This study was prospective, descriptive and not comparative. The inclusion of patients was performed consecutively in an Excel database.
During a 74-month period, from September 2011 to December 2017, uromune® was administered to a total of 784 patients from two hospital centers, all with a history of three or more uncomplicated UTI in the 12 months prior to their first visit. Six hundred nineteen patients were from Mataró Hospital and 165 from Moisés Broggi Hospital in Sant Joan Despí, both centers belonging to the province of Barcelona, Spain.
Uromune® was administered sublingually in the form of a spray, with two pumps following fasting and at a temperature not higher than 24 degrees Celsius, every 24 h for a continuous period of 3 months. The treatment was only interrupted in those episodes of a fever over 38 degrees Celsius of any origin, restarting it once the febrile episode was resolved.
Each pump of uromune® was equivalent to a suspension of 10 to the 9 inactive whole bacteria / ml, with an equal percentage for the four strains of the four most common pathogens causing UTI in Spain: Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus faecalis. The content was left under the tongue for 1 min, without the patient swallowing saliva for better absorption [8].
All patients initially underwent detailed anamnesis and an abdominal and genital physical examination blood analysis, urine culture and reno-vesical ultrasound in women and reno-vesico-prostatic ultrasound in men were performed. In cases of suspected complicated UTI, a urethrocystoscopy, urinary cytology, abdominal CT, uroflowmetry and urodynamics were also performed.
We defined causes of exclusion of the study the presence of neurogenic bladder, symptomatic urinary lithiasis, ureteral catheter or nephrostomy, moderate-severe urinary incontinence defined as the presence of three or more one-hour pad test equal to or greater than 50 cc, benign hyperplasia of prostate (BPH) in progression defined as patients with IPSS greater than 15 despite medical treatment combined with alpha-blockers and inhibitors of 5-phosphodiesterase, BPH and cystocele with postvoid residual greater than 100 ml and patients with Bricker urinary diversion, neobladder and cutaneous urostomy.
The variables analyzed were age, gender, and the number of UTI with positive urine culture in the first consultation and 3 and 6 months after the end of treatment.
The results were compared with positive urine culture 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. The pre-menopause was defined in this study as women under 50 years of age, and menopause as women of age equal to or greater than 50 years old.
It is a prospective study started in September 2011 and six urologists have participated. All the patients came from urban areas and were selected consecutively until December of 2017, taking into account that all had had three or more episodes of uncomplicated UTI in the 12 months prior to the start of treatment with uromune®, and taking into account as well the exclusion criteria mentioned before.
The variables studied were recorded in an Excel database and subsequently exported to carry out the process of the data to the SPSS system (Statistical Package for the Social Sciences) version 15.0, which is a statistical analysis software through syntax and processes.
From the sample of the study, the metric data was obtained for the quantitative variables that allowed the calculation of the statistical indexes, and the non-metric data for the categorical variables.
The qualitative variables were measured as number and proportion. The quantitative variables were expressed by the mean and median central tendency statistics, and by the statistics of standard deviation and range dispersion. To compare proportions, the Chi-square test was used with the Fisher modification when necessary. The comparison between quantitative variables was performed using the Student’s t test.
In all patients included in the sample of this study, uromune® was used as the first choice in the prophylaxis of uncomplicated recurrent UTI. We defined a favorable or effective response to the existence of zero or one episode of UTI at 3 and 6 months after finishing treatment with uromune®.
The side effects of uromune® therapy were local and rare. There were registered 8 patients with dry mouth, 4 with gastritis and 3 with sickness. The duration was less than 7 days except in 2 cases of dry mouth that lasted 15 days. Three patients discontinued the treatment for 10 days due to fever secondary a respiratory infection and subsequently continued the therapy. No secondary effects were grounds for abandonment of treatment.