Advice

Summary

Summary

BladderScan BVI 9400 is a portable 3D ultrasound device that measures bladder volume non‑invasively to help assess urinary retention and post‑void residual bladder volume. Four published prospective cohort studies (3 full papers, 1 abstract) were identified, involving 239 children and young people in secondary or tertiary care settings. These studies showed heterogeneity in the outcome measures and statistical analyses. The reproducibility and accuracy of the results were also varied. The study reported in the abstract contained several limitations and potential biases. The average cost of a BladderScan BVI 9400 system is between £6000 and £8000, excluding VAT.

Product summary and likely place in therapy

  • BladderScan BVI 9400 is a portable 3D ultrasound device designed for non‑invasive bladder volume measurement to help diagnose and assess urological conditions.

  • It would be used in place of either urinary catheterisation or ultrasound (including other portable bladder ultrasound scanners) in children or adults.

Effectiveness and safety

  • Four prospective cohort studies carried out in children and young people (0–19 years; total n=239) are summarised in this briefing.

  • No studies in adults met the inclusion criteria for this briefing.

  • Two studies assessed intra‑operator reproducibility. One study reported no difference between repeated BladderScan BVI 9400 measurements taken by the same observer. Another study reported 'poor' intra‑observer reproducibility.

  • Three studies compared the accuracy of the BladderScan BVI 9400 with catheterisation or real‑time ultrasound. One study reported poor accuracy, and 2 studies reported moderate to high accuracy.

  • One study assessed success rates of suprapubic aspiration when guided by the BladderScan BVI 9400, finding that they were lower than those observed in previous studies using real‑time ultrasound.

Technical and patient factors

  • The BladderScan BVI 9400 uses ultrasound to construct a picture of a 'slice' through the abdomen. Algorithms are used to estimate bladder volume from these ultrasound data.

  • The manufacturer states that BladderScan BVI 9400 does not need to be operated by a sonographer and can be used by a healthcare professional after relevant training.

  • Three models of the BladderScan are currently marketed in the UK. The BVI 9400 model, which is indicated for use in adults and children, is the focus of this briefing.

  • BladderScan BVI 9400 uses bespoke 'NeuralHarmonics' algorithms to derive an estimate of bladder volume from the ultrasound data. Compared with predecessor systems, algorithms have been refined to distinguish between the bladder and the uterus.

Cost and resource use

  • The average cost of a BladderScan BVI 9400 system is between £6000 and £8000, excluding VAT.

  • No evidence on cost consequences and resource use was available.