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

Lilly

Status and phase: Completed; Phase 2

Conditions: Urinary Stress Incontinence

Treatments: Drug: placebo; Drug: Duloxetine; Procedure: Pelvic Floor Muscle Training (PFMT); Procedure: Imitation PFMT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190606

2615

F1J-MC-SBAF

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind