Treatment of Nocturnal Enuresis Using Miniaturised Smart Mechatronics With Artificial Intelligence.

Our study was designed to develop a customisable, wearable, and comfortable medical device - the text so-called "MyPAD" that monitors the fullness of the bladder, triggering an alarm indicating the need to void, in order to prevent badwetting - i.e., treating Nocturnal Enuresis (NE) at the text pre-void stage using miniaturised mechatronics with Artificial Intelligence (AI). The developed features include: multiple bespoke ultrasound (US) probes for sensing, a bespoke electronic device housing custom US electronics for signal processing, a bedside alarm box for processing the echoed pulses and generating alarms, and a phantom to mimic the human body. The validation of the system is conducted on the text tissue-mimicking phantom and volunteers using Bidirectional Long Short-Term Memory Recurrent Neural Networks (Bi-LSTM-RNN) and Reinforcement Learning (RL). A Se value of 99% and a Sp value of 99.5% with an overall accuracy rate of 99.3% are observed. The obtained results demonstrate successful empirical evidence for the viability of the device, both in monitoring bladder expansion to determine voiding need and in reinforcing the continuous learning and customisation of the device for bladder control through consecutive uses. Clinical impact: MyPAD will treat the NE better and efficiently against other techniques currently used (e.g., post-void alarms) and will i) replace those techniques quickly considering sufferers' condition while being treated by other approaches, and ii) enable children to gain control of incontinence over time and consistently have dry nights. Category: Early/Pre-Clinical Research.

Systematic voiding programme in adults with urinary incontinence following acute stroke: the ICONS-II RCT.

BACKGROUND: Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively. OBJECTIVE: The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital. DESIGN: This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot. SETTING: Eighteen NHS stroke services with stroke units took part. PARTICIPANTS: Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment. INTERVENTION: Participants were randomised to the intervention, a systematic voiding programme, or to usual care. The systematic voiding programme comprised assessment, behavioural interventions (bladder training or prompted voiding) and review. The assessment included evaluation of the need for and possible removal of an indwelling urinary catheter. The intervention began within 24 hours of recruitment and continued until discharge from the stroke unit. MAIN OUTCOME MEASURES: The primary outcome measure was severity of urinary incontinence (measured using the International Consultation on Incontinence Questionnaire) at 3 months post randomisation. Secondary outcome measures were taken at 3 and 6 months after randomisation and on discharge from the stroke unit. They included severity of urinary incontinence (at discharge and at 6 months), urinary symptoms, number of urinary tract infections, number of days indwelling urinary catheter was in situ, functional independence, quality of life, falls, mortality rate and costs. The trial statistician remained blinded until clinical effectiveness analysis was complete. RESULTS: The planned sample size was 1024 participants, with 512 allocated to each of the intervention and the usual-care groups. The internal pilot did not meet the target for recruitment and was extended to March 2020, with changes made to address low recruitment. The trial was paused in March 2020 because of COVID-19, and was later stopped, at which point 157 participants had been randomised (intervention, n = 79; usual care, n = 78). There were major issues with attrition, with 45% of the primary outcome data missing: 56% of the intervention group data and 35% of the usual-care group data. In terms of the primary outcome, patients allocated to the intervention group had a lower score for severity of urinary incontinence (higher scores indicate greater severity in urinary incontinence) than those allocated to the usual-care group, with means (standard deviations) of 8.1 (7.4) and 9.1 (7.8), respectively. LIMITATIONS: The trial was unable to recruit sufficient participants and had very high attrition, which resulted in seriously underpowered results. CONCLUSIONS: The internal pilot did not meet its target for recruitment and, despite recruitment subsequently being more promising, it was concluded that the trial was not feasible owing to the combined problems of poor recruitment, poor retention and COVID-19. The intervention group had a slightly lower score for severity of urinary incontinence at 3 months post randomisation, but this result should be interpreted with caution. FUTURE WORK: Further studies to assess the effectiveness of an intervention starting in or continuing into the community are required. TRIAL REGISTRATION: This trial is registered as ISRCTN14005026. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 31. See the NIHR Journals Library website for further project information.

Urinary incontinence affects around half of stroke survivors. It causes embarrassment and distress, affecting patients' ability to take part in rehabilitation. It also has a major impact on families and may determine whether or not patients are able to return home. Finding the underlying cause and addressing it can prevent, cure or reduce problems. Doing this in a systematic way for everyone with incontinence problems as early as possible after the stroke, while they are still in hospital, may work best. We also wanted to avoid using catheters in the bladder to drain the urine away, as these are often unnecessary and can cause urinary tract infections. This study aimed to test whether or not continence problems and the use of urinary catheters could be reduced if everyone with incontinence was fully assessed and given the right management and support early after hospital admission. We also wanted to find out if the benefits outweighed the costs. We planned to involve 1024 men and women with incontinence from 18 stroke units in the study, with 512 people receiving the intervention and 512 receiving usual care. However, the trial was paused because of COVID-19, at which time only 157 participants had been recruited. When we were thinking about restarting the study and looked at its progress, we found that not enough people had agreed to take part and, of those who had agreed, many had not returned their outcome questionnaires. This indicated that the trial was not feasible and should not restart. We could not make any firm conclusions about whether or not the intervention worked, as not enough people were involved. We found that stays in hospital after stroke are shorter than they were in the past. This suggests that future studies investigating ways of treating incontinence should consider interventions with management and support for incontinence that continue after patients leave the hospital.

Intelligent autonomous treatment of bedwetting using non-invasive wearable advanced mechatronics systems and MEMS sensors : Intelligent autonomous bladder monitoring to treat NE.

Post-void alarm systems to monitor bedwetting in nocturnal enuresis (NE) have been deemed unsatisfactory. The aim of this study is to develop a safe, comfortable and non-invasive pre-void wearable alarm and associated technologies using advanced mechatronics. Each stage of development includes patient and public involvement and engagement (PPI). The early stages of the development involved children with and without NE (and parents) who were tested at a hospital under the supervision of physicians, radiologists, psychologists, and nurses. The readings of the wearable device were simultaneously compared with B-mode images and measurements, acquired from a conventional ultrasound device, and were found to correlate highly. The results showed that determining imminent voiding need is viable using non-invasive sensors. Following on from "proof of concept," a bespoke advanced mechatronics device has been developed. The device houses custom electronics, an ultrasound system, intelligent software, a user-friendly smartphone application, bedside alarm box, and a dedicated undergarment, along with a self-adhesive gel pad-designed to keep the MEMS sensors aligned with the abdomen. Testing of the device with phantoms and volunteers has been successful in determining bladder volume and associated voiding need. Five miniaturised, and therefore more ergonomic, versions of the device are being developed, with an enabled connection to the cloud platform for location independent control and monitoring. Thereafter, the enhanced device will be tested with children with NE at their homes for 14 weeks, to gain feedback relating to wearability and data collection involving the cloud platform. Graphical Abstract Design of the MyPAD advanced mechatronics system.

Patient Engagement in Medical Device Design: Refining the Essential Attributes of a Wearable, Pre-Void, Ultrasound Alarm for Nocturnal Enuresis.

BACKGROUND: To date, no pre-void wearable alarm exists to treat nocturnal enuresis (NE)-night-time bedwetting, and children with NE and their families are disappointed in relation to the post-void moisture alarms and medicine currently available. Development of a safe, comfortable and non-invasive wearable pre-void alarm and associated technology, using advanced mechatronics, is underway (the MyPAD device). Each stage of development includes patient and public involvement (PPI), particularly with respect to human factors, in collaboration with physicians, radiologists, psychologists, nurses, engineers and designers. OBJECTIVES: The aim of this study was to help us understand the families' experience of the condition of enuresis, and to provide opinion relating to existing NE alarms, designed to detect moisture, and most importantly, the initial design of the MyPAD wearable technology. METHODS: A PPI workshop in the form of a focus group, made up of children with enuresis and their parents, was conducted during the early stage of the MyPAD product development. The key research questions (RQs) were: (RQ1) What were the families' experiences of using existing post-void enuresis alarms? (RQ2) What do families like about the MyPAD prototype? and (RQ3) What do families not like about the MyPAD prototype? A nurse specialised in terms of NE treatment, including post-void alarms, from the Lancashire Teaching Hospitals NHS Foundation Trust, and two MyPAD design engineers were also present, to explain the MyPAD design concept. Braun and Clarke's six-phase approach to thematic analysis was implemented, which included familiarisation with the data, initial descriptive coding, identifying themes, reviewing themes, defining and labelling themes and producing a report. RESULTS: Four common themes were identified from the focus group discussions: the importance of sleep; children do not want to feel different; parents feel frustrated and concerned; resilience and perseverance. These themes applied across the research questions; for example, sleep disruption was highlighted as an issue with existing post-void alarms and as an important requirement for the design of MyPAD. The evaluation of the early version of the MyPAD device has prompted the consideration of changes to some existing facets of the device, including providing multiple alarm types, more options for the design of the garment that houses the device, and the need for clear, age-appropriate and informative instructions relating to how the device should be used, in order to maximise its performance/efficiency and acceptance. CONCLUSIONS: The qualitative data derived from the focus group discussion was incredibly valuable as it enabled the research and design team to experience the perspectives of the families in terms of the challenges and conflicts of managing the condition and the limited utility of existing post-void alarms. This has improved our understanding of the social and environmental challenges that will need to be considered during the design process.

A matrix for the qualitative evaluation of nursing tasks.

AIMS: To formulate a model for patient-nurse interaction; to compile a comprehensive list of nursing tasks on hospital wards; and to construct a nursing tasks demand matrix. BACKGROUND: The physical demands associated with nursing profession are of growing interest among researchers. Yet, it is the complexity of nursing tasks that defines the demands of ward nurses' role. This study explores nursing tasks, based on patient-nurse interaction on hospital wards. METHODS: Extant literature was reviewed to formulate a patient-nurse interaction model. Twenty ward nurses were interviewed to compile a list of nursing tasks. These nursing tasks were mapped against the patient-nurse interaction model. RESULTS: A patient-nurse interaction model was created, consisting of: (1) patient care, (2) patient surveillance and (3) patient support. Twenty-three nursing tasks were identified. The nursing tasks demand matrix was constructed. CONCLUSIONS: Ward managers may use a nursing tasks demand matrix to determine the demands of nursing tasks on ward nurses. IMPLICATIONS FOR NURSING MANAGEMENT: While many studies have explored either the physical or the psychosocial aspects of nursing tasks separately, this study suggests that the physicality of nursing tasks must be evaluated in tandem with their complexity. Ward managers may take a holistic approach to nursing tasks evaluation by using a nursing tasks demand matrix.