Actively Recruiting
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Led by Wellspect HealthCare · Updated on 2024-07-11
92
Participants Needed
9
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent.
- Be male or female aged 18 years or above.
- Have a confirmed diagnosis of Multiple Sclerosis based on McDonald criteria.
- Experience bowel symptoms that started after MS diagnosis.
- Have a Wexner fecal incontinence score of 10 or higher and/or a Cleveland Clinic constipation score of 10 or higher at baseline.
- Have never used any transanal irrigation (TAI) system before.
- Be judged eligible for TAI treatment according to the study's treatment pathway.
- Be able to read, write, and understand study information.
You will not qualify if you...
- Have confirmed or suspected anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, or unspecified perianal conditions.
- Have untreated rectal impaction.
- Have other significant neurological diseases besides MS or minor functional neurological syndromes.
- Have used opioids within 24 hours before enrollment.
- Have had previous colorectal surgery, sphincter injury, perianal sepsis, or rectal prolapse.
- Have undergone endoscopic polypectomy within 4 weeks before enrollment.
- Be currently pregnant or breastfeeding.
- Have any neuromodulation affecting pelvic organ function.
- Have a symptomatic urinary tract infection at enrollment.
- Be currently treated with anticoagulants (except acetylsalicylic acid or clopidogrel).
- Be currently treated with long-term systemic steroids (except inhalation or topical treatments).
- Be currently treated with prokinetics.
- Be involved in the planning or conduct of this study.
- Have previously enrolled in this study.
- Be participating in another clinical study that may interfere with this one.
- Be expected to have severe non-compliance to the study protocol.
- Have any other condition judged by the investigator as inappropriate for follow-up or investigations.
- Be deemed unsuitable for enrollment according to the Declaration of Helsinki.
- Have agranulocytosis (only applicable in Switzerland).
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
Paris, France, 75020
Actively Recruiting
3
Azienda Ospedaliero-Universitaria of Ferrara
Ferrara, Cona, Italy, 44124
Actively Recruiting
4
AISM Liguria Rehabilitation Centre
Genoa, Liguria, Italy, 16149
Actively Recruiting
5
AOU Careggi
Florence, Tuscany, Italy, 510 34
Actively Recruiting
6
Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari
Bari, Italy, 70124
Actively Recruiting
7
La Fé University Hospital
Valencia, Spain, 46026
Actively Recruiting
8
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Withdrawn
9
University College London Hospital
London, United Kingdom
Actively Recruiting
Research Team
W
Wellspect HealthCare
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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