Development and psychometric evaluation of the ICIQ-LTCqol: A self-report quality of life questionnaire for long-term indwelling catheter users.

AIMS: Long-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: www.iciq.net. METHODS: In-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 α 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. RESULTS: The 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. CONCLUSION: The 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.

Clinical Evaluation of a Prototype Underwear Designed to Detect Urine Leakage From Continence Pads.

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.

Living with a long-term, indwelling urinary catheter: catheter users' experience.

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.

Does nurse self-testing affect catheter choice?

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.

A clinical evaluation of a sensor to detect blockage due to crystalline biofilm formation on indwelling urinary catheters.

OBJECTIVE: To test the performance and acceptability of an early warning sensor to predict encrustation and blockage of long-term indwelling urinary catheters. PATIENTS AND METHODS: In 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. RESULTS: Urease-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. CONCLUSIONS: The 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.

An exploration of the hydration care of older people: a qualitative study.

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.

Developing a new treatment device: how to get an idea to the marketplace.

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.

In vitro multicompartmental bladder model for assessing blockage of urinary catheters: effect of hydrogel coating on dynamics of Proteus mirabilis growth.

OBJECTIVES: To investigate the effect of a hydrogel coating on the dynamics of bacterial growth in laboratory models of the catheterized bladder. Infection of the urinary tract by Proteus mirabilis can result in catheter blockage by crystalline biofilm, a common complication in patients undergoing long-term bladder catheterization. METHODS: Two series of catheters were tested in the infected bladder models: test series 1, silicone catheters impregnated with triclosan (0.5%, 1%, 4%), or silicone catheters with 0% triclosan impregnated with pure solvents and hydrogel coated (based on polyvinylpyrrolidone); and test series 2, silicone catheters, hydrogel-coated with hydrogel plus iodine (polyvinylpyrrolidone plus iodine) or hydrogel plus polyhexamethylene biguanide. Test series 1 was used to detect the influence of triclosan, solvents, impregnation time, and the presence of hydrogel coating on the interval to catheter blockage by P. mirabilis biofilm. The experiments with test series 2 focused on the dynamic interaction of the hydrogel coating and biofilm formation. The division of the catheterized bladder model into 3 sampling zones brought more information about the spatial segregation of the bacterial population. RESULTS: The bacteriostatic efficiency of the water-soluble polyhexamethylene biguanide and polyvinylpyrrolidone iodine complex was limited to the first hours after catheterization. Only catheters containing triclosan resisted encrustation for significantly longer (up to >7 days). In contrast, the uncoated and hydrogel-coated catheters were occluded by day 2. CONCLUSIONS: The hydrogel layer can increase aggregation of the planktonic cells and newly nucleated crystals, leading to even faster catheter blockage than in the case of uncoated silicone. However, the addition of active agents were able to suppress this negative effect.

Neuropeptide expression following constriction or section of the inferior alveolar nerve in the ferret.

Some of the sensory abnormalities that follow peripheral nerve injury may result from the development of ectopic discharge from the damaged axons. Previous studies in our laboratory have shown that, following tight ligation of the inferior alveolar nerve (IAN), there is a close association between the time-course of this neural activity and the accumulation of neuropeptides at the injury site. In this study we investigated whether the type of injury has any effect on the time-course or level of neuropeptide expression. In 36 adult ferrets, the IAN was either loosely constricted or sectioned, and the animals left to recover for 3 days, 3 weeks, or 3 months. The tissue was processed using indirect immunofluorescence and image analysis was used to quantify levels of substance P, calcitonin gene-related peptide, vasoactive intestinal polypeptide, enkephalin, galanin, and neuropeptide Y. Immunoreactivity to all of the neuropeptides was present within the injured nerve 3 days after both types of injury, and decreased to lower levels by 3 weeks and 3 months. Comparisons between the levels of neuropeptide immunoreactivity in each group revealed that the pattern of accumulation was similar following loose constriction or section, and also similar to that found in our previous study on tight ligation. For each injury the time-course of neuropeptide expression was similar to that of the spontaneous activity we had previously recorded. These data support the suggestion that neuropeptide accumulation may be linked to the development of ectopic neural activity but indicate that the type of injury has little effect on the extent of expression.