Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Trial Parameters
Brief Summary
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.
Eligibility Criteria
Inclusion Criteria: For inclusion in the study, subjects must fulfil all of the following criteria: 1. Provision of informed consent. 2. Female or male aged 18 years or above. 3. Established diagnosis of MS according to McDonald criteria. 4. Patients with bowel symptoms post-dating and related to a diagnosis of MS. 5. Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline. 6. Only TAI treatment naïve patient (not having previously used any particular TAI system). 7. Judged eligible for TAI as per standardized treatment pathway. 8. Able to read, write and understand information given to them regarding the study. Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Any confirmed or suspected diagnosis of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic coli