Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.
Author(s): 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; Pelvic
Floor Disorders Network.
Affiliation(s): Department of Obstetrics and Gynecology, Duke University Medical Center, Durham,
NC 27707, USA. anthony.visco@duke.edu
Publication date & source: 2012, N Engl J Med. , 367(19):1803-13
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.).
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