An interventional study of geko(TM) device in Fecal Incontinence, sponsored by Firstkind Ltd. Completed at 1 site in United Kingdom. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Firstkind Ltd · Not applicable, Interventional, and Other
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:
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 13 is below the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Firstkind Ltd is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The geko(TM) device will be used to electrically stimulate the posterior tibial nerve
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.
Time frame: 1 week
Studying the feasibility of older people or their carers applying the device
Interviews performed post treatment will measure this aspect of the study
Time frame: 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.
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Firstkind Ltd