Minnesota Medical Technologies faecal incontinence insert evaluation
Research type
Research Study
Full title
Evaluation of the Minnesota Medical Technologies faecal incontinence insert
IRAS ID
269238
Contact name
Christine Norton
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Faecal incontinence (FI) is a common healthcare issue, affecting 2-10% of the adult population (1). While various treatment options are available, cure rates are not high (2) and a significant proportion of patients have remaining symptoms even after maximal treatment options, including for some people surgery to repair or enhance the anal sphincter, have been tried.
A novel anal device, the Minnesota Medical Technologies faecal incontinence insert, has been developed specifically to manage FI and stop leakage. Preliminary (unpublished) user evaluation by the designers/manufacturers has suggested that the new device is both comfortable and effective at stopping FI. The device has CE marking for Europe, but is not yet available on the UK market.
The company has commissioned this independent proof of principle product evaluation. If the device receives positive evaluations, the plan is to proceed to obtaining external funding for a more definitive evaluation, possibly comparing with the current market leading product which is available on Drug Tariff in the UK.
The current project is a 6 month, multi-site, non-randomised interventional study. Adult participants not currently undergoing any active treatment for FI improvement will be invited to take part by their current clinical team. Once consented they will be asked to complete an initial (baseline) questionnaire about their FI experiences as well as a bowel diary. Then they will be given the insert along with instructions for use. Clinical staff will follow up with participants via telephone or clinical visit (depending on patient preference) to support their usage of the device and to answer any further questions they may have. After 12 weeks participants will be asked to complete the follow up questionnaire and a second bowel diary. Qualitative interviews will then be conducted with clinical staff and patient participants to gain more in-depth understanding of their views on the device.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0351
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion