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

University of California Irvine (UCI)

Status and phase: Enrolling; Phase 4

Conditions: Recurrent Urinary Tract Infection; Hypoestrogenism

Treatments: Drug: Estrace 0.01% Vaginal Cream; Drug: Vagifem; Drug: Estring Vaginal Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06353269

4255

Details and patient eligibility

About

• 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.

Enrollment: 111 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

Estrogen cream

Experimental group

Description:

Participants in this arm will receive the vaginal estrogen cream (Estrace 0.01%) for treatment. Participants will apply 0.5gm twice per week for the duration of the study.

Treatment:

Drug: Estrace 0.01% Vaginal Cream

Estrogen tablet

Experimental group

Description:

Participants in this arm will receive the vaginal estrogen tablets (Vagifem) for treatment. Participants will place one tablet (10 mcg) into the vagina twice per week for the duration of the study.

Treatment:

Drug: Vagifem

Estrogen drug-eluting ring

Experimental group

Description:

Participants in this arm will receive the vaginal estrogen drug-eluting ring (Estring) for treatment. Participants will have the ring placed by a provider at their clinical visit. The ring will be exchanged every 12 weeks.

Treatment:

Drug: Estring Vaginal Product