Eliciting preferences for drug treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Pharmacotherapy of benign prostatic hyperplasia: Inhibitor of 5 alpha-reductase Subtype selective alpha1-adrenoceptor antagonists for the treatment of benign prostatic hyperplasia. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. Comparison of α-Blocker Monotherapy and α-Blocker plus 5α-Reductase Inhibitor Combination Therapy Based on Prostate Volume for Treatment of Benign Prostatic Hyperplasia Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Intermittent alpha-blocker therapy in the treatment of men with lower urinary tract symptoms. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Progression of lower urinary tract symptoms after discontinuation of 1 medication from 2-year combined alpha-blocker and 5-alpha-reductase inhibitor therapy for benign prostatic hyperplasia in men--a randomized multicenter study. Evaluation of patient outcome after discontinuation of alfuzosin treatment for benign prostatic hyperplasia: a multicentre, prospective study. Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: Combined Treatment with Fesoterodine Fumarate Extended-Release and Tamsulosin - A Prospective Study 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. Effect of discontinuation of 5alpha-reductase inhibitors on prostate volume and symptoms in men with BPH: a prospective study.
PURPOSE There are 2 main medical preparations available for lower urinary tract symptoms result ing from benign prostatic hyperplasia ( BPH ) . Choosing between an alpha-blocker and a 5alpha-reductase inhibitor requires trade-offs between their attributes or characteristics . We investigated the relative importance of and trade-offs between the attributes of the 5alpha-reductase inhibitor dutasteride and alpha-blockers in community dwelling men using a vali date d technique . MATERIAL S AND METHODS A discrete choice experiment was administered to 211 men older than 40 years who were r and omly selected from the general United Kingdom population . Attributes investigated in the discrete choice experiment were time to symptom improvement , sexual and nonsexual side effects , the risks of acute urinary retention ( AUR ) and surgery , cost and prostate size decrease . Using regression analysis the relative importance of these attributes , the trade-offs that men are willing to make between these attributes and the willingness to pay for each attribute were estimated . RESULTS All attributes were important to respondents . The most important attribute was side effects . The least preferred side effects was impotence , followed by decreased libido and dizziness . Respondents were willing to wait 13 , 2 and 8 months longer for symptom improvement in exchange for decreased prostate size , and the risks of AUR and surgery , respectively . Men reporting moderate symptoms were less concerned about sexual side effects , time to symptom improvement and the risk of AUR compared with men reporting mild symptoms . CONCLUSIONS Given the attribute levels of BPH medical treatment , overall community dwelling men preferred the 5alpha-reductase inhibitor over alpha-blockers . In the interests of shared decision making it is important to consider the importance of eliciting the preferences of patients with BPH OBJECTIVE To assess the effect of tamsulosin on the Sexual Health Inventory for Men ( SHIM ) score in men diagnosed with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . PATIENTS AND METHODS Analysis from the national data base of a programme of the Prostate Cancer Educational Council identified 7974 men who completed the American Urologic Association Symptom Score ( AUA-SS ) and SHIM question naires . The patients were divided into three groups ; group 1 , men taking tamsulosin ;  group 2 , men on other prescription medications for treating BPH symptoms ;  and group 3 , men not currently taking any BPH medications .  Linear regression was used to assess the association of tamsulosin and other alpha-blocker prescriptions for treating BPH symptoms with the decline in SHIM score . The interaction terms between AUA and the intake of tamsulosin was also adjusted for in the final analysis . RESULTS The median age of the men was 60 years . In groups 1 , 2 and 3 , ( 234 , 291 and 7449 men , respectively ) the mean ( sd ) AUA-SS was 13.0 ( 7.2 ) , 12.1 ( 7.2 ) and 6.9 ( 5.8 ) , and the mean SHIM scores 11.7 ( 6.8 ) , 12.7 ( 6.5 ) and 15.9 ( 6.0 ) , respectively . Adjusting for the AUA-SS , men in group 1 on tamsulosin had a significantly higher SHIM score with increasing AUA-SS score than men on other medications ( P < 0.01 ) , off setting the negative correlation between the AUA-SS and SHIM ( P < 0.01 ) . Moreover , men in group 1 were more likely to have a higher AUA-SS and lower SHIM score than men in the other two groups , suggesting more severe symptoms in these men . CONCLUSIONS Men taking tamsulosin to treat LUTS appear to be at an advantage over men taking other alpha-blockers when the effect of LUTS on sexual health is considered . Furthermore , this effect was more profound in patients with more severe LUTS than those with mild and moderate symptoms . Future prospect i ve trials are warranted to confirm this effect OBJECTIVE To compare the efficacy 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 Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of  benign prostatic hyperplasia ( BPH )  . Taken as monotherapy , alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms . Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery . Direct comparison of the alpha-blocker terazosin with finasteride has been done , but only for a period of 1 year . The Medical Therapy of Prostatic Symptoms ( MTOPS ) trial is a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride , whether taken as a monotherapy or in combination , in preventing or delaying the progression of BPH . We describe in this paper the design of the MTOPS trial , the concept of BPH progression , the definition and methods of determining the primary outcome events and the proposed statistical analysis methods . A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of r and omized participants . Volunteers among r and omized participants are to undergo a biopsy of the prostate at predetermined time points during the trial . Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH We studied the effects of 5 alpha-reductase inhibitor ( finasteride ) in the treatment of benign prostatic hyperplasia ( BPH ) . This study is a r and omized controlled trial . Sixty-two patients were treated with 5 alpha-reductase ( finasteride 5 mg/day ) and 61 patients  ( control group )  with placebo for one year . Prostatic volume , maximal urine flow rate , AUA symptom scoring , residual urine volume and prostate-specific antigen ( PSA ) levels were evaluated at 3 , 6 , 9 and 12 months . In the first 6 months prostatic volume decreased rapidly ( 20.5 % ) , in the second 6 months it decreased slowly and reached the maximal rate ( 23.3 % ) . Maximal urine flow rate increased in the second 6 months . AUA symptom scores decreased first at 3 months and were 4.6 points lower at the end of the 12th month . There were no significant changes in residual volume . The 5 alpha-reductase inhibitor caused a 50 % decrease in PSA levels , like in other studies .Becuase of the prolonged use of the drug , treatment with 5 alpha-reductase inhibitor is not tolerated by many patients and being expensive its future in the pharmacotherapy of BPH is unclear Benign prostatic hyperplasia ( BPH ) is highly prevalent in the male population beyond the age of 60 . Impairment of urinary flow due to prostate enlargement gives rise to symptoms of ' prostatism ' that have a detrimental impact on the quality of life . The current trend in the management of symptomatic BPH favours pharmacotherapy as a first line option , while the number of surgical procedures being performed has experienced a steady decline during the last ten years . Among the pharmacological treatments , the use of alpha1-adrenoceptor blockers has demonstrated to be an effective treatment option for BPH . These agents reduce the adrenergic tone to the prostate and increase urinary flow , with a concomitant reduction of lower urinary tract symptoms . The alpha1-blockers currently approved include compounds such as alfuzosin , terazosin and doxazosin , originally developed for the treatment of hypertension , and more recently tamsulosin , an alpha1-subtype selective drug . The blockade of alpha1-adrenoceptors present in vascular smooth muscle is largely responsible for the most prominent side effects of current drugs , which can be severe and require patients dose titration . The limitation imposed by side effects naturally raises the possibility that complete blockade of prostatic alpha1 receptors is not attained at the maximum tolerated dose . The extensive efforts by the pharmaceutical industry towards the development of uroselective alpha1-blockers , is the subject of this review . Advances in the molecular cloning of genes encoding three alpha1-adrenoceptors led to the identification of the alpha1A-subtype as the predominant receptor responsible for the contraction of prostate smooth muscle . In pre clinical animal models , selective alpha1A-antagonists have consistently been found to have minimal cardiovascular effects , thus providing a pharmacological rationale for uroselectivity . It has also become apparent , however , that uroselectivity can emerge in a poorly understood manner from the pharmacodynamic properties of compounds without alpha1A-subtype selectivity . Clinical experience with tamsulosin , an alpha1A/alpha1D selective drug , has failed to demonstrate a significant improvement in efficacy beyond that demonstrated for non-subtype selective alpha1-blockers , and gives support to the notion that alpha1A-selective antagonists might achieve greater efficacy for the treatment of BPH . Given the demonstrated uroselectivity of alpha1A-selective antagonists in pre clinical models , it is anticipated that third generation alpha1-blockers will exhibit improved urinary flow efficacy and be better tolerated than tamsulosin . The extent to which the improvement in urinary flow will translate to the relief of symptoms of prostatism , however , remains to be demonstrated in r and omised placebo-controlled clinical trials of alpha1A-selective antagonists Benign prostatic hyperplasia ( BPH ) is a highly prevalent condition in aging men , which can be progressive and lead to acute urinary retention ( AUR ) and the need for surgery . It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors ( 5ARIs ) , both of which improve the symptoms of BPH . Long-term treatment with 5ARIs can also reduce the risk of developing AUR and the need for surgery . The l and mark Medical Therapy of Prostatic Symptoms ( MTOPS ) trial demonstrated that over 4 years the combination of the type 2-specific 5ARI , finasteride and the alpha-blocker doxazosin was more effective than either agent alone in reducing overall clinical progression . Since the initiation of MTOPS , it has been shown that patients with larger prostates and higher prostate-specific antigen ( PSA ) levels are at greater risk of BPH progression , and are therefore arguably more likely to benefit from combination therapy . The Combination of Avodart and Tamsulosin ( CombAT ) trial is a 4-year , global , multicenter , r and omized , double-blind , parallel-group study design ed to investigate the benefits of combination therapy with the dual 5ARI dutasteride and the alpha-blocker tamsulosin compared with each monotherapy in improving symptoms and long-term outcomes in men with moderate-to-severe symptoms of BPH and prostate enlargement .  Symptoms and long-term outcomes ( AUR and surgery ) will be assessed as separate primary endpoints at 2 and 4 years , respectively . Eligible patients were at least 50 years old with prostate volume > or = 30 cm(3 ) and PSA level > or = 1.5 ng/mL. A total of 4838 subjects have been enrolled . This paper describes the rationale , design and baseline data of the CombAT study OBJECTIVE : This study compared α-blocker monotherapy with combination therapy involving an α-blocker and a 5-α reductase inhibitor for benign prostatic hyperplasia ( BPH ) , according to baseline prostate volume . METHODS : Korean men diagnosed with BPH were r and omized to 12 months ' treatment with 0.2 mg tamsulosin or 0.2 mg tamsulosin plus 0.5 mg dutasteride . Prostate specific antigen ( PSA ) , prostate volume , transition zone volume ( TZV ) , International Prostate Symptom Score ( IPSS ) , maximal urinary flow rate ( Q max ) , postvoid residual urine volume and sexual function were assessed at baseline and after 12 months ' treatment . Variables were analysed based on baseline prostate volumes of ≤ 35 ml or > 35 ml . RESULTS : In total , 216 men with BPH were included . Combination therapy result ed in significant improvements in prostate volume , TZV , PSA , IPSS and Q max , which were most pronounced in men with a prostate volume > 35 ml . CONCLUSIONS : Tamsulosin monotherapy was sufficient treatment for BPH in Korean men with a prostate volume ≤ 35 ml . Combination tamsulosin and dutasteride therapy provided greater benefits than tamsulosin monotherapy in men with BPH whose prostate volume was > 35 ml OBJECTIVE The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy , in patients with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . METHODS Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score ( IPSS ) 8 or higher , were r and omized to receive 10 mg alfuzosin ( n = 25 ) , 10 mg tadalafil ( n = 25 ) or the combination of both the drugs ( n = 25 ) once daily for 3 months . Symptoms were assessed at baseline , 6 weeks and 3 months . The primary endpoint was the change in IPSS from the baseline . Secondary endpoints were changes in IPSS storage and voiding subscores , peak urinary flow rate , residual urine volume , IPSS quality of life score and erectile domain score . RESULTS There were significant improvements in all IPSS scores , peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups ( P < 0.003 ) . Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume ( P < 0.005 ) . Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate ( P = 0.22 ) , similar to tadalafil in improvement on erectile function ( P = 0.22 ) and better than each monotherapy in improving the IPSS quality of life ( P ≤ 0.015 ) . CONCLUSION Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH 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 determine the safety and efficacy of intermittent alpha-blocker therapy in men with lower urinary tract symptoms ( LUTS ) in a prospect i ve study . Alpha-blockers have been demonstrated to be safe and effective in the treatment of men with LUTS . To date , the role of varying dosing regimens in responding patients has not been well studied . METHODS Men with LUTS were entered into this prospect i ve open label , parallel , r and omized trial . In phase 1 , patients were treated with alfuzosin , 2.5 mg three times daily for 3 months . In phase 2 , those patients who had a significant therapeutic response were r and omized into one of the following three groups : ( 1 ) maintenance of alfuzosin ; ( 2 ) alfuzosin every other day ; and ( 3 ) discontinuation of alfuzosin ( ie , no treatment ) . Patients were followed up for a total of 6 months . Parameters of evaluation included the International Prostate Symptom Score ( IPSS ) , global satisfaction , peak urinary flow rate ( Qmax ) , and adverse events . RESULTS At 3 months , there were 79 patients who were categorized as having obtained a therapeutic response :  IPSS decreased to 7.6 + /- 3.2 and Qmax increased to 11.3 + /- 2.9 mL/s . After r and omization , IPSS was 7.1 + /- 2.9 and 6.5 + /- 2.5 for group 1 ; 6.5 + /- 3.2 and 6.7 + /- 2.1 for group 2 ; and 11.4 + /- 4.8 and 12.3 + /- 4.9 for group 3 at 3 and 6 months , respectively . Qmax was 12.7 + /- 4.8 and 11.7 + /- 5.2 mL/s for group 1 ; 12.2 + /- 3.9 and 11.9 + /- 3.7 mL/s for group 2 ; and 9.7 + /- 2.5 and 9.3 + /- 2.1 mL/s for group 3 at 3 and 6 months , respectively . Global satisfaction at 6 months was the same for groups 1 and 2 . There were no differences in adverse events among the three groups . CONCLUSIONS In men with LUTS who responded to alfuzosin , changing the dosing regimen from daily to once every other day result ed in similar efficacy and safety at 3 and 6 months . By contrast , complete cessation of alfuzosin result ed in recurrence of both symptoms and impaired urinary flow . These data provide evidence that in responding patients , intermittent alpha-blocker therapy may be a reasonable therapeutic regimen . The role of intermittent alpha-blocker therapy using other agents , as well as in a large cohort of men with LUTS , remains to be determined OBJECTIVES To study the efficacy and safety of dutasteride , a dual inhibitor of the 5-alpha-reductase isoenzymes types I and II . METHODS A total of 4325 men ( 2951 completed ) with clinical benign prostatic hyperplasia , moderate to severe symptoms ( American Urological Association-Symptom Index score of 12 points or greater ) , a peak flow rate of 15 mL/s or less , a prostate volume of 30 cm3 or greater ( as measured by transrectal ultrasonography ) , and a serum prostate-specific antigen level of 1.5 to 10.0 ng/mL ( inclusive ) were enrolled into three identical clinical trials and r and omized to 0.5 mg dutasteride daily or placebo . After a 1-month , single-blind , placebo lead-in , patients were followed up for 24 months in a double-blind trial with multiple interval assessment s. RESULTS At 24 months , serum dihydrotestosterone was reduced from baseline by a mean of 90.2 % ( median -93.7 % ; P < 0.001 ) , and the total prostate and transition zone volumes were reduced by a mean of 25.7 % and 20.4 % , respectively ( P < 0.001 ) . The symptom score was improved by as early as 3 months , with pooled significance from 6 months onward ( P < 0.001 ) and a reduction of 4.5 points ( 21.4 % ) at 24 months ( P < 0.001 ) . The maximal flow rate improved significantly from 1 month ( P < 0.01 ) , with an increase of 2.2 mL/s reported at 24 months ( P < 0.001 ) . Hence , the risk reduction of acute urinary retention was 57 % and the risk reduction of benign prostatic hyperplasia-related surgical intervention was 48 % compared with placebo . The drug was well tolerated . CONCLUSIONS Dutasteride is a potent inhibitor of dihydrotestosterone production that is safe and effective in terms of the reduction of prostate volume and symptoms , flow rate improvement , and the reduction of the risk of acute urinary retention and surgery during a 24-month study period OBJECTIVE To investigate the treatment outcome of discontinuing 1 medication from 2-year combination therapy for male benign prostatic hyperplasia/lower urinary tract symptoms . MATERIAL S AND METHODS Patients with International Prostate Symptom Score ≥ 8 , total prostatic volume ( TPV ) > 30 mL , and maximum flow rate ( Qmax ) < 15 mL/s were r and omly assigned to the 5α-reductase inhibitor ( 5ARI ) discontinue ( DC-5ARI ) or α-blocker discontinue ( DC-α-blocker ) group . All patients received combination therapy with dutasteride ( 0.5 mg QD ) and doxazosin ( 4 mg QD ) for 2 years and then discontinued either one drug for 12 months . The primary endpoint was the occurrence of resuming medication . The secondary endpoints were the net parameters changed or the need of transurethral resection of the prostate ( TURP ) . RESULTS A total of 117 patients in DC-5ARI and 113 in DC-α-blocker group completed the study .  The baseline TPV and Qmax were similar between groups before combination therapy . Resumption of combination therapy was significantly more in DC-5ARI than DC-α-blocker group ( 51.3 % vs 31.0 % ; P = .005 ) . The mean duration from discontinuing to resuming medication was 5.0 ± 4.4 months in DC-α-blocker and 7.8 ± 3.8 months in DC-5ARI group ( P < .05 ) . The TPV progression ( 29.1 % vs 8.0 % ; P < .001 ) and the need for TURP ( 14.5 % vs 7.1 % ; P = .043 ) were significantly higher in DC-5ARI than DC-α-blocker group . Patients with larger TPV ( 45.8 ± 18.1 mL ) had significantly greater need for resuming 5ARI than smaller TPV ( 36.3 ± 16.9 mL ; P = .007 ) , and a lower Qmax might predict resuming α-blocker . CONCLUSION After a 2-year combination therapy , discontinuation of either one drug induced benign prostatic hyperplasia progression in either group . Greater risk of resuming medication and needing TURP were noted in patients who discontinued 5ARI AIMS The aim of this study was to assess patient outcome after discontinuation of alfuzosin treatment in patients with benign prostatic hyperplasia ( BPH ) . METHODS This study included 200 BPH patients .  Alpha-blockers were discontinued after 12 weeks of treatment when the International Prostatic Symptom Score ( IPSS ) was reduced to < 8 points , peak urine flow rate ( Q(max ) ) was increased to ≥ 15 ml/s , the postvoiding residual ( PVR ) urine volume was ≤ 100 ml and the patient agreed to discontinue treatment . Urinary symptoms of the patients were assessed at 4 , 8 , 12 and 24 weeks after discontinuation of medication , and surveys were performed asking whether patients wanted to restart administration of medication . RESULTS Of 200 enrolled patients , 142 ( 71.00 % ) received 12 weeks of treatment with 10 mg of alfuzosin . The medication was discontinued in 58 of 142 patients ( 40.85 % ) because urinary symptoms had improved . Among these patients , follow-up observations were performed for 49 patients up to 24 weeks after treatment discontinued . Of these 49 patients , 28 ( 57.14 % ) showed correct urination without a need to restart treatment up to 24 weeks after the medication was discontinued . The discontinuation group demonstrated improved voiding symptoms , including Q(max ) and PVR , relative to the re-administration group at baseline . Furthermore , the discontinuation group showed a smaller prostate volume than the re-administration group ( p = 0.045 ) . CONCLUSION When patients with BPH displayed symptomatic improvement upon treatment with alpha-blockers , the improvements were maintained in a select sub population of patients without the need to re-administer the alpha-blockers Objective : To evaluate the efficacy and safety of fesoterodine extended-release ( ER ) plus tamsulosin in men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . Patients and Methods : Men aged ≥50 years , with LUTS , prostate volume ≤60 ml and International Prostate Symptom Score ( IPSS ) ≥13 were enrolled in this study . 