Actively Recruiting
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Led by Maimonides Medical Center · Updated on 2025-11-05
100
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
Sponsors
M
Maimonides Medical Center
Lead Sponsor
A
American Urological Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.
CONDITIONS
Official Title
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 60 to 90 years
- Postmenopausal status
- History of recurrent urinary tract infections with three or more culture-confirmed symptomatic episodes in the past year or two or more within the past six months
- Proficiency in English
- Unable or unwilling to use topical estrogen
- Patients with current or past endometrial or breast cancer on aromatase inhibitor therapy may be included
- Patients on oral estrogen therapy may be included
- Patients with vaginal slings, prior vaginal surgery, or pessary use may be included
You will not qualify if you...
- Current urinary tract infection confirmed by positive dipstick or culture
- Use of antibiotics (vaginal or oral) in the last 4 weeks
- Current sexually transmitted infection
- Chronic use of Foley catheter or ureteral stent
- Use of vaginal probiotics in the last 4 weeks
- Current use of vaginal estrogen
- Post-void residual urine volume greater than 150 mL or diagnosis of urinary retention
- Presence of unexplained hematuria (trace or more on dipstick, microscopic, or gross)
- Inability to complete study tasks or comply with follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
A
Alison Polland, MD
CONTACT
M
Mariela Martinez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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