None listed
Conditions
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 urodynamic assessment
Sponsors
Study design
Eligibility
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