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 .
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 .
Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity.
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
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 .
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 .