Kite Medical is developing the first safe, non-invasive and easy-to-use VUR detection method without radiation or trauma. Vesicoureteral reflux (VUR) is the most common urinary tract abnormality in babies and children up to five years. Progression of VUR is associated with complications including permanent kidney scarring, raised blood pressure (hypertension), and in some cases, the kidney stops functioning permanently (end-stage renal disease (ESRD)). In one study, VUR was the single leading cause of kidney damage, accounting for 25% of all children without kidney function that require a transplant or dialysis (Ardissino, Get al. J Urol 2004).
Early diagnosis is vital, but current diagnostic techniques are invasive and either involve radiation exposure or are unreliable. The gold standard voiding cystourethrogram (VCUG) is traumatising and painful for the child and is stressful for parents and clinicians. The VCUG requires children to undergo urethral catheterisation, radiation exposure (children have a greater radio-sensitivity to radiation due to growing tissues and children’s longer life expectancy) and forced bladder filling and emptying while awake. Behaviours of children after a VCUG are consistent with symptoms related to post-traumatic stress disorder. A VCUG procedure is challenging to carry out and may not reflect actual VUR severity. Furthermore, referral to radiology delays treatment and increases costs. Ultrasound does not carry such risks, however, the Cochrane database study (Shaikh et al. 2016 ) has reinforced the previously well-known fact that ultrasound is a poor screening test for VUR (sensitivity =44%).
Clinicians have raised concerns about the low sensitivity of ultrasound and low compliance rate for VCUG tests due to the traumatic nature of the procedure and that children with VUR may not be diagnosed in a timely manner.
The goals of the Kite Medical project are:
• To be the first safe, non-invasive and easy-to-use VUR detection method without radiation exposure and trauma;
• To disrupt the current patient care pathway, by offering physicians a point of care option for detecting VUR, transferring care from the radiology department to primary care settings and
• To facilitate early diagnosis and simple follow-up of VUR to avoid preventable, long term kidney damage due to unnecessary disease progression.
The objectives of the EU-funded project were to advance the technology to limit the impact of motion on the signal and to subsequently evaluate the clinical performance of a prototype system.
