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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04301934
Eligibility Criteria:
Inclusion Criteria:
* Female patient \>18 years old
* Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses \>12 months
* Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.(Positive urine cultures defined by \>100K colony forming units of 1 or 2 bacterial species on clean catch sample, or \>1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization).
* Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.
Exclusion Criteria:
* Hematuria without appropriate workup
* Pelvic organ prolapse at or beyond the hymen
* Clinically relevant urinary retention
* Pelvic reconstructive surgery within 6 months
* Prior synthetic mesh procedure for pelvic organ prolapse or urinary incontinence
* Clinically relevant nephrolithiasis
* History of breast cancer
* Contraindication to topical estrogen therapy
* Anticoagulation therapy
* Prior pelvic or vaginal radiation therapy
* Prior gynecologic malignancy
* Undiagnosed genital bleeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04301934
Study Brief:
Protocol Section:
NCT04301934