human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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  
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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  
    Output:
    