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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06353269
Eligibility Criteria:
Inclusion Criteria:
* female, at least 18 years old with diagnosis of hypoestrogenism (defined by post-menopausal status of 12 months or more of amenorrhea, history of bilateral salpingo-oophorectomy) AND recurrent UTI as defined by greater than or equal to 3 in 1 year or 2 in 6 months by positive urine culture or clinically suspected UTI)
Exclusion Criteria:
* Have a known etiology of infections (urologic stones, fistulas, fecal incontinence, catheterization, or poorly controlled diabetes - Hgb A1C cutoff of 8)
* Contraindication to vaginal estrogen (actively treated estrogen-sensitive tumor, allergies to medication formulation, inability to apply or place vaginal estrogen of any modality)
* Suspected mesh complications or voiding problems from pelvic reconstructive surgery
* Short vaginal length (less than 7cm) or poor dexterity or mobility that may prevent use of estrogen ring
* Do not speak English
* For the nested cohort only - patients currently using vaginal estrogen greater than 2x per month
Deferral criteria:
* Undiagnosed hematuria or vaginal bleeding; however enrollment may proceed after negative workup for malignancy
* Remote history of estrogen-sensitive tumor: enrollment allowed after approval by oncologist or primary care physician
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06353269
Study Brief:
Protocol Section:
NCT06353269