Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

Launched by MAIMONIDES MEDICAL CENTER · Mar 18, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a cream containing vaginal testosterone can help prevent recurrent urinary tract infections (UTIs) in women who are postmenopausal. Women over 60 often experience changes in their vaginal health after menopause, which can lead to a higher risk of UTIs. The study is comparing the effects of this testosterone cream to a placebo (a cream with no active ingredients) to see if it can reduce the number of UTIs and improve vaginal health.

To participate, women aged 60 to 90 who have had three or more UTIs in the past year may be eligible, especially if they prefer not to use estrogen-based treatments. Participants should not currently have a UTI or be on antibiotics, among other criteria. If you join the study, you can expect to apply the cream as directed and attend follow-up visits to monitor your health. This trial aims to understand better how vaginal testosterone affects UTI prevention and vaginal health in postmenopausal women.

Gender

FEMALE

Eligibility 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.