The Food and Drug Administration on Jan. 18 approved Botox for patients with overactive bladder who have contraindications to or don’t respond to anticholinergics.
"Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence," Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.
"With the approval of Botox [onabotulinumtoxinA], we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to 6 months," Dr. Victor Nitti, vice chairman in the department of urology at NYU Langone Medical Center, said in a statement released by Botox maker Allergan.
Overactive bladder (OAB) results in an uncontrolled urge to urinate, frequent urination, and uncontrollable leakage of urine, according to the Allergan statement. About 14.7 million American adults have overactive bladder, and 3.3 million use anticholinergics; however, at least half of them stop taking the drugs within a year because of intolerance.
Botox injected into the bladder muscle relaxes the organ and increases its storage capacity, thus reducing incontinence, according to the FDA. The Botox is injected via cystoscopy.
The FDA evaluated the drug’s safety and efficacy for overactive bladder through two studies in which 1,105 patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. At 12 weeks, patients who received Botox had 1.6 to 1.9 fewer incidents of incontinence per day, and also needed to urinate less frequently.
The treatment needs to be repeated to maintain effectiveness; the FDA recommends at least 12 weeks between injections. Side effects during trials included urinary tract infections, painful urination, and urinary retention.
Patients must take antibiotics before, during, and a few days after Botox treatment to reduce infection risk.
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