title: Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study. Effect of tolterodine extended release with or without tamsulosin on measures of urgency and patient reported outcomes in men with lower urinary tract symptoms. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. 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 Urodynamic parameters after solifenacin treatment in men with overactive bladder symptoms and detrusor underactivity. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. Influence of age, gender, and race on pharmacokinetics, pharmacodynamics, and safety of fesoterodine. Detrusor instability in men: correlation of lower urinary tract symptoms with urodynamic findings. Symptom-specific efficacy of tolterodine extended release in patients with overactive bladder: the IMPACT trial. 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 Prevalence and characteristics of lower urinary tract symptoms in men aged > or = 80 years. Effects of serum PSA on efficacy of tolterodine extended release with or without tamsulosin in men with LUTS, including OAB. Efficacy and tolerability of fesoterodine in men with overactive bladder: a pooled analysis of 2 phase III studies. Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms: effects of prostate size.
abstract: 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 bladder condition of at least moderate bother , and a bladder diary documenting micturition frequency ( > or=8 micturitions per 24 hours ) and urgency ( > or=3 episodes per 24 hours ) , with or without urgency urinary incontinence . Patients were recruited between November 2004 and February 2006 , and the study was completed May 2006 . INTERVENTIONS Patients were r and omly assigned to receive placebo ( n = 222 ) , 4 mg of tolterodine ER ( n = 217 ) , 0.4 mg of tamsulosin ( n = 215 ) , or both tolterodine ER plus tamsulosin ( n = 225 ) for 12 weeks . MAIN OUTCOME MEASURES Patient perception of treatment benefit , bladder diary variables , International Prostate Symptom Scores , and safety and tolerability were assessed . RESULTS A total of 172 men ( 80 % ) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients ( 62 % ) receiving placebo ( P<.001 ) , 146 ( 71 % ) receiving tamsulosin ( P=.06 vs placebo ) , or 135 ( 65 % ) receiving tolterodine ER ( P=.48 vs placebo ) . Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence ( -0.88 vs -0.31 , P=.005 ) , urgency episodes without incontinence ( -3.33 vs -2.54 , P=.03 ) , micturitions per 24 hours ( -2.54 vs -1.41 , P<.001 ) , and micturitions per night ( -0.59 vs -0.39 , P.02 ) . Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score ( -8.02 vs placebo , -6.19 , P=.003 ) and QOL item ( -1.61 vs -1.17 , P=.003 ) . All interventions were well tolerated . The incidence of acute urinary retention requiring catheterization was low ( tolterodine ER plus tamsulosin , 0.4 % ; tolterodine ER , 0.5 % ; tamsulosin , 0 % ; and placebo , 0 % ) . CONCLUSIONS These results suggest that treatment with tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder . Clinical Trials Registration clinical trials.gov Identifier : NCT00147654 PURPOSE We determined whether men treated with oral antimuscarinics  are at increased risk for acute urinary retention . MATERIAL S AND METHODS In this population based , retrospective cohort study using a nested case-control design we analyzed data from a large primary care data base containing patient information entered by general practitioners in the United Kingdom . Our study cohort comprised men 20 to 84 years old . Cases of acute urinary retention were identified by review ing diagnostic codes and were confirmed in a r and om sample through question naires sent to the treating physician . RESULTS The overall incidence of acute urinary retention in the study cohort ( 1,844 ) was 1.0 per 1,000 person-years , with the incidence rate increasing with age . The first 30 days ( early treatment ) of antimuscarinic use was associated with a relative risk of acute urinary retention of 8.3 ( 95 % CI 4.8 - 14.2 ) and with longer term use ( more than 30 days ) the relative risk was 2.0 ( 95 % CI 1.2 - 3.1 ) . The relative risk of acute urinary retention was similar for low/medium and high antimuscarinic doses ( relative risk 2.8 vs 3.0 , 95 % CI 2.1 - 3.8 and 1.3 - 6.8 , respectively ) . The relative risk of acute urinary retention was highest during early treatment for a urogenital indication ( relative risk 14.2 , 95 % CI 6.8 - 29.6 ) . The risk of acute urinary retention was not increased when antimuscarinics were used as antispasmodics or for drug induced parkinsonism . CONCLUSIONS Men prescribed antimuscarinics  , particularly for a urogenital condition , should be closely monitored during the first 30 days of treatment for signs or symptoms of urinary retention BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy OBJECTIVES To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release ( TER ) in men with overactive bladder ( OAB ) and nocturia . METHODS This was a post hoc analysis of data from two 12-week , double-blind , placebo-controlled trials of nighttime ( < 4 hours before bedtime ) TER ( 4 mg daily ) dosing . Men with a mean micturition frequency of eight or more times in 24 hours , including a mean of 2.5 or more nocturia episodes/night , were included . For each micturition , patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale ( 1 , none ; 2 , mild ; 3 , moderate ; 4 , severe ; 5 , urgency urinary incontinence ) . Micturitions were analyzed post hoc by urgency rating categories : total ( 1 to 5 ) , non-OAB ( 1 to 2 ) , OAB ( 3 to 5 ) , and severe OAB ( 4 to 5 ) . Adverse events were recorded throughout the study . RESULTS A total of 745 men ( mean age 64 years ) were r and omized to placebo ( n = 374 ) or TER ( n = 371 ) . Of the 745 men , 73 % reported no incontinence episodes in a 7-day diary at baseline . At week 12 , the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total , OAB , and severe OAB micturitions were significantly reduced in the TER group versus the placebo group . The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo . Adverse events associated with TER were low and comparable to those in the placebo group , with the exception of dry mouth ( 11 % versus 4 % ) . Withdrawals because of adverse events were infrequent ( 3 % TER , 4 % placebo ) . Five men were withdrawn for symptoms suggestive of urinary retention ( 3 TER , 2 placebo ) . CONCLUSIONS Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia BACKGROUND Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder ( OAB ) . OBJECTIVE To evaluate the efficacy of tolterodine extended release ( ER ) in men on alpha-blocker therapy . DESIGN , SETTING , AND PARTICIPANTS This double-blind trial included men aged > or = 40 yr with frequency , urgency , and at least moderate problems reported on the Patient Perception of Bladder Condition ( PPBC ) , despite being on a stable dose of alpha-blocker for > or = 1 mo . INTERVENTIONS Subjects were r and omized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy . MEASUREMENTS At baseline and week 12 , subjects completed the PPBC , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Question naire ( OAB-q ) , and 5-d bladder diaries using the five-point Urinary Sensation Scale ( USS ) . Frequency-urgency sum was defined as the sum of USS ratings for all micturitions . RESULTS AND LIMITATIONS PPBC improvement from baseline to week 12 was reported by 63.6 % and 61.6 % of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker , respectively ; this treatment difference , which was the primary end point , was not statistically significant ( p>0.6699 ) . At week 12 , subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions ( -1.8 vs -1.2 ; p=0.0079 ) and daytime micturitions ( -1.3 vs -0.8 ; p=0.0123 ) ; 24-h urgency episodes ( -2.9 vs -1.8 ; p=0.0010 ) , daytime urgency episodes ( -2.2 vs -1.4 ; p=0.0017 ) , and nocturnal urgency episodes ( -0.5 vs -0.3 ; p=0.0378 ) ; frequency-urgency sum ( -7.8 vs -5.1 ; p=0.0065 ) ; IPSS storage subscale ( -2.6 vs -2.1 ; p=0.0370 ) ; and OAB-q symptom bother scale ( -17.9 vs -14.4 ; p=0.0086 ) and coping domain ( 15.4 vs 12.4 ; p=0.0491 ) . Acute urinary retention requiring catheterization occurred in < 1 % of either group . There were no clinical ly meaningful changes in postvoid residual volume or maximum urinary flow rate .  