Fully understanding stakeholder needs is important. For each project the participants, methods and timing of involvement should be considered (Vink et al 2008). Methods of engaging stakeholders and users are numerous, but case study examples demonstrating consultation in practice for incontinence product development are not frequently reported. The authors have been involved in a number of user-centred design projects that have been undertaken to enhance the health and dignity of patients and users in the UK. These projects have involved different levels of stakeholder and user involvement in the product development and evaluation process. This paper will describe two case studies focussed on product design for urinary continence management. This is an area in which stakeholder and user engagement is important but can be challenging to achieve. The way in which stakeholders were involved and the resulting impact is described.

Aims: This two phase study aimed to explore health care professionals' teaching and prescribing practice related to intermittent catheterisation and to identify their perceptions about the possible implementation of a mixed (single and multi-use) package for intermittent catheterization.Introduction: Single-use intermittent catheters are the norm in the UK although multi-use is common in some other countries. A recent Cochrane review found no difference in complications, including urinary tract infection rates, between those using single or multi-use catheters. A flexible option of both multi-use and single use intermittent catheters could provide users with more flexible choices in self-care. However, understanding health care professionals' perspectives is one of the keys to developing a multi-use intervention.Design: A qualitative research framework using in-depth interviews to inform an on line survey.Method: In-depth interviews were conducted with health care professionals based in the UK who prescribe catheters, teach intermittent catheterisation or manage an intermittent catheterisation service. The interviewees were selected to represent a range of clinical areas, experience and professions continence advisors, urology, multiple sclerosis (MS) and spinal cord injury specialist nurses, and General Practitioners. Following framework analysis the themes and factors identified were used to develop an on-line survey which was disseminated through health care professional networks whose members saw patients who use intermittent catheters.Results: Nineteen health care professionals participated in the telephone interviews; 206 completed the survey. A wide range of professionals in terms of experience and specialty afforded rich information regarding the contextual issues around the teaching and prescribing of intermittent catheters. The primary finding was that health care professionals were concerned about `minimising health risk' and maximising 'normalcy' for those using intermittent self-catheterisation. Health care professionals who worked in the acute setting or had no experience of re-use were most resistant to the re-use of catheters. Professionals requested evidence that a multi-use package would not increase the risk of developing a urinary tract infection or increase the burden of use to a patient before a mixed package would be considered.Conclusions: For multi-use to be acceptable, evidence based guidelines must be available for healthcare professionals and cleaning methods must be acceptable and safe for intermittent catheter users. Further evidence may be required to establish that a mixed catheter package is equivalent to single use only, particularly for outcomes such as urinary tract infection, urethral injury and quality of life.Relevance to clinical practice: This paper highlights that if multi-use catheters are to be successfully introduced into clinical practice, the ease of use, safety and effectiveness of the cleaning technique will need to be convincingly demonstrated by a range of well-defined users.

Hypothesis / aims of study The MultICath study is investigating the feasibility of introducing a mixed catheter package (single use and re-usables) in the United Kingdom (UK) through the National Health Service (NHS). The creation of an implementation plan, should a mixed package be found to be as safe and acceptable as single use only, is a principal study output. Understanding the impact of this possible change in practice on stakeholders will be essential to successful implementation and normalisation. This paper discusses the barriers and enablers to the introduction of a mixed package identified by industry as a supply chain stakeholder.

© 2014 - IOS Press and the authors. All rights reserved. BACKGROUND: Current outcome measures for continence management devices do not adequately address psychosocial impact. The PIADS is an assessment tool that has been shown to reliably predict the adoption and use of assistive technology devices, but it is not widely used for continence devices.OBJECTIVE: To explore whether the PIADS requires modification to address the particular needs of continence device users and to inform any subsequent item development.METHODS: The study used interpretive methods in which qualitative information from semi-structured interviews was combined with the findings from cognitive interviews for questionnaire pre-testing. A total of 40 participants in UK and Canada were interviewed.CONCLUSIONS: The PIADS appears to fundamentally address many, but not all, of the important psychosocial concerns of adults who have continence difficulties. A version for continence, the C-PIADS, will require modification of the PIADS and is likely to contain some new items.RESULTS: Few participants had difficulty in understanding or relating to the majority of PIADS items. Several items were not considered relevant to continence and some areas for potential new items were uncovered. Embarrassment and concealment of urinary incontinence from others were common topics.

PURPOSE:We evaluated the performance of prototype underwear designed to detect urine leakage from continence pads, their acceptability to users, and their effect on health-related quality of life and psychosocial factors.DESIGN:Prototype product evaluation.SUBJECTS AND SETTING:Participants were 81 women with an average age of 67 years (range, 32-98 years) recruited between October 2010 and February 2012 from outpatient clinics, general practice surgeries, community continence services, and through charities and networks.METHODS:The TACT3 project developed and manufactured a prototype undergarment designed to alert the wearer to a pad leak before it reaches outer clothing or furniture. The study was conducted in 2 stages: a pilot/feasibility study to assess general performance and a larger study to measure performance, acceptability to users, health-related quality of life, and psychosocial impact. Participants were asked to wear the prototype underwear for a period of 2 weeks, keeping a daily diary of leakage events for the first 7 days. They also completed validated instruments measuring lower urinary tract symptoms, health-related quality of life, and psychosocial impact.RESULTS:On average, 86% of the time participants were alerted to pad leakage events. More than 90% thought the prototype underwear was "good" or "OK" and that it would or could give them more confidence. Mean scores for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form indicated no change in the level of symptoms reported before or after the intervention, and no significant changes in health-related quality of life status occurred, except improvement in for travel restrictions. Evaluation via the Psychosocial Impact of Assistive Devices Scale also indicated a positive impact.CONCLUSION:The prototype underwear evaluated in this study was effective and acceptable for 5 out of every 10 wearers. Findings also suggest that the prototype underwear is suitable for women of all ages, dress sizes, and continence severity.

PURPOSE: The purpose of this study was to explore the experiences of long-term catheter users within a heterogeneous population. SUBJECTS AND SETTINGS: The sample comprised 27 community-dwelling long-term catheter users. Participants included 14 female users (4 urethral, 10 suprapubic catheter) and 13 male users (6 urethral, 7 suprapubic) between 22 and 96 years of age. Interviews were conducted in participants' homes except 1, which took place in a urology outpatient department based on the participant's preference. METHODS: A qualitative research design using an interpretive description approach was used for data collection and analysis. All interviews were electronically recorded and transcribed verbatim. Interpretive description involved familiarization with the data, thematic analysis, and the development of an interpretive account. RESULTS: The impact of the catheter and daily living adjustments that catheter users made are captured within 8 themes: (1) making adjustments; (2) managing away from home; (3) nighttime adjustment; (4) catheter problems; (5) social interaction; (6) support from others; (7) unpredictability; and (8) intimacy and body image. CONCLUSIONS: Catheter users' experiences of living with a catheter are shaped by a variety of interrelated factors. Some participants were determined to overcome catheter-related problems and develop self-reliance while others adopted a more resigned approach to living with a catheter. Having a catheter enabled some participants to experience greater freedom while others led more restricted lives as a consequence of catheterization.

ObjectiveTo test the performance and acceptability of an early warning sensor to predict encrustation and blockage of long‐term indwelling urinary catheters.Patients and MethodsIn all, 17 long‐term indwelling catheter users, 15 ‘blockers’ and two ‘non‐blockers’ (controls) were recruited; 11 participants were followed prospectively until catheter change, three withdrew early and three did not start.Two sensors were placed in series between the catheter and the urine bag at catheter change. The sensor nearest the bag was changed at the same time as the bag change (weekly); the sensor nearest the catheter remained in situ for the duration of the catheter's life.Bacteriology and pH determinations were performed on urine samples at each bag, sensor and catheter change. The colour of the sensors was recorded daily. On removal, each sensor and the catheter were examined for visible evidence of encrustation and blockage.Participants were asked to keep a daily diary to record colour change and any other relevant observations and to complete a psychosocial impact of assistive devices tool at the end of the study. Participants and carers/healthcare professionals (when involved in urine bag or catheter change) were asked to complete a questionnaire about the sensor.ResultsUrease‐producing bacteria were isolated from seven of the 14 patients (including early withdrawals; P. mirabilis in four, Morganella or Providencia in three).In six of the seven patients the sensors turned blue‐black; two of these were early withdrawals, two went to planned catheter change (one of these was recruited as a ‘non‐blocker’) and three had catheter blockage.The number of days of catheterisation before blockage was 22, 23 and 25 days, and the sensor changed colour within 24–48 h after insertion.The urine mean (range) pH of the sensors that turned blue‐black was 7.6 (5.5–9.0) and of the sensors that remained yellow 6.1 (5.1–7.5).The sensor was generally well‐received and was positive in the psychosocial assessment.ConclusionsThe sensor is a useful indicator of urine pH and of the conditions that lead to catheter blockage.It may be particularly useful for new indwelling catheter users.To be a universally acceptable predictor of catheter blockage, the time from sensor colour change to blockage needs to be reduced.

