• Proportion of eligible traumatic SCI patients administered iAluRil within 10 days of SCI who completed seven iAluRil instillations as per protocol over 12 weeks [ Time Frame: 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
• Median time to first symptomatic UTI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
• Length of hospital stay [ Time Frame: Date of SCI to date of hospital discharge, an average of three months ]
  Number of days of initial hospitalisation (acute and subacute/rehabilitation)
• Bladder-related quality of life - bladder management difficulties [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

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.

• Experimental: Arm A
  Patients in this Arm will receive a series of seven iAluRil® intravesical instillations over a 12-week period as follows: Once per week for 4 weeks; then once every two weeks for 4 weeks; then once 4 weeks later.
  Intervention: Device: iAluRil® intravesical instillations
• No Intervention: Arm B
  Patients in this Arm will receive usual bladder care only.
• Experimental: Arm C
  Patients in this Arm will be Spinal Urology Outpatients or Inpatients who are eligible for inclusion and experiencing significant urinary tract infection recurrence and/or complications. Patients will receive a series of seven iAluRil® intravesical instillations over a 12-week period as follows: Once per week for 4 weeks; then once every two weeks for 4 weeks; then once 4 weeks later. Patients will be encouraged and supervised to self-administer iAluRil® intravesical instillations.
  Intervention: Device: iAluRil® intravesical instillations

• Damiano R, Cicione A. The role of sodium hyaluronate and sodium chondroitin sulphate in the management of bladder disease. Ther Adv Urol. 2011 Oct;3(5):223-32. doi: 10.1177/1756287211418723.
• Mañas A, Glaría L, Peña C, Sotoca A, Lanzós E, Fernandez C, Rivière M. Prevention of urinary tract infections in palliative radiation for vertebral metastasis and spinal compression: a pilot study in 71 patients. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):935-40. Epub 2006 Jan 10.
• Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18. Erratum in: Eur Urol. 2011 Jul;60(1):193.

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 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

• Royal Perth Hospital
• Fiona Stanley Hospital
• Perth Urology Clinic