title: Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.
abstract: 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.).
authors.affiliation: Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27707, USA. anthony.visco@duke.edu
authors.forename: Anthony G
authors.initials: AG
authors.lastname: Visco
authors.forename: Linda
authors.initials: L
authors.lastname: Brubaker
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Ingrid
authors.initials: I
authors.lastname: Nygaard
authors.forename: Marie Fidela R
authors.initials: MF
authors.lastname: Paraiso
authors.forename: Shawn A
authors.initials: SA
authors.lastname: Menefee
authors.forename: Joseph
authors.initials: J
authors.lastname: Schaffer
authors.forename: Jerry
authors.initials: J
authors.lastname: Lowder
authors.forename: Salil
authors.initials: S
authors.lastname: Khandwala
authors.forename: Larry
authors.initials: L
authors.lastname: Sirls
authors.forename: Cathie
authors.initials: C
authors.lastname: Spino
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Nolen
authors.forename: Dennis
authors.initials: D
authors.lastname: Wallace
authors.forename: Susan F
authors.initials: SF
authors.lastname: Meikle
mesh_terms: D000368:Aged; D001561:Benzilates; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016014:Linear Models; D008875:Middle Aged; D009662:Nortropanes / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use; D053202:Urinary Incontinence, Urge / Q000188:drug therapy*; D016055:Urinary Retention / Q000139:chemically induced; D014552:Urinary Tract Infections / Q000209:etiology; D014987:Xerostomia / Q000139:chemically induced
chemical_list: D001561:Benzilates; D018680:Cholinergic Antagonists; D009662:Nortropanes; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; C003330:trospium chloride; D019274:Botulinum Toxins, Type A; D000069464:Solifenacin Succinate