Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001752257
Ethics application status
Approved
Date submitted
21/01/2018
Date registered
24/10/2018
Date last updated
24/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized control trial comparing sterile water and chlorhexidine aqueous 0.5% as cleansing agent for clean intermittent self-catheterization (CIC) for patient with neurogenic bladder in children.
Scientific title
A randomized control trial comparing urinary tract infection rates with sterile water versus chlorhexidine aqueous 0.5% as cleansing agent for clean intermittent self-catheterization (CIC) in children with neurogenic bladder.
Secondary ID [1] 293783 0
nil
Universal Trial Number (UTN)
U1111-1208-2140
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurogenic bladder 306262 0
urinary tract infection 306263 0
Condition category
Condition code
Infection 305366 305366 0 0
Other infectious diseases
Neurological 308144 308144 0 0
Other neurological disorders
Renal and Urogenital 308920 308920 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient will be divided into two arms.
Arm 1: Using Chlorhexidine aqueous 0.5% as cleansing agent before procedure clean intermittent self-catheterization (CIC). This is a control group.

Arm 2: Using sterile water as cleansing agent before procedure CIC. This is an intervention group.

All patient / caretaker will be teach regarding CIC technique during clinic visit. Patient will be divide into group by choosing opaque envelop which contain group assignment. Randomization done by third party via computer generated randomization.

Material for intervention is a sterile water. 20 ml of sterile water is used to clean the urethra orifice using the three clean cotton wool. Meanwhile for control group is 20 ml of chlorhexidine aqueous 0.5% is used to clean the urethra orifice before CIC . Procedure CIC will be teach by investigator during clinic visit. Investigator has 7 years experiences in paediatric fraternity. Mode of teaching is via face to face learning.

Number of teaching is once during clinic visit before the starting the study. This is because all patients/parents were taught before the initiation of CIC procedure. Frequency of CIC is 4-5 times per day. Patient and parents are advised to adhere to frequency of doing CIC at home. Adherence to frequency of CIC is monitored by own diary and shown to investigator during clinic visit for urine sampling.
Intervention code [1] 300093 0
Prevention
Comparator / control treatment
Control group is pediatric patient with neurogenic bladder on regular clean intermittent self-catheterization and using 20 ml of chlorhexidine aqueous 0.5% as cleansing agent.
Control group
Active

Outcomes
Primary outcome [1] 304513 0
To measure the prevalence of symptomatic urinary tract infection (UTI) and asymptomatic bacteriuria. Measurement of UTI by analysis of urine full examination microscopic examination and urine culture.
Timepoint [1] 304513 0
after 2 weeks of study
Secondary outcome [1] 342209 0
1. To measure the commonest organism isolated from urine sample of patient doing CIC.
Timepoint [1] 342209 0
2 weeks
Secondary outcome [2] 352567 0
2. To measure the antibiotics sensitivity pattern of the isolated bacteria from urine sample.
Timepoint [2] 352567 0
After 2 weeks study period.

Eligibility
Key inclusion criteria
Patient with neurogenic bladder on regular CIC at least >3x per day
age 1-17 years old.
Minimum age
1 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patient/ parents refused to take part
2. average frequency of CIC < 3x per day
3. recent history of taking antibiotics for any infection.

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)
Once patient/parents consented. They will choose opaque conceal envelope which contain group assignment.
Adequate solution will be provided to patient base on group assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization done by third party. Forty six opaque conceal envelope was prepared which contain the assignment group; 23 are from controlled group and 23 are from intervention group.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
23 participant each arm

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/02/2018
Date of last participant enrolment
Anticipated
25/10/2018
Actual
Date of last data collection
Anticipated
8/11/2018
Actual
Sample size
Target
48
Accrual to date
46
Final
Recruitment outside Australia
Country [1] 9512 0
Malaysia
State/province [1] 9512 0
Kelantan

Funding & Sponsors
Funding source category [1] 298399 0
Self funded/Unfunded
Name [1] 298399 0
NORDIN ZAKARIA
Country [1] 298399 0
Malaysia
Primary sponsor type
University
Name
Malaysian University Science Hospital
Address
Malaysian University Science Hospital
Kubang Kerian. 16150
Kota Bharu
Kelantan Darul Naim
Country
Malaysia
Secondary sponsor category [1] 297593 0
None
Name [1] 297593 0
Address [1] 297593 0
Country [1] 297593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299393 0
Human Research Ethics Committee (JEPeM-USM)
Ethics committee address [1] 299393 0
Human Research Ethics Committee (JEPeM-USM)
Centre for Research Initiatives Clinical and Health Sciences
USM Health Campus.
Kubang Kerian, 16150
Kota Bharu, Kelantan Darul Naim
Ethics committee country [1] 299393 0
Malaysia
Date submitted for ethics approval [1] 299393 0
30/11/2017
Approval date [1] 299393 0
12/02/2018
Ethics approval number [1] 299393 0
USM/JEPeM/17100419

Summary
Brief summary
A randomized control trial comparing sterile water and chlorhexidine 0.5% aqueous as cleansing agent for clean intermittent self-catheterization (CIC) for patient with neurogenic bladder in children.

Neurogenic bladder is a disorder of the lower urinary tract due to damage or diseases of the nervous system. It can be either congenital or acquired. Neurogenic bladder can lead to problematic symptoms and complications including urinary incontinence, frequency, and urgency, along with risk for infection and involvement of the upper urinary tract and kidney disease.

Purpose: To compare the prevalence of urinary tract infection in patient clean self-catheterization using sterile water and chlorhexidine aqueous 0.5% as cleaning agent.
Hypothesis: There are no increase risk of urinary tract infection in group using sterile water as cleansing agent before CIC.

This is randomized control trial study involving pediatric patient with neurogenic bladder.
Patient will be divide in to 2 groups, 1st is control group whereby they will use chlorhexidine aqueous 0.5% as cleansing agent and intervention group is using sterile water as cleansing agent.

Study period is 2 weeks or if patient develop complication such as urinary tract infection.

At the end of study, Urine sample will be collected and send for urinalysis and urine culture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80262 0
Dr Nordin Zakaria
Address 80262 0
Pediatric Department
Malaysian University Science Hospital
Kubang Kerian
16150, Kota Bharu
Kelantan Darul Naim
Country 80262 0
Malaysia
Phone 80262 0
+60199737571
Fax 80262 0
Email 80262 0
[email protected]
Contact person for public queries
Name 80263 0
Dr Nordin Zakaria
Address 80263 0
Pediatric Department
Malaysian University Science Hospital
Kubang Kerian
16150, Kota Bharu
Kelantan Darul Naim
Country 80263 0
Malaysia
Phone 80263 0
+60199737571
Fax 80263 0
Email 80263 0
[email protected]
Contact person for scientific queries
Name 80264 0
Dr Mohamad Ikram bin Ilias
Address 80264 0
Pediatric Department
Malaysian University Science Hospital
Kubang Kerian
16150, Kota Bharu
Kelantan Darul Naim
Country 80264 0
Malaysia
Phone 80264 0
+60199115628
Fax 80264 0
Email 80264 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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