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

April 30, 2021 updated by: Sarah Dunlop, The University of Western Australia

Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: iAluRil® intravesical instillations
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.
Other Names:
  • Intravesical glycosaminoglycan (GAG) therapy
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.
Device: iAluRil® intravesical instillations
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.
Other Names:
  • Intravesical glycosaminoglycan (GAG) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury
Time Frame: 10 days pos-SCI for each participant
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
10 days pos-SCI for each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks (+/- 1 week) following recruitment for each participant
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
Date of SCI to date of hospital discharge, an average of three months
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
Date of SCI to date of hospital discharge, an average of three months
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
Date of SCI to date of hospital discharge, an average of three months
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)
Date of SCI to date of hospital discharge, an average of three months
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'
Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
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'
Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
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
During 12-week intervention period for each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Western Australia

Collaborators

Royal Perth Hospital
Fiona Stanley Hospital
Perth Urology Clinic

Investigators

  • Principal Investigator: Sarah A Dunlop, PhD, The University of Western Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Actual)

September 22, 2020

Study Completion (Actual)

March 18, 2021

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA/4/20/5351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for primary and secondary outcomes that form the basis of the final scientific paper will be made available.

IPD Sharing Time Frame

Data will be made available upon request immediately following publication and indefinitely thereafter via a link to the relevant section of The University of Western Australia's research repository.

IPD Sharing Access Criteria

Data will be available upon request to Researchers providing a methodologically sound research proposal, for the purpose of achieving the aims in this proposal. Proposals should be directed to sarah.dunlop@uwa.edu.au

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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