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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03057834
Eligibility Criteria:
Inclusion Criteria:
* Women, age 70 years or older
* Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)
* Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
* Willing and able to undergo an extensive physical function evaluation
Exclusion Criteria:
* Prior surgical intervention for urinary incontinence within the past 12 months
* Hysterectomy within 12 months
* Diagnosis of:
* Pelvic Organ Prolapse beyond the hymenal ring
* Urogenital Fistula
* Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)
* Incomplete Bladder Emptying/Urinary Retention with PVR \>150 ml (measured by bladder scan)
* Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound
* Having significant cognitive impairment or dementia
* Unsafe to exercise (severe cardiopulmonary disease)
* Unable/unwilling to provide informed consent
* Determined otherwise ineligible by the principal investigator
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT03057834
Study Brief:
Protocol Section:
NCT03057834