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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT03996057
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women
* History of recurrent UTI (\>=3 culture proven UTIs in one year or \>=2 in 6 months)
* Recurrent, culture proven UTI while on vaginal estrogen for at least 4 weeks + d-mannose prophylaxis
* English speaker
Exclusion Criteria:
* Not postmenopausal
* Complicated UTIs
* Known renal tract anomaly
* Liver dysfunction
* Neurogenic bladder
* Incomplete bladder emptying (PVR \> 150 cc when voided volume \>150 cc)
* Self-catheterization or use of indwelling catheter
* Contraindication to vaginal estrogen, methenamine hippurate, or d-mannose, including allergic reactions
* History of or current endometrial cancer
* History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling
* History of interstitial cystitis/painful bladder syndrome
* Urothelial cancer
* Enrolled in other clinical trials for UTIs other than Washington University study IRB# 201711120
* Currently on daily antibiotic prophylaxis and unwilling to stop this intervention
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03996057
Study Brief:
Protocol Section:
NCT03996057