A Retrospective Study of Immunotherapy Treatment with Uro-Vaxom (OM-89®) for Prophylaxis of Recurrent Urinary Tract Infections

Abstract

<b><i>Objectives</i></b>: To present our experience with the long-term preventive effect of immunotherapy with Uro-Vaxom® on recurrent urinary tract infections (UTI) in adult patients. <b><i>Materials and Methods</i></b>: Retrospective analysis of 79 patients with recurrent UTI treated with Uro-Vaxom. Recurrent UTIs were defined as ≥ 2 infections in 6 months or ≥ 3 in 12 months. Patients received a 6 mg Uro-Vaxom capsule daily for 90 days followed by discontinuation for 3 months and then administration for the first 10 days of subsequent months 7, 8 and 9 as a ‘booster' regime. The primary outcome measure was the number of UTIs encountered in the 12 months pre-treatment compared to 12 months post-treatment. <b><i>Results</i></b>: There was a significant decrease in the mean number of UTIs in the year following initiation of Uro-Vaxom® compared to the year preceding administration 3.14 versus 1.53 (p < 0.05) respectively. <b><i>Conclusion</i></b>: Uro-Vaxom represents a safe and effective treatment option for prophylaxis of recurrent UTIs. In the UK, Uro-Vaxom is currently unlicensed. This study adds to a growing body of evidence in favor of non-antibiotic immune-prophylaxis for recurrent UTI.

Urinary tract infection in women

“…Typical symptoms will still indicate the need for treatment. In the absence of abnormal vaginal discharge and burning sensation in the vulvar vestibule, typical UTI symptoms lead to infection confirmation in as many as 90% of young women [ 10 , 11 ]. In 15% of cases, urine cultures are positive in spite of elevated leukocyte count in the urinalysis [ 3 ].…”

“…OM-89 is an immunomodulatory drug [ 11 , 36 ]. It is effective against Escherichia coli infections, constituting 70–80% of all urinary tract infections.…”

“…In a multi-centre double blind study involving 453 women, a 34% reduction of urinary tract infections was observed after 3 months of initial treatment and a 10-day boos-ter course of OM-89 [ 30 ]. The same treatment structure was utilized in a retrospective study of 79 patients, with Escherichia coli identified as the main pathogen in 49% of the population [ 11 ]. Sixty-three per cent of those infected with Escherichia coli and 53% of the whole population had a positive response to treatment.…”

Prospective Study in Children with Complicated Urinary Tract Infection Treated with Autologous Bacterial Lysates

“…Due to the ineffective and even counterproductive prophylactic use of antimicrobials for the treatment and control of rUTI, as is the case for the patients herein analyzed, the need for a safe, effective, and acceptable alternative therapy has been proposed. The use of probiotics and other compounds such as cranberry juice has been proposed for this purpose and commercial immunostimulants such as Urovaxom ® have been designed to eliminate bacteriuria in adult patients with rUTI [ 2 , 25 , 49 , 50 , 51 , 52 ]. However, these types of immunogens are manufactured with bacteria that are different from the ones causing UTI in other parts of the world, a key aspect as we show in this study.…”

Strategies to Tackle Antimicrobial Resistance: The Example of Escherichia coli and Pseudomonas aeruginosa

“…Different vaccines are under development or available to prevent recurrent UTIs that base their action on surface antigens or whole inactivated bacteria [ 99 ]. Uro-Vaxom is an oral vaccine, licensed in over 30 countries, which is composed of bacterial crude extracts from eighteen UPEC strains and has been shown in several randomized placebo controlled trials to reduce the frequency of UTI recurrence [ 100 , 101 , 102 , 103 , 104 , 105 ]. Urovac is a vaginal mucosal multivalent vaccine made up of whole inactivated bacteria including six strains of heat inactivated UPEC along with four other strains of uropathogenic bacteria [ 106 , 107 ].…”