Contemporary clinical trials · 2025
Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zuo Stephanie W, Bradley Megan, Mowers Erin E, Zyczynski Halina M, Hillier Sharon L, Ackenbom Mary F
Аннотация
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 regarding the effectiveness of intravaginal versus periurethral estradiol application for UTI prevention.
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 regarding the effectiveness of intravaginal versus periurethral estradiol application for UTI prevention.