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Oral anticholinergic medications and onabotulinumtoxinA (Botox) injections are equally effective for the treatment of urgency urinary incontinence in women, according to new study findings, but have different side effects.
Oral anticholinergic medications and onabotulinumtoxinA (Botox) injections are equally effective for the treatment of urgency urinary incontinence in women, according to new study findings.1
Data from 241 women with idiopathic urgency urinary incontinence were analyzed in this double-blind, double-placebo randomized controlled trial. The average age of study participants was 58 years. For 6 months, approximately half of the women received oral anticholinergic medication (solifenacin, 5 mg initially up to a maximum dose of 10 mg if needed, with subsequent switch to trospium XR, 60 mg, if necessary) and saline injections in the bladder muscle; the other half received oral placebo pills and injections of onabotulinumtoxinA into the bladder muscle. All treatment was discontinued after 6 months. Researchers monitored the effectiveness of both treatments for an additional 6 months.
At 1 month, most study participants-about 90%-had responded to treatment. After 6 months of treatment, adequate symptom improvement was reported by approximately 70% of the women in each group. Specifically, the average number of daily episodes of incontinence was reduced from 5 episodes in both groups to 3.4 episodes in the anticholinergic group and 3.3 episodes in the onabotulinumtoxinA group. In addition, 13% of women in the anticholingergic group and 27% of women in the onabotulinumtoxinA group reported complete symptom resolution (P=0.003).
At 9 months, adequate symptom control was reported by 52% of women in the onabotulinumtoxinA group and 32% of women in the anticholinergic group. At 12 months, these percentages decreased to 38% and 25%, respectively.
Dry mouth was reported more often by women in the anticholinergic group (46% vs 31% in the onabotulinumtoxinA group). In contrast, more women in the onabotulinumtoxinA group required use of a catheter because of inability to completely empty their bladder (5% vs 0% in the anticholinergic group) and reported a higher rate of urinary tract infections (33% vs 13%, respectively).
According to the study authors, this is the first study comparing the effectiveness of onabotulinumtoxinA to oral medications for the treatment of urgency urinary incontinence. To date, FDA approval for onabotulinumtoxinA to treat urgency urinary incontinence is limited to patients whose symptoms have a known neurological cause, such as because of a spinal cord injury or multiple sclerosis. Susan F. Meikle, MD, MSPH, senior study author, has proposed that these results suggest that onabotulinumtoxinA may be a reasonable option for first-line treatment of the disorder. First, however, the cost-effectiveness of both approaches requires additional study.
- Oral anticholinergic medications and onabotulinumtoxinA injection are equally effective for the management of urgency urinary incontinence symptoms in women.
- Dry mouth was more common in patients taking anticholinergic medication, and catheter use and urinary tract infections occurred more often in patients receiving onabotulinumtoxinA injections.
1. Visco AG, Brubaker L, Richter HE, et al. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;DOI:10.1056/NEJMoa1208872.