Status:
RECRUITING
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Lead Sponsor:
Maimonides Medical Center
Collaborating Sponsors:
American Urological Association
Conditions:
Recurrent Urinary Tract Infection
Vaginal Atrophy
Eligibility:
FEMALE
60-90 years
Phase:
PHASE4
Brief Summary
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated w...
Detailed Description
Background: Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora...
Eligibility Criteria
Inclusion
- 60-90 yo Female
- Postmenopausal
- Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
- English Proficiency
- Unable or unwilling to use topical estrogen.
- Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
- Patient on oral estrogen therapy may be included.
- Patient with slings, prior vaginal surgery or pessary may be included.
Exclusion
- Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
- Antibiotic (vaginal or oral) use in the last 4 weeks
- Current sexually transmitted infection
- Chronic Foley catheter use or chronic ureteral stent placement.
- Vaginal probiotic use in the last 4 weeks
- Patient currently using vaginal estrogen.
- Post-void Residual Volume \>150 mL or current diagnosis of urinary retention
- Non-evaluated hematuria (\> trace on dipstick, microscopic, gross)
- Unable to complete study tasks or comply with follow up.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04807894
Start Date
November 1 2020
End Date
December 31 2026
Last Update
November 5 2025
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219