title: Long-term safety and efficacy of tamsulosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. Treatment satisfaction with low-dose tamsulosin for symptomatic benign prostatic hyperplasia: results from a multicentre cross-sectional survey. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. Transition zone ratio and prostate-specific antigen density as predictors of the response of benign prostatic hypertrophy to alpha blocker and anti-androgen therapy. Efficacy and Safety of Tamsulosin for Treating Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled, Open-Label Non-Inferiority Study Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. 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. Silodosin, a new α1A‐adrenoceptor‐selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo‐controlled, double‐blind study in Japanese men [A randomized controlled study comparing clinical effects of naftopidil and tamsulosin on benign prostatic hyperplasia]. Recovery of abnormal ejaculation by intermittent tamsulosin treatment. 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. A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients Ejaculatory Disorders Caused by Alpha-1 Blockers for Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Comparison of Naftopidil and Tamsulosin in a Randomized Multicenter Study Tamsulosin, a selective alpha 1c-adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic 'obstruction' (symptomatic BPH). The European Tamsulosin Study Group. Comparison of α-Blocker Monotherapy and α-Blocker plus 5α-Reductase Inhibitor Combination Therapy Based on Prostate Volume for Treatment of Benign Prostatic Hyperplasia Update on AUA guideline on the management of benign prostatic hyperplasia. [The clinical efficacy of Naftopidil tablet in the treatment of benign prostatic hyperplasia]. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Patient Reactions to a Program Designed to Facilitate Patient Participation in Treatment Decisions for Benign Prostatic Hyperplasia The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Effect of doxazosin gastrointestinal therapeutic system 4 mg vs tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms: a prospective, multicenter, randomized, open, parallel study.
abstract: PURPOSE We evaluated the long-term ( up to 6 years ) safety and efficacy of the selective alpha 1A-adrenoceptor antagonist tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 609 patients were enrolled in a 4-year multicenter open label extension study . Subjects entered the study after completion of a 1-year open label trial that included patients who previously completed up to 57 weeks of double-blind , placebo controlled studies . Maintenance doses ( 0.4 or 2 x 0.4 mg daily ) established in the 1-year study were continued . Efficacy and safety were assessed every 3 months . Primary efficacy evaluations were changes from baseline maximum urine flow rate and total American Urological Association symptom index , and the responder rates for those 2 end points . Secondary end points were changes in American Urological Association subset scores , Boyarsky symptom scores , average urine flow rate , post-void residual urine volume , quality of life index and investigator global assessment . RESULTS Of the 609 patients who entered the 4-year extension study 159 had a 2-year or greater prior experience with tamsulosin , yielding a potential 6-year experience on the medication . Of this 159 patient subset 109 completed the whole 6 years . Initial rapid improvements from baseline in primary and secondary end points were maintained each year throughout the duration of the study . Tamsulosin was well tolerated , confirming the safety profile demonstrated in earlier studies . Orthostatic hypotension was observed in 1.3 % of the patients . CONCLUSIONS This study demonstrates the sustained efficacy , safety and excellent long-term tolerability of tamsulosin for up to 6 years in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia 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 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 determine whether transrectal ultrasonography ( TRUS ) can predict the clinical response of patients with benign prostatic hypertrophy ( BPH ) to alpha 1-blocker and anti- and rogen therapy . PATIENTS AND METHODS From April 1994 to July 1995 , 128 patients with BPH were r and omized to treatment for 6 months with either tamsulosin ( a long-acting selective alpha 1-blocker ) or allylestrenol ( an anti- and rogen ) , with 64 patients receiving tamsulosin ( 0.2 mg/day ) and 64 receiving allylestrenol ( 50 mg/day ) . The results of TRUS , uroflowmetry and the American Urologic Association ( AUA ) symptom score were compared before and after treatment . TRUS was used to calculate the transition zone ( TZ ) volume , transition zone ratio ( TZ ratio = TZ volume/total prostate volume ) , total prostate volume and prostate-specific antigen density ( PSAD ) . RESULTS Both groups showed a statistically significant improvement in the AUA symptom score , quality -of-life ( QOL ) score and peak urinary flow rate ( Qmax ) at 6 months ( P < 0.001 ) . In the tamsulosin group , there was a significant negative correlation between the pretreatment PSAD and the percentage change in Qmax ( r = -0.640 , P < 0.001 ) , while there was a positive correlation between PSAD and the percentage change in the AUA symptom score ( r = 0.589 , P < 0.001 ) . On the other h and , the allylestrenol group showed a significant positive correlation between PSAD and the percentage change in Qmax ( r = 0.397 , P < 0.01 ) and a negative correlation between PSAD and the AUA symptom score ( r = -0.313 , P < 0.01 ) . CONCLUSION Patients with a high pretreatment PSAD responded well to anti- and rogen therapy , while those with a low PSAD responded better to alpha 1-blocker therapy Purpose To compare the efficacy and safety of Sulosin D ( PACIFICPHARMA , Korea ) and Harnal D ( ASTELLAS PHARMA KOREA , Korea ) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) . Material s and Methods This r and omized , controlled , open-label , multicenter non-inferiority study was conducted at four sites in Korea . We r and omly assigned 123 patients with an International Prostate Symptom Score ( IPSS ) ≥12 to receive either Sulosin D or Harnal D treatment for 8 weeks . The primary outcome was the mean change in IPSS from baseline to endpoint . Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores , maximum uroflowmetry ( Qmax ) , and post-voiding residuals ( PVR ) . Results In all , 123 patients were r and omly assigned ( 60 Sulosin D and 63 Harnal D ) . The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03 , respectively . There were significant decreases compared with baseline in both groups . The mean difference ( Sulosin D - Harnal D ) was -0.91 ( with a two-sided 90 % confidence interval ) , inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore , Qmax , and PVR from baseline were comparable between the groups ( both p>0.05 ) . During the treatment periods , the incidence of adverse events was 23.33 % and 34.92 % in the Sulosin D and Harnal D groups , respectively ( p=0.1580 ) . Conclusions We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH 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 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 This section contains papers from Japan , Austria , the UK , and joint papers from France , Denmark , Switzerl and , Australia and the USA . A wide variety of lower urinary tract topics is covered , from BPH to overactive bladder and urodynamic stress incontinence A prospect i ve r and omized controlled study was performed to compare the clinical effects of naftopidil and tamsulosin .  Men complaining of lower urinary tract symptoms due to benign prostatic hyperplasia were r and omized into two groups : one receiving 50 mg naftopidil once daily ( Naf group , n=36 patients ) , and the other receiving 0.2 mg tamsulosin once daily ( Tam group , n=32 patients ) . In the Naf group at 12 weeks , 7 items of the International Prostate Symptom Score ( IPSS ) , storage and voiding symptoms , total IPSS , quality of life ( QOL ) index ( QOLI ) and Qmax were improved significantly . In the Tam group at 12 weeks , 6 items of IPSS except urgency , storage and voiding symptoms , total IPSS , QOLI and Qmax were improved significantly . Improvement of residual urine volume ( PVR ) was insignificant in both groups . In intergroup comparison between the Naf and the Tam groups , variations of 7 items of IPSS , storage and voiding symptoms , total IPSS , QOLI , Qmax and PVR at 4 and 12 weeks after treatment were not statistically significant . There was almost no difference in clinical efficacy between Naf and Tam PURPOSE We assessed the impact of intermittent tamsulosin treatment on  abnormal ejaculation . MATERIAL S AND METHODS This prospect i ve study was performed between January 2001 and December 2004 . It included 405 patients who were at least 50 years old with lower urinary tract symptoms . This study was divided into 2 phases . In phase 1 patients received a 0.4 mg tamsulosin capsule daily after breakfast for at least 3 months . The second phase of this study was performed in the 30 patients with abnormal ejaculation . In this phase these patients received 0.4 mg tamsulosin once daily every other day . Patients were assessed at study entry and at study week 6 . RESULTS Abnormal ejaculation was reported as retro grade ejaculation by 18 patients , as decreased volume by 7 and as absent ejaculate by 5 . Ejaculatory function recovered during intermittent tamsulosin treatment in 12 patients with retro grade ejaculation and in 7 with decreased volume or absent ejaculate . As a result , 19 of 30 patients ( 63.3 % ) with abnormal ejaculation recovered . A significant improvement in retro grade ejaculation was found after intermittent tamsulosin treatment ( p = 0.02 ) . Although there were improvements in decreased volume or absent ejaculate at week 6 of intermittent treatment , these differences were not statistically significant ( p = 0.42 and 0.61 , respectively ) . CONCLUSIONS The results of the current study , which to our knowledge is the first report of the effect of intermittent tamsulosin treatment on abnormal ejaculation , show that this treatment modality is well tolerated and provides comparable improvements for abnormal ejaculation 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 Objective To compare the efficacy and safety of an incremental‐dose regimen of terazosin ( 1–2 mg daily ) and a fixed‐dose regimen of tamsulosin ( 0.2 mg daily ) , on Japanese patients with symptomatic benign prostatic hyperplasia ( BPH ) Introduction : To investigate the incidence of ejaculatory disorders caused by naftopidil and tamsulosin in patients with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Material s and Methods : Ninety-five patients with LUTS/BPH who had International Prostate Symptom Scores ( IPSS ) of 8 or more were r and omly assigned to receive naftopidil ( 50 mg/day , n = 48 ) or tamsulosin ( 0.2 mg/day , n = 47 ) . Before and 12 weeks after treatment , a question naire was used to evaluate ejaculation . Results : Among men who had sexual activity during the 12 weeks , the proportion who reported an abnormal feeling on ejaculation was higher in the tamsulosin group ( 16.7 % ) than in the naftopidil group ( 7.4 % ) , although the difference was not significant ( p = 0.402 ) . The proportion of men who reported reduced ejaculatory volume after treatment was significantly higher in the tamsulosin group ( 96.0 % ) than in the naftopidil group ( 73.1 % , p = 0.0496 ) . On the other h and , the improvements in IPSS and the quality of life index were significantly higher in the tamsulosin group than in the naftopidil group . Conclusions : Tamsulosin may cause a higher incidence of ejaculatory disorders than naftopidil , although the efficacy of 0.2 mg tamsulosin may be better than that of 50 mg naftopidil 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 OBJECTIVE : This study compared α-blocker monotherapy with combination therapy involving an α-blocker and a 5-α reductase inhibitor for benign prostatic hyperplasia ( BPH ) , according to baseline prostate volume . METHODS : Korean men diagnosed with BPH were r and omized to 12 months ' treatment with 0.2 mg tamsulosin or 0.2 mg tamsulosin plus 0.5 mg dutasteride . Prostate specific antigen ( PSA ) , prostate volume , transition zone volume ( TZV ) , International Prostate Symptom Score ( IPSS ) , maximal urinary flow rate ( Q max ) , postvoid residual urine volume and sexual function were assessed at baseline and after 12 months ' treatment . Variables were analysed based on baseline prostate volumes of ≤ 35 ml or > 35 ml . RESULTS : In total , 216 men with BPH were included . Combination therapy result ed in significant improvements in prostate volume , TZV , PSA , IPSS and Q max , which were most pronounced in men with a prostate volume > 35 ml . CONCLUSIONS : Tamsulosin monotherapy was sufficient treatment for BPH in Korean men with a prostate volume ≤ 35 ml . Combination tamsulosin and dutasteride therapy provided greater benefits than tamsulosin monotherapy in men with BPH whose prostate volume was > 35 ml 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 OBJECTIVES To evaluate the clinical efficacy and safety of Naftopidil tablet in treating benign prostatic hyperplasia . METHODS Eighty BPH patients were divided into two groups r and omly by double-blind , double-simulated and active control parallel study trials . Forty patients in treatment group were given Naftopidil tablet 25 mg , p.o . , qn for 42 days , while 40 patients in control group were given Tamsulosin 0.2 mg , p.o . , qn for 42 days . Statistical analysis was given from 77 cases in the groups . Estimation of the efficacy was done by the change of major indexes include international prostate symptom score ( IPSS ) , maximum flowrate ( Qmax ) and secondary indexes such as quality of life ( QOL ) , residual urine ( Ru ) and volume of prostate ( V ) . RESULTS The changes of IPSS , Qmax , QOL had significant difference between two groups before and after treatment(P < 0.05 ) . The change of Ru had no significant difference between two groups before and after treatment ( P > 0.05 ) while there was significant difference between two groups after six-week treatment(P < 0.05 ) . The change of V had no significant difference ( P > 0.05 ) . The adverse reactions in both groups were mild , and there was no significant difference between two groups(P > 0.05 ) . CONCLUSIONS Naftopidil tablet was safe and effective in treating benign prostatic hyperplasia 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 Patients often want considerable information about their conditions , and enhanced patient participation might reduce unwanted practice variation and improve medical decisions . The authors assessed how men with benign prostatic hyperplasia reacted to an educational program design ed to facilitate participation in decisionmaking , and how strongly ratings of their symptom state and the prospect of complications predicted their treatment choice . A prospect i ve cohort study was conducted in three hospital-based urology practice s : two in prepaid group practice s , and one Veterans Administration clinic . Four hundred twenty-one men with symptomatic benign prostatic hyperplasia without prior prostatectomy or benign prostatic hyperplasia complications were enrolled , and 373 provided usable ratings . Subjects participated in an interactive videodisc-based shared decisionmaking program about benign prostatic hyperplasia and its treatment options , prostatectomy , and “ watchful waiting . ” They rated the length , clarity , balance , and value of the program and were followed for 3 months to determine if they underwent surgery . Patients rated the program as generally clear , informative , and balanced . Across all three sites , 77 % of patients were very positive and 16 % were generally positive about the program 's usefulness in making a treatment decision . Logistic models predicting choice of surgical treatment documented the independent importance of negative ratings of the current symptom state ( odds ratio 7.0 , 95 % confidence interval 2.9–16.6 ) , as well as the prospect of postoperative sexual dysfunction ( odds ratio 0.20 , 95 % confidence interval 0.08–0.48 ) in decisionmaking . Patients rated the Shared Decisionmaking Program very positively and made decisions consistent with their assessed preferences . These results suggest that patients can be helped to participate in treatment decisions , and support a r and omized trial of the Shared Decisionmaking Program 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 OBJECTIVE To compare the efficacy of the doxazosin gastrointestinal therapeutic system ( doxazosin-GITS ) 4 mg and tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . METHODS Data were analyzed from a prospect i ve , multicenter , r and omized , open , parallel study of Chinese men aged 50 - 84 years with LUTS/BPH . Two hundred patients were r and omized to receive daily treatment with 4 mg doxazosin-GITS ( n=100 ) or 0.2 mg tamsulosin ( n=100 ) for 8 weeks . Nocturia was assessed by question 7 of the International Prostate Symptom Score ( IPSS- question 7 ) and a frequency-volume chart ( FVC ) at weeks 4 and 8 . Self-reported quality of sleep and quality of life by the last question of the IPSS question naire were also evaluated . RESULTS A total of 189 patients ( 94 receiving doxazosin-GITS , 95 tamsulosin ) completed the study . The reduction from baseline in mean nocturia was greater with doxazosin-GITS than tamsulosin by the FVC ( 1.7 vs 1.3 at week 4 ; 2.1 vs 1.7 at week 8 , both P=.001 ) and by the IPSS- question 7 ( 1.5 vs 1.1 at 4 weeks , P=.001 ; 2.0 vs 1.6 at 8 weeks , P<.001 ) . The patients who reported improved quality of sleep was significantly more with doxazosin-GITS than tamsulosin ( 43.6 % vs 27.4 % at 4 weeks , P=.020 ; 81.9 % vs 67.4 % at 8 weeks , P=.022 ) , and quality of life was better with doxazosin-GITS ( 2.5 vs 2.8 at 4 weeks , P=.001 ; 2.1 vs 2.5 at 8 weeks , P<.001 ) . CONCLUSION In Chinese patients with LUTS/BPH , doxazosin-GITS is slightly better than tamsulosin in reducing the frequency of nocturia
target: 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
background: 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 .