protocolSection identificationModule nctId: NCT06353269, orgStudyIdInfo id: 4255, briefTitle: Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: * The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed.* Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound.* A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina.Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.* The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.* There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.If a participant is part of the microbiome cohort, they will also be asked to do the following:* a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.* Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.* These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina., conditionsModule conditions: Recurrent Urinary Tract Infection, conditions: Hypoestrogenism, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: Estring Vaginal Product, interventions name: Vagifem, interventions name: Estrace 0.01% Vaginal Cream, outcomesModule primaryOutcomes measure: Adherence to vaginal estrogen treatment, secondaryOutcomes measure: UTI rates, secondaryOutcomes measure: validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6), secondaryOutcomes measure: validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA), secondaryOutcomes measure: validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q), secondaryOutcomes measure: validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I), secondaryOutcomes measure: validated patient questionnaires - Medication Adherence Report Scale (MARS-5), secondaryOutcomes measure: optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness, secondaryOutcomes measure: optical coherence tomography measurements for nested OCT cohort - blood vessel density, secondaryOutcomes measure: Vaginal health index for nested microbiome cohort, secondaryOutcomes measure: Vaginal maturation index for nested microbiome cohort, secondaryOutcomes measure: Urologic microbiome results for nested microbiome cohort, secondaryOutcomes measure: Vaginal microbiome results for nested microbiome cohort, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California Irvine Medical Center, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: CHARLOTTE TER HAAR, role: CONTACT, email: terhaarc@hs.uci.edu, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False