Actively Recruiting
A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
Led by Wellspect HealthCare · Updated on 2024-07-11
92
Participants Needed
9
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of transanal irrigation (TAI) with the Navina Smart device compared to standard bowel care in people with Multiple Sclerosis who have neurogenic bowel dysfunction. This randomized, controlled, multicenter study aims to assess whether the Navina Smart system offers benefits over usual care in managing bowel symptoms related to MS. The study involves 92 participants and lasts 8 weeks per person with two scheduled visits to study sites. Participants will be assigned to either use the Navina Smart electronic device, which includes an app to assist with transanal irrigation, or to receive standard bowel care without irrigation. Standard care includes scheduled bowel management every other day using diet, fluids, abdominal massage, physical activity, and medications if needed. The treatment period for each participant is 8 weeks. During the study, participants will undergo assessments to measure changes in fecal incontinence and constipation scores at 8 weeks. Additional evaluations include bowel symptom severity, quality of life related to bowel and bladder function, adherence to treatment, and frequency of urinary tract infections. The Navina Smart app data will be analyzed for correlation with irrigation parameters. Participants will be closely monitored throughout the 8-week period to assess outcomes and safety.
CONDITIONS
Brief 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...
- Provision of informed consent
- Female or male aged 18 years or above
- Established diagnosis of Multiple Sclerosis according to McDonald criteria
- Bowel symptoms related to a diagnosis of Multiple Sclerosis
- Neurogenic Bowel Dysfunction symptoms with Wexner fecal incontinence score 10 and/or Cleveland Clinic constipation score 10 confirmed at baseline
- No prior use of any transanal irrigation system
- Eligible for transanal irrigation as per standardized treatment pathway
- Able to read, write, and understand study information
You will not qualify if you...
- Diagnosis or suspicion of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, life-threatening autonomic dysreflexia, bleeding disorders, or unspecified peri-anal conditions
- Untreated rectal impaction
- Other significant neurological diseases excluding minor functional neurological syndromes or non-MS complications
- Opioid use within 24 hours prior to enrollment
- Previous colorectal surgery including haemorrhoidectomy and fistulotomy, sphincter injury, perianal sepsis, rectal prolapse
- Endoscopic polypectomy within 4 weeks prior to enrollment
- Ongoing pregnancy or lactation
- Neuromodulation affecting pelvic organ function
- Symptomatic urinary tract infection at enrollment
- Current treatment with anticoagulants except acetylsalicylic acid or clopidogrel
- Current long-term systemic steroid medication except inhalation or local topical treatments
- Current prokinetic treatment
- Involvement in study planning or conduct
- Previous enrollment in this study
- Participation in another interfering clinical study
- Expected severe non-compliance with protocol
- Any condition making follow-up or investigations inappropriate
- Unsuitability for enrollment as per Declaration of Helsinki
- Agranulocytosis (only applicable for Switzerland)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants use either the Navina Smart device for transanal irrigation or receive standard bowel care to manage bowel symptoms related to Multiple Sclerosis.
Visits may occur according to treatment schedule; specific visit frequency is not defined
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
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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