Discussion
StroVac reduced rUTI, urinary tract infections, fever, rUTI, UTIs
RECURRENCE, URINARY TRACT INFECTIONS, PERTUSSIS, FLU-LIKE ILLNESS, UTI, HEAT
Due to the emerging possibilities in non-antibiotic prophylaxis and a growing body of evidence proving their efficacy [Since the aim of the study was to prove the efficacy of StroVac in prophylaxis of rUTI, one has to state, that our study showed no significant advantage of StroVac over the placebo we used. We even saw a longer time till first recurrence and a higher rate of women with no UTI in the placebo group, even though not reaching statistical significance. But in spite of the failed statistical significance, StroVac reduced rUTI in patients with at least 5 UTI per year prior to prophylaxis to 1.0 UTI during follow up of 12 months. Overall, 71.7% of StroVac patients had only one or no UTI in the 12 months following the prophylactic injections.These results are in accordance with the existing literature. In the largest non-interventional trial on StroVac published until today with over 1200 patients, the authors found a reduction from 3.5 UTIs in 6 months before to 0.6 UTIs in the 6 months following therapy [When looking at other non-antibiotic prophylaxis regimens, similar results are described. Though, Wagenlehner et al. [This placebo-controlled study confirmed that vaccination with StroVac leads to the expected effect in reducing rUTI frequency clinically relevantly but not statistically significantly better than placebo. The flaw in our study was the placebo preparation we used. Because the placebo achieved a 1.5 times higher effect than was expected, the preparation utilized in our study was further investigated for possible beneficial qualities. Indeed, the analysis revealed an antibacterial effect of the placebo itself [Furthermore, the question remains, which definition of rUTI should be used in future studies. Since the study was conducted mainly in Germany, we used the definition provided by the German guidelines for recurrent uncomplicated urinary tract infections as established in 2010 [Lastly, since using heat activated bacterial strains, it is worth mentioning that we had only mild rates of reactions such as fever and flu-like illness, but despite the rate of 62.2% of AE in the StroVac group, 88.6% of the patients assessed the tolerability of StroVac as “very good” and “good”. This shows good tolerability and acceptance of the vaccine in patients. Even though comparable vaccines like whole cell pertussis vaccine showed high rates of AE, tolerability and safety in our study is supported by large studies on StroVac in Germany showing similar results [Nevertheless, the obvious remaining limitation of our study is the failure to show a statistically significant superiority over the placebo effect. On the other hand, we believe that our work was a well-designed randomized and double-blinded trial with a large and well-balanced patient cohort. Thus, we consider our study an important contribution to research on non-antibiotic prophylaxis of rUTI providing confirmation of the clinically relevant prophylactic effects of StroVac in rUTI.