Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Who is this study for? Adult female patients age 60 to 90 with recurrent UTI
What treatments are being studied? Vaginal testosterone cream
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
United States
New York
Maimonides Medical Center
Recruiting
Brooklyn
Contact Information
Primary
Alison Polland, MD
apolland@maimonidesmed.org
(718) 283-7770
Backup
Mariela Martinez, MD
mmrivera@maimonidesmed.org
Time Frame
Start Date: November 1, 2020
Estimated Completion Date: December 2022
Participants
Target number of participants: 100
Treatments
Experimental: Vaginal Testosterone Cream Arm
Women enrolled in this arm will receive vaginal testosterone cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.
Placebo Comparator: Vaginal Placebo Cream Arm
Women enrolled in this arm will receive vaginal placebo cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.
Authors
Alison Polland
Sponsors
Leads: Maimonides Medical Center
Collaborators: American Urological Association

This content was sourced from clinicaltrials.gov

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