ANZCTR - Registration

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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]

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

Renal and Urogenital

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]

Prevention

Intervention code [2]

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]

symptomatic UTI’s during the first 6 weeks postoperative period

Timepoint [1]

only if symptomatic of a urinary tract infection within 6 weeks postoperatively

Secondary outcome [1]

Change in Pyuria.

Timepoint [1]

day of surgery and again at the end of 6 weeks postoperatively,

Secondary outcome [2]

Change in asymptomatic bacteria

Timepoint [2]

day of surgery and at the end of 6 weeks postoperatively

Secondary outcome [3]

Tolerability of microdox

Timepoint [3]

at the end of 6 weeks postoperatively

Secondary outcome [4]

Change in other lower urinary tract symptoms,

Timepoint [4]

On recruitment and at the end of 6 weeks postoperatively

Secondary outcome [5]

Causative organisms with Microdox therapy.

Timepoint [5]

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]

Total number of days spent on antibiotics in both groups.

Timepoint [6]

At the end of 6 weeks postoperatively,

Secondary outcome [7]

Incidence of hospitalization for UTI’s during the treatment period.

Timepoint [7]

At the end of 6 weeks postoperatively,

Secondary outcome [8]

Sensitivity pattern with Microdox therapy.

Timepoint [8]

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?

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]

Hospital

Name [1]

Mercy Womens Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mercy Womens Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committee

Ethics committee address [1]

https://www.mercyhealth.com.au/our-organisation/research/human-research-ethics-committee-hrec/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/12/2023

Approval date [1]

Ethics approval number [1]

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

Dr Devorah Heymann

Address

Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61384584878

Fax

[email protected]

Contact person for public queries

Name

Devorah Heymann

Address

Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61384584878

Fax

[email protected]

Contact person for scientific queries

Name

Devorah Heymann

Address

Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61384584878

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21900	Study protocol		https://drive.google.com/file/d/1nOFl8IGeJmpjFT2OC4hAaRbUVreXT9Nk/view?usp=sharing	[email protected]

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

Documents added manually

Documents added automatically