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

NCT03945110 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-05-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Royal Perth Hospital

    collaborator OTHER

  • Fiona Stanley Hospital

    collaborator OTHER

  • Perth Urology Clinic

    collaborator UNKNOWN

  • The University of Western Australia

    lead OTHER

Principal Investigators

  • Sarah A Dunlop, PhD · The University of Western Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2020-09-22
Completion
2021-03-18

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945110 on ClinicalTrials.gov