FICUS Control - faecal incontinence cost utilisation study
Research type
Research Study
Full title
FICUS Control; Faecal Incontinence Cost Utilisation Study, a single-centre, controlled, prospective cohort study on standard faecal incontinence care pathway
IRAS ID
216665
Contact name
Diane Benson
Contact email
Sponsor organisation
Lucid Group Ltd
Duration of Study in the UK
1 years, 1 months, 28 days
Research summary
Faecal incontinence (FI), also known as bowel incontinence, is a condition whereby loss of anal sphincter control leads to involuntary release of gas, mucus, solid or liquid stool. Continence services are provided to diagnose and manage FI in the community. In the vast majority of patients an initial diagnosis of FI is made by digital examination of the patient’s ano-rectum alongside a thorough history of symptoms and relevant lifestyle. Some patients are referred to secondary or tertiary specialist health care centres to undergo anorectal manometry for more objective functional assessment. This test is lengthy, with the having to travel to get to the centre. The output of the investigation offers the clinician a better understanding of the physiological factors associated with the patients FI symptoms and allows for better decision making around their specific management and treatment. The FICUS Control study sponsor, LUCID Group, is developing a new medical device, called An-I-sys, to enable specialist continence nurses to perform a modified portable variant of traditional anorectal manometry in a community clinic or patient home setting. Initial studies are ongoing to establish the effectiveness and safety of the new An-I-sys device, with CE marking anticipated at end 2017. The Faecal Incontinence Cost Utilisation Study (FICUS Control) aims to ascertain what the baseline healthcare costs are concerning management of faecal incontinence in the community. This data will inform a follow-up study that will ascertain the cost utilisation concerning the LUCID An-I-sys device in the future. To measure this, the total costs associated with the standard patient pathway for FI in a primary care setting will be collated. Furthermore, patient related outcome measures will be evaluated to again compare this with data once the new device is introduced in a future study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0068
Date of REC Opinion
17 Feb 2017
REC opinion
Further Information Favourable Opinion