Paul K. Tulikangas, MD, FACOG, FACS
Visco AG, Brubaker L, Richter HE, et al; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.
Urinary urgency, frequency, and urge urinary incontinence are symptoms of overactive bladder (OAB). Almost one in five adult women in the United States is bothered by overactive bladder. Oral anticholinergic medications are a common treatment for this condition. Recently, onabotulinumtoxinA has been used to treat urinary incontinence due to detrusor overactivity associated with a neurologic condition (ex, spinal cord injury or multiple sclerosis). This is the first prospective study comparing onabotulinumtoxinA to oral anticholinergic medication in women with idiopathic OAB.
- The study was a double-blind, double-placebo-controlled, randomized trial
- Women were recruited for participation in the trial that had five or more urgency urinary incontinence (UUI) episodes as recorded in a 3-day voiding diary
- 249 women underwent randomization and 241 women were included in the primary outcome analysis
- The anticholinergic treatment group received daily anticholinergic medication (solifenacin 5 mg, with possible dose escalation to solifenacin 10 mg, or switch to trospium XR 60 mg) for 6 months and a single sham intradetrusor injection of saline
- The onabotulinumtoxinA treatment group received an oral placebo daily and a single intradetrusor injection of 100 U onabotulinumtoxinA
- The primary endpoint was the change from baseline in mean episodes of UUI per day documented in a 3-day diary (over the course of 6 months of treatment)
- The mean reduction in UUI episodes per day was the same in both treatment groups over 6 months. From a baseline of 5.0 UUI episodes per day, anticholinergic treatment was associated with a reduction of 3.4, and intradetrusor injection of onabotulinumtoxinA was associated with a reduction of 3.3 UUI episodes per day (P = 0.81)
- Women treated with onabotulinumtoxinA were more likely to report complete resolution of urgency urinary incontinence compared with anticholinergic treatment (27% vs. 13%; P = 0.03). Improvements in quality of life measures were not different between the treatment groups
- The frequency of dry mouth was greater in the anticholinergic group than the onabotulinumtoxinA treatment group (46% vs 31%, respectively; P = 0.02)
- Women treated with onabotulinumtoxinA had a higher rate of lower urinary tract infection (33% vs. 13%, P < 0.001) and were also more likely to use a catheter to empty their bladder at 2 months (5% vs. 0%, P = 0.01) compared with those taking oral anticholinergic medication
This represents the first trial comparing onabotulinumtoxinA to oral anticholinergic medications for overactive bladder. The women enrolled in the trial had idiopathic overactive bladder and did not have to be anticholinergic treatment failures for enrollment. Treatment with intradetrusor onabotulinumtoxinA or an oral anticholinergic medication regimen resulted in very similar improvements in overactive bladder symptoms.
Currently, onabotulinumtoxinA is approved by the FDA for treatment of urinary incontinence due to bladder overactivity associated with neurologic conditions. Overactive bladder is a morbid condition that affects millions of women, and for most of these women, the cause of their overactive bladder is unknown. The results of this trial are exciting, and the potential for an alternative treatment for women with idiopathic OAB is encouraging for clinicians and patients alike.