Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Last updated: October 21, 2024
Sponsor: Maimonides Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Vaginitis

Vaginal Atrophy

Treatment

Vaginal Cream with Applicator

Clinical Study ID

NCT04807894
702576
  • Ages 60-90
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 60-90 yo Female

  • Postmenopausal

  • Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or twoor 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 currentaromatase 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

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Vaginal Cream with Applicator
Phase: 4
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.