Status:
RECRUITING
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Lead Sponsor:
Wellspect HealthCare
Conditions:
Neurogenic Bowel (Disorder)
Fecal Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
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 sufferi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any of the following is regarded as a criterion for exclusion from the study:
- 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.
- Untreated rectal impaction.
- Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
- Opioid consumption ≤24 hours prior enrolment.
- Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
- Performed endoscopic polypectomy within 4 weeks prior enrolment.
- Ongoing, confirmed pregnancy or lactation.
- Any neuromodulation that can affect the pelvic organ function.
- 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).\*
- Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
- Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
- Current treatment of prokinetics.
- Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.
- Expected severe non-compliance to protocol as judged by the investigator.
- Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
- Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04707976
Start Date
December 1 2020
End Date
February 1 2025
Last Update
July 11 2024
Active Locations (9)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
Paris, France, 75020
3
Azienda Ospedaliero-Universitaria of Ferrara
Ferrara, Cona, Italy, 44124
4
AISM Liguria Rehabilitation Centre
Genoa, Liguria, Italy, 16149