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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well women with low estrogen levels, especially those who have had recurrent urinary tract infections (UTIs), follow their prescribed vaginal estrogen treatments. The study is particularly focused on post-menopausal women or those who have had certain surgeries that lower estrogen. Researchers want to understand not only if women are taking their medications as directed but also how vaginal estrogen affects the skin in that area and the balance of bacteria in the vagina and urinary tract.

To participate, women must be at least 18 years old and diagnosed with low estrogen levels and recurrent UTIs. If you join, you'll be randomly assigned to receive one of three types of vaginal estrogen (cream, tablets, or a ring). You'll start with an initial visit to gather information and answer some questions, followed by check-ins at 3 and 6 months to see how you're doing and whether you're using the treatment. If you're part of a special group studying bacteria, you'll also provide samples for testing and undergo a painless imaging test to look at the vaginal walls. This trial is currently recruiting participants, so if you fit the criteria, you may have the opportunity to contribute to important research.

Gender

FEMALE

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