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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190567

Collaborator

Boehringer Ingelheim (Industry)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Drug: duloxetine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2001

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	46202

Sponsors and Collaborators

Eli Lilly and Company
Boehringer Ingelheim

Investigators

Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00190567

Other Study ID Numbers:

2595
F1J-MC-SBAB

First Posted:

Sep 19, 2005

Last Update Posted:

Jan 26, 2007

Last Verified:

Jan 1, 2007

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Duloxetine Hydrochloride

Study Results

No Results Posted as of Jan 26, 2007