Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial.

Publisher: Blackwell Science Country of Publication: England NLM ID: 100886721 Publication Model: Print Cited Medium: Print ISSN: 1464-4096 (Print) Linking ISSN: 14644096 NLM ISO Abbreviation: BJU Int Subsets: MEDLINE

Original Publication: Oxford, UK : Blackwell Science, c1999-

Adrenergic Uptake Inhibitors/*therapeutic use ; Selective Serotonin Reuptake Inhibitors/*therapeutic use ; Thiophenes/*therapeutic use ; Urinary Incontinence, Stress/*drug therapy; Adrenergic Uptake Inhibitors/adverse effects ; Adult ; Aged ; Double-Blind Method ; Duloxetine Hydrochloride ; Female ; Humans ; Middle Aged ; Patient Compliance ; Quality of Life ; Selective Serotonin Reuptake Inhibitors/adverse effects ; Thiophenes/adverse effects ; Treatment Outcome

Objectives: To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women.
Patients and Methods: The study included 458 women aged 27-79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF < 14 and > or = 14). Analysis of covariance was used to analyse I-QOL scores.
Results: The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of > or = 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial.
Conclusions: These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.

0 (Adrenergic Uptake Inhibitors)
0 (Serotonin Uptake Inhibitors)
0 (Thiophenes)
9044SC542W (Duloxetine Hydrochloride)

Date Created: 20040207 Date Completed: 20040419 Latest Revision: 20221207

20240829

10.1111/j.1464-410x.2004.04607.x

14764128