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

Lilly

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence, Stress

Treatments: Drug: placebo; Drug: duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190827

F1J-MC-SBBR

6195

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind