Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

Phase 3CompletedNCT00190814

Eli Lilly and Company600 enrolled

Overview

The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Urinary Incontinence, Stress

Interventions

duloxetineDRUG

placeboDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * female outpatients greater than or equal to 18 years of age. * experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study. * have an educational level and degree of understanding English. * are free of urinary tract infections. * have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.) Exclusion Criteria: * have received treatment for incontinence within the last 5 years. * suffer from severe constipation. * currently nursing or breast feeding. * any nervous system disease that would affect normal urinary function. * any extension of internal organs beyond the vaginal opening.

Locations (3)

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Baltimore, Maryland, United States

London, Ontario, Canada

London, United Kingdom

Outcomes

Primary Outcomes

The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.

Secondary Outcomes

Additional assessments of incontinence episode frequency using various standardized instruments will be performed.

To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events.

Data from ClinicalTrials.gov

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