Botox Approved for Incontinence in Neurologic Conditions

Susan Jeffrey

August 24, 2011

August 24, 2011 — The US Food and Drug Administration (FDA) announced approval today for the use of onabotulinumtoxinA (Botox, Allergan Inc) to treat urinary incontinence resulting from detrusor overactivity in patients with spinal cord injury and multiple sclerosis (MS).

"Urinary incontinence associated with neurologic conditions can be difficult to manage," said George Benson, MD, deputy director of the FDA's Division of Reproductive and Urologic Products. "Botox offers another treatment option for these patients."

Uninhibited urinary bladder contractions in patients with certain neurological conditions can lead to an inability to store urine, a statement from FDA notes. Current management of this condition includes anticholinergic medications or use of a catheter.

A release from Allergan notes that the approval is for patients who have an inadequate response to anticholinergic therapy or in whom such therapy was not tolerated.

Treatment with onabotulinumtoxinA for this indication was based on results of 2 clinical trials involving 691 patients with spinal cord injury and MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the treated group vs placebo. Both studies, which were presented earlier this year — one at the European Association of Urology 26th Annual Congress and the other at the American Urological Association 2011 Annual Scientific Meeting — were reported by Medscape Medical News.

Injection of the drug into the bladder results in relaxation, allowing the bladder to increase storage capacity and decrease urinary incontinence, the statement notes. Injection is performed using cystoscopy, which may require general anesthesia. The duration of effect of treatment is about 9 months.

The most common adverse reactions seen following injection were urinary tract infection and urinary retention. "Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder," the FDA statement adds.

OnabotulinumtoxinA is already approved for other indications, including chronic migraine, upper limb spasticity, strabismus, and blepharospasm.

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