Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
Phase 3
Completed
- Conditions
- Urinary Incontinence, Stress
- Registration Number
- NCT00190814
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
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
🇬🇧London, United Kingdom