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

Lilly

Status and phase: Completed; Phase 2

Conditions: Urinary Stress Incontinence

Treatments: Drug: Placebo; Drug: duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190567

F1J-MC-SBAB

2595

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind