Trial of a transanal irrigation system in spinal cord injured patients
Research type
Research Study
Full title
An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients
IRAS ID
198946
Contact name
Anna-Karin Sundin
Contact email
Sponsor organisation
Wellspect HealthCare, part of DENTSPLY IH AB
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is an open, prospective, non-controlled, qualitative, multicenter post-marketing study of the Navina Smart system for transanal irrigation (TAI). Approximately 150 patients with neurogenic bowel dysfunction (NBD) arising from spinal cord injuries will be studied. NBD is characterised by defecation disorders including faecal incontinence and chronic constipation. The Navina Smart system consists of a standard TAI system that connects to an Electrical Control Unit (ECU) which regulates the pressure to the water container, the water volume and inflation and deflation of the balloon on the rectal catheter. The ECU also stores data on balloon size, water volume, flow rate and irrigation start and stop times. In this study, Navina Smart will be used in conjunction with an application, the App, to be used on smart phones or tablets. Data is transferred from the ECU to the App via Bluetooth to allow both users and healthcare professionals to manage bowel function better. The primary objective of the study is to evaluate the change in NBD score between baseline and 3 months. Patients will be treated for 12 months, making 3 visits to the site (0, 3 and 12 months) and with weekly telephone calls from the start of treatment until satisfactory bowel management has been established. At each visit, NBD scores, quality of life questionnaires and patient reported outcome questionnaires will be used to determine user satisfaction and acceptability of Navina Smart and its associated App.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0288
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion