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Efficacy and Safety of Duloxetine

Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00190619
Enrollment
100
Registered
2005-09-19
Start date
2001-05-31
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 Stress Incontinence

Brief summary

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Interventions

DRUGDuloxetine
DRUGPlacebo

Sponsors

Boehringer Ingelheim
CollaboratorINDUSTRY
Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Female out patients. * Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion criteria

* Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study. * Suffer from severe constipation.

Design outcomes

Primary

MeasureTime frame
Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence—

Secondary

MeasureTime frame
Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint.—
Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage—
Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores—
Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4)—
Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events—

Countries

United Kingdom

Outcome results

None listed

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