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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03945110
Ethics application status
Date submitted
3/05/2019
Date registered
10/05/2019
Date last updated
18/03/2020

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 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.


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 - 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
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 - The proportion of eligible traumatic SCI patients administered iAluRil within 10 days who then 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 - Median time (days) between SCI and first medically diagnosed 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 - Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation
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 - Number of other (non-UTI) urological complications per 100 days of hospitalisation
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 - Number of days of initial hospitalisation (acute and subacute/rehabilitation)
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 - Validated SCI-QOL Questionnaire: 'Bladder Management Difficulties SF8a'
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 - Validated SCI-QOL Questionnaire: '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 - Incidence of significant adverse events requiring medical intervention and/or impacting on hospital length of stay in Arm A will be described
Timepoint [8] 0 0
During 12-week intervention period for each participant

Eligibility
Key inclusion criteria
- Patients hospitalised at Royal Perth Hospital (RPH) in Western Australia following first
acute traumatic SCI (with any degree of neurological impairment)
Minimum age
18 Years
Maximum age
70 Years
Gender
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

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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT03945110
Trial related presentations / publications
Damiano R, Cicione A. The role of sodium hyaluronate and sodium chondroitin sulphate in the management of bladder disease. Ther Adv Urol. 2011 Oct;3(5):223-32. doi: 10.1177/1756287211418723.
Mañas A, Glaría L, Peña C, Sotoca A, Lanzós E, Fernandez C, Rivière M. Prevention of urinary tract infections in palliative radiation for vertebral metastasis and spinal compression: a pilot study in 71 patients. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):935-40. Epub 2006 Jan 10.
Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18. Erratum in: Eur Urol. 2011 Jul;60(1):193.
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
Louise M Goodes, BAppSc(Physio)
Address 0 0
Country 0 0
Phone 0 0
+61 418 911 878
Fax 0 0
Email 0 0
louise.goodes@uwa.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03945110