一款旨在检测失禁垫尿液渗漏的原型内衣的临床评估

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

作者信息

Long Adele, Edwards Julia, Worthington Joanna, Cotterill Nikki, Weir Iain, Drake Marcus J, van den Heuvel Eleanor

机构信息

Adele Long, MPhil, MBA, BSc (Hons), Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, England. Julia Edwards, BSc, Cert Adv Nursing, RN, Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, England. Joanna Worthington, PhD, BSc (Hons), Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, England. Nikki Cotterill, PhD, RN, Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, England. Iain Weir, PhD, MSc, BSc (Hons), Department of Mathematics and Statistics, University of the West of England, Bristol, England. Marcus J. Drake, FRCS Eng, BM, BCh, Oxon, Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, England. Eleanor van den Heuvel, BSc (Hons), MSc, Brunel Institute for Bioengineering, Brunel University, Uxbridge, Middlesex, United Kingdom.

出版信息

J Wound Ostomy Continence Nurs. 2015 Nov-Dec;42(6):632-9. doi: 10.1097/WON.0000000000000178.

DOI:10.1097/WON.0000000000000178

PMID:26528874

Abstract

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.

摘要

目的

我们评估了旨在检测失禁垫尿液渗漏的原型内衣的性能、用户对其的接受程度以及其对健康相关生活质量和心理社会因素的影响。

设计

原型产品评估。

研究对象与地点

参与者为81名女性，平均年龄67岁（范围32 - 98岁），于2010年10月至2012年2月间从门诊诊所、全科医疗诊所、社区失禁服务机构以及通过慈善机构和网络招募而来。

方法

TACT3项目研发并制造了一种原型内衣，旨在在垫料渗漏到外衣或家具之前提醒穿着者。该研究分两个阶段进行：一个试点/可行性研究以评估总体性能，以及一个更大规模的研究以测量性能、用户接受程度、健康相关生活质量和心理社会影响。参与者被要求穿着原型内衣两周，前7天每天记录渗漏事件。他们还完成了测量下尿路症状、健康相关生活质量和心理社会影响的有效工具。

结果

平均而言，参与者有86%的时间能收到垫料渗漏事件的提醒。超过90%的人认为原型内衣“好”或“还可以”，并且认为它会或能够给他们更多信心。国际尿失禁咨询问卷 - 尿失禁简表的平均得分表明干预前后报告的症状水平没有变化，除了旅行限制有所改善外，健康相关生活质量状况没有显著变化。通过辅助设备心理社会影响量表进行的评估也显示出积极影响。