The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. 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. Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin: a randomized, placebo-controlled trial Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Impact of a health education intervention in overactive bladder patients. 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 Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients. Symptom-specific efficacy of tolterodine extended release in patients with overactive bladder: the IMPACT trial. Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction. Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER) Clinical efficacy and tolerability of extended‐release tolterodine and immediate‐release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo‐controlled trial Dose and aging effect on patients reported treatment benefit switching from the first overactive bladder therapy with tolterodine ER to fesoterodine: post-hoc analysis from an observational and retrospective study Reduced Perception of Urgency in Treatment of Overactive Bladder With Extended‐Release Tolterodine Treatment of Overactive Bladder with Once-daily Extended-release Tolterodine or Oxybutynin: The Antimuscarinic Clinical Effectiveness Trial (ACET) Tolterodine: a safe and effective treatment for older patients with overactive bladder.
AIM To determine the efficacy of toterodine extended release ( ER ) treatment for 1 year in older men with benign prostatic hyperplasia ( BPH ) and storage symptoms treated with alpha-blockers and /or 5-alpha-reductase inhibitors ( 5ARI ) .  METHODS Men aged over 70 years with BPH/bladder outlet obstruction ( BOO ) and clinical storage symptoms were r and omly treated with or without tolterodine ER in combination with alpha-blockers and /or 5ARI for 12 months . Among them , 50 patients ( group 1 ) received additive tolterodine extended release ( ER ) 4 mg q.d . , another 87 patients ( group 2 ) did not . All patients had a baseline and 12th month post-treatment evaluation , which comprised of uroflowmetry , post-void residual ( PVR ) volume , International Prostate Symptom Score ( IPSS ) , and quality of life index ( QoL-I ) , transrectal ultrasound of the prostate and serum prostate specific antigen . RESULTS One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study . Treatment benefit demonstrated in both groups included deceased total , voiding and storage IPSS scores , increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score ( P = 0.012 ) . The mean PVR after treatment did not significantly differ between two groups . Two patients of group 1 and three of group 2 developed acute urinary retention . Among group 1 , six patients discontinued tolterodine ER for intolerable dry mouth ; among group 2 , three patients reported dizziness . CONCLUSIONS This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option 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 Overactive bladder ( OAB ) has a significant impact on a patient ’s health-related quality of life ( HRQoL ) . This study assessed the HRQoL of Japanese OAB patients following 12 weeks ’ treatment with tolterodine extended release ( ER ) or oxybutynin .  A total of 293 patients with symptoms of OAB were r and omized for treatment with tolterodine ER 4 mg once daily ( n=114 ) , oxybutynin 3 mg three times daily ( n=122 ) or a placebo ( n=57 ) . Treatment efficacy and safety assessment s were made over the 12-week period . HRQoL was assessed using the King ’s Health Question naire ( KHQ ) . Patients receiving tolterodine ER or oxybutynin showed a significant ( P<0.05 ) improvement in the Incontinence Impact , Role Limitations and most other KHQ domains compared with the placebo . These changes in HRQoL corresponded with significant ( P<0.05 ) improvements in micturition diary variables for patients receiving tolterodine ER and oxybutynin compared with placebo . Our findings demonstrate that Japanese OAB patients receiving tolterodine ER or oxybutynin experienced overall improvement in their quality of life 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 To assess a st and ardized and simple educational intervention in overactive bladder ( OAB ) patients to improve compliance with anticholinergic medication , increase the use of concomitant behavioral treatments , and improve patients ' perception of bladder symptoms . MATERIAL S AND METHODS This is a 16-week open-label r and omized trial of tolterodine combined with an education intervention for the experimental group versus tolterodine alone ( no intervention ) for the control group . The setting was in family medicine and urology clinics in Ontario . The participants were male and female adults with OAB symptoms . Both groups received tolterodine prescriptions . The intervention patients received printed information and an explanation about OAB , medication use , and behavioral treatments ( kegel exercise , bladder stretching , fluid