Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190996

Enrollment

2765

Registered

2005-09-19

Start date

2003-01-31

Completion date

2006-06-30

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Stress

Brief summary

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

Interventions

DRUGDuloxetine Hydrochloride

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female diagnosed with stress urinary incontinence

Exclusion criteria

* Currently taking a monoamine oxidase inhibitor

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.	—

Secondary

Measure	Time frame
Evaluate the maintenance of effect on IEF in long-term use	—
Kings Health Questionnaire	—
Patient Global Impression of Improvement Questionnaire	—
Safety effects	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026