SENS-U: continuous home monitoring of natural nocturnal bladder filling in children with nocturnal enuresis - a feasibility study.

INTRODUCTION: Enuresis is a common problem in children. One treatment option is a wetting alarm that provides an alarm when incontinence occurs. A drawback of this approach is that the child is still awakened by wet sheets. Recently, a wearable, wireless ultrasonic bladder sensor became available, the SENS-U, which has the potential to prevent the enuretic event by waking up the child before the bladder is full. In this first feasibility study, the aim is to perform a night-time, home-based evaluation of the SENS-U in children with monosymptomatic nocturnal enuresis (MNE). PATIENTS AND METHODS: In this study, children (6-12 years) with MNE were included for a one-night monitoring session. During the night, the SENS-U continuously (i.e. every 30 s) estimated the filling status [notifications were deactivated]. In addition, urine volume was collected in a measurement cup (or diaper weight). The total measured natural nocturnal bladder filling (NNBF) cycles was analyzed by descriptive statistics. Before and after the measurement, sleep behavior was assessed by a selection of the Children's Sleep Habits Questionnaire. RESULTS: Fifteen patients (boys/girls: 13/2) [mean age: 8.6 ± 1.5 years] have been enrolled. One patient was excluded due to inadequate sensor-to-skin contact. For 14 children, 18 NNBF cycles were recorded (voiding diary) of which three patients (21%) had more than one NNBF cycle. The SENS-U was able to successfully detect 83% of the NNBF cycles. The three missed NNBF cycles had a voided volume ≤30 ml, which was at the lower limit of the sensor's detection range. The SENS-U had no effect on sleeping behavior. CONCLUSION: The SENS-U was able to monitor the natural nocturnal bladder filling successfully in children with monosymptomatic nocturnal enuresis at home, without disturbing their sleep. Future research focuses on investigating the usability of the SENS-U for both diagnostic - and treatment purposes.

SENS-U: clinical evaluation of a full-bladder notification - a pilot study.

INTRODUCTION: Urinary incontinence is one of the most commonly treated disorders in children at school age. Recently, a new, wearable bladder sensor became available, the SENS-U Bladder Sensor. The SENS-U is a small, wireless ultrasonic sensor, which continuously monitors the bladder filling and provides a personalized notification when it is time to go to the toilet. In this study, the aim was to examine the performance of the SENS-U as a full-bladder-based notification system in children during daily life activities. PATIENTS AND METHODS: In this pilot study, children (6-16 years) who were admitted for an inpatient bladder training were included. Parallel to one training day, the child would wear the SENS-U to estimate the bladder filling and it informed the child when the bladder was almost full. When the child received a full-bladder notification, the child was taught to inform the urotherapist/researcher, in order to determine the level of response. RESULTS: Fifteen patients (boys/girls: 7/8; mean age: 11.5 ± 1.7 years) were included. Based on a personalized volume-based threshold, the SENS-U notified these children of a full bladder with a median notification rate of 92.9%. In the remaining cases, children voided before the threshold was reached (e.g. defecation). Children responded positively to the notification of the SENS-U, resulting in a median level of response equal to 100%. CONCLUSION: The SENS-U was able to monitor the natural bladder filling accurately during activities of daily living and provided a personalized notification to the children when it was almost time to go to the toilet. Future research will focus on investigating the efficacy of the SENS-U compared to daily clinical practices.

SENS-U: validation of a wearable ultrasonic bladder monitor in children during urodynamic studies.

PURPOSE: Urinary incontinence is a common problem in school-age children. Because many children remain unaware of a full-bladder sensation, the SENS-U™ Bladder Sensor was developed. The SENS-U is a small, wearable ultrasound sensor, which is positioned on the lower abdomen using a skin-friendly adhesive. The sensor continuously estimates the bladder filling status and informs the user when it is time to go to the toilet. In this study, the clinical performance of the SENS-U is evaluated in children during (video) urodynamics. MATERIAL AND METHODS: In this study, 30 children (6-12 years) were included who were scheduled for a (video) urodynamic study. During urodynamics, the SENS-U determined the average anterior-posterior (A-P) bladder dimension (every 30 s) to estimate the filling status. The correlation between the average A-P bladder dimension and the infused volume is analyzed by Spearman's correlation. RESULTS: Thirty patients (boys/girls: 15/15; mean age: 7.9 ± 1.4 years) were included, in whom the SENS-U detected the full bladder before voiding in 90% of the patients (27/30). In the other patients, the bladder was outside the detection area due to either erroneous sensor placement (n = 1) or an (relative) obese abdomen in the upright position (n = 2). There was a strong correlation (median rs = 0.94) between the average A-P bladder dimension and the infused volume. The detectable maximum bladder volume ranged between 71 and 463 ml. CONCLUSION: The SENS-U is able to detect a full bladder with a success rate of 90%. When excluding erroneous data due to sensor misplacement or an (relative) obese abdomen, the detection rate may even be higher. Future research will focus on investigating the effect of theSENS-U in incontinence training.