ARP and Renew Anal Inserts Efficacy
Research type
Research Study
Full title
Can anorectal manometry parameters predict efficacy of Renew® Anal Inserts in patients suffering from faecal incontinence?
IRAS ID
265562
Contact name
Fatima Meskin
Contact email
Sponsor organisation
Ashford and St. Peter's Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Faecal incontinence describes accidental stool leakage and is very common in older men and women. Incontinence can occur by not getting to a toilet in time, by unknowingly leaking or if stool has not been passed in a long time. Understandably, it causes a lot of bother to those suffering as people find it unhygienic and embarrassing. The treatment options available are limited and clinical practice aims to trial conservative methods first to avoid invasive options such as surgery.
Anal inserts are small, silicon inserts that are placed within the anal canal to prevent unwanted stool leakage. They can be removed by going to the toilet or being removed manually. Anal inserts are routinely used in the care of patients with FI. There is however, no clear evidence as to which patients in particular will benefit from their use.
Anorectal Physiology is an investigation routinely performed in patients with FI. It measures the muscle strength around the back passage and it may be that the results from this test can identify which patients are likely to find the inserts useful.
By prescribing the inserts to patients with FI who’ve been referred for this test, we can find out which patients see a benefit from their use. We will then see if there is any relationship between those who saw improvements and each patient’s original Anorectal Physiology results. This may help with treating patients with incontinence and streamlining their treatment and care with improved results.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0496
Date of REC Opinion
18 Oct 2019
REC opinion
Further Information Favourable Opinion