A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
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.
⁃ For inclusion in the study, subjects must fulfil all of the following criteria:
• Provision of informed consent.
• Female or male aged 18 years or above.
• Established diagnosis of MS according to McDonald criteria.
• Patients with bowel symptoms post-dating and related to a diagnosis of MS.
• Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline.
• Only TAI treatment naïve patient (not having previously used any particular TAI system).
• Judged eligible for TAI as per standardized treatment pathway.
• Able to read, write and understand information given to them regarding the study.