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Real-Time Bladder Volume Monitoring for Pediatric Patients Using a Commercially Available Wearable Ultrasound Device.

Peter Y Cai1, Tanya Logvinenko1, Badar Omar1

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A wearable ultrasound bladder sensor showed limited accuracy in estimating bladder volume in children with urologic conditions. Further research is needed to determine if this device is reliable for clinical use in pediatric patients.

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bladder ultrasoundcapacitydevicepediatricsreal‐time

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Area of Science:

  • Pediatric Urology
  • Medical Device Technology
  • Diagnostic Accuracy

Background:

  • Wearable bladder ultrasound devices offer a non-invasive method for estimating bladder volume.
  • Accuracy of such devices in pediatric populations with urologic conditions requires rigorous validation.
  • Previous studies have not extensively evaluated commercially available wearable ultrasound devices in children.

Purpose of the Study:

  • To assess the accuracy of a wearable bladder ultrasound device (DFree) in estimating bladder volume in children undergoing urodynamics.
  • To compare device readings with instilled volumes during cystometrography (CMG) in pediatric patients.
  • To determine the clinical utility of this device for managing pediatric urologic conditions.

Main Methods:

  • Prospective enrollment of 40 children (6 months to 18 years) with urologic conditions.
  • Placement of the wearable ultrasound sensor on the suprapubic region during CMG.
  • Analysis of device accuracy using a threshold of ≥8 (0-10 scale) for ≥80% of CMG-determined bladder capacity.
  • Mixed effects linear regression to model the relationship between sensor indication and instilled volume.

Main Results:

  • The device accurately measured bladder capacity in 46.2% of pediatric patients.
  • Sensitivity was 0.70, specificity 0.13, positive predictive value 0.53, and negative predictive value 0.22.
  • A 10% increase in sensor reading correlated with a 10% average increase in bladder volume (p < 0.001).

Conclusions:

  • The wearable ultrasound bladder sensor demonstrated moderate accuracy in a subset of children undergoing urodynamic studies.
  • Clinicians should exercise caution when recommending direct-to-consumer bladder sensors for pediatric use.
  • Further studies are necessary to confirm the reproducibility of accurate measurements and assess long-term reliability.