Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability.
研究概览
简要总结
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing:
- device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
- tolerability of device: skin tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Aged 60 and over?
- •Reporting faecal incontinence of any severity
- •Living in own home or a Care Home
- •Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements.
排除标准
- •Patients or Carers unable to speak, read or understand English
- •Patients or Carers unable to give informed consent because of lack of capacity
- •Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
- •Have implantable electronic devices
- •Has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted.
- •Any cancerous lesions in the lower limb
- •Is pregnant
研究组 & 干预措施
geko device arm
geko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day
干预措施: geko(TM) device (Device)
结局指标
主要结局
Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability.
时间窗: 1 week
Using semi-structured interview style with a topic guide pre and post treatment with gekoTM device- researching the views of the patients using their own words to describe what they felt using geko device. Interviews will be digitally recorded and professionally transcribed through verbatim. Data will be anonymised and analysed using a pragmatic thematic analysis (1). NVivo will be used to support the analysis.
次要结局
- Studying the feasibility of older people or their carers applying the device(1 week)
- Skin reactions to using the device on the leg of older people measured by clinical examination(1 week)