RecruitingPhase 3ACTRN12621001587897

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


Sponsor

North Sydney Local Health District

Enrollment

200 participants

Start Date

Oct 13, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People with spinal cord injuries often experience bladder problems due to nerve damage, and they frequently need a procedure called urodynamics to assess how their bladder is functioning. Unfortunately, this procedure can introduce bacteria into the urinary tract and cause urinary tract infections (UTIs) in up to 30% of patients. This is a significant problem since UTIs in spinal cord injury patients can lead to hospitalisation, repeated antibiotic use, and antibiotic resistance. This trial is testing whether adding a small amount of the antibiotic gentamicin directly into the bladder during the urodynamics procedure can reduce the rate of post-procedure UTIs. Neither the patients nor the medical staff will know whether they are receiving normal saline (the standard fluid used in urodynamics) or saline mixed with gentamicin — this is known as a double-blinded trial, and it ensures the results are reliable. You may be eligible if you have a confirmed spinal cord injury, are scheduled for urodynamic assessment at Royal North Shore or Prince of Wales Hospital, are 18 or older, are not pregnant, and do not have a known allergy to gentamicin. People on regular prophylactic antibiotics or with severe kidney impairment are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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


Locations(2)

Royal North Shore Hospital - St Leonards

NSW, Australia

Prince of Wales Hospital - Randwick

NSW, Australia

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ACTRN12621001587897


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