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

February 6, 2018 updated by: Firstkind Ltd

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstkind Ltd

Investigators

  • Principal Investigator: Christine Norton, Prof, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • FKD-SBRI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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