Using vaginal testosterone to prevent recurrent urinary tract infections in postmenopausal women
Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
This study is testing if a vaginal testosterone cream can help prevent repeated urinary tract infections in postmenopausal women aged 60 to 90.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | Female |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT04807894 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of topically applied vaginal testosterone cream compared to a placebo in reducing the incidence of recurrent urinary tract infections (UTIs) in postmenopausal women. The study involves a multi-center, randomized, double-blind, placebo-controlled design, enrolling 100 women aged 60 to 90 who have a history of recurrent UTIs. The trial aims to assess not only the reduction in UTI occurrences but also the impact of vaginal testosterone on vaginal pH and flora. Participants will be recruited from gynecology, urogynecology, and female urology clinics.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 60 to 90 with a history of recurrent UTIs.
Not a fit: Patients currently experiencing a UTI or those using vaginal estrogen or antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of recurrent UTIs in postmenopausal women, improving their quality of life.
How similar studies have performed: While the use of vaginal estrogen for similar purposes has been well established, the application of vaginal testosterone is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Study coordinator: Alison Polland, MD
- Email: apolland@maimonidesmed.org
- Phone: (718) 283-7770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.