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
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ClinicalTrials.gov Identifier: NCT00244296 |
Recruitment Status
:
Completed
First Posted
: October 26, 2005
Last Update Posted
: January 26, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Incontinence, Stress | Drug: Duloxetine hydrochloride Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence. |
Study Start Date : | October 2005 |
Study Completion Date : | January 2007 |
- 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
- 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.
- To compare the safety of duloxetine with placebo based on changes in vital signs, clinical lab values, occurrence and duration of adverse events and premature discontinuation of study due to adverse events.

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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244296
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Champcueil, France | |
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Limoges, France | |
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Nice, France | |
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Nimes, France | |
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Paris, France | |
Germany | |
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Alzey, Germany | |
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Bad Ems, Germany | |
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Dusseldorf, Germany | |
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Karlsruhe, Germany | |
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Koblenz, Germany | |
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Leipzig, Germany | |
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Muehlacker, Germany | |
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Rheinstetten/Baden, Germany | |
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Vellmar, Germany | |
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Wiesloch, Germany | |
Netherlands | |
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Amsterdam, Netherlands | |
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Apeldoorn, Netherlands | |
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Nieuwegein, Netherlands | |
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Tilburg, Netherlands | |
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Zeist, Netherlands | |
South Africa | |
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Johannesburg, South Africa | |
Spain | |
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Barcelona, Spain | |
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Castellon, Spain | |
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Tenerife, Spain | |
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Vigo, Spain | |
Sweden | |
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Lund, Sweden | |
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Stockholm, Sweden | |
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Uppsala, Sweden | |
Switzerland | |
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Basel, Switzerland | |
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Riehen, Switzerland | |
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Zurich, Switzerland |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00244296 History of Changes |
Other Study ID Numbers: |
8672 F1J-MC-SBCM |
First Posted: | October 26, 2005 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Additional relevant MeSH terms:
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders Duloxetine Hydrochloride |
Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |