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.
Investigators
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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