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). 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 combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study 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 Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction. 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. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: Combined Treatment with Fesoterodine Fumarate Extended-Release and Tamsulosin - A Prospective Study 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. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Solifenacin as add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms--ASSIST, randomized controlled study. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. Sildenafil citrate and tamsulosin combination is not superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. 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). Self-management for men with lower urinary tract symptoms 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. Efficacy of alfuzosin and sildenafil combination in male patients with lower urinary tract symptoms 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 [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin]. Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study. Intermittent alpha-blocker therapy in the treatment of men with lower urinary tract symptoms. Evaluation of the effect of sildenafil and/or doxazosin on Benign prostatic hyperplasia–related lower urinary tract symptoms and erectile dysfunction Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Aquablation – image‐guided robot‐assisted waterjet ablation of the prostate: initial clinical experience Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. The effect of benign lower urinary tract symptoms on subsequent prostate cancer testing and diagnosis. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected]. Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin Obesity increases and physical activity decreases lower urinary tract symptom risk in older men: the Osteoporotic Fractures in Men study. Naftopidil and propiverine hydrochloride for treatment of male lower urinary tract symptoms suggestive of benign prostatic hyperplasia and concomitant overactive bladder: A prospective randomized controlled study Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms—a placebo-controlled, double-blind, multicenter trial
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 OBJECTIVE The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy , in patients with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . METHODS Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score ( IPSS ) 8 or higher , were r and omized to receive 10 mg alfuzosin ( n = 25 ) , 10 mg tadalafil ( n = 25 ) or the combination of both the drugs ( n = 25 ) once daily for 3 months . Symptoms were assessed at baseline , 6 weeks and 3 months . The primary endpoint was the change in IPSS from the baseline . Secondary endpoints were changes in IPSS storage and voiding subscores , peak urinary flow rate , residual urine volume , IPSS quality of life score and erectile domain score . RESULTS There were significant improvements in all IPSS scores , peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups ( P < 0.003 ) . Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume ( P < 0.005 ) . Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate ( P = 0.22 ) , similar to tadalafil in improvement on erectile function ( P = 0.22 ) and better than each monotherapy in improving the IPSS quality of life ( P ≤ 0.015 ) . CONCLUSION Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH Background The 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 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 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 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 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 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 : 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 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 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 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 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 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 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 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 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 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 ) 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 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 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 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 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 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 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 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 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 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 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 To assess the safety and feasibility of aquablation in a first‐in‐man study . Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics ( AquaBeam ® ) for the targeted and heat‐free removal of prostatic tissue in men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) 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 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 BACKGROUND Tadalafil improved lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ; LUTS/BPH ) in clinical studies but has not been evaluated together with an active control in an international clinical study . OBJECTIVE Assess tadalafil or tamsulosin versus placebo for LUTS/BPH . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , international , placebo-controlled , parallel-group study assessed men ≥45 yr of age with LUTS/BPH , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urinary flow rate ( Q(max ) ) ≥4 to ≤15ml/s . Following screening and washout , if needed , subjects completed a 4-wk placebo run-in before r and omisation to placebo ( n=172 ) , tadalafil 5 mg ( n=171 ) , or tamsulosin 0.4 mg ( n=168 ) once daily for 12 wk . MEASUREMENTS Outcomes were assessed using analysis of covariance ( ANCOVA ) or ranked analysis of variance ( ANOVA ) ( continuous variables ) and Cochran-Mantel-Haenszel test or Fisher exact test ( categorical variables ) . RESULTS AND LIMITATIONS IPSS significantly improved versus placebo through 12 wk with tadalafil ( -2.1 ; p=0.001 ; primary efficacy outcome ) and tamsulosin ( -1.5 ; p=0.023 ) and as early as 1 wk ( tadalafil and tamsulosin both -1.5 ; p<0.01 ) . BPH Impact Index significantly improved versus placebo at first assessment ( week 4 ) with tadalafil ( -0.8 ; p<0.001 ) and tamsulosin ( -0.9 ; p<0.001 ) and through 12 wk ( tadalafil -0.8 , p=0.003 ; tamsulosin -0.6 , p=0.026 ) . The IPSS Quality -of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil ( both p<0.05 ) but not with tamsulosin ( both p>0.1 ) . The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil ( 4.0 ; p<0.001 ) but not tamsulosin ( -0.4 ; p=0.699 ) . Q(max ) increased significantly versus placebo with both tadalafil ( 2.4ml/s ; p=0.009 ) and tamsulosin ( 2.2ml/s ; p=0.014 ) . Adverse event profiles were consistent with previous reports . This study was limited in not being powered to directly compare tadalafil versus tamsulosin . CONCLUSIONS Monotherapy with tadalafil or tamsulosin result ed in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max ) . However , only tadalafil improved erectile dysfunction . TRIAL REGISTRATION Clinical trials.gov ID NCT00970632 INTRODUCTION Benign prostatic hypertrophy ( BPH ) is a common disease whose frequency has risen throughout the world in concomitance with the increase in life expectancy . BPH causes voiding disturbances known by the acronym LUTS ( lower urinary tract symptoms ) , which heavily influence the quality of life in the elderly . The treatment for LUTS is mainly divided into medical and surgical , the latter usually represented by prostate ablation . Medical therapy includes synthetic molecules that interfere with the hormonal control of BPH or act on the bladder neck tonus , as well as natural remedies based on plant extracts from Serenoa Repens and /or Urtica Dioica . MATERIAL AND METHODS Two groups of patients who were c and i date s for surgery for BPH-induced LUTS , were r and omly recruited in a six-month trial aim ed at comparing outcome of treatment with a new combination of plants extracts ( Pluvio ® ) , which differs from the previous ones in that it also contains avocado and soya oil , as well as a high dose of Urtica Dioica , with no therapy . Age , IPSS score , maximal uroflow , prostate volume , PSA , free-to-total PSA ratio , post voiding residual urine and number of nocturia episodes were recorded and statistically evaluated using a NCSS 60 ® program . RESULT A marked benefit in terms of quality of life , measured by IPSS score , uroflow , residual urine and nocturia , was observed in the treated group compared to controls . PSA and prostate volume were not significantly affected . No noteworthy adverse events were observed . CONCLUSIONS The new phytotherapeutic combination evaluated in the present study would seem to be highly effective for the treatment of LUTS in BPH patients and does not have negative side effects . Its use could therefore be strongly advocated in this setting 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 BACKGROUND Two potential targets for preventing chronic lower urinary tract symptoms ( LUTS )  in older men are obesity and physical activity . OBJECTIVE To examine associations of adiposity and physical activity with incident LUTS in community-dwelling older men . DESIGN , SETTING , AND PARTICIPANTS The Osteoporotic Fractures in Men Study ( MrOS ) is a prospect i ve cohort of men ≥65 yr of age . MrOS participants without LUTS and a history of LUTS treatment at baseline were included in this analysis . MEASUREMENTS Adiposity was measured with body mass index ( BMI ) , physical activity with the Physical Activity Scale for the Elderly ( PASE ) and self-report of daily walking , and LUTS with the American Urological Association Symptom Index . RESULTS AND LIMITATIONS The mean age ( st and ard deviation [ SD ] ) of the 1695 participants was 72 ( 5 ) yr at baseline . At a mean ( SD ) follow-up of 4.6 ( 0.5 ) yr , 524 ( 31 % ) of men  reported incident LUTS . In multivariate analyses , compared with men of normal weight at baseline ( BMI < 25 kg/m² ) , overweight ( BMI : 25.0 - 29.9 kg/m² ) and obese ( ≥30 kg/m² ) men were 29 % ( adjusted odds ratio [ OR(adj ) ] : 1.29 ; 95 % confidence interval [ CI ] , 1.00 - 1.68 ) and 41 % ( OR(adj ) : 1.41 ; 95 % CI , 1.03 - 1.93 ) more likely to develop LUTS , respectively . Men in the highest quartile of physical activity were 29 % ( OR(adj ) : 0.71 ; 95 % CI , 0.53 - 0.97 ) and those who walked daily 20 % ( OR(adj ) : 0.80 ; 95 % CI , 0.65 - 0.98 ) less likely than their sedentary peers to develop LUTS , adjusting for BMI . The homogeneous composition of MrOS potentially diminishes the external validity of these results . CONCLUSIONS In older men , obesity and higher physical activity are associated with increased and decreased risks of incident LUTS , respectively . Prevention of chronic urinary symptoms represents another potential health benefit of exercise in elderly men 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 BACKGROUND Alpha blockers are prescribed to manage lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) .  Antimuscarinics are prescribed to treat overactive bladder ( OAB ) . OBJECTIVE To investigate the safety of a combination of solifenacin ( SOLI ) and tamsulosin oral controlled absorption system ( TOCAS ) in men with LUTS and bladder outlet obstruction ( BOO ) . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , parallel-group , placebo-controlled study in men aged > 45 yr with LUTS and BOO for ≥3 mo , total International Prostate Symptom Score ( IPSS ) ≥8 , BOO index ≥20 , maximum urinary flow rate ( Q(max ) ) ≤12 ml/s , and voided volume ≥120 ml . INTERVENTIONS Once-daily coadministration of TOCAS 0.4 mg plus SOLI 6 mg , TOCAS 0.4 mg plus SOLI 9 mg , or placebo for 12 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary ( safety ) measurements : Q(max ) and detrusor pressure at Q(max ) ( P(det)Q(max ) ) . Other safety assessment s included postvoid residual ( PVR ) volume . Secondary end points included bladder contractile index ( BCI ) score and percent bladder voiding efficiency ( BVE ) . An analysis of covariance model compared each TOCAS plus SOLI combination with placebo . RESULTS AND LIMITATIONS Both active treatment groups were noninferior to placebo at end of treatment ( EOT ) for P(det)Q(max ) and Q(max ) . Mean change from baseline PVR was significantly higher at all time points for TOCAS 0.4 mg plus SOLI 6 mg , and at weeks 2 , 12 , and EOT for TOCAS 0.4 mg plus SOLI 9 mg versus placebo . Both treatment groups were similar to  placebo for BCI and BVE . Urinary retention was seen in only one patient receiving TOCAS 0.4 mg plus SOLI 6 mg . Limitations of the study were that prostate size and prostate-specific antigen level were not measured . CONCLUSIONS TOCAS 0.4 mg plus SOLI 6 mg or 9 mg was noninferior to placebo at EOT for P(det)Q(max ) and Q(max ) in men with LUTS and BOO , and there was no clinical or statistical evidence of increased risk of urinary retention OBJECTIVES The timely recruitment of study participants is a critical component of successful trials . Benign prostatic hyperplasia ( BPH ) , a common nonmalignant urologic condition among older men , is characterized by lower urinary tract symptoms ( LUTS ) . Successful recruitment methods for a trial of medical therapy for BPH , Medical Therapy of Prostate Symptoms ( MTOPS ) , were mass mailing and advertising . The Complementary and Alternative Medicines Trial for Urological Symptoms ( CAMUS ) was design ed to evaluate a botanical therapy , saw palmetto , for the treatment of BPH . The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy . DESIGN CAMUS is a r and omized , double-blind , placebo-controlled trial design ed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS . SUBJECTS The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period . The recruitment techniques used and participants contacted , screened , and r and omized through each technique were obtained from the clinical centers . Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS . RESULTS The target enrollment goal was achieved in 11 months . The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0 . The most successful recruitment methods were mass mailing and advertising , which accounted for 39 % and 35 % of the study participants , respectively . In comparison to MTOPS participants , CAMUS participants were younger , more highly educated , more diverse , and had less severe urinary symptoms . CONCLUSIONS Successful recruitment methods for CAMUS were similar to those in MTOPS . The use of botanical therapy attracted a less symptomatic and more educated study population The 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 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo  ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent
This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for < 1 yr , α1-blockers alone are just as effective .
The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events .
It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr .
The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy .
Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy .
The combination seems to be safe in men with postvoid residual < 200 ml .
The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports .
CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr .
Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
BACKGROUND Several drugs are approved for the treatment of lower urinary tract symptoms ( LUTS ) in men , but these are mostly used by clinicians as monotherapies .
The combination of different compounds , each of which targets a different aspect of LUTS , seems appealing .
However , only few clinical trials have evaluated the effects of combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS .