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) Dose-escalating study of the pharmacokinetics and tolerability of fesoterodine in children with overactive bladder. Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Phase III, randomised, double‐blind, placebo‐controlled study of the β3‐adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder Transcutaneous posterior tibial nerve stimulation in pediatric overactive bladder: A preliminary report. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study) Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. An overactive bladder online self-management program with embedded avatars: a randomized controlled trial of efficacy. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia. [Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder]. Long-term darifenacin treatment for overactive bladder in patients aged 65 years and older: analysis of results from a 2-year, open-label extension study Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin: a randomized, placebo-controlled trial Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation No immediate effect on urodynamic parameters during transcutaneous electrical nerve stimulation (TENS) in children with overactive bladder and daytime incontinence-A randomized, double-blind, placebo-controlled 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 Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study.
To examine the safety and efficacy of mirabegron as ‘ add‐on ’ therapy to solifenacin in patients with overactive bladder ( OAB ) 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 OBJECTIVES To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release ( TER ) in men with overactive bladder ( OAB ) and nocturia . METHODS This was a post hoc analysis of data from two 12-week , double-blind , placebo-controlled trials of nighttime ( < 4 hours before bedtime ) TER ( 4 mg daily ) dosing . Men with a mean micturition frequency of eight or more times in 24 hours , including a mean of 2.5 or more nocturia episodes/night , were included . For each micturition , patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale ( 1 , none ; 2 , mild ; 3 , moderate ; 4 , severe ; 5 , urgency urinary incontinence ) . Micturitions were analyzed post hoc by urgency rating categories : total ( 1 to 5 ) , non-OAB ( 1 to 2 ) , OAB ( 3 to 5 ) , and severe OAB ( 4 to 5 ) . Adverse events were recorded throughout the study . RESULTS A total of 745 men ( mean age 64 years ) were r and omized to placebo ( n = 374 ) or TER ( n = 371 ) . Of the 745 men , 73 % reported no incontinence episodes in a 7-day diary at baseline . At week 12 , the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total , OAB , and severe OAB micturitions were significantly reduced in the TER group versus the placebo group . The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo . Adverse events associated with TER were low and comparable to those in the placebo group , with the exception of dry mouth ( 11 % versus 4 % ) . Withdrawals because of adverse events were infrequent ( 3 % TER , 4 % placebo ) . Five men were withdrawn for symptoms suggestive of urinary retention ( 3 TER , 2 placebo ) . CONCLUSIONS Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia Introduction A prespecified pooled analysis of two placebo-controlled , phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder ( OAB ) patients with urinary incontinence ( UI ) . Methods Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo , sparing the trigone . Change from baseline at week 12 in UI episodes/day , proportion of patients reporting a positive response ( ‘ greatly improved ’ or ‘ improved ’ ) on the treatment benefit scale ( TBS ) , micturition and urgency were evaluated by number of prior anticholinergics ( 1 , 2 or ≥ 3 ) and reason for their discontinuation ( insufficient efficacy or side effects ) . Adverse events ( AE ) were assessed . Results Patients had taken an average of 2.4 anticholinergics before study enrolment . OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo , regardless of the number of prior anticholinergics ( −2.82 vs. −1.52 for one prior anticholinergic ; −2.58 vs. −0.58 for two prior anticholinergics ; and −2.92 vs. −0.73 for three or more prior anticholinergics ; all p < 0.001 ) . The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo ( 69.0 % vs. 37.2 % for one prior anticholinergic ; 58.8 % vs. 24.8 % for two prior anticholinergics and 56.4 % vs. 22.5 % for three or more prior anticholinergics ; all p < 0.001 ) . Similar results were observed regardless of the reason for discontinuation . OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups . AEs were well tolerated , with a comparable incidence in all groups . Conclusion In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics , onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB . Clinical Trials.gov : NCT00910845 , NCT00910520 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 BACKGROUND Overactive bladder ( OAB ) syndrome with urinary incontinence ( UI ) is prevalent in the population and impairs health-related quality of life ( HRQOL ) . OBJECTIVE To assess the impact on efficacy , safety , and HRQOL of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) treatment in patients with OAB with UI . DESIGN , SETTING , AND PARTICIPANTS This pivotal , multicentre , double-blind , r and omised , placebo-controlled , phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics . INTERVENTION OnabotulinumtoxinA at a 100U dose ( n=277 ) or placebo ( n=271 ) , administered as 20 intradetrusor injections of 0.5 ml . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Co- primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale ( TBS ) at week 12 . Additional end points included other OAB symptoms ( episodes of urinary urgency incontinence , micturition , urgency , and nocturia ) and HRQOL ( Incontinence Quality of Life [ I-QOL ] , King 's Health Question naire [ KHQ ] ) . Safety assessment s included adverse events ( AEs ) , postvoid residual ( PVR ) urine volume , and initiation of clean intermittent catheterisation ( CIC ) . RESULTS AND LIMITATIONS OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 ( -2.95 for onabotulinumtoxinA versus -1.03 for placebo ; p<0.001 ) . Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo ( p ≤ 0.01 ) . Patients perceived a significant improvement in their condition , as measured by patients with a positive treatment response on the TBS ( 62.8 % for onabotulinumtoxinA versus 26.8 % for placebo ; p<0.001 ) . Clinical ly meaningful improvements from baseline in all I-QOL and KHQ multi-item domains ( p<0.001 versus placebo ) indicated positive impact on HRQOL . AEs were mainly localised to the urinary tract . Mean PVR was higher in the onabotulinumtoxinA group ( 46.9 ml versus 10.1 ml at week 2 ; p<0.001 ) ; 6.9 % of onabotulinumtoxinA patients versus 0.7 % of placebo patients initiated CIC . CONCLUSIONS OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinical ly relevant improvements in all OAB symptoms , patient-reported benefit , and HRQOL in patients inadequately managed by anticholinergics . TRIAL REGISTRATION Clinical Trials.gov : NCT00910520 To evaluate the efficacy and safety of the β3‐adrenoceptor agonist mirabegron , in a Japanese population with overactive bladder ( OAB ) BACKGROUND Non-neurogenic overactive bladder ( OAB ) is a common problem in children that may affect their quality of life . Various methods of neuromodulation have been reported to treat refractory lower urinary tract dysfunction . Since most of these techniques are invasive , they are less applicable in children . OBJECTIVE To evaluate the efficacy of transcutaneous PTNS in treatment of OAB in children , in a r and omized clinical setting . STUDY DESIGN This study was single-blinded , prospect i ve , sham controlled r and omized trial . 40 children with non-neurogenic OAB refractory to behavioural and anticholinergic therapy were r and omized either to test group or sham group . Neuromodulation was performed using two self-adhesive electrodes cephalad to medial malleolus . In test group the stimulation was given with voltage pulse intensity of 0 to 10 mA , pulse width of 200 μs and frequency of 20 Hz . In sham group patch electrodes were applied to simulate the test group but no stimulation was given . In both groups , weekly session of 30 min was given for a period of 12 weeks . The OAB symptoms , severity of incontinence , number of voids daily ( NV ) , average voided volume ( AVV ) and maximum voided volume ( MVV ) were evaluated before and after treatment . RESULTS On assessment of subjective improvement of OAB symptoms , 66.66 % patients reported cure and 23.81 % patients reported significant improvement of symptoms in test group whereas in sham group only 6.25 % patients reported significant improvement . In test group 71.42 % patients