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OpenTrials
Completed

NCT Number: NCT00190567

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

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

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Key information

Conditions

Urinary Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

Placebo

Drug

Primary outcomes

  1. Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure

Secondary outcomes

  1. Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from

  2. non-instrumented and instrumented uroflowmetry studies

  3. Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint

  4. Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint

  5. Compare duloxetine responders with duloxetine non-responders with respect to:

  6. Baseline measures of urethral function

  7. Outcome measures of urethral function

  8. Outcome measures of emptying function

  9. Vital signs, laboratory values and the occurrence of treatment-emergent adverse events

  10. In the open-label extension:

  11. Determine the effects of duloxetine six to seven months after initiation on measures of urethral function

  12. Collect long-term data on the maintenance of effect of duloxetine in the treatment of GSI as measured by IEF, PGI-I, vital signs, laboratory values and the occurrence of treatment-emergent adverse events.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress Incontinence

Important dates

Study start
2001
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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