Recurrent urinary tract infections are associated with significant morbidity for patients and place a huge burden on the healthcare system. Uromune is a polyvalent bacterial whole-cell-based sublingual vaccine used as an active immunoprophylaxis for patients suffering with recurrent urinary tract infections. It is equal percentages of selected strains of four bacterial species: Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis and Proteus vulgaris. Current literature regarding the efficacy of Uromune is largely focused on the female population with a lack of studies aimed at measuring the efficacy in men. This study aims to provide the first local Australian report on the efficacy of Uromune in males with recurrent urinary tract infections.

In this single centre, retrospective, observational study conducted in an Australian health setting we included male patients diagnosed with recurrent urinary tract infections and commenced on a three month course of Uromune therapy between August 2021 and December 2024. To analyse the efficacy of Uromune we recorded the rate of urinary tract infection recurrence through a positive urine culture in patients that completed the full course of therapy at 3, 6, 12 and 18 months follow up. The secondary outcomes were to identify predisposing comorbidities and which microorganisms were most frequently isolated on urine cultures.

Forty eight patients (mean age of 57 years old) were included in the study. Two patients did not complete the course due to adverse side effects and six were lost to follow up. In the remaining cohort the urinary tract infection free rate was 62.5% (25/40) at 3 months, 50% (18/36) at 6 months, 46.2% (12/26) at 12 months and 34.6% (9/26) at 18 months. The most common microorganisms isolated in patients diagnosed with a recurrence after treatment were Escherichia coli (34.8%), Klebsiella pneumoniae (34.8%) and Pseudomonas (34.8%). Patients with a spinal cord injury had a 72.7% chance of a recurrence. Patients with a diagnosed bladder outlet obstruction (benign prostatic hyperplasia/urethral stricture) had a 40.9% chance of recurrence. All 5 of the patients with preexisting diabetes mellitus were diagnosed with a recurrence and one of the two patients immunosuppressed by medications had a recurrence.

Uromune therapy was associated with a good urinary tract infection free rate in all durations of follow up but particularly early on. Recurrence was often associated with an underlying predisposition, mostly spinal cord injury patients requiring intermittent self catheterisation or a suprapubic catheter. These findings support that Uromune therapy can be an effective option in managing recurrent urinary tract infections in men.