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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03945110




Registration number
NCT03945110
Ethics application status
Date submitted
3/05/2019
Date registered
10/05/2019

Titles & IDs
Public title
Intravesical Glycosaminoglycan Instillation and Urinary Tract Infection in Acute Spinal Cord Injury
Scientific title
Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study
Secondary ID [1] 0 0
RA/4/20/5351
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iAluRil® intravesical instillations

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.

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury
Timepoint [1] 0 0
10 days pos-SCI for each participant
Secondary outcome [1] 0 0
Proportion of eligible traumatic SCI patients administered iAluRil within 10 days of SCI who completed seven iAluRil instillations as per protocol over 12 weeks
Timepoint [1] 0 0
12 weeks (+/- 1 week) following recruitment for each participant
Secondary outcome [2] 0 0
Median time to first symptomatic UTI
Timepoint [2] 0 0
Date of SCI to date of hospital discharge, an average of three months
Secondary outcome [3] 0 0
Incidence of symptomatic UTI/100 patient days
Timepoint [3] 0 0
Date of SCI to date of hospital discharge, an average of three months
Secondary outcome [4] 0 0
Incidence of other urological complications/100 patient days
Timepoint [4] 0 0
Date of SCI to date of hospital discharge, an average of three months
Secondary outcome [5] 0 0
Length of hospital stay
Timepoint [5] 0 0
Date of SCI to date of hospital discharge, an average of three months
Secondary outcome [6] 0 0
Bladder-related quality of life - bladder management difficulties
Timepoint [6] 0 0
Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
Secondary outcome [7] 0 0
Bladder-related quality of life - bladder complications
Timepoint [7] 0 0
Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
Secondary outcome [8] 0 0
Incidence of Adverse Events
Timepoint [8] 0 0
During 12-week intervention period for each participant

Eligibility
Key inclusion criteria
Arm A & B

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

Arm A & B
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

* 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 design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2021
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Fiona Stanley Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Perth Urology Clinic
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah A Dunlop, PhD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data for primary and secondary outcomes that form the basis of the final scientific paper will be made available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
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.
Available to whom?
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 [email protected]
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03945110