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

NCT02875665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-02-07

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

geko(TM) device

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

Sponsors & Collaborators

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • Christine Norton, Prof · King's College London

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-08-31
Completion
2017-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875665 on ClinicalTrials.gov