Preventing Recurrent UTI With Vaginal Estrogen

NCT05551949 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB00314740R01DK130856
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystitis Recurrent; Urinary Tract Infections; Recurrent Urinary Tract Infection

Keywords

women

Outcome Measures

Primary Outcomes (4)

• Change in Vaginal Microbiota

  Changes to relative vaginal abundance of key Lactobacillus spp. before and after treatment.

  Baseline and 12 weeks

• Change in Vaginal Interleukin-6 Level

  Changes to vaginal Interleukin-6 before and after treatment.

  Baseline and 12 weeks

• Change in Urinary Microbiota

  Changes to relative urinary abundance of key Lactobacillus spp. before and after treatment.

  Baseline and 12 weeks

• Change in Urinary Interleukin-6 Level

  Changes to urinary Interleukin-6 before and after treatment.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Urinary Tract Infection Recurrence

  Weeks 12 to 24

Study Arms (1)

Vaginal estrogen therapy

OTHER

Participants receive Vaginal estrogen therapy.

Drug: Vaginal estradiol tablets

Interventions

Vaginal estradiol tablets DRUG

Vaginal estradiol tablets (10mcg).

Vaginal estrogen therapy

Eligibility Criteria

• Age: 55 Years - 100 Years
• Gender Eligibility Details: identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Maryland: collaborator
• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Victoria Handa MD
• Organization: Johns Hopkins University School of Medicine

vhanda1@Jhmi.edu

410-550-0336

Study Officials

• Victoria Handa, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single group clinical trial

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data sharing will be provided within one year of study conclusion.
• Access Criteria: To be determined

Locations

US (1)