5 % ) had at least 1 episode of nocturia at baseline and 38 ( 3.5 % ) had less than 1 episode ( baseline nocturia is an average of 2 measures ) . Of those 1,040 men 788 ( 75.8 % ) had 2 or more nocturia episodes . Overall , nocturia decreased from a baseline mean of 2.5 to 1.8 , 2.1 , 2.0 and 2.1 episodes in the terazosin , finasteride , combination and placebo groups , respectively . Of men with 2 or more episodes of nocturia 50 % reduction in nocturia was seen in 39 % , 25 % , 32 % and 22 % in the terazosin , finasteride , combination and placebo groups , respectively . Changes in nocturia were correlated with changes in reported bother from nocturia ( Pearson correlation 0.48 ) , BPH impact index ( 0.32 ) and overall satisfaction with urinary symptoms ( 0.33 ) . CONCLUSIONS Terazosin and combination therapy reduced nocturia in men with BPH , yet the net advantage of terazosin over placebo was a net reduction of 0.3 nocturia episode . For a person to reach a 50 % or greater reduction in nocturia , the advantage of terazosin over placebo was 17 percentage points . Changes in nocturia had a moderate impact on symptom specific quality of life measures This article reports the results of a post hoc analysis of the multicenter , r and omized , double-blind Combination of Avodart and Tamsulosin ( CombAT ) study , which aim ed to investigate the effects of dutasteride ( 0.5 mg ) , tamsulosin ( 0.4 mg ) , and their combination on storage and voiding symptoms in 4844 men aged ⩾50 years with moderate-to-severe lower urinary tract symptoms ( International Prostate Symptom Score ⩾12 ) , prostate volume ( PV ) ⩾30 cm3 and PSA 1.5–10 ng ml−1 . After 24 months , combination treatment achieved significantly greater mean reductions in both voiding and storage symptoms than either monotherapy , in each of the three baseline PV tertiles ( 30 to < 42 , 42 to < 58 , ⩾58 cm3 ) . Dutasteride was as effective as tamsulosin for control of storage symptoms , but provided significantly greater relief of voiding symptoms than tamsulosin Purpose To evaluate the efficacy of sildenafil citrate only , 25 mg . Four times/week , tamsulosin only , 0.4 mg once daily , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostate hyperplasia ( BPH ) and erectile dysfunction . Methods A total of 60 men with BPH-related LUTS were r and omized to receive sildenafil citrate only ( n = 20 ) , tamsulosin only ( n = 20 ) , and the combination of both ( n = 20 ) for 8 weeks . Changes from baseline in International Prostate Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , post voiding residual urine volume ( PRV ) , Sexual Health Inventory for Male ( SHIM ) score , 3rd and 4th questions of International Index of Erectile Function ( IIEF ) were assessed at the end of the treatment . Results The mean age was 58 years .  IPSS , Qmax , PRV , SHIM scores , and 3rd and 4th questions in IIEF significantly improved in each group . Improvement of IPSS was more remarkable in combination ( 40.1 % ) and tamsulosin only ( 36.2 % ) groups in comparison with sildenafil citrate only group ( 28.2 % ; p < 0.001 ) . Improvement of Qmax and PRV were greater in tamsulosin only and combination than sildenafil citrate only group . SHIM scores significantly improved in sildenafil citrate only ( 65 % ) and combination ( 67.4 % ) than tamsulosin only ( 12.4 % ; p < 0.001 ) . Increases in the 3rd and 4th questions of IIEF were greater in sildenafil only and combination than tamsulosin only ( p < 0.001 ) . Conclusions Treatment with the combination of tamsulosin only and sildenafil citrate only was not superior to tamsulosin only to enhance voiding symptoms . Also , sexual function improvement was similar for both the combination and sildenafil citrate only treatments Study Type – Symptom prevalence ( prospect i ve cohort PURPOSE Tadalafil , a phosphodiesterase type 5 inhibitor , is effective therapy for erectile dysfunction ( ED ) . Men with ED have a high incidence of comorbid conditions including cardiovascular disease , diabetes mellitus and benign prostatic hyperplasia . Although phosphodiesterase type 5 inhibitors are safe when administered with most medications , sildenafil given with doxazosin and vardenafil given with terazosin evoke orthostatic hypotension in some patients . We examined the hemodynamic interactions of tadalafil with the alpha-blockers doxazosin and tamsulosin . MATERIAL S AND METHODS In separate double-blind , placebo controlled , r and omized crossover studies ( 18 patients in each study ) we evaluated the hemodynamic effects of doxazosin 8 mg with tadalafil 20 mg , and tamsulosin 0.4 mg with tadalafil 10 and 20 mg .  Blood pressure ( BP ) and heart rate were recorded before dosing and for 24 hours after dosing . RESULTS Tadalafil 20 mg augmented the hypotensive effect of doxazosin by producing a mean maximal decrease in st and ing systolic BP ( SBP ) that was significantly greater than placebo ( a mean difference of 9.8 mm Hg ) . Analysis of BP outliers showed that the number of subjects with a st and ing SBP of less than 85 mm Hg was greater after doxazosin plus tadalafil ( 28 % ) versus doxazosin plus placebo ( 6 % ) . In subjects on tamsulosin , tadalafil 10 and 20 mg produced mean maximal decreases in st and ing SBP that were similar to placebo ( mean difference of 1.7 and 2.3 mm Hg , respectively ) . No subject taking tamsulosin had a decrease in st and ing SBP less than 85 mm Hg . CONCLUSIONS Tadalafil augmented the hypotensive effects of doxazosin but had little hemodynamic interaction with tamsulosin . In patients taking tadalafil for ED , tamsulosin 0.4 mg may be given for the treatment of benign prostatic hyperplasia OBJECTIVES To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms ( LUTS ) men with residual overactive bladder ( OAB ) symptoms despite tamsulosin monotherapy . METHODS In this r and omized , multicenter , double-blind study , male LUTS patients aged≥50 years with urgency episodes/24 hours≥2 and micturitions/24 hours≥8 were r and omized to 3 groups : 12-weeks tamsulosin plus placebo ( TAM+PBO ) , tamsulosin plus solifenacin 2.5 mg ( TAM+SOL ) , and tamsulosin plus solifenacin 5 mg ( TAM+SOL ) . Changes from baseline to end of treatment in the number of urgency episodes/24 hours ( primary endpoint ) , micturitions , nocturia , urgency incontinence episodes , International Prostate Symptom Scores ( IPSS ) , and Overactive Bladder Symptom Score ( OABSS ) were compared between the TAM+SOL groups and TAM+PBO . Safety was assessed on adverse events , postvoid residual volume , and maximal urinary flow rate ( Qmax . ) . RESULTS Six-hundred thirty-eight men were r and omized . Urgency was reduced by 2.2 and 2.4 episodes in the TAM+SOL 2.5 and 5 mg groups , respectively . The TAM+SOL 5 mg group showed significant improvement compared with TAM+PBO ( -2.4 vs -1.9 , P=.049 ) . The number of micturitions in both TAM+SOL groups were significantly reduced compared with TAM+PBO ( both P<.001 ) . IPSS storage symptom score and OABSS significantly improved in both TAM+SOL groups compared with TAM+PBO . Changes in IPSS voiding symptom score and Qmax . were similar in all groups . Four patients ( 1.9 % ) in the TAM+SOL 5 mg group had urinary retention , but all recovered after catheterization . CONCLUSIONS In male LUTS patients with residual OAB symptoms  despite tamsulosin monotherapy , TAM+SOL showed efficacy on urgency , which represents OAB symptoms and was well tolerated 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 PURPOSE We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement ( 30 cc or greater ) . We report preplanned 2-year analyses . MATERIAL S AND METHODS The CombAT study is an ongoing , multicenter , r and omized , double-blind , parallel group study . Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia , International Prostate Symptom Score 12 points or greater , prostate volume 30 cc or greater , total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were r and omized to 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months . The primary end point at 2 years was the change in International Prostate Symptom Score from baseline . RESULTS Combination therapy result ed in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9 , and in benign prostatic hyperplasia related health status from months 3 and 12 , respectively . There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6 . There was a significant increase in drug related adverse events with combination therapy vs monotherapies , although most did not result in the cessation of therapy . CONCLUSIONS In men with moderate to severe lower urinary tract symptoms and prostate enlargement ( 30 cc or greater ) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy OBJECTIVES The Symptom Management After Reducing Therapy ( SMART-1 ) study examined the combination of the dual action 5alpha-reductase inhibitor ( 5ARI ) dutasteride , and alpha(1)-blocker tamsulosin , followed by withdrawal of tamsulosin in men with symptomatic BPH . METHODS 327 BPH patients were r and omised to 0.5 mg dutasteride and 0.4 mg tamsulosin for 36 weeks ( DT36 ) or 0.5 mg dutasteride and 0.4 mg tamsulosin for 24 weeks followed by dutasteride and tamsulosin matched placebo for the remaining 12 weeks ( DT24+D12 ) . Patients ' assessment of their symptoms , IPSS at weeks 24 , 30 , and drug safety were evaluated . RESULTS 77 % of DT24+D12 patients felt the same/better at week 30 compared with week 24 ( changes in IPSS were consistent with this finding ) . Of those subjects with an IPSS < 20 who changed to dutasteride monotherapy at week 24 , 84 % switched without a noticeable deterioration in their symptoms . In the 27 % of men with severe baseline symptoms ( IPSS > or=20 ) who had withdrawal of tamsulosin therapy at week 24 , 42.5 % reported a worsening of their symptoms compared with 14 % in the DT36 group . The regimens were well tolerated . CONCLUSIONS Dutasteride can be used in a 24-week combination with tamsulosin , to achieve rapid onset of symptom relief in patients at risk of underlying disease progression . This symptom relief is maintained in the majority of patients after the alpha(1)-blocker is removed from the combination . Patients with severe symptoms may benefit from longer-term combination therapy BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia .  