Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Phase 2
Completed
- Conditions
- Urinary Stress Incontinence
- Registration Number
- NCT00190567
- Lead Sponsor
- Eli Lilly and Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
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