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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: geko(TM) device

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 3EW
      • Sussex Community NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: geko device arm; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Firstkind Ltd
• Investigators: Principal Investigator: Christine Norton, Prof, King's College London

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: FKD-SBRI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO