A transanal irrigation system study in Multiple Sclerosis patients
Research type
Research Study
Full title
A Randomized Controlled Trial comparing the efficacy of Transanal Irrigation with Navina Smart versus Standard Bowel Care in patients with Multiple Sclerosis
IRAS ID
249415
Contact name
Anton Emmanuel
Contact email
Sponsor organisation
Wellspect HealthCare, part of DENTSPLY IH AB
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This is a prospective, randomised, controlled, superiority, multicentre, post-market study of the Navina Smart system for transanal irrigation (TAI) compared with Standard Bowel Care (SBC). 92 Multiple Sclerosis (MS) patients with confirmed bowel issues arising from their MS disease, i.e. Neurogenic Bowel Dysfunction (NBD), will be studied. NBD is characterised by defecation disorders including faecal incontinence and chronic constipation.
Half of the participants will be treated with TAI and Navina Smart, and the other half with SBC.
TAI is an established bowel management therapy to assist the evacuation of feces from the bowel via the anus in patients with bowel dysfunction. The Navina Smart system consists of a standard TAI system, but also has an Electronic Control Unit (ECU) which regulates different parameters during the irrigation procedure, and an Application (App) that can be downloaded to a smart phone or tablet. Data from the irrigation procedures will be transferred from the ECU to the App via Bluetooth and will be used in the study to allow both the participants and the study personnel to manage bowel function better.
The primary objective is to evaluate the efficacy (change from Day 0) of TAI with Navina Smart compared to SBC regarding faecal incontinence (measured by Wexner faecal incontinence score) and/or constipation (measured by Cleveland Clinic constipation score) after 8 weeks treatment.
Participants will be treated for 8 weeks, making 2 visits to the clinic (Day 0 and 8 weeks) and one telephone follow-up call at 4 weeks. In addition, at least 2 phone calls will be performed during the 3 first weeks to ensure that satisfactory bowel management has been established. During the study, study data will be collected, and the participant will be asked to fill out questionnaires about his/her bowel problems, bladder, and quality of life throughout the treatment.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1328
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion