Clinical trial NCT06353269: Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
Official title: Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Recurrent Urinary Tract Infection
Hypoestrogenism
Keywords: vaginal estrogen
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: * 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.


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

Primary outcomes:
measure: Adherence to vaginal estrogen treatment
timeFrame: 6 month follow-up visit
Secondary outcomes:
measure: UTI rates
timeFrame: the 6 month duration of the study
measure: validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6)
timeFrame: Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up
measure: validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA)
timeFrame: Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up
measure: validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q)
timeFrame: Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up
measure: validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I)
timeFrame: Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up
measure: validated patient questionnaires - Medication Adherence Report Scale (MARS-5)
timeFrame: Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up
measure: optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness
timeFrame: baseline and 6 month follow-up visits
measure: optical coherence tomography measurements for nested OCT cohort - blood vessel density
timeFrame: baseline and 6 month follow-up visits
measure: Vaginal health index for nested microbiome cohort
timeFrame: baseline and 6 month follow-up visits
measure: Vaginal maturation index for nested microbiome cohort
timeFrame: baseline and 6 month follow-up visits
measure: Urologic microbiome results for nested microbiome cohort
timeFrame: baseline and 6 month follow-up visits
measure: Vaginal microbiome results for nested microbiome cohort
timeFrame: baseline and 6 month follow-up visits
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: CHARLOTTE TER HAAR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Olivia Chang, MD
role: STUDY_DIRECTOR
References:
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citation: Tan-Kim J, Shah NM, Do D, Menefee SA. Efficacy of vaginal estrogen for recurrent urinary tract infection prevention in hypoestrogenic women. Am J Obstet Gynecol. 2023 Aug;229(2):143.e1-143.e9. doi: 10.1016/j.ajog.2023.05.002. Epub 2023 May 11.
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