Botox Approved for Use in Urinary Incontinence

Botox Approved for Use in Urinary Incontinence

Botox (onabotulinumtoxinA) injection has been approved by the FDA to treat urinary incontinence caused be overactive bladder related to conditions such as spinal cord injury and multiple sclerosis.1 In persons with certain neurological conditions, uninhibited bladder contractions can make storing urine difficult. This condition traditionally has been managed with medication to relax the bladder and use of a catheter to empty the bladder.

With this newly approved indication for Botox, the drug now can be injected into the bladder through cystoscopy, which allows for visualization of the interior bladder. The result is relaxation of the bladder, an increase in the bladder’s storage capacity, and a decrease in urinary incontinence. Botox can improve the symptoms of urinary incontinence in patients with overactive bladder associated with a neurological condition for up to 10 months. However, general anesthesia may be required for the cystoscopy.

Approval of Botox for this indication was based on data from 2 clinical studies involving a total of 691 patients with urinary incontinence from spinal cord injury or multiple sclerosis. Significant decreases in the weekly frequency of incontinence episodes were noted in both studies in patients who received Botox. The most common adverse effects of Botox injection in the bladder were urinary tract infection and urinary retention. Persons with urinary retention following Botox treatment may need to self-catheterize to empty the bladder.


1. U.S. Food and Drug Administration. FDA approves Botox to treat specific form of urinary incontinence. August 25, 2011.  Accessed September 12, 2011.

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