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

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

Official Title
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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

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Drug: duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |