Status:
COMPLETED
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
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00244296
Start Date
October 1 2005
End Date
January 1 2007
Last Update
January 26 2007
Active Locations (31)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Champcueil, France
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Limoges, France
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nice, France
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nîmes, France