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A randomized control trial comparing sterile cotton balls versus urine bag for urine collection method in non-toilet trained children.

A randomized control trial comparing feasibility and contamination rate of urine collection using sterile cotton balls versus urine bag in non-toilet trained children.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000151336
Enrollment
50
Registered
2026-02-06
Start date
2025-06-01
Completion date
2026-05-31
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a single-centre, prospective randomized controlled trial aimed at evaluating the feasibility of using sterile cotton balls as an alternative method for urine collection in non-toilet-trained children. The study compares sterile cotton balls with the standard paediatric urine bag in terms of time required to obtain a sample, cost-effectiveness and contamination rates. Participants, aged 0 to 36 months and admitted to the paediatric or neonatal ward, will be recruited using convenience sampling after obtaining informed parental consent. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group (sterile cotton balls) or control group (urine bag) through block randomization. It is hypothesised that urine collection using sterile cotton balls is more feasible than using urine bags, offering advantages in terms of collection time, cost and contamination rates.

Interventions

All participants will be divided into two study arms: • Arm 1 (Intervention Group): Urine collection using sterile cotton balls. • Arm 2 (Control Group): Urine collection using a paediatric urine bag. All admitted patients in the paediatric ward will be assessed for eligibility. Those who meet the inclusion criteria and whose parents or guardians provide written informed consent will be recruited into the study. The intervention material consists of sterile cotton balls. Three sterile cotton b

All participants will be divided into two study arms: • Arm 1 (Intervention Group): Urine collection using sterile cotton balls. • Arm 2 (Control Group): Urine collection using a paediatric urine bag. All admitted patients in the paediatric ward will be assessed for eligibility. Those who meet the inclusion criteria and whose parents or guardians provide written informed consent will be recruited into the study. The intervention material consists of sterile cotton balls. Three sterile cotton balls will be placed in the child’s diaper and left in situ until urine passage is detected. Passage of urine will be checked every 10 minutes by inspection of the diaper. If urine is not passed within 30 minutes, the cotton balls will be replaced, and the procedure will be repeated until urine is passed. Parents or caregivers will be briefly instructed about the procedure, including the purpose of the cotton balls, the need to keep the diaper in place and to immediately inform the medical staff if they notice urine passage or if the child becomes uncomfortable. Parents will not be required to manipulate or remove the cotton balls themselves. Adherence to the intervention will be ensured through direct supervision by the principal investigator or trained medical staff, who will place the cotton balls, perform scheduled checks every 10 minutes, and remove the cotton balls once urine is passed. The procedure will be conducted in a face-to-face manner and participants will be continuously monitored until a urine sample is successfully collected. The principal investigator, who has six years of experience in paediatrics, will oversee all procedures. Each participant will undergo the procedure once. Urine collection procedures in both groups will be performed within the ward setting.

Sponsors

Nur Fadhilah Hanim Binti Mohamad Noor, Paediatric Department, Universiti Sains Malaysia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 36 Months
Healthy volunteers
No

Inclusion criteria

Patients aged 0 to 36 months who are non-toilet trained and admitted to the paediatric or neonatal ward

Exclusion criteria

-Patient with UTI or suspected UTI -Patient with current diarrhea -Patient who previously already recruited in the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026