reported complete improvement in incontinence whereas in sham group only 12.5 % patient reported complete improvement . The AVV , MVV and NV improved significantly in test group ( p < 0.001 ) as compared to sham group ( Table ) . DISCUSSION The present study is unique as none of the earlier studies in children were sham controlled . It is also first PTNS study in which patch electrodes were used ; therefore it is completely noninvasive . This technique provides better patient acceptability and compliance . This study proved that , there is a definite effect of PTNS as compared to placebo because when patients from sham group were treated actively , they responded well . The present study has few limitations as it has relatively short follow-up period of 12 weeks . Relapse of OAB symptoms and maintenance schedule of PTNS need to be assessed further . CONCLUSION Transcutaneous PTNS is superior to placebo in treatment of non-neurogenic overactive bladder in children . In view of its effectiveness and acceptability we believe that transcutaneous PTNS should be part of pediatric urology armamentarium for treatment of OAB 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 ) Abstract Objective : It is widely recognized that patient perception of overactive bladder ( OAB ) symptoms can vary considerably from mild to severe bother . This post hoc analysis reports outcomes in patients with severe OAB symptoms at baseline taken from the VESIcare Efficacy and Safety in PatieNts with Urgency Study ( VENUS ) . Methods : VENUS was a 12-week , r and omized , double-blind , placebo-controlled trial of solifenacin ( 5 or 10 mg/day , flexibly dosed ) in OAB patients . The primary endpoint in VENUS was mean change from baseline to study end in urgency episodes/day using 3-day bladder diaries . Secondary endpoints included other diary endpoints ( frequency , incontinence , and nocturia ) , warning time ( WT ; time between first sensation of urgency to voiding ) , and patient-reported outcome ( PRO ) measures of urgency ( the Indevus Urgency Severity Scale [ IUSS ] and Urgency Perception Scale [ UPS ] ) and of symptom bother and health-related quality of life ( HRQL ) ( the Patient Perception of Bladder Condition [ PPBC ] and Overactive Bladder Question naire ) . For this analysis , severe OAB was defined as baseline PPBC score ≥5 ( 1 = no problems , 6 = many severe problems ) . Trial registration : NCT00454896 Results : In total , 158/707 ( 22.3 % ) patients in the full analysis set ( FAS ) reported severe OAB symptoms  . Solifenacin  reduced mean urgency episodes/day  versus placebo in the severe subgroup ( −4.6 vs. −3.1 , p = 0.1150 ) , similar to the significant reduction observed in the FAS ( −3.9 vs. −2.7 , p < 0.0001 ) . Solifenacin also improved the other diary endpoints and PRO measures in the severe subgroup ; these changes were consistent with the significant solifenacin- versus placebo-related improvements for the FAS . Treatment-emergent adverse events were mostly mild/moderate , and few patients taking solifenacin or placebo discontinued treatment in the severe subgroup ( 4.5 % vs. 6.5 % ) or FAS ( 6.5 % vs. 4.6 % ) . Key limitations are that VENUS was not powered to detect treatment differences in subgroups , and that the lack of a st and ardized definition of OAB symptom severity may limit the generalizability of the findings . Conclusions : Patients with severe OAB symptoms showed objective and subjective improvements in symptoms , symptom bother , HRQL , and urgency severity with solifenacin similar to the FAS . Solifenacin was also well-tolerated in this subgroup 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 OBJECTIVE To determine whether an avatar-based , online , self-management program is an effective therapeutic approach for women with overactive bladder ( OAB ) . OAB is a highly prevalent symptom complex that significantly impacts health-related quality of life ( HRQOL ) . Behavioral interventions can produce substantial improvement in symptoms and HRQOL . Online education programs offer patients with OAB an alternative to face-to-face self-management instruction . Evidence suggests that avatars ( digital humans ) embedded into online programs may help persuade and motivate patients to adopt healthy behaviors . METHODS In a 12-week , r and omized , controlled trial , women ( aged > 55 years ) with symptoms of OAB for at least 3 months were r and omized to 2 versions of a 3-part , online , self-management program . After collecting the baseline metrics , the intervention group viewed a generic avatar coach with a self-avatar peer mentor design ed to resemble the participant , and the control group viewed the identical online program with voice only . Participants viewed part 1 at week 1 and parts 2 and 3 at week 6 . Participants completed daily bladder diaries throughout the 12-week period and OAB-related outcome measures at weeks 1 , 6 , and 12 . RESULTS Forty-one women completed the study ( mean age = 61 years , st and ard deviation = 6 ) . The analysis of covariance of week-12 outcome measures with the baseline as covariates demonstrated significant improvements in the intervention group in OAB question naire HRQOL ( P = .02 ; large effect ) , 24-hour frequency ( P < .001 ; large effect ) , night-time urination ( P < .001 ; large effect ) , urgency ( P < .001 ; large effect ) , and urge incontinence ( P < .001 ; large effect ) . CONCLUSION An avatar-based intervention embedded into an online self-management program improved OAB HRQOL and symptoms in women BACKGROUND Solifenacin , an effective , well-tolerated treatment for adult overactive bladder ( OAB ) symptoms , has not been evaluated in placebo-controlled paediatric clinical trials . OBJECTIVES To evaluate the efficacy and safety of once-daily oral solifenacin suspension in OAB patients aged 5-<12 yr ( children ) and 12-<18 yr ( adolescents ) . DESIGN , SETTING , AND PARTICIPANTS The study involved a 4-wk urotherapy run-in followed by 1:1 r and omisation to 12-wk double-blind solifenacin or placebo treatment alongside urotherapy . INTERVENTION Solifenacin paediatric equivalent doses ( PEDs ) of adult doses : 2.5 mg , 5 mg , 7.5 mg , and 10 mg . The starting dose was PED 5 mg ; all patients were titrated to an optimum dose at 3-wk intervals over 9 wk , result ing in ≥3 wk at the optimum dose before end of treatment ( EoT ) . OUTCOME MEASUREMENTS AND STATISTICS Superiority of solifenacin versus placebo in change from baseline to EoT for mean volume voided/micturition ( MVV , primary endpoint ) ; daytime maximum volume voided/micturition ( DMaxVV ) ; incontinence episodes ( mean/24h ) ; mean number of incontinence-free days or nights/7 d ; micturition frequency ; and Micturition frequency adjusted for baseline total voided volume ( VTB ) as an exploratory parameter ) . Efficacy parameters were analysed using analysis of covariance . Safety parameters ( treatment-emergent adverse events , serious adverse events , laboratory variables , vital signs , electrocardiogram , postvoid residual volume ) are summarised using descriptive statistics . RESULTS AND LIMITATIONS In children , solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV  ( solifenacin-placebo difference 12.1ml , 95 % confidence interval [ CI ] 0.2 - 24.0 ; p=0.046 ) , DMaxVV ( difference in adjusted mean change from baseline for solifenacin-placebo 31.9ml , 95 % CI 4.3 - 59.5 ; p=0.024 ) , VTB-adjusted micturition frequency ( p=0.028 ) . Other endpoints were not significantly different . Solifenacin was well tolerated . For adolescents , it was not possible to draw firm efficacy conclusions because of the low numbers recruited . CONCLUSIONS Once-daily solifenacin oral suspension in children with OAB was superior to placebo for MVV ( primary efficacy endpoint ) and was well tolerated . PATIENT SUMMARY In this 12-wk study , a once-daily oral suspension of solifenacin in children aged 5-<12 yr with overactive bladder was superior to placebo in increasing mean volume voided/micturition , the primary efficacy variable in the study . Solifenacin was well tolerated , with a low incidence of dry mouth and constipation . This study is registered at Clinical Trials.gov as NCT01565707 OBJECTIVES To evaluate the efficacy and tolerability of nighttime tolterodine dosing on urgency-related micturitions in patients with overactive bladder ( OAB ) and nocturia . METHODS This was a 12-week r and omized controlled study of 850 patients given 4 mg tolterodine extended release ( TER ) or placebo once daily 4 hours or less before bed . Patients with eight or more micturitions/24 hours and a mean of 2.5 episodes/night or more were included . Changes in the number of nighttime and 24-hour micturitions were analyzed by urgency rating per micturition . The urgency per micturition was recorded in 7-day diaries using a 5-point rating scale ( score 1 to 5 ) . Each micturition was classified