FPIN's Help Desk Answers

OnabotulinumtoxinA Injections for Urge Incontinence


Am Fam Physician. 2018 Feb 1;97(3):online.

Clinical Question

Are onabotulinumtoxinA (Botox) injections effective for treatment of urge incontinence in women?

Evidence-Based Answer

Detrusor muscle injections of onabotulinumtoxinA can be used to decrease the number of episodes of urinary incontinence in women for whom treatment with anticholinergic agents has been ineffective. (Strength of Recommendation: B, based on two randomized controlled trials [RCTs].) Compared with oral anticholinergics, detrusor muscle injections of onabotulinumtoxinA decrease urge incontinence episodes and have a higher rate of complete symptom resolution. Compared with anticholinergics, onabotulinumtoxinA injections cause less dry mouth but more urinary tract infections and urinary retention.

Evidence Summary

A 2013 multicenter, double-blind RCT compared onabotulinumtoxinA with placebo in 548 women 44 to 75 years of age with idiopathic overactive bladder for which anticholinergic therapy was ineffective.1 Patients were randomized to detrusor muscle injections of 100 U onabotulinumtoxinA vs. placebo injections of normal saline with 12-week follow-up. Primary outcomes included episodes of urinary incontinence per day and patient perception of treatment benefit as measured by the Treatment Benefit Scale, which includes responses of greatly improved, improved, not changed, or worsened. OnabotulinumtoxinA injections decreased daily episodes of urinary incontinence by 2.9 vs. 1.0 for placebo (P < .001). Approximately 63% of patients reported a treatment response of greatly improved or improved after the injections vs. 27% in the control group (P < .001).

A 2013 multicenter, double-blind RCT compared the effectiveness of detrusor muscle injections of 100 U onabotulinumtoxinA vs. placebo injections of normal saline in 492 women 48 to 74 years of age with idiopathic overactive bladder for which anticholinergic therapy was ineffective.2 Primary outcomes after 24 weeks of follow-up included the number of urge incontinence episodes per day and treatment response

Author disclosure: No relevant financial affiliations..

Address correspondence to Sara C. Wood, MD, MHPE, at swood@gvmh.org. Reprints are not available from the authors.


1. Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249–256.

2. Nitti VW, Dmochowski R, Herschorn S, et al.; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013;189(6):2186–2193.

3. 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.

Help Desk Answers provides answers to questions submitted by practicing family physicians to the Family Physicians Inquiries Network (FPIN). Members of the network select questions based on their relevance to family medicine. Answers are drawn from an approved set of evidence-based resources and undergo peer review. The strength of recommendations and the level of evidence for individual studies are rated using criteria developed by the Evidence-Based Medicine Working Group (http://www.cebm.net).

The complete database of evidence-based questions and answers is copyrighted by FPIN. If interested in submitting questions or writing answers for this series, go to http://www.fpin.org or e-mail: questions@fpin.org.

This series is coordinated by John E. Delzell Jr., MD, MSPH, Associate Medical Editor.

A collection of FPIN's Help Desk Answers published in AFP is available at http://www.aafp.org/afp/hda.



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