Vaginal Estrogen for Urinary Tract Infections

(TAPER Trial)

Recruiting at4 trial locations

Overseen by Stephanie W Zuo, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mary Ackenbom

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephanie W Zuo, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

This trial is for postmenopausal women who've had at least 2 UTIs in the last 6 months or 3 in a year, and are recommended vaginal estrogen to prevent more UTIs. They shouldn't be currently using any estrogen products, have significant vaginal narrowing, bladder stones, risk of estrogen-dependent cancer, or conditions preventing them from applying the cream themselves.

Inclusion Criteria

I am postmenopausal, meeting the age or lab criteria if I had a hysterectomy.

I have had 2 or more UTIs in 6 months or 3 or more in a year.

I stopped using vaginal estrogen over 3 months ago.

Exclusion Criteria

Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis)

I am currently using vaginal or oral estrogen products.

I am unable to give my own consent for medical procedures.

Treatment Details

Interventions

• Estradiol Cream (Hormone Therapy)

Trial Overview The study compares two ways of using estradiol cream to prevent recurrent urinary tract infections: periurethral (around the urethra) versus intravaginal application. It aims to determine if applying less cream around the urethra is as effective as the standard intravaginal method.

Participant Groups

Group I: Periurethral Estrogen Application Experimental Treatment 1 Intervention

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

Group II: Intravaginal Estrogen Application Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mary Ackenbom

Lead Sponsor

Trials

1

Recruited

110+

Stephanie Wang Zuo

Lead Sponsor

Trials

1

Recruited

110+