regulation ) . The primary outcomes were medication compliance and persistence at 16 weeks . Secondary outcomes were use of behavioral treatments and self-reported severity of symptoms . RESULTS More patients in the intervention group ( experimental ) purchased their prescriptions ( p<0.05 ) . Compliance rate was greater for the intervention group ( 39 % ) , versus the control group ( 31 % ) at 16 weeks although the difference was not significant ( p>0.05 ) . Significantly more patients started and /or continued non-drug treatments in the intervention group ( 82 % ) compared to the control group ( 53 % ) ( p<0.05 ) . Furthermore , more patients in this group reported improvement in severity of bladder symptoms ( p<0.05 ) . CONCLUSIONS The simple education intervention result ed in a greater , but not significant , increase in compliance with medication compared to the control group . It also result ed in a significantly increased use of behavior modification therapies and better self-perception of treatment outcome 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 OBJECTIVES To evaluate the efficacy , safety , and tolerability of a new , once-daily extended-release ( ER ) formulation of tolterodine in treating overactive bladder in older ( > or = 65 ) and younger ( < 65 ) patients . DESIGN A 12-week double-blind , placebo-controlled clinical trial . SETTING An international study conducted at 167 medical centers . PARTICIPANTS One thous and fifteen patients ( 43.1 % aged > or = 65 ) with urge incontinence and urinary frequency . INTERVENTION Patients were r and omized to treatment with tolterodine ER 4 mg once daily ( qd ) ( n = 507 ) or placebo ( n = 508 ) for 12 weeks . MEASUREMENTS Efficacy , measured with micturition charts ( incontinence episodes , micturitions , volume voided per micturition ) and subjective patient assessment s , safety , and tolerability endpoints were evaluated , relative to placebo , according to two age cohorts : younger than 65 and 65 and older . RESULTS  Mean age in the older and younger patient cohorts was 74 ( range 65 - 93 ) and 51 ( range 20 - 64 ) , respectively . Compared with placebo , significant improvements in micturition chart variables with tolterodine ER showed no age-related differences . Irrespective of age , significantly more tolterodine ER recipients than placebo recipients reported an improvement in urgency symptoms . After 12 weeks of treatment with tolterodine ER , a fivefold increase in the percentage of patients able to finish tasks before voiding in response to urgency was noted in both age groups ( < 65 : from 6.5 - 32.8 % , > or = 65 : from 5.1 - 26.2 % ) . Tolterodine ER recipients , irrespective of age , also had significant improvements in their bladder condition than did placebo recipients . Overall , a greater percentage of patients , irrespective of age , perceived any benefit with tolterodine ER than with placebo ( P < .001 ) . Dry mouth ( of any severity ) was the most common adverse event in both the tolterodine ER and placebo treatment arms , irrespective of age ( < 65 : ER 22.7 % , placebo 8.1 % ; > or = 65 : ER 24.3 % , placebo 7.2 % ) . Few patients ( < 2 % ) experienced severe dry mouth . No central nervous system , visual , cardiac ( per electrocardiogram ) , or laboratory safety concerns were noted . Withdrawal rates due to adverse events on tolterodine ER 4 mg qd were comparable in the two age cohorts ( < 65 : 5.5 % ; > or = 65 : 5.1 % ; P = .87 ) . CONCLUSIONS The new , once-daily ER formulation of tolterodine is efficacious , safe , and well tolerated in the treatment of patients with symptoms of overactive bladder , irrespective of age 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 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 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 Background The PREFER study was an assessment of medication tolerability , treatment preference and symptom improvement during treatment with mirabegron ( M ) and tolterodine ( T ) extended release ( ER ) in patients with overactive bladder ( OAB ) . In this analysis of PREFER , patient-reported outcomes ( PROs ) were assessed during treatment . Methods PREFER was a two-period , 8-week crossover , double-blind , phase IV study ( NCT02138747 ) of treatment-naïve adults with OAB ≥3 months r and omized to 1 of 4 treatment sequences ( M/T ; T/M ; M/M ; T/T ) , separated by a 2-week washout . Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks . At each visit , PROs related to treatment satisfaction , quality of life and symptom bother were assessed using the OAB Satisfaction ( OAB-S ; 3 independent scales/5 single-item overall assessment s ) , OAB-q ( total health-related QoL [ HRQoL ] and subscales [ Sleep , Social , Coping , Concern ] and Symptom Bother scale ) and Patient Perception of Bladder Condition ( PPBC ) question naires . Responder rates were reported for OAB-q subscales based on a minimal important difference ( MID ; ≥ 10-point improvement ) and OAB-S Medication Tolerability score ≥ 90 . Results In total , 358 r and omized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value ( OAB-S scale , OAB-q , PPBC ) : M/T ( n = 154 ) , T/M ( n = 144 ) , M/M ( n = 30 ) or T/T ( n = 30 ) . At end of treatment ( EoT ) , mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated , OAB-q scales and PPBC . A higher percentage of patients achieved clinical ly relevant improvements ( MID ) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER . Conclusions On average , patients with OAB experienced improvements in treatment satisfaction , HRQoL and symptom bother that were of a similar magnitude during treatment with mirabegron or tolterodine ER . However , during mirabegron treatment , patients were more likely to achieve clinical ly relevant improvements in tolerability and HRQoL ( as measured by the MID for the OAB-q or an OAB-S Medication Tolerability score ≥ 90 ) than during tolterodine ER treatment . Trial registration NCT02138747 ; registered May 13 , 2014 To compare extended‐release ( ER ) tolterodine and immediate‐release ( IR ) oxybutynin with placebo in Japanese and Korean patients with an overactive bladder ( OAB ) Background Previous r and omized studies have demonstrated that fesoterodine significantly improves the Overactive Bladder ( OAB ) symptoms and their assessment by patients compared with tolterodine extended-release ( ER ) . This study aim ed to assess the effect of aging and dose escalation on patient-reported treatment benefit , after changing their first Overactive Bladder ( OAB ) therapy with tolterodine-ER to fesoterodine in daily clinical practice . Methods A post-hoc analysis of data from a retrospective , cross-sectional and observational study was performed in a cohort of 748 OAB adults patients ( OAB-V8 score ≥8 ) , who switched to fesoterodine from their first tolterodine-ER-based therapy within the 3–4 months before study visit . Effect of fesoterodine doses ( 4 mg vs. 8 mg ) and patient age ( < 65 yr vs. ≥65 yr ) were assessed . Patient reported treatment benefit [ Treatment Benefit Scale ( TBS ) ] and physician assessment of improvement with change [ Clinical Global Impression of Improvement subscale ( CGI-I ) ] were recorded . Treatment satisfaction , degree of worry , bother and interference with daily living activities due to urinary symptoms were also assessed . Results Improvements were not affected by age . Fesoterodine 8 mg vs. 4 mg provides significant improvements in terms of treatment benefit [ TBS 97.1 % vs. 88.4 % , p < 0.001 ; CGI-I 95.8 % vs. 90.8 % p < 0.05 ) ] , degree of worry , bother and interference with daily-living activities related to OAB symptoms ( p < 0.05 ) . Conclusions A change from tolterodine ER therapy to fesoterodine with dose escalation to 8 mg in symptomatic OAB patients , seems to be associated with greater improvement in terms of both patient-reported-treatment benefit and clinical global impression of change . Improvement was not affected by age OBJECTIVE To evaluate the effect of once-daily , extended-release tolterodine on urinary urgency in patients with overactive bladder . METHODS Patients with urinary frequency ( eight or more micturitions per 24 hours ) and urge incontinence ( five or more episodes per week ) were r and omized to oral treatment with tolterodine extended release 4 mg once daily ( n = 398 ) or placebo ( n = 374 ) for 12 weeks . Efficacy was assessed by use of patient perception evaluations . RESULTS The results presented are a secondary analysis of this double-blind , placebo-controlled study . Of patients treated with tolterodine extended release , 44 % reported improved urgency symptoms ( compared with 32 % for placebo ) , and 62 % reported improved bladder symptoms ( placebo , 48 % ) ( both P < .001 compared with placebo ) . The odds of reducing urgency and improving bladder symptoms were 1.68 and 1.78 times greater , respectively , for patients in the tolterodine extended release group than for patients receiving placebo . In response to urgency , there was a more than six-fold increase in the proportion of patients able to finish a task before voiding in the tolterodine extended release group . The proportion of patients unable to hold urine upon experiencing urgency was also decreased by 58 % with tolterodine , compared with 32 % with placebo ( P < .001 ) . The proportion of patients reporting “ much benefit ” from treatment was greater for tolterodine extended release than for placebo ( 43 % versus 24 % ; P < .001 ) . The only adverse events with an incidence of greater than 5 % were dry mouth , headache , and constipation , with only dry mouth markedly more frequent with tolterodine than with placebo . CONCLUSION Tolterodine extended release has demonstrable efficacy in reducing the severity of urinary urgency and is associated with improvements in overactive bladder symptoms that are meaningful to patients Summary Treatment with the antimuscarinic