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

Firstkind

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: geko(TM) device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02875665

FKD-SBRI-001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

geko device arm

Experimental group

Description:

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

Treatment:

Device: geko(TM) device