Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial
Abstract
BACKGROUND
Recurrent urinary tract infections (UTIs) disproportionately affect older women. Vaginal estrogen is the only non-antibiotic therapy with a Grade A recommendation for the prevention of UTIs in postmenopausal women, but it is associated with a high rate of non-adherence due to reported difficulties with vaginal application and concerns about exogenous hormone exposure. To alleviate these challenges, some women apply estrogen cream periurethrally, although evidence supporting this approach is lacking.
METHODS
The Techniques of APplying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections (TAPER) trial is a randomized non-inferiority trial comparing the percentage of UTI-free participants after 6-months of vaginal estradiol via (1) intravaginal application of 1.0 g cream (standard) or (2) periurethral application of 0.5 g cream. Postmenopausal women with laboratory evidence of recurrent UTIs and without estrogen use in the prior 3 months were eligible. Secondary outcomes include urinary, sexual, and vulvovaginal symptoms, patient compliance, and translational measures, including change in vaginal pH, vaginal maturation index, and urinary and vaginal colonization by Lactobacillus and Escherichia coli.
RESULTS
A total of 114 participants were randomized, and participants are currently in the follow-up phase.
CONCLUSION
This report highlights the study design and implementation challenges of the TAPER trial. Results from this trial will provide evidence…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 114 participants or records.
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