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:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT01619995
Eligibility Criteria:
Inclusion Criteria:
* ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes.
* urinary incontinence (urge or predominantly urge) by clinical criteria.
* able to accurately complete a voiding diary, to perform a 24-hour pad test under direction.
Exclusion Criteria:
* significant mental impairment \[mini mental status exam (MMSE) ≤ 20)
* urethral obstruction
* history of bladder cancer
* spinal cord lesions
* multiple sclerosis
* pelvic radiation
* interstitial cystitis
* artificial sphincter implant
* expected to have changes in medications/doses during the trial
* medically unstable
* Patients with factors that could cause transient UI \[e.g., current urinary tract infection (UTI), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
* conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT01619995
Study Brief:
Protocol Section:
NCT01619995