None listed
Conditions
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.
Interventions
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
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.
Sponsors
Malaysian University Science Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Patient with neurogenic bladder on regular CIC at least >3x per day age 1-17 years old.
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.
Outcome results
None listed