Back to resultsBiomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Primary Purpose
Urinary Stress Incontinence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stress Incontinence
Eligibility Criteria
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.
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
Secondary Outcome Measures
Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
non-instrumented and instrumented uroflowmetry studies
Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
Compare duloxetine responders with duloxetine non-responders with respect to:
Baseline measures of urethral function
Outcome measures of urethral function
Outcome measures of emptying function
Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
In the open-label extension:
Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
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.
Full Information
NCT ID
NCT00190567
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00190567
Brief Title
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
Secondary Outcome Measure Information:
Title
Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
Title
non-instrumented and instrumented uroflowmetry studies
Title
Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
Title
Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
Title
Compare duloxetine responders with duloxetine non-responders with respect to:
Title
Baseline measures of urethral function
Title
Outcome measures of urethral function
Title
Outcome measures of emptying function
Title
Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
Title
In the open-label extension:
Title
Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
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