Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
NCT ID: NCT04707976
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2020-12-01
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Navina Smart
An electronic medical device to perform transanal irrigation. Treatment period 8 weeks.
Navina Smart
CE-marked NavinaTM Smart including Navina Smart App.
Standard Bowel Care
Supportive bowel care without using irrigation.
Standard Bowel Care
Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.
Interventions
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Navina Smart
CE-marked NavinaTM Smart including Navina Smart App.
Standard Bowel Care
Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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Wellspect HealthCare
INDUSTRY
Responsible Party
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Principal Investigators
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Brigitte Schürch, Prof.
Role: PRINCIPAL_INVESTIGATOR
Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne
Bonaventura Casanova, Dr.
Role: PRINCIPAL_INVESTIGATOR
Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
Paris, , France
Azienda Ospedaliero-Universitaria of Ferrara
Ferrara, Cona, Italy
AISM Liguria Rehabilitation Centre
Genoa, Liguria, Italy
AOU Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari
Bari, , Italy
La Fé University Hospital
Valencia, , Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
University College London Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Peter Christensen, Professor
Role: primary
Gérard Amarenco, Professor
Role: primary
Simona Ascanelli, Dr
Role: primary
Dr Giampaolo Brichetto, Dr
Role: primary
Giulio Del Popolo, Dr
Role: primary
Giuseppina Dr Frasca, Dr
Role: primary
Casanova Bonaventura
Role: primary
Anton Emmanuel, Professor
Role: primary
Other Identifiers
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NAV-0006
Identifier Type: -
Identifier Source: org_study_id
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