title: Clinical efficacy of a loading dose of naftopidil for patients with benign prostate hyperplasia Clinical effect of alpha 1D/A adrenoceptor inhibitor naftopidil on benign prostatic hyperplasia: an international prostate symptom score and King's Health Questionnaire assessment. Silodosin versus naftopidil for the treatment of benign prostatic hyperplasia: a multicenter randomized trial. Naftopidil for the treatment of urinary symptoms in patients with benign prostatic hyperplasia α1-Adrenoceptor blocker naftopidil improves sleep disturbance with reduction in nocturnal urine volume Clinical Feature of Men Who Benefit from Dose Escalation of Naftopidil for Lower Urinary Tract Symptoms: A Prospective Study Expression of alpha1-adrenoceptor subtype mRNA as a predictor of the efficacy of subtype selective alpha1-adrenoceptor antagonists in the management of benign prostatic hyperplasia. Effect of naftopidil on nocturia after failure of tamsulosin. 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. Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study. Short-term efficacy and long-term compliance/treatment failure of the alpha1 blocker naftopidil for patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Intraoperative floppy iris syndrome associated with tamsulosin 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 Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. Pharmacokinetics of naftopidil, a novel anti-hypertensive drug, in patients with hepatic dysfunction. 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 Incidence of intraoperative floppy iris syndrome in patients on either systemic or topical alpha(1)-adrenoceptor antagonist. 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. α1D/A-adrenoceptor antagonist naftopidil for the male lower urinary tract symptoms associated with benign prostatic hyperplasia: efficacy of dose increase therapy. 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 Prevalence and characteristics of lower urinary tract symptoms in men aged > or = 80 years.
abstract: Purpose The efficacy of a loading dose of α1-adrenoreceptor antagonist for patients with benign prostate hyperplasia who did not improve at a low dose has not been determined . We performed a prospect i ve study to estimate the efficacy of incremental naftopidil administration . Methods The efficacy of naftopidil was examined based on changes in the International Prostate Symptom Score ( IPSS ) . We defined a “ responder ” as a patient who improved by ≥5 points in IPSS total score . All patients were administered naftopidil at 50 mg/day for 12 weeks , and nonresponders at 50 mg/day were increased to 75 mg/day . Efficacy was finally evaluated after an additional 12 weeks of administration at 75 mg/day . Results Among 122 patients whose data could be analyzed , the efficacy rate after administration at 50 mg/day was 52.5 % . In all IPSS items except urgency score , the responders had significantly higher ( poorer ) values than nonresponders before the start of treatment . Of 40 patients whose dose was increased to 75 mg/day and whose data could be analyzed  , prostate volume in the responder group ( 9 patients ) was significantly smaller than that in the nonresponder group ( 31 patients ) . Multivariate analysis showed that patients with improved IPSS total score , voiding symptoms , urgency , and weak stream after administration of 50 mg/day naftopidil were more likely to improve after a dose increase . Conclusions A dose increment of naftopidil to 75 mg/day may be useful in patients with BPH who did not improve at 50 mg/day OBJECTIVES To examine the effect of alpha 1D/A adrenoceptor inhibitor naftopidil on health-related quality of life ( QOL ) in men with benign prostatic hyperplasia ( BPH ) . METHODS A total of 56 newly diagnosed patients with symptomatic BPH were prospect ively enrolled and treated with 50 mg naftopidil daily for more than 12 weeks . All underwent pre-treatment documentation of lower urinary tract symptoms , QOL assessment using the international prostate symptom score ( IPSS ) and King 's Health Question naire ( KHQ ) , and uroflowmetry . A post-treatment assessment was performed at 12 weeks . RESULTS IPSS scores as well as QOL index showed a significant improvement after naftopidil administration . Similarly , all seven domains except general health perceptions and social limitations in the KHQ question naire were significantly improved . When dividing the patients into overactive bladder ( OAB ) and non-OAB groups , only the OAB group showed significant improvement in almost all the domains of KHQ . Change ratios of the IPSS were not associated with those of KHQ domain scores in the OAB group . On the other h and , in the non-OAB group more domains presented improvements , which were associated with those of IPSS scores . CONCLUSIONS Twelve-week treatment with naftopidil for symptomatic BPH patients is associated with significant improvement in the IPSS , QOL index , maximum urinary flow rate , post-void residual urine volume ( PVR ) and almost all domains in KHQ . KHQ is useful for the evaluation of clinical response in BPH patients , particularly in those with associated OAB 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 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 Objectives To examine the mechanism underlying improvements in nocturia by α1-blockers , we investigated whether the α1-blocker naftopidil acts on nocturia with sleep disturbance using a frequency/volume chart ( FVC ) . Methods A total of 56 male patients with lower urinary tract symptoms were enrolled . The inclusion criteria were as follows : eight or more points on the I-PSS ; three or more points on the I-PSS score for nocturia ; and prostate volume larger than 20 ml . Patients received 50 mg of naftopidil once daily for 4 weeks , and non-responders received 75 mg for another 4 weeks . All patients were examined , and their data entered into FVC for 2 days before and after administration of naftopidil . Quality of sleep was also evaluated using modified Pittsburgh sleep quality index ( PSQI ) . Results Patients  with sleep quality scores of three or four were assigned to sleep disturbance group ( n = 33 ) , while those with scores of less than three were assigned to non-disturbance group ( n = 23 ) . After administration of naftopidil , total I-PSS decreased and nocturia score decreased from 3.5 to 2.6 ( P < 0.01 ) . Total mean score of modified PSQI in sleep disturbance group became significantly lower after administration of naftopidil ( from 16.9 to 14.0 ; P < 0.01 ) . Naftopidil significantly decreased nocturnal urine volume , result ing in a decrease in the nocturnal polyuria index in both sleep disturbance and non-disturbance groups . Conclusion These results suggest that α1-blockers have the ability to normalize sleep disorders . Naftopidil  improved nocturnal polyuria regardless of the presence of sleep disturbance , meaning that it might directly reduce nocturnal urine production Objectives . To examine the feature of men who benefit from dose escalation of naftopidil for lower urinary tract symptoms ( LUTSs ) . Methods . Based on the IPSS , men reporting LUTS were prospect ively studied using 50 mg/day of naftopidil for the first 4 weeks ; satisfied patients continued its 50 mg/day ( n = 11 ) , and those reporting unsatisfactory improvement received its 75 mg/day ( n = 35 ) for the next 4 weeks . Results . The 75 mg group showed improvement in the total IPSS and QOL score in a dose-dependent manner ( at 4 weeks : P < .001 , at 4 weeks versus 8 weeks : P < .05 ) . In the 50 mg group , both scores reduced at 4 weeks , thereafter unchanged . The baseline slow stream score alone was higher in the 75 mg group ( P = .013 ) . The rate of change in the QOL score during the initial 4 weeks ( ΔQOL ) and Δnocturia was smaller in the 75 mg group ( P < .05 ) . Conclusions . Men with high slow stream score and unsatisfactory improvement in nocturia may benefit from dose escalation of naftopidil PURPOSE We examined the correlation between the expression of alpha1-adrenoceptor subtype mRNA in the prostate and the clinical efficacy of subtype selective alpha1-adrenoceptor antagonists . We discuss the possibility of individualizing drug therapy in patients with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 33 patients r and omized to the tamsulosin group and 28 r and omized to the naftopidil group were enrolled in this study . Each group of patients was administered 0.2 mg tamsulosin hydrochloride or 50 mg naftopidil daily for 12 weeks . Four prostate needle biopsy specimens were obtained from the transition zone to examine the expression of alpha-adrenoceptor subtypes . Specimens were stored at -80 C until used for TaqMan quantitative reverse transcriptase-polymerase chain reaction , which was performed after 12 weeks of treatment . RESULTS Based on the results of quantitative reverse transcriptase-polymerase chain reaction the tamsulosin and naftopidil groups were grouped into alpha1a-adrenoceptor dominant ( 22 and 12 patients ) and alpha1d-adrenoceptor dominant ( 11 and 16 , respectively ) subgroups . The efficacy of tamsulosin hydrochloride and naftopidil differed depending on the dominant expression of the alpha1-adrenoceptor subtype in the prostate . Tamsulosin hydrochloride was more effective in patients with dominant expression of the alpha1a-adrenoceptor subtype , whereas naftopidil was more effective in those with dominant expression of the alpha1d-adrenoceptor subtype . CONCLUSIONS The expression level of alpha1-adrenoceptor subtype mRNA in the prostate could be a predictor of the efficacy of subtype selective alpha1-adrenoceptor antagonists in patients with benign prostatic hyperplasia . This result implies that genetic differences are responsible for the diverse responses to these drugs OBJECTIVES The clinical usefulness of naftopidil was evaluated in 122 patients with benign prostatic hyperplasia for urinary tract symptoms and signs , focused in particular on nocturia . METHODS A total of 122 patients with BPH whose symptoms did not improve after 6 weeks of tamsulosin administration were enrolled . After the treatment was followed by a washout period with placebo , patients were prescribed 75 mg of naftopidil to be taken after dinner for 6 weeks , and the efficacy was re-evaluated . All the drugs used were unidentified , and attention was given to not have the patients recognize the change in the drug given . The primary purpose of this study was the improvement of nocturia in patients with a poor response to tamsulosin . The clinical efficacy of naftopidil was defined as significant improvement in International Prostate Symptom Score , quality -of-life index , and maximal urinary flow rate . RESULTS After 6 weeks of naftopidil administration , significant improvements in daytime and nighttime frequency , International Prostate Symptom Score , quality -of-life index , maximal flow rate , average flow rate , and bladder compliance were examined . On the International Prostate Symptom Score question naire , improvement in the sensation of the bladder not emptying and a reduction in nighttime frequency stood out . Moreover , detrusor overactivity was observed in 40 patients before the start of treatment and was eliminated in 31 . The effective rate of this study was 69.7 % ( 85/122 ) . CONCLUSIONS Naftopidil has novel effects in patients with BPH whose main complaints are storage and voiding symptoms , especially that of nocturia of > or=3 times , as well as in patients with a low compliance bladder and detrusor overactivity , who did not respond to tamsulosin 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 OBJECTIVES To investigate the benefit of alpha1-adrenoceptor antagonist naftopidil on the quality of life ( QOL ) of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH/LUTS ) . METHODS A total of 99 men with BPH/LUTS were prospect ively recruited . The Short Form-8 ( SF-8 ) was used for generic QOL assessment and each parameter was compared with the norm in these patients . Longitudinal changes were evaluated using the SF-8 and the International Prostatic Symptoms Score ( I-PSS ) at baseline , 4 and 8 weeks after naftopidil administration . The relationship between SF-8 and I-PSS was analyzed . RESULTS Five of eight components in the SF-8 were significantly lower than the Japanese national norm at baseline . SF-8 score was improved by naftopidil at 4 and 8 weeks in general health ( GH ) and physical component summary ( PCS ) in the patients in their 70s . Mental health ( MH ) and mental component summary ( MCS ) were improved at 8 weeks in patients in their 60s . When analyzing the whole cohort , SF-8 GH , role emotional ( RE ) and MH had improved at 8 weeks , which was similar to the norm , and bodily pain ( BP ) results were better . Compared with the baseline , total I-PSS , storage/voiding symptoms and QOL index scores improved significantly under naftopidil . Each component of I-PSS ( except for hesitancy ) correlated with SF-8 sub-scales ( except for BP ) to some extent . CONCLUSIONS BPH/LUTS impairs generic QOL , which is improved by naftopidil treatment . SF-8 can be a useful instrument to assess the efficacy of BPH/LUTS treatment because its simplicity to complete and analyze , and its meaningful relationship to I-PSS OBJECTIVE To evaluate treatment failure during a 4-year follow-up period after administration of naftopidil for patients with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) in real-life clinical practice . MATERIAL AND METHODS A total of 247 patients with LUTS/BPH who had an International Prostate Symptom Score ( IPSS ) of > or = 8 were enrolled in the study .  Naftopidil , 50 mg/day , was given to the patients . They were followed for 4 years with periodic evaluation . Treatment failure was defined as conversion to other medical treatment or to surgery . RESULTS Of the 247 patients , treatment failure occurred in 42 ( 17.0 % ) during the 4-year follow-up period . The 4-year treatment failure rate was on the Kaplan-Meier curve 35.0 % . Among parameters assessed at baseline , prostate volume ( PV ) was the only significant determinant of treatment failure : patients with a PV of > or = 35 ml had a 2.1 times higher hazard of treatment failure than those with a PV of < 35 ml ( 95 % CI 1.06 - 4.33 ; p=0.03 ) . Patients with a severe IPSS at 12 weeks after administration of naftopidil had a 3.5 times higher hazard than those having a mild/moderate IPSS ( 95 % CI 1.34 - 9.26 ; p=0.01 ) . After 4 years , 200 patients ( 81 % ) had stopped taking naftopidil because of adverse events , treatment failure , loss to follow-up , etc . CONCLUSIONS There were significant improvements in IPSS and urinary flow rate with naftopidil although it is unknown whether these improvements were significantly larger than the placebo effect as the study was non-r and omized . However , only 19 % of patients were known to have continued with the same medication for 4 years in real-life clinical practice . Patients who have a large prostate at baseline and a severe IPSS at 12 weeks after treatment are more likely to have treatment failure , although a prospect i ve study is needed to confirm this Purpose : To assess the incidence and possible causative factors of a newly recognized syndrome , the intraoperative floppy iris ( IFIS )  . Setting : Clinical practice s in Los Altos and San Rafael , California , USA . Methods : A retrospective chart review of consecutive cataract surgeries performed in a 2‐surgeon practice over a 12‐month period ( 706 eyes ; 511 patients ) was used to assess the percentage of cataract patients on systemic sympathetic α‐1 antagonist medications  as well as the percentage of patients who manifested the IFIS . A separate prospect i ve study of 900 consecutive cases ( 741 patients ) performed by another surgeon was used to determine the incidence of IFIS  and the percentage of these patients who were taking α‐1 antagonist medications . Results : Three percent ( 16/511 ) of the patients in the retrospective study , representing 3.0 % ( 25/706 ) of the total eyes , were taking tamsulosin ( Flomax ) for benign prostatic hypertrophy . The overall prevalence of IFIS was 2.0 % ( 10/511 patients ) . The syndrome was noted intraoperatively in 63.0 % ( 10/16 ) of the tamsulosin patients but in none of the 11 patients on other systemic α‐1 blockers . In the prospect i ve study of 900 consecutive cataract surgeries , the prevalence of IFIS was 2.2 % ( 16/741 patients ) . Ninety‐four percent ( 15/16 ) of the IFIS patients were taking or had taken systemic tamsulosin . Twenty‐six patients ( 36 eyes ) in the 2 studies had IFIS associated with systemic tamsulosin . Sphincterotomies and mechanical pupil stretching were ineffective in maintaining adequate pupil dilation in this surgical population . Conclusion : Intraoperative floppy iris syndrome occurred in approximately 2 % of a cataract surgery population and appeared to be caused by tamsulosin , a systemic sympathetic α‐1A antagonist medication that is the most frequently prescribed medication for benign prostatic hypertrophy 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 PURPOSE We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . MATERIAL S AND METHODS The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability . All patients were initially treated with 0.4 mg . tamsulosin orally once a day . A week later the patients were r and omly allocated into group 1 - 25 who continued treatment with tamsulosin only and , group 2 - 25 who also received 2 mg . tolterodine orally twice daily . Reevaluation with a quality of life question naire and urodynamic study was performed after 3 months . RESULTS Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension . Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients ( mean score 525.0 and 628.4 before and after treatment , respectively , 2-sided t test p = 0.0003 ) . A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction . Additionally , in group 2 , a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment . CONCLUSIONS Combination treatment with an alpha-blocker ( tamsulosin ) plus an anticholinergic ( tolterodine ) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . Interestingly , no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume . The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability The pharmacokinetics of naftopidil , a novel alpha-1 adrenoceptor-blocking antihypertensive , were investigated in ten patients ( 9M/1F ) with hepatic dysfunction after oral administration ( 50 mg , tablet ) and after an intravenous infusion of 5.0 mg over 2 minutes . Results were compared to a control group of 12 healthy subjects ( 6M/6F ) of a previous investigation , which was carried out according to the identical study protocol . The pharmacokinetic parameters obtained for the i.v . administration were comparable in both groups ( half life 3.6 + /- 3.4 hours in liver-impaired subjects versus 3.3 + /- 2.1 hours in controls ; clearance 11.9 + /- 4.7 ml/minute/kg versus 11.0 + /- 1.6 ml/minute/kg ) . Following oral administration the plasma levels and half-life times of naftopidil  were significantly increased in liver impairment ( t1/2 16.6 + /- 19.3 hours versus 5.4 + /- 3.2 hours in controls ; P = 0.012 ) . Mean values for the absolute bioavailability in patients with hepatic dysfunction were significantly higher ( mean 75 % , median 53 % , range 13.4 - 211.0 % ) compared to healthy subjects ( mean 17 % , median 16 % , range 6.7 - 29.6 % , P = 0.001 ) . Reduction of functional hepatic blood flow in chronic liver disease or , as evidence d in one case as a consequence of shunt surgery , is the probable cause of the observed alteration in naftopidil kinetics . This phenomenon occurred only following the oral 50 mg dose whereas the intravenous 5 mg dose obviously still could be normally h and led .  Naftopidil demethylation and hydroxylation were both less and non-uniformly affected . The pharmacokinetic findings suggest that in patients with severe hepatic impairment or evidence for marked changes in hepatic blood flow the dose of naftopidil may require adjustment to the lower end of the therapeutic range and /or may be limited to once daily . However , before definite conclusions can be drawn , further steady-state studies are required . Despite the pharmacokinetic discrepancies no difference in drug tolerability was seen between patients and healthy subjects 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 evaluate the incidence of  Intraoperative Floppy Iris syndrome ( IFIS )  in relation to the usage of alpha(1)-adrenoceptor antagonists . DESIGN Prospect i ve , interventional case series . METHODS In 2,643 consecutive eyes of 1,968 patients undergoing cataract surgery , occurrence of IFIS and use of alpha(1 ) antagonists were recorded . RESULTS IFIS was observed in 29 eyes ( 1.1 % ) of 25 male patients , all of whom were receiving  alpha(1 ) antagonists . In those receiving systemic tamsulosin , alpha(1A ) selective antagonist ,  IFIS developed in 25 ( 43.1 % ) of 58 eyes . In those receiving systemic naftopidil , alpha(1A ) and alpha(1D ) antagonists , IFIS was found in 4 ( 19.0 % ) of 21 eyes . There was no case of IFIS in patients who received other systemic alpha(1 ) antagonists and in eyes treated with bunazosin eyedrops , a nonselective alpha(1 ) antagonist . CONCLUSIONS IFIS occurred in 1.1 % of cases treated with systemic alpha(1A)-adrenoceptor antagonists for benign prostatic hypertrophy . Topical nonselective alpha(1 ) antagonist did not induce IFIS 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 OBJECTIVES To examine the efficacy of dose increase therapy in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia who responded poorly to 50 mg/day of naftopidil .  