Clinical trial NCT05472779: Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants who are UTI-free at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in urinary symptoms at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in vaginal symptoms at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in sexual function at 6 months
timeFrame: Baseline, 6 months
measure: Amount of estrogen cream used
timeFrame: 6 months
measure: Participant experience with use of estrogen cream
timeFrame: 6 months
measure: Change from baseline in vaginal pH at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in vaginal maturation index at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in Vaginal and urinary E. coli levels at 6 months
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Cranberry Township
country: United States
facility: UPMC Lemieux Sports Complex
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Magee Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant-McCandless
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Stephanie W Zuo, MD
role: PRINCIPAL_INVESTIGATOR
References: