Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000429550p
Ethics application status
Submitted, not yet approved
Date submitted
20/03/2024
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravesical Microdox instillation versus standard practice for prevention of postoperative urinary tract infections: A Randomised Controlled Trial.
Scientific title
Intravesical Microdox instillation versus standard practice for prevention of postoperative urinary tract infections: A Randomised Controlled Trial.
Secondary ID [1] 311760 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 333263 0
Condition category
Condition code
Renal and Urogenital 329956 329956 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50ml intravesical Microdox bladder instillation by a doctor immediately prior to removal of the urinary catheter and voiding trial following pelvic organ prolapse or continence surgery. The Microdox will be emptied as the patient voids and we will record the time to first void.
Intervention code [1] 328215 0
Prevention
Intervention code [2] 328338 0
Treatment: Other
Comparator / control treatment
Standard practice. Administration of intravenous antibiotic prophylaxis at the time of surgery for prevention of urinary tract infection (UTI) with no intravesical or other therapy undertaken at the time of catheter removal or during the post-operative period.
Control group
Active

Outcomes
Primary outcome [1] 337716 0
symptomatic UTI’s during the first 6 weeks postoperative period
Timepoint [1] 337716 0
only if symptomatic of a urinary tract infection within 6 weeks postoperatively
Secondary outcome [1] 432937 0
Change in Pyuria.
Timepoint [1] 432937 0
day of surgery and again at the end of 6 weeks postoperatively,
Secondary outcome [2] 432938 0
Change in asymptomatic bacteria
Timepoint [2] 432938 0
day of surgery and at the end of 6 weeks postoperatively
Secondary outcome [3] 432939 0
Tolerability of microdox
Timepoint [3] 432939 0
at the end of 6 weeks postoperatively
Secondary outcome [4] 432940 0
Change in other lower urinary tract symptoms,
Timepoint [4] 432940 0
On recruitment and at the end of 6 weeks postoperatively
Secondary outcome [5] 432958 0
Causative organisms with Microdox therapy.
Timepoint [5] 432958 0
Day of surgery, at the end of the 6 week postoperative period and if become symptomatic of urinary tract infection during the 6 week postoperative period
Secondary outcome [6] 432959 0
Total number of days spent on antibiotics in both groups.
Timepoint [6] 432959 0
At the end of 6 weeks postoperatively,
Secondary outcome [7] 432960 0
Incidence of hospitalization for UTI’s during the treatment period.
Timepoint [7] 432960 0
At the end of 6 weeks postoperatively,
Secondary outcome [8] 433540 0
Sensitivity pattern with Microdox therapy.
Timepoint [8] 433540 0
Day of surgery, at the end of the 6 week postoperative period and if become symptomatic of urinary tract infection during the 6 week postoperative period

Eligibility
Key inclusion criteria
*Women aged 18 and over.
*Able to give informed consent for participation in the trial
* Women who have underwent pelvic organ prolapse or continence surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Permanent IDC
• Other permanent indwelling urinary tract foreign body (e.g. ureteric stents, nephrostomy tube) or anatomical variant causing obstruction or recurrent infection (e.g. Untreated bladder stones or upper tract stones).
• Age < 18 years

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)
sequentially numbered opaque sealed envelopes. Patient draws the next number in sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316095 0
Hospital
Name [1] 316095 0
Mercy Womens Hospital
Country [1] 316095 0
Australia
Primary sponsor type
Hospital
Name
Mercy Womens Hospital
Address
Country
Australia
Secondary sponsor category [1] 318262 0
None
Name [1] 318262 0
Address [1] 318262 0
Country [1] 318262 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314918 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 314918 0
https://www.mercyhealth.com.au/our-organisation/research/human-research-ethics-committee-hrec/
Ethics committee country [1] 314918 0
Australia
Date submitted for ethics approval [1] 314918 0
19/12/2023
Approval date [1] 314918 0
Ethics approval number [1] 314918 0

Summary
Brief summary
Urinary tract infections (UTIs) are the most common postoperative complication following pelvic organ prolapse surgery. The risk of UTI after incontinence and prolapse surgery has been reported to be 24-33%.

This study will see if placing a small amount (50ml) of an antibacterial solution called Microdox when the urinary catheter is removed could decrease the risk of urinary tract infection after surgery. We are comparing this to our current practice, which is to remove the catheter without placing any liquid inside the bladder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133138 0
Dr Devorah Heymann
Address 133138 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133138 0
Australia
Phone 133138 0
+61384584878
Fax 133138 0
Email 133138 0
urogyn@mercy.com.au
Contact person for public queries
Name 133139 0
Devorah Heymann
Address 133139 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133139 0
Australia
Phone 133139 0
+61384584878
Fax 133139 0
Email 133139 0
urogyn@mercy.com.au
Contact person for scientific queries
Name 133140 0
Devorah Heymann
Address 133140 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133140 0
Australia
Phone 133140 0
+61384584878
Fax 133140 0
Email 133140 0
urogyn@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21900Study protocol https://drive.google.com/file/d/1nOFl8IGeJmpjFT2OC4hAaRbUVreXT9Nk/view?usp=sharingurogyn@mercy.com.au



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.