American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone OBJECTIVES To investigate the therapeutic efficacy and safety of Amlodipine alone or in combination with terazosin for the presence of lower urinary tract symptoms ( LUTS ) and hypertension . LUTS and hypertension often coexist in elderly men . METHODS A total of 355 patients with Stage 1 or 2 hypertension and LUTS ( as defined by an International Prostate Symptom Score of > or = 10 ) were r and omly assigned to receive 2 mg of terazosin ( n = 117 ) , 5 mg of Amlodipine ( n = 119 ) , or 5 mg of Amlodipine plus 2 mg of terazosin ( n = 119 ) once daily for a total of 28 days . The primary outcomes were a reduction in the total and subscores of the International Prostate Symptom Score and blood pressure . Analyses were performed by intention to treat . This trial is registered with Clinical Trials.gov ( No. NCT00693199 ) . RESULTS At day 28 of the trial , the Amlodipine plus terazosin group demonstrated comparable efficacy in lowering the total International Prostate Symptom Score and significant improvement in the presence of overactive bladder compared with the terazosin group ( P < .05 ) and significant improvement in quality of life compared with the Amlodipine group ( P < .05 ) . The Amlodipine plus terazosin group also achieved the greatest blood pressure control compared with either the terazosin group ( P < .01 ) or Amlodipine group ( P < .05 ) . All 3 treatment regimens were well tolerated by the study patients . CONCLUSIONS The results of this 4-week , double-blind , r and omized trial have demonstrated that in Chinese male hypertensive patients with LUTS , low-dose Amlodipine plus terazosin therapy appears to be a safe and effective combination therapy to control both conditions , especially for those with predominant overactive bladder symptoms BACKGROUND And rogens are involved in the development of prostate cancer . Finasteride , an inhibitor of 5alpha-reductase , inhibits the conversion of testosterone to dihydrotestosterone , the primary and rogen in the prostate , and may reduce the risk of prostate cancer . METHODS In the Prostate Cancer Prevention Trial , we r and omly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen ( PSA ) level of 3.0 ng per milliliter or lower to treatment with finasteride ( 5 mg per day ) or placebo for seven years .  Prostate biopsy was recommended if the annual PSA level , adjusted for the effect of finasteride , exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal . It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study . The primary end point was the prevalence of prostate cancer during the seven years of the study . RESULTS Prostate cancer was detected in 803 of the 4368 men in the  finasteride  group who had data for the final analysis ( 18.4 percent ) and 1147 of the 4692 men in the placebo group who had such data ( 24.4 percent ) , for a 24.8 percent reduction in prevalence over the seven-year period ( 95 percent confidence interval , 18.6 to 30.6 percent ; P<0.001 ) . Tumors of Gleason grade 7 , 8 , 9 , or 10 were more common in the finasteride group ( 280 of 757 tumors [ 37.0 percent ] , or 6.4 percent of the 4368 men included in the final analysis ) than in the placebo group ( 237 of 1068 tumors [ 22.2 percent ] , P<0.001 for the comparison between groups ; or 5.1 percent of the 4692 men included in the final analysis , P=0.005 for the comparison between groups ) . Sexual side effects were more common in finasteride-treated men , whereas urinary symptoms were more common in men receiving placebo . CONCLUSIONS Finasteride prevents or delays the appearance of prostate cancer , but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high- grade prostate cancer Objectives : A prospect i ve study was conducted in a community hospital in order to evaluate the therapeutic effect of dibenyline , finasteride , and a combination of the two drugs for symptomatic benign prostatic hyperplasia ( BPH ) . Methods : 190 men suffering from severe prostatism entered this study . They were assessed by IPSS symptom score , digital rectal examination , transrectal sonography of the prostate , uroflowmetry and residual urine . The patients were r and omly selected for medical treatment with dibenyline 10 mg b.i.d . ( n = 71 ) , finasteride 5 mg q.d . ( n = 54 ) , and a combination ( n = 65 ) . Clinical assessment s were carried out before treatment and 3 and 6 months after starting treatment . Patients who could not complete the treatment and those with prostatic cancer were excluded from the final statistics . The quality of life after 6 months of treatment and side effects were also assessed . Results : A total of 172 patients completed the treatment course and 153 patients completed the periodic clinical assessment s. Improvement in IPSS was noted in all 3 groups of patients both at 3 and 6 months . The prostatic volume was found to decrease in the finasteride group and the combination group at 6 months by 24.3 and 10.5 % , respectively . Maximal flow rate ( Qmax ) was significantly improved in the dibenyline and combination groups but not in the finasteride group at 3 months . At 6 months a significant increase in Qmax was noted in all groups with a mean increase of 1.4–1.8 ml/s . The quality of life after treatment was satisfactory in 71.9 % of the dibenyline group , 70.4 % of the finasteride group and 83.1 % of the combination group . Side effects were higher in the dibenyline than the finasteride or combination group . The dropout rate was higher in the dibenyline group ( 15.5 % ) than in the finasteride ( 7.5 % ) and combination ( 4.6 % ) groups . After 6 months of treatment , some of the patients discontinued medication and symptom relapse was noted in 92.6 % of the dibenyline group , 57.6 % of the finasteride group , and 71 % of the combination group . Conclusions : Medical treatment is effective in treating symptomatic BPH . Combination dibenyline and finasteride provides a weak synergistic clinical effect without additive side effects OBJECTIVES To evaluate the efficacy of tolterodine extended release ( ER ) , tamsulosin , and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen ( PSA ) level . METHODS We performed a post hoc analysis of data from men > or=40 years old with frequency and urgency ( with or without urge urinary incontinence ) , postvoid residual urine volume < 200 mL , maximal urinary flow rate > 5 mL/s , International Prostate Symptom Score ( IPSS ) of > or=12 , and quality -of-life score of > or=3 . They had been r and omized to placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER plus tamsulosin for 12 weeks . The men were stratified by the median baseline PSA level ( > or=1.3 vs < 1.3 ng/mL ) . Assessment s included changes in bladder diary variables and IPSSs . The men rated the urgency level of each micturition , and the frequency-urgency sum was defined as the total of these ratings . RESULTS The PSA level correlated significantly with prostate size . Men with a PSA level of > or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency , daytime frequency , the frequency-urgency sum , total IPSS , and IPSS storage score compared with those receiving placebo . Tamsulosin significantly improved the IPSS voiding scores , but tolterodine ER was ineffective . In men with a PSA level < 1.3 ng/mL , tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency , daytime frequency , frequency-urgency sum , and IPSS storage scores compared with those receiving placebo ; tamsulosin alone was ineffective . No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group , and the acute urinary retention rates were low . CONCLUSIONS The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms , including overactive bladder , who had lower PSA levels ( < 1.3 ng/mL ) PURPOSE We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction . MATERIAL S AND METHODS This was a double-blinded , r and omized , placebo controlled crossover trial . Patients with benign prostatic hyperplasia and erectile dysfunction treated with the doxazosin gastrointestinal therapeutic system on a regular basis , with no other antihypertensive events , were recruited . Subjects took 10 mg vardenafil or placebo in a r and omized crossover fashion with a washout period of at least 7 days between each treatment . The supine and st and ing blood pressure of the subjects was recorded from 1 hour before to 6 hours after the administration of vardenafil or placebo . The primary outcome of the study was the maximal change in st and ing systolic blood pressure of the subjects from 1 half hour before to 6 hours after the administration of drugs . RESULTS A total of 37 patients , 25 ( 67.6 % ) and 12 ( 32.4 % ) on the doxazosin gastrointestinal therapeutic system at 4 mg and 8 mg , respectively , completed the trial . The combination drug therapy result ed in a maximal decrease in st and ing systolic blood pressure of 6.18 mm Hg ( 95 % CI -12.02 , -0.33 ; p = 0.039 ) . Only 1 patient had an asymptomatic st and ing systolic blood pressure of less than 85 mm Hg . Otherwise no symptomatic hypotension or clinical ly significant adverse cardiovascular event was observed during the study . CONCLUSIONS In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects BACKGROUND Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia ( BPH ) receiving medical therapy may help to improve outcomes and cost effectiveness . OBJECTIVES To examine the influence of baseline parameters on changes in International Prostate Symptom Score ( IPSS ) and maximum urinary flow rate ( Q(max ) ) in men with BPH receiving dutasteride , tamsulosin , or a combination of the two using 2-yr Combination of Avodart and Tamsulosin ( CombAT ) study data . DESIGN , SETTING , AND PARTICIPANTS CombAT is an ongoing , 4-yr , multicentre , r and omised , double-blind study in 4844 men aged > or=50 yr with clinical diagnosis of BPH , IPSS > or=12 , prostate volume > or=30 cm(3 ) , prostate-specific antigen ( PSA ) 1.5 - 10 ng/ml , and Q(max ) > 5 and < or=15 ml/s with minimum voided volume > or=125 ml . INTERVENTION Daily tamsulosin 0.4 mg , dutasteride 0.5 mg , or the combination . MEASUREMENTS Post hoc analyses of mean IPSS and Q(max ) changes from baseline by treatment group and by baseline prostate volume , PSA , age , body mass index ( BMI ) , IPSS , IPSS quality of life ( QoL ) score , BPH Impact Index score , Q(max ) , and previous BPH medical therapy . RESULTS AND LIMITATIONS Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups , with benefit onset varying by baseline prostate volume . Combination therapy was also more effective in improving Q(max ) versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups . At 24 mo , dutasteride monotherapy result ed in significantly greater IPSS improvements versus tamsulosin in men with lower age , worse symptoms , worse QoL , less bother , higher BMI , greater Q(max ) , higher prostate volume , and higher PSA at baseline . Post hoc analyses , the lack of placebo control , and the exclusion of men with unsuccessful medical BPH treatment are study limitations . CONCLUSIONS Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy . Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms BACKGROUND Some men with lower urinary tract symptoms ( LUTS ) including overactive bladder ( OAB ) symptoms may benefit from antimuscarinic therapy , with or without an alpha-adrenergic antagonist . OBJECTIVES To evaluate the safety and efficacy of tolterodine extended release ( ER ) , tamsulosin , or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials , stratified by prostate size . DESIGN , SETTING , AND PARTICIPANTS Subjects with an International Prostate Symptom Score ( IPSS ) > or=12 ; frequency and urgency , with or without urgency urinary incontinence ; postvoid residual volume ( PVR ) < 200 mL ; and maximum urinary flow rate ( Q(max ) ) > 5 mL/s were r and omized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER+tamsulosin for 12 wk . Data were stratified by median baseline prostate volume ( < 29 mL vs > or=29 mL ) . MEASUREMENTS Endpoints included week 12 changes in bladder diary variables , IPSS scores , and safety variables . RESULTS AND LIMITATIONS Among men with larger prostates , tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) ; urgency ( p=0.006 ) ; and IPSS total ( p=0.001 ) , storage ( p<0.001 ) , and voiding scores ( p<0.013 ) . Tamsulosin significantly improved IPSS voiding scores ( p=0.030 ) . Among men with smaller prostates , tolterodine ER significantly improved frequency ( p=0.016 ) , UUI episodes ( p=0.036 ) , and IPSS storage scores ( p=0.005 ) . Tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) and IPSS storage scores ( p=0.018 ) . Tamsulosin significantly improved nocturnal frequency ( p=0.038 ) and IPSS voiding ( p=0.036 ) and total scores ( p=0.044 ) . There were no clinical ly or statistically significant changes in Q(max ) or PVR ; incidence of acute urinary retention ( AUR ) was low in all groups ( < or=2 % ) . CONCLUSIONS Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER . Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size . Tolterodine ER , with or without tamsulosin , was well tolerated and not associated with increased incidence of AUR
target: This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for < 1 yr , α1-blockers alone are just as effective .
  The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events .
  It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr .
  The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy .
  Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy .
  The combination seems to be safe in men with postvoid residual < 200 ml .
  The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports .
  CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr .
  Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
background: BACKGROUND Several drugs are approved for the treatment of lower urinary tract symptoms ( LUTS ) in men , but these are mostly used by clinicians as monotherapies .
  The combination of different compounds , each of which targets a different aspect of LUTS , seems appealing .
  However , only few clinical trials have evaluated the effects of combination therapies .
  OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS .