Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
Status and phase
Completed
Phase 3
Conditions
Urinary Incontinence, Stress
Treatments
Drug: placebo
Drug: duloxetine
Details and patient eligibility
About
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.
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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