Abstract:Purpose: We evaluated the performance of the smart underwear in detecting 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 (females; pilot study: 8; mean age 62 years: main study 72; mean age 67 years)were recruited between October 2010 and February 2012 from out-patient clinics, GP surgeries, community Continence Services and through charities and networks. Methods: The Tact 3 project developed and manufactured prototype smart underwear designed to alert the wearer to a pad leak before it reached outer clothing or furniture.The clinical study was conducted in 2 stages: a pilot/feasibility study to assess general performance and acceptability of the smart underwear and a larger study to measure its performance, acceptability to users, health related quality of life and psychosocial impact. Participants were asked to wear the smart underwear for a period of two weeks, keeping a daily diary of leakage events for the first seven days. Health related quality of life questionnaires were completed before and after the trial period, and evaluation and psychosocial impact questionnaires completed at the end. Results: On average, 86% of the time participants were alerted to pad leakage events, and over 90% of participants thought the smart underwear to be "good" or "OK" and that it would or could give them more confidence. No symptom changes were recorded using the International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form; a significant difference was found in ability to travel using the International Consultation on Incontinence Questionnaire -Lower Urinary Tract Symptoms quality of life measure. The smart underwear were found to have a positive psychosocial impact using the self-reported PIADS tool. Conclusion: The smart underwear is an effective device in alerting pad wearers to leakage before it is visible to others, and is acceptable to users. Modifications are required to make the device suitable for a wider population of pad wearers who fear pad leakage.
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.
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