Urinary Incontinence, Stress
Conditions
Brief summary
The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.
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 \> or = 18 years of age * experience episodes of stress urinary incontinence * must have an educational level and degree of understanding English * are free of urinary tract infections * can use the toilet independently
Exclusion criteria
* any in or outpatient surgery in the last six months * suffer from severe constipation * extension of any internal organs beyond vaginal opening * currently breastfeeding * any nervous diseases affecting normal urinary function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase. | — |
| Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of overall patient safety. | — |
| Reduction of IEFs using standardized instruments. | — |
Countries
Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain
Outcome results
None listed