BLADDER STIMULATION IN PEDIATRIC EMERGENCY DEPARTMENT

CAN THE BLADDER STIMULATION TECHNIQUE SOLVE THE URINE COLLECTION CHAOS IN THE PEDIATRIC EMERGENCY DEPARTMENT?

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

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Tract Infections in Children; Diagnostic Techniques, Urological
• Intervention / Treatment: Procedure: Bladder Stimulation Technique; Procedure: Traditional Urine Bag Application

Detailed Description

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.

Primary and Secondary Objectives

The study focuses on three main questions regarding this specific age group:

Contamination Rates: Does BST provide a cleaner urine sample compared to the bag method in infants under 6 months, thereby significantly reducing the rate of false-positive cultures?

Time Efficiency: Does BST reduce the time required to successfully collect a urine sample compared to waiting for a bag collection?

Success Rate: What is the overall success rate of obtaining a viable urine sample using BST versus the bag method within a standard emergency room timeframe? The findings of this study have the potential to immediately change clinical guidelines and daily practices in acute pediatric care. If the Bladder Stimulation Technique proves to be faster and less prone to contamination than the traditional bag method, it will serve as a crucial "diagnostic firewall." For parents, this means less time waiting in the emergency room, protection from unnecessary antibiotic treatments, and avoiding the pain and trauma of invasive catheterization for their babies. For healthcare systems, it offers a cost-effective, evidence-based solution to resolve diagnostic dilemmas and operational bottlenecks in emergency departments.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Bladder Stimulation Technique; 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.	Procedure: Bladder Stimulation Technique; In the intervention group, the Bladder Stimulation Technique (BST) was performed. The infant was held safely suspended in the air by their armpits by a researcher to relax the abdominal muscles. The physician then initiated a stimulation cycle consisting of 30 seconds of gentle paravertebral (lower back) massage, followed immediately by 30 seconds of light suprapubic (lower abdomen) tapping. This 1-minute cycle was repeated continuously for a maximum of 5 minutes. The moment the natural voiding reflex was triggered and the infant began to urinate, a midstream urine sample was directly caught into a sterile specimen container
Active Comparator: Arm 2: Traditional Urine Bag Method; 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	Procedure: Traditional Urine Bag Application; The current standard care method for urine collection in non-toilet-trained infants. The infant's perineal area is cleaned, and a standard, sterile pediatric adhesive urine collection bag is attached. The infant is then closely monitored in the emergency department until spontaneous natural voiding occurs into the bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of the Bladder Stimulation Technique and Influencing Factors	The primary objective is to evaluate the percentage of successful urine collections, strictly defined as obtaining at least 1 cc (mL) of clean-catch midstream urine, achieved specifically by using bladder stimulation maneuvers (paravertebral massage and suprapubic tapping). Additionally, this outcome evaluates the clinical and demographic factors (e.g., patient age, gender, weight) that influence the success of this specific maneuver.	From the start of the stimulation maneuver until at least 1 cc of urine is obtained (maximum of 5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Emergency Department Waiting Time	To evaluate and compare the effect of both urine collection methods (the bladder stimulation technique versus the traditional adhesive bag) on the total waiting time in the emergency department, measured from the initiation of the procedure until at least 1 cc of urine is successfully obtained.	Up to 5 minutes for the bladder stimulation group, and until at least 1 cc of urine is obtained for the traditional bag group

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Specimen Contamination Rates	To evaluate and compare the effect of both urine collection methods on the rates of urine culture contamination, in order to determine which method yields more reliable clinical samples.	Up to 72 hours

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physical Stimulation,Bladder Massage, Paravertebral Massage, Suprapubic Tapping
• Other Study ID Numbers: IstabulMU-PED-AG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No