Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2025-06-25

Brief Summary

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Due to rising antibiotic resistance, there has been a focus on non-antibiotic prophylactic measures for postmenopausal patients with recurrent urinary tract infections (rUTI), one of which is the safe and efficacious option of vaginal estrogen therapy. Standard application of vaginal estrogen cream entails intravaginal application of the cream twice a week, but some providers counsel patients with rUTI to apply a small, pea-sized amount to the periurethral area. This ideally reduces the amount of vaginal estrogen used while attaining a similar effect. However, to date, there is no data to prove that the periurethral technique of application is similar or non-inferior to intravaginal application in preventing UTI.

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Detailed Description

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Conditions

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Recurrent Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravaginal Estrogen Application

Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months

Group Type ACTIVE_COMPARATOR

Intravaginal application of estradiol cream

Intervention Type DRUG

The control group will apply 1 gram estradiol cream intravaginally using an applicator.

Periurethral Estrogen Application

Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months

Group Type EXPERIMENTAL

Periurethral application of estradiol cream

Intervention Type DRUG

The experimental group will apply estradiol cream in a different location (periurethral) and at a smaller dose (0.5 gram) compared to the control group.

Interventions

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Periurethral application of estradiol cream

The experimental group will apply estradiol cream in a different location (periurethral) and at a smaller dose (0.5 gram) compared to the control group.

Intervention Type DRUG

Intravaginal application of estradiol cream

The control group will apply 1 gram estradiol cream intravaginally using an applicator.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal (definition: No menses for 1 or more years or surgical menopause (bilateral oophorectomy). If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause) or have laboratory evidence of menopause (ie. FSH \>30)
* Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6 months or 3 or more UTI in 1 year
* May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study.
* Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI

Exclusion Criteria

* Current use of vaginal or oral estrogen products
* Inability or refusal to use vaginal estrogen
* Daily antibiotic use
* Significant vaginal stenosis (eg. due to lichen sclerosis, radiation or obliterative prolapse surgery) that would prohibit use of a vaginal applicator (ie. genital hiatus \<1cm)
* Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis)
* Frequent (1x weekly or more frequent) use of bladder instillations containing an antibiotic
* Known hydronephrosis as a result of incomplete bladder emptying
* Use of intermittent or indwelling urinary catheterization
* Known bladder stones, mesh erosion into bladder, or foreign object in bladder
* Unable to consent for self
* Active treatment for an estrogen-dependent malignancy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No