FDA Expands Botox Incontinence Uses

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36921

SILVER SPRING, Md. -- The FDA approved use of onabotulinumtoxin A (Botox) to treat patients with overactive bladder who can't use or don't respond to anticholinergic drugs.

Previously, the drug was approved for overactive bladder resulting from spinal cord injury or multiple sclerosis.

"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 U.S.," said Hylton V. Joffe, MD, chief of the reproductive and urologic products division of the FDA's Center for Drug Evaluation and Research, in a statement.

The new approval was based primarily on two clinical trials involving a total of 1,105 patients, the FDA said. Patients received 20 injections of either 5 units of Botox or placebo.

After 12 weeks, patients receiving the active drug had 1.6 to 1.9 fewer daily incontinence episodes relative to the placebo group, and 1.0 to 1.7 fewer daily urinations. Average urine volume was higher by 30 mL with Botox versus placebo.

Treatment courses can be repeated when the effects appear to wane, but the FDA said that they should not be given more frequently than every 12 weeks.

Injections should be given in conjunction with cystoscopy.

Common adverse effects included urinary tract infections, painful urination, and incomplete emptying. Patients with the latter effect may need to use a urinary catheter until it resolves, the FDA said.

Antibiotic prophylaxis to prevent urinary tract infections should begin shortly before starting Botox therapy and continue for several days afterward, the agency said. Patients with active urinary tract infections should not start Botox.

Read more http://www.medpagetoday.com/Urology/UrinaryIncontinence/36921

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