[Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder]. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial. Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence. Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder. Safety and efficacy of mirabegron as ‘add‐on’ therapy in patients with overactive bladder treated with solifenacin: a post‐marketing, open‐label study in Japan (MILAI study) Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency. OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study) Phase III, randomised, double‐blind, placebo‐controlled study of the β3‐adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder Clinical Efficacy and Safety of Tolterodine Compared to Oxybutynin and Placebo in Patients with Overactive Bladder Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. Simplified bladder training augments the effectiveness of tolterodine in patients with an overactive bladder Tolterodine: as effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder. A randomized controlled study of the efficacy of tamsulosin monotherapy and its combination with mirabegron for overactive bladder induced by benign prostatic obstruction. A randomized controlled trial of tolterodine and oxybutynin on tolerability and clinical efficacy for treating Chinese women with an overactive bladder An investigation of dose titration with darifenacin, an M3‐selective receptor antagonist A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? Randomized Controlled Trial to Treat Benign Prostatic Hyperplasia with Overactive Bladder Using an Alpha-blocker Combined with Anticholinergics. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder Long‐term treatment with darifenacin for overactive bladder: results of a 2‐year, open‐label extension study Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Tolterodine in the treatment of overactive bladder: analysis of the pooled phase II efficacy and safety data. Treating Overactive Bladder in Older Patients with a Combination of Mirabegron and Solifenacin: A Prespecified Analysis from the BESIDE Study. Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Dose-escalating study of the pharmacokinetics and tolerability of fesoterodine in children with overactive bladder. 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 once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. 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 The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial. Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary. Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Comparison of Silodosin and Naftopidil for Efficacy in the Treatment of Benign Prostatic Enlargement Complicated by Overactive Bladder: A Randomized, Prospective Study (SNIPER Study) The combination of herbal medicine Weng-li-tong with Tolterodine may be better than Tolterodine alone in the treatment of overactive bladder in women: a randomized placebo-controlled prospective trial Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis. Fesoterodine dose response in subjects with overactive bladder syndrome. A comparison of the efficacy of darifenacin alone vs. darifenacin plus a Behavioural Modification Programme upon the symptoms of overactive bladder A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Efficacy and tolerability of fesoterodine in men with overactive bladder: a pooled analysis of 2 phase III studies. Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. Refractory idiopathic urge urinary incontinence and botulinum A injection. Efficacy and tolerability of fesoterodine in women with overactive bladder Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation A multicenter, double-blind, randomized, placebo controlled trial of a neurokinin-1 receptor antagonist for overactive bladder. Conventional and ambulatory urodynamic findings in women with symptoms suggestive of bladder overactivity. Efficacy and Safety of Tol Terodine in People With Neurogenic Detrusor Overactivity Efficacy and safety of propiverine and terazosine combination for one year in male patients with luts and detrusor overactivity. Efficacy of antimuscarinic therapy for overactive bladder with varying degrees of incontinence severity. [Treatment of overactive bladder with sodium chondroitin sulphate]. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction. Pharmacokinetics, Efficacy, and Safety of Intravesical Formulation of Oxybutynin in Patients with Detrusor Overactivity Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study [Posterior tibial nerve stimulation in the management of overactive bladder: a prospective and controlled study]. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study Intravesical atropine compared to oral oxybutynin for neurogenic detrusor overactivity: a double-blind, randomized crossover trial. Dose response with darifenacin, a novel once-daily M3 selective receptor antagonist for the treatment of overactive bladder: results of a fixed dose study Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder Time to onset of improvement in symptoms of overactive bladder using antimuscarinic treatment Tolterodine: a safe and effective treatment for older patients with overactive bladder. Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women. Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapy: Responder Analyses and Patient-Reported Outcomes from the BESIDE Study [corrected]. A randomized, double-blind, placebo- and propiverine-controlled trial of the novel antimuscarinic agent imidafenacin in Japanese patients with overactive bladder.
OBJECTIVE To compare the efficacy and safety of tolterodine and oxybutynin in the treatment of idiopathic overactive bladder in children . METHODS A total of 204 children with idiopathic overactive bladder were r and omly divided into three groups ( n=68 each ) : placebo , tolterodine-treated and oxybutynin-treated . The efficacy and safety were evaluated two weeks after treatment . RESULTS The effective rate was 25 % in the placebo group , 89 % in the tolterodine-treated group , and 92 % in the oxybutynin-treated group . The effective rate in the two treatment groups was significantly higher than that in the placebo group ( P<0.05 ) . There was a similar efficacy between the two treatment groups . The incidence of adverse events in the tolterodine-treated group ( 28 % ) was significantly lower than that in the oxybutnin-treated group ( 57 % ) ( P<0.05 ) . CONCLUSIONS Tolterodine has a similar efficacy to oxybutynin in the treatment of idiopathic overactive bladder in children , with better safety in pharmacotherapy PURPOSE We evaluated the efficacy , tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome . MATERIAL S AND METHODS This was a r and omized , double-blind , placebo controlled , multicenter trial performed in the United States . Overall 836 subjects with urinary frequency , urinary urgency or urgency urinary incontinence were r and omized to placebo ( 274 ) , 4 mg fesoterodine ( 283 ) or 8 mg fesoterodine ( 279 ) once daily for 12 weeks . The primary efficacy end point was the change in the number of micturitions per 24 hours . Co- primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response . Secondary efficacy end points were other bladder diary variables , such as the change in mean voided volume per micturition , number of continent days and number of urgency episodes per 24 hours . Tolerability and safety were assessed by evaluating adverse events , electrocardiograms , post-void residual urine volume , laboratory parameters and treatment withdrawals . RESULTS Treatment with 4 or 8 mg fesoterodine result ed in statistically significant and clinical ly relevant improvements from baseline to end of treatment for the primary and co- primary end points compared with placebo ( p < 0.05 ) . Results for most secondary end points , including mean voided volume per micturition , number of continent days and number of urgency episodes per 24 hours , were also significantly improved vs placebo . The adverse events reported more frequently with fesoterodine than with placebo were dry mouth , constipation and urinary tract infection . CONCLUSIONS The 2 doses of fesoterodine were well tolerated and they statistically significantly improved overactive bladder symptoms PURPOSE Treatment options for patients with overactive bladder refractory to anticholinergics are limited . We assessed the dose response across a range of doses of onabotulinumtoxinA ( BOTOX ® ) in patients with idiopathic overactive bladder and urinary urgency incontinence whose symptoms were not adequately managed with anticholinergics .  MATERIAL S AND METHODS In a phase 2 , multicenter , r and omized , double-blind study , 313 patients with idiopathic overactive bladder and urinary urgency incontinence experiencing 8 or more urinary urgency incontinence episodes a week and 8 or more micturitions daily at baseline received 50 , 100 , 150 , 200 or 300 U intradetrusor onabotulinumtoxinA , or placebo . Symptoms were recorded using a 7-day bladder diary . The primary efficacy variable was weekly urinary urgency incontinence episodes and the primary end point was week 12 . RESULTS Demographics and baseline characteristics were balanced across the treatment groups . Durable efficacy was observed for all onabotulinumtoxinA dose groups of 100 U or greater for primary and secondary efficacy measures , including the proportion of incontinence-free patients . When the dose response curves were analyzed , doses greater than 150 U contributed minimal additional or clinical ly relevant improvement in symptoms . This finding was also reflected in health related quality of life assessment s. Dose dependent changes in post-void residual urine volume were observed and the use of clean intermittent catheterization was also dose dependent . The only adverse events significantly greater with onabotulinumtoxinA than with placebo were urinary tract infection and urinary retention . CONCLUSIONS OnabotulinumtoxinA at doses of 100 U or greater demonstrated durable efficacy in the management of idiopathic overactive bladder and urinary urgency incontinence . A dose of 100 U may be the dose that appropriately balances the symptom benefits with the post-void residual urine volume related safety profile PURPOSE An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder . We investigated the safety , efficacy and tolerability of 60 mg trospium chloride once daily . MATERIAL S AND METHODS Subjects with overactive bladder were r and omized 1:1 to receive 60 mg trospium chloride once daily or placebo in this 12-week multicenter , parallel , double-blind , placebo controlled trial . Primary end points were calculated changes in diary recorded daily urinary frequency and daily urgency urinary incontinence episodes . Secondary end points were urgency severity , volume voided per void and the number of urgency voids per day . Safety was assessed by clinical examination , adverse event monitoring , clinical laboratory values and resting electrocardiograms . RESULTS Overall 601 subjects were prescribed  trospium once daily ( 298 ) or placebo ( 303 ) . Trospium once daily treatment result ed in significant improvements over placebo in all primary and key secondary efficacy outcomes at weeks 1 through 12 . The most common adverse events were dry mouth  ( trospium 8.7 % vs placebo 3 % ) and constipation  ( trospium 9.4 % vs placebo 1.3 % ) . Central nervous system adverse events were rare ( headache with trospium 1.0 % vs placebo 2.6 % ) . No clinical ly meaningful changes in laboratory , physical examination or electrocardiogram parameters were noted . CONCLUSIONS Trospium once daily provided significant improvements in overactive bladder symptoms ( frequency , urgency urinary incontinence and urgency ) . Efficacy was similar to that seen previously with trospium chloride twice daily , while class effect anticholinergic adverse events occurred at comparatively low levels . Dry mouth was elicited at the lowest reported rate in the oral antimuscarinic drug class PURPOSE Although antimuscarinic treatment is indicated for overactive bladder , many patients discontinue it because of dry mouth . Of available antimuscarinics oxybutynin is associated with the highest dry mouth rate . We compared the safety and tolerability of 5 mg solifenacin vs 15 mg oxybutynin immediate release . MATERIAL S AND METHODS At 12 Canadian centers a total of 132 patients with overactive bladder symptoms ( greater than 1 urgency episode per 24 hours , and 8 or greater micturitions per 24 hours ) were r and omized to 5 mg solifenacin once daily or 5 mg oxybutynin 3 times daily for 8 weeks . The primary end point was the incidence and severity of dry mouth reported after direct question ing . Efficacy end points ( 3-day diary documented changes in urgency , frequency , incontinence , nocturia and voided volume ) , and changes on the Patient Perception of Bladder Condition scale and the Overactive Bladder Question naire were evaluated secondarily . RESULTS Of patients on solifenacin vs oxybutynin immediate release 35 % vs 83 % reported dry mouth ( p < 0.0001 ) . Of patients reporting dry mouth severity was grade d moderate by 13 % and 42 % of those on solifenacin and oxybutynin immediate release , and severe by 13 % and 28 % , respectively ( p = 0.001 ) . Patients in each group showed improvements in efficacy end points , and Patient Perception of Bladder Condition scale and Overactive Bladder Question naire scores from baseline to treatment end . CONCLUSIONS Significantly fewer patients on 5 mg solifenacin once daily reported dry mouth vs those receiving 5 mg oxybutynin immediate release 3 times daily . Significantly fewer patients on solifenacin reported moderate/severe dry mouth . Significantly fewer patients on solifenacin withdrew from study due to dry mouth and there were significantly fewer overall adverse events .  Solifenacin and oxybutynin immediate release were efficacious in decreasing efficacy end points , and improved Patient Perception of Bladder Condition scale and Overactive Bladder Question naire results from baseline to treatment end PURPOSE The purpose of this study was to evaluate the efficacy and safety of onabotulinumtoxinA injections at bladder base/trigone and compare with injections at bladder body or bladder body/trigone for the treatment of idiopathic detrusor overactivity ( IDO ) refractory to antimuscarinics . MATERIAL S AND METHODS A single blind , r and omized , paralleled , actively controlled trial was performed in patients with urodynamically proven IDO who failed antimuscarinic therapy . Patients were r and omly assigned to receive intravesical injections of 100 U of onabotulinumtoxinA into three different bladder sites . All treatments were evaluated by voiding diary variables , urgency severity score , urodynamic studies , and patient perception of bladder condition . Long-term success rates over 12 months were also determined . RESULTS Among the patients , 37 were r and omized to injections in the bladder body , 35 into the bladder body/trigone , and 33 into the bladder base/trigone . Successful results were reported in 76 ( 72 % ) patients at 3 months : 26 ( 70 % ) in the bladder body group , 26 ( 74 % ) in the bladder body/trigone group , and 24 ( 73 % ) in the bladder base/trigone group . There were no significant differences in success rates , changes in urgency and urgency incontinence episodes , urodynamic variables , or long-term success rates among the three subgroups . The incidence of adverse events was similar among three groups . No vesicoureteral reflux was noted in all patients with or without involving trigone injection . CONCLUSION Intravesical onabotulinumtoxinA injection is an effective treatment for IDO regardless of the bladder injection site . Bladder base/trigone injection is as safe and effective as bladder body injections with or without trigone involvement PURPOSE Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects . Mirabegron , a β3-adrenoceptor agonist , may offer an effective and well tolerated alternative treatment for overactive bladder . MATERIAL S AND METHODS A r and omized , double-blind , placebo controlled trial was conducted in the United States and Canada . After a 2-week placebo run-in period , adults with overactive bladder symptoms for 3 or more months were r and omized 1:1:1 to receive placebo , 50 or 100 mg mirabegron once daily for 12 weeks . Efficacy data were collected via patient completed diaries and quality of life assessment s. Co- primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours . Key secondary micturition and incontinence end points were also evaluated . Safety assessment s included treatment emergent adverse events , laboratory assessment s , vital signs , electrocardiograms and post-void residual volume . RESULTS Compared to placebo , 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases ( 95 % CI ) from baseline for incontinence episodes ( -1.13 [ -1.35 , -0.91 ] , -1.47 [ -1.69 , -1.25 ] and -1.63 [ -1.86 , -1.40 ] ) and micturitions ( -1.05 [ -1.31 , -0.79 ] , -1.66 [ -1.92 , -1.40 ] and -1.75 [ -2.01 , -1.48 ] ) per 24 hours ( p < 0.05 ) . Significant improvements in all key secondary end points were observed for both mirabegron doses vs placebo . The incidence of frequently reported treatment emergent adverse events ( hypertension , urinary tract infection , headache , nasopharyngitis ) was similar in the mirabegron and placebo groups . Dry mouth was reported for 1.5 % , 0.5 % and 2.1 % of patients in the placebo , 50 and 100 mg mirabegron groups , respectively . CONCLUSIONS Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects PURPOSE We compared the tolerability and clinical efficacy of tolterodine with those of oxybutynin in patients with an overactive bladder using an upward oxybutynin dose titration strategy analogous to that used in routine clinical practice in the United Kingdom and Republic of Irel and . MATERIAL S AND METHODS In a r and omized double-blind trial 378 male and female patients 50 years old or older with symptoms of overactive bladder ( a urinary frequency of 8 or more voids per 24 hours with urgency and /or urge incontinence , that is 1 or more urge incontinence episodes per 24 hours ) received 10 weeks of treatment with 2 mg . tolterodine twice daily/or an initial dose of 2.5 mg . oxybutynin twice daily , increasing to 5 mg . twice daily after 2 weeks of treatment . The main outcome measures were changes in voiding diary variables combined with detailed tolerability-safety assessment s. RESULTS Patients treated with tolterodine had significantly fewer adverse events ( 69 % versus 81 % , p = 0.01 ) , notably dry mouth ( 37 % versus 61 % , p < 0.0001 ) , as well as a lower incidence of dose reduction ( 6 % versus 25 % , p < 0.0001 ) than those in the oxybutynin group . Each agent had comparable efficacy for improving urinary symptoms .  Tolterodine and oxybutynin caused a significant decrease ( p = 0.0001 ) in the mean number of voids per 24 hours ( -1.7 or -15 % and -1.7 or -15 % , respectively ) , urge incontinence episodes per 24 hours ( -1.3 or -54 % and -1.8 or -62 % , respectively ) and mean voided volume per void ( 33 ml . or 22 % and 34 ml . or 23 % ) after 10 weeks of treatment . CONCLUSIONS Tolterodine is as effective as oxybutynin for improving the symptoms of overactive bladder but it has superior tolerability . The combination of these qualities makes tolterodine the preferred pharmacological therapy for the long-term treatment of this condition PURPOSE We evaluated the efficacy and safety of an oxybutynin transdermal delivery system ( TDS ) in a general population of patients with overactive bladder and urge or mixed urinary incontinence . MATERIAL S AND METHODS Following symptom stabilization or treatment withdrawal 520 adult patients were r and omized to 12 weeks of double-blind daily treatment with 1.3 , 2.6 or 3.9 mg . oxybutynin TDS or placebo administered twice weekly , followed by a 12-week open-label , dose titration period to assess efficacy and safety further . Evaluations included patient urinary diaries , incontinence specific quality of life and safety . RESULTS A dose of 3.9 mg . daily oxybutynin TDS significantly reduced the number of weekly incontinence episodes ( median change -19.0 versus -14.5 , p = 0.0165 ) , reduced average daily urinary frequency ( mean change -2.3 versus -1.7 , p = 0.0457 ) , increased average voided volume ( median change 24 versus 6 ml . , p = 0.0063 ) and significantly improved quality of life ( Incontinence Impact Question naire total score , p = 0.0327 ) compared with placebo . Average voided volume increased in the daily 2.6 mg . group ( 19 ml . , p = 0.0157 ) but there were no other significant differences between 1.3 and 2.6 mg . oxybutynin TDS and placebo . The most common adverse event was application site pruritus  ( oxybutynin TDS 10.8 % to 16.8 % , placebo 6.1 % ) . Dry mouth incidence was similar in both groups ( 7.0 % versus 8.3 % , p not significant ) . In the open-label period a sustained reduction of nearly 3 incontinence episodes per day was reported for all groups . CONCLUSIONS Doses of 2.6 and 3.9 mg . oxybutynin TDS daily improve overactive bladder symptoms and quality of life , and are well tolerated . Transdermal oxybutynin is an innovative new treatment for overactive bladder OBJECTIVE To evaluate the efficacy , safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder . STUDY DESIGN A double-blind , multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms , and urodynamically verified detrusor overactivity , were r and omised to receive 4-week treatment with either placebo or tolterodine 1 or 2 mg twice daily ( bd ) . Efficacy was evaluated from patient micturition diaries . Safety and tolerability endpoints were also evaluated . RESULTS After 4-week treatment , the number of incontinence episodes/24h decreased significantly relative to placebo in the tolterodine 1 and 2 mgbd groups ( P=0.045 and P=0.0089 , respectively ) . Both dosages of tolterodine increased volume voided per micturition compared with placebo ( P=0.055 and P=0.056 , respectively ) , although significant decreases in micturition frequency were not apparent . Tolterodine was safe and well tolerated , few patients were withdrawn due to adverse events . Dry mouth , mainly of mild-to-moderate intensity , was the most common adverse event . No clinical ly relevant changes in blood pressure or laboratory safety variables were reported . CONCLUSION Tolterodine is effective , safe and well tolerated for the treatment of symptoms of an overactive bladder , particularly urge incontinence To examine the safety and efficacy of mirabegron as ‘ add‐on ’ therapy to solifenacin in patients with overactive bladder ( OAB ) PURPOSE Awakening from sleep to urinate is the hallmark of nocturia , a condition that impacts several facets of health related quality of life and for which current therapy is suboptimal . Given the paucity of prospect i ve data on antimuscarinics for the management of nocturia , we investigated the efficacy and safety of flexible dose fesoterodine for the treatment of nocturnal urgency in subjects with nocturia and overactive bladder . MATERIAL S AND METHODS Subjects with 2 to 8 nocturnal urgency episodes per 24 hours began a 2-week , single-blind , placebo run-in followed by 1:1 r and omization to 12 weeks of double-blind treatment with fesoterodine ( 4 mg daily for 4 weeks with an optional increase to 8 mg ) or placebo using predefined criteria for nocturnal urgency episodes , nocturnal urine volume voided and total 24-hour urine volume voided . The primary end point was change from baseline to week 12 in the mean number of micturition related nocturnal urgency episodes per 24 hours . RESULTS Overall 963 subjects were r and omized from 2,990 screened , and 82 % of subjects treated with fesoterodine and 84 % of those treated with  placebo completed the study . Significant improvements in the primary end point ( -1.28 vs -1.07 ) , in nocturnal micturitions per 24 hours ( -1.02 vs -0.85 ) and in nocturnal frequency urgency sum ( -4.01 vs -3.42 ) were observed with fesoterodine vs placebo ( all p ≤0.01 ) . Health related quality of life measures ( overactive bladder question naire Symptom Bother -20.1 vs -16.5 , sleep 22.3 vs 19.9 and other domains ; all p < 0.05 ) were improved with fesoterodine . CONCLUSIONS To our knowledge this is the first prospect i ve study to assess antimuscarinic efficacy for reducing nocturnal urgency . Flexible dose fesoterodine significantly reduced nocturnal urgency episodes vs placebo in subjects with overactive bladder Purpose : Overactive bladder affects 12 % to 17 % of the general population and almost a third experience urinary incontinence , which may severely impact health related quality of life . Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects , leading to a high discontinuation rate . We report the results of the first large ( 557 patients ) , phase 3 , placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics . Material s and Methods : Eligible patients with overactive bladder , 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were r and omized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo . Co‐ primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12 . Secondary end points included other overactive bladder symptoms and health related quality of life . Adverse events were assessed . Results : OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes  vs placebo ( −2.65 vs −0.87 , p < 0.001 ) and 22.9 % vs 6.5 % of patients became completely continent . A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale ( 60.8 % vs 29.2 % , p < 0.001 ) . All other overactive bladder symptoms improved vs placebo ( p ≤0.05 ) . OnabotulinumtoxinA improved patient health related quality of life across multiple measures ( p < 0.001 ) . Uncomplicated urinary tract infection was the most common adverse event . A 5.4 % rate of urinary retention was observed . Conclusions : OnabotulinumtoxinA 100 U showed significant , clinical ly relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated PURPOSE Overactive bladder affects 12 % to 17 % of the general population and almost a third experience urinary incontinence , which may severely impact health related quality of life . Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects , leading to a high discontinuation rate . We report the results of the first large ( 557 patients ) , phase 3 , placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics . MATERIAL S AND METHODS Eligible patients with overactive bladder , 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were r and omized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo . Co- primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12 . Secondary end points included other overactive bladder symptoms and health related quality of life . Adverse events were assessed . RESULTS OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo ( -2.65 vs -0.87 , p < 0.001 ) and 22.9 % vs 6.5 % of patients became completely continent . A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale ( 60.8 % vs 29.2 % , p < 0.001 ) . All other overactive bladder symptoms improved vs placebo ( p ≤ 0.05 ) . OnabotulinumtoxinA improved patient health related quality of life across multiple measures ( p < 0.001 ) . Uncomplicated urinary tract infection was the most common adverse event . A 5.4 % rate of urinary retention was observed . CONCLUSIONS OnabotulinumtoxinA 100 U showed significant , clinical ly relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated PURPOSE We determined the safety and efficacy of each of 2 doses of botulinum toxin type A ( BTX-A ) ( 200 or 300 U BOTOX ) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin . MATERIAL S AND METHODS A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity ( due to spinal cord injury in 53 and multiple sclerosis in 6 ) requiring clean intermittent self-catheterization were r and omized to receive a single dose into the detrusor of BTX-A ( 200 U or 300 U ) or placebo . Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks . Key urodynamic assessment s ( maximum cystometric capacity , reflex detrusor volume and maximum detrusor pressure during bladder contraction ) were used to provide objective measures of the treatment effect on bladder function . The impact of treatment on quality of life was assessed using the Incontinence Quality of Life question naire . RESULTS There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups ( p < /=0.05 ) but not in the placebo group . In addition , more patients who received BTX-A reported no incontinence episodes during at least 1 posttreatment evaluation period . Positive treatment effects were also reflected by significant improvements in bladder function in the BTX-A groups , as assessed by urodynamics and in patient quality of life . Benefits were observed from the first evaluation at week 2 to the end of the 24-week study . No safety concerns were raised . CONCLUSIONS Intramuscular injections of BTX-A into the detrusor can provide rapid , well tolerated , clinical ly significant decreases in the signs and symptoms of urinary incontinence caused by neurogenic detrusor overactivity during a 24-week study period PURPOSE The Study of Urgent PC vs Sham Effectiveness in Treatment of  Overactive Bladder Symptoms ( SUmiT ) was a multicenter , double-blind , r and omized , controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy . The improvement in global response assessment , voiding diary parameters , and overactive bladder and quality of life question naires was evaluated . MATERIAL S AND METHODS A total of 220 adults with overactive bladder symptoms were r and omized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy .  Overactive bladder and quality of life question naires as well as 3-day voiding diaries were completed at baseline and at 13 weeks . Subject global response assessment s were completed at week 13 . RESULTS The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5 % reporting moderately or markedly improved responses compared to 20.9 % of sham subjects from baseline ( p < 0.001 ) . All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham .  Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency , nighttime voids , voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham . No serious device related adverse events or malfunctions were reported . CONCLUSIONS This pivotal multicenter , double-blind , r and omized , sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms . The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder To evaluate the potential of solifenacin 5 mg combined with mirabegron 25 or 50 mg to deliver superior efficacy compared with monotherapy , with acceptable tolerability , in the general overactive bladder ( OAB ) population with urinary incontinence ( UI ) To evaluate the efficacy and safety of the β3‐adrenoceptor agonist mirabegron , in a Japanese population with overactive bladder ( OAB ) Abstract : This study compared the clinical efficacy ( determined from micturition diaries ) and safety of 12 weeks ’ treatment with either tolterodine 2 mg twice daily , oxybutynin 5 mg three times daily or placebo in patients with an overactive bladder . A total of 277 patients were r and omized and treated at 25 centers . Both tolterodine and oxybutynin significantly increased volume voided/micturition compared to placebo . Both treatment groups evoked greater decreases in micturitions per 24 hours and incontinence episodes per 24 hours compared to placebo  ; however , only tolterodine was significantly better than placebo in reducing micturition frequency .  Tolterodine and oxybutynin were equivalent in their effectiveness .  Tolterodine was significantly better tolerated than  oxybutynin when adverse events ( particularly frequency and intensity of dry mouth ) , dose reduction and patient withdrawals were considered . Oxybutynin is an effective drug whose frequent adverse effects limit its clinical usefulness . Tolterodine has equivalent efficacy to oxybutynin , but with less severe adverse effects . This will allow patients to receive more effective treatment for their condition , with better compliance PURPOSE We report the long-term efficacy and safety of percutaneous tibial nerve stimulation with the Urgent ® PC Neuromodulation System for overactive bladder after 3 years of therapy . MATERIAL S AND METHODS Fifty participants in the r and omized , double-blind SUmiT ( Sham Effectiveness in Treatment of Overactive Bladder Symptoms ) Trial who met the primary effectiveness end point after 12 weekly percutaneous tibial nerve stimulation treatments were enrolled in this prospect i ve study to assess long-term outcomes with percutaneous tibial nerve stimulation . STEP ( Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation ) Study patients were prescribed a fixed schedule 14-week tapering protocol followed by a personal treatment plan aim ed at sustaining overactive bladder symptom improvement . Overactive bladder and quality of life question naires were completed every 3 months and 3-day voiding diaries were completed every 6 months . RESULTS A total of 29 patients completed the 36-month protocol and received a median of 1.1 treatments per month after a 14-week treatment tapering protocol . A Bayesian model estimated that 77 % ( 95 % CI 64 - 90 ) of patients maintained moderate or marked improvement in overactive bladder symptoms at 3 years . Compared to baseline , median voids per day decreased from 12.0 ( IQR 10.3 - 13.7 ) to 8.7 ( IQR 7.3 - 11.3 ) , nighttime voids per night decreased from 2.7 ( IQR 1.7 - 3.3 ) to 1.7 ( IQR 1.0 - 2.7 ) and urge incontinence episodes per day decreased from 3.3 ( IQR 0.7 - 6.0 ) to 0.3 ( IQR 0.0 - 1.0 ) ( all p < 0.0001 ) . All quality of life parameters remained markedly improved from baseline through 3 years ( all p < 0.0001 ) . One patient experienced 2 mild treatment related adverse events of bleeding at the needle site during followup . CONCLUSIONS Most STEP participants with an initial positive response to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month PURPOSE In this prospect i ve , nonr and omized , ongoing study we evaluated the efficacy and safety of botulinum-A toxin injections in the detrusor muscle to treat patients with idiopathic overactive bladder resistant to conventional treatment , such as anticholinergic drugs . MATERIAL S AND METHODS A total of 23 men and 77 women with a mean age of 63 years ( range 24 to 89 ) with nonneurogenic overactive bladder , including urgency-frequency syndrome , and incontinence despite the administration of maximal doses of anticholinergics were consecutively treated with injections of 100 U botulinum-A toxin in the detrusor muscle at 30 sites under cystoscopic guidance . Micturition diary , full urodynamics , neurological status and urine probes were performed in all participants before treatment . Bladder biopsies were done only in cases of suspected bladder fibrosis or unclear findings . Special attention was given to reflex volume , maximal bladder capacity , detrusor compliance , post-void residual urine , urgency and frequency/nocturia . Clinical , urodynamic and quality of life assessment s were performed at baseline , and 4 , 12 and 36 weeks after botulinum-A toxin treatment . RESULTS Overall after 4 and 12 weeks 88 % of our patients showed significant improvement in bladder function in regard to subjective symptoms , quality of life and urodynamic parameters ( p < 0.001 ) . Urgency disappeared in 82 % of the patients and incontinence resolved in 86 % within 1 to 2 weeks after botulinum-A toxin injections . Mean frequency decreased from 14 to 7 micturitions daily ( -50 % ) and nocturia decreased from 4 to 1.5 micturitions . Mean maximal bladder capacity increased 56 % from 246 to 381 ml , mean detrusor compliance increased from 24 to 41 ml/cm H(2)O and pretreatment detrusor instability ( mean reflex volume 169 ml ) resolved in 74 % of patients . Mean volume at first desire to void increased from 126 to 212 ml and mean urge volume increased from 214 to 309 ml . There were no severe side effects except temporary urine retention in 4 cases . Only in 8 patients was the clinical benefit poor and analysis revealed preoperative low detrusor compliance . Mean efficacy duration + /- SD was at least approximately 6 + /- 2 months and then symptoms began to increase . CONCLUSIONS Our results show that intradetrusor botulinum-A toxin injections may be an efficient and safe treatment option in patients with severe overactive bladder resistant to all conventional treatments To compare the efficacy of tolterodine plus simplified bladder training  ( BT ) with tolterodine alone in patients with an overactive bladder BACKGROUND This double-blind , multicenter study compared the efficacy and tolerability of tolterodine ( Pharmacia , Los Angeles , USA ) with that of oxybutynin ( Alza , Palo Alto , USA ) in Asian patients with overactive bladder . METHODS Two-hundred- and -twenty-eight adults with overactive bladder symptoms were r and omized to receive tolterodine 2 mg twice daily ( bid ) ( n = 112 ) or oxybutynin 5 mg bid ( n = 116 ) . After 8 weeks ' treatment , changes in micturition diary variables , patients ' perception of treatment benefit , and tolerability endpoints were determined . RESULTS The mean ( + /- SD ) number of micturitions/24 h decreased by 2.6 + /- 2.9 ( -21 % ) with tolterodine and 1.8 + /- 4.2 ( -15 % ) with oxybutynin ( both P = 0.0001 vs baseline ) . The mean number of incontinence episodes/24 h decreased by 2.2 + /- 2.3 ( -85 % ) in the tolterodine group and by 1.4 + /- 1.8 ( -58 % ) in the oxybutynin group ( both P = 0.0001 vs baseline ) . Patient perception of treatment benefit was over 70 % in each treatment group . Adverse events were significantly lower in the tolterodine group compared with oxybutynin-treated patients ( 55 % vs 82 % ; P = 0.001 ) . Dry mouth was reported by significantly fewer patients on tolterodine , compared with oxybutynin ( 35 % vs 63 % ; P = 0.001 ) and withdrawals due to adverse events were lower in the tolterodine group than with those treated with oxybutynin ( 10 % vs 16 % ) . There were no safety concerns . CONCLUSIONS Tolterodine 2 mg bid is equally or more effective than oxybutynin 5 mg bid in the treatment of Asian patients with overactive bladder , and shows significantly better tolerability . This may enhance compliance during long-term treatment PURPOSE We evaluated the efficacy and safety of add-on treatment with a β3-adrenoceptor agonist ( mirabegron ) for overactive bladder symptoms remaining after α1-blocker ( tamsulosin ) treatment in men with benign prostatic obstruction . MATERIAL S AND METHODS Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study . They were r and omly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks . The primary end point was change in total OABSS . Safety assessment s included change in post-void residual urine volume and adverse events . RESULTS From January 2012 through September 2013 a total of 94 patients were r and omized . Of these patients 76 completed the protocol treatment . In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group ( -2.21 vs -0.87 , p=0.012 ) . The changes in scores for urinary urgency , daytime frequency , International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group . The change in post-void residual urine volume was significantly greater in the combination group . Although 6 patients experienced adverse events in the combination group , urinary retention was observed in only 1 patient . CONCLUSIONS Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms  after tamsulosin monotherapy Objective To compare the tolerability and clinical efficacy of tolterodine and oxybutynin in the treatment of Hong Kong Chinese women with an overactive bladder To evaluate the efficacy , tolerability and safety of a flexible‐dosing strategy with darifenacin , an M3‐selective receptor antagonist , in patients with symptoms of overactive bladder ( OAB ) Abstract This study evaluated the efficacy and tolerability of new extended-release ( ER ) tolterodine for the treatment of overactive bladder in women . In this sub population analysis of a double-blind multicenter trial , 1235 female patients were r and omized to oral therapy with tolterodine ER 4 mg once daily ( n=417 ) , tolterodine IR 2 mg twice daily ( n=408 ) or placebo ( n=410 ) for 12 weeks . Both formulations reduced the mean number of urge incontinence episodes per week ( both P=0.001 vs placebo ) ; tolterodine ER was more effective than tolterodine IR ( P=0.036 ) . Both formulations significantly improved all other micturition chart variables compared to placebo . Dry mouth was the most common adverse event . There were no safety concerns .  