The Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxinA; Allergan) for the treatment of neurogenic detrusor overactivity (NDO) in patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.

The approval is supported by data from a multicenter, randomized, double-blind phase 3 study (ClinicalTrials.gov: NCT01852045) that assessed the efficacy and safety of Botox in 113 patients aged 5 to 17 years with urinary incontinence due to NDO and using clean intermittent catheterization. Patients were randomly assigned to receive Botox 50 Units, 100 Units, or 200 Units, not exceeding 6 Units/kg body weight. 

Results showed that intradetrusor administration of Botox reduced daytime urinary incontinence episodes (primary end point), lowered maximum detrusor pressure, and increased bladder capacity at week 6. As for safety, the most common adverse reactions reported were bacteriuria (20%), urinary tract infection (7%), leukocyturia (7%), and hematuria (3%).

Botox is supplied as 100 Units and 200 Units of vacuum-dried powder in single-dose vials for reconstitution.


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References

  1. Botox® (onabotulinumtoxinA) receives FDA approval for pediatric detrusor overactivity associated with a neurologic condition. [press release]. North Chicago, IL: AbbVie; February 10, 2021. 
  2. Botox® [package insert]. Madison, NJ: Allergan, Inc.; 2021.