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Completed

NCT Number: NCT05472779

Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

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.

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Key information

Conditions

Recurrent Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UPMC Lemieux Sports Complex, Cranberry Township, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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
  • May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study.
  • Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI

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 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

Treatment and study plan

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.

Intravaginal application of estradiol cream

Drug

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

Primary outcomes

  1. Percentage of participants who are UTI-free at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline in urinary symptoms at 6 months

    Time frame: Baseline, 6 months

    Questionnaire assessment of urinary symptoms and symptom distress (Urogenital Distress Inventory, Short Form), total score range 0-100 with higher numbers representing worse urinary symptoms

  2. Change from baseline in vaginal symptoms at 6 months

    Time frame: Baseline, 6 months

    Questionnaire assessment of vaginal symptoms and bother using 5-point Likert scale, developed by research team

  3. Change from baseline in sexual function at 6 months

    Time frame: Baseline, 6 months

    Questionnaire assessment of sexual function (Female Sexual Function Index-6) with scores ranging from 2 to 30, with 19 and below denoting sexual dysfunction.

  4. Amount of estrogen cream used

    Time frame: 6 months

    Estradiol cream tubes will be weighed at each research visit in grams

  5. Participant experience with use of estrogen cream

    Time frame: 6 months

    Questionnaire assessment of patient experience using 5-point Likert and open-ended questions, developed by the research team

  6. Change from baseline in vaginal pH at 6 months

    Time frame: Baseline, 6 months

    Assessment using pH strips during pelvic examination

  7. Change from baseline in vaginal maturation index at 6 months

    Time frame: Baseline, 6 months

    Assessment of vaginal cell types using a superficial swab, collected from proximal vagina

  8. Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months

    Time frame: Baseline, 6 months

    Clean catch urine and vaginal swab sample collection with quantification of Lactobacillus

  9. Change from baseline in Vaginal and urinary E. coli levels at 6 months

    Time frame: Baseline, 6 months

    Clean catch urine and vaginal swab sample collection for quantification of E. coli

Sponsors and collaborators

Lead sponsor

Stephanie Wang Zuo

Other

Registry information

Official study 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

Acronym: TAPER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2022
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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