Toltrodine ER 4 mg once daily is effective and well tolerated in the treatment of women with overactive bladder , and reduces urge incontinence episodes more than the existing IR twice-daily formulation AIM To evaluate the urodynamic effects , therapeutic efficacy and safety of solifenacin versus tolterodine treatment for women with overactive bladder syndrome . METHODS Patients were r and omized to receive either solifenacin 5 mg or tolterodine ER 4 mg once a day for 12 weeks at each four-week visit in a post-marketing study . Only women ( solifenacin [ n = 26 ] vs. tolterodine [ n = 22 ] ) were included in this subgroup analysis . Adverse events and changes of urodynamic values and clinical data were compared between the solifenacin and tolterodine groups . RESULTS The volume voided per micturition increased in the solifenacin group ( n = 21 ) ( P = 0.04 ) . The strong desire to void and pad-test result improved in the tolterodine group ( n = 21 ; P = 0.02 and 0.03 , respectively ) . There were no between-group differences in changes of any urodynamic data , voiding diary values or adverse events after treatment ; however , changes of heart rate differed between the two groups ( P = 0.0004 ) , especially at visit 2 ( solifenacin vs. tolterodine , -4.3 vs. 3.8 , P = 0.02 ) and visit 3 ( -3.2 vs. 4.8 , P = 0.03 ) . CONCLUSIONS Both solifenacin and tolterodine had similar urodynamic effects , therapeutic efficacy and adverse events in treating women with overactive bladder syndrome ; however , tolterodine had a greater effect in increasing heart rate than solifenacin PURPOSE We assessed the efficacy and safety of oxybutynin chloride topical gel vs placebo in adults with overactive bladder . MATERIAL S AND METHODS Men and women 18 years or older with urge predominant urinary incontinence were enrolled in r and omized , parallel group , double-blind , placebo controlled Study OG05009 done at 76 clinics in the United States . Eligible patients were assigned to receive 1 gm oxybutynin chloride topical gel ( 10 % weight per weight ethanol based formulation of oxybutynin ) or matching placebo once daily for 12 weeks . Efficacy was assessed using data from 3-day urinary diaries and the primary outcome was the change from baseline in the number of urge incontinence episodes . Safety was monitored through adverse event reporting . Efficacy results in the oxybutynin chloride topical gel and placebo groups were compared by ANCOVA with last observations carried forward . RESULTS A total of 789 r and omized patients , including 704 women ( 89.2 % ) , with a mean age of 59 years were assigned to treatment with oxybutynin chloride topical gel ( 389 ) or placebo ( 400 ) . The mean number of urge incontinence episodes decreased significantly more in patients treated with oxybutynin chloride topical gel than in those given placebo ( -3.0 vs -2.5 per day , p < 0.0001 ) . Mean urinary frequency decreased ( -2.7 per day , p = 0.0017 ) and voided volume increased ( 21.0 ml , p = 0.0018 ) significantly more in the oxybutynin chloride group than in the placebo group ( -2.0 per day and 3.8 ml , respectively ) . Treatment related dry mouth was more frequent in the oxybutynin chloride group than in the placebo group ( 27 of 389 patients or 6.9 % vs 11 of 400 or 2.8 % ) . Application site reactions were infrequently observed in the oxybutynin chloride and placebo groups ( 21 of 389 patients or 5.4 % and 4 of 400 or 1.0 % , respectively ) . No serious treatment related adverse events occurred . CONCLUSIONS Oxybutynin chloride topical gel was efficacious in improving overactive bladder symptoms and was well tolerated in adult patients To determine the effect of a pause in percutaneous tibial nerve stimulation ( PTNS ) in successfully treated patients with an overactive bladder ( OAB ) , and the reproducibility of successful treatment when restored OBJECTIVES TAABO was a r and omized , controlled trial to evaluate the efficacy and safety of combination therapy of tamsulosin ( TAM ) with propiverine ( PROP ) in men with both benign prostatic hyperplasia and overactive bladder . METHODS It enrolled men 50 years or older who had an international prostate symptom score ( IPSS ) of 8 or higher , an urgency item score of 1 or higher , and a quality of life ( QOL ) score of 2 or higher . After 8 weeks of TAM 0.2 mg/day , patients who met the inclusion criteria ( 8 micturitions per 24 h and 1 urgency per 24 h , evaluated by bladder diary ) and were eligible for 12-weeks of continued Treatment II . Five hundred and fifteen patients were enrolled . Thereafter , 214 patients were assigned r and omly to receive either TAM alone ( n = 67 ) , TAM plus PROP 10 mg ( n = 72 ) , or TAM plus PROP 20 mg ( n = 75 ) in Treatment II . The primary efficacy end point was a change in micturitions per 24 h documented in the bladder diary . The change from baseline in urgency episodes per 24 h , IPSS , IPSS/QOL subscore , urinary flow rate and postvoid residual volume were assessed as secondary efficacy measures . RESULTS A total of 141 men ( 47 TAM , 49 TAM plus PROP 10 mg , and 45 TAM plus PROP 20 mg patients ) were assessed by week 12 . Compared with the TAM , TAM plus PROP 10 mg patients experienced significantly fewer micturitions ( P = 0.0261 ) , urgencies ( P = 0.0093 ) per 24 h , lower IPSS storage ( P = 0.0465 ) , and IPSS urgency ( P = 0.0252 ) subscores . CONCLUSIONS These results suggest that combining TAM and 10 mg of PROP for 12 weeks provides added benefit for men with both benign prostatic hyperplasia and overactive bladder ABSTRACT Objective : To evaluate the efficacy and safety of a single intra detrusor injection of BoNTA comparing two different doses ( 100 U or 200 U ) in patients with idiopathic overactive bladder . Material s and Methods : A r and omized prospect i ve study evaluated the efficacy of BoNTA in management of refractory idiopathic overactive bladder and included 80 patients . All patients were assessed initially by taking a history , a physical examination , overactive bladder symptom score , urine analysis , routine laboratory investigations , KUB and pelviabdominal . OABSS was adjusted on all patients postoperative at 1,3,6,9 months also Urodynamic was done for all patients preoperative and postoperative at 3 , 6 , 9 months . Results : The mean age was 30.22±8.37 and 31.35±7.61 in group I and II respectively . There was no statistically difference between both groups in all parameters all over the study except at 9 months after treatment . Hematuria was observed 6 and 9 patients in group I and II respectively . Dysuria was observed in 6 and 15 patients in group I and II respectively . UTI was detected in 3 and 7 patients in group I and II respectively . Conclusion : A single-injection procedure of 100 U or 200 U BoNTA is an effective and safe treatment for patients with IOAB who failed anticholinergic regimens . OABSS and QoL were improved for 6 months ; 100 U injections seemed to have comparable results with 200 U. There was a significant difference at month 9 towards 200 U with more incidences of adverse events To examine , in a 2‐year , non‐comparative , open‐label extension study , the safety , tolerability and efficacy of darifenacin controlled‐release ( CR ) 7.5/15 mg once daily in patients with overactive bladder ( OAB ) who completed two 12‐week r and omized , double‐blind , placebo‐controlled ‘ feeder ’ studies OBJECTIVE To determine the efficacy , tolerability , and safety of fesoterodine in subjects with overactive bladder ( OAB ) . METHODS This was a multicentre , r and omised , double-blind , placebo- and active-controlled trial with tolterodine extended release ( ER ) to assess the efficacy and safety of fesoterodine .  Eligible subjects ( > or = 18 yr ) with increased micturition frequency and urgency and /or urgency urinary incontinence ( UUI ) were r and omised to placebo , fesoterodine 4 mg , fesoterodine 8 mg , or tolterodine ER 4 mg for 12 wk . The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co- primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ( " yes " or " no , " based on four-point treatment benefit scale ) . Secondary efficacy variables included mean volume voided per micturition , continent days per week , and number of urgency episodes . RESULTS At the end of treatment , subjects taking fesoterodine 4 and 8 mg had significant ( p<0.05 ) and clinical ly relevant improvements versus placebo in the primary , co- primary , and most secondary efficacy variables .  Tolterodine ER ( active control ) also provided significantly greater improvement than placebo for most efficacy variables , confirming the sensitivity of the study design . A more pronounced effect was observed with fesoterodine 8 mg at most end points . CONCLUSIONS Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo .  Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments . Active treatments were well tolerated OBJECTIVES To summarize the efficacy and safety of tolterodine from the pooled data of four multicenter , r and omized , double-blind , placebo-controlled , dose-ranging , parallel-group Phase II studies in patients with urodynamically proved overactive bladder ( detrusor instability or detrusor hyperreflexia ) and to analyze the concentration-effect relation . METHODS After a 1-week run-in period to establish baseline values , 319 patients were r and omized to receive  placebo or tolterodine  0.5 , 1 , 2 , or 4 mg twice daily . Micturition diary and urodynamic variables and subjective urinary symptoms were assessed after 2 weeks of treatment . Patients were classified as " extensive " or " poor " metabolizers of tolterodine on the basis of serum levels of tolterodine . RESULTS A per- protocol analysis of efficacy in 262 patients showed dose-related improvements in micturition diary and urodynamic variables . A dosage of 4 mg twice daily was , however , associated with an increase in residual urinary volume . The incidence of adverse events ( mainly mild or moderate antimuscarinic effects ) was comparable between placebo and tolterodine dosages of 2 mg twice daily . No serious drug-related adverse events were observed , and tolterodine had no clinical ly significant impact on electrocardiographic or laboratory findings . Changes in urodynamic variables were found to be related to the sum of unbound serum concentrations of  tolterodine  and its major active 5-hydroxymethyl metabolite . In poor and extensive metabolizers of tolterodine , exposure to the sum of these active moieties was similar , and the efficacy and safety profiles were comparable . CONCLUSIONS The results of this pooled data analysis indicate that tolterodine offers an effective treatment for patients with urinary symptoms attributable to overactive bladder . The optimal dosage is 1 to 2 mg twice daily , irrespective of metabolic phenotype BACKGROUND The BESIDE study demonstrated that combination therapy ( mirabegron and solifenacin 5 mg ) improved  overactive bladder symptoms  versus solifenacin 5 mg or 10 mg , and was well tolerated . OBJECTIVE To ensure efficacy and safety is maintained in older patients ( > 65 yr ) , who usually experience greater symptom severity and comorbidities , a prespecified sub analysis stratified by age group was conducted . DESIGN , SETTING , AND PARTICIPANTS Patients remaining incontinent ( ≥1 episode during 3-d diary ) following 4-wk single-blind daily solifenacin 5 mg were r and omized 1:1:1 to a daily double-blind combination ( solifenacin 5 mg and mirabegron 25 mg , increased to 50 mg at wk 4 ) , solifenacin 5 mg or 10 mg for 12 wk . Four cohorts stratified by age ( < 65 yr , ≥65 yr and < 75 yr , ≥75 yr ) were investigated . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Efficacy assessment s : change from baseline to end of treatment in average daily incontinence ( primary ) and micturition frequency ( key secondary ) , number of incontinence episodes during the 3-d diary ( key secondary ) , and change from baseline in average daily urgency and urgency incontinence episodes . Safety included treatment-emergent adverse events and vital signs . RESULTS AND LIMITATIONS Full analysis set included 2110 patients : 30.9 % aged ≥65 yr and 8.9 % aged ≥75 yr . At the end of treatment , daily , and 3-d incontinence daily micturitions , urgency , and urgency incontinence , were improved in each treatment group and age group ; the largest reductions were observed with combination in each age cohort . There were no notable differences in vital signs or the incidence of treatment-emergent adverse events between treatment and age groups , with the exception of dry mouth , which was highest with solifenacin 10 mg . CONCLUSIONS Efficacy and safety in the overall population is maintained in older ( ≥65 yr ) and elderly ( ≥75 yr ) patients treated with a combination of solifenacin and mirabegron , or solifenacin monotherapy ; irrespective of age , combination was associated with the greatest improvement in overactive bladder symptoms . PATIENT SUMMARY This study investigated the effectiveness and safety of a combination of two different treatments ( mirabegron 50 mg and solifenacin 5 mg ) or solifenacin ( 5 mg or 10 mg ) alone in patients aged < 65 yr or ≥65 yr , and < 75 yr or ≥75 yr with overactive bladder . Symptoms of overactive bladder , such as the urgent need to visit the toilet , incontinence , and frequent urination , were improved with all treatments regardless of the patient 's age , but combination treatment demonstrated the greatest benefit , and was well tolerated BACKGROUND Efficacy and safety of botulinum toxin type A ( BoNTA ) injection is supported by level 1 evidence , but data regarding repeated injections are limited in patients with refractory overactive bladder ( OAB ) and idiopathic detrusor overactivity ( IDO ) . OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve data from a single centre were collected from the first 100 patients . INTERVENTION Bladder injection of BoNTA ( predominantly 200 U onabotulinumtoxinA ; Allergan Ltd. , Marlow , Buckinghamshire , UK ) in an outpatient setting . MEASUREMENTS OAB symptoms , quality of life , discontinuation rates , interinjection interval , and adverse events were recorded . Data comparisons were performed using a generalised linear model or a chi-square test where appropriate . RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients . All patients had 1 injection , 53 had a total of 2 , 20 had 3 , 13 had 4 , 10 had 5 , 5 had 6 , 3 had 7 , 1 had 8 , 1 had 9 , and 1 had 10 injections . Statistics were applied up to five repeated injections . A statistically significant reduction in frequency , urgency , and urge urinary incontinence were seen following the first BoNTA injection compared to baseline . This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections . Thirty-seven patients stopped treatment after the first two injections ; thereafter , dropouts were rare . The most common reasons for discontinuing treatment were poor efficacy ( 13 % ) and clean intermittent self-catheterisation (CISC)-related issues ( 11 % ) . The incidence of CISC after the first injection was 35 % . Bacteriuria was detected in 21 % of patients . The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients . CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO . The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues OBJECTIVE To determine the pharmacokinetics , safety and tolerability of fesoterodine , and assess the utility of 3-day bladder diaries ( exploratory objective ) in pediatric subjects with neurogenic detrusor overactivity or idiopathic overactive bladder ( OAB ) . METHODS In this 8-week open-label study , subjects ( 8 - 17 years , > 25 kg ) received fesoterodine 4 mg for 4 weeks , then 8 mg for 4 weeks . Blood sample s were obtained at weeks 4 and 8 . RESULTS Of 21 subjects enrolled , 11 had neurogenic detrusor overactivity and 10 had idiopathic OAB ; 1 discontinued ( personal reasons ) . Mean age and weight were 13.2 years and 54.0 kg for boys ( n = 12 ) and 13.1 years and 49.2 kg for girls ( n = 9 ) .  