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

NCT ID: NCT03945110

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2021-03-18

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iAluRil® intravesical instillations

Intervention Type: 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.

Arm B

Patients in this Arm will receive usual bladder care only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

iAluRil® intravesical instillations

Intervention Type: 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.

Interventions

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 Type: DEVICE

Other Intervention Names

Intravesical glycosaminoglycan (GAG) therapy

Eligibility Criteria

Inclusion Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Perth Hospital

OTHER

Sponsor Role: collaborator

Fiona Stanley Hospital

OTHER

Sponsor Role: collaborator

Perth Urology Clinic

UNKNOWN

Sponsor Role: collaborator

The University of Western Australia

OTHER

Sponsor Role: lead

Responsible Party

Sarah Dunlop

Coordinating Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah A Dunlop, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

Royal Perth Hospital

Perth, Western Australia, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 22046200 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16376493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21272992 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35792831 (View on PubMed)

Other Identifiers

RA/4/20/5351

Identifier Type: -

Identifier Source: org_study_id