Duloxetine in the Treatment of Stress Urinary Incontinence.

Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191087

Enrollment

458

Registered

2005-09-19

Start date

2001-04-30

Completion date

2006-05-31

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 purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Interventions

DRUGDuloxetine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Women with predominant stress urinary incontinence. * 7 or more incontinence episodes per week.

Exclusion criteria

* Use of monoamine inhibitors.

Design outcomes

Primary

Measure	Time frame
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence	—

Secondary

Measure	Time frame
To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.	—

Countries

United Kingdom

Outcome results

None listed

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