Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence

Urinary Stress Incontinence Clinical Trial

Official title:

Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190567
• Other study ID #: 2595
• Secondary ID: F1J-MC-SBAB
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: October 2001
• Est. completion date: April 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Drug:
• duloxetine

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
Secondary	Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
Secondary	non-instrumented and instrumented uroflowmetry studies
Secondary	Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
Secondary	Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
Secondary	Compare duloxetine responders with duloxetine non-responders with respect to:
Secondary	Baseline measures of urethral function
Secondary	Outcome measures of urethral function
Secondary	Outcome measures of emptying function
Secondary	Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
Secondary	In the open-label extension:
Secondary	Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
Secondary	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.