Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

Last updated: December 16, 2024
Sponsor: Mary Ackenbom
Overall Status: Active - Not Recruiting

Phase

2

Condition

Urinary Tract Infections

Treatment

Periurethral application of estradiol cream

Intravaginal application of estradiol cream

Clinical Study ID

NCT05472779
STUDY22010147
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal (definition: No menses for 1 or more years or surgical menopause (bilateral oophorectomy). If there is a past history of hysterectomy, patient mustbe age 56 or older (95th percentile for age at menopause) or have laboratoryevidence of menopause (ie. FSH >30)

  • Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6months or 3 or more UTI in 1 year

  • May include patients who used vaginal estrogen previously if they have stopped usefor 3 or more months prior to inclusion into study.

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

Exclusion

Exclusion Criteria:

  • 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 obliterativeprolapse surgery) that would prohibit use of a vaginal applicator (ie. genitalhiatus <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 anantibiotic

  • 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

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Periurethral application of estradiol cream
Phase: 2
Study Start date:
January 03, 2023
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • UPMC Lemieux Sports Complex

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • UPMC Hamot

    Erie, Pennsylvania 16550
    United States

    Site Not Available

  • UPMC Passavant-McCandless

    Pittsburgh, Pennsylvania 15237
    United States

    Site Not Available

  • University of Pittsburgh Medical Center-Magee Womens Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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