Evaluation of a therapeutic vaccine for the prevention of recurrent urinary tract infections versus prophylactic treatment with antibiotics.
OBJECTIVE
Urinary tract infections (UTIs) are considered the most common bacterial infections, especially in women. The objective of this study was to evaluate the use of the sublingual bacterial vaccine Uromune® in order to prevent recurrent UTIs (RUTIs).


METHODS
This study was conceived as a multicenter observational study. The clinical history of 319 women who presented at least 2 episodes of UTI in the last 6 months or 3 in 12 months was reviewed. Data related to treatment and clinical evolution were recorded and analyzed. A total of 159 patients received prophylactic treatment with Uromune® for a period of 3 months (group A) and 160 with sulfamethoxazole/trimethoprim 200/40 mg/day for a period of 6 months (group B). Uromune® contained an inactivated bacterial cell suspension of selected strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis.


RESULTS
Patients in group A experienced a highly significant reduction in the number of infections compared to patients in group B. In the first 3 months, the mean number of infections was 0.36 versus 1.60 (P < 0.0001), respectively. A significant reduction was also observed after 9 and 15 months (P < 0.0001). The numbers of patients who did not have any UTI at 3, 9, and 15 months were 101, 90, and 55 in group A versus 9, 4, and 0 in group B (P < 0.0001).


CONCLUSIONS
The results obtained in this study favor the use of this bacterial-based therapeutic vaccine as an effective strategy to reduce frequency, duration, severity, and costs of RUTIs.
Servicio de Urología, Complejo Asistencial Universitario de Salamanca, Paseo San Vicente 58-182, Instituto de Investigación Biomédica de Salamanca, 37007, Salamanca, Spain. mflorenzogo@yahoo.es
M F
MF
Lorenzo-Gómez
B
B
Padilla-Fernández
F J
FJ
García-Criado
J A
JA
Mirón-Canelo
A
A
Gil-Vicente
A
A
Nieto-Huertos
J M
JM
Silva-Abuin
D000704:Analysis of Variance; D019072:Antibiotic Prophylaxis; D001428:Bacterial Vaccines / Q000276:immunology*; D005260:Female; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D012044:Regression Analysis; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000276:immunology* / Q000382:microbiology / Q000517:prevention & control*
D001428:Bacterial Vaccines; C581747:uromune