ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urinary Tract Infection

Condition category

Condition code

Infection

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]

Treatment: Drugs

Intervention code [2]

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]

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]

Within 2 weeks of urodynamic assessment.

Secondary outcome [1]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Prince of Wales Hospital - Randwick

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal North Shore Hospital

Address [1]

Reserve Road
St. Leonards, NSW 2065

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Ramsay Health

Address [2]

PO Box 4007
Royal North Shore Hospital LPO
St Leonards NSW 2065

Country [2]

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]

Hospital

Name [1]

Royal North Shore Hospital

Address [1]

Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Level 13
Kolling Building
Westbourne Street
St. Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/05/2021

Ethics approval number [1]

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

Dr Cameron James Parkin

Address

Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065

Country

Australia

Phone

+61 437060192

Fax

Cameron.Parkin@health.nsw.gov.au

Contact person for public queries

Name

Cameron James Parkin

Address

Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065

Country

Australia

Phone

+61 437060192

Fax

Cameron.Parkin@health.nsw.gov.au

Contact person for scientific queries

Name

Cameron James Parkin

Address

Department of Urology
Royal North Shore Hospital
Reserve Road
St. Leonards NSW 2065

Country

Australia

Phone

+61 437060192

Fax

Cameron.Parkin@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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