title: Measurement of health status. Ascertaining the minimal clinically important difference. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Silodosin versus naftopidil for the treatment of benign prostatic hyperplasia: a multicenter randomized trial. Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin]. Naftopidil for the treatment of urinary symptoms in patients with benign prostatic hyperplasia [Comparison of different drugs on the treatment of benign prostate hyperplasia]. [A comparative study assessing clinical effects of naftopidil and tamsulosin hydrochloride on benign prostatic hyperplasia]. Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. What Is the Most Bothersome Lower Urinary Tract Symptom? Individual- and Population-level Perspectives for Both Men and Women [Comparison of naftopidil and silodosin in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, crossover study]. Naftopidil monotherapy vs naftopidil and an anticholinergic agent combined therapy for storage symptoms associated with benign prostatic hyperplasia: A prospective randomized controlled study. Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Crossover comparison study on the therapeutic effects of tamsulosin hydrochloride and naftopidil in lower urinary tract symptoms associated with benign prostatic hyperplasia. [A randomized controlled study comparing clinical effects of naftopidil and tamsulosin on benign prostatic hyperplasia]. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. Comparison of Silodosin and Naftopidil for Efficacy in the Treatment of Benign Prostatic Enlargement Complicated by Overactive Bladder: A Randomized, Prospective Study (SNIPER Study) Single-blind, randomized controlled study of the clinical and urodynamic effects of an alpha-blocker (naftopidil) and phytotherapy (eviprostat) in the treatment of benign prostatic hyperplasia. A Prospective, Randomized, Controlled, Multicenter Study of Naftopidil for Treatment of Male Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: 75 mg Once Daily in the Evening Compared to 25 mg Thrice Daily 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 Update on AUA guideline on the management of benign prostatic hyperplasia. Naftopidil versus tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia with special reference to the storage symptom: a prospective randomized controlled study. Usefulness of tamsulosin hydrochloride and naftopidil in patients with urinary disturbances caused by benign prostatic hyperplasia: a comparative, randomized, two-drug crossover study. [Efficacy of naftopidil in patients with overactive bladder associated with benign prostatic hyperplasia: prospective randomized controlled study to compare differences in efficacy between morning and evening medication]. Silodosin versus naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized multicenter study. Naftopidil and propiverine hydrochloride for treatment of male lower urinary tract symptoms suggestive of benign prostatic hyperplasia and concomitant overactive bladder: A prospective randomized controlled study Comparison of the Effect of Naftopidil 75 mg and Tamsulosin 0.2 mg on the Bladder Storage Symptom With Benign Prostatic Hyperplasia: Prospective, Multi-institutional Study. A comparison of the efficacy of naftopidil and tamsulosin hydrochloride in medical treatment of benign prostatic enlargement
abstract: In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials BACKGROUND Tadalafil improved lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ; LUTS/BPH ) in clinical studies but has not been evaluated together with an active control in an international clinical study . OBJECTIVE Assess tadalafil or tamsulosin versus placebo for LUTS/BPH . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , international , placebo-controlled , parallel-group study assessed men ≥45 yr of age with LUTS/BPH , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urinary flow rate ( Q(max ) ) ≥4 to ≤15ml/s . Following screening and washout , if needed , subjects completed a 4-wk placebo run-in before r and omisation to placebo ( n=172 ) , tadalafil 5 mg ( n=171 ) , or tamsulosin 0.4 mg ( n=168 ) once daily for 12 wk . MEASUREMENTS Outcomes were assessed using analysis of covariance ( ANCOVA ) or ranked analysis of variance ( ANOVA ) ( continuous variables ) and Cochran-Mantel-Haenszel test or Fisher exact test ( categorical variables ) . RESULTS AND LIMITATIONS IPSS significantly improved versus placebo through 12 wk with tadalafil ( -2.1 ; p=0.001 ; primary efficacy outcome ) and tamsulosin ( -1.5 ; p=0.023 ) and as early as 1 wk ( tadalafil and tamsulosin both -1.5 ; p<0.01 ) . BPH Impact Index significantly improved versus placebo at first assessment ( week 4 ) with tadalafil ( -0.8 ; p<0.001 ) and tamsulosin ( -0.9 ; p<0.001 ) and through 12 wk ( tadalafil -0.8 , p=0.003 ; tamsulosin -0.6 , p=0.026 ) . The IPSS Quality -of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil ( both p<0.05 ) but not with tamsulosin ( both p>0.1 ) . The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil ( 4.0 ; p<0.001 ) but not tamsulosin ( -0.4 ; p=0.699 ) . Q(max ) increased significantly versus placebo with both tadalafil ( 2.4ml/s ; p=0.009 ) and tamsulosin ( 2.2ml/s ; p=0.014 ) . Adverse event profiles were consistent with previous reports . This study was limited in not being powered to directly compare tadalafil versus tamsulosin . CONCLUSIONS Monotherapy with tadalafil or tamsulosin result ed in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max ) . However , only tadalafil improved erectile dysfunction . TRIAL REGISTRATION Clinical trials.gov ID NCT00970632 This was a multicenter r and omized trial to investigate the clinical efficacy and the impact on sexual function of alpha-1A selective silodosin and alpha-1D selective naftopidil for treatment of benign prostatic hyperplasia . A total of 97 patients with lower urinary tract symptoms/benign prostatic hyperplasia who had an International Prostate Symptom Score of 8 or more were r and omly assigned to receive silodosin ( 8 mg/day , n = 53 ) or naftopidil ( 75 mg/day , n = 44 ) . Before and 4 , 8 and 12 weeks after treatment , International Prostate Symptom Score and its quality of life score were used to assess lower urinary tract symptoms . Also , International Index of Erectile Function-5 , and an original question naire were used to evaluate erectile function and ejaculation for sexually active patients , respectively . The silodosin group showed advantages in terms of voiding symptoms and quality of life of International Prostate Symptom Score when compared with the naftopidil group . Both silodosin and naftopidil showed no significant effect on International Index of Erectile Function-5 . A total of 23 sexually active patients in the silodosin group experienced more ejaculatory impairment than 21 patients in the naftopidil group , with a decrease of ejaculation volume ( 87 % vs 40 % , P = 0.003 ) , prolonged time to ejaculation ( 56 % vs 33 % , P = 0.027 ) and decrease of orgasm ( 50 % vs 39 % , P = 0.027 ) . These results suggest that alpha-1A selective blockers are more effective for voiding symptoms , whereas alpha-1D selective blockers offer a minor degree of ejaculatory dysfunction To compare the efficacy and safety of two α1a/α1d adrenoceptor ( AR ) antagonists with different affinity for the α1AR subtypes , tamsulosin and naftopidil , in the treatment of benign prostatic hyperplasia ( BPH ) We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy Naftopidil , approved only in Japan , is an α1-adrenergic receptor antagonist ( α1-blocker ) used to treat lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Different from tamsulosin hydrochloride and silodosin , in that it has higher and extremely higher affinity respectively , for the α1A-adrenergic receptor subtype than for the α1D type , naftopidil has distinct characteristics because it has a three times greater affinity for the α1D-adrenergic receptor subtype than for the α1A subtype . Although well- design ed large-scale r and omized controlled studies are lacking and the optimal dosage of naftopidil is not always completely determined , previous reports from Japan have shown that naftopidil has superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin . On the other h and , the incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may be lower than for tamsulosin and silodosin having high affinity for the α1A-adrenergic receptor subtype . However , it remains unknown if the efficacy and safety of naftopidil in Japanese is applicable to white , black and Hispanic men having LUTS/BPH in western countries OBJECTIVE To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia ( BPH ) in order to ensure the optimal indication for different BPH patients . METHODS A r and omized , parallel-controlled , multicenter clinical trial was conducted . From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups , including selective-adrenoceptor antagonist ( terazosin , doxazosin tamsulosin and naftopidil ) , 5 alpha-reductase inhibitor ( finasteride and epristeride ) and natural product ( cernilton ) . International Prostate Symptom Score ( IPSS ) and Quality of Life ( QOL ) , uroflowmetry , total prostatic volume ( TPV ) and transitional zone volume and residual urine  were used as efficacy criteria . RESULTS According to the baseline , the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume ( P < 0.01 ) . At average follow-up of 6 months , significant improvements in IPSS , QOL , Qmax and residual urine volume were observed in each therapeutic group , and no difference in IPSS improvement was found among the groups . Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups ( P < 0.05 ) . In patients with baseline TPV greater than 35.5 cm3 , the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group ( P < 0.01 ) ( 5.7 ml/s and 2.2 ml/s respectively ) , and more significant symptomatic improvements were also found in cernilton , doxazosin and naftopidil group . In each group , the improvement of symptom were more significant in patients with IPSS higher than 20 points ( P < 0.01 ) . CONCLUSIONS Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients , especially for patients with higher IPSS baseline . When using 5alpha-reductase inhibitor , prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3 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 PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml ( p < 0.0001 ) , a baseline PSA of 1.6 ng/dl or greater vs PSA less than 1.6 ng/dl ( p = 0.0009 ) , a baseline Qmax of less than 10.6 ml per second vs 10.6 ml per second or greater ( p = 0.011 ) , a baseline PVR of 39 ml or greater vs less than 39 ml ( p = 0.0008 ) and baseline age 62 years or older vs younger than 62 years ( p = 0.0002 ) . CONCLUSIONS Among men in the placebo arm , baseline TPV , PSA , Qmax , PVR and age were important predictors of the risk of clinical progression of BPH Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome We compared the efficacy , safety , and patient preferences for two α1-adrenoceptor ( AR ) antagonists with different affinity for AR subtypes , naftopidil ( Naf ) and silodosin ( Silo ) , for the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia ( male LUTS/BPH ) . New patients diagnosed with male LUTS/BPH were r and omly divided into either the Naf-Silo group or the Silo-Naf group ( Naf : 50 - 75 mg once daily for 2 weeks followed by 75 mg once daily for 4 weeks ; Silo : 2 - 4 mg twice daily for 2 weeks followed by 4 mg twice daily for 4 weeks ) . A survey was conducted to evaluate patient drug preferences after completion of the study and the reasons for the preferences . Naf and Silo  improved the total International Prostate Symptom Score ( IPSS ) compared with baseline . There was no significant difference between Naf and Silo in improvement in the IPSS total score . Adverse effects were more frequent with Silo than with Naf ( P=0 . 002 ) . No significant difference in patient preference for the drugs was observed . These findings indicate that Naf and Silo provide similar clinical efficacy , with no difference in patient preference for the drugs , although adverse effects were significantly more frequent with Silo than with Naf AIM The aim of this study was to compare the efficacy and safety of alpha1-adrenoceptor ( alpha1-AR ) antagonist monotherapy with combination therapy using alpha1-AR antagonist and anticholinergic agent for benign prostatic hyperplasia ( BPH ) with storage symptoms as the chief complaint . METHODS In this prospect i ve comparative study , either 25 - 75 mg/day of naftopidil monotherapy ( monotherapy group ) or combination therapy using 25 - 75 mg/day of naftopidil and an anticholinergic agent ( 10 - 20 mg/day of propiverine hydrochloride or 2 - 6 mg/day of oxybutynin hydrochloride ; cotherapy group ) were administered for 12 weeks to 101 BPH patients with storage symptoms . RESULTS International prostate symptom score ( IPSS ) and quality of life ( QOL ) index improved significantly in both groups , with no marked differences between groups . Maximum flow rate ( Qmax ) and residual urine volume ( RUV ) tended to improve in both groups , again with no marked differences between groups . However , median post-therapeutic RUV was significantly worse for the cotherapy group ( 45.0 mL ) than for the monotherapy group ( 13.5 mL ; P = 0.0210 ) . Ratio of patients with increased RUV was also significantly worse for cotherapy ( 22.9 % ) than for monotherapy ( 5.0 % ; P = 0.038 ) . CONCLUSIONS Although the anticholinergic dosage was low , the present results suggest that naftopidil monotherapy was as useful as combination therapy of naftopidil and an anticholinergic agent . Therefore , naftopidil is a useful agent as the first choice in BPH patients with storage symptoms BACKGROUND The present study investigated the efficacy , safety , and utility of starting an alpha(1d)-selective antagonist , naftopidil , at 75 or 25 mg/day in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . METHODS In this prospect i ve comparative study , the subjects comprised 153 patients with LUTS associated with BPH . Patients were r and omized to receive either 25 mg/day ( Group LD ) or 75 mg/day ( Group HD ) of naftopidil for 4 weeks . The lower urinary tract disease symptom score ( LUTDSS ) , the International Prostate Symptom Score ( IPSS ) , the Quality of life assessment index , the maximum flow rate ( Q(max ) ) , and the residual urine volume were compared between the groups . RESULTS In both groups , the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified . However , the improvement in the Q(max ) was significantly better for Group HD than for Group LD . The overall efficacy did not differ significantly between the groups . The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD . The frequency of adverse reactions did not differ significantly between the groups . CONCLUSIONS Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms , particularly in improving voiding symptoms . The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients There is no consensus on the evaluated efficacy of individual alpha(1)-blockers in the treatment of lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . This study compared the clinical benefits of tamsulosin hydrochloride with those of naftopidil in BPH . Men aged 54 - 84 years with a main complaint of BPH were r and omly assigned to receive consecutive treatment with tamsulosin then naftopidil ( T-N group , 25 patients ) , or naftopidil then tamsulosin hydrochloride ( N-T group , 20 patients ) . The therapeutic effects were compared in a crossover design . Administration was continued for 28 days in each treatment period . Both groups showed similar improvements during the first treatment period . However , during the second treatment period after crossover , therapeutic effects were greater in the N-T group . Tamsulosin was more effective than naftopidil on intermittency , nocturia and quality of life scores .  Tamsulosin and naftopidil have different efficacy profiles for LUTS associated with BPH 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 BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy Purpose : We investigated the efficacy of 2 & agr;1‐blockers with different affinities for the & agr;1‐adrenoceptor subtypes silodosin and naftopidil in the treatment of benign prostatic enlargement complicated by overactive bladder . Material s and Methods : This was a prospect i ve , open label , r and omized , multicenter study of 350 out patients with untreated benign prostatic enlargement associated with urinary urgency at least once per week and an OABSS ( Overactive Bladder Symptom Score ) of 3 or greater . Patients were r and omly assigned to receive silodosin 8 mg per day or naftopidil 75 mg per day . Changes in parameters from baseline to 4 and 12 weeks were assessed based on I‐PSS ( International Prostate Symptom Score ) , I‐PSS quality of life , OABSS and voiding functions measured by uroflowmetry . Results : On efficacy analysis a total of 314 patients were included in the 2 groups . No significant difference in adverse effects was observed between the groups . Mean I‐PSS and I‐PSS quality of life scores , and OABSS significantly improved in both groups . Statistically significantly greater improvement in the silodosin group than in the naftopidil group was observed in total OABSS ( p = 0.03 ) , I‐PSS quality of life score ( p = 0.005 ) and OABSS urgency score ( p < 0.001 ) at 12 weeks . In regard to voiding function the maximum urinary flow rate showed significant improvements in both groups but the change in the maximum flow rate in the silodosin group at 12 weeks was significantly greater than in the naftopidil group ( 3.6 vs 2.1 ml per second ) . Conclusions : Silodosin , a pure & agr;1A‐adrenoceptor blocker , showed greater improvement in overactive bladder symptoms along with the urinary flow rate in patients with benign prostatic enlargement complicated by overactive bladder compared to naftopidil , an & agr;1D > A‐adrenoceptor blocker AIM The aim of our study was to examine the efficacy of naftopidil in terms of the international prostate symptom score ( IPSS ) and urodynamic parameters in the treatment of benign prostatic hyperplasia ( BPH ) . Eviprostat was used as a control to study the efficacy of naftopidil . METHODS Forty-nine patients with BPH ( mean age 67.9 + /- 7.8 years ) were involved in the study . Patients were r and omly assigned either to the naftopidil group , which was treated with the alpha-blocker naftopidil ( 50 - 75 mg daily , 36 