CONCLUSIONS Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables , IPSS Storage scores , and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker 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 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 AIMS To describe the changes in urodynamic parameters and to assess patients ' perceptions of voiding difficulties and improvements in symptom bother after solifenacin treatment in men with overactive bladder ( OAB ) and detrusor underactivity ( DUA ) . METHODS In this prospect i ve study , 49 neurologically intact men were enrolled . DUA was defined as a bladder contractility index ( BCI ) < 100 . All subjects received 5 mg of solifenacin once a day for 120 days . A complete urodynamic study was carried out on the day before to the first dose of solifenacin and at day 120 . RESULTS Solifenacin treatment result ed in a decrease in Q(max ) during UDS ( -0.6 ml/sec ; P = 0.007 ) , P(det)Q(max ) ( -6.4 cmH(2)O ; P < 0.001 ) , BOOI ( -7.5 ; P < 0.001 ) , BCI ( -3.8 ; P = 0.001 ) , BVE ( -4.4 % ; P = 0.006 ) , and voided volume ( -7.5 ml ; P = 0.09 ) . On the contrary , PVR ( + 6 ml ; P = 0.152 ) , and maximum cystometric capacity ( + 22.9 ml ; P = 0.001 ) increased . The regression analysis suggested that changes in urodynamic parameters after solifenacin treatment were limited for BOOI ( 9.4 % ) , P(det)Q(max ) ( 8.4 % ) , and BCI ( 6.5 % ) , with no significant impact on Q(max ) during UDS , BVE , volume voided and PVR . No significant change in subjective perception of voiding difficulties was found . The incidence of AUR was 2.2 % and improvement in patient 's experience of OAB symptoms bother after solifenacin treatment was observed . CONCLUSIONS Solifenacin treatment results in changes of urodynamic parameters . These changes , however , seem not to be of clinical significance as suggested by the lack of subjective deterioration in voiding difficulties and by the low incidence of AUR PURPOSE We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . MATERIAL S AND METHODS The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability . All patients were initially treated with 0.4 mg . tamsulosin orally once a day . A week later the patients were r and omly allocated into group 1 - 25 who continued treatment with tamsulosin only and , group 2 - 25 who also received 2 mg . tolterodine orally twice daily . Reevaluation with a quality of life question naire and urodynamic study was performed after 3 months . RESULTS Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension . Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients ( mean score 525.0 and 628.4 before and after treatment , respectively , 2-sided t test p = 0.0003 ) . A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction . Additionally , in group 2 , a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment . CONCLUSIONS Combination treatment with an alpha-blocker ( tamsulosin ) plus an anticholinergic ( tolterodine ) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . Interestingly , no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume . The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability OBJECTIVE Fesoterodine , a new antimuscarinic agent for overactive bladder , undergoes immediate and extensive hydrolysis by nonspecific esterases to 5-hydroxymethyl tolterodine ( 5-HMT ) , the metabolite principally responsible for its antimuscarinic activity . Formation of 5-HMT does not require cytochrome P450 (CYP)-mediated metabolism , but its further metabolism and inactivation involves CYP3A4 and CYP2D6 isoenzymes . Subject age , gender , and race can play a key role in inter-subject variability in pharmacokinetics and thus efficacy and safety of drugs . This article examines the effects of age , gender , and race on the pharmacokinetics and pharmacodynamics of fesoterodine . METHODS Data from two r and omized , double-blind , placebo-controlled , parallel-group trials in healthy subjects are presented : Study 1 investigated the effects of race ( white vs. black men ) and Study 2 investigated the effects of age ( young vs. old men ) and gender ( elderly men vs. elderly women ) on the pharmacokinetics and pharmacodynamics of single doses of fesoterodine 8 mg . In both studies , the primary endpoints were area under the concentration-time curve up to the last sample ( AUC0-tz ) and maximum concentration ( Cmax ) of 5-HMT in plasma . Pharmacodynamic variables included spontaneous salivary secretion ( Studies 1 and 2 ) and residual urine volume ( Study 2 only ) . The two studies included 5 groups of 16 subjects each ( r and omized 3 : 1 to fesoterodine or placebo ) : white men aged 18 - 45 years , black men aged 18 - 45 years ( Study 1 ) ; young white men aged 18 - 40 years , elderly white men aged > 65 years , and elderly white women aged > 65 years ( Study 2 ) . RESULTS There were no clinical ly meaningful differences in the primary endpoints between white and black subjects or between young white men , elderly white men , and elderly white women . Mean AUC0-tz was 70.7 ng/ml x h in whites and 64.1 ng/ml x h in blacks ; mean Cmax was 6.1 and 5.5 ng/ml in whites and blacks , respectively . Mean AUC0-tz in young white men , elderly white men , and elderly white women was 49 , 48 , and 54 ng/ml x h , respectively ; mean Cmax in young white men , elderly white men , and elderly white women was 4.1 , 3.8 , and 4.6 ng/ml , respectively . Consistent with the anticholinergic pharmacology of fesoterodine , declines in salivary volume were observed in both studies , and elevations in residual urinary volume were observed , especially in elderly subjects , in Study 2 . Fesoterodine was well tolerated , with common adverse events such as headache and dry mouth recognized as antimuscarinic class effects . CONCLUSIONS Subject demographics , such as age , gender , and race , do not have a clinical ly meaningful effect on 5-HMT pharmacokinetics or pharmacodynamics after single-dose administration of fesoterodine 8 mg ; thus , no dosage adjustment is required for fesoterodine based on age , gender , or race PURPOSE We evaluated the correlation of lower urinary tract symptoms suggestive of detrusor instability with urodynamic findings in men . MATERIAL S AND METHODS Enrolled in our prospect i ve study were 160 consecutive neurologically intact men referred for urodynamic evaluation of persistent lower urinary tract symptoms . All patients had storage symptoms suggestive of detrusor instability . Patients were further clinical ly categorized according to the chief complaint of urge incontinence , frequency and urgency , nocturia or difficult voiding . The clinical and urodynamic diagnosis in all patients as well as specific urodynamic characteristics of those with detrusor instability were analyzed according to the these 4 clinical categories . RESULTS Mean patient age was 61 + /- 15 years . The chief complaint was urge incontinence in 28 cases ( 17 % ) , frequency and urgency in 57 ( 36 % ) , nocturia in 30 ( 19 % ) and difficult voiding in 45 ( 28 % ) . Detrusor instability was diagnosed in 68 cases ( 43 % ) . A higher incidence of detrusor instability was associated with urge incontinence than with the other clinical categories ( 75 % versus 36 % , p < 0.01 ) . Of the patients 109 ( 68 % ) had bladder outlet obstruction , including 50 ( 46 % ) with concomitant detrusor instability . The prevalence of bladder outlet obstruction was similar in all patients regardless of the chief complaint . All other urodynamic diagnoses were also similar in the 4 clinical categories . The mean bladder volume at which involuntary detrusor contractions occurred were lower in patients with urge incontinence and frequency and urgency than in those with nocturia and difficult voiding ( 277.1 + /- 149.4 and 267.7 + /- 221.7 versus 346.7 + /- 204.6 and 306.2 + /- 192.1 ml . , respectively , not statistically significant , p = 0.07 ) . CONCLUSIONS Detrusor instability and bladder outlet obstruction are common in men with lower urinary tract symptoms . The symptom of urge incontinence strongly correlated with detrusor instability . Other lower urinary tract symptoms did not correlate well with any urodynamic findings . Therefore , we believe that an accurate urodynamic diagnosis may enable focused and more efficient management of lower urinary tract symptoms in men We evaluated the efficacy of