Deliverables
Women with severe continence difficulties have a very limited range of management options, either catheters or bulky pads. The Non-Invasive Continence Management System (NICMS) has been designed to provide a practical, non-invasive, alternative to conventional solutions. The device will provide suffers with independence and freedom from the inconvenience of coping with their incontinence throughout the day.
CE marked Prototype device were sent out to partners across Europe for evaluation by users. Results were gathered with evaluation questionnaires which were filled in by the user and/or carer with help if necessary from the researchers.
The system was mainly tested with the urinal interface but we have limited user feedback for the pad interface.
The clinical evaluation was designed to get the maximum feedback from the participants so that the device can be improved and developed to suit user requirements. The NICMS liquid handling system was given a good or ok rating by 74% of participants with 24% giving a poor rating. Positive themes included the ease of cleaning, the lack of odour and ease of use. Many of the negative findings were related to the prototype nature of the device. The recurrent negative themes were lack of reliability, size, weight and noise. The NICMS urinal was found to be easy to remove and clean, kind to skin and comfortable. Some participants lacked confidence in the urinal because of its small size and some found it difficult to position.
The NICMS with the urinal interface has the potential to provide an excellent toileting system for selected individuals by increasing independence, reducing the requirement for pads and reducing the amount of carer support required. However, we need to develop the finished product to be more reliable, smaller/lighter and quieter.
It has been estimated that some 200 million people worldwide are affected by the problem of urinary incontinence with around twice as many women as men suffering from the condition. People with neurological problems and/or mobility limitations are particularly prone to continence difficulties often exacerbated by the difficulty of transfer to the toilet in time. For women in particular continence management solutions are extremely limited. Indwelling catheters are associated with a host of medical problems, particularly urinary tract infections and urethral erosions. Large disposable pads to absorb urine are a safer, non-invasive option but are far from an ideal solution. Pads are bulky and require frequent changing if the wearer is to remain comfortable and free from odour problems.
For less mobile patients and those with sensory loss, wet pads can exacerbate the risk of pressure injury. The problem is particularly acute for wheelchair users whose restricted mobility can prevent them from changing pads independently. People, who might otherwise prefer independent living, are often forced to accept residential care because of difficulties in coping with their continence needs.
The NICMS Liquid handling system is a portable unit which is able to remove urine rapidly from a non-invasive interface (pad or urinal) into a secure storage container remote from the user's body. This patented technology has been developed into clinically applicable, CE marked prototypes which were tested in six countries across Europe.
Using the results of these clinical evaluations we aim to develop a manufacturable user-centred product that can provide an alternative continence management option for women.
Women with severe continence difficulties have a very limited range of management options, either catheters or bulky pads. The Non-Invasive Continence Management System (NICMS) has been designed to provide a practical, non-invasive, alternative to conventional solutions. The device will provide suffers with independence and freedom from the inconvenience of coping with their incontinence throughout the day.
The NICMS will automatically remove urine as quickly as it is produced, leaving the person dry and comfortable. The urine is discretely drawn away into a container that can be emptied when it is convenient. The small non-absorbent pad with integral sensor is designed to be worn all day. The pad provides a non-invasive interface between the user and the liquid handling system.
We have been able to produce prototypes suitable for clinical tests with the help of our healthy volunteers and have also completed a very limited number of patient tests. Further development work is needed before the pad interface is ready for production design. We need to collaborate with a manufacturer to prototype some pads from materials suitable for mass production.
The first prototype NICMS interfaces have been developed for day- time use. We envisage significant changes will be necessary to the design of the pad and the urinal to optimise the designs for night- time use.
The National Health Service estimates that 3-6 million people in the UK alone have some degree of incontinence. Urinary incontinence becomes more common as people get older but it does not only affect older people. It is twice as common in women than men and affects many women who have had children. Although the NICMS with pad interface will not be suitable for every woman with urinary incontinence, the potential market for a successful pad interface is very large.
The NICMS device uses a specialised high bubble-point filter to remove air from the flow of liquid into the storage container. This allows us to use a very small pump to create and to replenish the stored vacuum which drives the removal of urine from the non-invasive Patient/device interface.
In the original patent this high bubble point filter was unprotected but we soon discovered that additional particulate filters were needed to prolong the life of the high bubble point material.
The improved filter unit developed during the project has a pleat pack of particulate filtration to ensure that the high bubble point filter remains clean. We have also incorporated odour and moisture reducing material in the air outlet line in the centre of the filter unit. The odour protection was very efficient according to the results from our clinical evaluation.
This disposable unit will enable the device to function with optimum performance throughout the day. The filter is changed once every 24 hours to ensure effective liquid flow rates.
The prototype filter used for the project was effective but not optimum in performance or price. Rapidly tooling and lack of proper automated production meant that the filters were more expensive and less reliable than a commercially produced unit.
Conventional female urinals are very under used because they only work effectively if the user can stand or at least get to the edge of the chair if unable to stand. This is because sitting in a chair creates a dip and the urine outlet for a woman is close to the lowest point of this dip. Conventional female urinals need a large capacity so they are large and can be difficult to insert and remove.
NICMS slimline urinal does not need a large capacity because urine is drawn away as quickly as it is produced into the Liquid Handling System, which contains the urine safely until it is convenient for it to be emptied. This means the NICMS urinal can be very small. The user does not need to undress to use the NICMS; they only need to loosen clothes to put the small urinal interface in place. This NICMS is usable by far more women than traditional female urinals and will enable many women with limited mobility to retain their continence.
Until the development of the instrumented urinal there was no means of investigating urine flow position in women. The instrumented urinal was developed in the NICMS to inform the design of the slim line NICMS urinal.
While the instrumented urinal is unlikely to have huge commercial impact it is a useful research tool with the potential to improve a variety of continence management products and to increase understanding of urinary continence events.
A paper has been submitted describing the research tool.
The instrument urinal was developed to inform the design of patient device/interfaces for the NICMS device. Until this research and development tool was produced there was not information available about the position or flow characteristics of urine flow in women. The instrumented urinal can be used for investigating urine flow in control groups and in subjects treated with different pharmacological and surgical therapies. It is also an invaluable aid to continence product development.
Technology could be used for continence research by the by interested teams. UCL would be happy to consider collaborative research proposals for interested parties.
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