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

Methods and Protocols

article

Fabian P. Stangl¹  Laila Schneidewind²  Bernhard Kiss¹  Jennifer Kranz³  Florian M. Wagenlehner⁵  Truls E. Bjerklund Johansen⁶  Béla Köves⁹  Jose Medina-Polo^1,10  Ana Maria Tapia^1,11  Zafer Tandogdu^1,12 

[1] Department of Urology, University Hospital of Bern;Department of Urology, University Medical Center Rostock;Department of Urology and Paediatric Urology;Department of Urology and Kidney Transplantation, Martin Luther University;Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig-University Giessen;Institute of Clinical Medicine, University of Aarhus;Department of Urology, Oslo University Hospital;Institute of Clinical Medicine, University of Oslo;Department of Urology, University of Szeged;Department of Urology, Hospital Universitario 12 de Octubre;Department of Urology, Hospital Universitario Río Hortega;Department of Urology, University College London Hospitals

关键词: non-antibiotic prophylaxis;    urinary tract infection;    urinary tract dysfunction;    NLUTD;    self-catheterization;    Angocin;    UroVaxom;    StroVac;    bladder irrigation;    D-mannose;   

DOI  :  10.3390/mps6030052

学科分类：电力

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY