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Trial registered on ANZCTR


Registration number
ACTRN12621001587897
Ethics application status
Approved
Date submitted
18/10/2021
Date registered
19/11/2021
Date last updated
19/11/2021
Date data sharing statement initially provided
19/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 305576 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Infection 323994 0
Condition category
Condition code
Infection 321499 321499 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 321976 0
Treatment: Drugs
Intervention code [2] 322103 0
Prevention
Comparator / control treatment
Control -
500ml normal saline 0.9% instilled into the bladder during urodynamic assessment.

No change to procedural time

The non-blinded team members - CNCs and Urology Registrar will ensure monitoring and progress of the study
Control group
Placebo

Outcomes
Primary outcome [1] 329271 0
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.

Follow up will occur with both a telephone follow up to patients and linkage to medical records
Timepoint [1] 329271 0
Within 2 weeks of urodynamic assessment.
Secondary outcome [1] 401971 0
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
Timepoint [1] 401971 0
2 weeks since Urodynamics

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was performed by an unblinded staff member who undertakes urodynamic assessment for patients - continence nurse. Allocation has not been undertaken by the prinicipal investigator of this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software - randomised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The study team uses a box to collect the gentamicin from the clinical trial pharmacy. Investigators are not allowed to open the box at anytime. This way the gentamicin used is concealed from all blinded investigators and patients. Preparation and mixing of gentamicin is undertaken prior to patients entering the fluoroscopy suite. Those staff unblinded screen patients for suitability of enrolling in the trial.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic information collected will include:
• Age
• Gender
• Spinal Cord Injury, Time of Injury
• ASIA Score
• Bladder Management – Indwelling Urethral Catheter (IDC), Suprapubic Catheter (SPC), Intermittent Self Catheterisation (ISC), No adjuncts
• Anticholinergic Medication
• Date of UDS
• Allergies
Information from pre-procedural and post-procedural Urine MSU will be also recorded:
• Date of collection
• Pure Growth of Bacteria
• Bacteriuria level
• Leukocyte level within urine culture
Patients will be contacted two weeks following their UDS, to assess their symptoms. Any symptoms will be recorded as well as whether or not antibiotics have been commenced.
To compare the primary and secondary outcomes, the statistical test used primarily to evaluate the difference between the groups is a two sample ?2 test. A p value of <0.05 will be considered significant. The statistical analysis will be performed using the R software version 3.6.3.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/10/2021
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
15/02/2023
Actual
Sample size
Target
200
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20778 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 20781 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 35595 0
2031 - Randwick
Recruitment postcode(s) [2] 35592 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 309937 0
Hospital
Name [1] 309937 0
Royal North Shore Hospital
Country [1] 309937 0
Australia
Funding source category [2] 309940 0
Commercial sector/Industry
Name [2] 309940 0
Ramsay Health
Country [2] 309940 0
Australia
Primary sponsor type
Government body
Name
North Sydney Local Health District
Address
North Sydney Local Health District - Research Office
Level 13
Kolling Building
Westbourne Street
St. Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 310978 0
Hospital
Name [1] 310978 0
Royal North Shore Hospital
Address [1] 310978 0
Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065
Country [1] 310978 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309656 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309656 0
Level 13
Kolling Building
Westbourne Street
St. Leonards NSW 2065
Ethics committee country [1] 309656 0
Australia
Date submitted for ethics approval [1] 309656 0
Approval date [1] 309656 0
11/05/2021
Ethics approval number [1] 309656 0
2021/ETH00374

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114926 0
Dr Cameron James Parkin
Address 114926 0
Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065
Country 114926 0
Australia
Phone 114926 0
+61 437060192
Fax 114926 0
Email 114926 0
Cameron.Parkin@health.nsw.gov.au
Contact person for public queries
Name 114927 0
Dr Cameron James Parkin
Address 114927 0
Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065
Country 114927 0
Australia
Phone 114927 0
+61 437060192
Fax 114927 0
Email 114927 0
Cameron.Parkin@health.nsw.gov.au
Contact person for scientific queries
Name 114928 0
Dr Cameron James Parkin
Address 114928 0
Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065
Country 114928 0
Australia
Phone 114928 0
+61 437060192
Fax 114928 0
Email 114928 0
Cameron.Parkin@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Breach in patient confidentiality given relatively small number of patients within study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.