Please use this identifier to cite or link to this item: http://dx.doi.org/10.25673/109565
Title: Non-antibiotic prophylaxis for recurrent UTIs in neurogenic lower urinary tract dysfunction (NAPRUN) : study protocol for a prospective, longitudinal multi-arm observational study
Author(s): Stangl, Fabian P.
Schneidewind, LailaLook up in the Integrated Authority File of the German National Library
Kiss, Bernhard
Kranz, JenniferLook up in the Integrated Authority File of the German National Library
Wagenlehner, FlorianLook up in the Integrated Authority File of the German National Library
Bjerklund Johansen, Truls E.
Köves, BélaLook up in the Integrated Authority File of the German National Library
Medina-Polo, Jose
Tapia, Ana Maria
Tandogdu, Zafer
Issue Date: 2023
Type: Article
Language: English
Abstract: 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.
URI: https://opendata.uni-halle.de//handle/1981185920/111520
http://dx.doi.org/10.25673/109565
Open Access: Open access publication
License: (CC BY 4.0) Creative Commons Attribution 4.0(CC BY 4.0) Creative Commons Attribution 4.0
Journal Title: Methods and protocols
Publisher: MDPI
Publisher Place: Basel
Volume: 6
Issue: 3
Original Publication: 10.3390/mps6030052
Page Start: 1
Page End: 9
Appears in Collections:Open Access Publikationen der MLU

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