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临床试验/NCT07654725
NCT07654725进行中(未招募)不适用

Can the Bladder Stimulation Technique Solve the Urine Collection Chaos in the Pediatric Emergency Department?

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
124
试验地点
1

研究概览

简要总结

The purpose of this prospective, quasi-experimental study is to evaluate the efficacy of the Bladder Stimulation Technique (BST) compared to the traditional urine collection bag method in non-toilet-trained infants presenting to the Pediatric Emergency Department. The primary objective is to determine whether BST can significantly reduce urine contamination rates and the time required for successful sample collection. By comparing these two non-invasive methods, the study aims to provide a faster, cleaner, and more reliable diagnostic approach to solve the operational challenges of urine collection in acute pediatric care

详细描述

Diagnosing urinary tract infections (UTIs) in non-toilet-trained infants is a daily and critical challenge in pediatric emergency departments. In this highly vulnerable group, a UTI can rapidly progress to severe complications, making an accurate diagnosis via a sterile or very clean urine sample absolutely essential. Currently, the most common non-invasive method for collecting urine from these infants is the adhesive urine bag. However, this method has significant drawbacks. Bag samples have notoriously high contamination rates-often exceeding 50%-because bacteria from the baby's skin or stool easily mix with the urine.

When a urine sample is contaminated, it frequently leads to false-positive results. This forces physicians to either prescribe unnecessary antibiotics to a very young infant or subject the baby to invasive, painful procedures like urethral catheterization to secure a sterile sample. Furthermore, waiting for an infant to naturally void into a bag is highly unpredictable, often taking hours. This waiting period increases the length of hospital stays, frustrates parents, and creates operational bottlenecks in busy emergency departments.

The Proposed Intervention: Bladder Stimulation Technique (BST) To address these clinical and operational challenges, clinicians are exploring alternative non-invasive methods. The Bladder Stimulation Technique (BST) is a safe, completely non-invasive maneuver that involves gently tapping and massaging the infant's lower abdomen (suprapubic area) and lower back (lumbar region) in a specific sequence. This gentle stimulation triggers the infant's natural reflex to urinate, allowing healthcare providers to catch a midstream urine sample directly into a sterile container.

Study Design and Methodology This is a prospective, quasi-experimental comparative study conducted in a high-volume Pediatric Emergency Department. The study is designed to directly compare the traditional adhesive urine bag method with the Bladder Stimulation Technique.

The study will specifically include infants younger than 6 months of age who present to the emergency department and require a urine sample for clinical evaluation. Eligible infants will be evaluated using one of the two collection methods, and the study will rigorously track and compare the outcomes of both approaches in real-time.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
0 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants strictly under 6 months of age.
  • Patients presenting to the pediatric emergency department who require a urine sample collection for any clinical indication (e.g., fever without a source, suspected urinary tract infection).
  • Infants who are able to be fed orally or enterally (as the protocol requires the procedure to be performed 20 minutes after feeding to ensure bladder volume).
  • Presence of informed written consent from a parent or legal guardian.

排除标准

  • Infants aged 6 months or older.
  • Patients requiring immediate life-saving resuscitation or those who are hemodynamically unstable.
  • Patients with known congenital anomalies of the genitourinary tract.
  • Patients with known neurological disorders that may affect normal bladder function or voiding reflexes (e.g., neural tube defects, spina bifida).
  • Presence of skin lesions, active infections, trauma, or surgical incisions in the paravertebral (lower back) or suprapubic (lower abdomen) areas that would contraindicate physical massage and tapping.
  • Patients with any clinical contraindication to feeding.
  • Refusal of parental consent.

研究组 & 干预措施

Arm 1: Bladder Stimulation Technique

Experimental

Infants in this arm will undergo the Bladder Stimulation Technique. This completely non-invasive method involves a specific sequence of paravertebral (lower back) massage and suprapubic (lower abdomen) tapping to trigger the infant's natural voiding reflex, allowing for a midstream urine sample to be collected directly into a sterile container.

干预措施: Bladder Stimulation Technique (Procedure)

Arm 2: Traditional Urine Bag Method

Active Comparator

Infants in this arm will undergo the current standard of care. A standard, sterile adhesive urine collection bag will be applied to the infant's perineal area. The patient will be monitored until natural voiding occurs into the bag

干预措施: Traditional Urine Bag Application (Procedure)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aytaç Göktuğ

Assistant Professor

Istanbul Medeniyet University

研究点 (1)

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