Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

NCT05472779 | Completed Phase 2 FDA Drug

• 1 other identifier: STUDY22010147
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who are UTI-free at 6 months

  6 months

Secondary Outcomes (9)

• Change from baseline in urinary symptoms at 6 months

  Baseline, 6 months

• Change from baseline in vaginal symptoms at 6 months

  Baseline, 6 months

• Change from baseline in sexual function at 6 months

  Baseline, 6 months

• Amount of estrogen cream used

  6 months

• Participant experience with use of estrogen cream

  6 months

Study Arms (2)

Intravaginal Estrogen Application

ACTIVE COMPARATOR

Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months

Drug: Intravaginal application of estradiol cream

Periurethral Estrogen Application

EXPERIMENTAL

Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months

Drug: Periurethral application of estradiol cream

Interventions

Periurethral application of estradiol cream DRUG

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.

Periurethral Estrogen Application

Intravaginal application of estradiol cream DRUG

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

Intravaginal Estrogen Application

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie Wang Zuo: lead

Study Sites (4)

UPMC Lemieux Sports Complex

Cranberry Township, Pennsylvania, 16066, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

University of Pittsburgh Medical Center-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Passavant-McCandless

Pittsburgh, Pennsylvania, 15237, 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

Study Officials

• Stephanie W Zuo, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: January 3, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 25, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)