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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00335660
Eligibility Criteria:
Inclusion Criteria:
* Female, 18 to 65 years of age, inclusive
* A current primary diagnosis of OAB
* Idiopathic detrusor overactivity, demonstrated by a urodynamic observation
* Evidence of frequency in combination with urinary urgency
* Written informed consent form
* Willingness to avoid pregnancy and practice adequate birth control
* Negative serum pregnancy test
* Agrees to refrain from blood donation during the course of the study
Exclusion Criteria:
* Subjects who are pregnant or lactating
* Clinically significant abnormality or clinically significant unstable medical condition
* QTc interval of 470 msec or greater at Visit 1
* Predominant stress urinary incontinence versus urge urinary incontinence based on subject history
* Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.)
* Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system
* Urological or gynecological surgery within 3 months of the baseline urodynamic assessment
* Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter
* Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1
* History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria
* History of any kind of cancer within the last 2 years
* Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00335660
Study Brief:
Protocol Section:
NCT00335660