RecruitingPhase 4NCT04807894

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Sponsor

Maimonides Medical Center

Enrollment

100 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

Vaginal Atrophy Postmenopausal Disorder recurrent urinary tract infection

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 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.

Eligibility

Sex: FEMALEMin Age: 60 YearsMax Age: 90 Years

Inclusion Criteria8

-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 Criteria9

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.

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Interventions

DRUGVaginal Cream with Applicator

Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.