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

The University of Western Australia10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

iAluRil® intravesical instillationsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Perth Hospital

Perth, Western Australia, Australia

Outcomes

Primary Outcomes

Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury

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

Time frame: 10 days pos-SCI for each participant

Secondary Outcomes

Proportion of eligible traumatic SCI patients administered iAluRil within 10 days of SCI who completed seven iAluRil instillations as per protocol over 12 weeks

The proportion of eligible traumatic SCI patients administered iAluRil within 10 days who then completed seven iAluRil instillations as per protocol over 12 weeks

Time frame: 12 weeks (+/- 1 week) following recruitment for each participant

Median time to first symptomatic UTI

Median time (days) between SCI and first medically diagnosed symptomatic UTI

Time frame: Date of SCI to date of hospital discharge, an average of three months

Incidence of symptomatic UTI/100 patient days

Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation

Time frame: Date of SCI to date of hospital discharge, an average of three months

Incidence of other urological complications/100 patient days

Number of other (non-UTI) urological complications per 100 days of hospitalisation

Time frame: Date of SCI to date of hospital discharge, an average of three months

Length of hospital stay

Number of days of initial hospitalisation (acute and subacute/rehabilitation)

Time frame: Date of SCI to date of hospital discharge, an average of three months

Data from ClinicalTrials.gov

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