patients ) , or the eviprostat group , which was treated with phytotherapy ( six tablets of eviprostat daily , 13 patients ) . RESULTS The mean total IPSS , the total storage and voiding symptom scores , and the quality of life score decreased significantly ( P < 0.0001 for each variable ) in the naftopidil group , but not in the eviprostat group . In the naftopidil group , analyses showed significant increases in average and maximum flow rate and bladder capacity at first desire to void ( P < 0.001 , P = 0.001 and P = 0.024 , respectively ) , and significant decreases in the postvoid residual , the percent of residual and the Abrams-Griffiths number ( P = 0.009 , P = 0.008 and P = 0.042 , respectively ) . However , in the eviprostat group , no significant changes were noted in terms of these symptomatic and urodynamic parameters . In the pressure/flow study , an improvement in the International Continence Society nomogram grade was noted in 29 % of the naftopidil group , but in only 16 % of the eviprostat group . Among the 14 patients in the naftopidil group , detrusor overactivity disappeared in 21 % and cystometric capacity increased in 36 % , but no improvement in detrusor overactivity was noted in the eviprostat group . CONCLUSIONS Naftopidil appears to have been effective in this short-term treatment of BPH Introduction : We examined the tolerability of dosage methods of naftopidil in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH/male LUTS ) . Patients and Methods : A total of 80 patients with BPH/male LUTS who had an International Prostate Symptom Score ( IPSS ) ≧8 and IPSS quality of life ( QoL ) ≧2 were enrolled and r and omly administered naftopidil for 8 weeks at either 75 mg once daily ( OD ) in the evening ( group O ; n = 41 ) or 25 mg thrice daily ( TID ) in the morning , afternoon and evening ( group T ; n = 39 ) . Results : IPSS total score , IPSS-QoL and BPH impact index ( BII ) were significantly improved for both groups at 8 weeks after starting treatment compared to baseline . IPSS total score and daytime and 24-hour voiding frequencies were significantly improved at 8 weeks after starting treatment for group O in comparison to group T. Group O showed a significantly better degree of change in BII in comparison to group T. Conclusions : Naftopidil 75 mg OD in the evening was better tolerated than naftopidil 25 mg TID for the objective parameter and BII 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 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 In order to compare the clinical efficacy of naftopidil ( Naf ) and tamsulosin hydrochloride ( Tam ) , which differ in their selectivity to alpha receptor subtypes , we performed a multi-center prospect i ve r and omized controlled study . METHODS Men complaining of lower urinary tract symptoms due to benign prostatic hypertrophy , were r and omized into two treatment groups : one receiving 50 mg Naftopidil daily ( Naf group , n = 31 pts ) , and one receiving 0.2 mg Tam once daily ( Tam  group , n = 28 pts ) . Baseline symptom scores were compared to those at 2 weeks and at the end of the observation period ( 6 - 8 weeks ) . RESULTS In the Naf group at 2 weeks , the score of the daytime frequency significantly improved from 3.5 to 2.2 ( P = 0.03 ) , and the score of nocturia improved significantly from 3.5 to 2.2 ( P = 0.0004 ) , respectively . In the Tam group at 2 weeks , however , no significant improvement was noted in the increased score of daytime frequency ( P = 0.1 ) or nocturia ( P = 0.2 ) . At 2 weeks , the storage symptom score of the frequency to the combined score of daytime frequencies and the score of nocturia was better in the Naf group ( improved from 7.0 to 4.4 , P = 0.0017 ) than in the Tam group ( from 6.8 to 4.9 , P = 0.08 ) ( P < 0.05 ) . At 6 - 8 weeks , the effects of the two drugs on lower urinary tract symptoms were comparable . CONCLUSIONS Naf demonstrated a significant early response to improve storage symptoms at 2 weeks , including daytime frequency and nocturia , compared with Tam BACKGROUND The aim of the study presented here was to stratify drug therapy for patients with benign prostatic hyperplasia ( BPH ) displaying various voiding symptoms . METHODS Two different alpha1-adrenoceptor antagonists ; tamsulosin hydrochloride ( Tam ) and naftopidil ( Naf ) , were administered to 96 patients with BPH for 8 weeks in a crossover study . RESULTS With the administration of both drugs , the International Prostate Symptom Score ( I-PSS ) significantly decreased and the maximum urinary flow significantly increased . Whereas Naf monotherapy decreased the I-PSS for storage symptoms , Tam monotherapy decreased