Hypoestrogenism, Recurrent Urinary Tract Infection
Conditions
Keywords
vaginal estrogen
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.
Interventions
DRUGEstring Vaginal Product
estradiol vaginal ring, exchanged every 12 weeks
DRUGVagifem
vaginal estrogen tablet, used twice per week
vaginal estrogen cream, used twice per week
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to vaginal estrogen treatment | 6 month follow-up visit | The primary outcome will be the adherence to vaginal estrogen treatment at the 6 month follow-up visit. The 6 month follow-up visit will be the endpoint of the study. The investigators will consider both subjective, patient-reported adherence at 6 months, as well as objective data - tube weight for the estrogen cream, number of tablets left for the estrogen tables, and presence or absence of drug-eluting ring on physical exam for the estrogen ring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UTI rates | the 6 month duration of the study | number of culture-proven urinary tract infections |
| validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6) | Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up | Urinary Distress Inventory Short Form (UDI-6) - six questions, scored from 0 (not at all) to 3 (greatly), with higher scores indicating more distress from urinary symptoms. |
| validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA) | Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up | UTI Symptoms Assessment Questionnaire (UTISA) - 15 questions, rated from 0 (did not have/not at all) to 3 (severe/a lot), with higher scores indicating a more symptomatic UTI |
| validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q) | Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up | Treatment Satisfaction with Medications Questionnaire (SATMED-Q) - 17 questions, scored from 0 (not at all) to 4 (very much), with higher scores indicating greater satisfaction with medical treatment. |
| validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I) | Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up | Patient Global Impression of Improvement Questionnaire (PGI-I) - one-question with scores from 1 (very much better) to 7 (very much worse0, with higher scores indicating a worsening in symptoms after treatment. |
| validated patient questionnaires - Medication Adherence Report Scale (MARS-5) | Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up | Medication Adherence Report Scale (MARS-5) - 5 questions, rated from 1 (always) to 5 (never), with a higher score indicating lower medication adherence. |
| optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness | baseline and 6 month follow-up visits | changes to vaginal epithelial thickness (VET) before and after treatment as measured by vaginal optical coherence tomography (OCT). |
| optical coherence tomography measurements for nested OCT cohort - blood vessel density | baseline and 6 month follow-up visits | changes to blood vessel density (BVD) before and after treatment as measured by vaginal optical coherence tomography (OCT). |
| Vaginal health index for nested microbiome cohort | baseline and 6 month follow-up visits | vaginal health index (VHI) before and after treatment - The Vaginal Health Index Score is a clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration), allows to obtain a final score defining the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. Total score ranges from 5 to 25, with lower scores corresponding to greater urogenital atrophy |
| Vaginal maturation index for nested microbiome cohort | baseline and 6 month follow-up visits | vaginal maturation index (VMI) before and after treatment - microscopic evaluation of the ratio of vaginal epithelial cells (parabasal, intermediate and superficial) |
| Urologic microbiome results for nested microbiome cohort | baseline and 6 month follow-up visits | Urologic microbiome before and after treatment (Lactobacillus abundance processed by Zymo analysis). |
| Vaginal microbiome results for nested microbiome cohort | baseline and 6 month follow-up visits | Vaginal microbiome before and after treatment (Lactobacillus abundance processed by Zymo analysis). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCHARLOTTE TER HAAR, MD
University of California, Irvine
STUDY_DIRECTOROlivia Chang, MD
University of California, Irvine
Outcome results
None listed