These and other outcomes for effectiveness of BTX-A at different dosages in two observation periods indicate that a dose greater than 50 U is significantly more effective for certain symptoms of OAB compared with placebo .
However , there were no significant differences between some dosages .
Compared with placebo , the outcomes of total adverse events for NDO and for IDO show that doses of 300 U and 200 U for NDO are associated with more complications .
Conclusions In consideration that the treatments of BTX-A were with minimal , local , and manageable adverse effects , this meta- analysis demonstrates that BTX-A 200 U is recommended for management of NDO for short-term treatment for there was no significant difference from the larger dose of 300U .
Purpose To assess the effectiveness and safety of botulinum toxin A ( BTX-A ) at different dosages for overactive bladder ( OAB ) .
OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial.
PURPOSE Overactive bladder affects 12 % to 17 % of the general population and almost a third experience urinary incontinence , which may severely impact health related quality of life . Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects , leading to a high discontinuation rate . We report the results of the first large ( 557 patients ) , phase 3 , placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics . MATERIAL S AND METHODS Eligible patients with overactive bladder , 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were r and omized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo . Co- primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12 . Secondary end points included other overactive bladder symptoms and health related quality of life . Adverse events were assessed . RESULTS OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo ( -2.65 vs -0.87 , p < 0.001 ) and 22.9 % vs 6.5 % of patients became completely continent . A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale ( 60.8 % vs 29.2 % , p < 0.001 ) . All other overactive bladder symptoms improved vs placebo ( p ≤ 0.05 ) . OnabotulinumtoxinA improved patient health related quality of life across multiple measures ( p < 0.001 ) . Uncomplicated urinary tract infection was the most common adverse event . A 5.4 % rate of urinary retention was observed . CONCLUSIONS OnabotulinumtoxinA 100 U showed significant , clinical ly relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated
These and other outcomes for effectiveness of BTX-A at different dosages in two observation periods indicate that a dose greater than 50 U is significantly more effective for certain symptoms of OAB compared with placebo .
However , there were no significant differences between some dosages .
Compared with placebo , the outcomes of total adverse events for NDO and for IDO show that doses of 300 U and 200 U for NDO are associated with more complications .
Conclusions In consideration that the treatments of BTX-A were with minimal , local , and manageable adverse effects , this meta- analysis demonstrates that BTX-A 200 U is recommended for management of NDO for short-term treatment for there was no significant difference from the larger dose of 300U .
Purpose To assess the effectiveness and safety of botulinum toxin A ( BTX-A ) at different dosages for overactive bladder ( OAB ) .