NCT03945110

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The University of Western Australia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-18
• Primary completion: 2020-09-22
• Completion: 2021-03-18
• First posted: 2019-05-10
• Last updated: 2021-05-03

Locations

1 site across 1 country: Australia