Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Inclusion criteria

• Provision of informed consent
• Males and females, aged 18 years and over
• Practice TAI since at least 2 months and at least two times per week
• Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator

Exclusion criteria

• Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions
• Untreated rectal impaction
• Any radiotherapy to the pelvis
• Any current treatment with anticoagulants (not including aspirin or clopidogrel)
• Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
• Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
• Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
• Overt or planned pregnancy
• Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
• Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
• Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
• Previous enrolment in the present study
• Participation in another clinical study within the last 30 days that may interfere with the present study