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

Sponsor
The University of Western Australia (Other)
Overall Status
Completed
CT.gov ID
NCT03945110
Collaborator
Royal Perth Hospital (Other), Fiona Stanley Hospital (Other), Perth Urology Clinic (Other)
10
Enrollment
1
Location
3
Arms
18
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iAluRil® intravesical instillations
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Consenting participants meeting eligibility criteria will join the intervention arm of trial; participants not meeting eligibility criteria and/or unwilling to receive intervention but consenting for data collection on bladder health measures for the study duration will join the non-intervention (standard care only) arm of trial.Consenting participants meeting eligibility criteria will join the intervention arm of trial; participants not meeting eligibility criteria and/or unwilling to receive intervention but consenting for data collection on bladder health measures for the study duration will join the non-intervention (standard care only) arm of trial.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study
Actual Study Start Date :
Sep 18, 2019
Actual Primary Completion Date :
Sep 22, 2020
Actual Study Completion Date :
Mar 18, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    2. Median time to first symptomatic UTI [Date of SCI to date of hospital discharge, an average of three months]

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

    3. Incidence of symptomatic UTI/100 patient days [Date of SCI to date of hospital discharge, an average of three months]

      Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation

    4. Incidence of other urological complications/100 patient days [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

    5. Length of hospital stay [Date of SCI to date of hospital discharge, an average of three months]

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

    6. Bladder-related quality of life - bladder management difficulties [Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant]

      Validated SCI-QOL Questionnaire: 'Bladder Management Difficulties SF8a'

    7. Bladder-related quality of life - bladder complications [Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant]

      Validated SCI-QOL Questionnaire: 'Bladder Complications'

    8. Incidence of Adverse Events [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Perth Hospital Perth Western Australia Australia 6000

    Sponsors and Collaborators

    • The University of Western Australia
    • Royal Perth Hospital
    • Fiona Stanley Hospital
    • Perth Urology Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sarah Dunlop, Coordinating Principal Investigator, The University of Western Australia
    ClinicalTrials.gov Identifier:
    NCT03945110
    Other Study ID Numbers:
    • RA/4/20/5351
    First Posted:
    May 10, 2019
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Tract Infections
    Spinal Cord Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of May 3, 2021