What is the role of botulinum toxin in urinary incontinence treatment?

Updated: Jan 22, 2021
  • Author: Sandip P Vasavada, MD; Chief Editor: Edward David Kim, MD, FACS  more...
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A neurotoxin produced by Clostridium botulinum, onabotulinumtoxinA (Botox) prevents acetylcholine release from presynaptic membrane. Therapy for urinary incontinence consists of 30 intradetrusor injections via cystoscopy.

In August 2011, onabotulinumtoxinA was approved by the FDA for urinary incontinence in patients with neurologic conditions (eg, spinal cord injury, multiple sclerosis) who have overactive bladder. Placebo-controlled trials have shown significant reduction in urinary incontinence episodes and improved urodynamics at 12 weeks in patients who received onabotulinumtoxinA. [80, 81, 82]  

In January 2013, the FDA expanded the approved use of onabotulinumtoxinA to treatment of adults with overactive bladder who cannot use or do not adequately respond to anticholinergic drugs. The new indication was based on results of two placebo-controlled clinical trials in 1105 patients with symptoms of overactive bladder. After 12 weeks, patients who received injections of 100 units of onabotulinumtoxinA (20 injections of 5 units each) experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Treatment with onabotulinumtoxinA can be repeated if necessary, but at least 12 weeks should elapse between treatments. [83]

The ABC trial (Anticholinergic therapy vs onabotulinum toxinA for urgency incontinence) shed some light on the utility of 100 units of onabotulinumtoxinA in the setting of overactive bladder. The data have shown comparable efficacy of 100 units of onabotulinumtoxinA to anticholinergic medications with reduced systemic side effects in the onabotulinumtoxinA-injected group, yet higher rates of retention and urinary tract infections. Patients receiving onabotulinumtoxinA were more likely to be dry, however. Patients who received anticholinergic drugs were more likely to suffer from dry mouth and other systemic side effects. [84]

In a study that compared sacral neuromodulation and onabotulinumtoxinA in 364 women with refractory urge urinary incontinence, treatment with onabotulinumtoxinA resulted in a greater reduction in the 6-month mean number of daily episodes of urge incontinence. However, the authors note that although the difference was statistically significant, it is of uncertain clinical importance. In addition, treatment with onabotulinumtoxinA resulted in a higher risk of urinary tract infection (UTI) and need for transient self-catheterizations. [85]

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