Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections (TAPER)

Mary Ackenbom

Status and phase: Active, not recruiting; Phase 2

Conditions: Recurrent Urinary Tract Infection

Treatments: Drug: Intravaginal application of estradiol cream; Drug: Periurethral application of estradiol cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05472779

STUDY22010147

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Intravaginal Estrogen Application

Active Comparator group

Description:

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

Treatment:

Drug: Intravaginal application of estradiol cream

Periurethral Estrogen Application

Experimental group

Description:

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

Treatment:

Drug: Periurethral application of estradiol cream