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

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

iAluRil® intravesical instillations

About this trial

This is an interventional prevention trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

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.

Patients in this Arm will receive usual bladder care only.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Median time to first symptomatic UTI

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

Incidence of symptomatic UTI/100 patient days

Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation

Incidence of other urological complications/100 patient days

Number of other (non-UTI) urological complications per 100 days of hospitalisation

Length of hospital stay

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

Bladder-related quality of life - bladder management difficulties

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

Bladder-related quality of life - bladder complications

Validated SCI-QOL Questionnaire: 'Bladder Complications'

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

Full Information

NCT ID

NCT03945110

First Posted

May 3, 2019

Last Updated

April 30, 2021

Sponsor

The University of Western Australia

Collaborators

Royal Perth Hospital, Fiona Stanley Hospital, Perth Urology Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03945110

Brief Title

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

Official Title

Intravesical Glycosaminoglycan Instillation Following Spinal Cord Injury and Early Urinary Tract Infections; Safety and Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 18, 2019 (Actual)

Primary Completion Date

September 22, 2020 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Western Australia

Collaborators

Royal Perth Hospital, Fiona Stanley Hospital, Perth Urology Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

No Intervention

Arm Description

Patients in this Arm will receive usual bladder care only.

Arm Title

Arm C

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

iAluRil® intravesical instillations

Other Intervention Name(s)

Intravesical glycosaminoglycan (GAG) therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

10 days pos-SCI for each participant

Secondary Outcome Measure Information:

Title

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

Description

The proportion of eligible traumatic SCI patients administered iAluRil within 10 days who then completed seven iAluRil instillations as per protocol over 12 weeks

Time Frame

12 weeks (+/- 1 week) following recruitment for each participant

Title

Median time to first symptomatic UTI

Description

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

Time Frame

Date of SCI to date of hospital discharge, an average of three months

Title

Incidence of symptomatic UTI/100 patient days

Description

Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation

Time Frame

Date of SCI to date of hospital discharge, an average of three months

Title

Incidence of other urological complications/100 patient days

Description

Number of other (non-UTI) urological complications per 100 days of hospitalisation

Time Frame

Date of SCI to date of hospital discharge, an average of three months

Title

Length of hospital stay

Description

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

Time Frame

Date of SCI to date of hospital discharge, an average of three months

Title

Bladder-related quality of life - bladder management difficulties

Description

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

Time Frame

Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant

Title

Bladder-related quality of life - bladder complications

Description

Validated SCI-QOL Questionnaire: 'Bladder Complications'

Time Frame

Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant

Title

Incidence of Adverse Events

Description

Incidence of significant adverse events requiring medical intervention and/or impacting on hospital length of stay in Arm A will be described

Time Frame

During 12-week intervention period for each participant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah A Dunlop, PhD

Organizational Affiliation

The University of Western Australia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Perth Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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

Citations:

PubMed Identifier

22046200

Citation

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.

Results Reference

background

PubMed Identifier

16376493

Citation

Manas 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.

Results Reference

background

PubMed Identifier

21272992

Citation

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.

Results Reference

background

PubMed Identifier

35792831

Citation

King 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.

Results Reference

derived

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

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