173 consecutive patients were treated initially with tamsulosin ( 0.4 mg ) for 1 week . At the second visit , 47 patients out of the sample of 173 who were still experiencing inconvenient LUTS were r and omized into two groups . The first group received a therapy with tamsulosin and fesoterodine combination ( group 1 , n = 24 ) while the second continued the therapy with the single administration of tamsulosin ( group 2 , n = 23 ) for an additional 4-week period . Results : There was no statistically significant difference in age , prostate volume , Qmax , and postvoid residual urine between the two groups . A statistical significance appeared in the combination group regarding the storage and the total IPSS values among the second and third visits ( 10.5 ± 1.4 to 8.5 ± 1.3 and 16.1 ± 1.8 to 13.7 ± 1.5 respectively ) . Conclusion : Regarding bothersome LUTS and storage symptoms  , fesoterodine ER and tamsulosin combination was significantly more effective than the single administration of tamsulosin 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 OBJECTIVES To investigate the change in prostate volume and symptoms after discontinuation of 5alpha-reductase inhibitors ( 5ARIs ) in men with moderate to severe symptoms due to benign prostatic hyperplasia ( BPH ) . METHODS A total of 120 patients with BPH were enrolled from December 2004 to May 2008 . The patients were r and omized into 2 groups : group 1 received finasteride 5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily , and group 2 received dutasteride 0.5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily . All the patients received combination therapy for 1 year , followed by 1 year of alpha-blocker monotherapy . The prostate volume , International Prostate Symptom Score , and serum prostate-specific antigen level were determined at baseline and at 12 and 24 months after treatment . RESULTS At 1 year after treatment , the prostate volume was reduced by 24.5 % + /- 10.01 % ( P < .001 ) in group 1 and by 26.1 % + /- 5.06 % ( P < .001 ) in group 2 . One year after withdrawal of the 5ARIs , the prostate volume had increased by 20.7 % + /- 14.1 % ( P < .001 ) and 18.6 % + /- 7.4 % ( P < .001 ) in groups 1 and 2 , respectively , compared with at the end of 1 year of treatment . Furthermore , the International Prostate Symptom Score had significantly deteriorated at 1 year after cessation of the 5ARIs in both groups compared with the values at the end of 1 year of combination therapy . CONCLUSIONS Our data demonstrate that the discontinuation of 5ARIs during combination therapy induces prostate regrowth , as well as aggravation of symptoms in men with BPH . This result , therefore , suggests that the life-long use of 5ARIs should be considered for the prevention of BPH progression
Based on improvement of mean International Prostate Symptom Score and quality of life scores , the effectiveness of the newer ABs was not different from the older ABs ( moderate strength of evidence [ SOE ] ) , but had more AEs ( low SOE ) .
Antimuscarinics/AB combination therapy had similar outcomes  as AB monotherapy ( all moderate SOE ) , but often had more AEs .
Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone .
Evidence was insufficient for the beta-3 adrenoceptor agonist .
For all newer agents , the evidence was generally insufficient to assess long-term efficacy , prevention of symptom progression , or AEs .
None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment .
Given the lack of superior outcomes , the studies ' short time-horizon , and less assurance of their safety , their current value in treating LUTS attributable to BPH appears low .
We found none of the new drugs to be better but there was more concern about side effects
CONTEXT Alpha-blockers ( ABs ) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms ( LUTS ) attributed to benign prostatic hyperplasia ( BPH ) .
Recently , newer drugs have shown promise for this indication .
OBJECTIVE To assess the comparative effectiveness and adverse effects ( AEs ) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta- analysis .
PATIENT SUMMARY In this paper , we review ed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate .