Document Detail


Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.
MedLine Citation:
PMID:  23036134     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Anthony G Visco; Linda Brubaker; Holly E Richter; Ingrid Nygaard; Marie Fidela R Paraiso; Shawn A Menefee; Joseph Schaffer; Jerry Lowder; Salil Khandwala; Larry Sirls; Cathie Spino; Tracy L Nolen; Dennis Wallace; Susan F Meikle;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-10-04
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-08     Completed Date:  2012-11-19     Revised Date:  2013-09-26    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1803-13     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27707, USA. anthony.visco@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01166438
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MeSH Terms
Descriptor/Qualifier:
Aged
Botulinum Toxins, Type A / adverse effects,  therapeutic use*
Cholinergic Antagonists / adverse effects,  therapeutic use*
Double-Blind Method
Female
Humans
Intention to Treat Analysis
Linear Models
Middle Aged
Nortropanes / adverse effects,  therapeutic use
Quality of Life
Quinuclidines / adverse effects,  therapeutic use
Tetrahydroisoquinolines / adverse effects,  therapeutic use
Urinary Incontinence, Urge / drug therapy*
Urinary Retention / chemically induced
Urinary Tract Infections / etiology
Xerostomia / chemically induced
Grant Support
ID/Acronym/Agency:
1-U01-HD069010-01/HD/NICHD NIH HHS; 1-U10-HD069006-01/HD/NICHD NIH HHS; 2-U10-HD041261-11/HD/NICHD NIH HHS; 2-U10-HD04267-12/HD/NICHD NIH HHS; 2-U10-HD054214-06/HD/NICHD NIH HHS; 2-U10-HD054215-06/HD/NICHD NIH HHS; 2-U10-HD054241-06/HD/NICHD NIH HHS; U01-HD41249/HD/NICHD NIH HHS; U10 HD041250/HD/NICHD NIH HHS; U10 HD041261/HD/NICHD NIH HHS; U10 HD041267/HD/NICHD NIH HHS; U10 HD054136/HD/NICHD NIH HHS; U10 HD054214/HD/NICHD NIH HHS; U10 HD054215/HD/NICHD NIH HHS; U10 HD054241/HD/NICHD NIH HHS; U10 HD069006/HD/NICHD NIH HHS; U10 HD069010/HD/NICHD NIH HHS; U10-HD041250/HD/NICHD NIH HHS; U10-HD054136/HD/NICHD NIH HHS; UL1 TR000439/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Cholinergic Antagonists; 0/Nortropanes; 0/Quinuclidines; 0/Tetrahydroisoquinolines; 0/onabotulinumtoxinA; 1E6682427E/trospium chloride; A8910SQJ1U/solifenacin; EC 3.4.24.69/Botulinum Toxins, Type A
Comments/Corrections
Comment In:
Urology. 2013 Jul;82(1):14-5   [PMID:  23642706 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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