tolterodine extended release ( ER ) for patients ' most bothersome overactive bladder ( OAB ) symptom in a primary care setting . Patients with OAB symptoms for > or=3 months received tolterodine ER  ( 4 mg q.d . ) for 12 weeks . Among incontinent patients ( n = 772 ) , the most bothersome OAB symptoms were daytime frequency ( 28 % ) , urgency urinary incontinence ( UUI ; 27 % ) , nocturnal frequency ( 26 % ) and urgency ( 19 % ) ; among continent patients ( n = 91 ) , they were daytime frequency ( 47 % ) , nocturnal frequency ( 42 % ) and urgency ( 10 % ) . Sixty-nine per cent of patients had one or more comorbid conditions . By week 12 , there were significant reductions in patients ' most bothersome symptom : -80 % for UUI , -78 % for urgency episodes , -40 % for nocturnal frequency and -30 % for daytime frequency ( p < 0.0001 ) . The most common adverse events were dry mouth ( 10 % ) and constipation ( 4 % ) . In primary care practice , bothersome OAB symptoms can be effectively and safely treated with tolterodine ER , even in patients with comorbid conditions 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 OBJECTIVES We analyzed the prevalence and characteristics of  lower urinary tract symptoms ( LUTS ) in community-dwelling men aged 80 years and older . METHODS We administered the American Urological Association Symptom Index ( AUA-SI ) by mail to 291 surviving community-dwelling male participants in the Rancho Bernardo Study , a prospect i ve , community-based study of aging . We compared the prevalence , severity , and types of LUTS occurring in men who were > or = 80 years to those < 80 years . RESULTS The mean age was 74.6 years ( st and ard deviation [ SD ] 8.9 , range 48.3 - 97.1 ) . One third of the respondents were > or = 80 years . The mean total AUA-SI score increased steadily by decade of life ( P-trend = .002 ) . The prevalence of LUTS was 70 % in men > or = 80 years and 56 % in men < 80 years ( P = .03 ) . Men > or = 80 years had significantly higher mean total AUA-SI ( P = .05 ) and were more likely to complain of incomplete emptying ( odds ratio [ OR ] 2.12 , 95 % confidence interval [ CI ] 1.06 - 4.18 , P = .02 ) , frequency ( OR 1.83 , 95 % CI 1.00 - 3.31 , P = .03 ) , urgency ( OR 1.76 , 95 % CI 0.96 - 3.20 , P = .05 ) , and weak stream ( OR 1.78 , 95 % CI 1.01 - 3.12 , P = .03 ) . CONCLUSIONS In this cohort of community-dwelling men , prevalence and severity of LUTS increased into the 10th decade of life . Compared to younger men , men > or = 80 years were more likely to complain of incomplete emptying , frequency , urgency , and weak stream . Further studies of LUTS in older men are needed to better delineate these associations OBJECTIVES To evaluate the efficacy of tolterodine extended release ( ER ) , tamsulosin , and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen ( PSA ) level . METHODS We performed a post hoc analysis of data from men > or=40 years old with frequency and urgency ( with or without urge urinary incontinence ) , postvoid residual urine volume < 200 mL , maximal urinary flow rate > 5 mL/s , International Prostate Symptom Score ( IPSS ) of > or=12 , and quality -of-life score of > or=3 . They had been r and omized to placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER plus tamsulosin for 12 weeks . The men were stratified by the median baseline PSA level ( > or=1.3 vs < 1.3 ng/mL ) . Assessment s included changes in bladder diary variables and IPSSs . The men rated the urgency level of each micturition , and the frequency-urgency sum was defined as the total of these ratings . RESULTS The PSA level correlated significantly with prostate size . Men with a PSA level of > or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency , daytime frequency , the frequency-urgency sum , total IPSS , and IPSS storage score compared with those receiving placebo . Tamsulosin significantly improved the IPSS voiding scores , but tolterodine ER was ineffective . In men with a PSA level < 1.3 ng/mL , tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency , daytime frequency , frequency-urgency sum , and IPSS storage scores compared with those receiving placebo ; tamsulosin alone was ineffective . No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group , and the acute urinary retention rates were low . CONCLUSIONS The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms , including overactive bladder , who had lower PSA levels ( < 1.3 ng/mL ) OBJECTIVES To assess the efficacy , safety , and tolerability of fesoterodine 4 and 8 mg in men with overactive bladder . METHODS This was a sub analysis of pooled data from 358 men enrolled in 2 double-blind , placebo-controlled phase III trials . Subjects with frequency and urgency or urgency urinary incontinence ( UUI ) were r and omized to fesoterodine 4 mg , fesoterodine 8 mg , or placebo for 12 weeks . Efficacy endpoints included bladder diary variables and subject-reported treatment response . RESULTS By week 12 , men treated with fesoterodine 4 or 8 mg had significantly greater median percentage improvements in micturition frequency , urgency episodes , and UUI episodes versus placebo and significantly greater percentages reported a treatment response versus placebo . Significant increases in mean voided volume ( MVV ) per micturition versus placebo occurred with fesoterodine 8 mg only . At week 12 , fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg in improving UUI episodes and MVV per micturition . The most commonly reported adverse events with fesoterodine 4 and 8 mg were dry mouth ( 12.5 % and 37.7 % vs 5.6 % with placebo ) and constipation ( 2.5 % and 8.8 % vs 0.8 % with placebo ) . Symptoms suggestive of urinary retention were reported in 0.8 % , 0.8 % , and 5.3 % of men in the placebo , fesoterodine 4 mg , and fesoterodine 8 mg groups , respectively ; only 1 subject , in the fesoterodine 8 mg group , was catheterized . CONCLUSIONS Fesoterodine 4 and 8 mg are generally safe , efficacious , and well tolerated for the treatment of overactive bladder symptoms in men . The 8 mg dose provides additional benefit and allows for treatment individualization BACKGROUND Some men with lower urinary tract symptoms ( LUTS ) including overactive bladder ( OAB ) symptoms may benefit from antimuscarinic therapy , with or without an alpha-adrenergic antagonist . OBJECTIVES To evaluate the safety and efficacy of tolterodine extended release ( ER ) , tamsulosin , or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials , stratified by prostate size . DESIGN , SETTING , AND PARTICIPANTS Subjects with an International Prostate Symptom Score ( IPSS ) > or=12 ; frequency and urgency , with or without urgency urinary incontinence ; postvoid residual volume ( PVR ) < 200 mL ; and maximum urinary flow rate ( Q(max ) ) > 5 mL/s were r and omized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER+tamsulosin for 12 wk . Data were stratified by median baseline prostate volume ( < 29 mL vs > or=29 mL ) . MEASUREMENTS Endpoints included week 12 changes in bladder diary variables , IPSS scores , and safety variables . RESULTS AND LIMITATIONS Among men with larger prostates , tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) ; urgency ( p=0.006 ) ; and IPSS total ( p=0.001 ) , storage ( p<0.001 ) , and voiding scores ( p<0.013 ) . Tamsulosin significantly improved IPSS voiding scores ( p=0.030 ) . Among men with smaller prostates , tolterodine ER significantly improved frequency ( p=0.016 ) , UUI episodes ( p=0.036 ) , and IPSS storage scores ( p=0.005 ) . Tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) and IPSS storage scores ( p=0.018 ) . Tamsulosin significantly improved nocturnal frequency ( p=0.038 ) and IPSS voiding ( p=0.036 ) and total scores ( p=0.044 ) . There were no clinical ly or statistically significant changes in Q(max ) or PVR ; incidence of acute urinary retention ( AUR ) was low in all groups ( < or=2 % ) . CONCLUSIONS Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER . Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size . Tolterodine ER , with or without tamsulosin , was well tolerated and not associated with increased incidence of AUR
target: 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 .
background: Despite potential benefits , primary care clinicians may avoid using antimuscarinics in men with overactive bladder ( OAB ) symptoms because of safety concerns .