Recurrent Urinary Tract Infection
Conditions
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.
Interventions
DRUGPeriurethral application of estradiol cream
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.
DRUGIntravaginal application of estradiol cream
The control group will apply 1 gram estradiol cream intravaginally using an applicator.
Sponsors
Stephanie Wang Zuo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who are UTI-free at 6 months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in vaginal symptoms at 6 months | Baseline, 6 months | Questionnaire assessment of vaginal symptoms and bother using 5-point Likert scale, developed by research team |
| Change from baseline in sexual function at 6 months | 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. |
| Amount of estrogen cream used | 6 months | Estradiol cream tubes will be weighed at each research visit in grams |
| Participant experience with use of estrogen cream | 6 months | Questionnaire assessment of patient experience using 5-point Likert and open-ended questions, developed by the research team |
| Change from baseline in urinary symptoms at 6 months | 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 |
| Change from baseline in vaginal maturation index at 6 months | Baseline, 6 months | Assessment of vaginal cell types using a superficial swab, collected from proximal vagina |
| Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months | Baseline, 6 months | Clean catch urine and vaginal swab sample collection with quantification of Lactobacillus |
| Change from baseline in Vaginal and urinary E. coli levels at 6 months | Baseline, 6 months | Clean catch urine and vaginal swab sample collection for quantification of E. coli |
| Change from baseline in vaginal pH at 6 months | Baseline, 6 months | Assessment using pH strips during pelvic examination |
Countries
United States
Outcome results
None listed