Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial.
BMC Urol
; 8: 2, 2008 Jan 25.
Article
em En
| MEDLINE
| ID: mdl-18221532
ABSTRACT
BACKGROUND:
This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.METHODS:
Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I).RESULTS:
Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).CONCLUSION:
Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT00475358.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Tiofenos
/
Incontinência Urinária por Estresse
/
Inibidores Seletivos de Recaptação de Serotonina
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
BMC Urol
Assunto da revista:
UROLOGIA
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Taiwan