School of Biological Sciences, The University of Western Australia, Crawley, WA, Australia.
Perth Urology Clinic, Murdoch, WA, Australia.
J Spinal Cord Med. 2023 Sep;46(5):830-836. doi: 10.1080/10790268.2022.2089816. Epub 2022 Jul 6.
CONTEXT/OBJECTIVE: Prevention of urinary tract infection (UTI) after spinal cord injury is an important goal. Intravesical hyaluronic acid with chondroitin sulphate (HA+CS) has been effective in preventing UTI in other settings. We aimed to demonstrate safety and feasibility of a standard treatment course of 7 intravesical HA+CS instillations over 12 weeks, in patients with acute (Arm A) and chronic (Arm B) spinal cord injury (SCI).
Follow-up of adverse events, quality of life bladder management difficulty (BMD) and bladder complication (BC) -scores at baseline (Arm B only), 12 and 24 weeks, and symptomatic urinary tract infection (UTI).
Of 33 and 14 individuals screened, 2 and 8 participants were recruited to the study for Arm A and Arm B respectively. Of the 10 participants, 8 completed all 7 instillations. HA+CS commonly caused cloudy urine with urinary sediment which was mild and short-lived. In Arm B, a mean reduction in BMD and BC T-scores was observed from baseline (57.3 and 54.4 respectively), of 6.8 and 4.3 at 12 weeks and 1.6 and 2.8 at 24 weeks, respectively. Four participants with a history of frequent UTI in the prior 12 months did not have UTI in the 24 weeks of the study.
HA+CS was well tolerated. Recruitment was more difficult in early acute SCI; participants with chronic SCI were highly motivated to reduce UTI and manage self-administration without difficulty. Larger case-control or randomized controlled trials in patients with neurogenic bladder from SCI are warranted.
ClinicalTrials.gov identifier: NCT03945110.
背景/目的:预防脊髓损伤后的尿路感染(UTI)是一个重要目标。在其他情况下,腔内透明质酸联合硫酸软骨素(HA+CS)已被证明可有效预防 UTI。我们旨在证明在急性(A 组)和慢性(B 组)脊髓损伤(SCI)患者中,7 次腔内 HA+CS 灌注 12 周的标准治疗方案的安全性和可行性。
在基线时(仅 B 组)、12 周和 24 周时,随访不良反应、生活质量膀胱管理困难(BMD)和膀胱并发症(BC)评分,并记录有症状的尿路感染(UTI)。
在筛选的 33 人和 14 人中,分别有 2 人和 8 人入组 A 组和 B 组。在 10 名参与者中,有 8 人完成了所有 7 次灌注。HA+CS 常导致尿液混浊伴短暂的轻度尿沉渣。在 B 组中,从基线开始(分别为 57.3 和 54.4),12 周时 BMD 和 BC T 评分分别降低了 6.8 和 4.3,24 周时分别降低了 1.6 和 2.8。在过去 12 个月中有频繁 UTI 病史的 4 名参与者在研究的 24 周内未发生 UTI。
HA+CS 具有良好的耐受性。在早期急性 SCI 中招募更为困难;慢性 SCI 患者有强烈的动机减少 UTI,并能轻松自我管理。需要在 SCI 引起的神经源性膀胱患者中进行更大的病例对照或随机对照试验。
ClinicalTrials.gov 标识符:NCT03945110。