The U.S. Food and Drug Administration on Aug. 25 approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurological conditions such as spinal cord injury and multiple sclerosis who also have overactivity of the bladder.
Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine, according to an FDA news release. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.
The newly approved treatment consists of Botox being injected into the bladder, resulting in relaxation of the bladder, an increase in its storage capacity and a decrease in urinary incontinence.
“Urinary incontinence associated with neurologic conditions can be difficult to manage,” George Benson, deputy director of the FDA’s Division of Reproductive and Urologic Products, said in the news release. “Botox offers another treatment option for these patients.”
Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a clinician to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in patients with bladder overactivity associated with a neurological condition is up to 10 months.
The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The patients had urinary incontinence resulting from spinal cord injury or multiple sclerosis. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.
The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.
Botox is marketed in the United States by Allergan Inc., of Irvine, Calif.