Objective To report the development and testing of a device for the noninva
sive diagnosis of vesico-ureteric reflux (VUR) which avoids the need for ur
ethral catheterization (currently required to reliably determine the presen
ce of VUR). and which thus avoids the anxiety of parents and patients that
causes many families to refuse such evaluation,
Patients and methods Fifty-four children (49 girls and five boys, mean age
7.2 years, range 4-14) previously evaluated as having VUR volunteered to pa
rticipate: no child was symptomatic at the time of the study. Refluxing uni
ts were known to be present by voiding cysto-urethrography (within 1 year,
mean 7 months) in 45 and absent in 16. The device developed acquires electr
onically processed acoustic signals from the child during an observed urina
tion. The signals are then analysed 'off-line' to determine the presence or
absence of VUR. The initial preparation for the test included: (i) a full
bladder [at least 0.80 x {(2 + age) x 30 mL}] measured by ultrasonography:
and (ii) localization of the pelvi-ureteric junction by ultrasonography to
accurately place the device's sensors on the child's back. The children wer
e then positioned at a commode after placing the sensors: the recording was
started and continued until voiding occurred. The children were tested wit
h the recording and analysis team unaware of the presence and/or degree of
VUR. The first 47 studies were single-kidney examinations and the remaining
seven included simultaneous monitoring of both kidneys,
Results Sixty-one renal units: were assessed and interpretable signals were
obtained from 54 (89%). There were seven episodes of 'system failure' when
no interpretable data were obtained. One unit with no VUR had a 'reflux' s
ignal: in four kidneys, spontaneous (two) and postsurgical (two) resolution
of reflux was predicted by the testing and subsequently verified by cyclic
radionuclide cystography.
Conclusions This noninvasive diagnostic technique detected VUR in 35 of 37
refluxing units and verified no reflux in 16 of 17 units without VUR. Furth
er refinements may allow this technology to be used in all children with su
spected VUR.