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
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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