human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy .  Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p < 0.001 ) . Patient reported outcome measures showed no significant between group differences . CONCLUSIONS Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin 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 We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average micturition volume ( 32.3 % vs 19.2 % , p = 0.004 ) , and storage ( 41.3 % vs 32.6 % , p = 0.029 ) and urgency ( p = 0.019 ) International Prostate Symptom Score symptoms were more significant in group 2 . Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention . Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 ( p = 0.002 ) . Overall adverse event rates were higher in group 2 ( p = 0.002 ) , although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups . CONCLUSIONS This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction PURPOSE We evaluated the efficacy of tolterodine extended release and /or tamsulosin on micturition related urgency episodes , urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials . MATERIAL S AND METHODS Men 40 years old or older with an International Prostate Symptom Score of 12 or greater , frequency ( 8 or more voids per 24 hours ) and urgency ( 3 or more episodes per 24 hours ) with or without urgency urinary incontinence were r and omized to placebo , 4 mg tolterodine extended release , 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin  for 12 weeks . Subjects completed 5-day diaries ; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline , and weeks 1 , 6 and 12 ; Overactive Bladder Question naire at baseline , and weeks 6 and 12 ; Perception of Treatment Satisfaction question at weeks 1 , 6 and 12 ; and Willingness to Continue question at week 12 . Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater . Urgency severity was measured using frequency-urgency sum , defined as the sum of urgency ratings for all micturitions . RESULTS Compared with placebo , tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1 , 6 and 12 . It also improved Patient Perception of Bladder Condition scores at weeks 1 , 6 and 12 ; improved Urgency Perception Scale and Overactive Bladder Question naire , Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12 ; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12 , and willingness to continue at week 12 . CONCLUSIONS Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials 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 Antimuscarinic therapy for men with OAB and BOO is perceived as a potential risk for urinary retention . Using pressure flow urodynamics , we evaluated the safety of tolterodine vs placebo in men with OAB and BOO . MATERIAL S AND METHODS Men ( older than 40 years ) with BOO and confirmed detrusor overactivity were r and omized to tolterodine ( 2 mg twice daily in 149 ) or placebo ( in 72 ) for 12 weeks . Primary end points were Qmax and pdetQmax . RESULTS Median treatment differences in Qmax ( -0.7 ml per second , 95 % CI -1.6 to 0.4 ) and pdetQmax ( -7 cm H2O , 95 % CI -3 to 11 ) were comparable . Tolterodine significantly reduced the BOOI vs placebo ( -9 vs 0 , p < 0.02 ) . There were significant treatment differences in volume to first detrusor contraction ( + 59 ml , 95 % CI 19 - 100 ) and maximum cystometric capacity ( + 67 ml , 95 % CI 35 - 103 ) , favoring tolterodine over placebo ( p < 0.003 ) . Change in PVR was significantly greater among patients treated with tolterodine ( + 25 ml ) than placebo ( 0 ml , p < 0.004 ) . There were no significant between-group differences in the incidence of adverse events . Urinary retention was reported by 1 patient treated with placebo . CONCLUSIONS Tolterodine did not adversely affect urinary function in men with OAB and BOO .  Urinary flow rate was unaltered , and there was no evidence of clinical ly meaningful changes in voiding pressure and PVR or urinary retention .  Tolterodine was well tolerated . These results suggest that antimuscarinics can be safely administered in men with BOO CONTEXT Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists . OBJECTIVE To evaluate the efficacy and safety of tolterodine extended release ( ER ) , tamsulosin , or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and , an International Prostate Symptom Score quality -of-life ( QOL ) item score of 3 or higher , a self-rated 
    Output:
    
agent
Data from 12-week , r and omised , double-blind , placebo-controlled trials of tolterodine extended release ( ER ) , oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms .
The efficacy and safety  of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen ( PSA ) level .
In men meeting entry criteria for OAB and benign prostatic obstruction trials  , tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians .
Post hoc analyses from double-blind , placebo-controlled trials and prospect i ve studies of fesoterodine , oxybutynin , propiverine , solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men .
A retrospective data base study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter .
Antimuscarinics , alone or with an α-blocker , appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy .  Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p < 0.001 ) . Patient reported outcome measures showed no significant between group differences . CONCLUSIONS Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin 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 We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average micturition volume ( 32.3 % vs 19.2 % , p = 0.004 ) , and storage ( 41.3 % vs 32.6 % , p = 0.029 ) and urgency ( p = 0.019 ) International Prostate Symptom Score symptoms were more significant in group 2 . Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention . Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 ( p = 0.002 ) . Overall adverse event rates were higher in group 2 ( p = 0.002 ) , although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups . CONCLUSIONS This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction PURPOSE We evaluated the efficacy of tolterodine extended release and /or tamsulosin on micturition related urgency episodes , urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials . MATERIAL S AND METHODS Men 40 years old or older with an International Prostate Symptom Score of 12 or greater , frequency ( 8 or more voids per 24 hours ) and urgency ( 3 or more episodes per 24 hours ) with or without urgency urinary incontinence were r and omized to placebo , 4 mg tolterodine extended release , 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin  for 12 weeks . Subjects completed 5-day diaries ; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline , and weeks 1 , 6 and 12 ; Overactive Bladder Question naire at baseline , and weeks 6 and 12 ; Perception of Treatment Satisfaction question at weeks 1 , 6 and 12 ; and Willingness to Continue question at week 12 . Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater . Urgency severity was measured using frequency-urgency sum , defined as the sum of urgency ratings for all micturitions . RESULTS Compared with placebo , tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1 , 6 and 12 . It also improved Patient Perception of Bladder Condition scores at weeks 1 , 6 and 12 ; improved Urgency Perception Scale and Overactive Bladder Question naire , Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12 ; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12 , and willingness to continue at week 12 . CONCLUSIONS Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials 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 Antimuscarinic therapy for men with OAB and BOO is perceived as a potential risk for urinary retention . Using pressure flow urodynamics , we evaluated the safety of tolterodine vs placebo in men with OAB and BOO . MATERIAL S AND METHODS Men ( older than 40 years ) with BOO and confirmed detrusor overactivity were r and omized to tolterodine ( 2 mg twice daily in 149 ) or placebo ( in 72 ) for 12 weeks . Primary end points were Qmax and pdetQmax . RESULTS Median treatment differences in Qmax ( -0.7 ml per second , 95 % CI -1.6 to 0.4 ) and pdetQmax ( -7 cm H2O , 95 % CI -3 to 11 ) were comparable . Tolterodine significantly reduced the BOOI vs placebo ( -9 vs 0 , p < 0.02 ) . There were significant treatment differences in volume to first detrusor contraction ( + 59 ml , 95 % CI 19 - 100 ) and maximum cystometric capacity ( + 67 ml , 95 % CI 35 - 103 ) , favoring tolterodine over placebo ( p < 0.003 ) . Change in PVR was significantly greater among patients treated with tolterodine ( + 25 ml ) than placebo ( 0 ml , p < 0.004 ) . There were no significant between-group differences in the incidence of adverse events . Urinary retention was reported by 1 patient treated with placebo . CONCLUSIONS Tolterodine did not adversely affect urinary function in men with OAB and BOO .  Urinary flow rate was unaltered , and there was no evidence of clinical ly meaningful changes in voiding pressure and PVR or urinary retention .  Tolterodine was well tolerated . These results suggest that antimuscarinics can be safely administered in men with BOO CONTEXT Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists . OBJECTIVE To evaluate the efficacy and safety of tolterodine extended release ( ER ) , tamsulosin , or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and , an International Prostate Symptom Score quality -of-life ( QOL ) item score of 3 or higher , a self-rated 
    Output:
    