Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000500550p
Ethics application status
Submitted, not yet approved
Date submitted
20/03/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Hiprex versus standard management for preventing urinary tract infections post intravesical botox injection for overactive bladder: A randomised controlled trial
Scientific title
Hiprex versus standard management for preventing urinary tract infections post intravesical botox injection in women with overactive bladder: A randomised controlled trial
Secondary ID [1] 311755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 333258 0
Condition category
Condition code
Renal and Urogenital 329949 329949 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methanamine Hippurate (Hiprex) 1g oral tablet twice daily for 6 weeks, in addition to intraoperative antibiotics (1-2g intravenous cefazolin, 500 mg cephalexin oral tablet or another if antibiotic allergies) during Botulinum toxin (Botox) injection for overactive bladder. Hiprex treatment will start the evening of the procedure. We will monitor adherence by counting the left over tablets at the 6-week postoperative visit.
Intervention code [1] 328212 0
Prevention
Comparator / control treatment
standard management - intraoperative antibiotics during Botulinum toxin (Botox) injection for overactive bladder but no treatment with hiprex after. Our standard intraoperative antibiotics are 1-2g intravenous cefazolin, 500 mg cephalexin oral tablet or another if antibiotic allergies.
Control group
Active

Outcomes
Primary outcome [1] 337708 0
symptomatic urinary tract infection at 6 weeks after botox
Timepoint [1] 337708 0
within 6 weeks of Botox treatment
Secondary outcome [1] 432916 0
Symptomatic urinary tract infections
Timepoint [1] 432916 0
Between 6 weeks and 6 months after Botox treatment
Secondary outcome [2] 432917 0
Change in Pyuria.
Timepoint [2] 432917 0
day of surgery, 6 week and 6 months after Botox treatment
Secondary outcome [3] 432918 0
Asymptomatic bacteria
Timepoint [3] 432918 0
day of surgery, 6 week and 6 months after Botox treatment
Secondary outcome [4] 432919 0
Tolerability as per patient questionnaire.
Timepoint [4] 432919 0
6 weeks after Botox treatment
Secondary outcome [5] 432920 0
Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score

Timepoint [5] 432920 0
At recruitment, 6 weeks and 6 months after Botox treatment
Secondary outcome [6] 432922 0
Causative organisms after Methanamine Hippurate.
Timepoint [6] 432922 0
To be sent if symptomatic of a urinary tract infection within 6 months of Botox treatment
Secondary outcome [7] 432934 0
Total number of days spent on antibiotics in both groups.
Timepoint [7] 432934 0
6 weeks and 6 months after Botox treatment
Secondary outcome [8] 432935 0
Incidence of hospitalisation for urinary tract infections (UTI)’s during the treatment period.
Timepoint [8] 432935 0
6 weeks and 6 months after Botox treatment
Secondary outcome [9] 433791 0
urinary frequency
Timepoint [9] 433791 0
At recruitment, 6 weeks and 6 months after Botox treatment
Secondary outcome [10] 433792 0
nocturia
Timepoint [10] 433792 0
At recruitment, 6 weeks and 6 months after Botox treatment
Secondary outcome [11] 433793 0
urine incontinence episodes per day
Timepoint [11] 433793 0
At recruitment, 6 weeks and 6 months after Botox treatment
Secondary outcome [12] 433794 0
Sensitivity pattern after Methanamine Hippurate.
Timepoint [12] 433794 0
To be sent if symptomatic of a urinary tract infection within 6 months of Botox treatment
Secondary outcome [13] 434163 0
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score
Timepoint [13] 434163 0
At recruitment, 6 weeks and 6 months after Botox treatment
Secondary outcome [14] 434164 0
Change in Incontinence Impact Questionnaire (IIQ7) score
Timepoint [14] 434164 0
At recruitment, 6 weeks and 6 months after Botox treatment

Eligibility
Key inclusion criteria
• Women aged 18 and over receiving intravesical Botox treatment
• Able to give informed consent for participation in the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age < 18 years
• Known renal tract abnormalities
• Bladder pain syndrome as indication for Botox
• History of recurrent urinary tract infections prior to Botox treatment

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
Open (masking not used)
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
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316089 0
Hospital
Name [1] 316089 0
Mercy Womens Hospital
Country [1] 316089 0
Australia
Primary sponsor type
Hospital
Name
Mercy Womens Hospital
Address
Country
Australia
Secondary sponsor category [1] 318257 0
None
Name [1] 318257 0
Address [1] 318257 0
Country [1] 318257 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314911 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 314911 0
Ethics committee country [1] 314911 0
Australia
Date submitted for ethics approval [1] 314911 0
19/12/2023
Approval date [1] 314911 0
Ethics approval number [1] 314911 0

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

Contacts
Principal investigator
Name 133122 0
Dr Devorah Heymann
Address 133122 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133122 0
Australia
Phone 133122 0
+61384584878
Fax 133122 0
Email 133122 0
[email protected]
Contact person for public queries
Name 133123 0
Devorah Heymann
Address 133123 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133123 0
Australia
Phone 133123 0
+61384584878
Fax 133123 0
Email 133123 0
[email protected]
Contact person for scientific queries
Name 133124 0
Devorah Heymann
Address 133124 0
Mercy Womens Hospital 163 Studley Rd, Heidelberg VIC 3084
Country 133124 0
Australia
Phone 133124 0
+61384584878
Fax 133124 0
Email 133124 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21901Study protocol https://drive.google.com/file/d/1KJDyIXt5x5egeYzdd2mJCMag_SwqxQWP/view?usp=drive_link[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.