title: Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections.
abstract: OBJECTIVE
  To compare the clinical impact of a prophylactic treatment with sublingual immunostimulation in the prevention of recurrent urinary tract infections (rUTIs) with the use of antibiotics.
  
  
  METHODS
  Retrospective cohort study evaluating the medical records of 669 women with rUTIs; 339 had a 6-month prophylaxis with antibiotics and 360 a 3-month prophylaxis with a sublingual bacterial preparation (MV 140-Uromune®). The time frame after the prophylaxis-period until the appearance of a new infection (assessed by uroculture) was scored and followed during 1 year. The absolute risk reduction (ARR) and number needed to treat (NNT) were also calculated.
  
  
  RESULTS
  All patients treated with antibiotics experienced a new UTI during the scoring period of 12 months, being 19 days the median number of days free of UTIs (range 5-300). In the group treated with the bacterial preparation, 35 (9.7%) patients experienced an UTI in the same period. Kaplan-Meier curves comparing the accumulated survival (disease-free time) between both groups were significant different (P < 0.0001). The absolute risk reduction (ARR) was 90.28% (87.18-93.38) and the number needed to treat (NNT) 1.1 (1.1-1.1).
  
  
  CONCLUSIONS
  These results suggest that the treatment with this bacterial preparation significantly reduces the incidence of rUTIs, arising as an effective strategy to reduce the frequency of rUTIs. It reduces antibiotic consumption, matching the current recommendations due to the raise of antimicrobial resistance. Randomized, double-blind and placebo-controlled, clinical trials are needed to establish, more accurately, the clinical impact of this bacterial preparation in patients with rUTIs.
authors.affiliation: IBSAL Salamanca Biomedical Research Institute Salamanca, Spain ; Department of Surgery, University of Salamanca Salamanca, Spain ; Department of Urology, University Health Complex of Salamanca Salamanca, Spain.
authors.forename: María F
authors.initials: MF
authors.lastname: Lorenzo-Gómez
authors.affiliation: Department of Urology, University Hospital of the Canary Islands' Complex Tenerife, Spain.
authors.forename: Bárbara
authors.initials: B
authors.lastname: Padilla-Fernández
authors.affiliation: Department of Urology, University Health Complex of Salamanca Salamanca, Spain.
authors.forename: María B
authors.initials: MB
authors.lastname: García-Cenador
authors.affiliation: Department of Surgery, University of Salamanca Salamanca, Spain ; Department of Urology, University Health Complex of Salamanca Salamanca, Spain.
authors.forename: Álvaro J
authors.initials: ÁJ
authors.lastname: Virseda-Rodríguez
authors.affiliation: Primary Care Centre "Universidad Centro" Salamanca, Spain.
authors.forename: Isidoro
authors.initials: I
authors.lastname: Martín-García
authors.affiliation: Primary Care Centre "Peñaranda" Salamanca, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Sánchez-Escudero
authors.affiliation: Primary Care Centre "Capuchinos" Salamanca, Spain.
authors.forename: Manuel J
authors.initials: MJ
authors.lastname: Vicente-Arroyo
authors.affiliation: Department of Preventive Medicine and Public Health, University of Salamanca Salamanca, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Mirón-Canelo
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D018890:Chemoprevention / Q000379:methods*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000517:prevention & control*; D014612:Vaccines / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D014612:Vaccines
keywords: Uromune (MV 140); bacterial vaccine; recurrent urinary infections