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

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ClinicalTrials.gov Identifier: NCT04807894
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
American Urological Association
Information provided by (Responsible Party):
Maimonides Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Vaginal Atrophy Postmenopausal Disorder Drug: Vaginal Cream with Applicator Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Vaginal Cream with Applicator
Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.
Other Name: Testosterone Cream

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.
Drug: Vaginal Cream with Applicator
Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.
Other Name: Testosterone Cream




Primary Outcome Measures :
  1. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 1 month ]
    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 1 month to check for presence of UTI.

  2. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 4.5 months ]
    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 4.5 months to check for presence of UTI.

  3. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 9 months ]
    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 9 months to check for presence of UTI.

  4. To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 1 month ]
    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 1 month to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  5. To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 4.5 months ]
    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 4.5 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  6. To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections. [ Time Frame: 9 months ]
    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 9 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is aimed at postmenopausal women with history of recurrent UTIs.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807894


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

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Alison Polland, MD    718-283-7770    apolland@maimonidesmed.org   
Principal Investigator: Alison Polland, MD         
Sponsors and Collaborators
Maimonides Medical Center
American Urological Association
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Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT04807894    
Other Study ID Numbers: 702576
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Maimonides Medical Center:
urinary tract infections,
postmenopausal women
vaginal atrophy,
vaginal flora
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Atrophy
Pathological Conditions, Anatomical
Urologic Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs