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Trial registered on ANZCTR


Registration number
ACTRN12625000856415
Ethics application status
Approved
Date submitted
13/07/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and efficacy of intravesical gentamicin for recurrent urinary tract infections and/ or catheter blockages
Scientific title
Safety and efficacy of intravesical gentamicin for recurrent urinary tract infections and/ or catheter blockages in adult patients with any form of bladder drainage
Secondary ID [1] 314894 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection 338190 0
Condition category
Condition code
Infection 334469 334469 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient- or carer-administered 30mL of 0.48mg/mL gentamicin solution, intravesical, with solution retention in bladder for 60mins, once in the evening, for six months, as prophylaxis for recurrent urinary tract infection.
Adherence to intervention was assessed with telephone consults every two months.
Intervention code [1] 331499 0
Prevention
Intervention code [2] 331572 0
Treatment: Drugs
Comparator / control treatment
Historical control of patient's pre-prophylaxis experience, for the 12 months prior commencing prophylaxis.
For example, for patients commenced intravesical gentamicin for UTI prophylaxis in June 2024, the historical control was that patient's experience June 2023 - June 2024.
Control group
Historical

Outcomes
Primary outcome [1] 342169 0
For patients with recurrent urinary tract infections (UTI), subjective (patient-reported) rates of UTI per 12-month-equivalent, before versus during treatment.
Timepoint [1] 342169 0
Every 2 months post enrolment, until census date 01/04/2025
Primary outcome [2] 342271 0
For patients with recurrent urinary tract infections (UTI), objective (positive culture with symptoms) rates of UTI per 12-month-equivalent, before versus during treatment.
Timepoint [2] 342271 0
Every 2 months post enrolment, until census date 01/04/2025
Secondary outcome [1] 449802 0
For patients with recurrent UTIs, proportion of patients with >=1 UTIs per 12-month-equivalent caused by multi drug-resistant organism, before vs during treatment.
Timepoint [1] 449802 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [2] 450209 0
For patients with recurrent UTIs, proportion of patients with >=1 UTIs per 12-month-equivalent caused by gentamicin-resistant organisms, before vs during treatment.
Timepoint [2] 450209 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [3] 450210 0
For patients with recurrent UTIs, median rates of UTI-related emergency department presentations per 12-month-equivalent, before vs during treatment.
Timepoint [3] 450210 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [4] 450211 0
Patient-reported ease-of-use of intravesical gentamicin
Timepoint [4] 450211 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [5] 450212 0
Patient-reported likelihood-to-recommend treatment
Timepoint [5] 450212 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [6] 450213 0
Patient reported subjective decrease in urine mal-odour
Timepoint [6] 450213 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [7] 450214 0
Patient reported complications, including suprapubic pain, rash or malaise.
Timepoint [7] 450214 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [8] 450215 0
For patients with bothersome catheter blockages, median duration (days) between catheter changes
Timepoint [8] 450215 0
Patients contacted via telephone every two months, between enrolment & study census.
Secondary outcome [9] 450216 0
For patients with bothersome catheter blockages, subjective decrease in catheter blocking.
Timepoint [9] 450216 0
Patients contacted via telephone every two months, between enrolment & study census.

Eligibility
Key inclusion criteria
Eligible patients were adults with any form of bladder drainage (spontaneous voiding, clean intermittent catheterisation (CIC), indwelling urethral catheters [IUC] or suprapubic catheters [SPC]) with either recurrent UTIs failing low dose oral prophylaxis (antibiotic or non-antibiotic) and/ or frequent catheter blockages, who received >=14 consecutive days’ once daily intravesical gentamicin in period 01/06/2024 – 01/04/2025, and provided written study consent. A minimum of 14 days’ prophylaxis was selected to mirror criteria of previous studies. Recurrent UTIs were defined as >=2 UTIs in six months or >=3 in twelve months. Frequent catheter blockages were defined as those flagged as bothersome per patient report.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who did not complete 14 days’ prophylaxis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data was tabulated and presented qualitatively. Primary and secondary outcomes were expected to be non-parametric. Therefore, continuous data such as rate of UTI were summarised as medians and compared between groups using the Kruskal-Wallis/ Mann-Whitney U test. Categorical measures such as Likert score were summarised as proportions, and compared with the Pearson’s chi-squared test.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 27224 0
Canada
State/province [1] 27224 0
AB

Funding & Sponsors
Funding source category [1] 319450 0
Hospital
Name [1] 319450 0
Rockyview General Hospital
Country [1] 319450 0
Canada
Primary sponsor type
University
Name
University of Calgary
Address
Country
Canada
Secondary sponsor category [1] 321946 0
None
Name [1] 321946 0
Address [1] 321946 0
Country [1] 321946 0
Other collaborator category [1] 283586 0
Individual
Name [1] 283586 0
Dr Richard Baverstock, Rockyview General Hospital, Calgary, Canada
Address [1] 283586 0
Country [1] 283586 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318030 0
Conjoint Health Research Ethics Board (CHREB), University of Calgary
Ethics committee address [1] 318030 0
Ethics committee country [1] 318030 0
Canada
Date submitted for ethics approval [1] 318030 0
01/07/2024
Approval date [1] 318030 0
01/07/2024
Ethics approval number [1] 318030 0
REB24-1642

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142894 0
Dr Ned Kinnear
Address 142894 0
University of Adelaide, North Terrace, Adelaide, South Australia, 5005
Country 142894 0
Australia
Phone 142894 0
+61 8 8372 7502
Fax 142894 0
Email 142894 0
Contact person for public queries
Name 142895 0
Ned Kinnear
Address 142895 0
University of Adelaide, North Terrace, Adelaide, South Australia, 5005
Country 142895 0
Australia
Phone 142895 0
+61 8 8372 7502
Fax 142895 0
Email 142895 0
Contact person for scientific queries
Name 142896 0
Ned Kinnear
Address 142896 0
University of Adelaide, North Terrace, Adelaide, South Australia, 5005
Country 142896 0
Australia
Phone 142896 0
+61 8 8182 9000
Fax 142896 0
Email 142896 0

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
Researchers
Conditions for requesting access:
Yes, conditions apply:
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
De-identified individual participant data:
All outcomes data
What types of analyses could be done with individual participant data?
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.