title: Prospective and randomized comparison of electrical stimulation of the posterior tibial nerve versus oxybutynin versus their combination for treatment of women 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 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 Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study) Effectiveness and durability of solifenacin versus percutaneous tibial nerve stimulation versus their combination for the treatment of women with overactive bladder syndrome: a randomized controlled study with a follow-up of ten months Transcutaneous posterior tibial nerve electrostimulation with low dose trospium chloride: Could it be used as a second line treatment of overactive bladder in females. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Simplified bladder training augments the effectiveness of tolterodine in patients with an overactive bladder Percutaneous tibial nerve stimulation versus electrical stimulation with pelvic floor muscle training for overactive bladder syndrome in women: results of a randomized controlled study. Comparative Effectiveness of Combined Low- and Standard-Dose Trospium and Solifenacin for Moderate Overactive Bladder Symptoms in Elderly Men and Women Combined behavioral and individualized drug therapy versus individualized drug therapy alone for urge urinary incontinence in women. 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) Effects of Bladder Training and/or Tolterodine in Female Patients with Overactive Bladder Syndrome: A Prospective, Randomized Study Effect of Desmopressin with Anticholinergics in Female Patients with Overactive Bladder Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible‐dose regimen: results from a randomized study Anticholinergic drugs, bladder retraining and their combination for urge urinary incontinence: a pilot randomised trial The effects of drug and behavior therapy on urgency and voiding frequency Comparison of different treatment protocols in the treatment of idiopathic detrusor overactivity: a randomized controlled trial Combination of sacral neuromodulation and tolterodine for treatment of idiopathic overactive bladder in women: a clinical trial. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE). Low‐dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double‐blind, Randomized, Controlled Study Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment Combined behavioral and drug therapy for urge incontinence in older 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]. Posterior tibial nerve stimulation for treating neurologic bladder in women: a randomized clinical trial. Role of percutaneous posterior tibial nerve stimulation either alone or combined with an anticholinergic agent in treating patients with overactive bladder. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Bladder Training versus Combination of Propiverine with Bladder Training for Female Urinary Frequency The outcome of adding peripheral neuromodulation (stoller afferent neuro-stimulation) to anti-muscarinic therapy in women with severe overactive bladder Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II). Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Combined Vaginal Pelvic Floor Electrical Stimulation (PFS) and Local Vaginal Estrogen for Treatment of Overactive Bladder (OAB) in Perimenopausal Females. Randomized Controlled Trial (RCT).
abstract: Objective To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments . Methods We r and omized 75 women with OAB , in three groups : GI—30 min TENS , twice a week ; GII — daily slow release 10 mg oxybutynin ; and GIII — TENS + oxybutynin ( multimodal ) ; all for 12 weeks . Patients were evaluated with vali date d question naires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 . Results The groups were similar before treatment . After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) . At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 . At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 . Conclusions The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and 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 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 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 Purpose To assess effectiveness and durability of Solifenacin ( SS ) versus tibial nerve stimulation ( PTNS ) versus combination therapy ( PTNS + SS ) in women with overactive bladder syndrome ( OAB ) . Material s and Methods 105 women with OAB were divided r and omly into three groups of 35 patients each . In group A women received SS , in group B women underwent PTNS , in group C women underwent combination of PTNS + SS .  Improvements in OAB symptoms were assessed with OABSS question naire ; patients ’ quality of life was assessed with OAB-q SF question naire . Evaluation of effectiveness of treatments was performed with PGI-I question naire . OABSS and PGI-I were also assessed monthly for ten months . Results All treatments were effective on symptoms . PTNS showed a greater effectiveness than SS , but PTNS + SS was more effective than SS and PTNS . Furthermore , PTNS + SS showed a greater duration of effectiveness than PTNS and SS . Conclusions Combination of PTNS with SS showed more effectiveness and more durability than PTNS and SS alone AIM To evaluate the effect of adding low dose trospium chloride with transcutaneous posterior tibial nerve stimulation ( TPTNS ) in the treatment of overactive bladder ( OAB ) in females after failure of behavioral therapy . METHODS We r and omized 30 women with OAB , in two groups : G I received 30 min TPTNS , three times a week ; GII received TPTNS plus 20 mg trospium chloride daily . OAB Symptom Score question naire ( OABSS ) , Incontinence Impact Question naire-short form 7 ( IIQ-7 ) , 3 day voiding diary and urodynamics at weeks 0 and 8 were evaluated . RESULTS The groups were similar before treatment . Eight weeks after treatment , the mean OABSS decreased significantly to 8.53 ± 1.30 for group II vs 10.0 ± 2.0 for GI ( P < 0.024 ) . The mean IIQ-7 score decreased significantly to 51.86 ± 17.26 in group I vs 31.99 ± 9.26 in group II ( P < 0.001 ) . Before treatment , 11 ( 73.3 % ) and 4 ( 26.7 % ) patients in each group had moderate and poor quality of life ( QoL ) , respectively . After treatment , 6 ( 40 % ) and 14 ( 93.3 % ) had good QoL , 7 ( 46.7 % ) and 1 ( 6.7 % ) had moderate QoL in GI and GII , respectively . Two ( 13.3 % ) patients in GI had poor QoL. The mean frequency was reduced to 8.60 ± 0.83 vs 10.60 ± 2.32 for GII and GI respectively ( P = 0.006 ) . The cystometric capacity increased from 263.40 ± 50.45 to 377.80 ± 112.92 mL ( P = 0.001 ) for GII vs 250.13 ± 56.24 to 296.40 ± 99.0 mL ( P = 0.026 ) for GI . CONCLUSION TPTNS combined with low dose trospium chloride proved to be more effective than TPTNS alone in the treatment of OAB in females BACKGROUND Combining the β3-adrenoceptor agonist mirabegron and the antimuscarinic ( AM ) agent solifenacin may improve efficacy in the treatment of overactive bladder ( OAB ) while reducing the AM side effects . OBJECTIVE The primary objective was to evaluate the efficacy of combinations of solifenacin/mirabegron compared with solifenacin 5 mg monotherapy . The secondary objective was to explore the dose-response relationship and the safety/tolerability compared with placebo and monotherapy . DESIGN , SETTING , AND PARTICIPANTS A phase 2 , factorial design , r and omised , double-blind , parallel-group , placebo- and monotherapy-controlled trial , conducted at 141 sites in 20 European countries . Male and female patients were aged ≥18 yr with symptoms of OAB for ≥3 mo . INTERVENTION A total of 1306 patients ( 66.4 % female ) were r and omised to 12 wk of treatment in 1 of 12 groups : 6 combination groups ( solifenacin 2.5 , 5 , or 10 mg plus mirabegron 25 or 50 mg ) , 5 monotherapy groups ( solifenacin 2.5 , 5 , or 10 mg , or mirabegron 25 or 50 mg ) , or placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Change from baseline to end of treatment in mean volume voided per micturition ( MVV ) ( primary end point ) and mean numbers of micturitions per 24 h , incontinence episodes per 24 h , and urgency episodes per 24 h were analysed using an analysis of covariance model . Safety assessment s included treatment-emergent adverse events ( TEAEs ) , blood pressure , pulse rate , postvoid residual ( PVR ) volume , and laboratory and electrocardiography ( ECG ) parameters . RESULTS AND LIMITATIONS Compared with solifenacin 5 mg monotherapy , all combinations with solifenacin 5 or 10 mg significantly improved MVV , with adjusted differences ranging from 18.0 ml ( 95 % confidence interval [ CI ] , 5.4 - 30.0 ) to 26.3 ml ( 95 % CI , 12.0 - 41.0 ) . Three combination groups significantly reduced micturition frequency  compared with solifenacin 5 mg , ranging from -0.80 ( 95 % CI , -1.39 to -0.22 ) to -0.98 ( 95 % CI , -1.68 to -0.27 ) . Five of six combinations significantly reduced urgency episodes compared with solifenacin 5 mg , ranging from -0.98 ( 95 % CI , -1.78 , to -0.18 ) to -1.37 ( 95 % CI , -2.03 to -0.70 ) . No dose-related trends in TEAEs , blood pressure , pulse rate , PVR volume , or laboratory or ECG parameters were observed between combination and monotherapy groups , although the incidence of constipation was slightly increased with combination therapy . CONCLUSIONS Combination therapy with solifenacin/mirabegron significantly improved MVV , micturition frequency , and urgency compared with solifenacin 5 mg monotherapy . All combinations were well tolerated , with no important additional safety findings compared with monotherapy or placebo . PATIENT SUMMARY To improve treatment of overactive bladder ( OAB ) , mirabegron/solifenacin in combination was compared with each drug alone and placebo . Combination therapy improved OAB symptoms and had similar safety and acceptability . TRIAL REGISTRATION Clinical trials.gov : NCT01340027 To compare the efficacy of tolterodine plus simplified bladder training  ( BT ) with tolterodine alone in patients with an overactive bladder INTRODUCTION This study compared percutaneous tibial nerve stimulation ( PTNS ) versus electrical stimulation with pelvic floor muscle training ( ES + PFMT ) in women with overactive bladder syndrome ( OAB ) . MATERIAL S AND METHODS 60 women with OAB were enrolled . Patients were r and omized into two groups . In group A , women underwent ES with PFMT , in group B women underwent PTNS . RESULTS A statistically significant reduction in the number of daily micturitions , episodes of nocturia and urge incontinence was found in the two groups but the difference was more substantial in women treated with PTNS ; voided volume increased in both groups . Quality of life improved in both groups , whereas patient perception of urgency improved only in women treated with PTNS .  Global impression of improvement revealed a greater satisfaction in patients treated with PTNS . CONCLUSION This study demonstrates the effectiveness of PTNS and ES with PFMT in women with OAB , but greater improvements were found with PTNS Objective : To increase the safety and effectiveness of treatments for overactive bladder ( OAB ) with moderate symptoms in elderly patients . Patients and Methods : Patients were examined at the Urodynamic Department of the Regional Diagnostic Center ( Vladivostok , Russian Federation ) from September 1 , 2012 to December 31 , 2012 . The assignment of patients [ n = 177 , average age 69 . 4 years , 98 women ( 55.4 % ) and 79 men ( 44.6 % ) ] was r and om and blind in this placebo-controlled study . Patients were distributed into subgroups according to the method of treatment as follows : group А1 : n = 57 , trospium 30 mg/day + solifenacin 10 mg/day ; group А2 : n = 61 , trospium 15 mg/day + solifenacin 5 mg/day ; group А3 : n = 59 , placebo . All patients underwent a urodynamic examination in accordance with international st and ards before and 2 months after treatment . ICIQ-SF question naires recommended by the International Continence Society ( ICS ) and bladder diaries were used to evaluate the clinical results . The clinical severity of the OAB symptoms and the effectiveness of the treatment were evaluated based on the frequency of episodes of incontinence ( EI ) per day . Three or fewer EI per day were considered moderate dysfunction of the lower urinary tract . Results : Groups of elderly patients with moderate symptoms of OAB who were treated with st and ard- and low-dose trospium and solifenacin demonstrated a significant increase in the median values of reflex volume , bladder capacity , and detrusor compliance and a decrease in the frequency of urination and urinary urgencies . The frequency of EI in both of the main groups decreased by almost 2-fold in comparison to the initial data and reached the following values : group А1 : 1.27 ( -1.08 ) , p ≤ 0.05 ; group A2 : 1.49 ( -1.18 ) , p ≤ 0.05 . The correlation with the decrease in the frequency of EI in these groups was r = 0.85 ( p ≤ 0.01 ) . The percentage of patients with a significant decrease ( EI ≥1.0 ) among those treated with st and ard- and low-dose trospium and solifenacin increased synchronously , prompting us to suppose the absence of a direct correlation between medicine dose and therapeutic effect for moderate OAB symptoms . Conclusion : The combination of low-dose trospium and solifenacin provides good clinical and urodynamic effects in elderly patients with moderate symptoms of OAB . Combination of these drugs in st and ard doses for such patients is excessive PURPOSE We tested whether individualized drug therapy enhanced with behavioral training would result in better outcomes than individualized drug therapy alone . MATERIAL S AND METHODS Participants were community dwelling women with urge predominant incontinence . Using a r and omized clinical trial design women were r and omized to 8 weeks ( 4 visits ) of drug therapy alone ( 32 ) or drug therapy plus behavioral training ( 32 ) . Drug therapy was individually titrated , extended release oxybutynin with proactive management of side effects . Behavioral training included pelvic floor muscle training and urge suppression techniques . The primary outcome measure was reduction in frequency of incontinence episodes on bladder diary at 8 weeks ( with followup at 6 and 12 months ) . Secondary outcomes included patient satisfaction , global perception of improvement , Urogenital Distress Inventory and Incontinence Impact Question naire . RESULTS In intent to treat analysis frequency of incontinence was reduced a mean of 88.5 % in the drug alone group and 78.3 % in the combined therapy group ( p = 0.16 ) . Outcomes were not significantly different between the groups in the analysis of completers ( 91.5 % vs 86.2 % , p = 0.34 ) , or in either analysis at 6 or 12 months . The groups also did not differ significantly on secondary outcomes at any point . Participants in the drug alone group tended to be taking higher doses of  oxybutynin at 8 weeks but the final dose did not differ significantly between the groups . Based on a conditional power calculation the trial was stopped early for futility . CONCLUSIONS When drug therapy is implemented with frequent individualized dose titration , daily bladder diaries and careful management of side effects , initiating concurrent behavioral training does not enhance outcomes for urge incontinence in women To examine the safety and efficacy of mirabegron as ‘ add‐on ’ therapy to solifenacin in patients with overactive bladder ( OAB ) We compared the effects of bladder training and /or tolterodine as first line treatment in female patients with overactive bladder ( OAB ) . One hundred and thirty-nine female patients with OAB were r and omized to treatment with bladder training ( BT ) , tolterodine ( To , 2 mg twice daily ) or both ( Co ) for 12 weeks . Treatment efficacy was measured by micturition diary , urgency scores and patients ' subjective assessment of their bladder condition . Mean frequency and nocturia significantly decreased in all treatment groups , declining 25.9 % and 56.1 % , respectively , in the BT group ; 30.2 % and 65.4 % , respectively , in the To group ; and 33.5 % and 66.3 % , respectively in the Co group ( p<0.05 for each ) . The decrease in frequency was significantly greater in the Co group than in the BT group ( p<0.05 ) . Mean urgency score decreased by 44.8 % , 62.2 % and 60.2 % in the BT , To , and Co groups , respectively , and the improvement was significantly greater in the To and Co groups than in the BT group ( p<0.05 for each ) . Although BT , To and their combination were all effective in controlling OAB symptoms , combination therapy was more effective than either method alone . Tolterodine alone may be instituted as a first-line therapy , but may be more effective when combined with bladder training Purpose The aim of this study was to evaluate the effect of desmopressin combined with anticholinergics on daytime frequency and urgency in female patients with overactive bladder ( OAB ) . Material s and Methods We included 68 female patients with OAB . Patients were r and omly assigned to receive 5 mg of solifenacin ( group I ) or 5 mg of solifenacin and 0.2 mg of desmopressin ( group II ) for 2 weeks . A pre/post-treatment 3-day voiding diary and the Urinary Distress Inventory ( UDI-6 ) and Incontinence Impact Question naire ( IIQ-7 ) were used to assess changes in voiding symptoms and quality of life ( QoL ) ; results were compared between the two groups . Results Groups I and II included 31 and 37 patients , respectively . Time to first void was 12 min later in group II ( 105 min vs. 117 min ) , but this difference was not statistically significant . However , time to the second and third voids ( 203 min vs. 255 min , 312 min vs. 368 min ) and the first urgency episode ( 212 min vs. 255 min ) were significantly longer in group II . Compared with group I , patients in group II showed significant improvement in QoL scores . When improvement after treatment was defined as increase in time to first void of greater than 10 % after 2 weeks of treatment , desmopressin with anticholinergics was more effective in patients over the age of 65 years and with more than 150 ml of voided volume . Conclusions Desmopressin combined with anticholinergics was more effective than anticholinergics only in the treatment of female patients with OAB AIMS To assess the efficacy and safety of pregabalin alone or in combination with tolterodine extended release ( ER ) in subjects with idiopathic OAB . METHODS This 26-week , multicenter , r and omized , double-blind , placebo-controlled , three-period crossover study enrolled women aged ≥ 18 years that were diagnosed with OAB and reported ≥ 8 micturitions/24 hr and ≥ 4 urgency episodes/week on 5-day bladder diary at baseline . Subjects were r and omized to 1 of 10 treatment sequences and received three of five treatments , each for 4 weeks with 4-week washout periods : st and ard-dose pregabalin/tolterodine ER ( 150 mg twice daily [BID]/4 mg once daily [ QD ] , n=102 ) , pregabalin alone ( 150 mg BID , n=105 ) , tolterodine ER alone ( 4 mg QD , n=104 ) , low-dose pregabalin/tolterodine ER ( 75 mg BID/2 mg QD , n=105 ) , and placebo ( n=103 ) . Subjects completed 5-day diaries at the end of treatment and washout periods . The primary endpoint was change from baseline to week 4 in mean voided volume ( MVV ) per micturition . The primary comparison was st and ard-dose pregabalin/tolterodine ER versus tolterodine ER alone ; secondary comparisons were pregabalin alone versus tolterodine ER alone and versus placebo . RESULTS Baseline-adjusted changes in MVV were significantly greater after treatment with st and ard-dose pregabalin/tolterodine ER ( 39.5 ml ) versus tolterodine ER alone ( 15.5 ml ; P<0.0001 ) , and with pregabalin alone ( 27.4 ml ) versus tolterodine ER alone ( P=0.005 ) and placebo ( 11.9 ml ; P=0.0006 ) . Treatments were generally well tolerated ; discontinuation rates due to adverse events were 4 % , 2 % , 5 % , 0 % , and 1 % with st and ard- and low-dose pregabalin/tolterodine ER , pregabalin , tolterodine ER , and placebo , respectively . CONCLUSIONS Pregabalin , alone or with tolterodine ER may offer an alternative treatment option for idiopathic OAB in women Study Type – Therapy ( RCT ) Level of Evidence Bladder retraining and anticholinergic drugs in women with urge urinary incontinence need to be compared . Women with urge urinary incontinence were recruited by advertisements , from primary care and from a urogynaecology clinic . Women were r and omised using a web page to bladder retraining , anticholinergic drugs or both and followed up at 3 and 12 months . No blinding was attempted . The primary outcomes were the trial process and the Overactive Bladder Question naire ( OAB-q ) quality -of-life measure . Recruitment was much slower than anticipated . There were no differences in the OAB-q at 12 months ( 87.9 SD 11.6 bladder retraining , 81.6 SD 19.3 drug therapy and 88.9 SD 9.9 combination ) but dry mouth was more common in those taking drugs . It is feasible to run a pragmatic r and omised trial with 12-month follow-up for women with urinary urge incontinence . This will require about 500 participants per arm Introduction and hypothesisThe objective of this study was to examine the effects of drug therapy alone and combined with behavioral therapy on urgency and 24-voiding frequency in women with urge-predominant incontinence and to identify predictors of change . Methods A planned analysis of data from a