Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence

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

Summary

Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress 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

• Diagnosis of GSI

• Have discrete episodes of incontinence

Exclusion Criteria:

• Positive urine culture at visit 1

• Use of MAOI

• Have had continence or urethral surgery

• Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence

• Began pelvic floor muscle exercises within 6 months prior to study entry.