BridgeMD
Compares treatment options for Neurogenic Bowel (Disorder)
Official title Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
ClinicalTrials.gov ID: NCT04707976
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For inclusion in the study, people 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.
You likely can't join if
- 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...
- Untreated rectal impaction.
- Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related...
- Opioid consumption ≤24 hours prior enrolment.
- Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
See the full eligibility criteria
- For inclusion in the study, people 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Paris, France
- Ferrara, Cona, Italy
- Genoa, Liguria, Italy
- Florence, Tuscany, Italy
- Bari, Italy
- Valencia, Spain
- Lausanne, Switzerland
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Paris, France; Ferrara, Cona, Italy; Genoa, Liguria, Italy; Florence, Tuscany, Italy; Bari, Italy and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.