Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence

The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence

Inclusion Criteria:

• Female
• Between 18 and 75 years of age
• Confirmed pure genuine stress incontinence
• Have discrete episodes of incontinence
• Have pelvic organ prolapse of no greater than Stage II

Exclusion Criteria:

• Positive urine culture at visit 1
• Had formal PFMT with instruction
• Use of MAOI or other excluded medications
• Use of any anti-incontinence device, vaginal pessaries or any medication prescribed for the treatment of urinary incontinence