Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
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.
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 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.

 Methods:

 This will be a multi-center randomized, double- blind placebo-controlled study. Participating
 clinic sites include Maimonides Medical Center and Northwell Health. Subjects will be one
 hundred postmenopausal women presenting to a gynecology, urogynecology or female urology
 clinic with a history of three or more microbiologically confirmed symptomatic episodes of
 urinary tract infection during the either the previous year or two or more within six months.

 Patients will randomly assigned to one of two regimens: one group will receive VT cream to be
 used once each night for two weeks followed by twice-weekly applications for eight months,
 and the other group will receive a placebo cream to be used in the same manner. Demographic
 data, vaginal exam including vaginal swab to assess vaginal flora, vaginal pH measurement and
 vaginal atrophy index measurement will be collected at the initial study visit, again at a
 study visit at 4.5 months and another at 9 months.

 Anticipated Results and Conclusion:

 It is anticipated that vaginal testosterone cream will reduce the incidence of urinary tract
 infections in postmenopausal women when compared to placebo. It is expected that vaginal
 testosterone will improve vaginal atrophy and flora, thus, decreasing the frequency of
 urinary tract infections. Future aims of the study will focus on immune-dynamics associated
 with vaginal testosterone administration.
Inclusion Criteria:

 -  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 Criteria:

 -  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.