Spinal Cord Injuries
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiAluRil® intravesical instillations
50ml of a sterile solution of sodium hyaluronate (1.6% 800mg/50ml) and sodium chondroitin sulphate (2% - 1 g/50ml) is administered intravesically (directly into the bladder) via a pre-filled syringe connected to a catheter and held in the bladder for at least 30 minutes.
Sponsors
Royal Perth Hospital
Fiona Stanley Hospital
Perth Urology Clinic
The University of Western Australia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Consenting participants meeting eligibility criteria will join the intervention arm of trial; participants not meeting eligibility criteria and/or unwilling to receive intervention but consenting for data collection on bladder health measures for the study duration will join the non-intervention (standard care only) arm of trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Arm A & B Inclusion Criteria: \- Patients hospitalised at Royal Perth Hospital (RPH) in Western Australia following first acute traumatic SCI (with any degree of neurological impairment) Arm A & B
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median time to first symptomatic UTI | Date of SCI to date of hospital discharge, an average of three months | Median time (days) between SCI and first medically diagnosed symptomatic UTI |
| Incidence of symptomatic UTI/100 patient days | Date of SCI to date of hospital discharge, an average of three months | Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation |
| Incidence of other urological complications/100 patient days | Date of SCI to date of hospital discharge, an average of three months | Number of other (non-UTI) urological complications per 100 days of hospitalisation |
| 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 | The proportion of eligible traumatic SCI patients administered iAluRil within 10 days who then completed seven iAluRil instillations as per protocol over 12 weeks |
| Bladder-related quality of life - bladder management difficulties | Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant | Validated SCI-QOL Questionnaire: 'Bladder Management Difficulties SF8a' |
| Bladder-related quality of life - bladder complications | Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant | Validated SCI-QOL Questionnaire: 'Bladder Complications' |
| Incidence of Adverse Events | During 12-week intervention period for each participant | Incidence of significant adverse events requiring medical intervention and/or impacting on hospital length of stay in Arm A will be described |
| Length of hospital stay | Date of SCI to date of hospital discharge, an average of three months | Number of days of initial hospitalisation (acute and subacute/rehabilitation) |
Countries
Australia
Outcome results
None listed