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.
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
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 ) .