Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream
NCT ID: NCT05723601
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
24 participants
INTERVENTIONAL
2024-01-12
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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cream used first and then switch to tablets
participants will start with 3 months of cream and then switch to tablets
Estradiol vaginal cream
Participants will use vaginal estradiol cream for 3 months
Estradiol Vaginal Tablet
Participants will use vaginal estradiol tablet for 3 months
tablets used first and switch to cream
participants will start with 3 months of tablets and switch to cream
Estradiol vaginal cream
Participants will use vaginal estradiol cream for 3 months
Estradiol Vaginal Tablet
Participants will use vaginal estradiol tablet for 3 months
Interventions
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Estradiol vaginal cream
Participants will use vaginal estradiol cream for 3 months
Estradiol Vaginal Tablet
Participants will use vaginal estradiol tablet for 3 months
Eligibility Criteria
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Inclusion Criteria
* New or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or more UTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least one culture documented UTI, the remaining can be documented by urinalysis showing nitrites and leukocyte esterase.
* Not currently taking daily prophylactic antibiotics
* Willing to use vaginal estrogen for prevention of recurrent UTIs
Exclusion Criteria
* Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer
* Recent urologic surgery within 3 months
* Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis)
* Other medical reasons that are deemed incompatible with vaginal estrogen treatment
* Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period
* Inability to follow up at clinic study site to give sample, for example due to transportation issues
* Organ transplant patients
* Patients on systemic hormone replacement therapy (HRT)
20 Years
80 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Candace Parker-Autry, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Martina Gabra, MD
Role: primary
Sachin Vyas, PhD
Role: backup
References
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Walters, M.D. and M.M. Karram, Urogynecology and Pelvic Reconstructive surgery. 2022: Mosby Elsevier.
Minkin MJ, Maamari R, Reiter S. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int J Womens Health. 2013;5:133-9. doi: 10.2147/IJWH.S41897. Epub 2013 Mar 15.
Ferrante KL, Wasenda EJ, Jung CE, Adams-Piper ER, Lukacz ES. Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):112-117. doi: 10.1097/SPV.0000000000000749.
Raz R, Stamm WE. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993 Sep 9;329(11):753-6. doi: 10.1056/NEJM199309093291102.
Boris S, Suarez JE, Vazquez F, Barbes C. Adherence of human vaginal lactobacilli to vaginal epithelial cells and interaction with uropathogens. Infect Immun. 1998 May;66(5):1985-9. doi: 10.1128/IAI.66.5.1985-1989.1998.
O'Hanlon DE, Moench TR, Cone RA. Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. PLoS One. 2013 Nov 6;8(11):e80074. doi: 10.1371/journal.pone.0080074. eCollection 2013.
Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.
Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500. doi: 10.1002/14651858.CD001500.pub2.
Eriksen B. A randomized, open, parallel-group study on the preventive effect of an estradiol-releasing vaginal ring (Estring) on recurrent urinary tract infections in postmenopausal women. Am J Obstet Gynecol. 1999 May;180(5):1072-9. doi: 10.1016/s0002-9378(99)70597-1.
Weissmann-Brenner A, Bayevsky T, Yoles I. Compliance to vaginal treatment-tablets versus cream: a retrospective 9 years study. Menopause. 2017 Jan;24(1):73-76. doi: 10.1097/GME.0000000000000729.
Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83.
Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis and management of recurrent urinary tract infection in women. Can Urol Assoc J. 2011 Oct;5(5):316-22. doi: 10.5489/cuaj.11214. No abstract available.
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004 Feb 26;2:12. doi: 10.1186/1477-7525-2-12.
Rioux JE, Devlin MC, Gelfand MM, Steinberg WM, Hepburn DS. 17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. Menopause. 2018 Nov;25(11):1208-1213. doi: 10.1097/GME.0000000000001220.
Other Identifiers
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IRB00092892
Identifier Type: -
Identifier Source: org_study_id