FDA approves Botox to treat a form of urinary incontinence

September 2, 2011

FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Urinary incontinence (bladder leakage) resulting from detrusor (bladder muscle) overactivity in patients living with MS or SCI is a chronic condition affecting approximately 340,000 people in the United States. Current standard of care includes oral medications that are taken regularly, known as anticholinergics; however, it is estimated that 71% of people stop taking at least 1 oral medication within 12 months. If oral medications fail, then surgery may be considered (eg, for bladder augmentation or implantation of a neuromodulation device).

The treatment, consisting of Botox injection into the bladder, results in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor 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 neurologic condition is about 9 months.

Studies have shown that many patients are undiagnosed and undertreated because they are too embarrassed to talk to their doctor about their symptoms, Victor Nitti, MD, told Formulary. Nitti is vice-chairman of the department of urology, New York University Langone Medical Center.

“Botox now offers a new, long-lasting treatment option to reduce urinary incontinence episodes and address a particularly burdensome issue in this patient population,” added Nitti, who was involved in the Botox clinical trial program.

"We are proud to bring the seventh medical use of Botox in the United States to market,” said Scott Whitcup, MD, in a company press release. Whitcup is Allergan's executive vice president of research and development and its chief scientific officer. “Botox is the first neurotoxin to undergo formal clinical evaluation and receive FDA approval for a urological indication."

The effectiveness of Botox for treating this type of incontinence was demonstrated in 2 clinical studies involving 691 patients with urinary incontinence resulting from SCI or MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared to patients treated with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid, and strabismus, a condition in which the eyes are not properly aligned.

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.