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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001587897
Enrollment
2
Registered
2021-11-19
Start date
2021-10-13
Completion date
2023-02-01
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine whether or not instilling gentamicin, a type of antibiotic, into the bladder during urodynamic assessment, will reduce rates of post-procedural urinary tract infections (UTI). Patients with spinal cord injuries suffer from an increased rate of urinary tract infections due to a number of factors arising from the injuries to the nerves in the spine impacting on communication with the bladder. Further to this, intermittent self-catheterisation devices and indwelling catheters promote introduction and colonisation of the urinary tract. While spinal cord injured patients are frequently colonised with micro-organisms, some can lead to symptomatic infections requiring frequent courses of antibiotics, hospitalisations and urosepsis in the most severe cases. It is therefore critical that when we perform invasive procedures such as urodynamic assessment that we identify ways to reduce new bacteriuria and symptomatic urinary tract infections. Currently rates of UTIs after urodynamics in patients with spinal cord injuries is significant, ranging between 5-30%. Using gentamicin, an antibiotic, during urodynamics could be a new way in reducing rates of UTIs. Studies have shown that intravesical administration for high risk patients such as those with spinal cord injuries reduces symptomatic UTIs, oral antibiotic use and antibiotic resistance. The use of intravesical (instilled within the bladder) gentamicin irrigation for prevention and treatment of recurrent urinary tract infections was first reported by McGuide and Savastono in 1987. A systematic review of intravesical antibiotic agents (gentamicin, neomycin, polymyxin, colistin) showed a good response with a reduction in symptomatic UTI of 78.2% for both treatment and prophylaxis groups. A success rate of 71% (n=120) was seen in the prophylaxis group in the short term, with discontinuation rate of 8% (n=14). To assess the true effect of gentamicin used during urodynamics, both participants and medical staff performing the urodynamics will be ‘blinded’. This means that neither the participants or the staff will be aware of whether or not the patient will be receiving normal saline (routine solution used during urodynamics) or normal saline mixed with 240mg of gentamicin. This is what researchers refer to a randomised blinded controlled trial.

Interventions

Two-arm blinded randomised control trial Population - Patients with spinal cord injuries who are undergoing urodynamic assessment Intervention - 240mg gentamicin (once only dose) mixed into 500ml normal saline 0.9%. This is instilled into the bladder during urodynamic assessment. No change in procedural duration time. Administration of gentamicin will be undertaken by the unblinded team - this includes adherence to the intervention Patient's bladder's are emptied at the conclusion of urodyn

Two-arm blinded randomised control trial Population - Patients with spinal cord injuries who are undergoing urodynamic assessment Intervention - 240mg gentamicin (once only dose) mixed into 500ml normal saline 0.9%. This is instilled into the bladder during urodynamic assessment. No change in procedural duration time. Administration of gentamicin will be undertaken by the unblinded team - this includes adherence to the intervention Patient's bladder's are emptied at the conclusion of urodynamic assessment

Sponsors

North Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026