Intravesical Glycosaminoglycan Instillation and Urinary Tract Infection in Acute Spinal Cord Injury

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.

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.

Eligibility 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 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