Stangl Fabian P, Schneidewind Laila, Kiss Bernhard, Kranz Jennifer, Wagenlehner Florian M, Johansen Truls E Bjerklund, Köves Béla, Medina-Polo Jose, Tapia Ana Maria, Tandogdu Zafer
Department of Urology, University Hospital of Bern, 3010 Bern, Switzerland.
Department of Urology, University Medical Center Rostock, 18055 Rostock, Germany.
Methods Protoc. 2023 May 24;6(3):52. doi: 10.3390/mps6030052.
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.
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.
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.
German Clinical Trials Register: Number DRKS00029142.
依赖间歇性自我导尿来排空膀胱的神经源性下尿路功能障碍（NLUTD）患者反复发生尿路感染（rUTI）的风险增加。到目前为止，预防rUTI最常见的做法是长期低剂量抗生素预防、植物疗法和免疫调节，然而抗生素预防不可避免地会导致耐药病原体的出现以及感染治疗困难。因此，迫切需要预防rUTI的非抗生素替代方法。我们旨在确定一种非抗生素预防方案在预防进行间歇性自我导尿的神经源性膀胱功能障碍患者反复尿路感染方面的相对临床疗效。
在这项多中心、前瞻性纵向多臂观察性研究中，将纳入总共785例因NLUTD进行间歇性自我导尿的患者。纳入后，将采用以下非抗生素预防方案：UroVaxom（OM - 89）标准方案、StroVac（细菌溶解产物疫苗）标准方案、安哥辛、D - 甘露糖（口服剂量2 g）、生理盐水膀胱冲洗（每天一次）。管理方案将预先确定，但方案的选择由临床医生自行决定。从预防方案开始实施起，对患者进行12个月的随访。主要结局是确定突破性感染的发生率。次要结局是与预防方案相关的不良事件以及突破性感染的严重程度。其他结局包括通过可选的直肠和会阴拭子探索药敏模式的变化，以及随时间推移的健康相关生活质量（HRQoL），这将在30例患者的随机子组中进行测量。
本研究已获得罗斯托克大学医学中心伦理审查委员会的伦理批准（2021年10月28日的A 2021 - 0238）。研究结果将发表在同行评审期刊上，并在相关会议上展示。
德国临床试验注册中心：编号DRKS00029142。
