ABC

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.

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STUDY RESULTS

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.

This published article describes how the study was conducted, important information to be shared with other researchers.  It also discusses the challenges of recruiting women into the study, and in trying to keep their assigned treatment group not known to the women, their doctors, or study staff, until the end of the study (often called ‘masking’).  This is important because knowledge of the group assignment, especially in this study, could affect how women complete questionnaires and bladder diaries. Thus, all women took a pill every day (either active drug or placebo) and all women received a bladder injection (either containing Botox A ^® or placebo).

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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.

This article describes the main study results for the ABC study. The investigators found:

1. Both groups of women (those using Solifenacin or Trospium daily and those who had the Botox A^® injection) had less urge urinary incontinence episodes after treatment.  Both groups of women started out with about 5 episodes per day, and after treatment both groups recorded about 1.5 episodes.
2. Women who received the Botox A^® injection were more likely than those taking the oral medication to report no incontinence episodes (they were completely dry).  Six months after starting treatment, 27% of the Botox group as compared to 13% of the anticholinergic medication group reported experiencing no incontinence episodes.
3. Both groups of women had improved quality of life after treatment.
4. Side effects differed between groups.  Women in the Botox group needed to use a catheter intermittently to help them empty their bladder.  They were also more likely to get treatment for  urinary tract infections.  The women in the anticholinergic medication group reported more dry mouth.

The investigators concluded that the two treatments were successful in both groups.  Doctors and their patients should consider both route of administration and side effects of each treatment when considering treatment options. More information including the costs of each treatment will be coming in future articles.

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ClinicalTrials.gov

Read more about this study at clinicaltrials.gov.