Pelvipower for faecal incontinence
Research type
Research Study
Full title
Pilot study to determine clinical efficacy of extracorporeal pelvic floor magnetic neuromuscular stimulation in patients with faecal incontinence
IRAS ID
286909
Contact name
Sam Treadway
Contact email
Sponsor organisation
The Functional Gut Clinic
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Faecal incontinence (FI) is a common condition which drastically reduces patient’s quality of life and for which there are few effective treatments. If first line treatment with antidiarrheal or laxative therapy fails, then it is common practice to employ physiotherapy techniques as second line conservative management strategies with the aim of improving muscle strength, sensory awareness and effective toileting technique, which in turn helps to reduce FI episodes. Whilst these techniques can be effective, a significant proportion of patients remain symptomatic and are then considered for potential surgical treatment. One of the most common form of surgery is sacral nerve stimulation (SNS), which involves implanting a device under the skin that stimulates the sacral nerves, however this is invasive and expensive to perform.
Pelvipower is a commercially available stimulation device built into a patient friendly chair, incorporating a rapid rate magnetic stimulation system and a manoeuvrable stimulation coil. The coil can be used to non-invasively stimulate the nerves and muscles in the pelvic floor that contribute to continence, and it has several potential advantages over existing techniques in terms of cost and convenience, however little research data exists on it's ability to treat faecal incontinence. This study aims to test whether the pelvipower device can be used to successfully reduce faecal incontinence episodes and associated symptoms for sufferers. We will compare the Pelvipower chair to a Sham stimulation, with half the participants receiving the Pelvipower stimulation and half the sham stimulation.
The research will be conducted at the Functional Gut Clinic Manchester and be open to participants with faecal incontinence providing they meet all the criteria. Participants would be involved in the study for around 9 weeks and contacted at 1, 3 and 6 months after their participation for a quick follow up phone call.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
20/YH/0307
Date of REC Opinion
8 Dec 2020
REC opinion
Further Information Favourable Opinion