according to the following urgency rating categories : total ( 1 to 5 ) , non-OAB ( 1 to 2 ) , or OAB ( 3 to 5 ) . OAB-related micturitions were further classified as nonsevere ( score 3 ) and severe ( score 4 to 5 ) . RESULTS TER reduced the total number of nocturnal micturitions , but , compared with placebo , this difference was not statistically significant . However , TER did significantly reduce OAB-related and severe OAB-related nocturnal micturitions compared with placebo . TER had no effect on non-OAB micturitions . TER significantly reduced the total , OAB , and severe OAB micturitions during 24-hour and daytime intervals compared with placebo . Significantly more TER-treated than placebo-treated patients reported a treatment benefit and willingness to continue treatment . Adverse events associated with nighttime dosing of TER versus placebo were few . CONCLUSIONS TER significantly reduced OAB-related micturitions during 24-hour , daytime , and nighttime intervals . TER did not affect normal ( non-OAB ) micturitions . Nighttime dosing with TER was associated with few adverse events and adverse event-related withdrawals . The 24-hour efficacy of TER was maintained with nighttime dosing 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 ABSTRACT Objectives : This analysis evaluated the long-term safety , tolerability and efficacy of darifenacin , a muscarinic M3 selective receptor antagonist , in the treatment of overactive bladder ( OAB ) in patients ≥ 65 years of age . Methods : Patients who completed one of two 12-week , placebo-controlled , double-blind , feeder studies received once-daily ( o.d . ) treatment with darifenacin 7.5 mg for the first 2 weeks of the 2-year , open-label extension study . The dose could be subsequently adjusted ( 7.5 or 15 mg o.d . ) according to need . Safety and tolerability were assessed , and efficacy variables/endpoints were evaluated from patient diary data . Results : 214 patients ( 65–89 years ) entered and 137 ( 64.0 % ) completed the 2-year extension study , amounting to 308 patient-years ’ drug exposure .  Darifenacin was well tolerated with no new safety concerns . The most common adverse events ( AEs ) were dry mouth and constipation , which infrequently result ed in discontinuation ( 2.3 % and 4.2 % , respectively ) . Darifenacin produced significant improvements in OAB symptoms that were maintained over the 2-year period ( median reduction from feeder- study baseline to 2 years : –11.0 [ –83.7 % ] for incontinence episodes/week and –1.2 [ –12.4 % ] for micturitions/day , both p < 0.05 ) , with 44.4 % patients achieving ≥ 90 % reduction in incontinence episodes at 2 years . Conclusions : Darifenacin demonstrated good tolerability and safety in older patients with OAB .  The improvement in OAB symptoms was sustained throughout the 2-year extension , result ing in high treatment persistence rates . Results were comparable with those in the overall OAB population from this study , indicating that darifenacin treatment is effective and well tolerated irrespective of age BACKGROUND Until now no confirmatory clinical trial in children suffering from nonneurogenic overactive bladder ( OAB ) and urinary incontinence could demonstrate superiority for antimuscarinics over placebo . OBJECTIVES The following study was conducted to prove efficacy and tolerability of propiverine compared to placebo . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled phase 3 trial with parallel-group design in children aged 5 - 10 yr was performed . Prior to the 8-wk medical therapy urologic baseline diagnostics , a 3-wk lifestyle advice ( urotherapy ) was established . INTERVENTION After re-evaluation of in- and exclusion criteria and uroflowmetry , only children fulfilling the requested criteria were allocated to a body-weight-adjusted therapy ( 10 or 15 mg propiverine twice daily or corresponding placebo ) . MEASUREMENTS Efficacy parameters derived from bladder diary and a micturition volume protocol . Decrease in voiding frequency per day was chosen as primary efficacy parameter ; secondary endpoints included voided volume and incontinence episodes . A safety assessment was conducted . RESULTS AND LIMITATIONS Of 171 r and omized children , 87 were treated with propiverine and 84 with placebo .  