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