Non-Antibiotic Prophylaxis for Recurrent UTIs in Neurogenic Lower Urinary Tract Dysfunction (NAPRUN): Study Protocol for a Prospective, Longitudinal Multi-Arm Observational Study.

INTRODUCTION: Patients with neurogenic lower urinary tract dysfunction (NLUTD) reliant on intermittent self-catheterization for bladder emptying are at an increased risk of recurrent urinary tract infections (rUTI). So far, the most common practice in the prevention of rUTIs is long-term low-dose antibiotic prophylaxis, phytotherapy, and immunomodulation, whereby antibiotic prophylaxis inevitably leads to the emergence of drug-resistant pathogens and difficulty in treating infections. Therefore, non-antibiotic alternatives in the prevention of rUTIs are urgently required. We aim to identify the comparative clinical effectiveness of a non-antibiotic prophylaxis regimen in the prevention of recurrent urinary tract infections in patients with neurogenic bladder dysfunction who practice intermittent self-catheterization. METHODS AND ANALYSIS: In this multi-centre, prospective longitudinal multi-arm observational study, a total of 785 patients practising intermittent self-catheterisation due to NLUTD will be included. After inclusion, non-antibiotic prophylaxis regimens will be instilled with either UroVaxom® (OM-89) standard regimen, StroVac® (bacterial lysate vaccine) standard regimen, Angocin®, D-mannose (oral dose 2 g), bladder irrigation with saline (once per day). The management protocols will be pre-defined, but the selection of the protocol will be at the clinicians' discretion. Patients will be followed for 12 months from the onset of the prophylaxis protocol. The primary outcome is to identify the incidence of breakthrough infections. The secondary outcomes are adverse events associated with the prophylaxis regimens and the severity of breakthrough infections. Other outcomes include the exploration of change in susceptibility pattern via the optional rectal and perineal swab, as well as health-related quality of life over time (HRQoL), which will be measured in a random subgroup of 30 patients. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the ethical review board of the University Medical Centre Rostock (A 2021-0238 from 28 October 2021). The results will be published in a peer-reviewed journal and presented at relevant meetings. STUDY REGISTRATION NUMBER: German Clinical Trials Register: Number DRKS00029142.

Fosfomycin trometamol and N-acetyl-L-cysteine as combined oral therapy of difficult-to-treat chronic bacterial prostatitis: Results of a pilot study.

This paper presents the results of a pilot study of difficult-to-treat patients (exhibiting several previous treatment failures or detection of extended-spectrum beta-lactamase [ESBL] strains) with chronic bacterial prostatitis (CBP) who underwent treatment with fosfomycin trometamol (FT) and N-acetyl-L-cysteine (NAC). Twenty-eight patients with clinically- and microbiologically-confirmed CBP who attended a single urological institution between January 2018 and March 2019 were treated with oral administration of 3 g FT once a day for 2 days, followed by a dose of 3 g every 48 h for 2 weeks, in combination with oral administration of NAC 600 mg once a day for 2 weeks. Clinical and microbiological analyses were carried out at the time of admission (T0) and during follow-up at 1 month (T1) and 6 months (T2) after the end of treatment. Symptoms were assessed by the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostatic Symptom Score (IPSS), and quality of life was assessed by Quality of Well-Being (QoL) questionnaires. Isolated strains were Escherichia coli (23 patients), Enterococcus spp. (3 patients), and Klebsiella oxytoca (2 patients). ESBL strain was found in 19 (67.8%) patients. Microbiological eradication was documented in 21 (75%) patients at the second follow-up visit and clinical cure was achieved in 20 (71.4%) patients. Significant changes on questionnaires were recorded between baseline and follow-up visits. Fifteen of 19 patients (78.9%) with ESBL strains were cured. No significant side effects were reported. FT in combination with NAC is a promising alternative therapy in difficult-to-treat CBP patients.

Antibiotic resistance, hospitalizations, and mortality related to prostate biopsy: first report from the Norwegian Patient Registry.

