Clinical trial NCT00190814: Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
Official title: Efficacy and Safety of Duloxetine Compared With Placebo in Women With Symptoms of Mixed Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.


Eligibility criteria: Inclusion Criteria:

* female outpatients greater than or equal to 18 years of age.
* experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
* have an educational level and degree of understanding English.
* are free of urinary tract infections.
* have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)

Exclusion Criteria:

* have received treatment for incontinence within the last 5 years.
* suffer from severe constipation.
* currently nursing or breast feeding.
* any nervous system disease that would affect normal urinary function.
* any extension of internal organs beyond the vaginal opening.

Primary outcomes:
measure: The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.
Secondary outcomes:
measure: Additional assessments of incontinence episode frequency using various standardized instruments will be performed.
measure: To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Maryland
city: London
country: Canada
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Ontario
city: London
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: