Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed.
Methods: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events.
Results: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001).
Conclusions: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections.
(Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438 .).
Written by:
Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; the Pelvic Floor Disorders Network. Are you the author?
From the Department of Obstetrics and Gynecology, Duke University Medical Center, Durham (A.G.V.), and RTI International, Research Triangle Park (T.L.N., D.W.) - both in North Carolina; the Departments of Obstetrics and Gynecology and Urology, Stritch School of Medicine, Loyola University, Chicago (L.B.); the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham (H.E.R.); the Department of Obstetrics and Gynecology, University of Utah, Salt Lake City (I.N.); the Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland (M.F.R.P.); the Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA (S.A.M.); the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas (J.S.); the University of Pittsburgh, Pittsburgh (J.L.); Oakwood Hospital and Medical Center, Dearborn (S.K.), the Department of Urology, Beaumont Health System, Oakland University William Beaumont School of Medicine, Royal Oak (L.S.), and the Department of Biostatistics, University of Michigan, Ann Arbor (C.S.) - all in Michigan; and the Contraception and Reproductive Health Branch, Center for Population Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD (S.F.M.).
Reference: N Engl J Med. 2012 Oct 4. [Epub ahead of print]
doi: 10.1056/NEJMoa1208872
PubMed Abstract
PMID: 23036134
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