Urinary Incontinence, Stress
Conditions
Brief summary
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.
Interventions
DRUGduloxetine
DRUGplacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, United Kingdom, United States
Outcome results
None listed