Treating Urge Urinary Incontinence (UUI) or the accidental loss of urine while suddenly feeling an urge to urinate has been challenging. Traditional treatments have included behavioral therapies (like bladder training), pelvic floor muscle therapy (like muscle strengthening exercises), and medication, most commonly anticholinergics like tolterodine (Detrol), oxybutynin (Ditropan), solifenacin (Vesicare), darifenacin (Enablex). A newer treatment, injecting Botox A® into the bladder, was approved by the FDA for the treatment of urge urinary incontinence in January, 2013.
The ABC study was designed to compare treatment with an anticholinergic medication (Solifenacin or Trospium) to a single Botox A® injection into the bladder. Half of the women in the study received the Botox A® injection and also took a daily placebo (no active medication) pill. The other half had an injection of a simple salt solution into the bladder and took a pill of Solifenacin or Trospium daily. Neither the women in the study nor their doctors or nurses knew which active treatment that they had received.
All women completed bladder diaries before and after treatment, and also completed surveys and questionnaires which described their symptoms and their quality of life. The investigators wanted to compare the number of incontinence episodes (accidental leakages of urine) that women in each group recorded on a bladder diary to see whether one treatment was better than the other. The investigators were also interested in how the two treatments affected their bladder symptoms and their lives in general before and after treatment.
The study was completed in 2011. A total of 242 women participated in the study.
Visco AG, Brubaker L, et al. Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial. Contemporary Clinical Trials 2012 Jan;33(1):184-96.
Visco AG, Brubaker L et al. Anticholinergic therapy vs. onabotulinum toxin A for urgency urinary incontinence
. New England Journal of Medicine November 8 2012;367(19):1803.