Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age60-90
SponsorMaimonides Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vaginal Cream with Applicator

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maimonides Medical Center

Lead sponsor

American Urological Association

Collaborator