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

The University of Western Australia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Device: iAluRil® intravesical instillations

Study type: Interventional

Funder types: Other

Identifiers

NCT03945110

RA/4/20/5351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Device: iAluRil® intravesical instillations

Arm B

No Intervention group

Description:

Patients in this Arm will receive usual bladder care only.

Arm C

Experimental group

Description:

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.

Treatment:

Device: iAluRil® intravesical instillations