Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence

Eli Lilly and Company1 site in 1 country100 target enrollmentMay 2001

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Urinary Stress Incontinence
Sponsor: Eli Lilly and Company
Enrollment: 100
Locations: 1
Primary Endpoint: Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence
Status: Completed
Last Updated: 19 years ago

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Registry

clinicaltrials.gov

Start Date

May 2001

End Date

May 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

•Female out patients.
•Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

•Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
•Suffer from severe constipation.

Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence

Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint.
Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage
Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores
Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4)
Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events