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FDA Approves Botox Administration for Overactive Bladder

Update Date: Jan 20, 2013 06:10 AM EST

The administration of Botox or onabotulinumtoxinA was approved Jan. 18 to treat overactive bladder by the U.S. Food and Drug Administration agency. This treatment is strictly in cases where anticholinergics become ineffective; either the patient is non-responsive or cannot use them due to several reasons.

Anticholinergics are used to treat overactive bladder, where the patient has to urinate for more than eight times a day, which is an abnormally high rate. In case of overactive bladder, the urinary bladder contracts several times without any prior warning. The most common symptom is leaking urine, otherwise known as urinary incontinence, a sudden urge to urinate, as well as frequent urination.

When a person suffers from overactive bladder, the muscle in the urinary bladder contracts, which makes the urine storage capacity noticeably lower. Botox is administered into the muscle of the urinary bladder, which causes it to expand to its normal size, thus enabling it to store the normal amount of urine and reducing overactive bladder.

"Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence. Today's approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States," Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA's Center for Drug Evaluation and Research, said in a news release.

Prior to their approval, the FDA conducted two clinical trials of 1,105 patients suffering from overactive bladder. They were randomly administered 20 injections of 5 units each of Botox, a total of 100 units or placebo. After 12 weeks, the results were analyzed and it was found that the symptom of overactive bladder decreased at an average rate ranging between 1.6 and 1.9 times per day, as opposed to patients treated with a placebo. Patients who were injected with Botox also experienced their urgency to urinate decreasing on an average by 1.0 to 1.7 times, and also urinated an average of 30 milliliters more than those treated with a placebo.

The treatment can be repeated after giving a minimum of 12 week gap if the effect of the former treatment lessens. Botox is famous for reducing lines and wrinkles on the face on a short-term basis and is manufactured by Allergen Inc. of Irvine, Calif.

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