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Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance. There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.
This study is a cross-over randomized study to assess preference. Participants will be in the study for 6 months, they will use vaginal estradiol cream for 3 months and vaginal estradiol tablet for 3 months. Patients who meet diagnostic criteria for rUTI will be recruited. Group A participants will start with 3 months of cream and then switch to tablets. Group B will start with 3 months of tablets and switch to cream. In addition, participants may be started on other supplemental medications (Cranberry, D-mannose, methenamine) at the discretion of their provider. Patients will get monthly phone calls to assess for side effects, safety concerns, and symptoms of UTI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cream used first and then switch to tablets | Active Comparator | participants will start with 3 months of cream and then switch to tablets |
|
| tablets used first and switch to cream | Active Comparator | participants will start with 3 months of tablets and switch to cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol vaginal cream | Drug | Participants will use vaginal estradiol cream for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient preference rate for vaginal estradiol cream versus tablet | Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?" | month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream | Vaginal culture swab and urine culture specimens will be collected - The specimens will be sent for species-specific polymerase chain reaction (PCR) for Lactobacillus | Baseline, Month 3, and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Candace Parker-Autry, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Walters, M.D. and M.M. Karram, Urogynecology and Pelvic Reconstructive surgery. 2022: Mosby Elsevier. | ||
| 23526171 | Background | 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. | |
| 31232721 |
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No data will be shared with other researchers
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Estradiol Vaginal Tablet | Drug | Participants will use vaginal estradiol tablet for 3 months |
|
| Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM) |
Treatment Satisfaction Questionnaire for Medication (TSQM) - The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. |
| Month 3 and Month 6 |
| Changes in adherence scores | Adherence will be assessed by the medication adherence questionnaire (MAQ) - The MAQ will be used to determine medication adherence. This questionnaire asks respondents about past experience in taking medications. The responses are 'yes' or 'no' and are scored as yes=1 and no=0. Scores will be summed: high adherence = score of 0 points; medium adherence = score of 1-2 points, and low adherence = score of 3-4 points. Means and standard deviations will be compared within and between groups. | Month 3 and Month 6 |
| Background |
| 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. |
| 8350884 | Background | 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. |
| 9573080 | Background | 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. |
| 24223212 | Background | 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. |
| 31042112 | Background | 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. |
| 17054136 | Background | 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. |
| 10329858 | Background | 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. |
| 27648663 | Background | 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. |
| 25859123 | Background | Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83. |
| 22031610 | Background | 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. |
| 3945130 | Background | 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. |
| 14987333 | Background | 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. |
| 30358715 | Background | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |