Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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, United States
Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
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.
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