agents tolterodine and oxybutynin is the mainstay of therapy for overactive bladder , a chronic and debilitating condition characterized by urinary urgency with or without urge incontinence , usually in combination with urinary frequency and nocturia . This study consisted of two trials ; in one , patients with overactive bladder were r and omized to 8 weeks of open-label treatment with either 2 mg or 4 mg of once-daily extended-release tolterodine ( TER ) , and in the other to 5 mg or 10 mg of extended-release oxybutynin ( OER ) . The study protocol and design were identical for the two trials and site selection ensured that there was no bias in either trial for the tendency of investigators to prescribe one drug rather than the other , or for geographical location . A total of 1289 patients were enrolled , 669 in the tolterodine trial ( TER 2 mg , n = 333 ; TER 4 mg , n = 336 ) and 620 in the oxybutynin trial ( OER 5 mg , n = 313 ; OER 10 mg , n = 307 ) . Fewer patients prematurely withdrew from the trial in the TER 4 mg group ( 12 % ) than either the OER 5 mg ( 19 % ; p = 0.01 ) or OER 10 mg groups ( 21 % ; p = 0.002 ) . More patients in the OER 10 mg group than the TER 4 mg group withdrew because of poor tolerability ( 13 % vs 6 % ; p = 0.001 ) . After 8 weeks , 70 % of patients in the TER 4 mg group perceived an improved bladder condition , compared with 60 % in the TER 2 mg group , 59 % in the OER 5 mg group and 60 % in the OER 10 mg group ( all p < 0.01 vs TER 4 mg ) . Response to therapy was greater in a subgroup of patients whose perception of bladder condition was moderate to severe at baseline ( TER 4 mg 77 % vs OER 10 mg 65 % ; p < 0.01 ) . Dry mouth was dose-dependent with both agents , although differences between doses only reached statistical significance in the oxybutynin trial ( OER 5 mg vs OER 10 mg ; p = 0.05 ) . Patients treated with TER 4 mg reported a significantly lower severity of dry mouth compared with OER 10 mg . In conclusion , the greater efficacy and tolerability of tolterodine ER 4 mg suggests improved clinical effectiveness compared with oxybutynin ER 10 mg OBJECTIVE To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder . DESIGN R and omized , double-blind , placebo-controlled , parallel-group , multinational , phase III study . SETTING Incontinence , older care , urological , and urogynecological clinics in the United Kingdom , France , and the Republic of Irel and . PARTICIPANTS One hundred and seventy-seven older patients ( age > or = 65 years ) with symptoms of urinary urgency , increased frequency of micturition ( > or = 8 micturitions/24 hours ) , and /or urge incontinence ( > or = 1 episode/24 hours ) . INTERVENTION Tolterodine 1 mg or 2 mg twice daily ( bid ) , or placebo , for 4 weeks . MEASUREMENTS Safety and tolerability were evaluated through spontaneously reported adverse events , electrocardiogram , and blood pressure measurements . Efficacy was assessed using micturition diary variables : mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours . RESULTS The mean age of the patient population was 75 years . Overall , > or = 87 % of patients completed the study . Neither dosage of tolterodine was associated with serious drug-related adverse events during the study . No cardiac arrythmogenic events were noted . Dry mouth ( mild to moderate intensity ) was the most common adverse event in both the placebo and tolterodine treatment groups . Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth , compared with 2 % of placebo-treated patients . Compared with placebo , statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups . Furthermore , patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo . CONCLUSION Tolterodine ( taken for 4 weeks ) is safe and shows efficacy , particularly at a dosage of 2 mg bid , in the treatment of older patients with urinary symptoms attributable to overactive bladder
The efficacy and tolerability of tolterodine ER Vs .
A recent meta- analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h , urinary leakage episodes/24 h , urgency episodes/24 h , and urgency incontinence episodes/24 h. With regard to adverse events , tolterodine ER was associated with a good adverse event profile result ing in the third most favorable antimuscarinic .
Conclusion Tolterodine ER result ed effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS .
Dry mouth and constipation are the most frequently reported adverse events
Background Overactive bladder (OAB)/ storage lower urinary tract symptoms ( LUTS ) have a high prevalence affecting up to 90 % of men over 80 years .
The role of sufficient therapies appears crucial .
In the present review , we analyzed the mechanism of action of tolterodine extended-release ( ER ) with the aim to clarify its efficacy and safety profile , as compared to other active treatments of OAB/storage LUTS .
Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS ; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment .