Oxford Institute of Nursing, Midwifery and Allied Health Research (OxINMAHR), Faculty of Health & Life Sciences, Oxford Brookes University, Oxford, UK.
NSIC Research Programme Manager, National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK.
Clin Rehabil. 2020 Dec;34(12):1458-1464. doi: 10.1177/0269215520946065. Epub 2020 Aug 7.
To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction.
A parallel-group, double-blind, randomized, placebo-controlled trial.
Patients at home, recruited through out-patient contact, social media and patient support groups.
People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months.
All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months.
The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties.
Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants.
It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.
旨在建立一项随机、安慰剂对照试验，以研究特定免疫治疗细菌裂解物 OM-89（Uro-Vaxom）对减少神经源性膀胱功能障碍患者尿路感染频率的效果。
平行组、双盲、随机、安慰剂对照试验。
在家的患者，通过门诊接触、社交媒体和患者支持小组招募。
脊髓损伤、多发性硬化症、横断性脊髓炎或马尾综合征患者，在过去 12 个月内经历过三次或更多次经抗生素治疗的临床诊断尿路感染。
所有参与者每天早上口服 OM-89 免疫治疗（6mg）或匹配的安慰剂（随机化比例为 1:1），持续 3 个月。
主要结局是发生需要抗生素治疗的有症状尿路感染，在 3 个月和 6 个月时评估。可行性措施包括招募、保留和实际困难。
在 115 名筛查患者中，有 49 名被招募，1 名在随机分组前退出，23 名被分配到接受匹配安慰剂的对照组。6 名参与者，均在对照组，停止了干预；所有参与者在两次随访时均提供了完整的数据。在 6 个月内，25 名活性组患者中有 18 人发生 55 次感染，23 名对照组患者中有 18 人发生 47 次感染。大多数研究和临床程序是实用的，并且被参与者接受。
进行更大规模的试验是可行的。我们建议扩大纳入标准，以提高合格性和普遍性。