METHODS A total of 95 patients received 50 mg/day of naftopidil for 8 weeks . After this treatment period , they were divided into two groups : the poor responders were defined as those who either had an International Prostate Symptom Score- Quality of Life ≥ 4 or with an International Prostate Symptom Score- Quality of Life of 3 whose International Prostate Symptom Score- Quality of Life improved < 2 points ( group A ) . All other patients were defined as responders to naftopidil 50 mg/day ( group B ) . The dose of naftopidil was increased to 75 mg/day in group A , and maintained at 50 mg/day in group B. The treatment was continued for a further 8 weeks . RESULTS The prostate volume at the baseline was significantly larger in group A than group B. The improvement of International Prostate Symptom Score total score , International Prostate Symptom Score- Quality of Life , and voided volume after 8 weeks was significantly better in group B than in group A. However , there was no significant difference in the changes of all parameters between the two groups after 16 weeks . CONCLUSIONS A dose increase to 75 mg/day is an effective treatment strategy in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia who responded poorly to an initial dose of 50 mg/day of naftopidil . Furthermore , a starting dose of 75 mg/day should be considered in patients with a large prostate volume , as this is a predictive factor for dose increase 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 OBJECTIVES We analyzed the prevalence and characteristics of  lower urinary tract symptoms ( LUTS ) in community-dwelling men aged 80 years and older . METHODS We administered the American Urological Association Symptom Index ( AUA-SI ) by mail to 291 surviving community-dwelling male participants in the Rancho Bernardo Study , a prospect i ve , community-based study of aging . We compared the prevalence , severity , and types of LUTS occurring in men who were > or = 80 years to those < 80 years . RESULTS The mean age was 74.6 years ( st and ard deviation [ SD ] 8.9 , range 48.3 - 97.1 ) . One third of the respondents were > or = 80 years . The mean total AUA-SI score increased steadily by decade of life ( P-trend = .002 ) . The prevalence of LUTS was 70 % in men > or = 80 years and 56 % in men < 80 years ( P = .03 ) . Men > or = 80 years had significantly higher mean total AUA-SI ( P = .05 ) and were more likely to complain of incomplete emptying ( odds ratio [ OR ] 2.12 , 95 % confidence interval [ CI ] 1.06 - 4.18 , P = .02 ) , frequency ( OR 1.83 , 95 % CI 1.00 - 3.31 , P = .03 ) , urgency ( OR 1.76 , 95 % CI 0.96 - 3.20 , P = .05 ) , and weak stream ( OR 1.78 , 95 % CI 1.01 - 3.12 , P = .03 ) . CONCLUSIONS In this cohort of community-dwelling men , prevalence and severity of LUTS increased into the 10th decade of life . Compared to younger men , men > or = 80 years were more likely to complain of incomplete emptying , frequency , urgency , and weak stream . Further studies of LUTS in older men are needed to better delineate these associations
target: Although additional well design ed , worldwide , placebo-controlled and r and omized studies are necessary to confirm the long-term outcomes of naftopidil pharmacotherapy , current data suggest that naftopidil administration in BPH patients provides comparable improvements in total IPSS , QoL , and urinary symptoms from baseline relative to 0.2 mg/d tamsulosin and 8 mg/d silodosin .
  However , improvements in Qmax are generally less with naftopidil than with tamsulosin .
  Reported adverse effects related to naftopidil administration are negligible and usually mild .
background: OBJECTIVES The aim of the study was to systematic ally review the effects of the adrenoreceptor A1D antagonist naftopidil in the management of  lower urinary tract symptoms ( LUTS ) .