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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.
Conditions:
🦠 Recurrent Urinary Tract Infection 🦠 Vaginal Atrophy 🦠 Postmenopausal Disorder
🗓️ Study Start (Actual) 1 November 2020
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Brooklyn, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 60 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 October 2020
  • First Submitted that Met QC Criteria 18 March 2021
  • First Posted 19 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 October 2023
  • Last Update Posted 23 October 2023
  • Last Verified October 2023
I'm interested ...!!