BACKGROUND: A 68-year-old man died of cerebral arterial embolism 6 days after transrectal prostate biopsy with a single p.o. dose of trimethoprim sulfamethoxazole (TMP-SMX) as prophylaxis. The case precipitated analysis of local antibiotic resistance and complication rates. MATERIALS AND METHODS: Data on E. coli resistance from Oslo University Hospital and national data on hospitalizations and mortality after biopsy were retrieved from local microbiology files and the Norwegian Patient Registry (NPR) 2011-2017. RESULTS: Urine E. coli resistance against TMP-SMX increased from 35% in 2013 to more than 60% in 2015. For ciprofloxacin, the resistance increased from 15% in 2013 to about 45% in 2016. The highest annual E. coli resistance in blood cultures for TMP-SMX and ciprofloxacin was 37% and 28%, respectively. 10% of patients were hospitalized with a diagnosis of infection within the first 60 days after biopsy and there was a relative increase in mortality rate of 261% within the first 30 days. Due to the severity of the figures, the story and the NPR data were published in Norway's leading newspaper and were succeeded by a series of chronicles and commentaries. CONCLUSIONS: Several critical points of the biopsy procedure were not performed according to current standards. We believe that the patient might have died of septic embolism after biopsy. As a result of the findings and the debate, local practice was changed from transrectal to transperineal prostate biopsies.

Long-term cost analysis of treatment options for benign prostatic hyperplasia in Norway.

OBJECTIVE: To estimate and compare the costs of dutasteride, finasteride, tamsulosin and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH) from a Norwegian health service perspective. MATERIAL AND METHODS: A Markov model was developed to estimate the clinical progression that a cohort of 1000 men would undergo and the care they would receive over 4- and 15.5-year periods. Transitions between health states [BPH symptoms, improvement in symptoms, acute urinary retention (AUR), TURP, prostate cancer and death] were estimated from the published literature and knowledge of the Norwegian healthcare system. Sensitivity analyses were conducted of indirect costs, discount rates, the costs and probabilities of AUR and TURP and the probability of symptom improvement. RESULTS: The total costs of BPH management for patients initially treated with dutasteride, finasteride, tamsulosin or TURP at 4 years were NOK 13,946 (1703 Euro), NOK 16,111 (1967 Euro), NOK 16,833 (2054 Euro) and NOK 46,309 (5655 Euro), respectively and at 15.5 years NOK 32,137 (3924 Euro), NOK 37,173 (4539 Euro), NOK 40,528 (4946 Euro) and NOK 50,471 (6164 Euro), respectively. One- and multi-way sensitivity analyses did not significantly alter the relative order of the total costs. CONCLUSIONS. Given the conservative nature of the model and the robustness of the sensitivity analysis, it is concluded that dutasteride is less costly than finasteride, TURP or tamsulosin at both 4 and 15.5 years. Therefore, considering cost containment restraints in Norway, dutasteride is an appropriate choice of therapy for patients with moderate/severe symptoms and an enlarged prostate (>30 ml).

[Radical therapy for prostate cancer in Norway]. / Radikal behandling av prostatakreft i Norge.

There is an increasing incidence of localised prostate cancer in Norway. Treatment decisions should be based on published results for treatment modalities. This paper presents an overview of Norwegian results published between 1982 and 2003. The treatment modalities used were: transurethral resection of the prostate followed by laser coagulation, radical prostatectomy, external beam radiation, cryotherapy, and brachytherapy. There were no controlled studies and no evidence that the treatment offers health benefit to the patients. The observation periods were generally very short. Frequency of complications is significant. Radical surgery is followed by 8-77% urinary incontinence, 38-96% loss of erection, and 25% other complications. External beam radiation gives 20% lower urinary tract symptoms, 51% loss of erection and 13-86% intestinal complications. For cryotherapy there is no incontinence, 74% erectile failures and 10-43% other complications.