Stephanie W Zuo, Erin E Mowers, Shea Hem, Megan Bradley, Halina M Zyczynski, Sharon L Hillier, Mary F Ackenbom
{"title":"Vaginal Estrogen Application Techniques for Prevention of Urinary Tract Infection: A Randomized Trial.","authors":"Stephanie W Zuo, Erin E Mowers, Shea Hem, Megan Bradley, Halina M Zyczynski, Sharon L Hillier, Mary F Ackenbom","doi":"10.1097/AOG.0000000000006376","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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%.</p><p><strong>Results: </strong>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 periurethral estrogen application had a similar proportion of UTI-free participants at 6 months as those randomized to intravaginal estrogen application (50.9% vs 52.6%; risk difference, -1.75 percentage points; 95% CI, -20.0 to 17.0 percentage points). Both groups experienced a decrease in vaginal pH at 6 months; the decreases did not differ by application method (-1.2 intravaginal vs -0.8 periurethral, P =.30). Participants assigned to intravaginal estrogen were more likely to experience vaginal itching after 3 months of use than those assigned to periurethral application (24.0% vs 2.4%, P <.01). Other outcomes did not differ by route of estrogen application.</p><p><strong>Conclusion: </strong>For postmenopausal individuals who are experiencing recurrent UTI, periurethral application of estradiol cream is noninferior to intravaginal application for UTI prevention. Both application methods resulted in approximately half of the participants being UTI-free at 6 months.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov , NCT05472779.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":" ","pages":"671-679"},"PeriodicalIF":5.1000,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obstetrics and gynecology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/AOG.0000000000006376","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/7/27 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
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 periurethral estrogen application had a similar proportion of UTI-free participants at 6 months as those randomized to intravaginal estrogen application (50.9% vs 52.6%; risk difference, -1.75 percentage points; 95% CI, -20.0 to 17.0 percentage points). Both groups experienced a decrease in vaginal pH at 6 months; the decreases did not differ by application method (-1.2 intravaginal vs -0.8 periurethral, P =.30). Participants assigned to intravaginal estrogen were more likely to experience vaginal itching after 3 months of use than those assigned to periurethral application (24.0% vs 2.4%, P <.01). Other outcomes did not differ by route of estrogen application.
Conclusion: For postmenopausal individuals who are experiencing recurrent UTI, periurethral application of estradiol cream is noninferior to intravaginal application for UTI prevention. Both application methods resulted in approximately half of the participants being UTI-free at 6 months.
期刊介绍：
"Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics.
"Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
