Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo (PIVoT)

Maimonides Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Postmenopausal Disorder; Vaginal Atrophy; Recurrent Urinary Tract Infection

Treatments: Drug: Vaginal Cream with Applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT04807894

702576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Vaginal Testosterone Cream Arm

Experimental group

Description:

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.

Treatment:

Drug: Vaginal Cream with Applicator

Vaginal Placebo Cream Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vaginal Cream with Applicator