Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects. Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy normotensive men. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. The impact of adding low-dose oral desmopressin therapy to tamsulosin therapy for treatment of nocturia owing to benign prostatic hyperplasia [Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study]. Treatment satisfaction with low-dose tamsulosin for symptomatic benign prostatic hyperplasia: results from a multicentre cross-sectional survey. Effectiveness of Low-dose and Standard-dose Tamsulosin in the Treatment of Distal Ureteric Stones: A Randomized Controlled Study [A comparative study assessing clinical effects of naftopidil and tamsulosin hydrochloride on benign prostatic hyperplasia]. 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. Comparison and Efficacy of Low-Dose and Standard-Dose Tamsulosin and Alfuzosin in Medical Expulsive Therapy for Lower Ureteral Calculi: Prospective, Randomized, Comparative Study Tamsulosin and chlormadinone for the treatment of benign prostatic hyperplasia. The Kobe University YM617 Study Group. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Is there a role for tamsulosin in shock wave lithotripsy for renal and ureteral calculi? Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia 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 Intermittent tamsulosin therapy in men with lower urinary tract symptoms. 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 of the antagonistic activity of tamsulosin and doxazosin at vascular α1-adrenoceptors in humans 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
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 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 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 Abstract Purpose To evaluate the efficacy and safety of adding a low-dose oral desmopressin to tamsulosin therapy for treatment of nocturia in patients with benign prostatic hyperplasia ( BPH ) . Methods Eligible patients with BPH and nocturia ≥2/night were r and omly allocated to two treatment groups ; the first of which received 3-month treatment scheme of daily oral dose of tamsulosin OCAS 0.4 mg and desmopressin MELT 60 mcg ( D/T group ) , while the second one received tamsulosin OCAS 0.4 mg only ( T group ) . Patients were followed on monthly basis and changes in the parameters from baseline to 3 months after treatment were assessed on I-PSS/QoL question naire , 7-day voiding diary , urinalysis , serum sodium , abdominal ultrasonography and uroflowmetry . Results A total of 248 patients were included within the study ; 123 patients in the combined D/T group and 125 patients in T group . The frequencies of night voids decreased by 64.3 % in D/T group compared to 44.6 % in T group . The first sleep period , significantly increased from 82.1 to 160.0 min and from 83.2 to 123.8 min in D/T and T group , respectively ; and significant differences between both groups were observed at the end of study ( p < 0.001 ) . I-PSS , QoL score , post-void residual urine volume and Qmax were significantly improved with no statistical difference between both groups . No serious adverse effects were reported in both groups . Conclusion The addition of low-dose oral desmopressin therapy to an α-blocker tamsulosin provides effective treatment for nocturia in patients with LUTS/BPH OBJECTIVE While the lipidosterolic extract ( LSESr ) of Serenoa repens -- Permixon -- has been shown to have an equivalent efficacy to finasteride in patients with benign prostatic hyperplasia ( BPH ) , to date , there has been no valid comparison of phytotherapy with alpha-blockers . The aim of this study was to assess the equivalent efficacy of Permixon and tamsulosin . METHODS Eight hundred and eleven men with symptomatic BPH ( international prost date symptom score , I-PSS > or = 10 ) were recruited in 11 European countries for a 12-month , double-blind r and omized trial . After a 4-week run-in period , 704 patients were r and omly assigned to either tamsulosin 0.4 mg per day ( N = 354 ) or Permixon 320 mg per day ( N = 350 ) . I-PSS , QoL and maximum urinary flow rate ( Qmax ) were evaluated at baseline and periodically for 1 year . Prostate volume and serum prostate-specific antigen ( PSA ) were measured at selection and at endpoint . The endpoint analysis was performed on the per- protocol ( PP ) population of 542 patients ( tamsulosin : N = 273 ; Permixon : N = 269 ) . RESULTS At 12 months , I-PSS decreased by 4.4 in each group and no differences were observed in either irritative or obstructive symptom improvements . The increase in Qmax was similar in both treatment groups ( 1.8 ml/s Permixon , 1.9 ml/s tamsulosin ) . PSA remained stable while prostate volume decreased slightly in the Permixon-treated patients . The two compounds were well tolerated , however , ejaculation disorders occurred more frequently in the tamsulosin group . CONCLUSION This study demonstrated that Permiwon and tamsulosin are equivalent in the medical treatment of lower urinary tract symptoms in men with BPH , during and up to 12 months of therapy 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 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 We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for benign prostatic hyperplasia patients . Eighty-five patients without improvement of quality of life ( QOL ) score by the administration of 50 - 75 mg naftopidil for more than four weeks were assigned to receive doses of 0.1 - 0.2 mg tamsulosin hydrochloride and 89 patients without improvement of QOL score by the administration of 0.1 - 0.2 mg tamsulosin hydrochloride for more than four weeks were assigned to receive doses of 50 - 75 mg naftopidil once a day for 8 weeks . International prostate symptom score , maximum flow rate , residual urine volume and side effect profile were determined before the administration of the first medicine , before the administration of the second medicine and after 8 weeks of treatment with the second medicine . In the group without improvement of QOL score by naftopidil , significant improvements in symptoms of urgency , weak stream and straining were observed after 8 weeks of treatment with tamsulosin hydrochloride . In the group without improvement of QOL score by tamsulosin hydrochloride , significant improvements in symptoms of incomplete emptying , intermittency and nocturia were observed after 8 weeks of treatment with naftopidil . In conclusion , improvement of symptoms by each alpha 1-blocker differs symptom by symptom . Tamsulosin hydrochloride was superior to naftopidil for the symptoms of urine flow and naftopidil was superior to tamsulosin hydrochloride for the symptom of nocturia 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 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 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 INTRODUCTION Safety and efficacy of tamsulosin and vardenafil are well established : however , there is no report regarding combined therapy with these drugs for  lower urinary tract symptoms ( LUTSs ) secondary to benign prostatic hyperplasia ( BPH ) . AIM To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a r and omized trial with 12-week follow-up . METHODS We conducted a r and omized , double-blind , placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin .  MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS-bother , International Index of Erectile Function , Version 5 ( IIEF-5 ) and Over Active Bladder question naire ( OAB-q ) scores , uroflowmetry data ( Qmax , Qave ) , and postvoiding residual urine were recorded after run-in ( baseline ) , and 2 and 12 weeks after treatment . Differences between vardenafil and placebo at different times were calculated with unpaired sample s t-test . Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance . RESULTS We found a between-group significant difference from baseline to 12 weeks in the following : ( i ) Qmax ( placebo : + 0.07 , vardenafil : + 2.56 , P = 0.034 ) ; ( ii ) Qave  ( placebo : -0.15 , vardenafil : + 1.02 , P = 0.031 ) ; ( iii ) irritative-IPSS subscores ( placebo : -1.67 , vardenafil : -3.11 , P = 0.039 ) ; and ( iv ) IIEF ( placebo : + 0.06 , vardenafil : + 2.61 , P = 0.030 ) . No patient reported any serious ( grade ≥ 2 ) adverse event ( AE ) . There were no differences in the incidence of common , treatment-related AEs between men undergoing combined therapy or tamsulosin alone . CONCLUSIONS The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function , as compared with tamsulosin alone . Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH 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 PURPOSE We evaluated the effect of the alpha-blocker tamsulosin on stone clearance , analgesic requirements and steinstrasse in shock wave lithotripsy for solitary renal and ureteral calculus . MATERIAL S AND METHODS A prospect i ve , double-blind , r and omized placebo controlled study was performed during 1 year involving 60 patients with a solitary renal or ureteral calculus undergoing shock wave lithotripsy .  