The most frequently reported adverse reactions reported by ≥2% of BOTOX® treated patients and more often than in placebo-treated patients within the first 12 weeks after injection during clinical trials were urinary tract infection (UTI), dysuria, urinary retention, bacteriuria, and residual urine volume.4
|ADVERSE REACTIONS||BOTOX® 100 U
|Urinary tract infection (UTI)||18%||6%|
|Residual urine volume*||3%||0%|
No change was observed in the overall BOTOX® safety profile with repeat dosing during an open-label, uncontrolled extension trial.4>
|BOTOX® 100 U
|Median duration (days)||63||11|
† Pooled data from study 1 and study 2.
‡ 6.5% CIC rate (any time during complete treatment cycle); 6.0% rate of urinary retention in the first 12 weeks after BOTOX® injection (the primary time point).
In patients who initiated CIC, the median duration was 63 days for patients who received BOTOX® versus 11 days for those who received placebo.4
Catheterization was required for PVR ≥350 mL, regardless of symptoms, and for PVR ≥200 mL to <350 mL with symptoms (eg, voiding difficulty).