To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• female outpatient greater than or equal to 65 years of age

• have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months

• have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.

• is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria:

• at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year

• have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry

• began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.

• have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.

• intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study