multi-site , r and omized , controlled trial ( N = 307 ) . Bladder diaries were used to document voids , incontinence , and urgency severity . Results Urgency scores decreased significantly within both treatment groups , but changes did not differ between groups ( p = 0.30 ) . Improvement in urgency was associated with greater baseline urgency ( p < 0.0001 ) and black ethnicity ( p = 0.03 ) . Voiding frequency increased with drug alone and decreased slightly with combined therapy ( p = 0.009 ) , and improvement was associated with combined treatment ( p < 0.0001 ) , higher baseline frequency ( p < 0.0001 ) , and lower baseline incontinence episode frequency ( p = 0.001 ) . Conclusions Although combined drug and behavioral therapy does not appear to improve urgency more than drug alone , it result ed in better outcomes on voiding frequency Objective : To investigate and compare the effectiveness of various treatment protocol s for the treatment of women with idiopathic detrusor overactivity . Design : Prospect i ve , r and omized controlled trial . Setting : Departments of Physiotherapy and Rehabilitation and Obstetrics and Gynaecology , Hacettepe University . Subjects : Forty-six subjects were r and omized to three groups . Interventions : The first group received only pharmacotherapy , the second group received only physiotherapy and in the third group pharmacotherapy was combined with physiotherapy ( combined therapy group ) . Main measures : All patients were evaluated at the beginning and at the end of treatment . Assessment parameters were maximum cystometric capacity , electromyographic activity of pelvic floor muscles , voiding diary parameters , the amount of urine leakage and the quality of life score . Results : The maximum cystometric capacity and the electromyographic activity of pelvic floor muscles increased significantly and the number of voids/day and incontinence episodes/day , and the amount of urine leakage reduced significantly ( P < 0.05 ) in both physiotherapy and combined therapy groups while there was no significant difference in the pharmacotherapy group . After treatment , the number of voids/day increased by 0.3 ± 3.4 in the pharmacotherapy group ( P > 0.05 ) and decreased by 5.1 ± 5.5 and 4.7 ± 5.6 in the physiotherapy and combined therapy groups , respectively ( P < 0.05 ) . Statistically significant improvements were observed in all groups according to the number of voids/night and the quality of life scores at the end of the treatment . Conclusion : The physiotherapy protocol we introduced in the present study with or without anticholinergic therapy has a substantial positive impact on the treatment of female patients with idiopathic detrusor overactivity PURPOSE To evaluate the efficacy of intermittent percutaneous needle sacral nerve stimulation ( IPN-SNS ) in women with idiopathic overactive bladder ( IOAB ) treated with tolterodine . MATERIAL S AND METHODS A total of 240 female patients diagnosed with IOAB were r and omized to receive tolterodine only treatment ( group 1 , n = 120 ) or tolterodine combined with IPN-SNS ( group 2 , n = 120 ) . Each group included 120 participants , who were divided into subgroups depending on whether they had dry OAB ( urinary frequency and urgency ) or wet OAB ( urinary frequency and urgency with urgency incontinence ) . In the treatment group , patients received percutaneous IPN-SNS plus tolterodine ( 2 mg once daily ) , while in the control group , only tolterodine ( 2 mg once daily ) was administered for 3 months . The voiding diary and urodynamic parameters were monitored , and patients ' psychological depression and anxiety scores were recorded before and after treatment . RESULTS There were significantly greater improvements in the conditions of first desire to void ( FDV ) , max­imum cystometric capacity ( MCC ) , and daily average volumes , as well as the daily single maximum voided volumes in group 2 ( P = .001 ) than in group 1 . In addition , there were significantly greater decreases in self-rating depression scale ( SDS ) and self-rating anxiety scale ( SAS ) scores in group 2 compared with group 1 ( P < .001 ) . CONCLUSION Combined treatment with tolterodine plus IPN-SNS can not only improve the symptoms of voiding dysfunction but can also reduce the concomitant depression and anxiety in women with IOAB , there­by improving patients ' quality of life Importance Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information . Objective To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence . Design , Setting , and Participants Multicenter open-label r and omized trial ( February 2012-January 2015 ) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence . Interventions Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA ( n = 192 ) or sacral neuromodulation ( n = 189 ) . Main Outcomes and Measures Primary outcome , change from baseline mean number of daily urgency urinary incontinence episodes over 6 months , was measured with monthly 3-day diaries . Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Question naire Short Form ( SF ) ; range , 0 - 100 , higher scores indicating worse symptoms ; Overactive Bladder Satisfaction question naire ; range , 0 - 100 ; includes 5 subscales , higher scores indicating better satisfaction ; and adverse events . Results Of the 364 women ( mean [ SD ] age , 63.0 [ 11.6 ] years ) in the intention-to-treat population , 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group ( -3.9 vs -3.3 episodes per day ; mean difference , 0.63 ; 95 % CI , 0.13 to 1.14 ; P = .01 ) . Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Question naire SF for symptom bother ( -46.7 vs -38.6 ; mean difference , 8.1 ; 95 % CI , 3.0 to 13.3 ; P = .002 ) ; treatment satisfaction ( 67.7 vs 59.8 ; mean difference , 7.8 ; 95 % CI , 1.6 to 14.1 ; P = .01 ) and treatment endorsement ( 78.1 vs 67.6 ; mean difference ; 10.4 , 95 % CI , 4.3 to 16.5 ; P < .001 ) than treatment with sacral neuromodulation . There were no differences in convenience ( 67.6 vs 70.2 ; mean difference , -2.5 ; 95 % CI , -8.1 to 3.0 ; P = .36 ) , adverse effects ( 88.4 vs 85.1 ; mean difference , 3.3 ; 95 % CI , -1.9 to 8.5 ; P = .22 ) , and treatment preference ( 92.% vs 89 % ; risk difference , -3 % ; 95 % CI , -16 % to 10 % ; P = .49 ) . Urinary tract infections were more frequent in the onabotulinumtoxinA group ( 35 % vs 11 % ; risk difference , -23 % ; 95 % CI , -33 % to -13 % ; P < .001 ) . The need for self-catheterization was 8 % and 2 % at 1 and 6 months in the onabotulinumtoxinA group . Neuromodulation device revisions and removals occurred in 3 % . Conclusions and Relevance Among women with refractory urgency urinary incontinence , treatment with onabotulinumtoxinA compared with sacral neuromodulation result ed in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance . In addition , it result ed in a higher risk of urinary tract infections and need for transient self-catheterizations BACKGROUND Incontinence has a greater detrimental effect on quality of life than other symptoms of overactive bladder ( OAB ) and is often difficult to treat with antimuscarinic monotherapy . OBJECTIVE To evaluate the efficacy and the safety and tolerability of combination ( solifenacin 5 mg and mirabegron 50 mg ) versus solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of solifenacin 5 mg . DESIGN , SETTING , AND PARTICIPANTS OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-wk single-blind run-in were r and omised 1:1:1 to double-blind daily combination or solifenacin 5 or 10 mg for 12 wk . Patients receiving the combination were initiated on mirabegron 25 mg increasing to 50 mg after week 4 . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary end point was a change from baseline to end of treatment ( EOT ) in the mean number of incontinence episodes per 24h ( stratified rank analysis of covariance [ ANCOVA ] ) . Key secondary end points were a change from baseline to EOT in the mean number of micturitions per 24h ( ANCOVA ) and number of incontinence episodes noted in a 3-d diary at EOT ( mixed-effects Poisson regression ) . A trial ( BESIDE ) comparing combination treatment ( solifenacin plus mirabegron ) with one treatment alone ( solifenacin ) tested the superiority of combination versus solifenacin 5 mg , noninferiority ( and potential superiority ) of combination versus solifenacin 10 mg ( key secondary end points ) , and the safety and tolerability of combination therapy versus solifenacin monotherapy . RESULTS AND LIMITATIONS A total of 2174 patients were r and omised to combination ( n=727 ) , solifenacin 5 mg ( n=728 ) , or solifenacin 10 mg ( n=719 ) . At EOT , combination was superior to solifenacin 5 mg , with significant improvements in daily incontinence ( p=0.001 ) , daily micturitions ( p<0.001 ) , and incontinence noted in a 3-d diary ( p=0.014 ) . Combination was noninferior to solifenacin 10 mg for key secondary end points and superior to solifenacin 10 mg for improving daily micturitions . All treatments were well tolerated . CONCLUSIONS Adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms versus solifenacin 5 or 10 mg , and it was well tolerated in OAB patients remaining incontinent after initial solifenacin 5 mg . PATIENT SUMMARY In this 12-wk study , overactive bladder patients who remained incontinent despite initial solifenacin 5 mg treatment received additional treatment with mirabegron 50 mg . Combining mirabegron 50 mg with solifenacin 5 mg was superior to solifenacin 5 mg alone in improving symptoms of incontinence and frequent urination , and it was well tolerated . TRIAL REGISTRATION Clinical Trials.gov NCT01908829 OBJECTIVE Evaluation of safety and efficacy of desmopressin/tolterodine combination therapy in women . METHODS This double-blind , r and omized , proof-of-concept study enrolled 106 patients ( ≥18 years ) , with overactive bladder ( OAB ) and nocturia , with ≥2 nocturnal voids , receiving a 3-month once-daily combination ( desmopressin 25 µg , orally-disintegrating tablets [ODT]/tolterodine 4 mg [ Detrol ® LA ] ; n = 49 ) or monotherapy ( tolterodine 4 mg/placebo ODT ; n = 57 ) . Primary endpoint was change from baseline in mean number of nocturnal voids . Secondary endpoints were change from baseline in nocturnal voided volume , time to first nocturnal void , and quality -of-life . Post-hoc exploratory analysis were performed for patients with and without baseline nocturnal polyuria ( NP , n = 47 each ) . RESULTS Overall population showed a non-significant reduction in mean number of nocturnal voids with combination versus monotherapy ( full analysis set : adjusted treatment contrast [ TC ] , -0.34 ; P = 0.112 ) . Change in mean nocturnal void volume ( TC , -64.16 mL ; P = 0.103 ) , mean time to first nocturnal void ( TC , 18.00 min ; P = 0.385 ) and Nocturia Impact ( NI ) Diary © scores were comparable . In post-hoc analysis , NP patients showed a benefit with combination versus monotherapy for nocturnal void volume ( P = 0.034 ) and time to first nocturnal void ( P = 0.045 ) , and a non-significant improvement in NI Diary © scores . Safety profile was comparable between treatments . A single transient event of asymptomatic clinical ly significant hyponatremia in combination group resolved subsequently . CONCLUSION Low-dose desmopressin could be safely combined with tolterodine for treating nocturia in women with OAB , with a significant benefit in women with NP . Further , prospect i ve validation studies of combination therapy are warranted in mixed NP/OAB population , based on this favorable proof-of-concept finding AIMS To evaluate patient-reported outcomes ( PROs ) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder ( OAB ) from the SYNERGY trial . METHODS Following a 4-week placebo run-in , period patients ( ≥18 years ) with OAB were r and omized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg ( combination 5 + 25 mg ) , solifenacin 5 mg + mirabegron 50 mg , ( combination 5 + 50 mg ) , solifenacin 5 mg , mirabegron 25 mg , mirabegron 50 mg or placebo for 12 weeks , followed by a 2-week washout period . At each visit , PROs related to quality of life , symptom bother , and treatment satisfaction were assessed , including OAB-q Symptom Bother score , health-related quality of life ( HRQOL ) Total score , treatment satisfaction-visual analogue scale ( TS-VAS ) , and patient perception of bladder condition ( PPBC ) question naires . RESULTS Overall , 3527 patients were r and omized into the study , with 3494 receiving double-blind treatment . At end of treatment ( EoT ) , both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups ( nominal P < 0.001 ) . Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups ( P ≤ 0.002 ) . For both combination groups , the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy ( P < 0.05 ) . The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups . CONCLUSIONS PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters , including OAB-q Symptom Bother score , HRQOL Total score , and PPBC Objectives The aims of this study were to compare 12-week outcomes of single-therapy tolterodine ( Detrol LA ) extended release to intravaginal estrogen ( Estrace ) for overactive bladder ( OAB ) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy . Methods A single-site r and omized , open-label trial in women with urinary frequency , urgency , nocturia , and /or urgency urinary incontinence symptoms was performed . Fifty-eight participants were r and omized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week . The primary outcome was change in Overactive Bladder Question naire ( OAB-q ) symptom bother score at 12 weeks . Secondary outcomes included the Health-Related Quality of Life Question naire ( HRQL ) of the OAB-q and a 3-day bladder diary . At 12 weeks , subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks . Results There was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks ( 20.6 ± 21.7 , −15.8 ± 23.3 , respectively , P = 0.45 ) . There was a significant within-group decrease in symptom bother score from baseline to 12 weeks ( tolterodine , P < 0.0001 , and intravaginal estradiol , P = 0.002 ) . Secondary outcome improvement within groups was noted in the HRQL total , urinary incontinence episodes , and median voiding frequency ( all P ⩽ 0.03 ) in the tolterodine group and in the HRQL total score ( P = 0.03 ) in the intravaginal estradiol group , with no differences between groups . Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks ( 20.0 ± 23.9 , P = 0.008 ; −16.7 ± 23.3 , P = 0.02 , respectively ) . Conclusions Significant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms , with no difference between groups . Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol . The role of combined medical therapy for OAB symptoms needs further investigation OBJECTIVE The purpose of this study was to examine the effects of combining behavioral treatment and drug treatment for  urge incontinence in community-dwelling older women . DESIGN Modified crossover design ( extension of a r and omized clinical trial ) . Eligible subjects were stratified according to type and severity of incontinence and r and omized to behavioral treatment , drug treatment , or a control condition ( placebo ) .  Subjects not totally continent or not satisfied after 8 weeks of a single treatment were offered the opportunity to cross over into combined therapy . SETTING A university-based outpatient geriatric medicine clinic . PARTICIPANTS Subjects in the clinical trial were 197 ambulatory , nondemented , community-dwelling women ( age 55 years or older ) with persistent urge urinary incontinence . Thirty-five subjects participated in combined treatment . INTERVENTION One group of subjects received four sessions ( over 8 weeks ) of biofeedback-assisted behavioral training followed by 8 weeks of behavioral training combined with drug therapy ( oxybutynin chloride individually titrated from 2.5 mg to 15 mg daily ) . The second group received drug therapy first , followed by 8 weeks of drug therapy combined with behavioral training . MEASUREMENTS Bladder diaries completed by subjects before and after each treatment phase were used to calculate change in the frequency of incontinent episodes . RESULTS Eight subjects ( 12.7 % ) crossed from behavioral treatment alone to combined behavioral and drug therapy . Additional benefit was seen in improvement from a mean 57.5 % reduction of incontinence with single therapy to a mean 88.5 % reduction of incontinence with combined therapy ( P = .034 ) . Twenty-seven subjects ( 41.5 % ) crossed from drug therapy alone to combined drug and behavioral treatment . They also showed additional improvement , from a mean 72.7 % reduction of incontinence with single therapy to a mean 84.3 % reduction of incontinence with combined therapy ( P = .001 ) . CONCLUSIONS This study shows that combining drug and behavioral therapy in a stepped program can produce added benefit for patients with urge incontinence 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 Overactive bladder ( OAB ) is a disabling disorder . Treatment of cases with OAB includes behavioral , pharmacological , surgical interventions and peripheral electrical stimulation . The goal of this study was to determine effects of posterior tibial nerve stimulation on sexual function and pelvic disorders in women with Overactive bladder ( OAB ) . Fifty women were r and omly assigned to PTNS ( posterior tibial nerve stimulation ) plus tolterodine or tolterodine alone treatment . Tolterodine group received 4 mg tolterodine daily for three months while the other group received this treatment plus percutaneous tibial nerve stimulation for 12 consequence weeks . Two in PTNS group and 8 in the control group withdrew from the study . Age , education level , and occupation status were not significantly different between two groups . Mean total FSFI and its subscales were not significantly different before and after treatment between two groups . Urine leakage associated with a feeling of urgency and loss of stool or gas from the rectum beyond patient 's control became significantly different after treatment between two groups . Posterior tibial nerve stimulation could help urinary problems in women with a neurologic bladder OBJECTIVE To evaluate the efficacy of percutaneous tibial nerve stimulation ( PTNS ) , either alone or combined with an anticholinergic agent , in treating patients with an overactive bladder ( OAB ) in whom previous conservative treatment failed . MATERIAL AND METHODS In this study , we included a total of 30 female patients with OAB in whom all conventional therapies failed between January 2010 and April 2011 . Patients were r and omly divided into three groups : Group 1 , PTNS group ; Group 2 , patients receiving an anticholinergic agent ; and Group 3 , patients receiving both PTNS and anticholinergic agent . PTNS treatment continued for 12 weeks with each session lasting 30 min . RESULTS All parameters of the bladder diary significantly improved in all groups ( p<0.05 ) . Similarly , all scores measured by question naires ( UDI-6 , IIQ-7 , and OABSS ) revealed significant improvements in all groups . When the improvements in symptoms were compared among the groups , there was a statistically significantly higher improvement in groups 1 and 3 than in Group 2 . CONCLUSION PTNS is a safe , simple , and minimally invasive treatment modality in patients with OAB , and it may be suggested either alone or in combination with anticholinergics when conventional treatments fail BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications , but many discontinue therapy . OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training , compared with drug therapy alone , improves the ability of women with urge incontinence to achieve clinical ly important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy . DESIGN 2-stage , multicenter , r and omized clinical trial conducted from July 2004 to January 2006 . SETTING 9 university-affiliated outpatient clinics . PATIENTS 307 women with urge-predominant incontinence . INTERVENTION 10 weeks of open-label , extended-release tolterodine alone ( n = 153 ) or combined with behavioral training ( n = 154 ) , followed by discontinuation of therapy and follow-up at 8 months . MEASUREMENTS The primary outcome , measured at 8 months , was no receipt of drugs or other therapy for urge incontinence and a 70 % or greater reduction in frequency of incontinence episodes . Secondary outcomes were reduction in incontinence , self-reported satisfaction and improvement , and scores on vali date d question naires measuring symptom distress and bother and health-related quality of life . Study staff who performed outcome evaluations , but not participants and interventionists , were blinded to group assignment . RESULTS 237 participants completed the trial . According to life-table estimates , the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups ( 41 % in both groups ; difference , 0 percentage points [ 95 % CI , -12 to 12 percentage points ] ) . A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70 % or greater reduction in incontinence at 10 weeks ( 69 % vs. 58 % ; difference , 11 percentage points [ CI , -0.3 to 22.1 percentage points ] ) . Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Question naire ( both P < 0.001 ) at both time points for patient satisfaction and perceived improvement but not health-related quality of life . Adverse events were uncommon ( 12 events in 6 participants [ 3 in each group ] ) . LIMITATIONS Behavioral therapy components ( daily bladder diary and recommendations for fluid management ) in the group receiving drug therapy alone may have attenuated between-group differences . Assigned treatment was completed by 68 % of participants , whereas 8-month outcome status was assessed on 77 % . CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence .  Combination therapy has a beneficial effect on patient satisfaction , perceived improvement , and reduction of other bladder symptoms Objective : Among lower urinary tract symptoms , urinary frequency is one of the prevalent symptoms in the female population . The objective of this study was to evaluate the effect of bladder training with or without pharmacotherapy in women with only a frequency symptom . Methods : Patients were r and omized to either bladder training alone ( n = 23 ) or propiverine combined with bladder training ( n = 25 ) . All patients were treated during 3 months . Results : At baseline , daytime frequency was higher in the combination therapy group than in the bladder training group ( p = 0.031 ) . No difference in other characteristics was observed in the two groups . After treatment , there was no significant difference of functional bladder capacity and average voided volume between the two groups but daytime frequency was higher in the combination therapy group than in the bladder training group ( p = 0.013 ) . However , the changes of daytime frequency , functional bladder capacity and average voided volume were not significantly different in the groups . Of total patients , 15 ( 65.2 % ) in the bladder training group and 21 ( 84.0 % ) in the combination therapy group were rated as responders ( defined as improved or much improved ) ( p = 0.133 ) . Conclusions : Both bladder training with or without pharmacotherapy may improve the subjective and objec- tive frequency symptom in women with only a frequency symptom . However , we could not find that there was more symptomatic improvement when anticholinergics combined with bladder training were compared with bladder training alone Objective . Anti-muscarinic treatment alone and peripheral neuromodulation with concomitant anti-muscarinic treatment were compared in patients with severe overactive bladder . Methods . In this prospect i ve study , 40 women with severe overactive bladder according to the 7-day voiding diary without any prior treatment completed the Incontinence Impact Question naire ( IIQ-7 ) and were r and omised into anti-muscarinic-alone and combination treatment groups . Twenty women received daily 4 mgs of tolterodine orally and in 20 women Stoller afferent neuro-stimulation ( SANS ) therapy was performed concomitantly for 12 weeks to the same anti-muscarinic regimen . After 12 weeks of therapy , two of the patients drop out of the study and remaining patients filled out the IIQ-7 question naire and the 7-day voiding diary again . Pretreatment and post-treatment QoL scores and the 7-day voiding diaries were compared . Mann – Whitney U , Wilcoxon and two sided significance tests were used . Results . Thirty-eight women fulfilling the criteria were included in the study .  Severity of overactive bladder symptoms decreased significantly in both treatment groups . However , the decrease in combination treatment group was more significant than the anti-muscarinic-alone group . Adverse events were similar between the two groups . Conclusion . Combining SANS and anti-muscarinic therapy result ed in significantly better clinical outcomes and IIQ-7 scores as compared with anti-muscarinic treatment alone in patients with severe overactive bladder BACKGROUND The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder ( OAB ) has not been previously assessed . OBJECTIVES To evaluate the safety and efficacy of solifenacin succinate 5 mg plus mirabegron 50 mg tablets ( combination treatment ) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , multicentre , phase 3 trial ( SYNERGY II ) of patients with " wet " OAB symptoms ( urinary frequency and urgency with incontinence ) for ≥3 mo . The study was conducted from March 2014 to September 2016 ; with 1829 patients r and omised . The full analysis set was comprised of 1794 patients . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary objective was safety , measured as treatment-emergent adverse events ( TEAEs ) . Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h . RESULTS AND LIMITATIONS The median age was 60 yr ( range 19 - 86 yr ) and 1434 patients ( 80 % ) were female . Overall , 856 patients ( 47 % ) experienced ≥1 TEAE . TEAE frequency was slightly higher in the combination group ( 596 patients , 49 % ; mirabegron 126 patients , 41 % ; solifenacin 134 patients , 44 % ) . Serious TEAEs were reported by 67 patients ( 3.7 % ) ; one was considered possibly treatment-related ( mirabegron group , atrial fibrillation ) . Dry mouth was the most common TEAE ( combination 74 patients , 6.1 % ; solifenacin 18 patients , 5.9 % ; mirabegron 12 patients , 3.9 % ) . Combination therapy was statistically superior to mirabegron and solifenacin  for the number of incontinence episodes ( vs mirabegron : adjusted mean difference [ AMD ] -0.5 , 95 % confidence interval [ CI ] -0.7 to -0.2 , p<0.001 ; vs solifenacin : AMD -0.1 , 95 % CI -0.4 to 0.1 , p=0.002 ) and micturitions ( vs mirabegron : AMD -0.5 , 95 % CI -0.8 to -0.2 , p<0.001 ; vs solifenacin : AMD -0.4 , 95 % CI -0.7 to -0.1 , p=0.004 ) . CONCLUSIONS Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy . This innovative combination is a treatment option that could become widely used in the clinic . PATIENT SUMMARY This study looked at the safety and efficacy of a combination of solifenacin succinate 5 mg plus mirabegron 50 mg tablets over 12 mo in patients with the overactive bladder ( OAB ) symptoms of increased urination frequency , heightened urgency to urinate , and unintentional passing of urine .  We compared this treatment with solifenacin succinate 5 mg or mirabegron 50 mg alone , and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms . This novel combination could be an improved treatment option in the clinical setting for patients with OAB . This study is registered at Clinical Trials.gov as NCT02045862 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 ABCD : Appropriate Blood pressure Control in Diabetes ABI : ankle – brachial index ABPM : ambulatory blood pressure monitoring ACCESS : Acute C and esartan Cilexetil Therapy in Stroke Survival ACCOMPLISH : Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension ACCORD : Action to Control Cardiovascular Risk in Diabetes ACE : angiotensin-converting enzyme ACTIVE I : Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events ADVANCE : Action in Diabetes and Vascular Disease : Preterax and Diamicron-MR Controlled Evaluation AHEAD : Action for HEAlth in Diabetes ALLHAT : Antihypertensive and Lipid-Lowering Treatment to Prevent Heart ATtack ALTITUDE : ALiskiren Trial In Type 2 Diabetes Using Cardio-renal Endpoints ANTIPAF : ANgioTensin II Antagonist In Paroxysmal Atrial Fibrillation APOLLO : A R and omized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People ARB : angiotensin receptor blocker ARIC : Atherosclerosis Risk In Communities ARR : aldosterone renin ratio ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASCOT-LLA : Anglo-Sc and inavian Cardiac Outcomes Trial — Lipid Lowering Arm ASTRAL : Angioplasty and STenting for Renal Artery Lesions A-V : atrioventricular BB : beta-blocker BMI : body mass index BP : blood pressure BSA : body surface area CA : calcium antagonist CABG : coronary artery bypass graft CAPPP : CAPtopril Prevention Project CAPRAF : C And esartan in the Prevention of Relapsing Atrial Fibrillation CHD : coronary heart disease CHHIPS : Controlling Hypertension and Hypertension Immediately Post-Stroke CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease — EPIdemiology collaboration CONVINCE : Controlled ONset Verapamil INvestigation of CV Endpoints CT : computed tomography CV : cardiovascular CVD : cardiovascular disease D : diuretic DASH : Dietary Approaches to Stop Hypertension DBP : diastolic blood pressure DCCT : Diabetes Control and Complications Study DIRECT : DIabetic REtinopathy C and esartan Trials DM : diabetes mellitus DPP-4 : dipeptidyl peptidase 4 EAS : European Atherosclerosis Society EASD : European Association for the Study of Diabetes ECG : electrocardiogram EF : ejection fraction eGFR : estimated glomerular filtration rate ELSA : European Lacidipine Study on Atherosclerosis ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease  EXPLOR : Amlodipine – Valsartan Combination Decreases Central Systolic Blood Pressure more Effectively than the Amlodipine – Atenolol Combination FDA : U.S. Food and Drug Administration FEVER : Felodipine EVent Reduction study GISSI-AF : Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Atrial Fibrillation HbA1c : glycated haemoglobin HBPM : home blood pressure monitoring HOPE : Heart Outcomes Prevention Evaluation HOT : Hypertension Optimal Treatment HRT : hormone replacement therapy HT : hypertension HYVET : HYpertension in the Very Elderly Trial IMT : intima-media thickness I-PRESERVE : Irbesartan in Heart Failure with Preserved Systolic Function INTERHEART : Effect of Potentially Modifiable Risk Factors associated with Myocardial Infa rct ion in 52 Countries INVEST : INternational VErapamil SR/T Tr and olapril ISH : Isolated systolic hypertension JNC : Joint National Committee JUPITER : Justification for the Use of Statins in Primary Prevention : an Intervention Trial Evaluating Rosuvastatin LAVi : left atrial volume index LIFE : Losartan Intervention For Endpoint Reduction in Hypertensives LV : left ventricle/left ventricular LVH : left ventricular hypertrophy LVM : left ventricular mass MDRD : Modification of Diet in Renal Disease MRFIT : Multiple Risk Factor Intervention Trial MRI : magnetic resonance imaging NORDIL : The Nordic Diltiazem Intervention study OC : oral contraceptive OD : organ damage ONTARGET : ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial PAD : peripheral artery disease PATHS : Prevention And Treatment of Hypertension Study PCI : percutaneous coronary intervention PPAR : peroxisome proliferator-activated receptor PREVEND : Prevention of REnal and Vascular ENdstage Disease PROFESS : Prevention Regimen for Effectively Avoiding Secondary Strokes PROGRESS : Perindopril Protection Against Recurrent Stroke Study PWV : pulse wave velocity QALY : Quality adjusted life years RAA : renin-angiotensin-aldosterone RAS : renin-angiotensin system RCT : r and omized controlled trials RF : risk factor ROADMAP : R and omized Olmesartan And Diabetes MicroAlbuminuria Prevention SBP : systolic blood pressure SCAST : Angiotensin-Receptor Blocker C and esartan for Treatment of Acute STroke SCOPE : Study on COgnition and Prognosis in the Elderly SCORE : Systematic COronary Risk Evaluation SHEP : Systolic Hypertension in the Elderly Program STOP : Swedish Trials in Old Patients with Hypertension STOP-2 : The second Swedish Trial in Old Patients with Hypertension SYSTCHINA : SYSTolic Hypertension in the Elderly : Chinese trial SYSTEUR : SYSTolic Hypertension in Europe TIA : transient ischaemic attack TOHP : Trials Of Hypertension Prevention TRANSCEND : Telmisartan R and omised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease UKPDS : United Kingdom Prospect i ve Diabetes Study VADT : Veterans ' Affairs Diabetes Trial VALUE : Valsartan Antihypertensive Long-term Use Evaluation WHO : World Health Organization # # # 1.1 Principles The 2013 guidelines on hypertension of the European Society of Hypertension ( ESH ) and the European Society of Cardiology OBJECTIVE To evaluate the efficacy of combined vaginal pelvic floor electrical stimulation ( PFS ) and local vaginal estrogen in treatment of female overactive bladder ( OAB ) . MATERIAL AND METHODS This is a r and omized controlled trial carried out on 315 perimenopausal females with OAB who were r and omly allocated into 3 equal groups . Group A underwent PFS using vaginal probes twice weekly for 12 sessions . Group B received local vaginal estrogen , whereas group C received both PFS and local estrogen . All patients were evaluated by a voiding diary , quality -of-life question naire , vaginal examination , urine analysis , blood sugar , ultrasonography , and urodynamic study before and after therapy . Patients were followed up 1 week , 3 , and 6 months post-therapy . The analyzed variables included day and night time frequency , incontinence episodes , urgency , quality of life , detrusor overactivity ) , and functional bladder capacity ) . Outcome measure was urge incontinence . RESULTS Within each group , there was a statistically significant improvement in all variables after treatment . Improvement of urgency was better in group C than in groups A and B ( P = .000 , .009 ) . Improvement of incontinence was better in groups A and C than in group B ( P = .005 , .004 ) . Follow-up showed worsening of symptoms within 6 months in all groups except incontinence in group C. CONCLUSION Vaginal PFS and estrogen found to be effective in treating OAB symptoms in perimenopausal females . Estrogen seems to augment the effect of PFS especially in the treatment of urgency incontinence and can delay its recurrence
target: Combination therapy studies of third-line treatments were rare and centered on medication with PTNS .
  Combination therapy , with certain first , second , and third-line OAB therapies , appears to be efficacious .
background: AIMS Overactive bladder ( OAB ) affects over 17 % of the population and significantly effect the health-related quality of life .
  The treatments for OAB include first line ( lifestyle modification , pelvic floor muscle training ) , second line ( anticholinergic or beta-3 agonist medications ) , and third line therapies ( intradetrusor botulinum toxin injection , sacral neurostimulation [ SNM ] , or percutaneous tibial nerve stimulation [ PTNS ] ) .
  For those with urinary incontinence secondary to OAB , complete continence is the goal of therapy , though cure rates are only 5 % to 40 % .
  The use of combination therapies can be employed in refractory OAB , however , the efficacy of pooled modalities is relatively unknown .
  Our objective was to determine the volume of data supporting combination therapy in treating OAB .