Stress Urinary Incontinence
Conditions
Brief summary
The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.
Interventions
DRUGduloxetine HCl
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week. * Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception. * Must provide informed consent. * Must not have urinary tract infection at screening.
Exclusion criteria
* Sensitivity to duloxetine * Unstable medical conditions * Pregnancy * Acute liver damage * Suicidal in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries | — |
Countries
United States
Outcome results
None listed