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Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
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.
Age
20 - 80 years
Sex
FEMALE
Healthy Volunteers
No
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Start Date
January 12, 2024
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2027
Last Updated
December 2, 2025
21
ACTUAL participants
Estradiol vaginal cream
DRUG
Estradiol Vaginal Tablet
DRUG
Lead Sponsor
Wake Forest University Health Sciences
NCT06353269
NCT06124820
Data Source & Attribution
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