Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis

Launched by WELLSPECT HEALTHCARE · Jan 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to manage bowel symptoms in people with Multiple Sclerosis (MS) who also have a condition called Neurogenic Bowel Dysfunction. Researchers want to compare a new device called Navina Smart, which helps with bowel irrigation, to standard bowel care methods. The trial will involve 92 participants who will be monitored for about 8 weeks with two visits to the research site.

To join the study, participants must be at least 18 years old, have a confirmed diagnosis of MS, and experience bowel issues related to their condition. They should not have used bowel irrigation devices before. The study is currently recruiting people of all genders. Participants will need to provide consent and be able to understand the study information. It's important to note that some individuals, such as those with certain bowel diseases or ongoing infections, will not be eligible for the study. If you qualify, you'll receive guidance and support throughout the trial, helping to determine if the new device is more effective than traditional methods.

Gender

ALL

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 colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
• • 2. Untreated rectal impaction.
• • 3. Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
• • 4. Opioid consumption ≤24 hours prior enrolment.
• • 5. Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
• • 6. Performed endoscopic polypectomy within 4 weeks prior enrolment.
• • 7. Ongoing, confirmed pregnancy or lactation.
• • 8. Any neuromodulation that can affect the pelvic organ function.
• • 9. Ongoing, symptomatic Urinary Tract Infection (UTI) at enrolment (defined as a positive urine culture of ≥10\^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection).\*
• • 10. Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
• • 11. Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
• • 12. Current treatment of prokinetics.
• • 13. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
• • 14. Previous enrolment in the present study.
• • 15. Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.
• • 16. Expected severe non-compliance to protocol as judged by the investigator.
• • 17. Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
• • 18. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
• • 19. Agranulocytosis (\<0.5 10\^9 / L) \[Only applicable for Switzerland\].
• • If symptoms and signs compatible with UTI is present but no urine culture test has been performed yet, a test should be performed, and the result received prior evaluating if the subject is eligible for study participation. After successful and completed treatment of a UTI, the subject may be rescheduled for Visit 1 in order to re-evaluate study participation.