PURPOSE:The purpose of this study was to explore the experiences of long-term catheter users within a heterogeneous population.SUBJECTS AND SETTINGS:The sample comprised 27 community-dwelling long-term catheter users. Participants included 14 female users (4 urethral, 10 suprapubic catheter) and 13 male users (6 urethral, 7 suprapubic) between 22 and 96 years of age. Interviews were conducted in participants' homes except 1, which took place in a urology outpatient department based on the participant's preference.METHODS:A qualitative research design using an interpretive description approach was used for data collection and analysis. All interviews were electronically recorded and transcribed verbatim. Interpretive description involved familiarization with the data, thematic analysis, and the development of an interpretive account.RESULTS:The impact of the catheter and daily living adjustments that catheter users made are captured within 8 themes: (1) making adjustments; (2) managing away from home; (3) nighttime adjustment; (4) catheter problems; (5) social interaction; (6) support from others; (7) unpredictability; and (8) intimacy and body image.CONCLUSIONS:Catheter users' experiences of living with a catheter are shaped by a variety of interrelated factors. Some participants were determined to overcome catheter-related problems and develop self-reliance while others adopted a more resigned approach to living with a catheter. Having a catheter enabled some participants to experience greater freedom while others led more restricted lives as a consequence of catheterization.

BACKGROUND:Involving patients in decision making about their care requires expert knowledge and understanding of patients' perspectives. Knowledge comes from several sources and experience; however, the self-testing of products by health professionals who teach clean intermittent self-catheterisation (CISC) has not been investigated.AIM:This study aimed to assess the impact of self-testing on catheter evaluation by continence nurses.METHODS:Sixteen continence nurses self-tested two catheters and completed a questionnaire on their opinions about the catheter, routine self-testing and whether the study would make them change their usual practice.RESULTS:Almost half of the participants found self-testing intermittent catheters a useful experience and some of those who did not routinely self-test said they would do so in future.CONCLUSION:Self-testing intermittent catheters can provide useful knowledge to those who teach CISC.

AimsLong-term indwelling catheterisation may affect health related quality of life, but clinical assessment and monitoring of people with indwelling catheters is poorly recorded because there are no validated measures to capture these criteria. In this paper, we describe the development of the ICIQ-Long Term Catheter quality of life (ICIQ-LTCqol), one of the modules of the ICIQ series, an international project to standardise assessment of lower pelvic dysfunction: .MethodsIn-depth interviews were conducted with 27 catheter-users and 4 informal carers and cognitive debriefing with a further 31 catheter-users and clinical experts to evaluate clarity and comprehensiveness. The draft 44 item questionnaire was then sent by post to 893 long-term catheter-users; the 370 completed questionnaires were used to test content validity, test re-test reliability and internal consistency (Cronbach coefficient). Factor analysis alongside expert opinion was used to formulate the final questionnaire of 16 items. This was then sent by post to another 438 long-term catheter-users to evaluate domain scores.ResultsThe final questionnaire consists of two scored domains: catheter function and concern (9 items) and lifestyle impact (3 items) and four standalone items, relating to pads, pain, sexual activity and bladder spasm. Levels of missing data are good (mean 3.6%) with moderate to good agreement and acceptable internal consistency (Cronbach's alpha 0.76 and 0.74 for each domain respectively), suggesting acceptability and stability of the questionnaire.ConclusionThe ICIQ-LTCqol is a psychometrically robust self-report questionnaire for the clinical assessment and evaluation of health related quality of life for long-term catheter users. Neurourol. Urodynam. 35:423-428, 2016. (c) 2015 Wiley Periodicals, Inc.

A good idea does not inevitably lead to successful innovation; it needs additional “drivers” and coherent activity of a specialized team. The initial idea needs proof‐of‐concept and prototype testing. Alongside, market review must anticipate future need and competitors, and ensure that no current patents are infringed. The likelihood that reimbursement will be secured and that health systems will “adopt” the device has to be considered. Intellectual property (IP) protection is needed to maintain sole rights to exploit the core concept. Non‐disclosure agreements (NDA) should be put in place, and commercial considerations should be remembered before any disclosure in the public domain, including publications. Prospective business partners will review the concept from many perspectives, including stage of device development, effective IP protection, any clinical trial evidence, and whether the device aligns with their business strategy. Royalties arising from sales of a marketed device are distributed to all parties contributing to its development; the party bearing the greater financial burden of developing the final product will gain the greater share of royalties. The innovator's employer will have a call on proceeds if the idea arose in the course of employment. All stages of development require fastidious documentation to meet requirements of the regulatory authorities responsible for permitting use in patients. Specific regulatory requirements depend on which region(s) of the world the device will be marketed in. This review explains all stages of the innovation pathway from concept to adoption, giving practical advice and signposting expertise relevant to each stage. Neurourol. Urodynam. 31:429–436, 2012. © 2011 Wiley Periodicals, Inc.

Social isolation, loss of self esteem and depression are often a consequence of incontinence. The overall aim of this interdisciplinary project was to reduce the impact of continence difficulties and, thus, assist older people in maintaining a positive identity and good quality of life. The TACT3 project was comprised of three research work packages:Assistive technology development:Vibrating underpants: A washable fabric underwear wetness sensor and alert mechanism has been developed to alert continence pad users of leakage. In addition, a colour change odour indicating formula has been developed to indicate the presence of the odour of urine at a just imperceptible level.Challenging environmental barriers to continence: Two sets of stakeholders were involved, older people with continence difficulties and toilet providers. Focus groups, workshops, interviews and photographic diaries were conducted to identify key issues. A web based map locating toilets in London was developed which is called the Great British Toilet Map.Improving continence interventions and services: 140 patients and their carers were interviewed twice within a 12 month interval from a specialist continence clinic for older people and generic continence clinic. Twenty health and social care managers and 200 practitioners were also be interviewed. Care outcomes are being analysed from each clinic and a cost benefit analysis will be carried out.Key findings from this three year interdisciplinary project are highlighted. Prototypes of the vibrating underpants and the odour sensor will be on display. This research was funded by the UK New Dynamics of Ageing Programme.

Background: Older adults are more susceptible to water imbalance and ensuring they drink sufficiently is a complex and challenging issue for nurses. The factors that promote adequate hydration and the barriers which prevent older people from drinking are not well understood.Objective: This study aimed to understand the complexity of issues associated with the hydration and hydration care of older people.Design: A qualitative study using multiple methods.Settings: Two healthcare sites providing care for older people in the South West of England: a hospital ward in a major hospital and a care home providing personal and nursing care.Participants: Twenty-one older people aged 68-96 years, were recruited to the study from the hospital ward and care home. The inclusion criteria for older people to participate were men or women aged 65 years and over and the exclusion criteria were being unable to provide informed consent, or being too ill or distressed to take part in the study. The staff participants of nurses and health care assistants totalled 21. The inclusion criterion for staff was any nurse or health care assistant providing hydration care. Seven friends or relatives participated by making anonymous comments via a suggestion box available to all friends and relatives.Methods: Data were collected via interviews with older people, focus group discussions involving staff, suggestion box comments made by friends and relatives and twelve hours observation of hydration practice. The data were analysed using thematic analysis.Results: Health professionals successfully employed several strategies to promote drinking including verbal prompting, offering choice, placing drinks in older people's hands and assisting with drinking. Older people revealed their experience of drinking was diminished by a variety of factors including a limited aesthetic experience and a focus on fluid consumption rather than on drinking as a pleasurable and social experience.Conclusion: The rich and varied dimensions usually associated with drinking were lacking and the role of drinking beverages to promote social interaction was underplayed in both settings. Hydration practice which supports the individual needs of older people is complex and goes beyond simply ensuring the consumption of adequate fluids. (C) 2012 Elsevier Ltd. All rights reserved.

Continence problems are extremely common in the adult population and prevalence increases with age. Urinary system function can decline with age and concomitant diseases (congestive heart failure, Parkinson's Alzheimer's etc) and mobility problems are more prevalent. Any limitation in mobility is likely to cause difficulties with continence simply because the person finds it difficult to reach the toilet in time or transfer onto it when they get there. The most common method of managing ongoing continence problems is with the use of continence pads. Pads provide a hygienic and socially acceptable solution to incontinence but they are associated with problems that affect both physical and psychological well-being. The objective of this part of our project was to develop underwear that would alert the wearer to a leak from the continence pad. The purpose of this product is to assist the wearer to avoid leakage spreading to outer clothing and the seating surface. This would in turn help prevent the embarrassment of visible leakage and reduce the associated additional cleaning of clothes and soft furnishings. Content: This paper outlines the user-focused design process employed in creating the underwear and describes the technical development of the signaling system. The system comprises a wetness sensor and an electronic signaling unit. The sensor consists of tracks of conductive yarn that are stitched into the underwear. They are used to detect overspills of urine from the pad to the underwear. The signaling unit is a microcontroller-based unit that operates in deep sleep mode and is awoken by electrical contact between the conductive tracks. When triggered, the signaling unit responds by vibrating, alerting to the wearer to a pad leakage event. The paper also discusses user evaluation of the underwear. Results: The results of the technical development and the clinical evaluation are reported. Pilot user evaluation data indicates that prototype product function is acceptable and that the underwear has a role in aiding management of continence problems. Conclusion The product will be a welcome addition to continence aids in the continence market.