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 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. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. Sildenafil citrate in combination with tamsulosin versus tamsulosin monotherapy for management of male lower urinary tract symptoms due to benign prostatic hyperplasia: A randomised, double-blind, placebo-controlled trial Update on AUA guideline on the management of benign prostatic hyperplasia. An open, comparative, multicentre clinical study of combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients with erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia. 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. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. 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Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial). Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial Initial combined treatment with anticholinergics and α-blockers for men with lower urinary tract symptoms related to BPH and overactive bladder: a prospective, randomized, multi-center, double-blind, placebo-controlled study Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study. Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin Evaluation of the effect of sildenafil and/or doxazosin on Benign prostatic hyperplasia–related lower urinary tract symptoms and erectile dysfunction Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study. Prevalence and characteristics of lower urinary tract symptoms in men aged > or = 80 years. 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. 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. 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. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study.
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 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 Storage symptoms are often undertreated in men with lower urinary tract symptoms ( LUTS ) . OBJECTIVE To evaluate the combination of an antimuscarinic ( solifenacin ) with an α-blocker ( tamsulosin ) versus tamsulosin alone in the treatment of men with LUTS . DESIGN , SETTING , AND PARTICIPANTS A double-blind , 12-wk , phase 2 study in 937 men with LUTS ( ≥ 3 mo , total International Prostate Symptom Score [ IPSS ] ≥ 13 , and maximum urinary flow rate 4.0 - 15.0 ml/s ) . INTERVENTION Eight treatment groups : tamsulosin oral controlled absorption system ( OCAS ) 0.4 mg ; solifenacin 3 , 6 , or 9 mg ; solifenacin 3 , 6 or 9 mg plus tamsulosin OCAS 0.4 mg ; or placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary efficacy end point was change from baseline in total IPSS . Secondary end points included micturition diary and quality -of-life ( QoL ) parameters . Post hoc subgroup analyses were performed by severity of baseline storage symptoms , with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy , due to the small sample size of the solifenacin monotherapy and placebo subgroups . RESULTS AND LIMITATIONS Combination therapy was associated with significant improvements in micturition frequency and voided volume  versus tamsulosin OCAS alone in the total study population ; improvements in total IPSS were not significant . Statistically significant improvements in urgency episodes , micturition frequency , total urgency score , voided volume , IPSS storage subscore , IPSS-QoL index , and Patient Perception of Bladder Condition were observed in a sub population of men with two or more urgency episodes per 24h ( Patient Perception of Intensity of Urgency Scale grade 3 or 4 ) and eight or more micturitions per 24h at baseline ( storage symptoms subgroup ) with combination therapy versus tamsulosin OCAS alone ( p ≤ 0.05 for the dose-response slope , all variables ) . Combination therapy was well tolerated , and adverse events were consistent with the safety profiles of both compounds . CONCLUSIONS Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline . Combination therapy was well tolerated . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00510406 INTRODUCTION Alpha1-blockers ( AB ) are the first-line monotherapy for lower urinary tract symptoms ( LUTS ) .  Phosphodiesterase type 5 ( PDE5 ) inhibitors are the first-line treatment for erectile dysfunction ( ED ) . Numerous studies have supposed a significant association between ED and LUTS , but a causal relationship can not be established . AIM The aim was to evaluate the efficacy of a combined therapy with an AB ( alfuzosin ) and PDE5 inhibitors ( tadalafil ) in patients with LUTS and ED . METHODS This was a r and omized , open-label , three-arm study . A total of 66 men complaining of ED and LUTS were included in the study . Patients were assessed at baseline and after 12 weeks of study treatment , and then underwent r and omized allocation to either alfuzosin 10 mg once a day ( 22 patients ) or tadalafil 20 mg on alternative days ( 21 patients ) , or a combination of both ( 23 patients ) . MAIN OUTCOME MEASURES All participants completed the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) and the International Prostatic Symptom Score ( IPSS ) . Other efficacy variables included maximum urinary flow rate ( Qmax ) and medium urinary flow rate ( Qave ) . RESULTS IIEF-EF tended to improve with alfuzosin alone ( + 15 % ) , while it was clearly improved with tadalafil alone ( + 36.3 % ) . The greatest improvement was experienced with the combination therapy ( + 37.6 % ) . Improvement in Qmax was observed in all groups , but patients receiving combination therapy had greater improvement ( 29.6 % ) than patients receiving either only alfuzosin ( 21.7 % ) or only tadalafil ( 9.5 % ) . IPSS was significantly improved in alfuzosin group ( 27.2 % ) , was more marked with the combination therapy ( 41.6 % ) , and a small increase , although not significant , was also observed with tadalafil ( 8.4 % ) . CONCLUSIONS Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores . A significant improvement was also observed in quality of life assessment s. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED , although present , were smaller Abstract Objective : To assess the additive effect of sildenafil citrate to tamsulosin in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) in men with or without erectile dysfunction ( ED ) . Patients and methods : In all , 150 men with untreated LUTS/BPH with or without ED were r and omised to receive sildenafil 25 mg once daily ( OD ) or placebo OD ( night time ) combined with tamsulosin 0.4 mg OD ( day time ) for 6 months . Changes from pre-treatment scores in International Prostate Symptom Score ( IPSS ) , IPSS- quality of life ( QoL ) score , maximum urinary flow rate ( Qmax ) , and the five-item version of the International Index of Erectile Function question naire ( IIEF-5 ) were assessed at 3 and 6 months . Safety profiles were assessed by physical examination and monitoring clinical adverse events . Results : Group A comprised of men who received tamsulosin and sildenafil ( 75 men ) , whilst those in Group B received tamsulosin and placebo ( 75 ) . The IPSS was significantly improved in Group A compared to Group B , at −29.3 % vs −13.7 % ( P = 0.039 ) at 3 months and −37 % vs −19.6 % ( P = 0.043 ) at 6 months after treatment . Qmax significantly improved in both groups compared with before treatment ( P < 0.001 ) . The IIEF-5 scores improved more in Group A than in Group B , at 58.7 % vs 11.7 % at 3 months and 62.4 % vs 12.4 % at 6 months after treatment ( both P < 0.001 ) . Conclusion : Sildenafil citrate combined with tamsulosin  improved LUTS , erectile function , and patient QoL more than tamsulosin monotherapy with the merit of a comparable safety profile in patients with LUTS/BPH PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ( ED ) and lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH/LUTS ) . The trial was conducted in hospitals in Beijing , Shanghai , Changsha , Wuhan and Guangzhou , five major cities in China . A total of 250 patients diagnosed with ED and BPH/LUTS aged 50 - 75 years , and who had International Index of Erection Function-5 ( IIEF-5 ) scores ≤21 and International Prostate Symptom Score ( IPSS ) ≥10 points , were enrolled and r and omly divided into Group A ( 168 cases ; doxazosin GITS 4 mg once daily plus sildenafil 25 - 100 mg on dem and ) and Group B ( 82 cases ; sildenafil 25 - 100 mg on dem and ) . Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life ( QoL ) question naire , and adverse effects were evaluated during the treatment period . There were no statistically significant differences in mean age , and IIEF-5 , IPSS and QoL scores pre-treatment between the two groups . After treatment , IIEF-5 , IPSS and QoL scores were significantly improved in Group A , while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment . There were no significant differences in side effects between the two groups . The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy 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 BACKGROUND Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews .  A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed OBJECTIVES To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms ( LUTS ) men with residual overactive bladder ( OAB ) symptoms despite tamsulosin monotherapy . METHODS In this r and omized , multicenter , double-blind study , male LUTS patients aged≥50 years with urgency episodes/24 hours≥2 and micturitions/24 hours≥8 were r and omized to 3 groups : 12-weeks tamsulosin plus placebo ( TAM+PBO ) , tamsulosin plus solifenacin 2.5 mg ( TAM+SOL ) , and tamsulosin plus solifenacin 5 mg ( TAM+SOL ) . Changes from baseline to end of treatment in the number of urgency episodes/24 hours ( primary endpoint ) , micturitions , nocturia , urgency incontinence episodes , International Prostate Symptom Scores ( IPSS ) , and Overactive Bladder Symptom Score ( OABSS ) were compared between the TAM+SOL groups and TAM+PBO . Safety was assessed on adverse events , postvoid residual volume , and maximal urinary flow rate ( Qmax . ) . RESULTS Six-hundred thirty-eight men were r and omized . Urgency was reduced by 2.2 and 2.4 episodes in the TAM+SOL 2.5 and 5 mg groups , respectively . The TAM+SOL 5 mg group showed significant improvement compared with TAM+PBO ( -2.4 vs -1.9 , P=.049 ) . The number of micturitions in both TAM+SOL groups were significantly reduced compared with TAM+PBO ( both P<.001 ) . IPSS storage symptom score and OABSS significantly improved in both TAM+SOL groups compared with TAM+PBO . Changes in IPSS voiding symptom score and Qmax . were similar in all groups . Four patients ( 1.9 % ) in the TAM+SOL 5 mg group had urinary retention , but all recovered after catheterization . CONCLUSIONS In male LUTS patients with residual OAB symptoms  despite tamsulosin monotherapy , TAM+SOL showed efficacy on urgency , which represents OAB symptoms and was well tolerated OBJECTIVES This pilot study was undertaken to assess the efficacy and safety of the alpha(1)-blocker alfuzosin 10 mg once daily ( OD ) , the PDE-5 inhibitor sildenafil 25 mg OD , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) and erectile dysfunction ( ED ) . MATERIAL AND METHODS Men aged 50 - 76 yr with previously untreated LUTS and ED were r and omized to receive alfuzosin ( n=20 ) , sildenafil ( n=21 ) , or the combination of both ( n=21 ) for 12 wk . Changes from baseline in International Prostate Symptom Score ( IPSS ) , voiding diary , maximum urinary flow rate ( Qmax ) , postvoid residual urine ( PVRU ) volume , and erectile function domain of the International Index of Erectile Function ( IIEF ) were assessed at week 12 . RESULTS Improvement of IPSS was significant with the three treatments but greatest with the combination ( -24.1 % ) compared with alfuzosin ( -15.6 % ) and sildenafil ( -11.8 % ) [ corrected ] alone ( p<0.03 ) . Frequency , nocturia , PVR , and Qmax were significantly improved with alfuzosin only and the combination . Improvement in IIEF was slight with alfuzosin ( 16.7 % ) , marked with sildenafil ( 49.7 % ) , and greatest with the combination ( 58.6 % ) . Likewise , increases in the frequency of penetration ( Q3 ) and of maintained erection ( Q4 ) were greater with the combination therapy ( 65.2 % and 68.2 % , respectively ) than with sildenafil ( 41.7 % and 59.1 % , respectively ) and alfuzosin ( 27.3 % and 33.3 % , respectively ) alone . All three treatments were well tolerated . CONCLUSIONS In this pilot study , the combination of alfuzosin 10 mg OD and sildenafil 25 mg OD is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH 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 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 Treatment for men with lower urinary tract symptoms ( LUTS ) has developed into a “ cascade ” that escalates from watchful waiting through medical treatment to surgery . Self-management can help men to adopt lifestyle and behavioral modifications that will avoid or delay an escalation in treatment and reduce symptoms . Although many of these interventions are advised to men with LUTS , it is usually in a nonst and ardized and un systematic way . Recent work in this area has defined a self-management program for men with uncomplicated LUTS using formal methods and assessed its effectiveness in a r and omized controlled trial . Self-management significantly reduced the frequency of escalation through the treatment cascade and reduced urinary symptoms ( as effective as medication ) , suggesting that self-management could be considered as first-line treatment for men with LUTS OBJECTIVES To investigate the therapeutic efficacy and safety of Amlodipine alone or in combination with terazosin for the presence of lower urinary tract symptoms ( LUTS ) and hypertension . LUTS and hypertension often coexist in elderly men . METHODS A total of 355 patients with Stage 1 or 2 hypertension and LUTS ( as defined by an International Prostate Symptom Score of > or = 10 ) were r and omly assigned to receive 2 mg of terazosin ( n = 117 ) , 5 mg of Amlodipine ( n = 119 ) , or 5 mg of Amlodipine plus 2 mg of terazosin ( n = 119 ) once daily for a total of 28 days . The primary outcomes were a reduction in the total and subscores of the International Prostate Symptom Score and blood pressure . Analyses were performed by intention to treat . This trial is registered with Clinical Trials.gov ( No. NCT00693199 ) . RESULTS At day 28 of the trial , the Amlodipine plus terazosin group demonstrated comparable efficacy in lowering the total International Prostate Symptom Score and significant improvement in the presence of overactive bladder compared with the terazosin group ( P < .05 ) and significant improvement in quality of life compared with the Amlodipine group ( P < .05 ) . The Amlodipine plus terazosin group also achieved the greatest blood pressure control compared with either the terazosin group ( P < .01 ) or Amlodipine group ( P < .05 ) . All 3 treatment regimens were well tolerated by the study patients . CONCLUSIONS The results of this 4-week , double-blind , r and omized trial have demonstrated that in Chinese male hypertensive patients with LUTS , low-dose Amlodipine plus terazosin therapy appears to be a safe and effective combination therapy to control both conditions , especially for those with predominant overactive bladder symptoms BACKGROUND Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms ( LUTS ) . The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS ( oral controlled absorption system ) in Males with Lower Urinary Tract Symptoms ( NEPTUNE ) II is the first long-term study using solifenacin ( Soli ) and the oral controlled absorption system formulation of tamsulosin ( TOCAS ) . OBJECTIVE To evaluate long-term ( up to 52 wk ) safety and efficacy of flexible dosing of two fixed-dose combinations ( FDC ) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms . DESIGN , SETTING , AND PARTICIPANTS Patients with both storage and voiding LUTS , maximum urinary flow rate of 4.0 - 12.0 ml/s , prostate size < 75 ml , and postvoid residuals ≤ 150 ml , who completed the 12-wk , double-blind NEPTUNE study could continue in the 40-wk , open-label NEPTUNE II study . INTERVENTION FDC of Soli 6 mg plus TOCAS 0.4 mg , or Soli 9 mg plus TOCAS 0.4 mg ; patients could switch between doses in NEPTUNE II . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Safety and efficacy data from NEPTUNE and NEPTUNE II were combined to cover a 52-wk period . Primary efficacy end points were total International Prostate Symptom Score ( IPSS ) and total urgency and frequency score ( TUFS ) ; secondary end points included IPSS storage and voiding subscores , micturition diary variables , and quality of life parameters . RESULTS In all , 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II . Treatment-emergent adverse events were reported in 499 ( 46.8 % ) patients who participated in NEPTUNE II ; most were mild or moderate . Urinary retention occurred in 13 of 1208 ( 1.1 % ) patients receiving one or more FDCs in NEPTUNE and /or NEPTUNE II ; 8 ( 0.7 % ) required catheterisation ( acute urinary retention [ AUR ] ) . Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment , with mean reductions of 9.0 ( st and ard deviation [ SD ] : 5.7 ) and 10.1 ( SD : 9.2 ) , respectively , from baseline to end of treatment . Clinical ly relevant improvements were also observed for secondary efficacy end points . CONCLUSIONS Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS , with a low incidence of AUR . PATIENT SUMMARY Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms . Improvements in symptoms were achieved after 4 wk of treatment , with further improvements at week 16 maintained for up to 52 wk throughout the study Purpose The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) . While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies . We therefore sought to further assess nocturia based on data integrated from four tadalafil registration al studies . Methods Data were integrated from four r and omized , placebo-controlled  , double-blind , 12-week registration al studies of tadalafil for LUTS/BPH . Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) . Efficacy results were analyzed using analysis of covariance . Results For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2 . The mean treatment change was −0.4 with placebo and −0.5 with tadalafil ; the least-squares mean ( st and ard error ) treatment difference was −0.2 ( 0.05 ) , p = 0.002 . For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % . Conclusions A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinical ly meaningful . Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH Objective . To assess the efficacy and safety of propiverine hydrochloride ( antimuscarinic ) , naftopidil ( α1-adrenoceptor antagonist ) or both in patients with male lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia and concomitant overactive bladder ( OAB ) . Material and methods . Men aged at least 50 years who had a total International Prostate Symptom Score ( IPSS ) of 8 or higher and bladder dairy documenting micturition frequency ( more than eight micturitions/24 h ) and urgency ( more than one episode/24 h ) , with or without urgency urinary incontinence were r and omized into three groups : group N , naftopidil ( 50 mg once daily ) only ; group P , propiverine hydrochloride ( 20 mg once daily ) ; and group NP , naftopidil ( 50 mg once daily ) plus propiverine hydrochloride ( 20 mg once daily ) for a 4-week treatment regimen . Results . A total of 66 men , including 20 in group N , 23 in group P and 23 in group NP , were treated and 58 ( 87.9 % ) completed the 4 weeks of treatment . IPSS improved significantly in groups N and NP . Urinary frequency improved significantly in groups P and NP . Postvoid residual urine volume increased significantly in groups P and NP . Significant improvements in urgency episodes were noted in each group . One patient in group P required catheterization owing to acute urinary retention and another stopped medication because of difficulty in voiding . Conclusion . These results suggest that each treatment showed effectiveness for male LUTS with OAB . However , there are some possibilities of adverse effects with propiverine hydrochloride monotherapy Objective : To 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 Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome Purpose To evaluate the efficacy of sildenafil citrate only , 25 mg . Four times/week , tamsulosin only , 0.4 mg once daily , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostate hyperplasia ( BPH ) and erectile dysfunction . Methods A total of 60 men with BPH-related LUTS were r and omized to receive sildenafil citrate only ( n = 20 ) , tamsulosin only ( n = 20 ) , and the combination of both ( n = 20 ) for 8 weeks . Changes from baseline in International Prostate Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , post voiding residual urine volume ( PRV ) , Sexual Health Inventory for Male ( SHIM ) score , 3rd and 4th questions of International Index of Erectile Function ( IIEF ) were assessed at the end of the treatment . Results The mean age was 58 years .  IPSS , Qmax , PRV , SHIM scores , and 3rd and 4th questions in IIEF significantly improved in each group . Improvement of IPSS was more remarkable in combination ( 40.1 % ) and tamsulosin only ( 36.2 % ) groups in comparison with sildenafil citrate only group ( 28.2 % ; p < 0.001 ) . Improvement of Qmax and PRV were greater in tamsulosin only and combination than sildenafil citrate only group . SHIM scores significantly improved in sildenafil citrate only ( 65 % ) and combination ( 67.4 % ) than tamsulosin only ( 12.4 % ; p < 0.001 ) . Increases in the 3rd and 4th questions of IIEF were greater in sildenafil only and combination than tamsulosin only ( p < 0.001 ) . Conclusions Treatment with the combination of tamsulosin only and sildenafil citrate only was not superior to tamsulosin only to enhance voiding symptoms . Also , sexual function improvement was similar for both the combination and sildenafil citrate only treatments INTRODUCTION Lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) and erectile dysfunction are common disorders of advancing age . AIM To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH . METHODS In this prospect i ve r and omized study , 133 men complaining of LUTS due to BPH were included . Forty-five patients received tamsulosin 0.4 mg/day alone ( Group A ) , 44 patients received tadalafil 10 mg/day ( Group B ) , and combination therapy ( tamsulosin and tadalafil both ) was instituted in 44 patients ( Group C ) . After a 2-week medication free run-in period , they were evaluated for International Prostatic Symptom Score ( IPSS ) , International Index of Erectile Function score ( IIEF5 ) , quality of life ( IPSS QoL ) , maximum urinary flow rate ( Qmax ) , post-void residual urine ( PVR ) volume , and safety parameters before and at 3 months of treatment . MAIN OUTCOME MEASURES There were primary ( IPSS , IPSS QoL index , Qmax , and PVR ) and secondary ( erectile function [ EF ] domain scores from IIEF5 ) efficacy end points . Safety assessment included laboratory tests and patient 's reporting of adverse event . RESULTS A significant improvement in IPSS score was observed in all the 3 groups A , B , and C ( -50.90 % , P < 0.05 ; -33.50 % , P < 0.05 ; and -53.90 % , P < 0.05 , respectively ) . IIEF5 score increased significantly in these three groups ( + 39.28 % , P < 0.05 ; + 45.96 % , P < 0.05 ; and + 60.23 % , P < 0.05 , respectively ) . A significant increase in Qmax and decrease in PVR were also observed ( 33.99 % , P < 0.05 ; 29.78 % , P < 0.05 ; and 37.04 % , P < 0.05 ) and ( -60.90 % , P < 0.05 ; -49.45 % , P < 0.05 ; and -62.97 % , P < 0.05 , respectively ) . The QoL scores improved significantly ( -73.35 % , P < 0.05 ; -70.26 % , P < 0.05 ; and -79.65 % , P < 0.05 , respectively ) . Side effects were dyspepsia , heartburn , headache , flushing , myalgia , and backache . Adverse effect dropout was 3.7 % . No participant experienced any severe or serious adverse events . CONCLUSIONS In patients with LUTS due to BPH , tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS . Their EF also improves with these medications . The improvement is better with combination therapy compared with single agent alone BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) PURPOSE We examined data from the Medical Therapy of Prostatic Symptoms trial to determine the relationship between baseline TPV and the effect of medical therapy in men with LUTS secondary to BPH . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to placebo , 4 to 8 mg doxazosin , 5 mg finasteride or the combination of doxazosin and finasteride . Average treatment duration was 4.5 years The primary outcome was time to overall clinical progression of BPH , defined as a confirmed 4 point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency or recurrent urinary tract infection . Secondary outcomes were the need for invasive therapy for BPH , and changes in AUA SS and the maximum urinary flow rate with time . TPV was measured by transrectal ultrasound at baseline and study end . RESULTS In patients with a small prostate ( baseline TPV less than 25 ml ) combination therapy was no better than doxazosin alone for decreasing the risk of clinical progression of BPH and need for invasive therapy as well as improving AUA SS and the maximum urinary flow rate . However , in patients with moderate size ( 25 to less than 40 ml ) or enlarged ( 40 ml or greater ) gl and s combination therapy led to a clinical benefit in these outcomes that was superior to that of doxazosin or finasteride . CONCLUSIONS Combination therapy with doxazosin and finasteride led to a greater decrease in the risk of clinical progression of BPH than either drug alone in patients with LUTS with a baseline TPV of 25 ml or greater BACKGROUND Lower urinary tract symptoms ( LUTS ) are common and have been associated with the subsequent diagnosis of prostate cancer ( PCa ) in population cohorts . OBJECTIVE To determine whether the association between LUTS and PCa is due to the intensity of PCa testing after LUTS diagnosis . DESIGN , SETTING , AND PARTICIPANTS We prospect ively followed a representative , population -based cohort of 1922 men , aged 40 - 79 yr , from 1990 until 2010 with interviews , question naires , and abstract ing of medical records for prostate outcomes . Men were excluded if they had a previous prostate biopsy or PCa diagnosis .  Self-reported LUTS was defined as an American Urological Association symptom index score > 7 ( n=621 ) . Men treated for LUTS ( n=168 ) were identified from review of medical records and /or self report . Median follow-up was 11.8 yr ( interquartile range : 10.7 - 12.3 ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Associations between self-reported LUTS , or treatment for LUTS , and risk of subsequent prostate biopsy and PCa were estimated using Cox proportional hazard models . RESULTS AND LIMITATIONS Fifty-five percent of eligible men enrolled in the study . Men treated for LUTS were more likely to undergo a prostate biopsy ( hazard ratio [ HR ] : 2.4 ; 95 % confidence interval [ CI ] , 1.7 - 3.3 ) . Men younger than 65 yr who were treated for LUTS were more likely to be diagnosed with PCa ( HR : 2.3 , 95 % CI , 1.5 - 3.5 ) , while men aged > 65 yr were not ( HR : 0.89 , 95 % CI , 0.35 - 1.9 ) . Men with self-reported LUTS were not more likely to be biopsied or diagnosed with PCa . Neither definition of LUTS was associated with subsequent intermediate- to high-risk cancer . The study is limited by lack of histologic or prostate-specific antigen level data for the cohort . CONCLUSIONS These results indicate that a possible cause of the association between LUTS and PCa is increased diagnostic intensity among men whose LUTS come to the attention of physicians . Increased symptoms themselves were not associated with intensity of testing or diagnosis OBJECTIVE To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia ( LUTS/BPH ) . METHODS Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score ( IPSS ) of ≥8 were enrolled in the r and omized crossover study and divided into silodosin-preceding ( S-T ) and tamsulosin-preceding ( T-S ) groups . The S-T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks . The T-S group received the reverse treatment sequence . A washout period prior to drug crossover was not included . Subjective and objective efficacy parameters including IPSS , quality of life ( QOL ) index , uroflowmetry , and safety were compared between the two groups . RESULTS Thirty of 34 men ( S-T group n = 16 ; T-S group n = 14 ) completed the study . Both drugs significantly improved all IPSS items and QOL index in the first treatment period . Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods . Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period . Adverse events occurred more frequently with silodosin than with tamsulosin ; however , none of the adverse events required treatment discontinuation . Ejaculation disorders occurred in three participants ( 10 % ) and were associated with silodosin use . CONCLUSION Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus , may represent an effective , safe , and affordable treatment option Lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) are frequently encountered in ageing males . We compared the efficacy of alfuzosin 10 mg alone or in combination with sildenafil 50 mg in the treatment of LUTS due to benign prostatic hyperplasia . One hundred male patients older than 45 years were r and omized to two groups containing 50 patients each ; one group receiving alfuzosin 10 mg and the other group alfuzosin 10 mg combined with sildenafil 50 mg  . International Prostate Symptom Score ( IPSS ) , quality of life ( QoL ) , maximum flow rate ( Qmax ) , prostate volume and post‐void residual urine were evaluated . The mean age was 60.2 ± 17.8 . Mean data of evaluated parameters in both groups at the end of 3rd month compared with baseline values are given respective order as ; 5.1 ( 26.8 % ) and 5.8 ( 28.2 % ) points decreases in IPSS ; 1.6 ( 41.1 % ) and 1.8 ( 45 % ) points decreases in QoL ; and 3.4 ( 29.6 % ) and 3.4 ( 33 % ) points increases in Qmax . The outcomes of our study can not be interpreted in such a way to report that alpha blocker‐PDE5 inhibitor combination  has a better efficacy than alpha blocker treatment alone in patients with LUTS Question What is the optimal chemotherapy treatment for women with recurrent ovarian cancer who have previously received platinum-based chemotherapy  ? Perspectives Currently , st and ard primary therapy for advanced disease involves a combination of maximal cytoreductive surgery and chemotherapy with carboplatin plus paclitaxel or with carboplatin alone . Despite initial high response rates , a large proportion of patients relapse , result ing in a therapeutic challenge . Because these patients are not curable , the goal of therapy becomes improvement in both quality and length of life . The search has therefore been to find active agents for women with recurrent disease following platinum-based chemotherapy .  Outcomes Outcomes of interest included any combination of tumour response rate , progression-free survival , overall survival , adverse events , and quality of life . Methodology The medline , embase , and Cochrane Library data bases were systematic ally search ed for primary articles and practice guidelines . The result ing evidence informed the development of clinical practice recommendations . The systematic review and recommendations were approved by the Report Approval Panel of the Program in Evidence -Based Care , and by the Gynecology Cancer Disease Site Group ( dsg ) . The practice guideline was externally review ed by a sample of practitioners from Ontario , Canada . Results Thirteen r and omized trials compared various chemotherapy regimens for patients with recurrent ovarian cancer . In five of the thirteen trials in which 100 % of patients were considered sensitive to platinum-containing chemotherapy , further platinum-based combination chemotherapy significantly improved response rates ( two trials ) , progression-free survival ( four trials ) , and overall survival ( three trials ) when compared with single-agent chemotherapy involving carboplatin or paclitaxel . Only two of these r and omized trials compared the same chemotherapy regimens : carboplatin alone versus the combination of carboplatin and paclitaxel . Both trials were consistent in reporting improved survival outcomes with the combination of carboplatin and paclitaxel . In one trial , the combination of carboplatin and gemcitabine result ed in significantly higher response rates and improved progression-free survival when compared with carboplatin alone . Median survival with carboplatin alone ranged from 17 months to 24 months in four trials . In eight of the thirteen trials in which 35%–100 % of patients had platinum-refractory or -resistant disease , one trial reported a statistically significant 2-month improvement in overall survival with liposomal doxorubicin as compared with topotecan ( 15 months vs. 13 months , p = 0.038 ; hazard ratio : 1.23 ; 95 % confidence interval : 1.01 to 1.50 ) . In that trial , because of the limited clinical benefit and the unusual finding that a survival difference emerged only after a year of treatment with no corresponding improvement in the rate of response or of progression-free survival , the authors concluded that further confirmation by results from r and omized trials were needed to establish the superiority of one agent over another in their trial . In one trial , topotecan was superior to treosulphan in patient progression-free survival by a span of approximately 2 months ( 5.4 months vs. 3.0 months , p < 0.001 ) . Toxicity was reported in all of the r and omized trials , and although data on adverse events varied by treatment regimen , the observed adverse events correlated with known toxicity profiles . As expected , combination chemotherapy was associated with higher rates of adverse events . Practice Guideline Target Population This clinical recommendation applies to women with recurrent epithelial ovarian cancer who have previously received platinum-based chemotherapy .  Of specific interest are women who have previously shown sensitivity to platinum therapy and those who previously were refractory or resistant to platinum-based chemotherapy . As a general categorization within what is actually a continuum , “ platinum sensitivity ” refers to disease recurrence 6 months or more after prior platinum-containing chemotherapy , and “ platinum resistance ” refers to a response to platinum-based chemotherapy followed by relapse less than 6 months after chemotherapy is stopped . “ Platinum-refractory disease ” refers to a lack of response or to progression while on platinum-based chemotherapy . Recommendations Although the body of evidence that informs the clinical recommendations is based on r and omized trial data , those data are incomplete . Based on the available data and expert consensus opinion , the Gynecology Cancer dsg makes these recommendations : Systemic therapy for recurrent ovarian cancer is not curative . It is therefore recognized that each patient must be individually assessed to determine optimal therapy in terms of recurrence , sensitivity to platinum , toxicity , ease of administration , and patient preference . All suitable patients should be offered the opportunity to participate in r and omized trials , if available . In the absence of contraindications , combination platinum-based chemotherapy should be considered for patients with prior sensitivity to platinum-containing chemotherapy . As compared with carboplatin alone , the combination of carboplatin and paclitaxel significantly improved both progression-free and overall survival . If combination platinum-based chemotherapy is not indicated , then a single platinum agent should be considered . Carboplatin has demonstrated efficacy across trials and has a manageable toxicity profile . If a single platinum agent is not being considered , then monotherapy with paclitaxel , topotecan , or pegylated liposomal doxorubicin are seen as reasonable treatment options . Some patients may be repeatedly sensitive to treatment and may benefit from multiple lines of chemotherapy . For patients with platinum-refractory or platinum-resistant disease , the goals of treatment should be to improve quality of life by extending the symptom-free interval , by reducing symptom intensity , and by increasing progression-free interval , and , if possible , to prolong life . With non-platinum agents , monotherapy should be considered because no advantage appears to accrue to the use of non-platinum-containing combination chemotherapy in this group of patients . Single-agent paclitaxel , topotecan , or pegylated liposomal doxorubicin have demonstrated activity in this patient population and are reasonable treatment options . No evidence either supports or refutes the use of more than one line of chemotherapy in patients with platinum-refractory or platinum-resistant recurrence . Many treatment options have shown modest response rates , but their benefits over best supportive care have not been studied in clinical trials 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 The up date d 2003 American Urological Association ( AUA ) Guidelines for the treatment of  benign prostatic hyperplasia ( BPH ) are the culmination of an exhaustive effort predicated on scientifically accepted methods of review ing the medical literature . In this second publication of the guidelines , a multidisciplinary panel review ed a new meta- analysis of outcome data from the BPH literature from before and after 1994 . The major differences between the 2 guidelines are the changes in our underst and ing of the biology of the prostate and the introduction of new therapies . The vast majority of r and omized controlled trials , particularly with respect to minimally invasive therapies and progression of BPH , were performed after the release of the 1994 guidelines . Also , the most recent AUA panel carefully review ed unpublished data to make the guidelines as timely as possible . Studies that were subsequently published included those on the value of combination medical therapy for BPH . The panel agreed on up date d recommendations for the treatment of moderate-to-severe lower urinary tract symptoms associated with BPH , and diagnostic algorithms were revised . The durability and utility of the present guidelines should exceed that of its predecessor 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 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 Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) . We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies . METHODS PROCOMB trial ( IS RCT N78639965 ) was a r and omized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA ≤ 4 ng/ml , IPSS ≥12 , prostate volume ≤60 cc , Qmax ≤15 ml/sec , postvoid residual urine ( PVR ) < 150 ml . Participants were r and omized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) . The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups . RESULTS The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months . A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months . At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) . The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C. CONCLUSION SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS In an open-label extension of a r and omized , double-blind clinical trial , the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule ( PRO 160/120 ) were investigated in elderly men with moderate or severe lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) . Two hundred and fifty-seven patients were r and omly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks , followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120 . Efficacy measures included the assessment of LUTS [ International Prostate Symptom Score ( ( I-PSS ) self-rating question naire ] and uroflow and sonographic parameters . Two hundred and nineteen subjects participated in the follow-up . Between baseline and end of observation ( week 96 ) the I-PSS total score was reduced by 53 % ( P < 0.001 ) , peak and average urinary flow increased by 19 % ( P < 0.001 ) , and residual urine volume decreased by 44 % ( P = 0.03 ) . The incidence of adverse events during follow-up was one in 1,181 treatment days ; in only one event a causal relationship with intake of PRO 160/120 could not be excluded . Treatment with PRO 160/120 thus provides a clinical ly relevant benefit over a period of 96 weeks We aim ed to evaluate the efficacy and safety of combination treatment using anticholinergics with α-blocker for initial treatment of both overactive bladder ( OAB ) and other lower urinary tract symptoms ( LUTS ) , secondary to BPH . A 12-week , r and omized , double-blind , placebo-controlled trial was conducted at four urology clinics in Korea , involving men , aged 50 years or older , with LUTS related to BPH and OAB . A total of 176 patients were r and omly assigned to receive doxazosin ( 4 mg ) plus placebo or doxazosin ( 4 mg ) plus tolterodine SR ( 4 mg ) , once a day for 12 weeks . Changes from baseline in total International Prostate Symptom Score ( IPSS ) , bladder diary variables , patient perception of bladder condition ( PPBC ) , uroflowmetry , postvoid residual volume and IPSS subscores ( voiding and storage ) were analyzed . Of the 176 enrolled patients , 91 had doxazosin gastrointestinal therapeutic system ( GITS ) and placebo , and 85 had combined medication with doxazosin GITS and tolterodine SR . Compared with the doxazosin plus placebo group , the doxazosin plus tolterodine group showed significant reductions in IPSS storage subscore and improvement in the quality of life item , urgency episodes , as well as in micturition frequency at weeks 4 and 12 . However , it failed to improve PPBC at week 4 as well as at week 12 . Earlier intervention with anticholinergics plus α-blocker was tolerated well , including the questions about urinary retention ( n=1 ) and dry mouth ( n=2 ) . Initial combination treatment of anticholinergics plus α-blocker showed positive results for men with LUTS related to BPH and OAB symptoms and did not increase the risk of urinary retention 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 Purpose To evaluate how much the improvement of lower urinary tract symptoms ( LUTS ) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function . Material s and Methods A total of 187 patients were enrolled in this study . Patients were r and omly assigned to receive either tamsulosin 0.2 mg ( group A ) or tamsulosin 0.2 mg and solifenacin 5 mg ( group B ) . At 4 weeks and 12 weeks , the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 ( IIEF5 ) , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Symptom Score ( OABSS ) question naire , uroflowmetry , and bladder scan . Results Both groups A and B showed statistically significant improvements in IPSS , OABSS , and quality of life ( QoL ) . Group A showed improved maximum flow rate , mean flow rate , and residual urine volume by time . Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time . The IIEF5 score was not improved in either group . In group A , the IIEF5 score dropped from 13.66±4.97 to 11.93±6.14 after 12 weeks ( p=0.072 ) . Group B showed a decline in the IIEF5 score from 13.19±5.91 to 12.45±6.38 ( p=0.299 ) . Although group B showed a relatively smaller decrease in the IIEF5 score , the difference between the two groups was not significant ( p=0.696 ) . Conclusions Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL. The improvement in storage symptoms did not affect erectile function Purpose : To verify the association between lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) and evaluate the influence of sildenafil and doxazosin either as single agents or combined on both symptoms . Material and Methods : A prospect i ve r and omized study including 150 patients presented with LUTS caused by BPH in association with clinical ly diagnosed ED , with age equal or more than 45 years from April 2010 to April 20011 . They were categorized into three comparative groups each one containing 50 patients . These groups were comparable regarding pretreatment international prostate symptoms score ( IPSS ) and international index of erectile function ( IIEF ) . The patients of the first group were given sildenafil 50 mg as monotherapy , those of the second group were given doxazosin 2 mg and those of the third group were given combination of both drugs for 4 months for each group . The main post-treatment parameters for assessment and comparison include assessment of patient 's symptoms by repeated IPS S and IIEF , uroflowmetry and assessment of PVR . The statistics was done by use of the Qui -- square test . Results : Pre-treatment parameters were assessed and compared between the three groups . After 4 months of treatment , the comparative parameters were applied to all groups and the differences were measured post-treatment regarding IPSS , erectile function score , uroflowmetry , and post-void residual ( PVR ) urine . Sildenafil alone caused mild improvement in IPSS , more improvement in IIEF score , and little effect on flow rate and PVR urine .  Doxazosin alone caused more improvement in IPSS , flow rate and PVR urine and less improvement in IIEF score . A combination of both sildenafil and doxazosin caused more improvement in all of the comparative parameters than when each drug was given alone . Conclusions : There is a strong relationship between LUTS and ED . Doxazosin or sidenafil as a single drug could be used in treating mild or mild to moderate symptoms but more severe symptoms may usually need a combination of both drugs 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 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 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 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 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 OBJECTIVE To investigate the effect of combination therapy with dutasteride plus tamsulosin compared with each monotherapy on patient-reported health outcomes over 4 years in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) because of benign prostatic hyperplasia ( BPH ) . METHODS CombAT was a 4-year international , double-blind , r and omised , parallel-group trial in men ( n = 4844 ) with moderate-to-severe symptoms of BPH and at increased risk of disease progression [ age > or = 50 years , International Prostate Symptom Score ( IPSS ) > or = 12 , prostate volume > or = 30 cc , serum prostate-specific antigen > or = 1.5 ng/ml to < or = 10 ng/ml and maximum urinary flow rate 5 - 15 ml/s with minimum voided volume > or = 125 ml ] . Subjects were r and omised to receive 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . The primary endpoint at 4 years was the time to event and proportion of subjects with acute urinary retention or undergoing BPH-related prostate surgery . Secondary endpoints included the health- outcomes measures , BPH Impact Index ( BII ) , IPSS question 8 ( IPSS Q8 ) and the Patient Perception of Study Medication ( PPSM ) question naire . RESULTS At 4 years , combination therapy result ed in significantly superior improvements from baseline in BII and IPSS Q8 than either monotherapy ; these benefits were observed from 3 months onwards compared with dutasteride and from 9 months ( BII ) or 12 months ( IPSS Q8 ) onwards compared with tamsulosin . Also at 4 years , the PPSM question naire showed that a significantly higher proportion of patients was satisfied with , and would request treatment with , combination therapy compared with either monotherapy . CONCLUSIONS Combination therapy ( dutasteride plus tamsulosin ) provides significantly superior improvements in patient-reported quality of life and treatment satisfaction than either monotherapy at 4 years in men with moderate-to-severe BPH symptoms
EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .