Preventing Recurrent UTI With Vaginal Estrogen

Completed · Phase 4

Conditions studied: Recurrent Urinary Tract Infection, Urinary Tract Infections, Cystitis Recurrent

In brief

Among postmenopausal women who suffer from recurrent urinary tract infections (UTI), vaginal estrogen therapy prevents UTI recurrences for 50% of sufferers. This research will investigate why some women benefit but others do not, focusing on (a) the effects of vaginal estrogen therapy on the bacteria that inhabit the vagina and bladder, (b) its influence on immune responses in both compartments, and (c) the extent to which those changes are critical to successful UTI prevention. The findings will be a first step in the development of more effective strategies to prevent UTI, one of the most common and costly benign urologic conditions.

Key facts

Study ID

NCT05551949

Run by

Johns Hopkins University

People needed

27

Starts

2022-01-01

Expected to finish

2025-08-31

Last updated by the study team

2026-03-05

Who can join

Age: 55 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants in this study will be
• Postmenopausal women (menopausal for at least 1 year)
• Minimum age of 55 years
• Participants will have documentation of recurrent UTI, defined as follows:
• History of treatment for at least 3 UTIs in the past year or 2 episodes within 6 months AND
• At least one positive urine culture during an acute symptomatic episode.

You may not qualify if…

• Women receiving antibiotic prophylaxis to prevent UTI recurrence;
• Women with contraindications to vaginal estrogen (as indicated on the FDA-mandated package insert) and those who have used vaginal or systemic estrogen within the past 6 months;
• Women with an active UTI and those who have received antibiotics within the prior 2 weeks;
• Women with complicated rUTI, defined by immune compromise, anatomic or functional abnormalities of the urinary tract, indwelling catheterization, those performing self-catheterization, and those with neurological disease or illness relevant to the lower urinary tract;
• Women with only asymptomatic bacteriuria (rather than recurrent symptomatic UTI)

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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