COMPLETED

Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections: TAPER (Techniques of APplying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections) Trial

Quick Facts

Study Start:2023-01-03
Study Completion:2025-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05472779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6 months or 3 or more UTI in 1 year
  3. * May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study.
  4. * Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI
  1. * Current use of vaginal or oral estrogen products
  2. * Inability or refusal to use vaginal estrogen
  3. * Daily antibiotic use
  4. * 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)
  5. * Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis)
  6. * Frequent (1x weekly or more frequent) use of bladder instillations containing an antibiotic
  7. * Known hydronephrosis as a result of incomplete bladder emptying
  8. * Use of intermittent or indwelling urinary catheterization
  9. * Known bladder stones, mesh erosion into bladder, or foreign object in bladder
  10. * Unable to consent for self
  11. * Active treatment for an estrogen-dependent malignancy

Contacts and Locations

Principal Investigator

Stephanie W Zuo, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center

Study Locations (Sites)

UPMC Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066
United States
UPMC Hamot
Erie, Pennsylvania, 16550
United States
University of Pittsburgh Medical Center-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States
UPMC Passavant-McCandless
Pittsburgh, Pennsylvania, 15237
United States

Collaborators and Investigators

Sponsor: Stephanie Wang Zuo

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-03
Study Completion Date2025-06-25

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2025-06-25

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Urinary Tract Infection