Methenamine in a Non-antibiotic, Multimodal Approach to UTI Prevention
Status:
Not yet recruiting
Trial end date:
2021-11-05
Target enrollment:
Participant gender:
Summary
Urinary tract infections (UTIs) are the most common bacterial infection and are especially
common in postmenopausal women, who often experience recurrent UTIs. Women with recurrent
UTIs are commonly treated with antibiotics, but side effects, collateral damage to commensal
bacteria, and antimicrobial resistance result from frequent antibiotic use. It is paramount
that researchers develop non-antibiotic treatment strategies for UTIs.
Several non-antibiotic strategies may be successful in preventing recurrent UTIs in
postmenopausal women, including low-dose vaginal estrogen, d-mannose, and methenamine
hippurate. Methenamine hippurate (MH) is interesting as it causes few side effects, kills
bacteria by denaturing bacterial proteins, RNA, and DNA, and does not develop resistance.
Several studies have demonstrated the efficacy of daily methenamine on the incidence of UTI.
However, women often require multiple therapies in order to prevent recurrence. There are
currently few guidelines to help clinicians identify optimal treatment regimens for
non-antibiotic prevention of UTI.
The purpose of this pilot study is to examine the feasibility of developing a sequential,
multiple assignment, randomization trial (SMART); and examine the treatment effect of MH in
combination with vaginal estrogen (VET) and D-mannose on prevention of UTI. The investigators
plan to examine the efficacy of the addition of MH to low dose VET and d-mannose in the UTI
prevention through randomization to MH + VET + D-mannose vs continuing VET + D-mannose alone.
The primary outcome will be the proportion of patients who have symptomatic, culture-proven
UTI during a 3 month treatment period. The investigators hypothesize that women on low dose
VET, d-mannose, and MH will be less likely to have recurrent UTI than those with VET and
d-mannose alone.
This study uses a pragmatic, longitudinal approach that mimics patients' clinical experiences
and physicians' decision points during management of UTI prophylaxis. Through this
randomized, controlled pilot study, this proposal would allow the investigators to examine
the feasibility of conducting a larger-scale, adaptive study trial, and estimate the
treatment effect of a non-antibiotic regimen augmented with MH in women who continue to
develop recurrence.