Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephanie Wang Zuo
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal (definition: No menses for 1 or more years. If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause))

• 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

• Unable to consent for self

• History of or at high risk for estrogen-dependent malignancy