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Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

NCT05472779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Urinary Tract Infection

Interventions

DRUG

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.

DRUG

Intravaginal application of estradiol cream

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

Sponsors & Collaborators

  • Stephanie Wang Zuo

    lead OTHER

Principal Investigators

  • Stephanie W Zuo, MD · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2025-06-15
Completion
2025-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472779 on ClinicalTrials.gov