Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000997954p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravesical Microdox versus normal saline bladder instillation for recurrent urinary tract infections: A Randomised Controlled Trial.
Scientific title
Intravesical Microdox versus normal saline bladder instillation for recurrent urinary tract infections: A Randomised Controlled Trial.
Secondary ID [1] 301405 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Urinary tract infections 317669 0
Condition category
Condition code
Renal and Urogenital 315744 315744 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Microdox (Te Arai Biofarma - intravesical catheter rinse)
50ml Intravesical weekly for 12 weeks. The intravesical treatment is administered by a nurse. The patients retains the treatment for as long as possible before they will the pass the treatment by voiding at their own convenience.
NB - Microdox is TGA registered as a DEVICE...
Intervention code [1] 317710 0
Treatment: Devices
Comparator / control treatment
Normal saline bladder rinse.
50ml Intravesical wekly for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 323960 0
Number of symptomatic urinary tract infections assessed by asking the patient at each follow up visit
Timepoint [1] 323960 0
Number of symptomatic UTI's in the 3 month treatment period and 6 months following completion of Microdox,
Assessments will be done at one month, 3 months and 6 months.
Secondary outcome [1] 383438 0
Pyuria assessed at freshly spun microscopy
Timepoint [1] 383438 0
Compare pre treatment to 3 months and 6 months
Secondary outcome [2] 385950 0
LUTS symptoms including frequency, urgency, nocturia, bladder pain, voiding difficulty, flow and incontinence by using the validated symptom questionnaire ICIQ-FLUTS
Timepoint [2] 385950 0
Pre treatment, 3 months and 6 Months
Secondary outcome [3] 385951 0
To evaluate the total number of days spent on antibiotics in both groups. Assessed by participant diares.
Timepoint [3] 385951 0
evaluated at 6 months
Secondary outcome [4] 385952 0
To assess the incidence of inpatient care/hospitalisation required for UTI’s during the 6 month trial period. Assessed by hospital records and participant diary.
Timepoint [4] 385952 0
Assessed at 6 months
Secondary outcome [5] 385953 0
To evaluate patient tolerability of intavesical Microdox in comparison to normal saline using a VAS score questionnaire
Timepoint [5] 385953 0
1 month, 3 months and 6 months

Eligibility
Key inclusion criteria
• Women >18 years.
• Women meeting the criteria for recurrent UTI: > 3 documented symptomatic UTIs in the preceding 12 months or 2 or more UTI’s in the preceding 6 months.
• Willing to participate and return for follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Permanent IDC, ureteric stents or nephrostomy
• Foreign body causing obstruction or recurrent infection (e.g. Untreated bladder stones, upper tract stones, mesh).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done by a computer program. Randomisation will be performed by a research nurse not providing care to the patient. Allocation concealment will done by providing the treatment in concealed containers. Doctors providing care for the patients are not involved in the treatment administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Information will be analysed in a de-identified manner. SPSS will be used to perform the statistical analysis. Paired non parametric data will be analysed using Wilcoxon signed rank sum test and independent categorical data will be analysed with the chi-squared test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
29/08/2022
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
276
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16775 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 16776 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 30398 0
3084 - Heidelberg
Recruitment postcode(s) [2] 30399 0
3168 - Clayton
Recruitment outside Australia
Country [1] 22586 0
New Zealand
State/province [1] 22586 0
aukland
Country [2] 23040 0
Sweden
State/province [2] 23040 0
stockholm

Funding & Sponsors
Funding source category [1] 305843 0
Hospital
Name [1] 305843 0
Mercy Hospital for Women
Country [1] 305843 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital
Address
163 Studley road
Heidleberg 3084
Vic
Country
Australia
Secondary sponsor category [1] 306289 0
None
Name [1] 306289 0
Address [1] 306289 0
Country [1] 306289 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306108 0
HREC mercy Hospital for women
Ethics committee address [1] 306108 0
163 Studley road
heidleberg 3084
Vic
Ethics committee country [1] 306108 0
Australia
Date submitted for ethics approval [1] 306108 0
20/08/2020
Approval date [1] 306108 0
Ethics approval number [1] 306108 0

Summary
Brief summary
The aim of this study is to evaluate the effectiveness of microdox bladder rinse in patients with recurrent UTIs. Efficacy will be assessed by the number of symptomatic UTI’s during the 3 month treatment period and 3 months following completion of Microdox. Women must meet criteria for recurrent UTI i.e. > 2 documented symptomatic UTIs in preceding 12 months. We are aiming to exclude catheterised women.
This is a multi-centre, double blinded, randomised trial. Intravesical Microdox treatment is superior to intravesical normal saline wash for the prevention of recurrent UTI’s at 6 months. There is currently no human trials using Microdox in the bladder. Most research on Microdox is based on wound care. There is one recent randomized trial using normal saline wash in catheterised patients and the UTI rate decreased markedly. The cost and suffering resulting from Recurrent UTI’s is significant. Hence better treatments of Recurrent UTI’s is desperately needed, particularly treatment that won’t contribute to the growing antibiotic resistance, and we are hoping that Microdox could be the answer.
Trial website
n/a
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102734 0
Dr Frida Carswell
Address 102734 0
Mercy Hospital for Women
169 Studley road,
Heidleberg 3084, Victoria
Country 102734 0
Australia
Phone 102734 0
+61 3 84584444
Fax 102734 0
Email 102734 0
[email protected]
Contact person for public queries
Name 102735 0
Dr Frida Carswell
Address 102735 0
Mercy Hospital for Women
169 Studley road, Heidleberg 3084, Victoria
Country 102735 0
Australia
Phone 102735 0
+61 3 8458444
Fax 102735 0
Email 102735 0
[email protected]
Contact person for scientific queries
Name 102736 0
Dr Frida Carswell
Address 102736 0
Mercy Hospital for Women
169 Studley road, 3084 Heidleberg, Victoria
Country 102736 0
Australia
Phone 102736 0
+61 3 8458444
Fax 102736 0
Email 102736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will only be available to the primary researchers.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8156Study protocol    379919-(Uploaded-20-08-2020-12-15-50)-Study-related document.docx
8157Informed consent form    379919-(Uploaded-20-08-2020-12-15-24)-Study-related document.docx



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.