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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The intervention is the using geko device

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

geko(TM) device

Intervention Type DEVICE

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

Interventions

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geko(TM) device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No