Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

Phase 3CompletedNCT00190853

Eli Lilly and Company93 enrolled

Overview

Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Stress Incontinence

Interventions

DuloxetineDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (19)

Outcomes

Primary Outcomes

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 Outcomes

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.

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

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

Denver, Colorado, United States

West Palm Beach, Florida, United States

Oak Lawn, Illinois, United States

Fort Wayne, Indiana, United States

Indianapolis, Indiana, United States

Jeffersonville, Indiana, United States

Metairie, Louisiana, United States

Durham, North Carolina, United States

Morganton, North Carolina, United States

...and 9 more locations