5-Hydroxy-methyltolterodine plasma concentrations did not differ by diagnosis and were consistent with predictions based on adult data . Treatment-related adverse events ( all mild or moderate ) included 1 event each of dry mouth , constipation , dry eyes and blurred vision , and 2 events each of nausea and increased post-void residual volume . Three-day bladder diaries proved feasible . CONCLUSIONS Oral administration of fesoterodine in pediatric subjects ( > 25 kg ) with idiopathic OAB or neurogenic detrusor overactivity produced steady-state plasma 5-hydroxy-methyltolterodine exposures similar to those in adults . The doses given were well tolerated 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 OBJECTIVES To evaluate the efficacy and tolerability of a new extended-release ( ER ) , once-daily , capsule formulation of tolterodine , relative to placebo and the existing immediate-release ( IR ) , twice-daily , tablet formulation , for treatment of the overactive bladder . METHODS This was a double-blind , multicenter , r and omized , placebo-controlled trial . One thous and five hundred twenty-nine patients ( 81 % women ) with urinary frequency ( eight or more micturitions every 24 hours ) and urge incontinence ( five or more episodes per week ) were r and omized to oral therapy with tolterodine ER 4 mg once daily ( n = 507 ) , tolterodine IR 2 mg twice daily ( n = 514 ) , or placebo ( n = 508 ) for 12 weeks . Efficacy was assessed at the end of the treatment period on the basis of the micturition diary variables . Tolerability and safety were assessed by evaluating the adverse events , electrocardiogram parameters , laboratory values , and treatment withdrawals . RESULTS Tolterodine ER 4 mg once daily ( P = 0.0001 ) and tolterodine IR 2 mg twice daily ( P = 0.0005 ) both significantly reduced the mean number of urge incontinence episodes per week compared with placebo . The median reduction in these episodes as a percentage of the baseline values was 71 % for tolterodine ER , 60 % for tolterodine IR , and 33 % for placebo . The ER formulation was 18 % more effective than the IR formulation ( P < 0.05 ) . Treatment with both formulations of tolterodine was also associated with statistically significant improvements in all other micturition diary variables compared with placebo . For both formulations , the mean decreases in micturition frequency ( P < 0.0079 ) and pad usage ( P < 0.0145 ) were significant , and the mean volume voided per micturition increased ( P = 0.0001 ) . The rate of dry mouth ( of any severity ) was 23 % for tolterodine ER , 30 % for tolterodine IR , and 8 % for placebo . The overall dry mouth rate for patients taking tolterodine ER was 23 % lower than for tolterodine IR ( P < 0.02 ) , and the rate of severe dry mouth in the ER group was only 1.8 % . The rates of withdrawal were comparable for the two active groups and the placebo group . No safety concerns were noted . CONCLUSIONS Tolterodine ER 4 mg once daily is effective and well tolerated in the treatment of overactive bladder with no safety concerns . Tolterodine ER demonstrated an improved efficacy for reducing urge incontinence episodes and a lower frequency of dry mouth compared with the existing IR twice-daily formulation To compare extended‐release ( ER ) tolterodine and immediate‐release ( IR ) oxybutynin with placebo in Japanese and Korean patients with an overactive bladder ( OAB ) OBJECTIVE The objective of the study was to determine the impact of overactive bladder on sexual function from a preliminary analysis of the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study . STUDY DESIGN The Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study was an open-label , prospect i ve trial of 2878 subjects with overactive bladder , treated with transdermal oxybutynin for 6 months or less . The impact of overactive bladder on sexual function before and after treatment was assessed via item responses from the King 's Health Question naire and Beck Depression Inventory-II ( kappa-test ) . RESULTS At baseline , 586 ( 23.1 % ) reported that overactive bladder had an impact on their sex life . Coital incontinence in 569 ( 22.8 % ) decreased after treatment to 438 ( 19.3 % ) . Effects of overactive bladder on subjects ' sex lives improved in 19.1 % ( worsened in 11.2 % ) , and the effect on relationships with partners improved in 19.6 % ( worsened in 11.9 % ) . Reduced interest in sex , reported by 52.1 % at baseline , improved significantly . ( all P < .0001 ) . CONCLUSION Overactive bladder negatively affects sexual function . Treatment with transdermal oxybutynin improved sexual function and marital relationships PURPOSE We compared changes in nocturia and sleep related parameters between the anticholinergic solifenacin and placebo in patients with overactive bladder associated with nocturia . MATERIAL S AND METHODS We performed subgroup analysis of data from a r and omized , controlled trial of solifenacin ( 5 or 10 mg ) in Japan . Men and women 20 years old or older with overactive bladder were eligible for study participation . Patients who voided at least once during the night at baseline and who completed efficacy and quality of life assessment at baseline and 12 weeks ( treatment end ) were included in analysis . We compared placebo with the posttreatment change in nocturia and daytime frequency , volume voided per micturition , sleeping time , hours of undisturbed sleep and sleep related quality of life . RESULTS Subgroup analysis included 962 patients .  Solifenacin 10 mg significantly decreased nocturia episodes by 0.46 episodes ( p = 0.0449 ) . Solifenacin 5 and 10 mg significantly increased nighttime volume voided per micturition by 30 and 41 ml ( p = 0.0033 and < 0.0001 , respectively ) . Compared with placebo ( 33 minutes ) the hours of undisturbed sleep significantly increased by 59 and 60 minutes ( p = 0.0196 and 0.0195 ) in patients with solifenacin 5 and 10 mg , respectively . Significant improvement was observed in sleep related quality of life for solifenacin 5 and 10 mg ( each p < 0.001 ) . Results must be interpreted with caution due to the exploratory nature of this analysis . CONCLUSIONS Solifenacin 10 mg decreases nocturia episodes .  Solifenacin 5 and 10 mg increases nighttime volume voided per micturition and may improve quality of sleep and sleep related quality of life in patients with overactive bladder OBJECTIVES To study the efficacy and safety of trospium chloride in treating overactive bladder .  Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity and thus has potential therapeutic value in treating patients with overactive bladder . METHODS Patients with overactive bladder were r and omized on a 1:1 basis to either placebo or trospium chloride 20 mg twice daily in this 12-week , multicenter , parallel , double-blind , placebo-controlled study . The primary endpoint was the change in the average number of toilet voids per 24 hours . The secondary efficacy variables were changes in the average void urgency severity , volume per toilet void , urge frequency , number of daily urge urinary incontinence episodes , and daytime sleepiness . RESULTS A total of 658 patients were r and omized at 52 sites .  Trospium chloride significantly decreased the average number of daily toilet voids , average urgency severity , urge frequency , and urge urinary incontinence episodes and increased the average volume per void at weeks 1 , 4 , and 12 . All effects occurred by the end of week 1 and all improved and were sustained throughout the 12-week study . Adverse events included dry mouth and constipation . CONCLUSIONS Trospium chloride had significant and sustained effectiveness beginning at the end of week 1 and continuing through 12 weeks of treatment . Trospium chloride was also safe and generally well tolerated Purpose : We investigated the efficacy of 2 & agr;1‐blockers with different affinities for the & agr;1‐adrenoceptor subtypes silodosin and naftopidil in the treatment of benign prostatic enlargement complicated by overactive bladder . Material s and Methods : This was a prospect i ve , open label , r and omized , multicenter study of 350 out patients with untreated benign prostatic enlargement associated with urinary urgency at least once per week and an OABSS ( Overactive Bladder Symptom Score ) of 3 or greater . Patients were r and omly assigned to receive silodosin 8 mg per day or naftopidil 75 mg per day . Changes in parameters from baseline to 4 and 12 weeks were assessed based on I‐PSS ( International Prostate Symptom Score ) , I‐PSS quality of life , OABSS and voiding functions measured by uroflowmetry . Results : On efficacy analysis a total of 314 patients were included in the 2 groups . No significant difference in adverse effects was observed between the groups . Mean I‐PSS and I‐PSS quality of life scores , and OABSS significantly improved in both groups . Statistically significantly greater improvement in the silodosin group than in the naftopidil group was observed in total OABSS ( p = 0.03 ) , I‐PSS quality of life score ( p = 0.005 ) and OABSS urgency score ( p < 0.001 ) at 12 weeks . In regard to voiding function the maximum urinary flow rate showed significant improvements in both groups but the change in the maximum flow rate in the silodosin group at 12 weeks was significantly greater than in the naftopidil group ( 3.6 vs 2.1 ml per second ) . Conclusions : Silodosin , a pure & agr;1A‐adrenoceptor blocker , showed greater improvement in overactive bladder symptoms along with the urinary flow rate in patients with benign prostatic enlargement complicated by overactive bladder compared to naftopidil , an & agr;1D > A‐adrenoceptor blocker Background To assess the efficacy and safety of the herbal medicine , Weng-li-tong ( WLT ) as monotherapy or combined with tolterodine in women with overactive bladder ( OAB ) . Methods A prospect i ve , r and omized , single-blind multi-center trial was performed which included 182 OAB patients treated with either placebo ( n = 26 ) , WLT ( n = 52 ) , tolterodine ( n = 52 ) or WLT plus tolterodine ( n = 52 ) . The overactive bladder symptom score ( OABSS ) and micturition behavior were measured to evaluate treatment efficacy . Results In total , 146 patients [ placebo ( n = 23 ) , WLT ( n = 39 ) , tolterodine ( n = 41 ) and WLT plus tolterodine ( n = 43 ) ] completed 8 weeks of treatment . Compared to those treated with placebo , patients in three intervention groups showed significant improvements in the OABSS , voiding frequency , average voided volume and urgency incontinence .  WLT had a slower onset than tolterodine or combination therapy in reducing urgency incontinence . Compared with tolterodine , WLT had a weaker effect in improving OABSS ( P = 0.022 ) and daily voiding frequency ( P = 0.034 ) . The combination therapy had better efficacy than WLT or tolterodine alone in improving the OABSS , voiding frequency and voided volume . No significant differences in the changes in quality of life scores were observed among the three intervention groups . Residual urine increased significantly in tolterodine group ( P = 0.004 ) , but not in combination group . WLT result ed in fewer adverse effects than tolterodine such as dry mouth ( P = 0.002 ) , weak stream ( P = 0.002 ) and less residual urine ( P < 0.001 ) . Conclusions WLT could improve OAB symptoms in women , while it had slower onset and weaker efficacy but fewer adverse effects than tolterodine . The combination of WLT and tolterodine was more efficacious than tolterodine alone in improving OAB symptoms . Trial registration Chinese Clinical Trial Registry [ ChiCTR-IPR-14005626 ] . Date of registration : 7 December 2014 OBJECTIVES To examine the safety , efficacy , and tolerability of tolterodine in four r and omized , double-blind , parallel , multicenter , 12-week studies of patients with overactive bladder . METHODS Two of the four studies compared tolterodine ( 2 mg twice daily ) to oxybutynin ( 5 mg three times daily ) and placebo , one study compared tolterodine ( 2 mg twice daily ) to oxybutynin ( 5 mg three times daily ) , and one study compared two dosages of tolterodine ( 1 and 2 mg twice daily ) to placebo .  Efficacy was determined from micturition diaries and patient perception of their bladder condition . Safety and tolerability were assessed from adverse events and laboratory measures . RESULTS A total of 1,120 patients were r and omized and treated at 134 centers . For the primary efficacy variable , the number of micturitions/24 hours , pooled results showed a significant decrease from baseline for the 1 mg tolterodine ( P < 0.001 ) , 2 mg tolterodine ( P < 0.001 ) , and 5 mg oxybutynin ( P < 0.01 ) groups , compared to placebo . Both tolterodine doses and oxybutynin significantly decreased incontinence episodes/24 hours and significantly increased volume voided/micturition , compared to placebo . Tolterodine at a dose of 2 mg twice daily and 5 mg oxybutynin twice daily were significantly more effective in improving patient perception of bladder condition than placebo . Tolterodine at a dose of 2 mg and 5 mg oxybutynin were equivalent in their effectiveness . Tolterodine at doses of 1 mg and 2 mg were tolerated significantly better than oxybutynin when adverse events , dry mouth ( both frequency and intensity ) , dose reductions , and patient withdrawals were considered . CONCLUSIONS Although oxybutynin is highly effective , its clinical utility is limited by systemic side effects that lead to frequent discontinuation of treatment or dose reductions . Patients receiving tolterodine should not experience these limitations and instead will get safe and long-term effective treatment for their condition OBJECTIVES To compare the efficacy of fesoterodine 4 mg versus 8 mg in treating subjects with overactive bladder ( OAB ) syndrome .  METHODS This is a pooled analysis of data from 2 r and omized placebo (PBO)-controlled phase III trials . Eligible subjects with frequency and urgency or urgency urinary incontinence ( UUI ) were r and omized to PBO or fesoterodine 4 or 8 mg for 12 weeks . Subjects assessed efficacy using 3-day bladder diaries recording the time of each void , urgency , and incontinence episode . Endpoints included treatment response ( based on a 4-point Treatment Benefit scale ) and change from baseline in micturitions , UUI episodes , mean volume voided , urgency episodes , and continent days . We assessed tolerability and safety by evaluating adverse events , residual urine volume , laboratory parameters , and treatment withdrawals . RESULTS At the end of treatment , both doses of fesoterodine showed statistically significant improvements in all efficacy endpoints versus PBO ( P < 0.01 ) . These effects were seen 2 weeks after initiation of treatment ( the earliest evaluation point ) and were sustained throughout the treatment period . Fesoterodine 8 mg performed significantly better than fesoterodine 4 mg in improving all diary variables ( P < 0.05 ) except micturition frequency , demonstrating a dose-response relationship . Adverse events reported more frequently with fesoterodine than with PBO included dry mouth , constipation , and urinary tract infection . CONCLUSIONS Both fesoterodine 4 and 8 mg are effective in improving OAB symptoms . The higher 8-mg dose provides additional benefit compared with the lower dose in improving most bladder diary variables , thus offering the possibility of dose flexibility and titration Purpose This study assessed the benefit of adding behavioural modification to darifenacin treatment for overactive bladder ( OAB ) . Material s and methods The ABLE trial was a r and omised , open-label , parallel-group , multicentre study of 12 weeks of darifenacin treatment [ with voluntary up-titration from 7.5 mg once daily ( qd ) to 15 mg qd at week 2 ] alone or in combination with a Behavioural Modification Programme ( BMP ) for men and women with dry or wet OAB .  Efficacy was assessed as the change in the number ( per day ) of micturitions ( primary variable ) , urge urinary incontinence ( UUI ) episodes , urgency episodes , pads used and nocturnal voids . Health-related quality of life ( HRQoL ) was also evaluated . Tolerability and safety assessment s included adverse events and the number of discontinuations . Results Of 592 patients screened , 395 were r and omised , 190 to darifenacin alone and 205 to darifenacin + BMP .  At baseline , the majority of subjects were dry ( mean 2.8 and three UUI episodes per day in the darifenacin and darifenacin + BMP groups respectively ) . At study end , darifenacin alone and darifenacin + BMP both produced significant reductions from baseline in median numbers of micturitions , UUI episodes , urgency episodes and nocturnal voids ( all p < 0.05 ) , but not in the number of pads used . HRQoL also improved . There were no significant differences between treatment groups in efficacy or HRQoL variables . Conclusions Darifenacin treatment provides a degree of normalisation of micturition variables and improvement in HRQoL that can not be further enhanced by behavioural therapy of the type used in this study . Whether behavioural modification would add benefit over darifenacin treatment in patients with more pronounced incontinence problems remains to be determined OBJECTIVE To compare two new generation antimuscarinics at their recommended doses for treatment of overactive bladder syndrome ( OAB ) . METHODS A prospect i ve , double blind , double-dummy , two-arm , parallel-group , 12-week study was conducted to compare the efficacy and safety of solifenacin 5 or 10 mg and tolterodine extended release ( ER ) 4 mg once daily in OAB patients . After 4 weeks of treatment patients had the option to request a dose increase but were dummied throughout as approved product labelling only allowed an increase for those on solifenacin . RESULTS Solifenacin , with a flexible dosing regimen , showed greater efficacy to tolterodine in decreasing urgency episodes , incontinence , urge incontinence and pad usage and increasing the volume voided per micturition . More solifenacin treated patients became continent and reported improvements in perception of bladder condition assessment s. The majority of side effects were mild to moderate in nature , and discontinuations were comparable and low in both groups . CONCLUSIONS Solifenacin , with a flexible dosing regimen , was found to be superior to tolterodine ER with respect to the majority of the efficacy variables 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 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 PURPOSE The Overactive Bladder Innovative Therapy trial was a r and omized , multicenter , controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine . The reduction in overactive bladder symptoms along with global response assessment s was evaluated . MATERIAL S AND METHODS A total of 100 adults with urinary frequency were r and omized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine . Voiding diaries and an overactive bladder question naire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency , urinary urge incontinence episodes , voids causing waking , volume voided , urgency episodes and quality of life indices . Global response assessment s were completed by subjects and investigators after 12 weeks of therapy . RESULTS The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5 % reporting cure or improvement compared to 54.8 % of subjects on tolterodine ( p = 0.01 ) . Assessment s by investigators were similar but did not reach statistical significance ( p = 0.05 ) . After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency , urge urinary incontinence episodes , urge severity and nighttime voids , as well as for improvement in voided volume . There were no serious adverse events or device malfunctions . CONCLUSIONS This multicenter , r and omized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms , and with objective effectiveness comparable to that of pharmacotherapy . Percutaneous tibial nerve stimulation may be considered a clinical ly significant alternative therapy for overactive bladder PURPOSE We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence . MATERIAL S AND METHODS This institutional review board approved , multicenter registered trial r and omized women with refractory urge incontinence , detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio . Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence . The primary outcome measure was time to failure , as evidence d by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection , or changes in treatment ( initiation or increase ) at any time after injection . Safety data , including increased post-void residual volume , defined as more than 200 ml irrespective of symptoms , was obtained at specified time points . RESULTS Approximately 60 % of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement . The median duration of their responses was 373 days , significantly longer than the 62 days or less for placebo ( p < 0.0001 ) . In the botulinum toxin A group increased post-void residual urine ( 12 of 28 women or 43 % ) and urinary tract infection in those with increased post-void residual urine ( 9 of 12 or 75 % ) exceeded expected ranges . Further injections were stopped after 43 patients were r and omized , including 28 to botulinum toxin A and 15 to placebo . CONCLUSIONS Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder . However , a transient post-void residual urine increase was experienced in 43 % of patients . Botulinum toxin A for idiopathic overactive bladder is still under investigation Introduction and hypothesisWe assessed fesoterodine  efficacy and tolerability in women with overactive bladder ( OAB ) . Methods This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB r and omized to placebo , fesoterodine 4 or 8 mg , or tolterodine extended release ( ER ) 4 mg ( in 1 trial ) for 12 weeks . Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12 . Results By weeks 2 and 12 , all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo . Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week . The most common adverse events were dry mouth and constipation , which were predominately mild or moderate . Conclusions Fesoterodine is efficacious and well tolerated in women with OAB Introduction and hypothesisThis study evaluated the efficacy and safety of flexible-dose fesoterodine and factors associated with dose escalation in subjects with overactive bladder ( OAB ) . Methods In this 12-week , open-label study , 331 adults with OAB symptoms for ≥3 months , ≥8 micturitions and ≥3 urgency episodes per 24 h and who reported at least “ some moderate ” bladder-related problems were treated with fesoterodine 4 mg once daily for 4 weeks , with the option to escalate to 8 mg for the remaining 8 weeks based on discussion of efficacy and tolerability with the investigator . Factors influencing dose escalation were identified using stepwise logistic regression . Efficacy was assessed via 3-day bladder diaries and patient-reported outcomes . Results Of the subjects , 59 % dose escalated at week 4 ; 93 % of escalators cited insufficient clinical response . The decision to escalate was most often made by the subject ( alone or with the investigator ) . Improvements from baseline were observed in diary and patient-reported outcomes at weeks 4 and 12 . Smaller improvements in micturition frequency and worse bladder-related problems at week 4 were significantly associated with increased likelihood of dose escalation ; baseline micturition frequency , age , sex , body mass index , antimuscarinic-associated adverse events and OAB symptom duration were not . Non-escalators had greater improvement from baseline to week 4 than escalators ; by week 12 , improvement was similar among escalators and non-escalators . Fesoterodine was well tolerated . Conclusions Treatment with flexible-dose fesoterodine  improved bladder diary and patient-reported outcomes . Lower clinical response was related to dose escalation ; after escalation , response in escalators approached that of non-escalators PURPOSE Neurokinin-1 receptor dependent mechanisms may regulate urinary frequency and urgency . We conducted this study to assess the efficacy and tolerability of the neurokinin-1 receptor antagonist serlopitant vs placebo or tolterodine in patients with overactive bladder . MATERIAL S AND METHODS This r and omized , double-blind , 69-center trial enrolled adults with overactive bladder ( 8 or more average daily micturitions and 1 or more daily urge incontinence episodes ) . After a 1-week placebo run-in the patients were r and omized to 8 weeks of daily 0.25 , 1 or 4 mg serlopitant , 4 mg tolterodine extended release or placebo . Patients kept 7-day voiding diaries . The primary end point was change from baseline in micturitions per day . Secondary end points included urgency , total incontinence , urge incontinence episodes and incidence of dry mouth . RESULTS Of 557 patients r and omized 476 completed the trial and had valid efficacy data for analysis . Mean change from baseline in daily micturitions was significantly greater for 0.25 ( -1.1 ) and 4 mg ( -1.1 ) serlopitant , and for tolterodine ( -1.5 ) than for placebo ( -0.5 ) , but not for 1 mg serlopitant ( -0.8 ) . No serlopitant dose response was demonstrated . Tolterodine was numerically superior to all doses of serlopitant in mean micturitions per day and secondary end points . The incidence of dry mouth on serlopitant ( 3.3 % ) was comparable to placebo ( 4.6 % ) and lower than tolterodine ( 8.8 % ) . Serlopitant was generally well tolerated . CONCLUSIONS Serlopitant ( 0.25 and 4 mg ) significantly decreased the primary end point of daily micturitions but not the secondary end points compared with placebo . Serlopitant was generally well tolerated . Thus , NK-1 receptor antagonists may have a role in the treatment of overactive bladder but this compound does not offer advantages in efficacy compared to tolterodine PURPOSE We compared ambulatory urodynamics and conventional video cystometry findings in women with symptoms of bladder overactivity . MATERIAL S AND METHODS In a prospect i ve r and omized crossover study 106 women with symptoms of urinary urgency with or without incontinence were comprehensively investigated by video cystometry and ambulatory urodynamics in r and om order . In addition , all women completed a vali date d symptoms question naire and voiding diary . RESULTS Involuntary detrusor activity was detected in 32 and 70 cases on video cystometry and ambulatory urodynamics , respectively ( p < 0.001 ) . Video cystometry done according to International Continence Society st and ards diagnosed detrusor instability in 4 women with no involuntary detrusor activity on ambulatory urodynamics . Involuntary detrusor activity result ing in incontinence was observed in 39 cases on ambulatory urodynamics , including 20 ( 51 % ) with stable video cystometry results . Stress incontinence was diagnosed in 42 cases on video cystometry and in 34 on ambulatory urodynamics ( p = 0.629 ) . Increasingly severe urge and stress incontinence reported in the symptoms question naire correlated positively with the subsequent detection of detrusor overactivity and stress incontinence , respectively , on the 2 urodynamic tests . CONCLUSIONS In contrast to video cystometry , ambulatory urodynamics provides objective evidence of clinical ly important bladder overactivity in the majority of women with symptoms suggestive of bladder overactivity . The correlation of symptoms with ambulatory urodynamic findings implies that greater reliance may be placed on symptomatic diagnosis of bladder overactivity . Improved objective assessment of detrusor function provided by ambulatory urodynamics has implication s for the definition of bladder overactivity and relevance of conventional cystometry in this context . In women who complain of urgency stable conventional cystometrography findings should be interpreted with caution Abstract Objective : To compare tolterodine with oxybutynin and placebo in people with neuragenie detrusor overactivity . Design : Prospect i ve , r and omized , double-blind , crossover trial plus open-label comparative stage . Participants : Ten participants with neuragenie detrusor overactivity due to spinal cord injury or multiple sclerosis who usedintermittent catheterization . Methods : Bladder capacity on cystometrogram , a 10-day record of catheterization volumes , number of incontinent episodes perday , and perceived dry mouth using a visual analog scale ( VAS ) were measured for the following : ( a ) a blinded comparison : tolterodine , 2 mg twice daily , vs placebo , twice daily ; and ( b ) an unblinded comparison : oxybutynin vs tolterodine , each atself-selected doses ( SSDs ) . Results : Tolterodine , 2 mg twice daily , was superior to placebo in enhancing catheterization volumes ( P<0.0005 ) and reducingincontinence ( P<0.001 ) , but was comparable with placebo in cystometric bladder capacity . Efficacy of tolterodine SSD wascomparable with oxybutynin SSD with regard to catheterization volumes , degree of incontinence , and cystometric bladder capacity . The side effect profile ( dry mouth ) was comparable between tolterodine , 2 mg twice daily , and placebo , but differed significantlywhen comparing tolterodine SSD with oxybutynin SSD ( P<0.05 ) . Conclusion : T olterodine , when used at SSDs , is comparable with oxybutynin at SSDs in enhancing bladder volume and improvingcontinence , but with less dry mouth .  T olterodine at the recommended dosage of 2 mg twice daily improves incontinence and bladdervolumes compared with placebo , and without significant dry mouth . Larger doses of tolterodine may be needed to achieve best effectin this population , but further studies are required PURPOSE To evaluate the long term efficacy and safety of the use of propiverine and terazosine combination in patients with LUTS and DO by a placebo controlled study . MATERIAL S AND METHODS One hundred patients were enrolled in the study . They were r and omized into two groups ( each group consisted of 50 patients ) . Terazosine and placebo were administered to the patients in Group 1 and terazosine plus propiverine HCL was administered to Group 2 . The patients were evaluated by international prostate symptom score ( IPSS ) , the first four questions of IPSS ( IPSS4 ) , the 8th question of IPSS ( quality of life-QoL ) , overactive bladder symptom score question naire ( OAB-q V8 ) , PSA test , urodynamic studies , post voiding residue ( PVR ) . All patients were followed for one year and were reassessed for comparison . RESULTS IPSS , IPSS4 , OAB symptoms , QoL score , PVR , and Qmax scores of the groups did not differ . After one year treatment , there was significant improvement in IPSS , IPSS4 , OAB symptoms , QoL and Qmax values in Group 2 . No significant improvement was noted for the same parameters in Group 1 . CONCLUSION This is the first study to show long term safety and efficacy of anticholinergic therapy for patients with LUTS . In patients with OAB or DO , long term anticholinergic treatment may be regarded as a treatment option PURPOSE We analyze the efficacy of tolterodine extended release ( ER ) for overactive bladder in patients with severe incontinence . MATERIAL S AND METHODS Patients with urinary frequency ( 8 micturitions or greater per 24 hours ) , urge incontinence ( 5 episodes or greater a week ) and symptoms of overactive bladder for 6 months or greater were r and omized to treatment with 4 mg tolterodine ER once daily or placebo for 12 weeks . Severe incontinence was defined as 21 episodes or greater per week at baseline . Changes in the number of incontinence episodes per week and micturition frequency after 12 weeks were compared between treatments . RESULTS A total of 986 patients were eligible for this post-hoc analysis . After 12 weeks tolterodine ER produced a significant absolute median reduction in incontinence episodes per week compared to placebo ( 9.0 vs 5.0 , p < 0.0001 ) . For patients with severe incontinence at baseline median absolute and percentage reductions in incontinence episodes per week were significantly greater with tolterodine ER than placebo ( 21.0 vs 9.5 , p < 0.0001 ; 67.6 % vs 29.8 % , p = 0.022 ) . Micturition frequency decreased ( p < 0.02 ) and volume voided per micturition ( p < 0.0001 ) increased significantly more with tolterodine ER compared with placebo in these patients . For patients with nonsevere incontinence at baseline median reductions in incontinence episodes per week were also significantly greater with tolterodine ER than placebo ( 6.0 vs 4.0 , p < 0.0001 ; 71.4 % vs 38.5 % , p = 0.026 ) . CONCLUSIONS Patients with more severe incontinence at baseline achieved greater absolute reductions in incontinence with tolterodine compared to those with less severe symptoms . The degree of improvement , as measured by percent change , was comparable across the entire range of baseline incontinence severity strata . Benefits of antimuscarinic therapy may be greater in these patients than previously reported OBJECTIVE It is not always possible to clearly differentiate the symptoms of overactive bladder and interstitial cystitis . A prospect i ve r and omized study was performed to determine whether instillation of sodium chondroitin sulphate for treatment of interstitial cystitis is also effective in treating overactive bladder . The expected benefit of this therapeutic approach in overactive bladder is based on the assumption that the glycosaminoglycan layer may be damaged in overactive bladder as well . MATERIAL AND METHODS Patients with chronic overactive bladder were r and omized to one of two study groups each including 41 patients . Group A was treated with an anticholinergic agent ( tolterodine ) , group B with sodium chondroitin sulphate ( Uropol S ) . The diagnosis was established on the basis of a gynecologic examination and history , urodynamic testing , introital ultrasound , and cystoscopy . Patients were treated for 12 months . RESULTS An improvement of symptoms was reported by 15/35 ( 43 % ) of the patients in group A ( p = 0.000 ) as compared with 23/32 ( 72 % ) of the patients in group B. The subjective outcome was corroborated by means of urodynamic testing , number of pads used , voiding frequency , and nycturia ( voiding diary ) . Quality of life increased significantly in both groups in the course of treatment but there was no significant difference between both groups . CONCLUSION The results of the study presented here suggest that restoring the glycosaminoglycan layer also improves or cures the symptoms in patients with overactive bladder . Patients clearly benefit from instillation of sodium chondroitin sulphate . These results must be confirmed in larger studies before a wider use of this therapeutic option can be recommended 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 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 Objective : To determine the pharmacokinetics of oxybutynin and its main active metabolite , N-desethyloxybutynin , after multiple dosage ( 5 mg/30 ml three times daily ) of intravesical oxybutynin formulation . Furthermore , to determine the efficacy and safety of intravesical oxybutynin in the symptomatic relief of urge incontinence or urgency in adult patients with detrusor hyperreflexia or instability . Material and Methods : Nine patients were r and omly allocated to treatment with a special bladder instillation formulation of oxybutynin or placebo for two 14-day treatment periods in a double-blind , cross-over manner . The third , open study period was design ed for pharmacokinetic purpose s with all patients on the active drug . The pharmacokinetics was depicted by AUC 0 - 24 , C max , C min and t max . The efficacy was evaluated from the data collected from urinary voiding diaries and cystometries . The safety was measured by recording adverse events on question naires . Patients who were willing to continue with the intravesical oxybutynin treatment entered the 1-year extension part of the study . Results : Oxybutynin was absorbed from the bladder with a geometric mean C max of 9.4 ng/ml and AUC 0 - 24 of 92 ng*h/ml . For N-desethyloxybutynin , the geometric mean C max was 14.4 ng/ml and AUC 0 - 24 186 ng*h/ml . Elimination of the drug was protracted , as there were detectable serum concentrations of both oxybutynin and N-desethyloxybutynin even 24 hours postdose . The mean number of toilet visits/day decreased from the baseline value of 6.9 to 5.7 during oxybutynin treatment , whereas during the placebo period the value increased to 7.4 ( p = 0.022 ) . It remained at the same decreased level during the one-year follow-up period . Conclusions : Oxybutynin is readily absorbed from the bladder after intravesical administration . The serum concentrations of oxybutynin after single 5 mg intravesical doses are at least as high as those reported after oral drug intake , but the parent drug/ metabolite ratio is much higher after intravesical administration . The elimination of oxybutynin as well as its metabolite is prolonged after intravesical administration compared with that reported after oral drug intake . The mean number of daily toilet visits decreased significantly in the oxybutynin group Purpose : We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder ( OAB ) in Korean patients . Material s and methods : The study was r and omised , double-blind ,  tolterodine-controlled trial in Korea . Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3-day voiding diary period . Patients were r and omised to 12-week double-blind treatment with either tolterodine immediate release ( IR ) 2 mg twice daily ( TOL4 ) or solifenacin 5 mg ( SOL5 ) or 10 mg ( SOL10 ) once daily . The outcome measure was mean change in daily micturition frequency , volume , daily frequency of urgency incontinence , urgency and nocturia from baseline to week 12 . Quality of life was assessed using the King ’s Health Question naire . Results : A total of 357 were r and omised and 329 were evaluated for efficacy . All voiding parameters recorded in micturition diary improved after treatment in all three groups . Mean changes in volume voided were 19.30 ml ( 26.69 % ) in TOL4 , 30.37 ml ( 25.89 % ) in SOL5 and 37.12 ml ( 33.36 % ) in SOL10 group ( p = 0.03 ) . Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4 . Quality of life improved in all three groups . Dry mouth was the most common adverse event ; its incidence was the lowest in SOL5 group ( 7.63 % , compared with 19.49 % and 18.64 % in SOL10 and TOL4 groups respectively ) . Conclusions : Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg . Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB UNLABELLED The aim of this study was to evaluate the efficacy of the Posterior Tibial Nerve stimulation in women with overactivity bladder symptoms and the impact in the quality of life using the Overactivity Bladder Question naire ( OABq ) . METHODS thirty seven women from female urology outpatient clinic of the Hospital das Clinicas de Campinas ( HC/UNICAMP ) were enrolled in this prospect i ve , controlled and r and omized clinical trial . The patients were r and omly placed in one of two groups : TREATMENT GROUP : patients were su bmi tted to tibial posterior nerve electrical stimulation ( n=21 ) and Sham group : patients had electrodes placed without electricity ( n = 16 ) . After informed consent the patients underwent a physiotherapeutic evaluation , that included voiding diary and the overactivity bladder question naire ( OABq ) . The treatment schedule included eight sessions of electrical stimulation in the posterior tibial nerve , twice a week . RESULTS there were significant changes in symptoms such as frequency and nocturia ( p=0,003 and p=0,001 ) . The urgency and quality of life was improved in both group after treatment . CONCLUSION The posterior tibial nerve electrical stimulation is an effective treatment in overactive bladder Aims : To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder ( OAB ) who were dissatisfied with previous tolterodine treatment . Methods : This was a 12-week , open-label , flexible-dose study of adults with OAB ( ≥ 8 micturitions and ≥ 3 urgency episodes per 24 h ) who had been treated with tolterodine ( immediate- or extended-release ) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment . Subjects received fesoterodine 4 mg once daily for 4 weeks ; thereafter , daily dosage was maintained at 4 mg or increased to 8 mg based on the subject ’s and physician ’s subjective assessment of efficacy and tolerability . Subjects completed 5-day diaries , the Patient Perception of Bladder Condition ( PPBC ) and the Overactive Bladder Question naire ( OAB-q ) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question ( TSQ ) . Safety and tolerability were assessed . Results : Among 516 subjects treated , approximately 50 % opted for dose escalation to 8 mg at week 4 . Significant improvements from baseline to week 12 were observed in micturitions , urgency urinary incontinence episodes , micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h ( all p < 0.0001 ) . Approximately 80 % of subjects who responded to the TSQ at week 12 reported satisfaction with treatment ; 38 % reported being very satisfied . Using the PPBC , 83 % of subjects reported improvement at week 12 with 59 % reporting improvement ≥ 2 points . Significant improvements from baseline ( p < 0.0001 ) exceeding the minimally important difference ( 10 points ) were observed in OAB-q Symptom Bother and Health-Related Quality of Life ( HRQL ) scales and all four HRQL domains . Dry mouth ( 23 % ) and constipation ( 5 % ) were the most common adverse events ; no safety issues were identified . Conclusion : Flexible-dose fesoterodine  significantly improved OAB symptoms , HRQL , and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy PURPOSE We tested the efficacy and side effect profiles of intravesical atropine compared to oxybutynin immediate release when used by individuals with multiple sclerosis . MATERIAL S AND METHODS We performed a study to determine the most effective dose of atropine .  Eight participants used increasing doses of intravesical atropine during a 12-day period . Bladder diary data showed that the instillation of 6 mg atropine 4 times daily was most effective for increasing bladder capacity ( voided/catheter volumes ) . We then did a r and omized , double-blind crossover trial . Participants received 14 days of treatment with oral oxybutynin or with intravesical atropine , followed by 14 days of alternative treatment . Participants recorded a bladder diary and rated side effects and quality of life . The primary outcome variable was bladder capacity . RESULTS A total of 57 participants with multiple sclerosis completed the study . Average change in bladder capacity was higher in the atropine arm . The mean + /- SD  oxybutynin change was 55.5 + /- 67.2 ml , the mean atropine change was 79.6 + /- 89.6 ml and the mean difference between arms was 24.1 ml ( 95 % CI -0.4 , 49.7 ; p = 0.053 ) . Changes in incontinence events and voiding frequency were not statistically different between the arms . Changes in total side effect and dry mouth scores were significantly better in the atropine treatment arm . CONCLUSIONS Intravesical atropine was as effective as oxybutynin immediate release for increasing bladder capacity and it was probably better with less antimuscarinic side effects . We recommend that intravesical atropine should be made available to patients with neurogenic detrusor overactivity and voiding problems requiring intermittent catheterization as an alternative to oral therapy , which often has troublesome side effects This study evaluated the efficacy , tolerability , and safety of darifenacin , an M3 selective receptor antagonist ( M3 SRA ) , in patients with overactive bladder ( OAB ) . In a multicenter , double-blind , placebo-controlled dose-ranging study , 439 adult OAB patients ( 85.4 % female ) were r and omized  to darifenacin controlled-release tablets 7.5 mg ( n = 108 ) , 15 mg ( n = 107 ) or 30 mg ( n = 115 ) qd , or placebo ( n = 109 ) for 12 weeks . Darifenacin significantly reduced the median number of incontinence episodes/week ( −68.7 , −76.5 , and −77.3 % from baseline at 7.5 , 15 , and 30 mg , respectively , vs −46 % with placebo , all p < 0.01 ) and dose relatedly improved micturition frequency , frequency and severity of urgency , nocturia , and bladder capacity . Darifenacin was well tolerated . Adverse events were commonly mild to moderate dry mouth and constipation . There were no safety concerns . Darifenacin is effective and well tolerated in the treatment of OAB , with 7.5 and 15 mg doses offering flexibility of dosing for optimal treatment outcome A r and omized , double-blind , placebo-controlled , four-way crossover , safety study of darifenacin versus oxybutynin was carried out on 76 patients with overactive bladder ( OAB ) . Adults with OAB received 2 weeks each of darifenacin 15 and 30 mg once daily ( q.d . ) , oxybutynin 5 mg three times daily ( t.i.d . ) and placebo , in r and om sequence at 10-day intervals . Darifenacin and oxybutynin significantly reduced incontinence episodes , and the number/severity of urgency episodes ( all P<0.05 versus placebo ) . Improvements in OAB symptoms with darifenacin were dose-dependent . Dry mouth was less common with darifenacin 15 mg than oxybutynin ( 13 % and 36 % ; P<0.05 ) , while constipation was comparable ( 10 % and 8 % , respectively ) . Corresponding rates for darifenacin 30 mg were 34 % and 21 % , respectively . Patients only reported blurred vision or dizziness with oxybutynin ( 3 % and 2 % , respectively ) . Darifenacin ( 15 mg q.d . ) provides comparable efficacy with improved tolerability versus oxybutynin ( 5 mg t.i.d . ) in the treatment of patients with OAB To evaluate the time to onset of statistically significant and clinical ly meaningful effects of trospium chloride in patients with an overactive bladder ( OAB ) 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 INTRODUCTION Overactive bladder syndrome ( OAB ) is a chronic disorder that often requires long-term treatment . There is a growing interest in new substances . In vitro experiments of Bryophyllum pinnatum ( BP ) on porcine bladder muscle have shown a muscle-relaxing effect . In this clinical trial we evaluated BP versus placebo regarding efficacy and safety . MATERIAL S AND METHODS Prospect i ve , double-blind r and omized , placebo-controlled study with 20 patients ( 10 BP , 10 placebo ) ; medication over 8 weeks ; dosage 3 × 2 capsules BP 50 % ( 350 mg)/day or placebo ( lactose ) . Primary aim : reduction of the micturition frequency/24h . Secondary aim : change in quality of life , alterations of parameters in the bladder diary and adverse events ( AE ) . Statistical analysis was performed with IBM SPSS Statistics 20 . The groups were compared using Fisher 's exact test and the Mann-Whitney test ; the visits using the Wilcoxon signed ranks test . RESULTS Both groups did not differ significantly in demographical data . For the primary endpoint , a trend in the reduction of the micturition frequency/24h in the BP group was found : 9.5±2.2 before and 7.8±1.2 after BP versus 9.3±1.8 before and 9.1±1.6 after placebo , p=0.064 . From visit 2 to visit 4 , micturition frequency/24h improved in 8/10 patients in the BP group ( p=0.037 ) . In the placebo group , micturition frequency/24h improved in 5/9 patients ( p=0.89 ) . Improvement of the QoL did not differ between the two groups . The incidence of AE was similar in both groups , no SAE occurred . CONCLUSION The successful safety outcome and positive trend for efficacy permits BP to be further evaluated as a favorable treatment option for OAB PURPOSE We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron  50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg . MATERIAL S AND METHODS Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were r and omized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg , or solifenacin 5 or 10 mg for 12 weeks . The mirabegron dose was increased from 25 to 50 mg after week 4 . Symptom bother , health related quality of life and patient perception of bladder condition were assessed by OAB-q ( Overactive Bladder Question naire ) and the PPBC ( Patient Perception of Bladder Condition ) question naire , respectively . Responder rates were based on a 50 % reduction in daily incontinence , zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC . RESULTS Overall 2,174 patients with a median age of 59 years were r and omized , including 727 to the combination , 728 to solifenacin 5 mg and 719 to solifenacin 10 mg . Symptom bother , total health related quality of life and its subscales ( coping , concern and social ) , and PPBC were significantly improved with combination vs solifenacin monotherapy ( p < 0.05 ) . The odds of achieving clinical ly meaningful improvements in incontinence , micturition frequency , symptom bother , health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy . The odds of becoming continent was 47 % and 28 % higher for combination vs solifenacin 5 and 10 mg ( OR 1.47 , 95 % CI 1.17 - 1.84 , p = 0.001 and OR 1.28 ; 95 % CI 1.02 - 1.61 , p = 0.033 , respectively ) . CONCLUSIONS Significantly more patients on the combination achieved clinical ly meaningful improvements in incontinence and micturition frequency . Improvements were accompanied by similar improvements in PPBC , symptom bother and health related quality of life OBJECTIVES To compare the efficacy and tolerability of imidafenacin , a novel antimuscarinic agent , with propiverine and a placebo in Japanese patients with overactive bladder ( OAB ) . METHODS Men and women having OAB symptoms were r and omized to double-blind treatment with 0.1 mg of imidafenacin twice daily , 20 mg of propiverine once daily , or a placebo for 12 weeks , and assessed for efficacy and safety . RESULTS Overall , 781 patients were r and omized to imidafenacin ( 324 ) , propiverine ( 310 ) , or a placebo ( 147 ) . After 12 weeks of treatment , a significantly larger reduction in the mean number of incontinence episodes was observed in the imidafenacin group than in the placebo group ( P < 0.0001 ) . The non-inferiority of imidafenacin compared with propiverine was confirmed for the reduction in using incontinence episodes ( P = 0.0014 , non-inferiority margin : 14.5 % ) . Imidafenacin was well tolerated . The incidence of adverse events with imidafenacin was significantly lower than with propiverine ( P = 0.0101 ) . Dry mouth , the most common adverse event , was significantly more common in the propiverine group than in the imidafenacin group ( P = 0.0302 ) . There were no significant increases in either the imidafenacin or placebo group in the mean QTc interval , whereas there was a significant increase in the mean QTc interval in the propiverine group ( P < 0.0001 ) , but there were no clinical arrhythmia and clinical arrhythmic events in any of the treatment groups . CONCLUSIONS The novel antimuscarinic agent imidafenacin at a dose of 0.1 mg twice daily was not inferior to propiverine for the reduction of incontinence episodes , and well tolerated for the treatment of OAB symptoms
Pelvic floor exercises are more effective in subjective and objective outcomes with biofeedback or verbal feedback .
Weight loss with diet and exercise , caffeine reduction , 25 - 50 % reduction in fluid intake , and pelvic floor muscle exercises with verbal instruction and or biofeedback were all efficacious .
Botulinum toxin A improves urge incontinence episodes , urgency , frequency , quality of life , nocturia , and urodynamic testing parameters .
Acupuncture  improves quality of life and urodynamic testing parameters .
Extracorporeal magnetic stimulation improves urodynamic parameters .
Mirabegron improves daily incontinence episodes , nocturia , number of daily voids , and urine volume per void , whereas solabegron improves daily incontinence episodes .
Short-term posterior tibial nerve stimulation is more efficacious than pelvic floor muscle training exercises and behavioral therapy for improving : urgency , urinary incontinence episodes , daily voids , volume per void , and overall quality of life .
Sacral neuromodulation is more efficacious than antimuscarinic treatment for subjective improvement of overactive bladder and quality of life .
Transvaginal electrical stimulation demonstrates subjective improvement in overactive bladder symptoms and urodynamic parameters .
Multiple therapies , including physical therapy , behavioral therapy , botulinum toxin A , acupuncture , magnetic stimulation , mirabegron , posterior tibial nerve stimulation , sacral neuromodulation , and transvaginal electrical stimulation , are efficacious in the treatment of overactive bladder
The purpose of the study was to determine the efficacy and safety of nonantimuscarinic treatments for overactive bladder .