None listed
Conditions
Brief summary
The main objective of this study is to determine whether transanal irrigation is quicker than standard bowel care for adults who have a spinal cord disorder. Another important outcome is to see whether transanal irrigation can reduce the amount of bowel accidents and constipation that people with spinal cord disorder experience. Finally, the study wishes to know if people report an improvement in their quality of life if they use transanal irrigation.
Interventions
The participant will use transanal irrigation daily or second daily (depending upon his/her current bowel routine) for a period of 6 weeks. Bowel care will occur at the usual time that the participant normally attends to his/her toileting. The irrigation system includes a reservoir for water, tubing, a rectal catheter and operating controls that inflate/ deflate the rectal catheter balloon and start/stop the flow of water. The process includes filling the water reservoir with lukewarm/tepid wat
The participant will use transanal irrigation daily or second daily (depending upon his/her current bowel routine) for a period of 6 weeks. Bowel care will occur at the usual time that the participant normally attends to his/her toileting. The irrigation system includes a reservoir for water, tubing, a rectal catheter and operating controls that inflate/ deflate the rectal catheter balloon and start/stop the flow of water. The process includes filling the water reservoir with lukewarm/tepid water, sitting the participant on a commode chair over the toilet, inserting the rectal catheter into the anus, inflating the balloon, and using a switch to start the flow of water and using the hand pump periodically to instill approx 400mL into the colon before deflating the balloon and waiting for bowel result. It is anticipated that this process will not take any longer than 30 minutes. Partipants will record bowel care interventions on a bowel chart which will be checked by a study nurse via weekly phone follow up.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People will be eligible for inclusion if they: * sustained a spinal cord injury more than 6 months prior or have Spina Bifida * have a Neurogenic Bowel Dysfunction Score greater than or equal to 3 * are aged 18 years or over at the time of consent * are willing to participate in the trial * have been recommended to trial transanal irrigation by a clinician because they spend more than 30 mins on toileting AND ANY OF THE FOLLOWING: had more than 1 episode of faecal incontinence per month had a Bristol stool chart result of less than 3 or greater than 6 for more than 3 cycles of bowel care experienced abdominal symptoms such as bloating/cramping experienced inconsistency with defaecation experienced rectal symptoms (bleeding haemorrhoids, rectal prolapse, fissures etc) experienced autonomic dysreflexia in response to bowel care
Exclusion criteria
People will be excluded if: * they are unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, and behavioural problem) * they are unable to speak sufficient English to provide informed consent * they are currently using bisacodyl suppositories or enemas as the primary method for managing bowel care routine. * transanal irrigation is contraindicated for use for any of the following reasons: anal / rectal stenosis active inflammatory bowel disease acute diverticulitis colorectal cancer within 3 months of rectal surgery within 4 weeks of endoscopic polypectomy ischaemic colitis * current or planned pregnancy * long term steroid therapy * radiotherapy to the pelvis * dense sigmoid disease * on anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran)
Outcome results
None listed