The primary efficacy parameter showed a decrease in voiding frequency ( -2.0 episodes for propiverine versus -1.2 for placebo ; p=0.0007 ) . Superiority could also be demonstrated for voided volume ( 31.4 vs. 5.1 ml ; p<0.0001 ) and incontinence episodes ( -0.5 vs. -0.2 episodes per d ; p=0.0005 ) . The trial design did not allow for separate evaluation of the effect of urotherapy prior to medical treatment . Propiverine was well-tolerated in children . Altogether 23 % of side-effects were reported for propiverine and 20 % for placebo . CONCLUSIONS This clinical trial showed superior efficacy of propiverine over placebo and good tolerability for the treatment of children suffering from OAB and urinary incontinence . An important additional factor for the success of the trial was a modified trial design with previous urotherapy . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00603343 BACKGROUND Despite several antimuscarinic treatment options for overactive bladder ( OAB ) , there is still a need for distinct treatment approaches to manage this condition . Mirabegron , a β(3)-adrenoceptor agonist , has demonstrated efficacy and tolerability for up to 12 wk in phase 3 trials . OBJECTIVE To assess the 12-mo safety and efficacy of mirabegron . DESIGN , SETTING , AND PARTICIPANTS Patients ≥ 18 yr of age with OAB symptoms for ≥ 3 mo . INTERVENTIONS After a 2-wk single-blind placebo run-in , patients with eight or more micturitions per 24h and three or more urgency episodes in a 3-d micturition diary were r and omized 1:1:1 to once-daily mirabegron 50 mg , mirabegron 100 mg , or tolterodine extended release ( ER ) 4 mg for 12 mo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary variable : incidence and severity of treatment-emergent AEs ( TEAEs ) . Secondary variables : change from baseline at months 1 , 3 , 6 , 9 , and 12 in key OAB symptoms . RESULTS AND LIMITATIONS A total of 812 , 820 , and 812 patients  received mirabegron 50 mg , mirabegron 100 mg , and tolterodine ER 4 mg , respectively . Baseline demographic and OAB characteristics were similar across groups . TEAEs were reported in 59.7 % , 61.3 % , and 62.6 % of patients , respectively ; most were mild or moderate . Serious TEAEs were reported in 5.2 % , 6.2 % , and 5.4 % of patients , respectively . The most common TEAEs were similar across groups . Dry mouth was reported by 2.8 % , 2.3 % , and 8.6 % of patients , respectively . Adjusted mean changes from baseline to final visit in morning systolic blood pressure were 0.2 , 0.4 , and -0.5 mm Hg for mirabegron 50 mg , 100 mg , and tolterodine ER 4 mg , respectively . Mirabegron and the active control , tolterodine , improved key OAB symptoms from the first measured time point of 4 wk , and efficacy was maintained throughout the 12-mo treatment period . The study was not placebo controlled , which was a limitation . CONCLUSIONS The safety and tolerability of mirabegron was established over 1 yr , with sustained efficacy observed over this treatment period . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00688688 Overactive bladder ( OAB ) has a significant impact on a patient ’s health-related quality of life ( HRQoL ) . This study assessed the HRQoL of Japanese OAB patients following 12 weeks ’ treatment with tolterodine extended release ( ER ) or oxybutynin .  A total of 293 patients with symptoms of OAB were r and omized for treatment with tolterodine ER 4 mg once daily ( n=114 ) , oxybutynin 3 mg three times daily ( n=122 ) or a placebo ( n=57 ) . Treatment efficacy and safety assessment s were made over the 12-week period . HRQoL was assessed using the King ’s Health Question naire ( KHQ ) . Patients receiving tolterodine ER or oxybutynin showed a significant ( P<0.05 ) improvement in the Incontinence Impact , Role Limitations and most other KHQ domains compared with the placebo . These changes in HRQoL corresponded with significant ( P<0.05 ) improvements in micturition diary variables for patients receiving tolterodine ER and oxybutynin compared with placebo . Our findings demonstrate that Japanese OAB patients receiving tolterodine ER or oxybutynin experienced overall improvement in their quality of life 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 AIM To evaluate the immediate effect on natural fill urodynamic parameters and bladder function during transcutaneous electrical nerve stimulation ( TENS ) in children with overactive bladder ( OAB ) and daytime urinary incontinence ( DUI ) . MEETHODS In this double-blind , placebo-controlled study , 24 children with severe OAB and DUI ( mean age 8.5 ± 1.2 years ) underwent 48-h natural fill urodynamics . After 24 h of baseline investigation , the children were r and omized to either active continuous TENS ( n = 12 ) or placebo TENS ( n = 12 ) over the sacral S2-S3 outflow . The urodynamic recordings were analyzed manually for three different bladder contraction patterns result ing in a void . The number of bladder contractions not leading to a void was also calculated . Maximum voided volume ( MVV ) and average voided volume ( AVV ) were identified for both the baseline and the intervention day . RESULTS We found that TENS had no immediate objective effect on bladder capacity . The difference ( before minus after treatment ) in MVV/EBC in the active TENS group = 0.03 ± 0.23 versus placebo TENS group = -0.01 ± 0.10 ( P = 0.61 ) . Also , there was no significant difference in the proportion of different bladder contraction types between the two groups . TENS did not significantly influence the number of bladder contractions not leading to a void . Results are presented as mean ± SD . CONCLUSION There is no immediate objective effect of TENS on bladder activity assessed by natural fill urodynamics in children with OAB and DUI 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 OBJECTIVE To assess the objective efficacy of transcutaneous posterior tibial nerve stimulation in children presenting with overactive bladder resistant to well conducted treatment . MATERIAL AND METHOD This was a r and omized , double-blind , controlled study on 20 children with OAB . All patients were previously treated with anticholinergic drugs associated with detrusor rehabilitation , diet advice , bladder-voiding hygiene and constipation treatment , with poor clinical results . Patients were r and omized into two groups : -Group A : treatment with PTNS ( n = 11 ) . -Group B : sham treatment  ( n = 9 ) . The program lasted 12 consecutive weeks with two 30-minutes sessions a week . Each patient underwent pre-stimulation urodynamic testing to vali date bladder overactivity followed by a post-stimulation testing . Pre- and post-stimulation urodynamic parameters were compared in order to objective ly evaluate the treatment 's efficacy . The patients noted their incontinence episodes for 7 consecutive days in a diary before the beginning of the program , in the middle and at the end of it : this led to computing an incontinence score ( score ranged from 0 to 13 , from good to poor ) . The difference between the pre-stimulation and post-stimulation score enabled to express clinical results in terms of poor ( less than a 3-point decrease ) , medium ( a 3 to 5-point decrease ) , good ( 6 to 8-point decrease ) , very good ( final score ranged between 0 and 3 ) . Children were question ed regarding their impression of being stimulated or not . RESULTS In Group A , there were five very good clinical results ( 45 % ) , one medium ( 10 % ) and five poor results ( 45 % ) . In group B , nine very good results ( 66 % ) and three poor results ( 33 % ) were noted . Regarding urodynamic testing , volume voided during urgency ( 184 mL to 265 mL ) , maximal cystomanometry volume ( 215 mL to 274 mL ) and volume at the onset of the first overactive detrusor contraction ( ODC ) ( 48 mL to 174 mL ) were significantly increased in Group A ( p = 0.002 , p = 0.024 and p = 0.001 ) and maximal bladder pressure during ODC had decreased ( 61 to 46 ) ( p = 0.042 ) . 85 % children in group A thought they were being stimulated vs. 70 % in group B. CONCLUSION Even though we noticed urodynamics improvements in group A , which objective ly supports the efficacy of TCTPNS , clinical results remained the same between the two groups . In spite of the small size of our sample , this underlines the placebo effect of any type management in this pediatric population . Study ing precisely the maximal useful voltage and duration of stimulation should then be relevant in order to yield maximal benefits from this easy-to-use procedure
No significant difference was found between other treatments .
Conclusion Compared with antimuscarinic drugs , PTENS was associated with significant better efficacy considering MVV , but more constipation events in de novo OAB children .
Antimuscarinic drugs showed remarkably better efficacy considering MVV and comparable safety profile compared with urotherapy .
Objective To compare these managements focusing on the efficacy and safety to treat overactive bladder ( OAB ) in children through network meta- analysis ( NMA ) .