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

Eli Lilly and Company276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

276

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine hydrochlorideDRUG

placeboDRUG

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

Assess the efficacy of duloxetine for up to 12 weeks, compared to placebo, in community dwelling women > or = 65 years of age with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence

Secondary Outcomes

Compare the efficacy of duloxetine 40 mg twice daily with that of placebo in the treatment of the symptoms of SUI and stress-predominant MUI as measured by:Absolute change in IEF

Change in mean time between voids

Percent change in the number of continence pads used per week

Change in the Incontinence Quality of Life total score and 3 sub-domain scores

Responder analysis based on the established within-treatment minimal clinically important difference established for the I-QOL

Responder analysis based on percent change in IEF

Patient's rating of improvement using the PGI-I

Compare efficacy of duloxetine 40 mg twice daily with that of placebo as measured by the percent change in IEF using in the SUI and MUI subgroups

To assess the impact of treatment with duloxetine 40 mg twice daily and placebo on the development of suicidal ideation.

Assess the impact of treatment with duloxetine 40 mg twice daily and placebo in cognition.

Assess the impact of treatment with duloxetine 40 mg twice daily and placebo as measured by changes in BDI-II.

Data from ClinicalTrials.gov

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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

Limoges, France

Nice, France

Nîmes, France

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.

Paris, France

Alzey, Germany

Bad Ems, Germany

Düsseldorf, Germany

Karlsruhe, Germany

Koblenz, Germany

...and 21 more locations