NCT05723601

Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Estradiol vaginal cream	Participants will use vaginal estradiol cream for 3 months
DRUG	Estradiol Vaginal Tablet	Participants will use vaginal estradiol tablet for 3 months

Timeline

• Start date: 2024-01-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-02-10
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study