Role of the bacterial vaccine Solco-Urovac® in treatment and prevention of recurrent urinary tract infections of bacterial origin.

Urinary Tract Infections (UTI) represent a serious medical problem with considerably high rate of morbidity. Recurrent episodes of urinary tract infection (rUTI) may commonly develop in the way of relapse or reinfection. For patients, rUTI is always associated with costs, discomfort and decreased quality of life. Standard treatment of rUTI is through antibiotics and usually such treatment is required repeatedly. Repeat course of antibiotics leads to increase of resistance of uropathogenic strains. According to the European Association of Urology, "the present state of microbial resistance development is alarming". Our post-marketing trial was designed to demonstrate the substantial effect of the bacterial vaccine Solco-Urovac® both with independent administration and in conjunction with standard antibacterial medication within therapy and prevention of rUTI. Total of 115 patients (men and non-pregnant women) were enrolled in our open-label post-marketing trial. Each patient had more than one year history of rUTI and in the past had already taken appropriate course of standard therapy. The trial group included 50 patients: 32 men, 18 women (average age ± 32.5). 32 patients (men) of the trial group received vaccination with Solco-Urovac® together with the standard antibacterial medication. According to bacteriologic tests, in 62% cases infection was caused by Escherichia coli, and in 38% cases by Morganella morganii, Proteus mirabilis, Klebsiella pneumoniae, Enterococcus faecalis. 18 patients within the trial group were women with no recurrence episode at the start and during the trial period. Each woman was involved as the intercourse partner of the respective man within the trial group. The women received only vaccination with Solco-Urovac®. 65 patients of the control group had more than one year history of rUTI and had been treated earlier, too. Patients of the control group received appropriate antibacterial medication without Solco-Urovac®. After therapy and follow-up examination, results in the both groups were classified, also in consideration of the pathogen-specified subgroups, and then summarized and compared respectively. During the follow-up period no case of rUTI was noticed in women. In total, analysis of the medical records of 50 patients of the trial group demonstrated no case of rUTI in 46 patients during the follow-up period. Altogether, the rate of improvement of symptoms was as follows: the trial group - 92%, the control group - 74%. Through comparison with the past medical histories of patients, the higher rate of improvement and longer absence of rUTI episodes after treatment were certainly associated with the effect of Solco-Urovac®. The results of our post-marketing trial allow recommending Solco-Urovac® for appropriate reference within the Georgian National Guideline on Urologic Infections.