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Pilot trial for PIVoT: Prevention of recurrent urinary tract infection using vaginal testosterone

  • Mariela Martinez,
  • Arshia Sandozi,
  • Jeffrey Lee,
  • Liliya Vafina,
  • Cassandra Pond,
  • Robert Adelson,
  • Elie Kaplan-Marans,
  • Katiana Vazquez-Rivera,
  • Annette Lee,
  • Allison Polland

Introduction and objective

Recurrent urinary tract infections (rUTI) in postmenopausal women have been associated with changes in vaginal flora. Vaginal estrogen treats atrophy thereby restoring flora, which prevents UTIs. While estrogen is effective, some patients have contraindications or are unwilling to use it. Vaginal testosterone cream (VT) has been shown to improve atrophy, however, its effects on flora and rUTIs are unknown. The purpose of this study was to determine the effect of VT versus placebo on vaginal flora in postmenopausal women with rUTI.


This randomized, double- blind pilot study enrolled postmenopausal women with rUTIs. Patients were randomized to VT or placebo. Vaginal health index (VHI) and vaginal swab to assess flora via DNA sequencing were collected at baseline and at one month follow up.


A total of 21 patients were enrolled. Average VHI at enrollment was 16.68±4. There was no difference between groups at baseline with regard to VHI. There was diversity of vaginal flora in both treatment arms at baseline (Figure 1). Among patients who completed follow up, almost half of those in the VT arm had an increase in relative abundance of lactobacilli, which was not seen in the placebo patients. As compared to the placebo arm, a greater number of patients in the VT arm had a decrease in relative abundance of uropathogens such as Bacteroides and Pseudomonas. The majority of patients in the VT arm had improvement in VHI, which was not seen with placebo at one month. Four patients developed UTIs during the study, two in each arm.


Initial data demonstrates increased abundance of lactobacilli and improvement in VHI at one-month post treatment with VT. Although there was no difference in the number of patients who developed UTIs between groups, longer treatment follow up and increased patient enrollment will be valuable in determining if VT is effective for UTI prevention.

Source of Funding

AUA Urology Care Foundation Residency Research Award