NCT02875665

Brief 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. 1.device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
  2. 2.tolerability of device: skin tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

May 11, 2016

Last Update Submit

February 6, 2018

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Studying the feasibility of older people or their carers applying the device

    1 week

  • Skin reactions to using the device on the leg of older people measured by clinical examination

    1 week

Study Arms (1)

geko device arm

EXPERIMENTAL

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

Interventions

geko(TM) deviceDEVICE

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

geko device arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Aged 60 and over?
  • Reporting faecal incontinence of any severity
  • Living in own home or a Care Home
  • Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
  • Able and willing to follow the protocol requirements.

You may not qualify if:

  • Patients or Carers unable to speak, read or understand English
  • Patients or Carers unable to give informed consent because of lack of capacity
  • Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
  • Have implantable electronic devices
  • 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.
  • Any cancerous lesions in the lower limb
  • Is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Community NHS Foundation Trust

Brighton, East Sussex, BN2 3EW, United Kingdom

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christine Norton, Prof

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The intervention is the using geko device
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

August 23, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 30, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)