Quality of life in patients with chronic prostatitis treated with elaborated polybacterial vaccine

Lorenzo-Gómez M F1, Padilla-Fernández B2, Martínez-Huélamo M3, Valverde-Martínez L S4, Hernández-Hernández D2, García-García M Á1, Perán-Teruel M5, García-Cenador M B6

Research Type


Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 250
Male Incontinence
Scientific Podium Short Oral Session 13
Wednesday 29th August 2018
16:30 - 16:37
Hall C
Male Infection, other Quality of Life (QoL) Prevention
1. Department of Urology, Complejo Hospitalario Universitario de Salamanca, Salamanca, Spain, 2. Department of Urology, Hospital Universitario de Canarias, Tenerife, Spain, 3. Primary Healthcare, Complejo Hospitalario Universitario de Salamanca, Salamanca, Spain, 4. Department of Urology, Complejo Hospitalario Universitario de Ávila, Ávila, Spain, 5. Department of Urology, Hospital Arnau de Vilanova, Valencia, Spain, 6. Department of Surgery, University of Salamanca, Salamanca, Spain

Bárbara Padilla-Fernández



Hypothesis / aims of study
Chronic prostatitis is a condition that greatly deteriorates the quality of life of patients and poses a therapeutic challenge. Following the classification suggested by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH), bacterial prostatitis, with confirmed or suspected infection, must be distinguished from chronic pelvic pain syndrome (CPPS). Enterobacteriaceae, especially E. coli, are the predominant pathogens in acute bacterial prostatitis. In chronic bacterial prostatitis, the spectrum of strains is wider (1).
The objective of this study is to know the impact on the quality of life measured through the SF-36 questionnaire in patients receiving a sublingual polybacterial vaccine due to chronic bacterial prostatitis.
Study design, materials and methods
A prospective study of 100 patients diagnosed of chronic bacterial prostatitis was conducted. Study groups: 
* Group A (n = 50): patients receiving Uromune® sublingual vaccine for 3 months plus bromazepam p.o. 1.5 mg q.d. plus extract of Serenoa repens 160 mg b.i.d.; 
* Group B (n = 50): patients receiving bromazepam p.o. 1.5 mg q.d. plus extract of Serenoa repens 160 mg b.i.d. 
In both groups, antimicrobial treatment was indicated when an episode of acute infection was diagnosed.
Evaluation variables: age, body mass index, rectal examination, clinical records, secondary diagnoses, concomitant treatments, toxic habits, time of evolution of prostatitis, number of exacerbation episodes, positive urine cultures (UC) (+), result in the HRQOL test SF-36 (0 = worst, 100 = best) in the control points (at the beginning of the treatment and in months 3, 9 and 15), follow-up mean time. Descriptive statistics, ANOVA analysis, Student's t test, Fisher's exact test were used; p <0.05 was considered significant.
Mean age for the whole sample was 45.33 years old, median 49 years ( range21-73); it was similar in Group A (42.33 years; SD 13.67) and in Group B (49.33 years; SD 11.90) (p = 0.2354). 
Mean follow-up time was 19.85 months for the whole sample, median 18 months (range 6-36); it was similar in Group A (19.92 months, SD 9.24) and in Group B (19.83 months, SD 6.01) (p = 0.9793). 
There was no difference in clinical records, secondary diagnoses, concomitant treatments, toxic habits between both groups. Table 1 shows the results of the average responses in SF-36 questionnaire at the beginning of the treatment and during the follow-up.
Interpretation of results
Chronic bacterial prostatitis is a diagnostic and therapeutic challenge in both urological and primary care settings. Although it might not carry mortality, morbidity in chronic bacterial prostatitis is high, as quality of life's affectation. This study shows the efficacy and benefit of the use of the polybacterial vaccine (Uromune ®) in this specific population. The vaccine favours immunoactive prophylaxis using a suspension of inactivated complete cells of differents strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Enterococcus faecalis (25% each). Furthermore, the avoidance of continuous antimicrobial treatment may prevent the appearance of antibiotic-resistant strains in a population that is mainly treated empirically with numerous medical and physical modalities due to the difficulty to detect a causative pathogen (1).
Concluding message
The elaborated sublingual polybacterial vaccine is associated with an improvement in the health-related quality of life in patients with chronic bacterial prostatitis. It could be interesting to include Immunoactive prophylaxis in antimicrobial stewardship programmes .
Figure 1
  1. G. Bonkat (Co-chair), R. Pickard (Co-chair), R. Bartoletti, F. Bruyère, S.E. Geerlings, F. Wagenlehner, B. Wullt Guidelines Associates: T. Cai, B. Köves, A. Pilatz, B. Pradere, R. Veeratterapillay. EAU Guidelines on Urological Infections, 2018. Available at: http://uroweb.org/guideline/urological-infections/
Funding None Clinical Trial No Subjects Human Ethics Committee IRB Complejo Hospitalario Universitario de Salamanca Helsinki Yes Informed Consent Yes
28/01/2021 09:16:43