FICUS - faecal incontinence cost utilisation study

• Research type

  Research Study

• Full title

  FICUS; Faecal Incontinence Cost Utilisation Study, a single-centre, controlled, prospective cohort comparative study

• IRAS ID

  216665

• Contact name

  Diane Benson

• Contact email

  diane.benson@cumbria.nhs.uk

• Sponsor organisation

  Lucid Group Ltd

• Duration of Study in the UK

  1 years, 7 months, 31 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. The development of FI often has various contributing factors, such as a patient’s age, a history of childbirth or other conditions such as stroke, colorectal cancer, spinal injury, or gastrointestinal disorders. A large degree of stigma surrounds FI, and therefore it has a severe negative impact on both physical and mental well-being.
  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.
  It is generally agreed that a sound diagnosis of the causative factors is important in the gaining the best outcomes with treatment and management of the patients FI, since it can determine which patients will benefit from either conservative medical or invasive surgical intervention.
  The newly developed An-I-sys medical device is designed to enable specialist continence nurses to perform a modified variant of traditional anorectal manometry in a community clinic or patient home setting. The main difference between the An-I-sys and traditional anorectal manometry is that it is portable, has multifunctionality, yet is easy to use in a primary care setting. Anorectal pressure measurements are fed wirelessly to a dedicated tablet computer rather than by the numerous leads used in traditional anorectal manometry. Initial studies are ongoing to establish the effectiveness and safety of the new An-I-sys device. The results will be known by the end of 2017 and a CE-mark obtained to enable its use in a standard NHS setting, before this present study will utilise the An-I-sys device.
  The Faecal Incontinence Cost Utilisation Study (FICUS) aims to ascertain if the An-I-sys system is a cost effective medical device in a routine primary care-based clinical setting. To measure this, the total costs associated with the use of An-I-sys will be compared to the standard patient pathway for FI in a primary care setting. An appraisal of the cost effectiveness of a new medical device is key, since the National Institute for Health and Care Excellence (NICE), NHS Trusts and commissioners will only support the use of new technology if it is safe and clinically effective, and offers value for money

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  17/NW/0028

• Date of REC Opinion

  13 Jan 2017

• REC opinion

  Unfavourable Opinion