Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT00475358
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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT00475358
Study Brief:
Protocol Section:
NCT00475358