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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945110
• Other study ID #: RA/4/20/5351
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 18, 2019
• Est. completion date: March 18, 2021

Study information

• Verified date: April 2021
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 18, 2021
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Urinary Tract Infections
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth	Western Australia

Sponsors (4)

Lead Sponsor	Collaborator
The University of Western Australia	Fiona Stanley Hospital, Perth Urology Clinic, Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 weeks (+/- 1 week) following recruitment for each participant
Secondary	Median time to first symptomatic UTI	Median time (days) between SCI and first medically diagnosed symptomatic UTI	Date of SCI to date of hospital discharge, an average of three months
Secondary	Incidence of symptomatic UTI/100 patient days	Number of medically diagnosed symptomatic UTIs per 100 days of hospitalisation	Date of SCI to date of hospital discharge, an average of three months
Secondary	Incidence of other urological complications/100 patient days	Number of other (non-UTI) urological complications per 100 days of hospitalisation	Date of SCI to date of hospital discharge, an average of three months
Secondary	Length of hospital stay	Number of days of initial hospitalisation (acute and subacute/rehabilitation)	Date of SCI to date of hospital discharge, an average of three months
Secondary	Bladder-related quality of life - bladder management difficulties	Validated SCI-QOL Questionnaire: 'Bladder Management Difficulties SF8a'	Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
Secondary	Bladder-related quality of life - bladder complications	Validated SCI-QOL Questionnaire: 'Bladder Complications'	Conducted at 12 weeks post recruitment and at 24 weeks post recruitment for each participant
Secondary	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	During 12-week intervention period for each participant