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

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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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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