title: Intradetrusor versus suburothelial onabotulinumtoxinA injections for neurogenic detrusor overactivity: a pilot study Clinical Efficacy and Changes of Urothelial Dysfunction after Repeated Detrusor Botulinum Toxin A Injections in Chronic Spinal Cord-Injured Bladder Protocol for a prospective magnetic resonance imaging study on supraspinal lower urinary tract control in healthy subjects and spinal cord injury patients undergoing intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity Detrusor botulinum toxin A injection significantly decreased urinary tract infection in patients with traumatic spinal cord injury An exploratory, placebo-controlled, dose–response study of the efficacy and safety of onabotulinumtoxinA in spinal cord injury patients with urinary incontinence due to neurogenic detrusor overactivity Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence. Submucosal Administration of OnabotulinumtoxinA in the Treatment of Neurogenic Detrusor Overactivity: Pilot Single-Centre Experience and Comparison with Standard Injection into the Detrusor OnabotulinumtoxinA is Effective in Patients with Urinary Incontinence due to Neurogenic Detrusor Activity Regardless of Concomitant Anticholinergic Use or Neurologic Etiology Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. The therapeutic effects of repeated detrusor injections between 200 or 300 units of onabotulinumtoxinA in chronic spinal cord injured patients. Botulinum toxin type A injections for treating neurogenic detrusor overactivity combined with low-compliance bladder in patients with spinal cord lesions. Botulinum toxin-A injections into neurogenic overactive bladder--to include or exclude the trigone? A prospective, randomized, controlled trial. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. Validation of a self-administered instrument to measure adherence to anticholinergic drugs in women with overactive bladder. Therapeutic effects of detrusor botulinum toxin A injection on neurogenic detrusor overactivity in patients with different levels of spinal cord injury and types of detrusor sphincter dyssynergia Botulinum toxin A detrusor injections in patients with neurogenic detrusor overactivity significantly decrease the incidence of symptomatic urinary tract infections. Botulinum toxin A improves the quality of life of patients with neurogenic urinary incontinence. Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial.
abstract: Study design : This was a multicentre , prospect i ve , r and omised study . Objectives : To compare the outcomes of intradetrusor and suburothelial onabotulinumtoxinA injections in patients with spinal cord injury and refractory neurogenic detrusor overactivity ( NDO ) . Setting : Urology departments of two tertiary hospitals in the Czech Republic . Methods : A total of 32 spinal cord injury patients with severe NDO refractory to the st and ard anticholinergic treatment were r and omised to receive either intradetrusor or suburothelial 300 IU onabotulinumtoxinA injections .  Subjective satisfaction , bladder diary data and urodynamic data were compared in both groups before treatment and at 3 months post treatment . Results : In all , 64.3 % patients in the intradetrusor group and 88.8 % patients in the suburothelial group were subjectively satisfied with the treatment . There was a significant post-treatment improvement in both groups regarding the number of catheterisations over 24 h , number of incontinence episodes over 24 h , catheterised volume , cystometric capacity , volume at first involuntary detrusor contraction , maximal detrusor pressure during filling and detrusor compliance . No significant differences between the groups were observed , with the exception of improvement of detrusor compliance , which was better in the intradetrusor group . There was one adverse effect comprising transient muscle weakness that was reported by one patient in the intradetrusor group . Conclusion : Results in both groups were comparable . The authors favour suburothelial onabotulinumtoxinA injection because this method allows more precise toxin localisation Chornic spinal cord injury ( SCI ) will induce bladder urothelium dysfunction . This study investigated the therapeutic effects on urothelial dysfunction after repeated detrusor injections of onabotulinumtoxinA ( BoNT-A ) in SCI patients with neurogenic detrusor overactivity ( NDO ) . Twenty chronic suprasacral SCI patients with NDO were enrolled . The patients received 300 U BoNT-A injection into the detrusor every six months . The urothelium was assessed by cystoscopic biopsy at baseline and six months after each BoNT-A treatment . Immunofluorescence staining for urothelial dysfunction , including E-cadherin , zonula occludens-1 ( ZO-1 ) , tryptase for mast cell activity , and urothelial apoptosis were investigated . The outcome of urothelial dysfunction parameters after BoNT-A injection were compared between baseline and six months after each treatment . Repeated 300 U BoNT-A injections showed a sustained decrease of detrusor pressure compared with baseline . After three repeated BoNT-A detrusor injections , significantly greater distributions of E-cadherin ( p = 0.042 ) and ZO-1 ( p = 0.003 ) expressions , but no significant changes , of urothelial apoptosis and mast cell activation were found after repeated BoNT-A therapy . Urothelial dysfunction , such as adhesive and junction protein concentrations in SCI patients ’ bladders , recovered after three repeated cycles of BoNT-A treatment . The therapeutic effects sustained . However , urothelial inflammation and apoptosis after SCI were not significantly improved after three repeated BoNT-A injections Background The control of the lower urinary tract is a complex , multilevel process involving both the peripheral and central nervous system . Due to lesions of the neuraxis , most spinal cord injury patients suffer from neurogenic lower urinary tract dysfunction , which may jeopardise upper urinary tract function and has a negative impact on health-related quality of life . However , the alterations to the nervous system following spinal cord injury causing neurogenic lower urinary tract dysfunction and potential effects of treatments such as intradetrusor onabotulinumtoxinA injections on lower urinary tract control are poorly understood . Methods / Design This is a prospect i ve structural and functional magnetic resonance imaging study investigating the supraspinal lower urinary tract control in healthy subjects and spinal cord injury patients undergoing intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity . Neuroimaging data will include structural magnetic resonance imaging ( T1-weighted imaging and diffusion tensor imaging ) as well as functional , i.e. blood oxygen level-dependent sensitive magnetic resonance imaging using a 3 T magnetic resonance scanner . The functional magnetic resonance imaging will be performed simultaneously to three different bladder stimulation paradigms using an automated magnetic resonance compatible and synchronised pump system . All subjects will undergo two consecutive and identical magnetic resonance imaging measurements . Healthy subjects will not undergo any intervention between measurements but spinal cord injury patients will receive intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity . Parameters of the clinical assessment including bladder diary , urinalysis , medical history , neuro-urological examination , urodynamic investigation as well as st and ardised question naires regarding lower urinary tract function and quality of life will serve as co-variates in the magnetic resonance imaging analysis . Discussion This study will identify structural and functional alterations in supraspinal networks of lower urinary tract control in spinal cord injury patients with neurogenic detrusor overactivity compared to healthy controls . Post-treatment magnetic resonance imaging measurements in spinal cord injury patients will provide further insights into the mechanism of action of treatments such as intradetrusor onabotulinumtoxinA injections and the effect on supraspinal lower urinary tract control . Trial registration Clinical Trials.gov NCT01768910 Study design : The study was design ed as a single-arm clinical trial . Objectives : To investigate the effect of detrusor botulinum toxin A ( BoNTA ) injection on urinary tract infection ( UTI ) in patients with spinal cord injury ( SCI ) . Setting : The study was performed in a national rehabilitation research center of China . Methods : Between September 2010 and May 2012 , 41 male in patients with neurogenic detrusor overactivity ( NDO ) caused by traumatic SCI , mean age 36.0±8.8 years , duration of SCI since inclusion 21.5±17.3 months , received an injection of 300 U BoNTA into detrusor . Before and 3 months after injection , each patient kept a bladder diary , underwent video-urodynamic investigation and urine culture . All UTIs occurring in the 6 months before and the 6 months after injection were recorded . Results : Before injection , the mean number of UTI over 6 months was 1.39±1.36 . After injection , the mean significantly decreased to 0.78±0.96 ( P=0.023 ) . The mean maximum detrusor pressure during filling decreased significantly in the patients of detrusor overactivity ( n=24 ) compared with patients of normo-active detrusor ( n=17 ) after injection ( 35.4±12.2 vs 20.9±7.9 cmH2O , P=0.000 ) , meantime , the decrease of UTI was significant in the former ( 1.29±1.21 vs 0.41±0.62 cmH2O , P=0.015 ) while no significant in the latter ( 1.46±1.47 vs 1.04±1.08 , P=0.319 ) . Conclusion : Detrusor BoNTA injection significantly decreased UTI in SCI patients with NDO . This effect seems to be related to the decrease of detrusor pressure Purpose To explore the dose response to onabotulinumtoxinA 50 , 100 , and 200 U in patients with spinal cord injury ( SCI ) with urinary incontinence ( UI ) due to neurogenic detrusor overactivity ( NDO ) . Methods Patients ( N = 73 ) with SCI ( level T1 or lower ) with NDO and UI ( ≥14 UI episodes/week ) received 30 intradetrusor injections of onabotulinumtoxinA ( 50 U [ n = 19 ] , 100 U [ n = 21 ] , or 200 U [ n = 17 ] ) or placebo ( n = 16 ) via cystoscopy , avoiding the trigone . Changes from baseline in UI episodes/week , volume voided/micturition , maximum cystometric capacity , and maximum detrusor pressure ( MDP ) during first involuntary detrusor contraction ( IDC ) were evaluated . Adverse events ( AEs ) were assessed . Results A significant linear dose response for UI episodes/week was identified at weeks 18 , 30 , 36 , 42 , and 54 ( P < 0.05 ) with a similar trend ( P = 0.092 ) at week 6 ( primary time point ) . A significant linear dose response was observed in volume/void at all post-treatment time points up to week 54 ( P < 0.05 ) and in MDP during first IDC at week 6 ( P = 0.034 ) . The proportion of patients who achieved continence at week 6 was highest in the 200 U group . Duration of effect was longest with the 200 U dose , compared with other treatment groups . The AEs were comparable across groups ; urinary tract infection was the most common AE across all treatment groups . Conclusions In this exploratory dose – response study of SCI patients with UI due to NDO , onabotulinumtoxinA 200 U was the most effective dose . The AE profile was comparable across all groups OBJECTIVE To assess the reliability , validity , responsiveness , and minimally important difference ( MID ) of the Incontinence Quality of Life ( I-QOL ) question naire in patients with urinary incontinence due to neurogenic detrusor overactivity . DESIGN R and omized , double-blind , multicenter , placebo-controlled study . SETTING Eight centers across Belgium , France , and Switzerl and . PARTICIPANTS Patients with urinary incontinence due to neurogenic detrusor overactivity inadequately managed on oral anticholinergics . Fifty-nine patients ( spinal cord injury , n=53 ; multiple sclerosis , n=6 ) were enrolled . INTERVENTION Single dose of botulinum toxin type A ( Botox ) ( 200 or 300 U ) or placebo . MAIN OUTCOME MEASURES I-QOL question naire completed at screening and over a 24-week post-treatment period . RESULTS The Cronbach alpha ranged from .79 to .93 , indicating that I-QOL is a reliable measure of QOL in neurogenic urinary incontinence patients . No item had more than 5.1 % missing or out of range values . With the exception of 2 items , questions showed acceptable item-scale correlation and scaling success results varied by domain . Post-treatment correlations indicated acceptable construct validity . The I-QOL was responsive to improvements in symptoms . MID values ranged from 4 to 11 points . CONCLUSIONS Results suggest that I-QOL is a reliable , valid , and responsive measure of incontinence-related QOL in neurogenic patients Introduction : Apart from the st and ard intramural administration of botulinum neurotoxin A ( BoNT/A ) to the detrusor , intense research is taking place into new means of administration in view of the complex mechanism of action of BoNT/A. Methods : An open , r and omised , prospect i ve study was performed on a total of 23 patients with neurogenic detrusor overactivity . Following r and omisation , patients were treated with 300 U of onabotulinumtoxinA ( onaBoNT/A ) in either the submucosa or the detrusor . Urodynamic examinations were carried out , and a bladder diary was kept both prior to and 12 weeks after the treatment . All patients stopped taking anticholinergics 1 week prior to the treatment . Results : In both the submucosa and detrusor groups , we recorded a significant improvement in the monitored urodynamic parameters and significant decreases in the frequency of urinary incontinence episodes following the treatment . A comparison of the two groups showed no significant difference between the two forms of application , with the exception of voided volume ( p = 0.007 ) . Conclusion : A comparison of the two administration methods did not show any significant difference between onaBoNT/A administration to the submucosa and to the detrusor . Thus , the submucosal injection of onaBoNT/A represents an equally effective approach for its administration to patients Introduction To evaluate the efficacy and safety of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity ( NDO ) in sub population s of etiology ( multiple sclerosis [ MS ] or spinal cord injury [ SCI ] ) and concomitant anticholinergics ( use/non-use ) . Methods Data were pooled from two double-blind , placebo-controlled , pivotal , phase 3 studies including a total of 691 patients with ≥14 urinary incontinence ( UI ) episodes/week due to MS ( n = 381 ) or SCI ( n = 310 ) . Patients received intradetrusor injections of onabotulinumtoxinA 200U ( n = 227 ) , 300U ( n = 223 ) , or placebo ( n = 241 ) . Change from baseline at week 6 in UI episodes/week ( primary endpoint ) , urodynamics , quality of life ( QOL ) , and adverse events ( AEs ) were assessed . Results Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use : at week 6 , mean weekly decreases of −22.6 and −19.6 were seen in MS and SCI patients , respectively , and −20.3 and −22.5 in anticholinergic users and non-users , respectively , treated with onabotulinumtoxinA 200U . The 300U dose did not add to the clinical efficacy in any sub population . Similar proportions of patients achieved ≥50 % or 100 % reductions in UI episodes in all subgroups . Improvements in maximum cystometric capacity , maximum detrusor pressure during first involuntary detrusor contraction , and QOL were significant in both etiologies and were independent of anticholinergic use . The most common AEs in all groups were urinary tract infection and urinary retention . Conclusion Regardless of concomitant anticholinergic use or etiology , onabotulinumtoxinA significantly improved UI symptoms , urodynamics , and QOL  in patients with UI due to NDO . OnabotulinumtoxinA was well tolerated in all groups PURPOSE We determined the safety and efficacy of each of 2 doses of botulinum toxin type A ( BTX-A ) ( 200 or 300 U BOTOX ) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin . MATERIAL S AND METHODS A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity ( due to spinal cord injury in 53 and multiple sclerosis in 6 ) requiring clean intermittent self-catheterization were r and omized to receive a single dose into the detrusor of BTX-A ( 200 U or 300 U ) or placebo . Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks . Key urodynamic assessment s ( maximum cystometric capacity , reflex detrusor volume and maximum detrusor pressure during bladder contraction ) were used to provide objective measures of the treatment effect on bladder function . The impact of treatment on quality of life was assessed using the Incontinence Quality of Life question naire . RESULTS There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups ( p < /=0.05 ) but not in the placebo group . In addition , more patients who received BTX-A reported no incontinence episodes during at least 1 posttreatment evaluation period . Positive treatment effects were also reflected by significant improvements in bladder function in the BTX-A groups , as assessed by urodynamics and in patient quality of life . Benefits were observed from the first evaluation at week 2 to the end of the 24-week study . No safety concerns were raised . CONCLUSIONS Intramuscular injections of BTX-A into the detrusor can provide rapid , well tolerated , clinical ly significant decreases in the signs and symptoms of urinary incontinence caused by neurogenic detrusor overactivity during a 24-week study period OBJECTIVES To investigate the therapeutic effects of repeated detrusor onabotulinumtoxinA injections on treatment outcomes , quality of life ( QoL ) , and glomerular filtration rate ( GFR ) in chronic spinal cord injured ( SCI ) patients with neurogenic lower urinary tract dysfunction and urinary incontinence . MATERIAL S AND METHODS Patients with SCI who failed antimuscarinic treatment were enrolled . All patients had urodynamic detrusor overactivity ( DO ) or increased detrusor tonicity without anatomical bladder outlet obstruction or intrinsic sphincter deficiency . They were r and omly assigned to receive 200-U or 300-U onabotulinumtoxinA detrusor injections every 6 months . The primary endpoint was 6 months after the second injection . The urodynamic parameters , QoL measures , and 99mTc renal scans were evaluated at baseline and every 3 months and compared between dosages . RESULTS A total of 72 patients were enrolled , including 43 men and 29 women and mean injury duration of 8.7 years . Among them , 38 patients received 200-U and 34 received 300-U onabotulinumtoxinA injections . At the end-point , the urodynamic parameters and incontinence severity improved significantly , without a significant difference between the two groups . QoL also improved in both groups , without differences between groups . Uninhibited DO improved more in 300-U group compared to 200-U group at end-point ( P = 0.01 ) . The GFR did not change significantly in either group . The most common complication was urinary tract infection , which occurred in one third of patients . CONCLUSIONS Either 200-U or 300-U repeated detrusor onabotulinumtoxinA injections improved incontinence , urodynamic parameters , and QoL in SCI patients with neurogenic DO . Renal function was maintained in patients receiving both dosage of repeated injections OBJECTIVE To evaluate botulinum toxin type A ( BTX-A ) for treating neurogenic detrusor overactivity in patients with spinal cord lesions , including those with abnormally low bladder compliance . DESIGN Nonr and omized , before-after trial ( 9-mo follow-up ) . SETTING Hospitalized care . PARTICIPANTS Ten patients with high detrusor contraction pressure and /or poor response to oxyphencyclimine with incontinence selected as a consecutive sample . INTERVENTION BTX-A ( Botox ; 300U ) was injected into the detrusor muscle . MAIN OUTCOME MEASURES Urinary continence , functional bladder capacity , bladder compliance , detrusor contraction pressure , and volume at first reflex voiding . Measurements were taken before and 6 , 16 , and 36 weeks posttreatment . RESULTS Six weeks after treatment , complete continence was restored in 7 patients without oxyphencyclimine .  Mean functional bladder capacity ( P=.008 ) , compliance ( P=.012 ) , and reflex volume ( P=.045 ) significantly increased , whereas maximal detrusor contraction pressure significantly decreased ( P<.001 ) . Urodynamic variables remained significantly improved at 16 weeks , but values were returning toward baseline levels by 36 weeks . The procedure was generally uneventful , without any serious side effects . CONCLUSIONS BTX-A injections are an effective , well-tolerated treatment for neurogenic detrusor overactivity in patients with spinal cord lesions , even in patients with abnormally low bladder compliance . Patients may require repeat injections after 16 weeks to remain continent PURPOSE The short-term outcomes of initial detrusor injections vs combined detrusor-trigone botulinum toxin-A injections were determined in patients with spinal cord injury-neurogenic detrusor overactivity . MATERIAL S AND METHODS Adults with refractory spinal cord injury-neurogenic detrusor overactivity who strictly discontinued anticholinergics were recruited for the study . At a 1:1 ratio patients r and omly received 300 U botulinum toxin-A intradetrusor injections excluding the trigone ( detrusor arm ) or 200 U intradetrusor plus 100 U intratrigonal injections ( combined arm ) . Study end points were determination of the impact on incontinence episodes , complete dryness , quality of life , reusing anticholinergics , maximum detrusor pressure , reflex volume , maximum cystometric capacity , vesicoureteral reflux and adverse events . Patients were evaluated at baseline , and 2 , 8 , 12 and 18 weeks after injection . Statistical significance was considered at p<0.05 . RESULTS Analysis included 18 patients per arm with no significant baseline differences . On within group analysis all parameters improved significantly compared to baseline . On between group analysis in the detrusor vs the combined arm at week 8 incontinence decreased by 52.4 % vs 80.9 % ( number needed to treat 1.91 vs 1.23 patients , p<0.001 ) , complete dryness was achieved in 33.3 % vs 66.7 % of patients ( number needed to treat 3 vs 1.5 , p<0.001 ) and quality of life score was decreased by 46.76 % vs 48.13 % ( number needed to treat 2.14 vs 2.08 , p<0.44 ) . The absolute difference was 60 % vs 82.5 % for reflex volume ( p<0.001 ) , 66.2 % vs 68.4 % for maximum cystometric capacity ( p<0.22 ) and -42.3 % vs -41.9 % for maximum detrusor pressure ( p<0.21 ) . At week 18 anticholinergics were needed again in 9 ( 50 % ) and 4 patients ( 22.2 % ) patients , respectively . No patient showed new or up grade d vesicoureteral reflux or reported significant adverse events . CONCLUSIONS In the short term all parameters improved significantly in each arm . The superiority of including rather than excluding the trigone was significant AIMS OnabotulinumtoxinA significantly reduces urinary incontinence ( UI ) and improves bladder management in patients with neurogenic detrusor overactivity ( NDO ) . We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes ( PROs ) in patients with UI due to NDO in a double-blind , placebo-controlled study . METHODS Patients with UI due to NDO ( from multiple sclerosis or spinal cord injury ) were r and omized to  intradetrusor placebo ( n = 92 ) or onabotulinumtoxinA 200 U ( n = 92 ) or 300 U ( n = 91 ) . PROs included Incontinence Quality of Life ( I-QOL ) Question naire to assess health-related quality of life ( HRQoL ) , the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Question naire ( OAB-PSTQ ) to assess treatment satisfaction , and Patient Global Assessment to assess treatment goal achievement . RESULTS Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo ( Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo ; P < 0.001 ) , and was clinical ly meaningful . For those patients who completed the OAB-PSTQ , improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo ( P < 0.001 , all comparisons ) . At 6 weeks , greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied ( 200 U , 77.5 % and 300 U , 67.8 % vs. placebo , 39.5 % ) , and significant progress toward or complete achievement of primary treatment goal ( 200 U , 62.9 % and 300 U , 61.6 % vs. placebo , 16.5 % ) . CONCLUSIONS NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients , with no clinical ly relevant differences between onabotulinumtoxinA doses BACKGROUND Neurogenic detrusor overactivity ( NDO ) frequently results in urinary incontinence ( UI ) which impairs quality of life ( QOL ) and puts the upper urinary tract at risk . OBJECTIVE To assess the effects of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) on UI , urodynamic variables , and QOL in incontinent patients with NDO . DESIGN , SETTING , AND PARTICIPANTS This multicentre , r and omised , double-blind , placebo-controlled study enrolled patients with multiple sclerosis ( MS ; n=154 ) or spinal cord injury ( SCI ; n=121 ) with UI due to NDO ( ≥14 UI episodes per week ) . INTERVENTION Patients received 30 intradetrusor injections of onabotulinumtoxinA 200 U ( n=92 ) , 300 U ( n=91 ) , or placebo ( n=92 ) , avoiding the trigone . MEASUREMENTS Primary end point was change from baseline in UI episodes per week ( week 6 ) . Secondary end points included urodynamics ( maximum cystometric capacity [ MCC ] , maximum detrusor pressure during first involuntary detrusor contraction [ P(detmaxIDC ) ] ) , and Incontinence Quality of Life ( I-QOL ) total score . Adverse events ( AEs ) were assessed . RESULTS AND LIMITATIONS At baseline , mean UI episodes per week ( 33.5 ) were similar across groups . At week 6 , onabotulinumtoxinA 200 U and 300 U significantly reduced UI episodes per week ( -21.8 and -19.4 , respectively ) compared with placebo ( -13.2 ; p<0.01 ) ; onabotulinumtoxinA benefit was observed by the first posttreatment study visit at week 2 . Improvements in MCC , P(detmaxIDC ) , and I-QOL at week 6 were significantly greater with both onabotulinumtoxinA doses than with placebo ( p<0.001 ) . Benefits were observed in both the MS and SCI population s. The median time to patient request for retreatment was the same for both onabotulinumtoxinA doses ( 42.1 wk ) and greater than placebo ( 13.1 wk ; p<0.001 ) . Most frequent AEs were localised urologic events ( urinary tract infections and urinary retention , which were dose related in patients not using clean intermittent catheterisation [ CIC ] at baseline ) . Significant increases in postvoid residual were observed in patients not using CIC prior to treatment , and 12 % , 30 % , and 42 % of patients in the placebo , 200-U , and 300-U groups , respectively , initiated CIC posttreatment . CONCLUSIONS OnabotulinumtoxinA significantly reduced UI and improved urodynamics and QOL in MS and SCI patients with NDO . Both doses were well tolerated with no clinical ly relevant differences in efficacy or duration of effect between the two doses ( http://www . clinical trials.gov ; NCT00461292 ) PURPOSE We assessed the efficacy , safety and effects on quality of life of onabotulinumtoxinA in patients with neurogenic detrusor overactivity . MATERIAL S AND METHODS In this 52-week , international , multicenter , double-blind , r and omized , placebo controlled trial 416 patients with neurogenic detrusor overactivity and urinary incontinence ( 14 or more episodes per week ) result ing from multiple sclerosis ( 227 ) and spinal cord injury ( 189 ) were treated with intradetrusor injections of onabotulinumtoxinA ( 200 or 300 U ) or placebo . The primary end point was the change from baseline in the mean number of urinary incontinence episodes per week at week 6 . Maximum cystometric capacity , maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life total score were secondary end points . Adverse events were monitored . RESULTS OnabotulinumtoxinA at a dose of 200 U in 135 patients and 300 U in 132 decreased mean urinary incontinence at week 6 by 21 and 23 episodes per week , respectively , vs 9 episodes per week in 149 on placebo ( each dose p<0.001 ) . Also , maximum cystometric capacity , maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life score were significantly improved over values in the placebo group ( each dose p<0.001 ) . Median time to patient re-treatment request was greater for onabotulinumtoxinA 200 and 300 U than for placebo ( 256 and 254 days , respectively , vs 92 ) . The most common adverse events were urinary tract infection and urinary retention . Of patients who did not catheterize at baseline 10 % on placebo , 35 % on 200 U and 42 % on 300 U initiated catheterization due to urinary retention . CONCLUSIONS OnabotulinumtoxinA significantly improved neurogenic detrusor overactivity symptoms vs placebo . Clean intermittent catheterization initiation due to urinary retention appeared to increase in a dose dependent fashion . No clinical ly relevant benefit in efficacy or duration was identified for the 300 U dose over the 200 U dose AIM To vali date a self-administered instrument , the Medication Adherence Self-Report Inventory ( MASRI ) for measuring adherence to anti-cholinergic medication for overactive bladder ( OAB ) . METHODS Prospect i ve study in 131 women with OAB treated with fesoterodine .  Adherence was measured at 8 and 12 weeks using an interviewer administered brief medication question naire ( BMQ ) that assesses barriers to adherence ( criterion st and ard ) , the MASRI , and pill count . Construct , concurrent and discriminant validity of the MASRI was assessed . We hypothesized that women who were non-adherent as measured by the MASRI would be more likely to have a belief barrier than women who were adherent to medication . RESULTS Women diagnosed as non-adherent by the MASRI were more likely to report a belief barrier to taking medication as compared to adherent women at 8 weeks ( 80 % vs. 38 % , P < 0.001 ) and at 12 weeks ( 70 % vs. 40 % , P = 0.003 ) . Significant correlations were noted between adherence rates measured by the MASRI and the BMQ at 8 weeks ( r = 0.87 , P < 0.001 ) and 12 weeks ( r = 0.90 , P < 0.001 ) . Moderate correlation was noted between the adherence rate as measured by the MASRI and pill count at 8 weeks ( r = 0.49 , P = 0.02 ) but not at 12 weeks ( r = 0.05 , P = 0.87 ) . The MASRI correctly identified 93 % and 96 % of non-adherent women at 8 and 12 weeks , respectively . Sensitivity , specificity , and positive likelihood ratio of the MASRI for predicting non-adherence was 91 % , 82 % , and 5.1 at 8 weeks and 90 % , 85 % and 6.1 at 12 weeks . CONCLUSIONS The MASRI is a valid self-administered tool for measuring adherence to anti-cholinergic medication in women with OAB Study design : The study was design ed as a single-arm clinical trial . Objectives : To investigate the therapeutic effects of detrusor botulinum toxin A ( BoNT-A ) treatment in patients with different levels of spinal cord injury ( SCI ) and types of detrusor sphincter dyssynergia ( DSD ) . Setting : Patients with chronic suprasacral SCI and neurogenic detrusor overactivity ( NDO ) were treated with 200-U BoNT-A detrusor injection in a tertiary university hospital in Taiwan . Methods : Outcome assessment of urodynamic parameters and therapeutic satisfaction were performed at 3 and 6 months among patients with different demographics , SCI levels and types of DSD . The treatment outcomes were assessed by changes in Urogenital Distress Inventory 6-item short form ( UDI-6 ) , quality of life ( QoL ) index and detrusor pressure at maximum flow rate ( Pdet . Qmax ) . Results : A total of 38 patients with a mean age of 40.1±12.4 years and median duration of SCI of 10.3 years were enrolled . Satisfactory response was reported in 23 ( 60 % ) patients . Significant improvements in the UDI-6 and QoL were reported and significant increases of cystometric bladder capacity and post-void residual were noted in overall patients after treatment . Patients with different clinical demographics and urodynamic parameters had similar treatment outcomes and UDI-6 scores . In 11 patients receiving repeat injections of 300 U of BoNT-A after failure of a previous 200 U injection , the treatment outcomes were not significantly different , except that the PdetQmax at 6 months were higher in the group that received 200 U of BoNT-A. Conclusion : Patients with different SCI levels or DSD types had similar treatment outcomes after detrusor 200 U BoNT-A injections for NDO OBJECTIVES To study the effect of botulinum toxin A ( BoNTA ) injections into the detrusor muscle on the incidence of symptomatic urinary infections in patients with neurogenic detrusor overactivity . METHODS Between February 2004 and June 2005 , 30 patients ( 18 men , 12 women ) , mean age 39.4+/-12.1 yr , with neurogenic detrusor overactivity received an injection of 300 U Botox ( Allergan Inc. , Irvine , CA , USA ) into the detrusor .  Fifteen patients had multiple sclerosis , 14 had spinal cord injury , and 1 had myelitis . Twenty-two patients had urinary incontinence . Patients were either resistant to anticholinergic medications , had discontinued treatment because of adverse effects , or had contraindications to anticholinergic drugs . Before and 6 wk after injection , each patient kept a bladder diary and underwent urodynamic investigation , retro grade and voiding cystourethrography , and urine culture . All symptomatic urinary infections ( pyelonephritis , orchitis , prostatitis ) occurring in the 6 mo before and the 6 mo after injection were recorded . RESULTS Before injection , the mean number of symptomatic urinary infections over 6 mo was 1.75+/-1.87 . After injection , the mean was 0.2+/-0.41 ( p=0.003 ) , and only 3 patients presented symptomatic urinary infections . These patients were those who showed less improvement in their urodynamic parameters after injection ( volume of the first uninhibited contraction , maximum bladder pressure , and maximum cystometric capacity , respectively ; p=0.0037 , p=0.0002 , p=0.0027 , ANOVA ) . CONCLUSIONS BoNTA injections into the detrusor muscle significantly decreased the incidence of symptomatic urinary infections . This effect seems to be related to improvement in urodynamic parameters , reflecting improved reservoir capacity at low pressure OBJECTIVE To evaluate the impact of botulinum toxin type A ( BoNTA ) on health-related quality of life in patients with neurogenic urinary incontinence ( UI ) using the Incontinence Quality of Life question naire ( I-QOL ) . METHODS R and omized , double-blind , multicenter , placebo-controlled study involving eight centers across Belgium , France , and Switzerl and . Patients ( n = 59 ) with UI due to neurogenic detrusor overactivity ( spinal cord injury , n = 53 ; multiple sclerosis , n = 6 ) who were inadequately managed on oral anticholinergics  received a single dose of BoNTA ( 200U or 300U , Botox ) or placebo .  I-QOL scores at screening and after treatment at weeks 2 , 6 , 12 , 18 , and 24 were recorded . RESULTS Median total and subscale I-QOL scores increased significantly from screening with BoNTA 300U compared with placebo at all time points ( p<0.05 ) and with BoNTA 200U compared with placebo at all time points for total score and the Avoidance Limiting Behavior subscale ( p<0.05 ) , and at weeks 2 , 6 , 12 , and 18 ( p<0.05 ) , but not 24 for the Psychosocial Impact and Social Embarrassment subscales . Approximately twice as many BoNTA recipients as placebo recipients achieved at least a minimal important difference in total I-QOL score at 2 , 6 , 12 , and 24 wk . CONCLUSIONS BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic UI PURPOSE We determined the efficacy of onabotulinumtoxinA for neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis . MATERIAL S AND METHODS In a prospect i ve , double-blind , multicenter study 57 patients 18 to 75 years old with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis and urinary incontinence ( defined as 1 or more occurrences daily ) despite current antimuscarinic treatment were r and omized to  onabotulinumtoxinA 300 U ( 28 ) or placebo ( 29 ) via cystoscopic injection at 30 intradetrusor sites , sparing the trigone . Patients were offered open label onabotulinumtoxinA 300 U at week 36 and followed a further 6 months while 24 each in the treatment and placebo groups received open label therapy . The primary efficacy parameter was daily urinary incontinence frequency on 3-day voiding diary at week 6 . Secondary parameters were changes in the International Consultation on Incontinence Question naire and the urinary incontinence quality of life scale at week 6 . Diary and quality of life evaluations were also done after open label treatment . RESULTS The mean daily frequency of urinary incontinence episodes was significantly lower for onabotulinumtoxinA than for placebo at week 6 ( 1.31 vs 4.76 , p < 0.0001 ) , and for weeks 24 and 36 . Improved urodynamic and quality of life parameters for treatment vs placebo were evident at week 6 and persisted to weeks 24 to 36 . The most common adverse event in each group was urinary tract infection . CONCLUSIONS In adults with antimuscarinic refractory neurogenic detrusor overactivity and multiple sclerosis onabotulinumtoxinA is well tolerated and provides clinical ly beneficial improvement for up to 9 months
target: There were no statistically significant differences between doses of 200 U and 300 U or between injections into the detrusor and submucosa .
  CONCLUSION BoNT-A is effective and safe in treating NDO after SCI .
  There were no statistically significant differences between doses of 200 U and 300 U or between injecting into the detrusor and submucosa .
background: PURPOSE OnabotulinumtoxinA ( BoNT-A ) is a promising therapy for treating neurogenic detrusor overactivity ( NDO ) in individuals with spinal cord injury ( SCI ) .
  This systematic review and meta- analysis aim ed to carry out an in-depth review and to make an objective estimation of the efficacy and safety of BoNT-A on NDO after SCI .