Efficacy and Safety Stress Urinary Incontinence Study

Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence

Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.

Inclusion Criteria:

• Are greater than 20 years of age.
• Are female outpatients.
• Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
• Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
• Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.

Exclusion Criteria:

• Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
• Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
• Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
• Have had any major inpatient surgery within 3 months prior to study entry.
• Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
• Uncorrected congenital abnormality leading to urinary incontinence
• Detrusor instability or noncompliant bladder
• Adult enuresis
• Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).