Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of administering glycosaminoglycan (GAG) therapy, iAluRil®, intravesically in individuals with acute spinal cord injury (SCI), commencing within the first ten days of injury, to prevent early urinary tract infections.
详细描述
iAluRil®, listed as a medical device on the Australian Therapeutic Goods Registry (ATGR), contains both hyaluronic acid and chondroitin sulphate. This trial utilises iAluRil® for the same clinical indication as it is listed for on the ATGR, i.e. to re-establish the glycosaminoglycan (GAG) layers of the urothelial vesical tissue in cases in which their loss can cause problems, such as recurrent urinary tract infection in neurologically intact populations, but in a specific and vulnerable patient population (acute SCI). The trial will demonstrate the safety and feasibility of providing a series of iAluRil® treatments in early acute SCI, and provide an indication of effectiveness to prevent early urinary tract infections (compared to current standard infection control), informing researchers about the suitability of conducting a large randomised controlled clinical trial with this intervention.
An 'Intervention post-UTI' arm for eligible inpatients and outpatients with SCI who have significant recurrent UTIs, will allow equivalent data collection and observations, informing researchers about a trial to reduce UTI recurrence during sub-acute/chronic SCI. Additionally, these patients will self-administer iAluRil® treatments providing data on the feasibility of SCI patients self-administering iAluRil® treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalised at Royal Perth Hospital (RPH) in Western Australia following first acute traumatic SCI (with any degree of neurological impairment)
排除标准
- •Admitted to a hospital outside of Western Australia following SCI (prior to RPH)
- •Unable to commence intervention within 10 days post-SCI
- •Bladder or urethral trauma on admission
- •Known history of bladder cancer or other bladder pathology
- •Known hypersensitivity to hyaluronic acid, sodium salt or sodium chondroitin sulphate
- •Diagnosis of a symptomatic urinary tract infection prior to commencing treatment
- •Pregnancy
- •Previous neurological disorder
- •Inability to provide own consent due to intellectual, mental or cognitive impairment
- •Arm C Inclusion Criteria:
- •Previous traumatic or non-traumatic (sudden onset) SCI
- •Experience significant, recurrent UTIs (in the opinion of the treating Spinal / Urology Consultant
- •Willing and able to partake in all study requirements
- •Emptying bladder via intermittent catheterisation (self or carer administered)
- •Arm C Exclusion Criteria:
- •Bladder or urethral trauma
- •Known history of bladder cancer or other bladder pathology
- •Known hypersensitivity to hyaluronic acid sodium salt or sodium chondroitin sulphate
- •Pregnancy
- •Previous neurological disorder
- •Inability to provide own consent due to intellectual, mental or cognitive impairment
- •Significant known history of Autonomic Dysreflexia associated with urological procedures
结局指标
主要结局
Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury
时间窗: 10 days pos-SCI for each participant
The proportion of eligible traumatic SCI patients who were urinary tract infection (UTI) free, able to provide informed consent and receive the first iAluRil instillation within 10 days of SCI
次要结局
- Length of hospital stay(Date of SCI to date of hospital discharge, an average of three months)
- Median time to first symptomatic UTI(Date of SCI to date of hospital discharge, an average of three months)
- Proportion of eligible traumatic SCI patients administered iAluRil within 10 days of SCI who completed seven iAluRil instillations as per protocol over 12 weeks(12 weeks (+/- 1 week) following recruitment for each participant)
- Incidence of symptomatic UTI/100 patient days(Date of SCI to date of hospital discharge, an average of three months)
- Incidence of other urological complications/100 patient days(Date of SCI to date of hospital discharge, an average of three months)
- Bladder-related quality of life - bladder management difficulties(Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant)
- Incidence of Adverse Events(During 12-week intervention period for each participant)
- Bladder-related quality of life - bladder complications(Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant)
研究者
Sarah Dunlop
Coordinating Principal Investigator
The University of Western Australia