Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

Phase 3

Completed

• Conditions: Urinary Incontinence, Stress

• Registration Number: NCT00190827
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-05
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• female outpatients > or = 18 years of age
• experience episodes of stress urinary incontinence
• must have an educational level and degree of understanding English
• are free of urinary tract infections
• can use the toilet independently

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Exclusion Criteria

• any in or outpatient surgery in the last six months
• suffer from severe constipation
• extension of any internal organs beyond vaginal opening
• currently breastfeeding
• any nervous diseases affecting normal urinary function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.
Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.

Secondary Outcome Measures

Name	Time	Method
Reduction of IEFs using standardized instruments.
Assessment of overall patient safety.

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician; 🇨🇦 Quebec, Canada

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician; 🇪🇸 Barcelona, Spain