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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride

Criteria

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