Rectal Catheter Evaluation
Research type
Research Study
Full title
Evaluation of a new transanal irrigation catheter
IRAS ID
127696
Contact name
Maureen Coggrave
Contact email
Research summary
Trans-anal irrigation is a method of managing bowel dysfunction. Individuals with central neurological conditions such as spinal cord injury and multiple sclerosis, and individuals with functional bowel disorders may use this method of management.
Bowel dysfunction has a considerable impact on quality of life, causing faecal incontinence and difficulty with evacuation, it may effectively limit an individuals social integration and ability to work. Trans anal irrigation is a relatively recent introduction for adults, becoming available for prescription in 2006. It has been found to improve outcomes and quality of life in these individuals. Until recently there was only one irrigation system available but another system has now become available and several more are in development. We have been working with Welland/Clinimed advising on product development and the company now has two CE marked rectal catheters ready for patient evaluation, one disposable catheter with integral balloon, the other a fully biodegradable flushable non-balloon catheter. A small pilot study is proposed. Twenty participants will be invited to try 5 of each of the catheters with their usual irrigation system and provide feedback on their experience. If the outcomes of this study are satisfactory a further study of the catheters and a new irrigation system is planned.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0111
Date of REC Opinion
25 Jun 2013
REC opinion
Further Information Favourable Opinion