Clinical comparison of selective and non-selective alpha 1A-adrenoceptor antagonists for bladder outlet obstruction associated with benign prostatic hyperplasia: studies on tamsulosin and terazosin in Chinese patients. The Chinese Tamsulosin Study Group. Comparison and Efficacy of Low-Dose and Standard-Dose Tamsulosin and Alfuzosin in Medical Expulsive Therapy for Lower Ureteral Calculi: Prospective, Randomized, Comparative Study Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Effectiveness of Low-dose and Standard-dose Tamsulosin in the Treatment of Distal Ureteric Stones: A Randomized Controlled Study Clinical comparison of selective and non-selective alpha 1A-adrenoreceptor antagonists in benign prostatic hyperplasia: studies on tamsulosin in a fixed dose and terazosin in increasing doses. Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects. 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. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. Tamsulosin, a selective alpha 1c-adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic 'obstruction' (symptomatic BPH). The European Tamsulosin Study Group. A Randomized Crossover Study Comparing Patient Preference for Tamsulosin and Silodosin in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Efficacy of low dose tamsulosin in medical expulsive therapy for ureteral stones in Japanese male patients: a randomized controlled study. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. 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. Treatment satisfaction with low-dose tamsulosin for symptomatic benign prostatic hyperplasia: results from a multicentre cross-sectional survey. A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia
To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists , we compared a selective ( tamsulosin ) and non-selective ( terazosin ) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia ( BPH ) . The study was a single-blind , r and omized , multicenter design to compare a fixed dose of tamsulosin ( 0.2 mg ) or terazosin ( 2 mg ) given once daily after breakfast for four weeks . A total of 212 patients were enrolled with 201 patients included in the analysis . The primary variables assessed were changes in total International Prostatic Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , and average urinary flow rate ( AFR ) four weeks after dosing . Adverse events were recorded through the treatment period . Both tamsulosin and terazosin produced significant improvements in total IPSS ( total score of 11.8 + /- 4.5 ; decrease in 45.1 % and total score of 13.3 + /- 5.3 ; decrease in 39.0 % , respectively ) ( p < 0.001 ) , Qmax ( 13.2 + /- 4.1 mL/s , 37.5 % increase and 13.6 + /- 3.6 mL/s , 30.8 % increase , respectively ) ( p < 0.001 ) and AFR ( 7.7 + /- 3.3 mL/s , 37.5 % increase and 7.8 + /- 3.1 mL/s , 25.8 % increase , respectively ) ( p < 0.001 ) at endpoint . Tamsulosin was superior to terazosin in improvement of total IPSS ( p < 0.05 ) and AFR ( p < 0.05 ) . The incidence of adverse events by administration of tamsulosin was less than that by terazosin ( 13 and 50 , respectively ; p < 0.01 ) . Among the adverse event , incidence of dizziness ( p < 0.001 ) and hypotension ( p < 0.01 ) by administration of terazosin were significantly greater than that by tamsulosin . Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin ( p < 0.01 ) . These results suggest that tamsulosin , a selective alpha 1A-adrenoceptor antagonist , was superior to terazosin , a non-selective alpha 1-adrenoceptor antagonist , in efficacy and adverse events in patients with symptomatic BPH Purpose Typically in Korea , for a st and ard dose ( 0.4 mg ) of tamsulosin , two low doses ( 0.2 mg ) are administered . The aim of this study was to evaluate and compare the efficacy of tamsulosin ( 0.2 mg and 0.4 mg ) and alfuzosin ( 10 mg ) in the treatment of lower ureteral stones . Material s and Methods A total of 141 patients presenting with a single 4- to 10-mm sized lower ureteral stone were r and omly assigned to 4 groups . Patients in group 1 ( n=41 ) and group 2 ( n=30 ) received an oral dose of 0.2 mg tamsulosin once and twice daily , respectively , and patients in group 3 ( n=36 ) received a daily oral dose of 10 mg alfuzosin . Patients in group 4 ( n=34 ) received trospium chloride only . The spontaneous passage of stones , the stone expulsion time , and adverse effects were evaluated . Results There were no significant differences in patient background , including age , sex , BMI , stone size , stone side , and symptom duration . The spontaneous stone passage rate through the ureter was higher and the stone expulsion time was faster in groups 1 , 2 , and 3 than in group 4 . There were no statistically different changes in groups 1 , 2 , and 3 . The adverse effects observed in all groups were comparable and were mild . Conclusions Tamsulosin at 0.2 mg and 0.4 mg and alfuzosin ( 10 mg ) proved to be safe and effective . A first cycle of medical expulsive therapy with tamsulosin 0.2 mg could be considered as an option in the management of single lower ureteral stone OBJECTIVES To evaluate the efficacy and safety of two once-daily doses of tamsulosin , the first selective alpha1A-antagonist studied in clinical trials . METHODS Patients with benign prostatic hyperplasia ( BPH ) were r and omized to receive either tamsulosin ( 0.4 and 0.8 mg/day ) or placebo ( n = 756 ) . Primary efficacy parameters were improvement in the total American Urological Association ( AUA ) symptom score and peak urinary flow ( Qmax ) . Secondary efficacy parameters were improvement in measurements at individual double-blind visits corresponding to the primary efficacy parameters ; percentage of patients with a 3-mL/s increase in Qmax ; total AUA irritative , obstructive , and bother scores ; individual AUA symptom scores ; total , irritative , obstructive , and individual Boyarsky symptom scores ; average urinary flow rate and other uroflowmetric parameters ; and investigator 's global assessment . RESULTS Statistically significant improvements in all efficacy parameters were observed in tamsulosin-treated compared with placebo-treated patients . Additionally , the 0.4-mg/day dose demonstrated a rapid onset of action ( 4 to 8 hours ) based on Qmax after the first dose of double-blind medication . A review of the safety parameters demonstrated excellent tolerance at 1 week after the initial 0.4-mg/day dose and continued tolerance during the additional 12 weeks of 0.4- and 0.8-mg/day dosing . The incidence of positive orthostatic test results in the tamsulosin groups was comparable to that observed in the placebo group . Adverse events were comparable in the 0.4-mg/day tamsulosin and placebo groups and were somewhat higher in the 0.8-mg/day tamsulosin group . CONCLUSIONS Tamsulosin was effective , safe , and well tolerated in the target BPH population at both the 0.4- and 0.8-mg/day dose levels , without the blood pressure-lowering effects typical of nonselective alpha-adrenergic antagonists Low-dose ( 0.2 mg/day ) and st and ard-dose ( 0.4 mg/day ) tamsulosin were studied in a r and omized controlled trial of 75 out patients with distal ureteroliths in Thail and . Group 1 ( n = 25 ; control ) received oral sodium diclofenac 50 mg twice a day for 10 days ; group 2 ( n = 25 ) received oral sodium diclofenac 50 mg twice a day for 10 days , with oral tamsulosin 0.2 mg once a day up to 28 days ; and group 3 ( n = 25 ) received oral sodium diclofenac 50 mg twice a day for 10 days , with oral tamsulosin 0.4 mg once a day up to 28 days . For groups 1 , 2 and 3 , respectively , the expulsion rates were 4 % , 40 % and 68 % ( significantly different for group 1 vs group 2 , and for group 1 vs group 3 ) and mean expulsion times were 23.00 , 9.30 and 10.76 days . Both doses of tamsulosin increased stone expulsion rate and decreased expulsion time in comparison with the control , and have been shown to be safe and effective in Asian patients OBJECTIVE To compare the efficacy and safety of a fixed dose ( 0.2 mg ) of tamsulosin , a selective alpha 1A-adrenoreceptor antagonist , with an increasing dose ( 1 - 5 mg ) of terazosin , a non-selective antagonist , in the treatment of urinary outflow obstruction associated with benign prostatic hyperplasia ( BPH ) in Korean patients . PATIENTS AND METHODS The study comprised a single-blind and r and omized design with tamsulosin or terazosin taken once daily for 8 weeks . A total of 98 patients was enrolled , with 72 patients included in the analyses after 4 and 8 weeks . The primary variables assessed were changes in the maximum urinary flow rate Qmax and the total International Prostate Symptom Score ( IPSS ) , with the post-void residual urine volume , ' obstructive ' and ' irritative ' questions in the IPSS , and the investigators ' global assessment of efficacy also determined . The number of patients with a clinical ly significant response to treatment with tamsulosin or terazosin was determined and defined as those with > 20 % improvement