Clinical trial NCT00475358: Efficacy and Safety Stress Urinary Incontinence Study
Official title: Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.


Eligibility criteria: Inclusion Criteria:

* Are greater than 20 years of age.
* Are female outpatients.
* Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
* Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[IUD\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
* Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.

Exclusion Criteria:

* Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
* Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
* Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
* Have had any major inpatient surgery within 3 months prior to study entry.
* Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
* Uncorrected congenital abnormality leading to urinary incontinence
* Detrusor instability or noncompliant bladder
* Adult enuresis
* Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).

Primary outcomes:
measure: To assess efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by percent change in incontinence episode frequency from baseline.
Secondary outcomes:
measure: To compare the efficacy of duloxetine with that of placebo as measured by the change in the disease-specific quality of life instrument (I QOL) scores from baseline to endpoint.
measure: To compare the efficacy of duloxetine with that of placebo in subject perceived improvement in SUI as measured by the Patient's Global Impressions of Improvement (PGI I) questionnaire.
measure: To compare the safety of duloxetine with that of placebo in the treatment of SUI based on vital signs, laboratory values, and the occurrence of treatment-emergent adverse events (TEAEs).
Other outcomes:
Locations:
city: Tao-Yuan
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 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 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Lin AT, Sun MJ, Tai HL, Chuang YC, Huang ST, Wang N, Zhao YD, Beyrer J, Wulster-Radcliffe M, Levine L, Chang C, Viktrup L. Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial. BMC Urol. 2008 Jan 25;8:2. doi: 10.1186/1471-2490-8-2.