Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Description

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

Recurrent Urinary Tract Infection, Vaginal Atrophy, Postmenopausal Disorder

Study Overview

Study Details

Study overview

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.

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Condition
Recurrent Urinary Tract Infection
Intervention / Treatment

-

Contacts and Locations

Brooklyn

Maimonides Medical Center, Brooklyn, New York, United States, 11219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

60 Years to 90 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Maimonides Medical Center,

Study Record Dates

2025-12-31