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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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