Assessing the effect of instilling gentamicin into the bladder during Urodynamics on the rate of post procedure urinary tract infections in patients with spinal cord injuries

Phase 3

Recruiting

• Conditions: rinary Tract Infection; Urinary Tract Infection; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12621001587897
• Lead Sponsor: orth Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-19
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-procedural (following urodynamics) urinary tract infection. For the purpose of this study, a urinary tract infection is defined as significant bacteriuria defined by pure bacterial growth on urine MSU or a bacterial colony count >10^8 cfu/L or urine white cells > 100 x 10^6/L. This must be accompanied with symptoms including dysuria, urinary incontinence, fever, autonomic dysreflexia, cloudy urine, lethargy and malaise. <br><br>Follow up will occur with both a telephone follow up to patients and linkage to medical records<br>[Within 2 weeks of urodynamic assessment.]

Secondary Outcome Measures

Name	Time	Method
Asymptomatic UTI - significant bacteriuria defined by pure bacterial growth on urine MSU or a bacterial colony count >10^8 cfu/L or urine white cells > 100 x 10^6/L, without presence of symptoms[2 weeks since Urodynamics]