|
|
| [PMID]: | 23036134 |
| [Au] Autor: | 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 |
| [Ad] Endereço: | Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27707, USA. anthony.visco@duke.edu |
| [Ti] Título: | Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. |
| [So] Source: | N Engl J Med;367(19):1803-13, 2012 Nov 8. | | [Is] ISSN: | 1533-4406 |
| [Cp] País de publicação: | United States |
| [La] Idioma: | eng |
| [Ab] Resumo: | 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.). |
| [Mh] Termos MeSH primário: |
Toxinas Botulínicas Tipo A/uso terapêutico
Antagonistas Colinérgicos/uso terapêutico
Incontinência Urinária de Urgência/quimioterapia
|
| [Mh] Termos MeSH secundário: |
Idoso
Toxinas Botulínicas Tipo A/efeitos adversos
Antagonistas Colinérgicos/efeitos adversos
Método Duplo-Cego
Feminino
Humanos
Análise de Intenção de Tratamento
Modelos Lineares
Meia-Idade
Nortropanos/efeitos adversos
Nortropanos/uso terapêutico
Qualidade de Vida
Quinuclidinas/efeitos adversos
Quinuclidinas/uso terapêutico
Tetra-Hidroisoquinolinas/efeitos adversos
Tetra-Hidroisoquinolinas/uso terapêutico
Retenção Urinária/induzido quimicamente
Infecções Urinárias/etiologia
Xerostomia/induzido quimicamente
|
| [Pt] Tipo de publicação: | COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, N.I.H., EXTRAMURAL |
[Nm] Nome de substância:
| 0 (Cholinergic Antagonists); 0 (Nortropanes); 0 (Quinuclidines); 0 (Tetrahydroisoquinolines); 0 (onabotulinumtoxinA); 10405-02-4 (trospium chloride); A8910SQJ1U (solifenacin); EC 3.4.24.69 (Botulinum Toxins, Type A) |
| [Em] Mês de entrada: | 1211 |
| [Cu] Atualização por classe: | 130513 |
[Lr] Data última revisão:
| 130513 |
| [Sb] Subgrupo de revista: | AIM; IM |
| [Da] Data de entrada para processamento: | 121108 |
| [Cl] Clinical Trial: | ClinicalTrial
|
| [St] Status: | MEDLINE |
| [do] DOI: | 10.1056/NEJMoa1208872 |
| |
|
|
