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Effectiveness and Safety of Different Stimulation Methods for Collecting Urine from pre-continent infants: A Prospective, Multicenter, Open-Label, Three-Arm, Parallel-Design Randomized Controlled Trial

Effectiveness and Safety of Different Stimulation Methods for Collecting Urine from pre-continent infants: A Prospective, Multicenter, Open-Label, Three-Arm, Parallel-Design Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098691
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

None

Interventions

Quick-Wee group:The medical staff continuously rubbed the infant's suprapubic area in a circular motion with cold saline-soaked gauze held with disposable plastic forceps until 2 ml of clean urine was
Bladder Stimulation group:One operator held the child under his armpit, the male legs suspended, the female hips bent, one operator alternately performed continuous bladder stimulation (tapping gently
clean catch urine group:Wait for natural urination until 2ml of clean urine has been successfully collected or the timer has reached 5 minutes.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Hospitalized infants aged 1-12 months (including infants aged 1 and 12 months, corrected for gestational age if pregnancy <36 weeks); 2. pre-continent infants; 3. Suspected febrile urinary tract infection, urinary tract disease, kidney disease or metabolic disease, urine analysis is required; 4. An immediate relative or legal guardian voluntarily participates and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The vital signs of the child are unstable and there are life-threatening diseases; 2. The child has been diagnosed with abnormal urinary system anatomy or neuromicturition/sensory disorders and other diseases affecting normal urination; 3. Urinary catheter or cystostomy tube has been placed; 4. Urine samples should be collected immediately by invasive methods after clinical evaluation.

Design outcomes

Primary

MeasureTime frame
Success rate of urine collection within 5 minutes;

Secondary

MeasureTime frame
urination time;Voiding rate within 5 minutes;Intervention Comfort/Pain ;intervention satisfaction;sample contamination rate;Risk factors for collection failure;adverse event rates;

Countries

China

Contacts

Public ContactWenjiao Huang

West China Hospital, Sichuan University

huangwenjiao@scu.edu.cn+86 189 8060 6946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026