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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| geko device arm | Experimental | gekoâ„¢ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geko(TM) device | Device | The geko(TM) device will be used to electrically stimulate the posterior tibial nerve |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Norton, Prof | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sussex Community NHS Foundation Trust | Brighton | East Sussex | BN2 3EW | United Kingdom |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The intervention is the using geko device
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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 |