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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875665
• Other study ID #: FKD-SBRI-001
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: February 6, 2018
• Start date: April 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2018
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 30, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sussex Community NHS Foundation Trust	Brighton	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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