Urinary Stress Incontinence
Conditions
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
Interventions
DRUGduloxetine
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from | — |
| 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. | — |
| Outcome measures of urethral function | — |
Countries
United States
Outcome results
None listed