from the baseline Qmax or > 20 % decrease in total IPSS . Adverse reactions possibly or probably related to study medication were recorded throughout the treatment period . RESULTS Both tamsulosin and terazosin produced similar significant improvements in subjective and objective symptoms of urinary outflow obstruction ( P > 0.05 ) . Systolic and diastolic ( st and ing ) blood pressures decreased significantly in patients treated with terazosin ( P < 0.05 ) . The adverse reactions , most frequently dry mouth and dizziness which were usually mild and transient , were significantly higher in patients on terazosin ( 18 patients , versus one on tamsulosin , P < 0.001 ) . The changes led to discontinuation of therapy in two patients on terazosin . CONCLUSION Tamsulosin was as effective as terazosin in treating urinary outflow obstruction associated with BPH , but had a markedly better safety profile PURPOSE We systematic ally review ed the effectiveness and adverse effects of tamsulosin for lower urinary tract symptoms compatible with benign prostatic obstruction . MATERIAL S AND METHODS Studies were included in analysis when they involved a r and omized trial of at least 1 month in duration , men with lower urinary tract symptoms and a comparison of tamsulosin with placebo or an active control . Study , patient and outcome data were extracted onto st and ard forms using a prospect i ve protocol . RESULTS Of the series 13 involving 3,418 men with a mean age of 64 years met our inclusion criteria . Study duration was 4 to 26 weeks . Baseline symptom scores and flow rates showed moderate lower urinary tract symptoms . Tamsulosin improved symptoms and peak urine flow compared with placebo . The weighted mean difference in the mean change from baseline for the Boyarsky symptom score for 0.4 and 0.8 mg . tamsulosin versus placebo was -1.1 ( 95 % confidence interval [ CI ] -1.49 to -0.72 or 12 % improvement ) and -1.6 points ( 95 % CI -2.3 to -1.0 or 16 % improvement ) , respectively . The weighted mean difference in the mean change from baseline in peak urine flow was 1.1 ( 95 % CI 0.59 to 1.51 ) and 1.1 ml . per second ( 95 % CI 0.65 to 1.48 ) for 0.4 and 0.8 mg . , respectively . The 0.2 to 0.4 mg . tamsulosin dose was as effective as other alpha-antagonists for improving symptoms and the flow rate , although the doses of all alpha-antagonists evaluated may not have been optimal . Treatment withdrawals and adverse effects increased markedly as the tamsulosin dose increased . CONCLUSIONS Tamsulosin improves lower urinary tract symptoms and flow . Its effectiveness was similar to that of other alpha-antagonists , increasing slightly at higher doses . Adverse effects were generally mild but the incidence , including treatment withdrawals , increased substantially at higher doses 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 Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China OBJECTIVE To evaluate the efficacy and safety of tamsulosin 0.4 mg once daily ( as a modified-release formulation ) compared with placebo in patients with benign prostatic enlargement , lower urinary tract symptoms and prostatic ' obstruction ' ( symptomatic benign prostatic hyperplasia [ BPH ] ) . PATIENTS AND METHODS Of 313 patients with symptomatic BPH enrolled in a 2-week placebo run-in period , 296 were subsequently r and omized to receive either placebo ( 98 patients ) or tamsulosin 0.4 mg once daily ( 198 patients ) for 12 weeks . The primary variables assessed to determine efficacy were maximum urinary flow rate ( Qmax ) from free-flow measurements and the total Boyarsky symptom score . RESULTS Tamsulosin produced greater improvements in Qmax ( 1.4 mL/s , 13.1 % ) than did placebo ( 0.4 mL/s , 3.8 % ) ( P = 0.028 ) and a greater decrease in total symptom score ( 3.4 points , 35.8 % reduction ) than did placebo ( 2.2 points , 23.7 % reduction ) ( P = 0.002 ) . Significantly more tamsulosin-treated patients ( 67 % ) than placebo-treated patients ( 44 % ) had a > or = 25 % decrease in total symptom score after 12 weeks ( P < 0.001 ) . Treatment with tamsulosin for 12 weeks also produced significant improvements in average urinary flow rate ( P = 0.040 ) , irritative ( P = 0.013 ) and obstructive ( P = 0.014 ) symptom scores and symptoms of nocturia ( P = 0.022 ) and hesitancy ( P = 0.004 ) . Tamsulosin was tolerated well by the patients . The incidence of adverse events emerging during treatment was comparable in the tamsulosin- and placebo-treated groups ( 34 % and 24 % respectively , P = 0.109 ) , as was the incidence of cardiovascular-related adverse events ( 5 % and 7 % respectively ; P = 0.596 ) . There were no significant differences in changes in blood pressure or pulse rates between the tamsulosin- and placebo-treated groups . CONCLUSION Tamsulosin 0.4 mg once daily is safe , well tolerated and clinical ly effective in improving symptoms and urinary flow rate in patients with symptomatic BPH Patient preference for benign prostatic hyperplasia ( BPH ) treatment with the α1-blockers , tamsulosin or silodosin , was compared using patient-reported outcomes . Japanese patients with lower urinary tract symptoms associated with BPH were r and omly allocated to either the T – S group ( tamsulosin 0.2 mg orally once daily for 4 weeks then silodosin 4 mg orally twice daily for 4 weeks ) or the S – T group ( silodosin 4 mg orally twice daily for 4 weeks then tamsulosin 0.2 mg orally once daily for 4 weeks ) . The primary endpoint was the preferred drug for treatment continuation at 8 weeks , determined by a patient-reported question naire . In total , 102 patients ( mean age 70.3 years ) were enrolled and 84 ( n = 42 per group ) completed the study . A significant difference was observed between the proportion of patients who preferred tamsulosin ( 59/84 patients ; 70.2 % ) and those who preferred silodosin ( 18/84 patients ; 21.4 % ) . A major reason for preference of either drug was ‘ good efficacy ’ . Incidence of adverse effects was significantly lower with tamsulosin ( 3/91 patients ; 3.3 % ) than with silodosin ( 25/88 patients ; 28.4 % ) . These findings indicate that tamsulosin is very effective for BPH , has few adverse effects and that patients want to continue to use it OBJECTIVES To evaluate the long-term efficacy and safety of once-daily tamsulosin ( 0.4 and 0.8 mg ) , a unique selective alpha1A-adrenoceptor antagonist in patients with benign prostatic hyperplasia ( BPH ) . METHODS This trial extended a 13-week , Phase III multicenter placebo-controlled , double-blind outpatient trial for an additional 40 weeks . Of 618 patients , 418 ( 68 % ) continued into the extension phase on the same double-blind medication and dose . The primary efficacy parameters were total American Urological Association ( AUA ) symptom score and maximum urinary flow ( Qmax ) . RESULTS The mean changes in AUA symptom score from baseline to end point were statistically significant in all groups ( P < 0.001 ) . Significant improvements were observed in Qmax for both tamsulosin groups but not for the placebo group . The statistically significant improvements from baseline in efficacy parameters observed for each tamsulosin group at the end of the 13-week Phase III trial were maintained during the long-term extension phase . Tamsulosin at both dosages was well tolerated as maintenance therapy . Clinical ly significant orthostatic hypotension was not observed . Vital sign changes in either hypertensive or normotensive patients were not clinical ly significantly different across the three groups . CONCLUSIONS Tamsulosin once-daily at 0.4 or 0.8 mg was shown to be effective , safe , and well tolerated in the target BPH population during long-term use OBJECTIVE To evaluate the efficacy of low dose tamsulosin for facilitating spontaneous passage of ureteral stones in Japanese male patients . METHODS A total of 71 patients with symptomatic ureteral stones , 10 mm or smaller in size , were r and omly allocated into groups 1 and 2 . Group 1 received tamsulosin ( 0.2 mg/day ) for a maximum of 4 weeks and group 2 received no medication . The primary endpoint was the stone expulsion rate and the secondary endpoints were stone expulsion time and analgesic use . RESULTS There were no significant differences between the groups in terms of age , stone size and location . The stone expulsion rate was significantly higher in group 1 than in group 2 ( 77 % vs 50 % , P = 0.002 ) . No significant differences were noted in the stone expulsion time and analgesic use between the groups . CONCLUSION Low dose tamsulosin can significantly facilitate spontaneous passage of ureteral stones without significant side-effects in Japanese male patients 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 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 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 AIMS To evaluate the efficacy and treatment satisfaction with low-dose ( 0.2 mg ) tamsulosin in patients with symptomatic benign prostatic hyperplasia ( BPH ) , and to investigate individual lower urinary tract symptoms according to treatment satisfaction . METHODS A cross-sectional study was conducted in a total sample of 2574 patients from multiple centres .  International Prostate Symptom Score ( IPSS ) , prostate volume , uroflowmetry and combined medications were review ed . Detailed question naires were used to assess treatment satisfaction and IPSS 8 weeks after treatment with low-dose tamsulosin . RESULTS After 8 weeks of treatment with low-dose tamsulosin , IPSS improved significantly . Among the 2574 patients , 1,630 ( 63.42 % ) were satisfied and 940 patients ( 36.50 % ) were dissatisfied with low-dose tamsulosin . The reasons for dissatisfaction included efficacy problems ( 84.66 % ) and side effects ( 3.72 % ) . Treatment satisfaction was affected by symptom duration , baseline IPSS , and prostate size ( p = 0.0441 , < 0.001 , < 0.009 , respectively ) . IPSS voiding ( IPSS-V ) and IPSS storage ( IPSS-S ) after treatment differed significantly depending on the degree of satisfaction ( p < 0.001 ) . IPSS-V after treatment did not improve in patients who were ' not satisfied ' or ' totally not satisfied ' ( p = 0.170 , 0.240 , respectively ) . All the individual IPSS items except urgency ( p = 0.1436 ) varied significantly with the degree of satisfaction ( p < 0.001 ) . CONCLUSIONS Treating symptomatic BPH with low-dose tamsulosin improved IPSS , but more than one-third of patients were dissatisfied with the treatment . The main reason for dissatisfaction was efficacy problems , and the degree of satisfaction was related to symptom duration , baseline IPSS , and prostate size , and also to IPSS-V. In patients with severe LUTS , the tamsulosin dose should be increased earlier Objectives : Benign prostatic hyperplasia ( BPH ) is a common and progressive disease affecting elderly males , often associated with lower urinary tract symptoms ( LUTS ) . α1-blockers are the mainstay in symptomatic therapy of BPH . Because of their greater uroselectivity and minimal hemodynamic effects , alfuzosin , tamsulosin , and silodosin are generally preferred . The aim of this study was to compare the efficacy and tolerability of alfuzosin , tamsulosin , and silodosin in patients with BPH and LUTS . Methods : Ninety subjects with BPH and LUTS were r and omized into three groups of thirty in each , to receive alfuzosin sustained release ( SR ) 10 mg , tamsulosin 0.4 mg , or silodosin 8 mg for 12 weeks . The primary outcome measure was a change in the International Prostate Symptom Score ( IPSS ) , and the secondary outcome measures were changes in individual subjective symptom scores , quality of life score ( QLS ) , and peak flow rate ( Qmax ) from baseline . The treatment response was monitored at 2 , 4 , 8 , and 12 weeks . Results : IPSS improved by 88.18 % , 72.12 % , and 82.23 % in alfuzosin SR , tamsulosin and silodosin groups ( P < 0.001 ) at 12 weeks . Improvement in QLS was > 75 % in all the three groups ( P < 0.001 ) . A significant improvement in Qmax was seen with alfuzosin and tamsulosin ( P = 0.025 and P < 0.001 ) but not with silodosin ( P = 0.153 ) . However , the intergroup differences in IPSS , QLS , and Qmax were not significant . Ejaculatory dysfunction was more common with silodosin and corrected QT ( QTc ) prolongation occurred only with alfuzosin ( two subjects ) and tamsulosin ( three subjects ) . Conclusion : Alfuzosin , tamsulosin , and silodosin showed similar efficacy in improvement of LUTS secondary to BPH , with good tolerability , acceptability , and minimum hemodynamic adverse effects . Alfuzosin , tamsulosin , and silodosin are comparable in efficacy in symptomatic management of BPH . The occurrence of QTc prolongation in three subjects with tamsulosin in the present study is an unexpected adverse event as there are no reports of QTc prolongation with tamsulosin in any of the previous studies
Although this study did not consider placebo effect and has high IPSS baseline scores , this study clarifies that low-dose tamsulosin has generally positive effect and safety in treatment of LUTS and could be a suitable option as an initial treatment , especially for patients with low body mass index , as is typical of Asian people
PURPOSE In Asian countries , low-dose tamsulosin ( 0.2 mg ) is used widely but this dose has been less popular than 0.4 mg tamsulosin or other types of alpha blockers .
The aim of this study was to investigate the efficacy and safety of low-dose tamsulosin by systematic review and meta- analysis .