Using vaginal estrogen to help women with recurrent urinary tract infections
Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
This study is testing different types of vaginal estrogen treatments to see if they can help women with low estrogen levels who keep getting urinary tract infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06353269 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate medication adherence to different types of vaginal estrogen in hypoestrogenic women, particularly those experiencing recurrent urinary tract infections (UTIs). Participants will be randomly assigned to receive one of three vaginal estrogen treatments: a drug-eluting ring, cream, or tablets. The study will also assess changes in vaginal skin and the microbiome before and after treatment using advanced imaging techniques and microbiome analysis. The goal is to understand how these treatments can improve adherence and health outcomes for women with low estrogen levels.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with hypoestrogenism and a history of recurrent urinary tract infections.
Not a fit: Patients with known causes of infections or contraindications to vaginal estrogen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for women suffering from recurrent UTIs by improving adherence to vaginal estrogen therapy.
How similar studies have performed: Other studies have shown promise in using vaginal estrogen for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orange, California
- University of California Irvine Medical Center — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Charlotte Ter Haar, Md — University of California, Irvine
- Study coordinator: Charlotte Ter Haar, Md
- Email: terhaarc@hs.uci.edu
- Phone: 714-506-6351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.