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Clinical Trials/ACTRN12621001587897
ACTRN12621001587897
Recruiting
Phase 3

A double-blinded randomised controlled trial to assess the effect of intravesical gentamicin instillation during Urodynamics to on the rate of post procedure urinary tract infections in spinal cord injured patients

orth Sydney Local Health District0 sites200 target enrollmentNovember 19, 2021

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
rinary Tract Infection
Sponsor
orth Sydney Local Health District
Enrollment
200
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 19, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orth Sydney Local Health District

Eligibility Criteria

Inclusion Criteria

  • Confirmed Spinal Cord Injury
  • \- Undergoing Urodynamic Assessment through either Royal North Shore Hospital or Prince of Wales Hospital
  • \- Sterile pre\-procedure urine or urine deemed suitable to proceed based on the UDS protocol of the hospital

Exclusion Criteria

  • \- Cannot consent to participate in the study
  • \- Age \< 18
  • \- Pregnant
  • \- Patients with colonised with gentamicin resistant bacteria on pre\-procedural urine cultures
  • \- Patients on regular prophylactic antibiotics to reduce urinary tract infections
  • \- Severe renal impairment (eGFR \< 30ml/min)
  • \- Severe autonomic dysreflexia precluding complete urodynamic assessment
  • \- Allergy/Anaphylaxis to Gentamicin

Outcomes

Primary Outcomes

Not specified

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