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

NCT03945110 | Completed Phase 1 DMC

• 1 other identifier: RA/4/20/5351
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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

  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

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

• Median time to first symptomatic UTI

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

• Incidence of symptomatic UTI/100 patient days

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

• Incidence of other urological complications/100 patient days

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

• Length of hospital stay

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

Study Arms (3)

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.

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.

Device: iAluRil® intravesical instillations

Interventions

iAluRil® intravesical instillations DEVICE

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.

Also known as: Intravesical glycosaminoglycan (GAG) therapy

Arm A; Arm C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)
• Bladder or urethral trauma
• Known history of bladder cancer or other bladder pathology

Sponsors & Collaborators

• The University of Western Australia: lead
• Royal Perth Hospital: collaborator
• Fiona Stanley Hospital: collaborator
• Perth Urology Clinic: collaborator

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (4)

• 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.

  PMID: 22046200 BACKGROUND

• 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.

  PMID: 16376493 BACKGROUND

• 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.

  PMID: 21272992 BACKGROUND

• 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.

  PMID: 35792831 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah A Dunlop, PhD

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: September 18, 2019
• Primary Completion: September 22, 2020
• Study Completion: March 18, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

AU (1)