Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: geko(TM) device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The intervention is the using geko device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: geko device arm<br>geko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day | Device: geko(TM) device<br>* The geko(TM) device will be used to electrically stimulate the posterior tibial nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Studying the feasibility of older people or their carers applying the device | Interviews performed post treatment will measure this aspect of the study | 1 week | 
| Skin reactions to using the device on the leg of older people measured by clinical examination | digital photos will be takes pre and post treatment with geko TM device. The digital photos will be viewed in random order from each participant by a second researcher blinded as to before or after status, and rated for signs of skin reaction using the categories: none, mild, moderate and severe. | 1 week |