the I-PSS for voiding symptoms . In both the Naf-to-Tam and Tam-to-Naf groups , crossover was effective when the initial drug was judged subjectively and objective ly to have been ineffective . Compliance was acceptable with both drugs . CONCLUSION Our results show that either Naf or Tam can be used to treat patients on the basis of objective and subjective assessment of voiding symptoms . Our findings should be helpful for patient guidance and treatment of BPH A total of 100 patients with benign prostatic hyperplasia ( BPH ) and overactive bladder ( OAB ) symptoms ( BPH/OAB ) , enrolled between June 2006 to March 2008 , were r and omly divided into 2 groups of morning medication ( M ) and evening medication ( E ) groups , then 50 mg of naftopidil was given once a day after breakfast or supper for 8 weeks . Data were available for efficacy analysis on 80 patients ( M group ; 43 , E group ; 37 ) . Naftopidil significantly improved the overall international prostatic symptom score ; from 19.2±7.9 to 11.7±5.8 in the M group and from 19.4±6.4 to 12.3±6.8 in the E group ( p<0.0001 ) , QOL score from 4.9±0.8 to 3.2±1.4 in the M group and from 5.0±0.8 to 3.6±1.3 in the E group ( p<0.0001 ) , and OAB symptom score from 7.8±2.6 to 5.0±2.5 in the M group ( p<0.0001 ) and from 8.6±2.9 to 5.8± 3.3 in the E group ( p<0.0001 ) . There was no significant difference in the incidence of adverse effects between the M group ( 6.1 % ) and E group ( 2.2 % ) . These results suggest that naftopidil improves storage symptoms as well as voiding symptoms regardless of timing of administration OBJECTIVES Silodosin is a novel drug that is highly selective to subtype alpha 1A and , since 2006 , has been used in Japan for treating benign prostatic hyperplasia . This study aim ed to compare the clinical effects of the alpha-adrenoceptor antagonist , silodosin , with those of naftopidil in patients presenting lower urinary tract symptoms associated with benign prostatic hyperplasia . METHODS This was a r and omized , open-label , controlled multicenter study carried out in Japan . Overall , 121 participants with lower urinary tract symptoms associated with benign prostatic hyperplasia were r and omized to receive silodosin ( 4 mg twice daily ) or naftopidil ( 50 mg once daily ) for 4 or 8 weeks . Patients were divided into four groups : the alpha-blocker-naive groups received silodosin ( 35 patients ) or naftopidil ( 33 patients ) and the drug-switching groups changed from tamsulosin to silodosin ( 26 patients ) or naftopidil ( 27 patients ) . The outcomes parameters were the International Prostate Symptom Score , quality of life , maximum urinary flow rate and post-void residual urine volume . P < 0.05 was considered statistically significant by using the Wilcoxon signed-rank and rank-sum tests , and analysis of covariance . RESULTS In all the groups , silodosin and naftopidil significantly improved the total International Prostate Symptom Score and quality of life . However , silodosin obtained significantly better improvement in total International Prostate Symptom Score in the alpha-blocker-naive patients at 4 and 8 weeks . The maximum urinary flow rate and residual urine did not change significantly in all the treatment groups . CONCLUSIONS The present study confirms the clinical usefulness of silodosin in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia Objective . To assess the efficacy and safety of propiverine hydrochloride ( antimuscarinic ) , naftopidil ( α1-adrenoceptor antagonist ) or both in patients with male lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia and concomitant overactive bladder ( OAB ) . Material and methods . Men aged at least 50 years who had a total International Prostate Symptom Score ( IPSS ) of 8 or higher and bladder dairy documenting micturition frequency ( more than eight micturitions/24 h ) and urgency ( more than one episode/24 h ) , with or without urgency urinary incontinence were r and omized into three groups : group N , naftopidil ( 50 mg once daily ) only ; group P , propiverine hydrochloride ( 20 mg once daily ) ; and group NP , naftopidil ( 50 mg once daily ) plus propiverine hydrochloride ( 20 mg once daily ) for a 4-week treatment regimen . Results . A total of 66 men , including 20 in group N , 23 in group P and 23 in group NP , were treated and 58 ( 87.9 % ) completed the 4 weeks of treatment . IPSS improved significantly in groups N and NP . Urinary frequency improved significantly in groups P and NP . Postvoid residual urine volume increased significantly in groups P and NP . Significant improvements in urgency episodes were noted in each group . One patient in group P required catheterization owing to acute urinary retention and another stopped medication because of difficulty in voiding . Conclusion . These results suggest that each treatment showed effectiveness for male LUTS with OAB . However , there are some possibilities of adverse effects with propiverine hydrochloride monotherapy OBJECTIVE To compare the efficacies of naftopidil and tamsulosin in terms of reducing storage symptoms in patients with benign prostatic hyperplasia . MATERIAL S AND METHODS This prospect i ve r and omized study was performed at 10 centers . Ninety-four patients that had been taking tamsulosin for more than 8 weeks , but had an Overactive Bladder Symptom Score ( OABSS ) of greater than 3 points , were initially enrolled . After a 1-week washout period , patients were divided into 2 groups . Forty-five patients were treated with tamsulosin 0.2 mg daily , and 49 patients were treated with naftopidil 75 mg daily for 8 weeks . Total International Prostate Symptoms Score ( IPSS ) , storage symptom scores , nocturia times , OABSS , maximal flow rates ( Qmax ) , and postvoid residual volumes were checked before and after the 8-week treatment period . RESULTS Mean patient ages in the tamsulosin and naftopidil groups were 64.8 and 66.0 years , respectively . Baseline characteristics were not significantly different . In the tamsulosin group , mean total IPSS decreased from 19.1 to 15.1 after the 8-week treated period ( P = .001 ) , and in the naftopidil group , mean total IPSS decreased from 16.9 to 13.1 ( P = .001 ) . Mean storage symptom scores were reduced in the tamsulosin and naftopidil groups from 8.0 to 6.6 ( P = .002 ) and from 7.6 to 6.1 ( P = .001 ) , respectively . Mean nocturia times in the naftopidil groups decreased significantly from 2.5 to 1.9 ( P = .001 ) , and mean OABSSs were reduced from 7.7 to 6.0 ( P = .001 ) and from 7.4 to 6.0 ( P = .001 ) , respectively . CONCLUSION Total IPSS , storage symptom scores , nocturia times , and OABSS were significantly reduced by naftopidil and tamsulosin . Moreover , the naftopidil group showed better improvements in nocturia than the tamsulosin group Introduction : Lower urinary tract symptoms in men , over age of 50 years is suggestive of benign prostatic enlargement ( BPE ) . Different alpha-blockers have been evaluated for the treatment of benign prostatic hyperplasia for over last 30 years . This study was conducted in a tertiary care institution during the period of year between June 2011 and August 2013 to compare the effect of naftopidil and tamsulosin in reducing the obstructive and irritable symptoms of BPE . Subjects and Methods : A prospect i ve r and omized comparative study was carried on 60 patients of BPE by assigning half of them to treatment with tamsulosin and rest with naftopidil .  Pre- and post-treatment uroflowmetry ( UFM ) , post-void residue ( PVR ) , International Prostate Symptoms Score ( IPSS ) , were obtained at 15 and 30 days after starting treatment . Results : The age of patients ranged from 51 to 78 . At base line there was no statistical difference between UFM parameter , PVR and IPSS in the two groups . UFM and PVR showed significantly better response at both intervals with naftopidil . Comparison of IPSS showed better improvement in Group A both at 15 and 30 days . It was seen that the obstructive symptoms showed a significantly better response with tamsulosin and symptoms of irritability was seen better response with naftopidil . Conclusion : It was seen that during the period of follow-up of 30 days naftopidil had a better effect on UFM , PVR , IPSS compared with tamsulosin . In general , obstructive symptoms showed better improvement in tamsulosin and irritative symptoms showed better improvement in naftopidil
target: Naftopidil appears to have similar effects in the urological symptom scores and QoL compared to tamsulosin and silodosin .
  Naftopidil has similar sexual adverse events compared to tamsulosin but has fewer compared to silodosin
background: BACKGROUND Benign prostatic hyperplasia ( BPH ) is a common condition in ageing men that may cause lower urinary tract symptoms ( LUTS ) .
  Treatment aims are to relieve symptoms and prevent disease-related complications .
  Naftopidil is an alpha-blocker ( AB ) that has a high affinity for the A1d receptor that may have advantages in treating LUTS in this setting .
  This is an up date of a Cochrane Review first published in 2009 .
  Since that time , several large r and omised controlled trials ( RCTs ) have been reported , making this up date relevant .
  OBJECTIVES To evaluate the effects of naftopidil for the treatment of LUTS associated with BPH .