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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945110
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Royal Perth Hospital
Fiona Stanley Hospital
Perth Urology Clinic
Information provided by (Responsible Party):
Sarah Dunlop, The University of Western Australia

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
Spinal Cord Injuries 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 patients with SCI who could not be enrolled within 10 days of injury, and have significant recurrent UTIs during their inpatient admission, will allow equivalent data collection and observations, informing researchers about a trial to reduce UTI recurrence during sub-acute/chronic SCI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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.
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 : September 18, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 recruited during the sub-acute inpatient rehabilitation phase if eligible for inclusion and in the event of 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.
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 Name: Intravesical glycosaminoglycan (GAG) therapy




Primary Outcome Measures :
  1. 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


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 [ 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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'

  7. 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'

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients hospitalised at Royal Perth Hospital (RPH) in Western Australia following first acute traumatic SCI (with any degree of neurological impairment)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945110


Contacts
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Contact: Louise M Goodes, BAppSc(Physio) +61 418 911 878 louise.goodes@uwa.edu.au
Contact: Gabby Simpson, BSc(Nurs) +61 499 888 448 gabby.simpson@uwa.edu.au

Locations
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Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Sheryl Jonescu, Nursing    +61 8 9224 2244 ext 3752    sheryl.jonescu@health.wa.gov.au   
Sponsors and Collaborators
The University of Western Australia
Royal Perth Hospital
Fiona Stanley Hospital
Perth Urology Clinic
Investigators
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Principal Investigator: Sarah A Dunlop, PhD The University of Western Australia
Publications:
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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    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Spinal Cord Injuries
Wounds and Injuries
Infection
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Urologic Diseases