Urge Incontinence Bladder Overactivity Study

Inclusion criteria

• Are female outpatients.
• Are at least 18 years of age.
• Are ambulatory and able to use a toilet independently and without difficulty.
• Have no language or cognitive barriers, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.
• Are women of non-childbearing potential by reason of hysterectomy or natural menopause, or are women of childbearing potential agreeing 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 3 months prior to the study.
• Have post-void residual (PVR) volume 100 mL within 15 minutes of a spontaneous void.
• Patients must have predominant symptoms of bladder overactivity defined as meeting both of the following criteria:

• bothersome urinary urgency (the sensation of the urgent need to void for fear of leakage) for a minimum of 3 consecutive months prior to study entry, or urge urinary incontinence (UUI; the involuntary loss of urine preceded by urgency) for a minimum of 3 consecutive months prior to study entry
• abnormal frequency of micturition (an average voiding interval of 2 hours or less [2] during waking hours) as confirmed by at least two days of recording on the screening dairy collected at Visit 1.
• Have UDS established DI or sensory urgency (determined at Visit 2).
• Have responded appropriately to all screening questions prior to Visit 1.

Exclusion criteria

• Use any medication other than duloxetine for urinary incontinence within 1 day prior to starting study medication or at any time during the study.
• Use monoamine oxidase inhibitors (MAOIs) or other excluded medications within 14 days prior to starting study medication or at any time during the study.
• Have any of the following:

• A significant arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG within 6 months prior to study entry that, in the opinion of the investigator, requires investigation or intervention.
• Any active cardiac ischemic condition, including myocardial infarction within 6 months prior to study entry
• Uncontrolled or poorly controlled hypertension
• Active seizure disorder
• Unstable diabetes mellitus
• Spinal cord lesions, multiple sclerosis, or other neurological abnormalities that affect the lower urinary tract
• History of severe allergies requiring emergency medical treatment or multiple adverse drug reactions
• History of chronic lung disease associated with four (4) or more acute exacerbations per year resulting in severe coughing
• Active or chronic hepatitis A, B, or C.
• Are pregnant, have been pregnant in the previous 6 months, or have not resumed normal menstruation for 3 months prior to study entry due to breastfeeding.
• Are breastfeeding.
• Have received treatment within the last 30 days with a drug other than duloxetine that has not received regulatory approval in any country for any indication at the time of study entry.
• Have any condition, limitation, disease, or abnormal laboratory value that could, in the judgment of the investigator, preclude evaluation of response to duloxetine.
• Are directly affiliated with the conduct of this study, or are immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.