Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

Stephanie Wang Zuo114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

114

Conditions

Recurrent Urinary Tract Infection

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

UPMC Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States

UPMC Hamot

Erie, Pennsylvania, United States

University of Pittsburgh Medical Center-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

UPMC Passavant-McCandless

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Are UTI-free at 6 Months

The primary outcome was the percentage of participants who were UTI-free at 6 months after study drug initiation.

Time frame: 6 months

Secondary Outcomes

Change From Baseline in Urinary Symptoms at 6 Months

Questionnaire assessment of urinary symptoms and symptom distress (Urogenital Distress Inventory, Short Form), total score range 0-100 with higher numbers representing worse urinary symptoms

Time frame: Baseline, 6 months

Change From Baseline in Sexual Function at 6 Months

Questionnaire assessment of sexual function (Female Sexual Function Index-6) with scores ranging from 2 to 30, with 19 and below denoting sexual dysfunction.

Time frame: Baseline, 6 months

Change From Baseline in Vaginal pH at 6 Months

Assessment using pH strips during pelvic examination

Time frame: Baseline, 6 months

Participant Experience With Study Drug

Agreement with the statement: "I am satisfied with the estrogen cream." (Positive response of "agree" or "strongly agree" on 5-point Likert Scale)

Time frame: 6 months

Vaginal Maturation Value

Vaginal maturation value at 3 months (score 0-100, higher values correlating with greater vaginal estrogenization)

Time frame: 3 months

Average Amount of Estrogen Used Per Tube

Study drug tubes were weighed at baseline and then at follow-up visits (weight in grams) and the average amount of study drug used per tube was calculated.

Time frame: 6 months

Percentage of Participants With Lactobacillus Crispatus Positive Vaginal Specimens

Lactobacillus crispatus is a species of Lactobacillus known to assist with UTI prevention through the maintenance of an acidic environment. It generally is elevated in the vagina in the presence of estrogen.

Time frame: 6 months

Percentage of Participants With E. Coli Positive Vaginal Specimens

E. coli is a common uropathogen and thus was investigated in the pilot translational sub-aim of this research study.

Time frame: 6 months