Could sublingual vaccination be a viable option for the prevention of recurrent urinary tract infection in Canada? A systematic review of the current literature and plans for the future.

Introduction: We conducted a systematic review to examine the role of a novel sublingual vaccine – Uromune – for prevention of recurrent urinary tract infection (rUTI) to understand its potential role for Canadian women suffering from rUTI. Methods: Databases were searched for studies published from 2010– 2020 that investigated use of Uromune in the management of rUTI. Only original clinical studies that included use of Uromune as prophylaxis for uncomplicated rUTI in women that included UTI-free rate following initiation of vaccine as an outcome were included. Results: Of 73 publications related to Uromune and UTIs, 19 unique clinical studies were identified evaluating Uromune for prevention of rUTI. Five studies met our inclusion criteria for primary review. These included 1408 women treated with Uromune. In two retrospective comparative studies, subjects treated with Uromune daily for three months (519 women in total) had significantly higher UTI-free rates (35–90%) than subjects treated with six months of antibiotic prophylaxis (0% in 499 women in total) over 15 months (p<0.001 for both studies). In three prospective, uncontrolled studies, UTI-free rates for subjects treated with Uromune ranged from 33–78% over 9–24 months. No major safety issues were identified in these trials. Additional unique studies evaluating Uromune for rUTI that did not meet our criteria added consistent confirmation of the potential effectiveness and safety of Uromune to prevent rUTI. Conclusions: Although these findings require confirmation in currently active, prospective clinical studies, including a randomized placebo-controlled trial, Uromune may be an alternative to antibiotics to prevent rUTI in Canadian women.