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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Incontinence, Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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duloxetine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No