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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03166150
Eligibility Criteria:
Inclusion Criteria:
1. Women ≥ 65 years older
2. Symptomatic UI
3. Symptoms ≥ 3 months
4. Episodes of UI on 3-day bladder diary
5. Stress, urgency, and mixed UI
Exclusion Criteria:
1. Women unable to have functional assessment and/or complete bladder diary
2. Impaired mental status (MMSE \<25)
3. Post-void residual ≥ 150 ml
4. Non-ambulatory (wheelchair bound), unable to complete mobility assessments
5. Hematuria
6. Urinary tract infection
7. Continuous Incontinence
8. Pelvic Organ prolapse \> stage 2
9. Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
10. Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
11. Women with contraindications to undergo MRI including claustrophobia.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT03166150
Study Brief:
Protocol Section:
NCT03166150