The control group ( 30 ) received 0.4 mg tamsulosin and the study group ( 30 ) received placebo daily until stone clearance or for a maximum of 30 days . An oral preparation of dextropropoxyphene hydrochloride and acetaminophen was the analgesic used on an on-dem and basis . The parameters assessed were stone size , position , clearance time , effect on steinstrasse and analgesic requirement . RESULTS The overall clearance rate was 96.6 % ( 28 of 29 ) in the study group and 79.3 % ( 23 of 29 ) in the control group ( p = 0.04 ) . With larger stones 11 to 24 mm the difference in the clearance rate was significant ( p = 0.03 ) but not so with the smaller stones 6 to 10 mm ( p = 0.35 ) . The average dose of analgesic used was lower with tamsulosin than with controls , without statistical significance . Steinstrasse resolved spontaneously in the tamsulosin group whereas 25 % ( 2 of 8) required intervention in the placebo group . There was no difference between the 2 groups with regard to age , stone size or location . CONCLUSIONS The alpha-blocker tamsulosin seemed to facilitate stone clearance , particularly with larger stones during shock wave lithotripsy for renal and ureteral calculus . It also appeared to improve the outcome of steinstrasse .  Tamsulosin may have a potential role in routine shock wave lithotripsy OBJECTIVE To compare the efficacy of the lipido-sterolic extract of Serenoa repens , Permixon , to that of the alpha-blocker , tamsulosin , in the treatment of severe low urinary tract symptoms ( LUTS ) of benign prostatic hyperplasia ( BPH ) . METHODS In a 12-month , double-blind , r and omized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ( " PERMAL study ") , 685 BPH patients with IPSS > or = 10 had been analyzed for efficacy . Of these , the 124 patients with severe LUTS ( IPSS > 19 ) at r and omization were retained for this subset analysis . After a 4-week run-in period , 59 and 65 patients had been r and omized to tamsulosin and Permixon groups , respectively . Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores , LUTS-related QoL , prostate volume , Q(max ) and MSF-4 ( sexual activity question naire ) at different time points over 1 year . An analysis of variance of changes from baseline to end point was performed for all the parameters . The over-time evolutions of total , irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements . RESULTS At 12 months , total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin ( p=0.051 ) ; the irritative symptoms improved significantly more ( p=0.049 ) with Permixon ( -2.9 versus -1.9 with tamsulosin ) . The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 ( p=0.03 ) . CONCLUSION Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment BACKGROUND Storage symptoms are often undertreated in men with lower urinary tract symptoms ( LUTS ) . OBJECTIVE To evaluate the combination of an antimuscarinic ( solifenacin ) with an α-blocker ( tamsulosin ) versus tamsulosin alone in the treatment of men with LUTS . DESIGN , SETTING , AND PARTICIPANTS A double-blind , 12-wk , phase 2 study in 937 men with LUTS ( ≥ 3 mo , total International Prostate Symptom Score [ IPSS ] ≥ 13 , and maximum urinary flow rate 4.0 - 15.0 ml/s ) . INTERVENTION Eight treatment groups : tamsulosin oral controlled absorption system ( OCAS ) 0.4 mg ; solifenacin 3 , 6 , or 9 mg ; solifenacin 3 , 6 or 9 mg plus tamsulosin OCAS 0.4 mg ; or placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary efficacy end point was change from baseline in total IPSS . Secondary end points included micturition diary and quality -of-life ( QoL ) parameters . Post hoc subgroup analyses were performed by severity of baseline storage symptoms , with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy , due to the small sample size of the solifenacin monotherapy and placebo subgroups . RESULTS AND LIMITATIONS Combination therapy was associated with significant improvements in micturition frequency and voided volume  versus tamsulosin OCAS alone in the total study population ; improvements in total IPSS were not significant . Statistically significant improvements in urgency episodes , micturition frequency , total urgency score , voided volume , IPSS storage subscore , IPSS-QoL index , and Patient Perception of Bladder Condition were observed in a sub population of men with two or more urgency episodes per 24h ( Patient Perception of Intensity of Urgency Scale grade 3 or 4 ) and eight or more micturitions per 24h at baseline ( storage symptoms subgroup ) with combination therapy versus tamsulosin OCAS alone ( p ≤ 0.05 for the dose-response slope , all variables ) . Combination therapy was well tolerated , and adverse events were consistent with the safety profiles of both compounds . CONCLUSIONS Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline . Combination therapy was well tolerated . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00510406 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 To evaluate the efficacy and safety of two doses ( 10 and 15 mg ) of alfuzosin once daily and tamsulosin ( 0.4 mg ) once daily , compared with placebo , in men with 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 PURPOSE We investigated in what is to our knowledge the first prospect i ve study the safety and efficacy of intermittent tamsulosin therapy in patients with lower urinary tract symptoms . MATERIAL S AND METHODS This study was performed between January 2001 and February 2003 in 140 patients . In phase 1 of this study patients received 1 , 0.4 mg tamsulosin capsule daily for 3 months and were reevaluated after 3 months . At this assessment uroflowmetry , International Prostate Symptom Score and ultrasonographic estimation of residual urine were determined . In phase 2 responders to tamsulosin therapy were then r and omized into 1 of 3 groups , namely group 1 - -continued 4 mg tamsulosin once daily every day , group 2 - -0.4 mg tamsulosin once daily every other day and group 3 - -discontinued tamsulosin . Efficacy assessment s were done again at 4 , 12 and 24 weeks . RESULTS There were no statistically differences among the patients in groups 1 and 2 at 6 months for International Prostate Symptom Score , maximum or average urine flow , or residual urine . Differences between patients in groups 1 and 3 were statistically significant at 6 months . Differences between patients in groups 2 and 3 were also statistically significant at 6 months for these parameters . CONCLUSIONS Tamsulosin at a dose of 0.4 mg once daily and 0.4 mg once daily every other day for lower urinary tract symptoms provide comparable improvements in urinary flow and symptoms . Each treatment was well tolerated 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 Abstract α1-Adrenoceptor blockers such as prazosin and doxazosin are used to treat hypertension as well as benign prostatic hyperplasia ( BPH ) , whereas the new αl-adrenoceptor blocker tamsulosin is used only for BPH and does not reduce blood pressure at the doses used to relax prostatic smooth muscle . In contrast to prazosin , tamsulosin has a higher affinity for prostatic than vascular α1-adrenoceptors in vitro . The functional correlate of this observation in humans is the subject of this study . The α1-adrenoceptor blockade by oral tamsulosin ( 0.2 mg ) , doxazosin ( 1 mg ) or placebo on finger tip vascular and dorsal h and venous α1-adrenoceptors stimulated by cold treatment ( immersion in ice water ) and the αl-adrenoceptor agonist phenylephrine , was thus studied in a 3-way crossover study in eight , healthy , male adults .  Finger tip vasoconstriction after cold stimulation was assessed by laser Doppler flowmetry . A linear variable differential transformer was used to assess the drug effect on phenylephrine-induced venoconstriction . All study parameters were assessed at around 2 and 3.5 h after oral intake of doxazosin and tamsulosin respectively . The drug plasma levels were not significantly different . No significant differences were found for blood pressure or heart rate in the three treatments in supine and erect position . The reduction in finger tip blood flow after cold stimulation was significantly smaller after doxazosin treatment ( P<0.01 ) than after tamsulosin or placebo , whereas there was no significant difference between tamsulosin and placebo treatments . The infusion rate of phenylephrine producing a half-maximum venoconstriction was significantly larger after doxazosin than after tamsulosin ( P<0.05 ) or placebo ( P<0.01 ) , whereas there was again no significant difference between tamsulosin and placebo treatments . The data suggest that , at doses producing equal plasma levels after single oral doses in human subjects , the blocking activity at vascular α1-adrenoceptors is lower for tamsulosin than for doxazosin 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
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 .