Naftopidil for the treatment of urinary symptoms in patients with benign prostatic hyperplasia Crossover comparison study on the therapeutic effects of tamsulosin hydrochloride and naftopidil in lower urinary tract symptoms associated with benign prostatic hyperplasia. Ejaculatory Disorders Caused by Alpha-1 Blockers for Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Comparison of Naftopidil and Tamsulosin in a Randomized Multicenter Study Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study. 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 [Comparison of naftopidil and silodosin in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, crossover 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. [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin]. Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study. 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. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Effects of hexanic extract of serenoa repens (permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected].
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 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 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 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 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 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 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 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 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 Background The primary objectives of the treatment for the  lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels .  Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P<0.01 ) . A decrease in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P < .01 ) . Also , Q(max ) and AFR significantly improved in both groups ( P < .01 ) . The improvements in IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile OBJECTIVE To assess the effect of tamsulosin on the Sexual Health Inventory for Men ( SHIM ) score in men diagnosed with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . PATIENTS AND METHODS Analysis from the national data base of a programme of the Prostate Cancer Educational Council identified 7974 men who completed the American Urologic Association Symptom Score ( AUA-SS ) and SHIM question naires . The patients were divided into three groups ; group 1 , men taking tamsulosin ;  group 2 , men on other prescription medications for treating BPH symptoms ;  and group 3 , men not currently taking any BPH medications .  Linear regression was used to assess the association of tamsulosin and other alpha-blocker prescriptions for treating BPH symptoms with the decline in SHIM score . The interaction terms between AUA and the intake of tamsulosin was also adjusted for in the final analysis . RESULTS The median age of the men was 60 years . In groups 1 , 2 and 3 , ( 234 , 291 and 7449 men , respectively ) the mean ( sd ) AUA-SS was 13.0 ( 7.2 ) , 12.1 ( 7.2 ) and 6.9 ( 5.8 ) , and the mean SHIM scores 11.7 ( 6.8 ) , 12.7 ( 6.5 ) and 15.9 ( 6.0 ) , respectively . Adjusting for the AUA-SS , men in group 1 on tamsulosin had a significantly higher SHIM score with increasing AUA-SS score than men on other medications ( P < 0.01 ) , off setting the negative correlation between the AUA-SS and SHIM ( P < 0.01 ) . Moreover , men in group 1 were more likely to have a higher AUA-SS and lower SHIM score than men in the other two groups , suggesting more severe symptoms in these men . CONCLUSIONS Men taking tamsulosin to treat LUTS appear to be at an advantage over men taking other alpha-blockers when the effect of LUTS on sexual health is considered . Furthermore , this effect was more profound in patients with more severe LUTS than those with mild and moderate symptoms . Future prospect i ve trials are warranted to confirm this effect PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial .  Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial .  Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score  ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated This prospect i ve study evaluated the safety of tadalafil 5 mg taken once a day in terms of hypotensive side effects and whether it improves lower urinary tract symptoms ( LUTS ) and restores sexual function in patients with erectile dysfunction who are receiving concomitant α-blocker ( AB ) therapy for benign prostatic hyperplasia ( BPH ) . A total of 158 LUTS/BPH patients receiving AB therapy for ≥3 months were given tadalafil 5 mg once a day . Before treatment with tadalafil ( V1 ) , and 4 weeks ( V2 ) and 12 weeks ( V3 ) after starting  tadalafil , blood pressure , heart rate , International Prostate Symptom Score ( IPSS ) , maximal urine flow rate ( Qmax ) , postvoiding residual urine volume , and International Index of Erectile Function ( IIEF-5 ) score were measured . Of the 158 LUTS/BPH patients , a total of 119 completed the trial . Blood pressure ( systolic and diastolic ) and heart rate did not change . IPSS and IIEF-5 scores improved significantly , but Qmax and postvoiding residual urine volume did not ; however , in the 39 men with a low baseline Qmax ( ≤10 mL/s ) , Qmax rose significantly from 7.97 ± 1.44 mL/s ( baseline ) to 8.91 ± 1.60 mL/s ( V3 ; P = .012 ) . The remaining patients ( baseline Qmax > 10 mL/s ) did not change . At V2 and V3 , adverse side effects were observed in 10 men ( 7.30 % ) and 6 men ( 5.04 % ) , respectively . Facial flushing was the most common adverse side effect ( 6 men at V2 and 4 men at V3 ) , followed by headache ( 2 men each at V2 and V3 ) and dizziness ( 2 men at V2 ) . Two patients dropped out of the study because of adverse side effects . In conclusion , tadalafil 5 mg once a day in combination with AB appeared to have few adverse effects on hypotensive events and can improve LUTS and restore sexual function 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 OBJECTIVE To assess the efficacy and safety of tadalafil , a phosphodiesterase 5 ( PDE5 ) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) , in population subgroups , using pooled data from 4 international , r and omized , placebo-controlled studies in men with LUTS/BPH . METHODS The safety data base included 1500 men r and omized to tadalafil 5 mg once daily or placebo for 12 weeks . Changes in total International Prostate Symptom Score ( IPSS ) , IPSS- quality of life index , and BPH impact index were examined overall , and changes in IPSS or adverse events ( AEs ) were examined across subgroups of interest . Treatment-group differences were assessed using analysis of covariance . RESULTS Results of pooled data confirmed that tadalafil ( N = 752 ) result ed in significant improvements from baseline vs placebo ( N = 746 ) in IPSS ( mean difference -2.3 ; P < .001 ) , and also in BPH impact index and IPSS- quality of life index ( both P < .001 ) . Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity ( IPSS < 20/≥20 ) , age ( ≤65/>65 years ) , recent previous use of α-blockers or PDE5 inhibitors , total testosterone level ( < 300/≥300 ng/dL ) , or prostate-specific antigen predicted prostate volume ( < 40/≥40 mL ) . [ corrected ] Rates of treatment emergent AEs were comparable between subgroups of baseline age ( ≤65/>65 years ) , previous PDE5 inhibitor use , and the presence or absence of pre-existing diabetes , hypertension , or cardiovascular disease ( including hypertension ) , but somewhat higher for recent previous α-blocker use . CONCLUSION In these pooled data analyses , tadalafil 5 mg improved LUTS/BPH across subgroups of age , LUTS severity , testosterone levels , and prostate volume . Rates of AEs were similar across the subgroups assessed Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , OBJECTIVE This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia ( BPH ) . METHODS The study was a r and omized , placebo-controlled , double blind trial comparing three doses ( low , medium , and high ) of a new uro-selective alpha-blocker with an active comparator . A total of 536 men aged 40 years and older with lower urinary tract symptoms ( LUTS ) result ing from BPH were r and omized into the study . Patients ' perceptions of satisfaction with efficacy , dosing , and side effects were explored using a vali date d disease-specific instrument , the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ) . The TSS-BPH was administered at the end of the study or at withdrawal . RESULTS Compared with placebo , the medium and high doses showed the greatest efficacy on the primary endpoint , the International Prostate Symptom Score ( IPSS ) . Patient satisfaction with efficacy at these doses was significantly better than that for placebo . Nevertheless , adverse events were most frequent in the high dose group . Satisfaction with side effects was significantly worse than placebo for this group , and this was reflected in the total scores on the TSS-BPH , with patients being most satisfied overall with the medium dose . CONCLUSIONS Exploring patients ' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects , and can be used to inform the selection of doses for later trials . This is especially useful for products that require adherence with medication over long periods of time BACKGROUND Tadalafil is being investigated for the treatment of lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH-LUTS ) . OBJECTIVE To assess efficacy , including onset , and safety of tadalafil on BPH-LUTS and the subject 's and clinician 's perception of changes in urinary symptoms . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , placebo-controlled , 12-week trial enrolled men ≥45 yr of age with BPH-LUTS for > 6 mo , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urine flow rate ( Q(max ) ) ≥4 to ≤15 ml/s . INTERVENTION Tadalafil 5 mg ( n=161  ) or placebo ( n=164 ) , once daily . MEASUREMENTS Analysis of covariance ( ANCOVA ) modeling evaluated change from baseline in continuous efficacy variables . Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test , and between-group differences in treatment-emergent adverse events ( TEAEs ) were assessed using the Fisher exact test . RESULTS AND LIMITATION : Tadalafil significantly improved IPSS results , from baseline to endpoint , compared to placebo ( -5.6 vs -3.6 ; p=0.004 ) . Reduction in IPSS results was apparent after 1 wk and significant after 4 wk ( tadalafil -5.3 vs placebo -3.5 ; p=0.003 ) . The BPH Impact Index ( BII ) was not assessed at week 1 ; however , BII improvement was apparent at 4 wk ( tadalafil -1.8 vs placebo -1.2 ; p=0.029 ) and continued at 12 wk ( tadalafil -1.8 vs placebo -1.3 ; p=0.057 ) . Tadalafil  significantly improved the International Index of Erectile Function-Erectile Function score in sexually active men with erectile dysfunction ( ED ; 6.7 vs 2.0 ; p<0.001 ) at 12 wk ( not assessed at week 1 ) . Few subjects reported one TEAE or more ( p=0.44 ) . For tadalafil , the most common TEAEs were headache ( 3.7 % ) and back pain ( 3.1 % ) . Tadalafil did not significantly improve Q(max ) or reduce postvoid residual volume . CONCLUSIONS Tadalafil 5 mg once daily for 12 wk result ed in a clinical ly meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS . The adverse event profile was consistent with that previously reported in men with ED . TRIAL REGISTRATION This clinical trial is registered on the clinical trials.gov website ( http://www . clinical trials.gov ) . The registration number is NCT00827242 INTRODUCTION Safety and efficacy of tamsulosin and vardenafil are well established : however , there is no report regarding combined therapy with these drugs for  lower urinary tract symptoms ( LUTSs ) secondary to benign prostatic hyperplasia ( BPH ) . AIM To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a r and omized trial with 12-week follow-up . METHODS We conducted a r and omized , double-blind , placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin .  MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS-bother , International Index of Erectile Function , Version 5 ( IIEF-5 ) and Over Active Bladder question naire ( OAB-q ) scores , uroflowmetry data ( Qmax , Qave ) , and postvoiding residual urine were recorded after run-in ( baseline ) , and 2 and 12 weeks after treatment . Differences between vardenafil and placebo at different times were calculated with unpaired sample s t-test . Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance . RESULTS We found a between-group significant difference from baseline to 12 weeks in the following : ( i ) Qmax ( placebo : + 0.07 , vardenafil : + 2.56 , P = 0.034 ) ; ( ii ) Qave  ( placebo : -0.15 , vardenafil : + 1.02 , P = 0.031 ) ; ( iii ) irritative-IPSS subscores ( placebo : -1.67 , vardenafil : -3.11 , P = 0.039 ) ; and ( iv ) IIEF ( placebo : + 0.06 , vardenafil : + 2.61 , P = 0.030 ) . No patient reported any serious ( grade ≥ 2 ) adverse event ( AE ) . There were no differences in the incidence of common , treatment-related AEs between men undergoing combined therapy or tamsulosin alone . CONCLUSIONS The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function , as compared with tamsulosin alone . Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH INTRODUCTION Benign prostatic hypertrophy ( BPH ) is a common disease whose frequency has risen throughout the world in concomitance with the increase in life expectancy . BPH causes voiding disturbances known by the acronym LUTS ( lower urinary tract symptoms ) , which heavily influence the quality of life in the elderly . The treatment for LUTS is mainly divided into medical and surgical , the latter usually represented by prostate ablation . Medical therapy includes synthetic molecules that interfere with the hormonal control of BPH or act on the bladder neck tonus , as well as natural remedies based on plant extracts from Serenoa Repens and /or Urtica Dioica . MATERIAL AND METHODS Two groups of patients who were c and i date s for surgery for BPH-induced LUTS , were r and omly recruited in a six-month trial aim ed at comparing outcome of treatment with a new combination of plants extracts ( Pluvio ® ) , which differs from the previous ones in that it also contains avocado and soya oil , as well as a high dose of Urtica Dioica , with no therapy . Age , IPSS score , maximal uroflow , prostate volume , PSA , free-to-total PSA ratio , post voiding residual urine and number of nocturia episodes were recorded and statistically evaluated using a NCSS 60 ® program . RESULT A marked benefit in terms of quality of life , measured by IPSS score , uroflow , residual urine and nocturia , was observed in the treated group compared to controls . PSA and prostate volume were not significantly affected . No noteworthy adverse events were observed . CONCLUSIONS The new phytotherapeutic combination evaluated in the present study would seem to be highly effective for the treatment of LUTS in BPH patients and does not have negative side effects . Its use could therefore be strongly advocated in this setting
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 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 .