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

Lilly

Status and phase

Completed

Phase 4

Conditions

Urinary Incontinence, Stress

Treatments

Drug: placebo

Drug: Duloxetine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00244296

F1J-MC-SBCM

8672

Details and patient eligibility

About

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.

Sex

Female

Ages

65+ years old

Volunteers

No Healthy Volunteers

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