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Actas Urol Esp. 2016 May;40(4):203-8. doi: 10.1016/j.acuro.2015.04.008. Epub 2015 Oct 24.

Oral vaccine (OM-89) in the recurrent urinary tract infection prophylaxis: a realistic systematic review with meta-analysis.

[Article in English, Spanish]

Author information

Faculty of Medicine, Center of Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, São Paulo, Brasil.
Radium Institute, Campinas, São Paulo, Brasil.
Faculty of Medicine, Center of Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, São Paulo, Brasil. Electronic address:



To evaluate the efficacy of Escherichia Coli extract (OM-89) in the prophylaxis of recurrent uncomplicated urinary tract infection (UTI) through a contemporary systematic review and meta-analysis.


Inclusion criteria were double-blind randomized trials using orally administrated OM-89, 6mg daily, during three months with a minimum of three months of monitoring. Outcomes were the frequency of bacteriuria in 3 and 6 months, dysuria in 6 months and UTI in 6 months.


PubMed, MEDLINE, Cochrane Collaboration and their key references. After analysis by three independent reviewers, 15 double-blind randomized trials were identified, 10 papers excluded due to methods flaws and 5 used for data analysis due to double blinding and reporting drop-outs.


Among 5 selected studies the date of publication ranged from 1985 to 2005, totalizing 396 patients in the OM-89 group and 392 in the control group. Overall, there were 61 dropouts in the control group and 76 in the OM-89 group. As a major limitation there was no appropriate description of their methodologies and none of the studies described conflict of interest or commitment to the pharmaceutical industry. All studies were multi-centric, except for two, which showed no clarity on allocation concealment. All studies show benefit in favor of vaccine.


Current literature on prospective randomized controlled trials evaluating the use of oral OM-89 vaccine in the recurrent UTI prophylaxis is of low quality, limited to the first six months only and with variable definition of bacteriuria and UTI. Although all studies show benefit in favor of vaccine, no robust trial was identified, resulting in a high heterogeneity in the data analyzed. Also, publication bias could not be excluded and future higher quality studies are warranted adding intermediate (>12 months) and long-term follow-up.


Active immunization; Bacterial vaccines; Cistitis; Cystitis; Disuria; Dysuria; Escherichia coli; Infección del tracto urinario; Inmunización activa; Urinary tract infection; Vacunas bacterianas

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