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NCT Number: NCT06353269

Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections

* 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Recurrent Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypoestrogenism Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California Irvine Medical Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estring Vaginal Product

Drug

estradiol vaginal ring, exchanged every 12 weeks

Vagifem

Drug

vaginal estrogen tablet, used twice per week

Estrace 0.01% Vaginal Cream

Drug

vaginal estrogen cream, used twice per week

Primary outcomes

  1. Adherence to vaginal estrogen treatment

    Time frame: 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 outcomes

  1. UTI rates

    Time frame: the 6 month duration of the study

    number of culture-proven urinary tract infections

  2. validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6)

    Time frame: 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.

  3. validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA)

    Time frame: 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

  4. validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q)

    Time frame: 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.

  5. validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I)

    Time frame: 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.

  6. validated patient questionnaires - Medication Adherence Report Scale (MARS-5)

    Time frame: 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.

  7. optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness

    Time frame: 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).

  8. optical coherence tomography measurements for nested OCT cohort - blood vessel density

    Time frame: 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).

  9. Vaginal health index for nested microbiome cohort

    Time frame: 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

  10. Vaginal maturation index for nested microbiome cohort

    Time frame: 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)

  11. Urologic microbiome results for nested microbiome cohort

    Time frame: baseline and 6 month follow-up visits

    Urologic microbiome before and after treatment (Lactobacillus abundance processed by Zymo analysis).

  12. Vaginal microbiome results for nested microbiome cohort

    Time frame: baseline and 6 month follow-up visits

    Vaginal microbiome before and after treatment (Lactobacillus abundance processed by Zymo analysis).

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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