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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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
geko(TM) device
Sponsored by
Firstkind Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fecal Incontinence

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female
  2. Aged 60 and over?
  3. Reporting faecal incontinence of any severity
  4. Living in own home or a Care Home
  5. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
  6. Able and willing to follow the protocol requirements.

Exclusion Criteria:

  1. Patients or Carers unable to speak, read or understand English
  2. Patients or Carers unable to give informed consent because of lack of capacity
  3. Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
  4. Have implantable electronic devices
  5. 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.
  6. Any cancerous lesions in the lower limb
  7. Is pregnant

Sites / Locations

  • Sussex Community NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

geko device arm

Arm Description

geko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Studying the feasibility of older people or their carers applying the device
Interviews performed post treatment will measure this aspect of the study
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.

Full Information

First Posted
May 11, 2016
Last Updated
February 6, 2018
Sponsor
Firstkind Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02875665
Brief Title
Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
Official Title
Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The intervention is the using geko device
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
geko device arm
Arm Type
Experimental
Arm Description
geko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day
Intervention Type
Device
Intervention Name(s)
geko(TM) device
Intervention Description
The geko(TM) device will be used to electrically stimulate the posterior tibial nerve
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Studying the feasibility of older people or their carers applying the device
Description
Interviews performed post treatment will measure this aspect of the study
Time Frame
1 week
Title
Skin reactions to using the device on the leg of older people measured by clinical examination
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Norton, Prof
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sussex Community NHS Foundation Trust
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 3EW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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