Active immunoprophyilaxis with uromune® decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects

Abstract

Background: To prospectively analyze the efficacy of uromune® in the prevention of uncomplicated recurrent urinary tract infections at 3 and 6 months, and according to gender and menopause.

Methods: From September 2011 to December 2017 uromune® was administered sublingually every 24 h along 3 months to 784 patients with history of three or more uncomplicated urinary tract infections in the 12 months prior to the first visit. The variables analyzed with statistical package system for science version 15.0 were age, gender, number of urinary tract infections with positive urine culture in the first consultation, and 3 and 6 months after the end of treatment. The results with positive urine culture were registered at 3 and 6 months after the end of the treatment according to gender and also in the menopausal group with respect to pre-menopausal women.

Results: Mean age was 73.5 years. 82.7% were women and 94.3% menopausal. The number of episodes of urinary tract infections in the 12 months prior to uromune® were 3 in 37.2%, 4 in 28.1%, 5 in 19.5%, 6 in 9.6%, 7 in 4%, 8 in 1.4%, 9 in 0.1% and 10 in 0.1%. Three months after uromune® 44.1% had 0 urinary tract infections and 27.6% had 1. After 6 months the results were 0 urinary tract infections in 32.3% and 1 in 32.4%. Women had 0 urinary tract infections after 3 months in 45.4% and 1 in 28.5%. At 6 months the female had 0 episodes in 32.7% and 1 in 33.2%. Menopausal women had 0 urinary tract infections at 3 months in 46.5% and 1 in 28% and at 6 months scored 0 episodes in 33.6% and 1 in 32.9%.

Conclusions: Uromune® was highly effective to reduce the number of episodes of urinary tract infections at three and six months of follow-up. Uromune® reduced the number of episodes to zero or one in 71.7 and 64.7% at three and six months with minimal side effects. The best results were observed in women over 50 years old. Sublingual immunoprophylaxis with uromune® could be the treatment of first choice in the prevention of uncomplicated recurrent urinary tract infections according to the sample analyzed.

Keywords: Bacterial vaccine; Prevention; Urinary tract infection.

Conflict of interest statement

The need for ethics approval was deemed unnecessary according to national and european regulations. The 2019 European Association of Urology Guidelines recommend strongly the use of immunoactive prophylaxis to reduce recurrent UTI in all age groups, and also recommend the use of continuous or post-coital antimicrobial prophylaxis to prevent recurrent UTI when non-antimicrobial interventions like inmunoactive prophylaxis have failed.

This is the summary of evidence and recommendations for the diagnosis evaluation and treatment or recurrent UTI of the 2019 European Association of Urology Guidelines:

This article has been not submitted to a committee of ethics because the study was only descriptive. Only a collection and analysis of patient data was done without influencing the treatment decision or the evolution of the disease and without disclosing patient data.

The treatment with uromune® is an authorized treatment in Spain since October 2010.

The authors of this study declare no conflicts of interest.

The consent to participate was verbal because uromune® is an option to prevent urinary tract infections authorized in Spain since October 2010 by the National Drug Agency.

The authors declare that they have no competing interests.

Figures

Fig. 1

Distribution of the UTI number in the first visit

Fig. 2

UTI results three and six months after treatment with uromune®

Fig. 3

Results with zero or one UTI according to sex

Fig. 4

Results with zero or one UTI according to menopause