RECRUITING

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Quick Facts

Study Start:2020-11-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04807894

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.

Ages Eligible for Study:60 Years to 90 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 60-90 yo Female
  2. * Postmenopausal
  3. * Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
  4. * English Proficiency
  5. * Unable or unwilling to use topical estrogen.
  6. * Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
  7. * Patient on oral estrogen therapy may be included.
  8. * Patient with slings, prior vaginal surgery or pessary may be included.
  1. * Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
  2. * Antibiotic (vaginal or oral) use in the last 4 weeks
  3. * Current sexually transmitted infection
  4. * Chronic Foley catheter use or chronic ureteral stent placement.
  5. * Vaginal probiotic use in the last 4 weeks
  6. * Patient currently using vaginal estrogen.
  7. * Post-void Residual Volume \>150 mL or current diagnosis of urinary retention
  8. * Non-evaluated hematuria (\> trace on dipstick, microscopic, gross)
  9. * Unable to complete study tasks or comply with follow up.

Contacts and Locations

Study Contact

Alison Polland, MD
CONTACT
(718) 283-7770
apolland@maimonidesmed.org
Mariela Martinez, MD
CONTACT
mmrivera@maimonidesmed.org

Study Locations (Sites)

Maimonides Medical Center
Brooklyn, New York, 11219
United States

Collaborators and Investigators

Sponsor: Maimonides Medical Center

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

Study Start Date2020-11-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-11-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • urinary tract infections,
  • postmenopausal women
  • vaginal atrophy,
  • vaginal flora

Additional Relevant MeSH Terms

  • Recurrent Urinary Tract Infection
  • Vaginal Atrophy
  • Postmenopausal Disorder