Vaginal Estrogen Application Techniques for Prevention of Urinary Tract Infection: A Randomized Trial
Abstract
OBJECTIVE
To determine whether periurethral estrogen application is noninferior to intravaginal estrogen application for the prevention of urinary tract infections (UTIs) in postmenopausal individuals with laboratory-proven recurrent UTI.
METHODS
The TAPER (Techniques of Applying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections) trial was a single-center, nonblinded, randomized noninferiority trial that compared outcomes after a twice-weekly intravaginal estradiol applicator instillation of 1.0 g cream (intravaginal) compared with periurethral digital application of 0.5 g cream (periurethral) in postmenopausal individuals with recurrent UTIs. The primary outcome was the proportion of UTI-free participants at 6 months postintervention. Secondary outcomes included number of UTIs, the amount of time elapsed to the first UTI, vaginal pH, PGI-I (Patient Global Impression of Improvement) scores, patient experience with the study drug, study drug adverse effects, and urinary and sexual function. To achieve 80% power with a type 1 error of 5% and to account for loss to follow-up, 114 participants needed to be randomized based on a noninferiority margin of 25%.
RESULTS
Of 270 eligible individuals, 114 consented and were randomized (57 intravaginal, 57 periurethral). Participants were predominantly White (92.1%) with a mean age of 71.1 years (range 52-93). Participants reported a median of three UTIs in the 12 months before enrollment. Individuals randomized to…
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: 270 participants or records.
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