Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence
Phase 3
Completed
- Conditions
- Urinary Stress Incontinence
- Registration Number
- NCT00190853
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
Inclusion Criteria
- Have a diagnosis of only stress urinary incontinence
- Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen
Exclusion Criteria
- At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year.
- Have had more than one continence surgery.
- Have a current or past urogenital cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess the effects of duloxetine in women with urodynamically proved stress urinary incontinence on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint.
- Secondary Outcome Measures
Name Time Method To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months. To describe the percent change in incontinence episode frequency (IEF) from baseline to post-baseline and define two groups, responders and non-responders, based on threshold value of < 50% IEF reduction values. To compare the changes in VLPP and EMG ratios from baseline to 4 weeks and from baseline to 6 months in responder and non responders To evaluate the safety and tolerability of duloxetine for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence.Based on treatment-emergent adverse events, discontinuation rates, vital signs, and laboratory analyses To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram (EMG) at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint.
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇬🇧Manchester, United Kingdom