Does FENIX Magnetic Sphincter Augmentation alter Anorectal Physiology?
Research type
Research Study
Full title
Does FENIX Magnetic Sphincter Augmentation alter the functional and sensory components of anal continence? A physiological assessment.
IRAS ID
186493
Contact name
John Casey
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Faecal incontinence is a distressing disorder that reduces quality of life and affects ability to cope with day-to-day tasks. Thorough investigation of patients with faecal incontinence is necessary to select the most appropriate treatment options. Anorectal Physiology (ARP) testing helps to identify functional problems with the lower bowel that account for incontinence symptoms. These tests are routinely performed before deciding on management options.
Aims:
The aim of this study is to look at the way a relatively new surgical treatment for faecal incontinence (FENIX-magnetic sphincter) affects the strength and function of the lower bowel (anal muscles and rectum) through ARP testing. A comparison between pre-FENIX and post-FENIX ARP will be made to determine this. We will also look at how this treatment affects symptoms of faecal incontinence through a validated symptom severity questionnaire.Method:
The study will take part within the Department of Gastrointestinal Physiology based at the Leeds General Infirmary. Pre-surgical ARP investigations are routinely requested by patients’ specialists, these form part of the normal diagnostic work-up. Anorectal manometry, a key ARP test, involves passage of a small pressure-measuring catheter into the anal canal, various measurements are performed to determine the strength, function and sensitivity of the anal muscles and rectum. All patients routinely undergo pre-surgical symptom severity assessment via a validated questionnaire.Patients who have previously attended for anorectal manometry within our department, who later go onto have FENIX-MSA for treatment of faecal incontinence will be invited to take part in the study (aim: 10-15 participants). For those who decide to take part, post-FENIX anorectal manometry and symptom severity assessment will be performed by a qualified Clinical Physiologist.
The main objective is to assess whether the relatively new surgical treatment of faecal incontinence (FENIX) modifies ARP findings assessed via anorectal manometry.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0304
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion