Spinal Cord InjuriesPhase 1/2NCT03945110
Intravesical Glycosaminoglycan Instillation and Urinary Tract Infection in Acute Spinal Cord Injury
A Phase 1/2 study testing iAluRil® intravesical instillations in people with Spinal Cord Injuries, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- iAluRil® intravesical instillations
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Sep 2019to 18 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- iAluRil® intravesical instillations
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iAluRil® intravesical instillationsDevice
Also called Intravesical glycosaminoglycan (GAG) therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Device: iAluRil® intravesical instillations |
| Arm B | No intervention | Patients in this Arm will receive usual bladder care only. |
| Arm C | Experimental | 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. Receives: Device: iAluRil® intravesical instillations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days pos-SCI for each participant
Secondary outcomes (8)
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
Measured: 12 weeks (+/- 1 week) following recruitment for each participant
Median time to first symptomatic UTI
Median time (days) between SCI and first medically diagnosed symptomatic UTI
Measured: Date of SCI to date of hospital discharge, an average of three months
Incidence of symptomatic UTI/100 patient days
Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation
Measured: Date of SCI to date of hospital discharge, an average of three months
Incidence of other urological complications/100 patient days
Number of other (non-UTI) urological complications per 100 days of hospitalisation
Measured: Date of SCI to date of hospital discharge, an average of three months
Length of hospital stay
Number of days of initial hospitalisation (acute and subacute/rehabilitation)
Measured: Date of SCI to date of hospital discharge, an average of three months
Bladder-related quality of life - bladder management difficulties
Validated SCI-QOL Questionnaire: 'Bladder Management Difficulties SF8a'
Measured: Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
Bladder-related quality of life - bladder complications
Validated SCI-QOL Questionnaire: 'Bladder Complications'
Measured: Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
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
Measured: During 12-week intervention period for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start18 Sep 2019
- Primary completion22 Sep 2020
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital, Fiona Stanley Hospital, Perth Urology Clinic
- Responsible party
- Principal investigator, Sarah Dunlop, The University of Western Australia
- Investigators
- Sarah A Dunlop, PhD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945110
- Sponsor's protocol ID
- RA/4/20/5351
- Status last verified
- Apr 2021
- First submitted
- 3 May 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for primary and secondary outcomes that form the basis of the final scientific paper will be made available.
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.
PubMed 22046200Manas A, Glaria L, Pena C, Sotoca A, Lanzos E, Fernandez C, Riviere 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. doi: 10.1016/j.ijrobp.2005.09.016. Epub 2006 Jan 10.
PubMed 16376493Damiano 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.
PubMed 21272992King GK, Goodes LM, Hartshorn C, Thavaseelan J, Jonescu S, Watts A, Rawlins M, Woodland P, Synnott EL, Barrett T, Hayne D, Boan P, Dunlop SA. Intravesical hyaluronic acid with chondroitin sulphate to prevent urinary tract infection after spinal cord injury. J Spinal Cord Med. 2023 Sep;46(5):830-836. doi: 10.1080/10790268.2022.2089816. Epub 2022 Jul 6.
PubMed 35792831
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03945110
- Acronym / sponsor ID
- RA/4/20/5351
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Royal Perth Hospital, Fiona Stanley Hospital, Perth Urology Clinic
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: iAluRil® intravesical instillationsPatients 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. |
| Arm B | No intervention | –Patients in this Arm will receive usual bladder care only. |
| Arm C | Experimental | Device: iAluRil® intravesical instillationsPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iAluRil® intravesical instillationsAlso: Intravesical glycosaminoglycan (GAG) therapy50ml 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. | Device | Arm A, Arm C |
Primary outcome
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
8 secondary outcomes
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
Median time to first symptomatic UTI
Time frame: 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
Incidence of other urological complications/100 patient days
Time frame: 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
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
Bladder-related quality of life - bladder complications
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 22046200Damiano 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.
- Background: PubMed 16376493Manas A, Glaria L, Pena C, Sotoca A, Lanzos E, Fernandez C, Riviere 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. doi: 10.1016/j.ijrobp.2005.09.016. Epub 2006 Jan 10.
- Background: PubMed 21272992Damiano 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.
- Derived from this study: PubMed 35792831King GK, Goodes LM, Hartshorn C, Thavaseelan J, Jonescu S, Watts A, Rawlins M, Woodland P, Synnott EL, Barrett T, Hayne D, Boan P, Dunlop SA. Intravesical hyaluronic acid with chondroitin sulphate to prevent urinary tract infection after spinal cord injury. J Spinal Cord Med. 2023 Sep;46(5):830-836. doi: 10.1080/10790268.2022.2089816. Epub 2022 Jul 6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for primary and secondary outcomes that form the basis of the final scientific paper will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Dunlop, PhD principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iAluRil® intravesical instillations in people with Spinal Cord Injuries, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible traumatic SCI patients who start iAluRil within 10 days post injury (time frame: 10 days pos-SCI for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945110, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.