Vaginal Estrogen for Urinary Tract Infections
(PRUVE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byVictoria Handa, MD MHS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for postmenopausal women aged 55 or older who have had at least 3 UTIs in the past year or 2 within the last 6 months, with one confirmed by urine culture. It's not for those currently on antibiotics to prevent UTIs, those with contraindications to vaginal estrogen, recent antibiotic use, complicated recurrent UTI due to other health issues.

Inclusion Criteria

I am a woman aged 55 or older and have been postmenopausal for at least 1 year.

I have had 3 UTIs in the last year or 2 in the last 6 months, with at least one confirmed by a lab test.

Exclusion Criteria

I cannot use vaginal estrogen due to health risks and haven't used any estrogen treatments in the last 6 months.

I am a woman with frequent UTIs and have conditions like immune issues or use a catheter.

I am a woman currently with a UTI or have taken antibiotics in the last 2 weeks.

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Treatment Details

Interventions

Vaginal Estradiol Tablets (Estrogen)

Trial OverviewThe study tests if vaginal estradiol tablets can prevent recurrent urinary tract infections in postmenopausal women. It examines how this treatment affects vaginal and bladder bacteria and immune responses to understand why it helps some women but not others.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Vaginal estrogen therapyExperimental Treatment1 Intervention

Participants receive Vaginal estrogen therapy.