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OpenTrials
Completed

NCT Number: NCT02875665

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

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:

1. device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions; 2. tolerability of device: skin tolerability.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sussex Community NHS Foundation Trust

Brighton, East Sussex, BN2 3EW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geko(TM) device

Device

The geko(TM) device will be used to electrically stimulate the posterior tibial nerve

Primary outcomes

  1. 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.

    Time frame: 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.

Secondary outcomes

  1. Studying the feasibility of older people or their carers applying the device

    Time frame: 1 week

    Interviews performed post treatment will measure this aspect of the study

  2. Skin reactions to using the device on the leg of older people measured by clinical examination

    Time frame: 1 week

    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.

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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