Comparing two bowel care methods for patients with Multiple Sclerosis

A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis

This study is testing if a new bowel care system works better than the usual methods for people with Multiple Sclerosis who have bowel problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wellspect HealthCare (industry)
• Locations: 9 sites (Aarhus and 8 other locations)
• Trial ID: NCT04707976 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Navina Smart transanal irrigation system compared to standard bowel care in patients with Multiple Sclerosis who experience neurogenic bowel dysfunction. It is a randomized, controlled, multicenter trial involving 92 subjects, each participating for 8 weeks with two scheduled site visits. The goal is to determine if the Navina Smart system provides superior bowel management outcomes. Participants will be assessed based on their bowel symptoms and quality of life improvements.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Multiple Sclerosis and neurogenic bowel dysfunction.

Not a fit: Patients with anal or colorectal stenosis, active inflammatory bowel disease, or other severe gastrointestinal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved bowel management and quality of life for patients with Multiple Sclerosis.

How similar studies have performed: Previous studies have shown promise in using transanal irrigation for bowel management, suggesting potential success for this approach.

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.

Where this trial is running

Aarhus and 8 other locations

• Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
• Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales — Paris, France (RECRUITING)
• Azienda Ospedaliero-Universitaria of Ferrara — Ferrara, Cona, Italy (RECRUITING)
• AISM Liguria Rehabilitation Centre — Genoa, Liguria, Italy (RECRUITING)
• AOU Careggi — Florence, Tuscany, Italy (RECRUITING)
• Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari — Bari, Italy (RECRUITING)
• La Fé University Hospital — Valencia, Spain (RECRUITING)
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland (WITHDRAWN)
• University College London Hospital — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Brigitte Schürch, Prof. — Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne
• Study coordinator: Wellspect HealthCare

Conditions: Neurogenic Bowel, Fecal Constipation, Fecal Incontinence, Multiple Sclerosis