BLADDER STIMULATION IN PEDIATRIC EMERGENCY DEPARTMENT

NCT07654725 | Active Not Recruiting

• 1 other identifier: IstabulMU-PED-AG-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infections in Children; Diagnostic Techniques, Urological

Keywords

Physical Stimulation,Bladder Massage, Paravertebral Massage, Suprapubic Tapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect on Emergency Department Waiting Time

  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 Outcomes (1)

• Effect on Specimen Contamination Rates

  Up to 72 hours

Study Arms (2)

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.

Procedure: Bladder Stimulation Technique

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

Procedure: Traditional Urine Bag Application

Interventions

Bladder Stimulation Technique PROCEDURE

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

Arm 1: Bladder Stimulation Technique

Traditional Urine Bag Application PROCEDURE

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.

Arm 2: Traditional Urine Bag Method

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Interventional, Quasi-experimental

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: February 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: June 15, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)